March 2022 Print issue by McMahon Group

CONVENTION ISSUE

The Society of American Gastrointestinal and Endoscopic Surgeons

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

March 2022 • Volume 49 • Number 3

MONEY MATTERS

Surgical Innovation: Taking an Idea All the Way

Residents On Par With Attendings in ‘Appropriately Selected’ Cases Investigators Say More Should Be Done To Promote Resident Autonomy

By MONICA J. SMITH

urgeons are natural inventors, coming up with new ideas on a neardaily basis to help them perform better, more safely and more efficiently based on their patients’ unique characteristics and needs. But what does it take to move an idea from concept to bedside? At a session on innovation in surgery at the 2021 virtual American College of Surgeons Clinical Congress, experts discussed how to generate ideas, protect them and ultimately attract industry interest.

By CHRISTINA FRANGOU

perations performed by surgical residents alone do not result in more deaths or complications compared with procedures performed by attending surgeons or performed jointly by attending surgeons and residents, according to a large study of surgical procedures performed in Veterans Affairs facilities over a 15-year period. Investigators say the study, which was published in JAMA Surgery, shows that operations performed by residents, when appropriately selected, do not result in poorer patient outcomes (2021 Dec 22. doi:10.1001/jamasurg.2021.6444). They argue the findings justify greater efforts to reverse an ongoing trend of decreased resident autonomy in the United States.

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MONEY MATTERS

Getting to the Source of Chronic Groin Pain

‘Auf Hinweis’? Translating the Operative Note By LUCIAN NEWMAN III, MD

ver the recorded history of sururgery, the operative note’s funcnction has changed from a narrative tive description, which persists today, to a document that includes additional information that affects billing and coding, and carries medicolegal importance as well. The words surgeons use to describe what we do must be translated into a recognized service or CPT code otherwise known as the “op note.” In fact, when doing research for this article, “Auf Henweis” came up when searching the term “op note” in an online translator. After checking with other German-speaking

What to Do When Pain Persists Even After Mesh Has Been Removed

Continued on page 34

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Managing Surgical Smoke Risk While Improving Visualization and Minimizing Patient CO2 Exposure Using the Ultravision™ System During Laparoscopy PAGE 10

facebook.com/generalsurgerynews

By IOANA BAIU, MD, MPH

t the 2021 annual meeting of the American Hernia Society, Brian P. Jacob, MD, FACS, an associate professor of surgery at Mount Sinai Icahn School of Medicine and a partner at the Laparoscopic Surgical Center of New York, both in New York City, gave a presentation on chronic groin pain, titled “What Did I Miss and What Can I Do Now.” To find out more about the presentation and

Human Xtensions

PAGE 38

The Downsides of a Consumer-Based Approach to Medicine

n a system of limited resources, fullllbody screening MRIs may seem preposterous. However, in the unique microcosm of Silicon Valley, where money is abundant and technology is omnipresent, it has become almost fashionable to have a headto-toe radiological examination. Whether the goal is to tame anxiety or prove that the history and physical are old-fashioned and inadequate, the result is often the opposite—increased anxiety followed by a calm reassurance in light of a negative H&P. Empowering patients with access to information has unveiled a restless dichotomy of knowledge without understanding,

Continued on page 28

Activ Surgical’s Imaging Module, ActivSight™

Text Without Context

By KATE O’ROURKE

PRODUCT ANNOUNCEMENTS

PAGE 35

OPINION

@gensurgnews

ENTER A NEW WORLD OF POSTOPERATIVE PAIN MANAGEMENT With the First and Only Extended-Release Dual-Acting Local Anesthetic (DALA)1-4 ZYNRELEF redeﬁnes postoperative pain management by providing superior pain relief for up to 72 hours, with fewer patients experiencing severe pain, and reducing or eliminating the need for opioids in many patients following surgery versus standard-of-care bupivacaine HCl solution.1-4

SYNERGISTIC MECHANISM OF ACTION1,5,a

SUPERIOR 72-HOUR PAIN RELIEF1-3,b

OPIOID REDUCTION & ELIMINATION1-3,b

NEEDLE-FREE APPLICATION1

BROAD ACCESS PRICING & FAVORABLE REIMBURSEMENT

Synergistic increases in analgesia compared with meloxicam or bupivacaine alone shown in preclinical and Phase 2 studies.1,5 b Clinical ﬁndings were demonstrated in Phase 3 trials for bunionectomy with osteotomy and open inguinal herniorrhaphy comparing ZYNRELEF to both placebo and bupivacaine HCl solution.1-3

DISCOVER MORE AT ZYNRELEF.COM

Indication

Contraindications

ZYNRELEF is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.

ZYNRELEF is contraindicated in patients with a known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to any amide local anesthetic, NSAIDs, or other components of ZYNRELEF; with history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (severe, sometimes fatal, anaphylactic reactions to NSAIDS have been reported in such patients); undergoing obstetrical paracervical block anesthesia; or undergoing CABG.

Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS • Nonsteroidal anti-inﬂammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. • ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Warnings and Precautions Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after application of ZYNRELEF. When using ZYNRELEF with other local anesthetics, overall local anesthetic exposure must be considered through 72 hours. Hepatotoxicity: If abnormal liver tests persist or worsen, perform a clinical evaluation of the patient. Hypertension: Patients taking some antihypertensive medication may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. Heart Failure and Edema: Avoid use of ZYNRELEF in patients with severe heart failure unless beneﬁts are expected to outweigh risk of worsening heart failure. Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ZYNRELEF in patients with advanced renal disease unless beneﬁts are expected to outweigh risk of worsening renal failure. Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.

PP-HTX011-0557 | 01/22

Chondrolysis: Limit exposure to articular cartilage due to the potential risk of chondrolysis. Methemoglobinemia: Cases have been reported with local anesthetic use. Serious Skin Reactions: NSAIDs, including meloxicam, can cause serious skin adverse reactions. If symptoms present, evaluate clinically. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): If symptoms are present, evaluate clinically. Fetal Toxicity: Due to the risk of oligohydramnios/fetal renal dysfunction and premature closure of the ductus arteriosus with NSAIDS, limit use of ZYNRELEF between about 20 to 30 weeks gestation, and avoid use after about 30 weeks.

Use in Speciﬁc Populations Infertility: NSAIDs are associated with reversible infertility. Consider avoidance of ZYNRELEF in women who have difficulties conceiving. Severe Hepatic Impairment: Only use if beneﬁts are expected to outweigh risks; monitor for signs of worsening liver function. Severe Renal Impairment: Not recommended. Adverse Reactions Most common adverse reactions (incidence *10%) in controlled clinical trials with ZYNRELEF are constipation, vomiting, and headache. Report side effects to Heron at 1-844-437-6611 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Hematologic Toxicity: Monitor hemoglobin and hematocrit in patients with any signs or symptoms of anemia.

For additional information about ZYNRELEF, please refer to the Brief Summary of Prescribing Information on adjacent page.

Drug Interactions

References: 1. ZYNRELEF [package insert]. San Diego, CA: Heron Therapeutics Inc; 2021. 2. Viscusi E, Gimbel JS, Pollack RA, Hu J, Lee G-C. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: Phase III results from the randomized EPOCH 1 study. Reg Anesth Pain Med. 2019;44(7):700-706. doi:10.1136/rapm-2019-100531. 3. Viscusi E, Minkowitz H, Winkle P, Ramamoorthy S, Hu J, Singla N. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the Phase 3 EPOCH 2 study. Hernia. 2019;23(6):1071-1080. doi:10.1007/s10029-019-02023-6. 4. Lachiewicz PF, Lee G-C, Pollak R, Leiman D, Hu J, Sah A. HTX-011 reduced pain and opioid use after primary total knee arthroplasty: results of a randomized Phase 2b trial. J Arthroplasty. 2020;35(10):2843-2851. doi:10.1016/j.arth.2020.05.044. 5. Ottoboni T, Quart B, Pawasauskas J, Dasta JF, Pollak RA, Viscusi ER. Mechanism of action of HTX-011: a novel, extended-release, dual-acting local anesthetic formulation for postoperative pain. Reg Anesth Pain Med. 2020;45(2):117-123. doi:10.1136/rapm-2019-100714.

Drugs That Interfere with Hemostasis: Monitor patients for bleeding who are using ZYNRELEF with drugs that interfere with hemostasis (eg, warfarin, aspirin, SSRIs/SNRIs). ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), or Beta-Blockers: Use with ZYNRELEF may diminish the antihypertensive effect of these drugs. Monitor blood pressure. ACE Inhibitors and ARBs: Use with ZYNRELEF in elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function. Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.

REDEFINE POSTOPERATIVE PAIN MANAGEMENT

ZYNRELEF® (bupivacaine and meloxicam) extended-release solution, for soft tissue or periarticular instillation use

Dose-Related Toxicity: The toxic effects of local anesthetics are additive. When using with other local anesthetics, overall local anesthetic exposure must be considered through 72 hours. Monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION

Risk of Use in Patients with Impaired Cardiovascular Function: Patients with impaired cardiovascular function may be less able to compensate for the prolongation of AV conduction. Monitor patients closely for blood pressure, heart rate, and ECG changes.

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS • Nonsteroidal anti-inﬂammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use • ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events

INDICATIONS AND USAGE ZYNRELEF is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

DOSAGE AND ADMINISTRATION Important Dosage and Administration Information: ZYNRELEF is intended for single-dose administration only. Avoid intravascular administration of ZYNRELEF. ZYNRELEF should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurologic or cardiac toxicity. Avoid additional use of local anesthetics within 96 hours following administration of ZYNRELEF. The safety of concomitant administration of ZYNRELEF and other NSAID medications has not been evaluated. If additional NSAID medication is indicated in the post-operative period, monitor patients for signs and symptoms of NSAID toxicity. ZYNRELEF should only be prepared and administered with the components provided in the ZYNRELEF kit. See ZYNRELEF Instructions for Use included in the kit for complete administration instructions. ZYNRELEF should not be administered via the following routes: epidural, intrathecal, intravascular or intra-articular, regional nerve blocks, and pre-incisional or pre-procedural locoregional anesthetic techniques. Administration Instructions: ZYNRELEF is applied without a needle into the surgical site using a Luer lock cone-shaped applicator attached to the syringe following ﬁnal irrigation and suction of each layer and prior to suturing. Only apply ZYNRELEF to the tissue layers below the skin incision and not directly onto the subdermal layer or skin. Use only the amount necessary to coat the tissues, such that ZYNRELEF does not leak from the surgical wound after closure. Dosing Instructions: As a general guidance in selecting the proper dosing of ZYNRELEF, the following examples of dosing are provided: − Foot and ankle surgical procedures, such as bunionectomy: up to 2.3 mL to deliver 60 mg/1.8 mg. − Small-to-medium open abdominal surgical procedures, such as open inguinal herniorrhaphy: up to 10.5 mL to deliver 300 mg/9 mg. − Lower extremity total joint arthroplasty surgical procedures, such as total knee arthroplasty: up to 14 mL to deliver 400 mg/12 mg.

Hepatotoxicity: Bupivacaine should be used cautiously in patients with hepatic disease because of their inability to metabolize local anesthetics normally. NSAIDs are associated with elevations of ALT or AST and rare, sometimes fatal cases of severe hepatic injury. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur, perform a clinical evaluation of the patient. The risk of these events following single-dose local application of ZYNRELEF is uncertain. Hypertension: NSAID use in patients taking ACE inhibitors, thiazide, or loop diuretics may result in impaired blood pressure control. Monitor blood pressure. Heart Failure and Edema: NSAID use in patients with heart failure may increase the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retention and edema have been observed with NSAIDs. Avoid use in patients with severe heart failure unless the benefits outweighs the risk of worsening heart failure; if used, monitor for signs of worsening heart failure. The risk of these events following single-dose local application of ZYNRELEF is uncertain. Renal Toxicity: NSAIDs may cause a dose-dependent reduction in renal blood flow and overt renal decompensation. Additionally, the metabolites of meloxicam are excreted by the kidney which may hasten the progression of renal dysfunction in those with renal disease. Correct dehydration and hypovolemia prior to initiating ZYNRELEF. Avoid use in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Anaphylactic Reactions: Meloxicam has been associated with anaphylactic reactions in patients with and without known hypersensitivity to meloxicam and in patients with aspirin-sensitive asthma. Seek emergency help if an anaphylactic reaction occurs. Chondrolysis: Limit exposure to articular cartilage due to the potential risk of chondrolysis. Intra-articular infusions of local anesthetics have been associated with chondrolysis. Methemoglobinemia: Local anesthetics have been associated with methemoglobinemia. Treat with supportive care, and, if necessary, methylene blue, exchange transfusion, or hyperbaric oxygen. Exacerbation of Asthma Related to Aspirin Sensitivity: NSAIDs are contraindicated in patients with aspirin-sensitive asthma. When ZYNRELEF is used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for exacerbation of asthma symptoms. Serious Skin Reactions: NSAIDs can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, which can be fatal. If symptoms present, evaluate clinically. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): NSAIDs may cause DRESS. If signs or symptoms are present, evaluate the patient immediately and treat as clinically indicated. Fetal Toxicity: NSAIDs may cause fetal renal dysfunction leading to oligohydramnios at about 20 weeks gestation and premature closure of the fetal ductus arteriosus at about 30 weeks gestation or later. Limit use between about 20 to 30 weeks gestation, and avoid use after about 30 weeks. Hematologic Toxicity: NSAIDs may cause anemia due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet agents (eg, aspirin), SSRIs and SNRIs may increase this risk. Monitor these patients’ hemoglobin and hematocrit and for signs or symtoms of anemia.

See full Prescribing Information for all important dosage and administration information, preparation instructions and compatibility considerations.

Masking of Inﬂammation and Fever: NSAIDs reduce inﬂammation, and possibly fever, which may diminish detection of infections.

CONTRAINDICATIONS

The safety of ZYNRELEF has been evaluated in a total of 1067 patients undergoing various surgical procedures across 7 randomized, double-blind, bupivacaine- and placebo-controlled studies designed to investigate ZYNRELEF to reduce postoperative pain for 72 hours and the need for opioid analgesics. Among 504 patients who received ZYNRELEF in single doses of 60 mg/1.8 mg to 400 mg/12 mg via instillation into the surgical site, the most common adverse reactions (incidence greater than or equal to 10%) following ZYNRELEF administration were constipation, vomiting, and headache. The most common adverse reactions (* 5% and higher than placebo) in the following 3 studies were:

ZYNRELEF is contraindicated in patients with known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to any amide local anesthetic, NSAIDs, or other components of ZYNRELEF; with history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients); undergoing obstetrical paracervical block anesthesia; or undergoing coronary artery bypass graft (CABG) surgery.

WARNINGS AND PRECAUTIONS Cardiovascular (CV) Thrombotic Events with NSAID Use: To minimize the potential risk of CV thrombotic events, do not exceed the recommended dose. Monitor for serious CV events. Aspirin does not mitigate the risk of these thrombotic events. In patients with a recent MI, avoid the use of ZYNRELEF unless the beneﬁts are expected to outweigh the risk, and if used, monitor patients for signs of cardiac ischemia. The risk of these events following single-dose local application of ZYNRELEF is uncertain. Gastrointestinal Bleeding, Ulceration, and Perforation with NSAID Use: To minimize the risk of GI bleeding, do not exceed the recommended dose and avoid using more than one NSAID at a time. If additional NSAID medication is indicated in the post-operative period, monitor patients for signs and symptoms of NSAID-related GI adverse reactions. In high-risk patients, evaluate if the beneﬁts outweighs the risk of bleeding, remain alert for GI ulcerations and bleeding, and promptly evaluate and treat suspected serious GI adverse events. In patients using concomitant low-dose aspirin, monitor for GI bleeding.

ADVERSE REACTIONS

• Bunionectomy: 157 patients received ZYNRELEF 60 mg/1.8 mg and the most common adverse reactions were dizziness, incision site edema, headache, incision site erythema, bradycardia, impaired healing, and muscle twitching. With the exception of muscle twitching, these events were also higher for bupivacaine HCl compared to placebo. A total of four subjects had delayed bone healing (assessed by X-ray on Days 28 and 42), with no clinically meaningful difference between treatment groups. Additional local inﬂammatory adverse events observed at a higher incidence for ZYNRELEF compared to placebo or bupivacaine HCl included incision site cellulitis, wound dehiscence, and incision site infection. • Herniorrhaphy: 163 patients received ZYNRELEF 300 mg/9 mg and the most common adverse reactions were headache, bradycardia, dysgeusia, and skin odor abnormal. With the exception of skin odor abnormal, these events were also higher for bupivacaine HCl compared to placebo. • Total knee arthroplasty: 58 patients received ZYNRELEF 400 mg/ 12 mg and the most common reactions were nausea, constipation,

vomiting, hypertension, pyrexia, leukocytosis, and pruritus. With the exception of hypertension, these events were also higher for bupivacaine HCl compared to placebo.

DRUG INTERACTIONS Bupivacaine Drug Interactions: Local anesthetics: In clinical studies, other local anesthetics (including ropivacaine and lidocaine) have been administered before, during, or after application of ZYNRELEF without evidence of local anesthetic systemic toxicity. Administration of ZYNRELEF with other formulations of local anesthetics (ie, bupivacaine liposome injectable suspension) has not been studied. Drugs associated with methemoglobinemia: Bupivicane may increase risk of methemoglobinemia when concurrently used with nitrates, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, and other methemoglobinemia-associated drugs. Meloxicam Drug Interactions: Drugs That Interfere with Hemostasis: Meloxicam use with anticoagulants has an increased risk of serious bleeding compared to the use of either drug alone. Monitor patients with concomitant use of ZYNRELEF with anticoagulants, antiplatelet agents, SSRIs, and SNRIs for signs of bleeding. ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), or Beta-Blockers: Meloxicam may diminish the antihypertensive effect of these drugs. Monitor blood pressure. ACE Inhibitors and ARBs: Meloxicam use with ACE inhibitors and ARBs in elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, adequately hydrate and monitor for signs of worsening renal function. Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy, including antihypertensive effects. Digoxin: NSAIDs increase the serum concentration and prolong the half-life of digoxin. Monitor serum digoxin levels. Lithium: NSAIDs elevate plasma lithium levels and reductions in renal lithium clearance. Monitor for signs of lithium toxicity. Methotrexate: NSAIDs use with methotrexate may increase risk for neutropenia, thrombocytopenia, and other methotrexateassociated toxicities. Monitor for signs of methotrexate toxicity Cyclosporine: NSAIDs use with cyclosporine may increase nephrotoxicity. Monitor for signs of worsening renal function. Pemetrexed: Meloxicam used with pemetrexed may increase myelosuppression, renal, and GI toxicities. In patients with creatinine clearance 45 to 79 mL/min, monitor for pemetrexedassociated toxicities.

OVERDOSE No data are available with regard to overdose of ZYNRELEF. Management of Local Anesthetic Overdose: At the first sign of change, oxygen should be administered. The first step for convulsions, underventilation, or apnea is immediate maintenance of a patent airway and assisted or controlled ventilation capable of immediate positive airway pressure. After assuring airway and ventilation, evaluate and establish adequate circulation as indicated. Drugs that treat convulsions may depress the circulation. If convulsions persist despite adequate respiration, and if the circulation permits, small increments of an ultra-short acting barbiturate or a benzodiazepine may be administered intravenously. Supportive treatment of circulatory depression may require intravenous fluids and, when appropriate, a vasopressor. If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias, and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. Endotracheal intubation, employing drugs, and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask if maintenance of a patent airway is inadequate or if prolonged ventilatory support is indicated.

CLINICAL PHARMACOLOGY ZYNRELEF contains bupivacaine, an amide local anesthetic, and meloxicam, an NSAID. The contribution of each active ingredient in ZYNRELEF has been studied in clinical studies in herniorrhaphy or bunionectomy, utilizing ZYNRELEF and formulations of meloxicam alone or bupivacaine alone in the ZYNRELEF vehicle. Meloxicam alone provided negligible local analgesia and bupivacaine alone provided greater analgesia compared with placebo through 24 hours post surgery, despite exposure to bupivacaine for approximately 72 hours. Compared with bupivacaine alone in both studies, ZYNRELEF demonstrated greater and longer analgesia through 24, 48, and 72 hours. The instillation of ZYNRELEF into the surgical site results in signiﬁcant systemic plasma levels of bupivacaine and meloxicam through 96 hours. Systemic plasma levels of bupivacaine or meloxicam following application of ZYNRELEF do not correlate with local efficacy.

PATIENT COUNSELING Inform patients of the risks and mitigations for: CV thrombotic events; GI bleeding, ulceration, and perforation, including the increased risk of GI toxicity with use of NSAIDs in the postoperative period; anaphylactic reactions; serious skin reactions, including DRESS; methemoglobinemia; fetal toxicity; and temporary loss of sensation near the surgical site. This information is not comprehensive. Visit www.zynrelef.com to obtain the full Prescribing Information, including Boxed Warning.

Manufactured and marketed by: Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA, 92121, USA. Copyright© 2021 Heron Therapeutics, Inc. All rights reserved. ZYNRELEF® is a registered trademark of Heron Therapeutics, Inc. PP-HTX011-0102 12/21

OPINION

MARCH 2022 / GENERAL SURGERY NEWS

Automation Dependence By FREDERICK L. GREENE, MD, FACS

n the early morning hours of Dec. 20, 2021, Emirates flight 231, using one of the newest Boeing 777 aircraft, taxied onto the active runway in Dubai to commence a 14-hour nonstop flight to Dulles Airport, in Washington, D.C. Four experienced pilots were in the cockpit, allowing two to initiate the flight and the other two to take over mid-flight because of the trip’s duration. The crew that operated the previous flight with the aircraft had set the altitude to zero in the flight director system (which controls the autopilot); the crew on this flight was supposed to—but did not—set the altitude to 4,000 feet, which is a standard altitude to first climb to after liftoff. During the departure, the pilot flying the aircraft decided to “follow” what the flight director was showing, which was an altitude of zero feet. While the plane typically would lift off at a much lower speed, the plane was still on the ground at 216 knots, and overran the standard runway area, taking off in the runway safety area. The plane was already flying over houses at an altitude of 75 feet, going a minimum of 234 knots. The plane barely gained altitude, and was 175 feet in the air when it was flying at a speed of 262 knots. As a point of comparison, ordinarily the plane would be well under 200 knots at that altitude, and would be climbing much faster. While it would be standard procedure to return to the airport to assess damage when something like this happens (given the potential for overspeed with the flaps,

Senior Medical Adviser Frederick L. Greene, MD Charlotte, NC

Editorial Advisory Board Gina Adrales, MD, MPH Baltimore, MD Maurice Arregui, MD Indianapolis, IN Philip S. Barie, MD, MBA New York, NY L.D. Britt, MD, MPH Norfolk, VA James Forrest Calland, MD Charlottesville, VA David Earle, MD Lowell, MA Sharmila Dissanaike, MD Lubbock, TX Edward Felix, MD Pismo Beach, CA Robert J. Fitzgibbons Jr., MD Omaha, NE Michael Goldfarb, MD Long Branch, NJ Leo A. Gordon, MD Los Angeles, CA

plus the potential damage if the aircraft did unknowingly hit something), the pilots made the decision to continue to Washington and eventually landed safely. In analyzing this scenario, airline experts have been critical of the complete lack of conThe technical advances in robots, virtual reality, artificial intelligence trol that the crew had exercised during take- and more may create situations in which surgeons may depend too off. The crew was manmuch on their tools and not enough on their logic and common sense. aging the computers instead of flying the aircraft. What would possess a crew to overrun the stan- may create situations in which surgeons may depend dard portion of a runway while going over 200 knots, too much on their tools and not enough on their logic when there was nothing wrong with the plane? Further- and common sense. Similar to the Emirates crew, are more, there were four pilots in the cockpit who contin- we doomed to suffer from “automation dependence”? As I began preparing this editorial, an article appeared ued to rely on the plane’s automatic technology despite (Sci Robot 2022;7[62]. doi:10.1126/scirobotics.abj2908), the real likelihood of impending disaster. In discussing this recent aviation event with a good touting a platform developed by a leading academic surfriend who is a veteran trans-continental commercial gical research group that would allow a robot to perform pilot and flight instructor, he alerted me to the term complex surgical maneuvers on a pig without human “automation dependence,” which, to the aeronautical interference! While this is indeed exciting technology, neophyte, equates to dependence on a plane’s automat- we need to continue to learn from other disciplines that ic pilot system associated with a lack of confidence or have created “autonomous” systems that further disenexperience in taking over manual controls even when gage the human element from critical tasks. I certainly facing impending disaster. This discussion created an am in favor of modern technology to improve surgical immediate “aha moment” for me as I realized that every outcomes, but we must resist, at all costs, tumbling into day surgeons are depending to a greater degree on tech- the trap of “automation dependence”! ■ nology that establishes a vaster interface between the operative team and the patient. The technical advances —Dr. Greene is the senior medical adviser for in robots, virtual reality, artificial intelligence and more General Surgery News

Jarrod Kaufman, MD Brick, NJ

MISSION STATEMENT OF GSN It is the mission of General Surgery News to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for discussion and opinions, from all viewpoints, on the issues most important to surgeons. DISCLAIMER Opinions and statements published in General Surgery

Peter K. Kim, MD Bronx, NY

News are of the individual author or speaker and do not represent the views of the editorial advisory board, editorial staff or reporters.

Lauren A. Kosinski, MD Chestertown, MD

DISCLOSURE POLICY We endeavor to obtain relevant financial

Marina Kurian, MD New York, NY

disclosures from all interviewees and rely on our sources to accurately provide this information, which we believe can be important in evaluating the research discussed in this publication.

Raymond J. Lanzafame, MD, MBA Rochester, NY

CONTACT THE EDITOR

Timothy Lepore, MD Nantucket, MA

Editorial Staff

Robert Lim, MD Tulsa, OK

Kevin Horty Group Publication Editor khorty@mcmahonmed.com

John Maa, MD San Francisco, CA Gerald Marks, MD Wynnewood, PA Yosef Nasseri, MD Los Angeles, CA Eric Pauli, MD Hershey, PA Richard Peterson, MD San Antonio, TX Ajita Prabhu, MD Cleveland, OH Bruce Ramshaw, MD Knoxville, TN

Send letters, article ideas or queries to khorty@mcmahonmed.com.

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IN THE NEWS

GENERAL SURGERY NEWS / MARCH 2022

FIRST LOOK All Articles by ETHAN COVEY

COVID-19 Increases Mortality, Complications for Emergency General Surgery Patients Patients with COVID-19 who undergo emergency general surgery (EGS) have significantly elevated rates of mortality and pulmonary complications, according to a study conducted by the COVIDSurg Collaborative. “The COVID-19 pandemic continues to cause major disruption to the delivery of surgical services globally,” said Anthony Gebran, MD, the lead author and a postdoctoral research fellow at Massachusetts General Hospital, in Boston. “However, the majority of EGS procedures cannot be postponed or canceled, especially when nonoperative alternatives are deemed unacceptable in efficacy or safety.” Yet, data remain scarce regarding the postoperative outcomes of EGS patients with preoperative COVID-19. In addition, it is unclear whether the presence, or absence, of COVID-19 symptoms affects the outcomes of EGS patients (paper 19). In an effort to research these issues, the study authors sought to determine 30-day mortality and pulmonary complications (acute respiratory distress syndrome, unexplained postoperative mechanical ventilation or pneumonia) among EGS patients, and compare clinical outcomes of patients with and without preoperative respiratory signs or symptoms of COVID-19 infection. The study included 1,045 patients at least 17 years of age who were diagnosed with COVID-19 at least seven days before surgery, which was defined as urgent/emergent performance of appendectomy, cholecystectomy or laparotomy. Of the patients. 61.9% had preoperative symptoms of COVID-19. Overall rates of 30-day mortality were 15%, and 30-day pulmonary complications were 32.9%. They found that patients with COVID-19 who underwent EGS had significantly higher rates of both mortality and pulmonary complications, compared with pre-pandemic baseline levels. Among patients who underwent laparotomy, mortality was 33% among those with COVID-19 versus 14.3% without COVID-19. Cholecystectomy patients with COVID-19 had mortality rates of 19.2%, and pulmonary complication rates of 41%, compared with 0% and

The Eastern Association for the Surgery Of Trauma

4.5%, respectively. Among appendectomy patients, rates were 2.7% versus 1.5% for mortality, and 21.5% versus 3.3% for pulmonary complications among those with and without COVID-19. Dr. Gebran, who is a member of the collaborative, noted that the research had limitations, including not being able to confirm whether mortality and pulmonary complications were due to the surgery itself, not evaluating whether the indication for EGS was related to COVID19, and that none of the patients included in the study had been vaccinated against COVID-19 or infected with the delta or omicron variant. He also cautioned that the findings incorrectly affect practice behaviors. “The results should not be interpreted as a recommendation against an operation in emergency surgery patients,” he said. Disclosure: The COVIDSurg Collaborative has received funding from the Association of Coloproctology of Great Britain and Ireland, Association of Upper Gastrointestinal Surgeons, Bowel and Cancer Research, Bowel Disease Research Foundation, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, National Institute for Health Research, NIHR Academy, Sarcoma UK, Vascular Society of Great Britain and Ireland, and Yorkshire Cancer Research.

Physiologic Factors Leading to Temporary Abdominal Closure In EGS Patients Identified

surgery resident at Mayo Clinic in Rochester, Minn. The aim of the study was to determine which clinical factors are most predictive of a surgeon’s decision to use TAC, specifically in patients undergoing EGS (quick shot 20). The multi-institutional, prospective observational study looked at a total of 766 adult patients who underwent exploratory laparotomy for abdominal sepsis at 21 centers. Of these patients, 44% were managed with TAC, and they were more likely to have higher ASA physical status and Charlson Comorbidity Index scores, lactate levels, international normalized ratios (INRs), vasopressor use, and mortality. Upon conducing multivariable analysis, the team found the need for preoperative vasopressors was the clinical factor most predictive of being managed with an open abdomen. Sepsis/severe sepsis also was predictive of open abdomen procedures. Achievement of source control at time of index operation, as well as a complex interaction term consisting of an ASA physical status class no more than III, source control completion and an INR test no more than 1.3 were predictive of not being managed with an open abdomen. “The decision to manage EGS patients with an open abdomen seems to be primarily driven by patient factors and, really, by [patients’] physiology,” Dr. Zhu said. “This study serves as a springboard for future investigation to better clarify what are the indications for using an open abdomen technique, specifically in this population.” Dr. Zhu also noted that while the study indicates that EGS patients who are managed with an open abdomen have higher rates of mortality, additional research is needed to determine whether this is due to patient factors or the use of TAC itself.

wRVU Questioned as Ideal Pay Model for Trauma Surgeons

Preoperative coagulopathy, vasopressor use and incomplete source control at index operation are the clinical features most likely to lead to a surgeon performing temporary abdominal closure (TAC) among emergency general surgery (EGS) patients, according to new research. “There is a lack of consensus on the indications for use of second-look laparotomy, specifically in EGS,” said Rebecca Zhu, MD, a fourth-year general

A recent study demonstrated a positive correlation between monthly length of stay (LOS) and generation of work relative value units (wRVUs) for trauma patients. This may mean that as hospitals continue to implement cost-saving procedures to reduce LOS, doing so may negatively affect trauma surgeon reimbursement through wRVU pay scales (quick shot 8). “Burgeoning healthcare costs in the [United States] have demanded that healthcare systems eliminate unnecessary

spending and utilize benchmarks to assess ongoing cost-reduction efforts,” said Eden K. Hunt, MD, a surgical resident at Lehigh Valley Health Network in Allentown, Pa. Dr. Hunt said LOS is a frequently used metric targeted in cost-reduction efforts. And trauma surgeon reimbursements are largely based on wRVUs. “However,” Dr. Hunt added, “RVU compensation in the literature has been shown to incompletely account for the complexity, and the cognitive effort, required in the management of emergency surgical patients.” In order to assess the relationship between LOS and wRVUs, the researchers conducted a retrospective chart review of over 15,000 patients from the Trauma Registry between 2011 and 2015. The groups were divided into two groups representing before and after LOS reduction initiatives were put into place in the Lehigh Valley Health Network during 2013. The findings demonstrated a positive correlation (R=0.55) between monthly hospital LOS and wRVU generation. Monthly LOS decreased by 6.2% following the implementation of reduction initiatives, which resulted in a 16% decrease in monthly wRVU generation. In the Lehigh Valley Health Network, Dr. Hunt noted, this reduction resulted in approximately 3,200 fewer admissions and 6,400 less RVUs on an annual basis—leading to approximately $400,000 per year in lost revenue. Dr. Hunt noted that the findings signal “a huge financial incentive” to reevaluate the financial effects of these LOS reductions, and what may be done to better balance cost-saving needs against procedures for compensation. “LOS is certainly a positive for the overall institution, but may have a negative impact on the trauma surgeon,” she said. “It’s prudent to reevaluate if the RVU model is really the best model for reimbursement.”

Synthetic Mesh Favorable For Emergent Ventral Hernia Repair A large study of patients who underwent emergent ventral hernia repair (eVHR) has found that synthetic mesh exhibited favorable readmission rates and lower risk for surgical complications compared with other techniques. “eVHR is associated with significant morbidity, and the prevalence of this has only been increasing during the last continued on page 8

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IN THE NEWS

EAST First Look continued from page 6

two decades, particularly in the last few years with the COVID-19 pandemic,” said Caroline A. Ricard, MD, a thirdyear general surgery resident at Tufts Medical Center, in Boston. “There have been numerous studies evaluating various techniques and materials used. However, there has not been surgical consensus for optimal management of this disease process, particularly in the emergent setting.” The retrospective analysis consisted of data from 43,819 patients who underwent

GENERAL SURGERY NEWS / MARCH 2022

eVHR, sourced from the Nationwide Readmissions Database. Approximately 28% of the cohort were readmitted within six months, and half of readmissions occurred within the first 30 days after discharge. Superficial surgical site infection and bowel obstruction/ileus were the most common surgical readmission diagnoses in 30.1% and 12.2% of cases, respectively (quick shot 17). When studying specific techniques, primary repair had the lowest odds of readmission, with an odds ratio (OR) of 1. Synthetic mesh had lower odds for readmission than biologic mesh repair (OR,

ook:

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on in the ER, may be key to identifying the presence of necrotizing soft 8). ow that there still remains significant morbidity, as well as complicay at the David Geffen School of Medicine at UCLA, in Los Angeles. Whether that delay in diagnosis occurs early during the patient’s prerecognize these patients immediately, and we need to intervene sur-

have not proven to be particularly successful. date a clinical risk index score for identifying NSTIs in EGS patients. ological tests performed on initial presentation in the ER. ough September 2021, and focused on adult EGS patients with suss, admission vital signs and lab findings, physical examinations, and s existed that could efficiently indicate NSTIs. d a logistic regression model identified three factors that were predicm Hg (OR, 2.9), a white blood cell count of at least 15 (OR, 3.0) and

rly sensitive, highly specific risk index based upon three readily avail.

1.7 vs. 1.26). And laparoscopic repair was protective against readmission, with an OR of 0.67. “Regardless of repair type, eVHR is associated with significant risk of readmission,” Dr. Ricard said. “Yet, the most novel finding of this review is that synthetic mesh had lower rates of readmission when compared to biologic mesh repair.”

3 Parameters May Indicate Presence of Necrotizing Soft Tissue Infections The results of three key parameters, noted during a patient’s initial presentation

in the ER, may be key to identifying the presence of necrotizing soft tissue infections (NSTIs), according to data presented at the meeting (paper 18). “Despite all the research over the last 20 or 30 years on this topic, we know that there still remains significant morbidity, as well as complications in these patients,” said Dennis Kim, MD, an assistant professor of surgery at the David Geffen School of Medicine at UCLA, in Los Angeles. Time is of the essence in managing patients with NSTIs, Dr. Kim said. “Whether that delay in diagnosis occurs early during the patient’s presentation or there are delays to definitive operative debridement, we need to recognize these patients immediately, and we need to intervene surgically immediately.” However, existing tools that aid in the prompt diagnosis of the infections have not proven to be particularly successful.

In order to address this, Dr. Kim and his colleagues sought to derive and validate a clinical risk index score for identifying NSTIs in EGS patients. The score would be based on clinical findings, physical examination and radiological tests performed on initial presentation in the ER. The prospective study was conducted over 24 months, from June 2019 through September 2021, and focused on adult EGS patients with suspected NSTIs at 16 centers located across the United States. Demographics, admission vital signs and lab findings, physical examinations, and radiographic and operative findings were analyzed to identify whether signals existed that could efficiently indicate NSTIs. A number of factors were more common among patients with NSTIs, and a logistic regression model identified three factors that were predictive of the infections: spontaneous bacterial peritonitis no more than 120 mm Hg (OR, 2.9), a white blood cell count of at least 15 (OR, 3.0) and violaceous skin (OR, 3.8). “Through this multicenter, prospective observational study, we derived a fairly sensitive, highly specific risk index based upon three readily available clinical parameters to identify patients with ■ NSTIs,” Dr. Kim concluded.

BULLETIN BOARD

MARCH 2022 / GENERAL SURGERY NEWS

GSN Welcomes New Editorial Advisory Board Member General Surgery News is pleased to welcome its newest editorial board member, Barret Halgas, MD. Dr. Halgas is a board-certified general surgeon and burn surgery fellow in San Antonio. He obtained his medical degree from the Paul L. Foster School of Medicine of Texas Tech University Health Sciences Center in Lubbock, and completed his internship and general surgery residency at William Beaumont Army Medical Center, in El Paso, Texas. Several years ago, Dr. Halgas began writing a regular opinion column called “The Resident Corner” for this publication that explored topics such as resident autonomy, research and mentorship. He found the whole experience professionally rewarding and hopes to continue writing here and in similar forums.

TRENDING Read the most-viewed articles last month on generalsurgerynews.com.

1 How Do Surgeons Get

Fairly Compensated for Their Work? ▼

2 Preventing Parastomal

Hernias: A ‘Silver Bullet’ Remains Elusive

3 AI in Surgery: Promise

Mixed With Uncertainty

4 Robotic Surgery in Oncology Gaining Traction

HEARD HERE FIRST Considerable variation is seen among individual surgeons as to their views of how much psychological performance skills can affect various aspects of surgical performance, with a range from 10% to 90%. However, these results suggest that contemporary surgeons perceive an important influence of psychological performance skills on important aspects of surgical practice. This may be especially true for influence on surgical errors and managing surgical emergencies, where psychological performance skills are rated as more influential than technical skills. From “The Importance of Psychological Performance Skills to Surgical Performance,” page 32

COMING NEXT ISSUE

Beyond Your First Contract: Networking Is Key for Active Job Seekers No one should be in the dark, including your current boss. Answer recruiter emails and calls, consult job boards and contact employers who might match your profile. There’s no harm in calling or emailing people, saying, ‘I’m moving to your city and would love to work for you. —Steven Chen, MD

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Managing Surgical Smoke Risk While Improving Visualization and Minimizing Patient CO2 Exposure Using the Ultravision™ System During Laparoscopy Jin S. Yoo, MD Assistant Professor of Surgery Duke University Health System Durham, North Carolina

Introduction Surgical smoke, along with other particulate matter generated in the operating room (OR) poses a health problem for staff, as well as reduces visualization for the surgeon and acts as a potential impediment to OR efficiency in laparoscopic surgery due to increased wait times for smoke clearance or camera cleaning.1,2 At high concentrations during a procedure, surgical smoke also may cause eye and upper respiratory tract irritation among staff.3 In the United States, to combat the risk for health effects from surgical smoke, 5 states have implemented laws to require smoke management for laparoscopic procedures4 and 6 additional states have legislation pending for such requirements, according to the Association of periOperative Registered Nurses (AORN).5,6 Understanding smoke management technology and available options is growing in importance for the surgical community.7,8 In contrast to traditional technologies that clear smoke by evacuating smoke particulates and carbon dioxide (CO2) from the abdomen, the Ultravision system uses electrostatic precipitation to clear smoke and increase visualization in laparoscopy.9 Additionally, it offers the advantages of reducing aerosolized biomatter and minimizing patient CO2 exposure with a stable pneumo and increasing procedural efficiency.2

Need for Smoke Management Systems Surgical smoke, produced by a variety of heat-generating energy sources such as electrosurgical devices, laser tissue ablation, and drills or saws, is associated with health hazards to OR staff.1,10 In addition to the symptoms of exposure—including cough, headache, nausea, and throat irritation11—surgical smoke can contain mutagens and carcinogens.12 Evidence that surgical smoke also carries live bacteria and viruses has intensified interest in strategies for surgical smoke abatement, particularly in the COVID-19 era.13,14 Various smoke management options, all evacuating smoke using different mechanisms for capturing and filtering smoke and particulates, have been used to clear the surgical field.15 Most utilize the pressure of

10 GENERAL SURGERY NEWS • MARCH 2022

the pneumoperitoneum in combination with a passive filter or a type of suction action with a capture velocity in the range of 100 to 150 feet per minute within the surgical site and include a filter to clear the evacuated CO2 from smoke particulates. This affects the pressure of the pneumoperitoneum and creates the need for continuous insufflation.16 Smoke management is of particular importance in laparoscopic surgery because unlike open procedures, smoke concentrates within the abdominal cavity, impairs visibility, and may be released into the OR by opening a valve of the trocar. Once open, smoke can be emitted into the OR at a high velocity, thereby exposing surgical staff to high concentrations of surgical smoke at once. Even without opening the valve, smoke can still leak from functional trocars during instrument changes.17 When using a filtration-based smoke management device, only the smoke that is being captured by the filter is being contained. In other words, while the smoke evacuator may have a ULPA filter capable of more than 99% filtration efficiency, not all smoke reaches the filter. For example, a recent paper reported that the use of a smoke evacuator only reduced detectable OR particulates by 32% during laparoscopic surgery.17 Over a sustained period of time with regular OR smoke exposure, this can become hazardous to the health of OR staff and surgeons.18

wonder about the smoke particles left in the patient’s body, but in my experience, there is no significant risk about this one-time exposure to the patient. On the contrary, I believe it actually enhances patient outcomes,” said Jin S. Yoo, MD, an assistant professor of surgery with the Duke University Health System, in Durham, North Carolina, who specializes in minimally invasive surgery with clinical expertise in hernia, foregut, and bariatric surgeries. “In a demonstration of the Ultravision™ system, I learned that it rapidly eliminated smoke, but also permitted low-pressure surgery as it allowed procedures to be performed with less CO2, due to its working principle of not evacuating smoke from the pneumoperitoneum.” In the demonstration, Dr Yoo noted that he was intrigued about the potential for Ultravision™ to maintain pneumoperitoneum without requiring continuous CO2 insufflation as it is required by the common technique. Continuous and high CO2 inflow insufflation for creating a pneumoperitoneum presents its own potential health hazards for clinicians when released into the OR due to higher CO2 concentrations.20,21 It can also be associated with surgical complications, including the risk for postoperative pain.22 “Intraabdominal insufflation with CO2 has several disadvantages, including increased pressure on the abdominal wall and vital organs in the abdomen. I already had developed an interest in low-pressure

Ultravision™ System Unlike other devices, only one commercially available system uses electrostatic precipitation: the Ultravision™ System (Alesi Surgical; distributed by Olympus in the United States). It has been shown to eliminate the release of smoke into the OR2 with near-complete smoke and particle clearing after 1 minute of use.9,19 Electrostatic precipitation functions based on the creation of low-energy gas ions in the abdominal cavity. When these ions are released by the generator into the abdomen during a laparoscopic procedure, they transiently associate with the smoke and aerosolized particulate, including biomatter, and thus accelerate their sedimentation, preventing them from exiting the body and circulating in the OR environment.2,9 Ultravision™ is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.9 “When Ultravision™ was first demonstrated to me, the smoke seemed to magically disappear. However, there is a science to the device technology, which has several advantages. On the other hand, one might initially

Figure. Dr Yoo using the Ultravision™ system during surgery. Image courtesy of Jin S. Yoo, MD.

Supported by

surgery when AORN began to lobby for smoke evacuators,” Dr Yoo said. However, Dr Yoo had struggled with the fact that these 2 surgical goals, smoke evacuation and low-pressure surgery, could not be combined due to the continuous insufflation and high flow need, which strengthened his interest in using Ultravision™ for smoke management.

Filling Unmet Needs in Surgery: Ultravision™ Use Dr Yoo began using the Ultravision™ system in 2019 (Figure). Since then, he has performed more than 600 cases with this device in a wide variety of laparoscopic and some robotic procedures, such as cholecystectomy; inguinal and ventral hernia repairs; and bariatric procedures such as sleeve gastrectomy, gastric bypass, and duodenal switch. According to Dr Yoo, the use of Ultravision™ has been easily and seamlessly adopted in the OR. Ultravision™ requires a compact low-power generator that delivers the voltage that creates the gas ions and one of 2 options for a single-use, sterile consumable, both containing an active Ionwand™ electrode. The Ionwand™, which delivers the ions to the pneumoperitoneum, is placed into the operative field either through a dual-function 5-mm trocar or a dedicated 2.5-mm catheter.9 The 5-mm trocar option replaces an existing 5-mm trocar and is placed in that trocar’s standard location.9 The 2.5-mm catheter is placed according to clinician preference, typically between the laparoscope trocar and an adjacent working trocar.9 Dr Yoo noted that while the Ionwand™ should be in reasonable proximity to the surgical site where smoke is being generated and biomatter is likely to be aerosolized, it also needs adequate space to produce negative ions. “Positioning of the wand is important,” Dr Yoo said, “but the learning curve for the optimal positioning is short. I became comfortable using the device within a few cases.” Ultravision™ has been shown to silently clear 99.9% of surgical smoke and mist within 1 minute in the abdomen.19 Additionally, the unintentional release of smoke in the OR through leaks in trocars or as a result of instrument exchanges is 23 times less when using Ultravision™ than when using a smoke evacuator.23

and additionally emphasizes its role in low-pressure, low-flow surgery and in enhancing reduced patient exposure to, and consumption of, cold, dry CO2. “In procedures performed with Ultravision™, I can turn off the CO2 valves once pneumoperitoneum is achieved. This allows me to use 20 to 25 L of CO2 overall rather than the typical 300 to 500 L for a 1-hour laparoscopic case when using a high-flow insufflator and maintain a stable pneumo,” Dr Yoo said. Lower intraoperative pressure on the abdominal wall is associated with reduced postoperative pain.24 Dr Yoo explained that most laparoscopic and robotic procedures are performed with a CO2 pneumoperitoneum pressure of 15 mm Hg, a level that has long been associated with potential adverse consequences in selected patient populations.25 Due to potential risks, Dr Yoo said lower pressures often are needed in high-risk individuals, such as patients who have heart and/or lung disease that cannot tolerate standard pneumoperitoneal pressure of 15 mm Hg well, or patients who are morbidly obese and/or elderly. But he thinks the approach should be used more broadly. “Why limit low-pressure surgery only to high-risk cases? I currently lower the intraabdominal pressure down as much as possible on all my minimally invasive surgery cases without sacrificing the surgical view and exposure I need to safely perform the operation. For some patients that may be 6 mm Hg and for some it may be 12 mm Hg,” he said.

from circulating in the OR environment, while offering further meaningful benefits and improvements in visualization, OR efficiency, and patient exposure to CO2.2,23 The simultaneous enhancement of a stable pneumoperitoneum is an independent but meaningful additional benefit over traditional smoke evacuation. “Ultravision™ is the only technology that will allow the surgeon to perform laparoscopy with low-pressure, low-flow, and low-volume CO2,” Dr Yoo said. “This is one way we can take minimally invasive surgery to the next level in an effort to reduce physiological stress and postoperative pain while providing enhanced visualization for the surgeon and protecting OR staff from smoke and particulate generated by the procedure.”

Improving OR Efficiency The first clinical trial on the use of Ultravision™ for laparoscopic surgery was performed by Ansell et al and they concluded that improved visibility using the system led to reduced operating times, as clinicians did not need to pause procedures to wait for smoke clearance or to clean the laparoscope.2 Dr Yoo also said the lower consumption of CO2 during cases translates to less changing of CO2 gas tanks during the procedure or the OR day, which increases efficiency and can lead to cost savings in the OR. Additionally, Dr Yoo noted that the setup of the device is fast and easy to understand. Ultravision™ also operates silently —a notable benefit as evacuator noise often is a cited issue when using other technology.7

References 1.

Asghar MS, et al. J Pak Med Assoc. 2020;70(10):1807-1810.

Ansell J, et al. Surg Endosc. 2014;28(7):2057-2065.

Ogg MJ. NIOSH science blog. June 18, 2020. Accessed January 11, 2022. https://blogs.cdc.gov/ niosh-science-blog/2020/06/18/surgical-smoke/

Association of periOperative Registered Nurses. August 25, 2021. Accessed January 11, 2022. https:// www.aorn.org/about-aorn/aorn-newsroom/ health-policy-news/2021-health-policy-news/ illinois-smoke-free-in-2022

Pennock J. The Joint Commission. June 9, 2021. Accessed January 11, 2022. https://www.jointcommission.org/ resources/news-and-multimedia/blogs/leading-hospitalimprovement/2021/06/surgical-smoke-legislation-gaining-traction-across-the-country/

StateTrack. Accessed January 11, 2022. https://www.cqstatetrack.com/texis/statetrack/insession/viewrpt/main. html?event=5ba109c419e

Chavis S, et al. AORN J. 2016;103(3):289-296.

Levine D, et al. JSLS. 2020;24(4):e2020.00051.

Ultravision Visual Field Clearing System instructions for use. Accessed January 11, 2022. https://medical. olympusamerica.com/sites/default/files/us/files/pdf/ DLU-001-024_5-Manual-Harmonised-(5).pdf

10. Liu Y, et al. J Cancer. 2019;10(12):2788-2799. 11. Ilce A, et al. J Clin Nurs. 2017;26(11-12):1555-1561. 12. Chung YJ, et al. Int J Urol. 2010;17(11):944-949. 13. Capizzi PJ, et al. Lasers Surg Med. 1998;23(3):172-174. 14. Garden JM, et al. Arch Dermatol. 2002;138(10):1303-1307. 15. Liu N, et al. Spine J. 2020;20(2):166-173. 16. Fan JK, et al. Surgical smoke. Asian J Surg. 2009;32(4):253-257. 17. Cahill RA, et al. Br J Surg. 2020;107(11):1401-1405.

Low-Pressure Surgery and CO2 Reduction

Conclusion

18. Choi SH, et al. Surg Endosc. 2014;28(8):2374-2380.

Ultravision™ is a smoke management system that offers the user the advantage of controlling smoke and other aerosolized matter from the surgical procedure at the surgical site. It further clears the field of view, supports a more efficient workflow, promotes a smoke-free OR, and improves air quality for surgical staff without influencing intraabdominal pressure. It combines multiple advantages in one system and overcomes the pitfalls of standard smoke evacuation in laparoscopy. In addition to these indications and main advantages of using Ultravision™, Dr Yoo remains enthusiastic about

The effort to reduce staff exposure to surgical smoke has been led by OR nurses (through initiatives like the AORN Go Clear Award Program), but the issue is relevant to all members of the OR team.5 Even in states that do not pass legislation mandating smoke management during surgical procedures, the growing interest in this issue has the potential to establish the use of smoke management devices as a standard of care. Of the methods for surgical smoke management, electrostatic precipitation utilized by Ultravision™ has been shown to be uniquely effective in preventing smoke and toxins

19. Data on file. Alesi Surgical. 20. Nair AS, et al. Med Gas Res. 2021;11(1):46. 21. Azuma K, et al. Environ Int. 2018;121(pt 1):51-56. 22. Sabzi Sarvestani A, et al. Anesth Pain Med. 2014;4(4):e17366.

25. Taura P, et al. Surg Endosc. 1998;12(3):198-201.

LCR43331V03

Disclosure: Dr Yoo reported that he is a consultant to Alesi Surgical, Medtronic, and Olympus, and has received grant/research support from Alesi Surgical, Cook Medical, and Medtronic.

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23. Buggisch JR, et al. J Am Coll Surg. 2020;231(6):704-712. 24. Ozdemir-van Brunschot DM, et al. Surg Endosc. 2016; 30(5):2049-2065.

For more information about the Ultravision™ system, please visit: https://medical.olympusamerica.com/products/ultravision GENERAL SURGERY NEWS • MARCH 2022 11

GENERAL SURGERY NEWS / MARCH 2022

Controversies in Surgical Endoscopy Hot Topics on Tap at the SAGES 2022 Annual Meeting. n this issue, I am tackling a familiar topic for the On the Spot column: surgical endoscopy. This time, I have looked at it from the standpoint of the Society of American Gastrointestinal and Endoscopic Surgeons, as well as what’s being addressed, discussed, debated and taught at the 2022 annual meeting. This topic transcends all surgical specialties, and I’d like to thank Rami Lutfi, MD, FACS, FASMBS, and Jaime Ponce, MD, FACS, for weighing in regarding the current debates in this field. Should endoscopic approaches to gastroesophageal reflux disease be offered as first-line before surgical tre treatment with Nissen fundoplication? Should preoperative endoscopy before bariatric surgery be performed rou routinely and not only selectively? Should bariatric endoscopies have their own codes in order to be offered widely? Is the current requirement for minimum endoscopy numbers for general surgery residents adequate to allow gra graduates to perform safe and effective endoscopy? Read on to see what some of the experts think! I would like to thank all contributors to this column. Their hard work and time make this a compelling lling an and informative installment for all surgeons and endoscopists. Don’t forget to check out the Gut Re Reaction on page 14 as well for some quick candid thoughts from these contributors. Feel free to email me at colleen@cmhadvisors.com with any ideas for a debate. Thanks for reading! —Colleen Hutchinson n

Colleen Hutchinson is a medical communications consultant at CMH Media, based in Philadelphia. She can be reached at colleen@cmhadvisors.com

PARTICIPANTS Manoel Galvao Neto, MD, MSc, FASGE, IFASBMS Head of Bariatric Endoscopy Services, Mohak Bariatrics and Robotics Center, Indore, India, and Instituto EndoVitta, São Paulo Disclosure: Alacer Biomédica, Apollo Endosurgery, GI Dynamics, Keyron, USGI.

Anna Carolina Hoff, MD Director of the Interventional Endoscopy Sector of Angioskope, São Paulo Disclosure: Medicone.

Matthew Kroh, MD, FACS, FASMBS, FASGE Vice Chair of Innovation and Technology in the Digestive Disease and Surgery Institute, Cleveland Clinic Section Head of Foregut Surgery and Surgical Endoscopy and Professor of Surgery, Department of General Surgery, Cleveland Clinic Lerner College of Medicine

Rami Lutfi, MD, FACS, FASMBS Medical Director and Section Chief of Metabolic Surgery and Weight Loss, and Director, Bariatric Fellowship Program, Advocate Illinois Masonic Medical Center; Chief of Surgery, Mercy Hospital and Medical Center; Clinical Associate Professor, University of Illinois, Chicago Disclosure: Karl Storz, Olympus.

Amber Shada, MD Assistant Professor of Surgery and Associate Program Director, General Surgery Residency, University of Wisconsin–Madison Disclosure: Boston Scientific, Ethicon, Intuitive Surgical.

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Preoperative endoscopy before bariatric surgery should be performed routinely and not only selectively. DR. RAMI LUTFI: AGREE. I believe endoscopy provides valuable

information that may alter the management or choice of bariatric surgery. While not often a financial burden, it happens certainly enough to warrant its application. In primary surgery, it shows the anatomy better than upper GI due to its ability to inspect the mucosa and obtain tissue samples, and rule out hiatal hernias, Barrett’s esophagus and other pathologies that may contraindicate certain surgeries. In revisional surgery, it’s more critical, as it shows the anatomy and certainly guides the decision and proper planning for revisions. More so, I believe, especially prior to revisions, endoscopy should only be performed by the surgeon to help him or her make proper judgment about the best revisional choice. DR. MATTHEW KROH: ON THE FENCE, depending on which

region of the world you are practicing in. Endoscopy is an invaluable tool and can detect anomalies that may change the planned operation. This occurs uncommonly in the United States but may be critical in areas of the world where endemic gastric cancer and other pathologies are high. Patients with foregut symptoms should routinely undergo preoperative endoscopy. DR. MANOEL GALVAO NETO: AGREE. I’ve been saying this pub-

licly since the beginning, and now it has been endorsed by societies, such as the International Federation for the Surgery of Obesity and Metabolic Disorders and the American Society for Metabolic and Bariatric Surgery, in their statements. Consider the most popular procedures like sleeve gastrectomy and Roux-en-Y gastric bypass (RYGB). The sleeve is a known refluxogenic procedure, so endoscopy should be mandated to help rule out mild to severe GERD and associated conditions like large hiatal hernias and Barrett’s esophagus. And with RYGB there may be an excluded stomach left behind that needs to be cleared of any suspicious conditions prior to surgery. Not to mention, in doing pre-op

endoscopy, Helicobacter pylori can be managed as well. DR. AMBER SHADA: ON THE FENCE. In an ideal world, yes! In our current reality, all patients undergoing sleeve gastrectomy need endoscopy (performed off proton pump inhibitors [PPIs]). All patients who take PPIs or have symptoms of heartburn, regurgitation or dysphagia need endoscopy. A comprehensive esophagogastroduodenoscopy should fully examine, and document, the lower esophageal sphincter (LES) anatomy including Hill grade and where the LES lies with respect to the diaphragm. It should include, at minimum, Seattle protocol biopsies of any irregularities of the gastroesophageal junction for metaplasia. The unfortunate reality is that endoscopy performance and reporting are too operator dependent and not standardized enough to give us this information reliably prior to bariatric surgery. With improvement in performance and documentation standards, I think routine endoscopy will prove to be high yield before all surgical bariatric operations. The data are not there yet, however. DR. CAROLINA HOFF: AGREE. Absolutely. If we are talking about RYGB, where the surgeon is about to exclude a significant part of the stomach, we should perform a very thorough upper endoscopy to toss out premalignant lesions; sometimes, we could even treat those before performing surgery. If we think of sleeve gastrectomy, it’s mandatory to rule out signs of GERD, as the literature shows us that this particular procedure leads to, or exacerbates, reflux. Signs of the illness could change the surgeon’s plans or even expand by adding an anti-reflux approach.

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Bariatric endoscopies should have their own CPT (Current Procedural Terminology) codes in order to be offered widely. DR. GALVAO NETO: AGREE. One of the major barriers to

improve bariatric endoscopy adoption is indeed the actual lack of CPT codes that will eventually lead to reimbursement. continued on page 14

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ON THE SPOT

On the Spot continued from page 12

DR. LUTFI: ON THE FENCE. As far as coding, yes, I agree that

bariatric endoscopies earned their place to have unique codes. The problem is reimbursement, which is the logical next step after obtaining a code. On the one hand, insurance companies resist paying for therapy that’s often temporary (six-month balloons). We need more studies showing durability (such as the MERIT trial; clinicaltrials.gov/ct2/show/NCT03406975) to help us make the argument. Alternatively, while a code and fee schedule will increase access to care, I predict low relative value units for these procedures, resulting in much lower reimbursement. Therefore, adoption by many endoscopists may decrease as bariatric endoscopy moves away from the current lucrative cash-pay packages. DR. KROH: AGREE. The increasing diversity and complexity of bariatric endoscopy needs to be correctly coded and identified as a distinct procedure. DR. SHADA: DISAGREE. CPT codes should be based on the procedure performed, not the indication for the endoscopy. It is important that the proper diagnosis codes are being used. For example, GERD is a better code to use for preoperative endoscopy compared with morbid obesity. DR. HOFF: AGREE Since overweight and obese patients

represent a significant parcel of the population, every single hospital should be prepared to perform bariatric endoscopy.

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Endoscopic approaches to GERD should be offered as firstline therapy before surgical treatment with Nissen fundoplication.

DR. HOFF: AGREE—couldn’t agree more. I’ll quote my

mentor, Dr. Neto. Decades ago, we had medications and open-heart surgery to treat coronary artery disease. Suddenly and brilliantly, stents were introduced, permitting a minimally invasive procedure. Today we have incisionless and very effective treatments, such as the Stretta procedure and transoral incisional fundoplication (TIF) technique. These incisionless techniques are a game changer in current interventional endoscopy. DR. KROH: DISAGREE. Endoscopic GERD therapies can

be highly effective in correctly selected patients. These patients typically have fewer mechanical and motility abnormalities. Patients who are good candidates for endoscopic GERD therapies are often quite different from

GENERAL SURGERY NEWS / MARCH 2022

those who would benefit most from Nissen fundoplication. Endoscopic and surgical intervention should be tailored to specific patients and not necessarily a stepwise process.

reason they have not yet overtaken the fundoplication as a first-line treatment for anti-reflux surgery.

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The current requirement for minimum endoscopy numbers tainly be the first-line treatment. We don’t have Level I for general surgery residents is evidence to change the standard of care. Much data are driven from industry, although good-quality data cer- adequate to allow graduates to tainly exist. I do question the rapid adoption by endos- perform safe and effective endoscopy.

DR. LUTFI: ON THE FENCE. Medical management should cer-

copists who have historically been resistant to refer patients—even those with suboptimal or poor response to PPIs—and now their practice patterns are changing, as they are the ones doing the procedure!

Patients who are good candidates for endoscopic GERD therapies are often quite different from those who would benefit most from Nissen fundoplication. Endoscopic and surgical intervention should be tailored to the specific patient and not necessarily a stepwise process. —Matthew Kroh, MD, FACS I also worry about practice patterns with profit sharing (high profit) with the combined approach, with a surgeon repairing the hernias—often the general surgeon since no fundoplication is needed—and endoscopist performing the endoscopic therapy. DR. GALVAO NETO: AGREE. Despite laparoscopic Nissen still being the gold standard, endoscopic methods, specifically TIF, are demonstrating equivalence on cases such as refractory GERD without hiatal hernias, and even in those cases with the c-TIF (concomitant laparoscopic hiatal hernia repair with TIF) that adds a laparoscopic hiatus repair. And there is less dysphagia and less gas bloat. So, if equivalence is demonstrated, why not give endoscopy a chance? DR. SHADA: DISAGREE. Endoscopic approaches to GERD

have not been shown to be superior to surgical treatments like Nissen. However, it is important to counsel patients on all available options to treat GERD, including endoscopic approaches, within formation that entails efficacy and durability. It is also important to differentiate between a purely endoscopic and an endoscopic/ laparoscopic hybrid procedure (c-TIF, looking at you!). There are patients for whom an endoscopic approach to treat reflux is a very reasonable first-line treatment with appropriate preoperative counseling. But there’s a

DR. SHADA: AGREE. The key words are “safe and effec-

tive,” and I believe the current case minimum of 35 upper endoscopies fulfills that for most trainees. There are a couple of things to think about in terms of this requirement, however. First, we’ve begun the transition to defining proficiency using progressive entrustment instead of purely case numbers for other operations in general surgical training. I believe there is space for changing the training paradigm for endoscopy similarly. Second, diagnostic endoscopy and advanced therapeutic endoscopy are very different, and will require different levels of training to achieve safety and efficacy. DR. KROH: ON THE FENCE. The number is likely adequate for basic competency and practice of a graduating general surgery resident. However, exposure to more complex endoscopic procedures during residency will better prepare trainees to build upon that foundation in a bariatric or complex gastrointestinal surgery fellowship. DR. LUTFI: AGREE. I am agreeing only because most grad-

uating residents are not going to be performing endoscopies. I believe the current number is adequate for the bare minimum of exposure to the basics. For those moving on to becoming bariatric surgeons, endoscopy should be a core competency in their fellowship. DR. HOFF: DISAGREE. Minimum is often the synonym

of basics. Residents are going to be able to deal with the diagnosis but won’t have the competence to deal with complications or accomplish sophisticated techniques. And as surgical patient quantities rise, so does the need for highly competent endoscopists. Suddenly surgery and endoscopy have been incorporated, so must our teaching methods considering general surgery residents. DR. GALVAO NETO: ON THE FENCE. If we are attached to the

previous numbers of 50 colonoscopies and 150 upper endoscopies, it is barely enough to perform diagnostic endoscopies. But now the trend is to perform therapeutic endoscopy to treat complications and start doing endobariatric therapy. And for those clinicians, these numbers are definitely not high enough. ■

GUT REACTION Most significant recent technique or device-driven advancement in endoscopy ... Dr. Kroh: Peroral pyloromyotomy (POP) for gastroparesis. Gastroparesis is increasing in incidence, either by overall growing numbers of patients or by better diagnosis of this unusual disease process. Dietary modifications are often unhelpful, and medications have lower efficacy or unwanted side effects. At least in the short term, POP is a minimally invasive approach with good outcomes for this challenging condition.

A 2017 Todd Heniford, MD, tweet: “If studying your outcomes closely doesn’t make you uncomfortable, you are probably not doing it right.” Dr. Kroh: Continuous improvement requires careful and transparent review of outcomes and processes. These are opportunities for all of us to improve the care we deliver to our patients.

Dr. Galvao Neto: Endolumenal suturing leading to gastric remodeling procedures.

Dr. Galvao Neto: I say Todd Heniford is no Friedrich Nietzsche!

Dr. Shada: Intraluminal negative pressure therapy—game changer for bariatric complications!

Dr. Shada: 100%; studying closely and publishing.

Dr. Hoff: Endosuturing devices; advantages of a sewing machine.

Dr. Hoff: Never settle. Be open-minded to try something different. Compare the outcomes.

Dr. Lutfi: Robotic endoscopy.

Dr. Lutfi: Best statement from Todd I have heard!

IN THE NEWS

MARCH 2022 / GENERAL SURGERY NEWS

Experts Discuss Hot Topics in General Surgery ACS Session Provides Snapshot of Timely Issues in Surgery By MICHAEL VLESSIDES

he 2021 American College of Surgeons Clinical Congress was a hive of virtual activity, but one session proved particularly interesting to clinicians. During “Hot Topics in General Surgery,” a lineup of six expert speakers used a rapid-fire approach to give a brief overview of several timely issues. As co-moderator E. Christopher Ellison, MD, explained, “I have worked with Dr. Ken Sharp over the past nine years to select the topics where surgeons share common thoughts, ideas and questions with one another. We keep tabs on that and pick the most interesting ones, reflecting a broad swath of topics in general surgery.”

1. Nonoperative Management Of Appendicitis Liane Feldman, MD, the Edward W. Archibald Professor and Chair, Department of Surgery at McGill University, in Montreal

According to Dr. Feldman, there are various benefits in nonoperative management, such as surgery avoidance and preservation of the appendix, but there are also drawbacks, including initial treatment failure, disease recurrence, potential for complicated surgery and missed neoplasm. Nevertheless, there is recent evidence supporting nonoperative management of uncomplicated appendicitis, including a systematic review and metaanalysis (Ann Surg 2019;270[6]:10281040) and a randomized controlled trial (N Engl J Med 202012;383[20]:1907-1919). “In summary, most patients with appendicitis can safely avoid immediate surgery,” Dr. Feldman said. “There’s an early failure rate of at least 10%, and recurrence of about 30% at one year and 40% at five years. Appendicolith is associated with complicated disease, early surgery and complications. In terms of neoplasms, there is about a 1% incidence of missed neoplasms in patients with uncomplicated disease, in which the clinical impact is unknown. However, there is a much higher rate (10%30%) for patients with complicated disease, in whom interval appendectomy is recommended.”

2. Pheochromocytoma and Paraganglioma: More Genetic Than You Think Nancy D. Perrier, MD, the Ruth and Walter Sterling Endowed Professor of Surgery at The University of Texas MD Anderson Cancer Center, in Houston

According to Dr. Perrier, the clinical manifestations of these conditions are “pretty classic” and include headaches,

palpitations and diaphoresis. Biochemical diagnosis is confirmed with very high sensitivity and specificity when plasma-free metanephrines are obtained. Historically, pheochromocytomas have fallen into the rule of 3: About 30% of all adrenal tumors are of inherited origin; nine genes (and counting) have been confirmed to participate in tumorigenesis; and germline mutations are found in 100% of syndromic cases and up to 90%

in patients with a strong family history. For these reasons, genetic testing is recommended for all patients. “We live in an era of targeted therapies, and deciding which antiangiogenic drugs are useful should be prioritized, particularly in patients who have a hypoxia predisposition,” Dr. Perrier added. “Again, I remind you that genetic testing is important when we see patients with pheochromocytoma. It should be done

(From left) Co-moderators E. Christopher Ellison, MD, and Ken Sharp, MD preoperatively so that preoperative imaging can be personalized, as well as assessment for multiple tumors and tumors at continued on the following page

MORE THAN 8 MILLION ADULT PATIENTS HAVE RECEIVED EXPAREL SINCE 20121

FEWER OPIOIDS. IMPROVED RECOVERY. Non-opioid EXPAREL® (bupivacaine liposome injectable suspension) delivers safe, extended pain control over the most critical days after surgery ERAS and multimodal protocols with EXPAREL have demonstrated improved clinical and economic outcomes in multiple general surgery procedures:

74%

fewer opioids

31%

were used over 3 days in laparoscopic colorectal surgery2*†

faster return to bowel function

in open ventral hernia repair (P <0.001)3

2 days shorter LOS 4.0 days vs 6.1 days in open ventral hernia repair (P <0.001)3

Connect with us to learn more about how EXPAREL can support your practice ERAS=Enhanced Recovery After Surgery; LOS=length of stay; TAP=transversus abdominis plane. *The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials. † Opioid use was measured by the defined daily dose, with 1 unit equaling 100 mcg of intravenous (IV) fentanyl, 2 mg of IV hydromorphone HCl, 4 mg of oral hydromorphone HCl, 20 mg of oral oxycodone, or 10 mg of oral hydrocodone. For laparoscopic colorectal surgery trial: Retrospective trial comparing patients receiving local infiltration of EXPAREL (n=70) as part of an ERP (enhanced recovery protocol) with those being placed in an ERP (n=70). For open ventral hernia repair trial: Retrospective, observational study comparing patients who received an ERAS protocol with EXPAREL (n=100) with a historical group prior to the introduction of the protocol (n=100).

Indication EXPAREL® (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. Adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via interscalene brachial plexus nerve block were nausea, pyrexia, and constipation. Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia. If EXPAREL and other non-bupivacaine local anesthetics, including lidocaine, are administered at the same site, there may be an immediate release of bupivacaine from EXPAREL. Therefore, EXPAREL may be administered to the same site 20 minutes after injecting lidocaine. EXPAREL is not recommended to be used in the following patient populations: patients <6 years old for infiltration, patients younger than 18 years old for interscalene brachial plexus nerve block, and/or pregnant patients. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Warnings and Precautions Specific to EXPAREL Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, or intravascular or intra-articular use. The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials. Warnings and Precautions for Bupivacaine-Containing Products Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression. Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to dysrhythmias, sometimes leading to death. Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients. Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use. Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use. Please refer to brief summary of Prescribing Information on adjacent page. For more information, please visit www.EXPAREL.com or call 1-855-793-9727. References: 1. Data on file. 6450. Parsippany, NJ: Pacira BioSciences, Inc.; January 2021. 2. Keller DS, Pedraza R, Tahilramani RN, Flores-Gonzalez JR, Ibarra S, Haas EM. Impact of long-acting local anesthesia on clinical and financial outcomes in laparoscopic colorectal surgery. Am J Surg. 2017;214(1):53-58. 3. Majumder A, Fayezizadeh M, Neupane R, Elliott HL, Novitsky YW. Benefits of multimodal enhanced recovery pathway in patients undergoing open ventral hernia repair. J Am Coll Surg. 2016;222(6):1106-1115.

06/21

IN THE NEWS

ACS Hot Topics continued from the previous page

other sites. Also, the genetic determinants will help personalize the operative plan, as well as with appropriate surveillance strategies for follow-up care.”

3. Management of Ingested Foreign Bodies in Children Harold N. Lovvorn III, MD, professor of pediatric surgery at Vanderbilt University Medical Center, in Nashville, Tenn.

Dr. Lovvorn said button batteries can cause severe tissue burns in as fast as two

Brief Summary (For full prescribing information refer to package insert) INDICATIONS AND USAGE EXPAREL is indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Limitation of Use: Safety and efficacy has not been established in other nerve blocks. CONTRAINDICATIONS EXPAREL is contraindicated in obstetrical paracervical block anesthesia. While EXPAREL has not been tested with this technique, the use of bupivacaine HCl with this technique has resulted in fetal bradycardia and death. WARNINGS AND PRECAUTIONS Warnings and Precautions Specific for EXPAREL As there is a potential risk of severe life-threatening adverse effects associated with the administration of bupivacaine, EXPAREL should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity. Caution should be taken to avoid accidental intravascular injection of EXPAREL. Convulsions and cardiac arrest have occurred following accidental intravascular injection of bupivacaine and other amidecontaining products. Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL has not been evaluated for the following uses and, therefore, is not recommended for these types of analgesia or routes of administration. • epidural • intrathecal • regional nerve blocks other than interscalene brachial plexus nerve block • intravascular or intra-articular use EXPAREL has not been evaluated for use in the following patient population and, therefore, it is not recommended for administration to these groups. • patients younger than 6 years old for infiltration • patients younger than 18 years old for interscalene brachial plexus nerve block • pregnant patients The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days as seen in clinical trials. ADVERSE REACTIONS Clinical Trial Experience Adverse Reactions Reported in Local Infiltration Clinical Studies The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical site clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 to 532 mg of EXPAREL. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting. The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration were pyrexia, dizziness, edema peripheral, anemia, hypotension, pruritus, tachycardia, headache, insomnia, anemia postoperative, muscle spasms, hemorrhagic anemia, back pain, somnolence, and procedural pain. Adverse Reactions Reported in All Local Infiltration Clinical Studies in Pediatric Patients Aged 6 to Less Than 17 Years The safety of EXPAREL in 110 pediatric patients between the age of 6 and 17 years old undergoing various surgical procedures was evaluated in one randomized, open-label, clinical study in which EXPAREL was administered by infiltration into the surgical site and one single-arm, open-label study in which EXPAREL was administered by infiltration into the surgical site. Patients were administered a weight-based dose of EXPAREL at 4 mg/kg (maximum dose of 266 mg) or bupivacaine HCl 2 mg/kg (maximum dose of 175 mg). In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia. The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration were bradycardia, muscle spasms, tachypnea, hypoesthesia oral, anemia postoperative, dizziness, pyrexia, diarrhea, hypoacusis, hypoesthesia, back pain, hematuria, incontinence, muscular weakness, and visual impairment. Adverse Reactions Reported in Nerve Block Clinical Studies The safety of EXPAREL was evaluated in four randomized, double-blind, placebo-controlled nerve block clinical studies involving 469 patients undergoing various surgical procedures. Patients were administered a dose of either 133 or 266 mg of EXPAREL. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, pyrexia, and constipation. The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration as a nerve block were muscle twitching, dysgeusia, urinary retention, fatigue, headache, confusional state, hypotension, hypertension, hypoesthesia oral, pruritus generalized, hyperhidrosis, tachycardia, sinus tachycardia, anxiety, fall, body temperature increased, edema peripheral, sensory loss, hepatic enzyme increased, hiccups, hypoxia, post-procedural hematoma.

GENERAL SURGERY NEWS / MARCH 2022

hours, in addition to lifelong injuries. An ingested battery can induce a hydroxide-rich alkaline burn that dissolves the esophHarold N. ageal mucosa, Lovvorn III, MD resulting in liquefaction necrosis. Batteries can also be very difficult to find, and once removed, can leave a large erosive crater behind. However, after removal, it’s important to irrigate with

Postmarketing Experience These adverse reactions are consistent with those observed in clinical studies and most commonly involve the following system organ classes (SOCs): Injury, Poisoning, and Procedural Complications (e.g., drug-drug interaction, procedural pain), Nervous System Disorders (e.g., palsy, seizure), General Disorders And Administration Site Conditions (e.g., lack of efﬁcacy, pain), Skin and Subcutaneous Tissue Disorders (e.g., erythema, rash), and Cardiac Disorders (e.g., bradycardia, cardiac arrest). DRUG INTERACTIONS The toxic effects of local anesthetics are additive and their coadministration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity. Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. Patients who are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia:

Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic cyclophosphamide, ﬂutamide, hydroxyurea, ifosfamide, agents rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine Bupivacaine Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2. Non-bupivacaine Local Anesthetics EXPAREL should not be admixed with local anesthetics other than bupivacaine. Nonbupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. There are no data to support administration of other local anesthetics prior to administration of EXPAREL. Other than bupivacaine as noted above, EXPAREL should not be admixed with other drugs prior to administration. Water and Hypotonic Agents Do not dilute EXPAREL with water or other hypotonic agents, as it will result in disruption of the liposomal particles USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are no studies conducted with EXPAREL in pregnant women. In animal reproduction studies, embryo-fetal deaths were observed with subcutaneous administration of bupivacaine to rabbits during organogenesis at a dose equivalent to 1.6 times the maximum recommended human dose (MRHD) of 266 mg. Subcutaneous administration of bupivacaine to rats from implantation through weaning produced decreased pup survival at a dose equivalent to 1.5 times the MRHD [see Data]. Based on animal data, advise pregnant women of the potential risks to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Clinical Considerations Labor or Delivery Bupivacaine is contraindicated for obstetrical paracervical block anesthesia. While EXPAREL has not been studied with this technique, the use of bupivacaine for obstetrical paracervical block anesthesia has resulted in fetal bradycardia and death. Bupivacaine can rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity. The incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus, and neonate involve alterations of the central nervous system, peripheral vascular tone, and cardiac function. Data Animal Data Bupivacaine hydrochloride was administered subcutaneously to rats and rabbits during the period of organogenesis (implantation to closure of the hard plate). Rat doses were 4.4, 13.3, and 40 mg/kg/day (equivalent to 0.2, 0.5 and 1.5 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight) and rabbit doses were 1.3, 5.8, and 22.2 mg/ kg/day (equivalent to 0.1, 0.4 and 1.6 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight). No embryofetal effects were observed in rats at the doses tested with the high dose causing increased maternal lethality. An increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity. Decreased pup survival was noted at 1.5 times the MRHD in a rat pre- and post-natal development study when pregnant animals were administered subcutaneous doses of 4.4, 13.3, and 40 mg/kg/day buprenorphine hydrochloride (equivalent to 0.2, 0.5 and 1.5 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight)

approximately 150 mL of 0.25% acetic acid. Other objects that children may ingest can include magnets, jewelry and toys. “In summary, we can often retrieve these ingested foreign bodies using minimally invasive techniques—either endoscopy or laparoscopy. However, sometimes we do have to be maximally invasive,” Dr. Lovvorn said. “Remember that long-term esophageal complications can arise from button batteries, and magnets can pose significant acute problems, which need to be monitored according to symptoms.”

from implantation through weaning (during pregnancy and lactation). Lactation Risk Summary Limited published literature reports that bupivacaine and its metabolite, pipecoloxylidide, are present in human milk at low levels. There is no available information on effects of the drug in the breastfed infant or effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EXPAREL and any potential adverse effects on the breastfed infant from EXPAREL or from the underlying maternal condition. Pediatric Use The safety and effectiveness of EXPAREL for single-dose infiltration to produce postsurgical local anesthesia have been established in pediatric patients aged 6 years and older. Use of EXPAREL for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 6 years and older. Safety and effectiveness have not been established in pediatric patients aged less than 6 years old for local infiltration or less than 18 years old for interscalene brachial plexus nerve block. Geriatric Use Of the total number of patients in the EXPAREL local infiltration clinical studies (N=823), 171 patients were greater than or equal to 65 years of age and 47 patients were greater than or equal to 75 years of age. Of the total number of patients in the EXPAREL nerve block clinical studies (N=531), 241 patients were greater than or equal to 65 years of age and 60 patients were greater than or equal to 75 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients. Clinical experience with EXPAREL has not identified differences in efficacy or safety between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Hepatic Impairment Amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity. Therefore, consider increased monitoring for local anesthetic systemic toxicity in subjects with moderate to severe hepatic disease. Renal Impairment Bupivacaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. This should be considered when performing dose selection of EXPAREL. OVERDOSAGE Clinical Presentation Acute emergencies from local anesthetics are generally related to high plasma concentrations encountered during therapeutic use of local anesthetics or to unintended intravascular injection of local anesthetic solution. Signs and symptoms of overdose include CNS symptoms (perioral paresthesia, dizziness, dysarthria, confusion, mental obtundation, sensory and visual disturbances and eventually convulsions) and cardiovascular effects (that range from hypertension and tachycardia to myocardial depression, hypotension, bradycardia and asystole). Plasma levels of bupivacaine associated with toxicity can vary. Although concentrations of 2,500 to 4,000 ng/mL have been reported to elicit early subjective CNS symptoms of bupivacaine toxicity, symptoms of toxicity have been reported at levels as low as 800 ng/mL. Management of Local Anesthetic Overdose At the first sign of change, oxygen should be administered. The first step in the management of convulsions, as well as underventilation or apnea, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to the use of anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine to enhance myocardial contractile force). If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. Endotracheal intubation, employing drugs and techniques familiar to the clinician, maybe indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated. DOSAGE AND ADMINISTRATION Important Dosage and Administration Information • EXPAREL is intended for single-dose administration only. • Different formulations of bupivacaine are not bioequivalent even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL. • DO NOT dilute EXPAREL with water or other hypotonic agents, as it will result in disruption of the liposomal particles. • Use suspensions of EXPAREL diluted with preservative-free normal (0.9%) saline for injection or lactated Ringer’s solution within 4 hours of preparation in a syringe. • Do not administer EXPAREL if it is suspected that the vial has been frozen or exposed to high temperature (greater than 40°C or 104°F) for an extended period.

4. Cologuard Versus Colonoscopy: Choosing Wisely Sandra Kavalukas, MD, colorectal surgeon at the University of Louisville, in Kentucky

In 2014, Cologuard (Exact Sciences) gained FDA approval as a colon cancer screening test. It is an assay for different DNA mutations in a stool sample; it detects methylation, mutation and hemoglobin, and the result that comes back is simply a positive or negative. In comparing the numbers, colonoscopy has a 95% detection sensitivity versus a comparable 92% for Cologuard. However, in terms of polyp detection, colonoscopy has a 75% to 93%

• Inspect EXPAREL visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer EXPAREL if the product is discolored. Recommended Dosing Local Analgesia via Infiltration Dosing in Adults The recommended dose of EXPAREL for local infiltration in adults is up to a maximum dose of 266mg (20 mL), and is based on the following factors: • Size of the surgical site • Volume required to cover the area • Individual patient factors that may impact the safety of an amide local anesthetic As general guidance in selecting the proper dosing, two examples of infiltration dosing are provided: • In patients undergoing bunionectomy, a total of 106 mg (8 mL) of EXPAREL was administered with 7 mL infiltrated into the tissues surrounding the osteotomy, and 1 mL infiltrated into the subcutaneous tissue. • In patients undergoing hemorrhoidectomy, a total of 266 mg (20 mL ) of EXPAREL was diluted with 10 mL of saline, for a total of 30 mL, divided into six 5 mL aliquots, injected by visualizing the anal sphincter as a clock face and slowly infiltrating one aliquot to each of the even numbers to produce a field block. Local Analgesia via Infiltration Dosing in Pediatric Patients The recommended dose of EXPAREL for single-dose infiltration in pediatric patients, aged 6 to less than 17 years, is 4 mg/kg (up to a maximum of 266 mg), and is based upon two studies of pediatric patients undergoing either spine surgery or cardiac surgery. Regional Analgesia via Interscalene Brachial Plexus Nerve Block Dosing in Adults The recommended dose of EXPAREL for interscalene brachial plexus nerve block in adults is 133 mg (10 mL), and is based upon one study of patients undergoing either total shoulder arthroplasty or rotator cuff repair. Compatibility Considerations Admixing EXPAREL with drugs other than bupivacaine HCl prior to administration is not recommended. • Non-bupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. • Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2. The toxic effects of these drugs are additive and their administration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity. • When a topical antiseptic such as povidone iodine (e.g., Betadine®) is applied, the site should be allowed to dry before EXPAREL is administered into the surgical site. EXPAREL should not be allowed to come into contact with antiseptics such as povidone iodine in solution. Studies conducted with EXPAREL demonstrated that the most common implantable materials (polypropylene, PTFE, silicone, stainless steel, and titanium) are not affected by the presence of EXPAREL any more than they are by saline. None of the materials studied had an adverse effect on EXPAREL. Non-Interchangeability with Other Formulations of Bupivacaine Different formulations of bupivacaine are not bioequivalent even if the milligram dosage is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL and vice versa. Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Do not substitute. CLINICAL PHARMACOLOGY Pharmacokinetics Administration of EXPAREL results in significant systemic plasma levels of bupivacaine which can persist for 96 hours after local infiltration and 120 hours after interscalene brachial plexus nerve block. In general, peripheral nerve blocks have shown systemic plasma levels of bupivacaine for extended duration when compared to local infiltration. Systemic plasma levels of bupivacaine following administration of EXPAREL are not correlated with local efficacy. PATIENT COUNSELING Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

Pacira Pharmaceuticals, Inc. San Diego, CA 92121 USA Patent Numbers: 6,132,766 5,891,467

5,766,627

8,182,835

Trademark of Pacira Pharmaceuticals, Inc. For additional information call 1-855-RX-EXPAREL (1-855-793-9727) Rx only

March 2021

IN THE NEWS

MARCH 2022 / GENERAL SURGERY NEWS

sensitivity (adenomas >6 mm), whereas Cologuard has a 42% sensitivity. Finally, there is one other very important caveat to this decision, and that’s Sandra Kavalukas, MD financial consideration, according to Dr. Kavalukas. For the uninsured patient, the cost of Cologuard is around $500, while a colonoscopy can be up to $3,000, she reported. “Colonoscopy isn’t just diagnostic of cancers, but it’s preventative of cancers by removing all polyps found,” Dr. Kavalukas said. “Nevertheless, as healthcare practitioners, some screening is better than no screening. In other words, the best test is the test that’s going to get done. However, keep in mind that Cologuard is only tested and indicated for the average-risk individual with no semblance of risk factors for colon cancer.”

5. Current Use of Neoadjuvant Chemo for Breast Cancer Ingrid Meszoely, MD, associate professor of clinical oncology at Vanderbilt University Medical Center, in Nashville, Tenn.

Historically, The initial goal of neoadjuvant therapy was to convert unresectable to resectable disease, particularly in cases of inflammatory or locally advanced breast cancer, according to Dr. Meszoely. “We then realized that it can decrease the size of the primary tumor and convert mastectomy only to breast conservation candidates,” she said. This resulted in better cosmetic outcomes and improved negative margin resection rates. Researchers have since learned that it can also convert N2/N3 stage disease to N1, can potentially convert node-positive patients to node-negative, and omit axillary node dissection for sentinel lymph node biopsy only, Dr. Meszoely said. Response can be seen in up to 90% of patients; less than 5% of tumors will progress; and complete pathologic response in all comers is achieved in 20% to 30% of patients. Nevertheless, neoadjuvant therapy should only be considered in a multidisciplinary approach. “Over time, the use of neoadjuvant therapy in breast cancer has become more compelling with more indications for its use,” Dr. Meszoely said. “In conclusion, neoadjuvant therapy offers multidisciplinary tools for tailoring therapy and allowing for less surgery with improved outcomes. It can convert unresectable to resectable disease, and decrease the burden of disease to allow for less surgery.”

6. Current Use of REBOA In Trauma Joseph V. Sakran, MD, MPH, MPA, associate professor of surgery and nursing at Johns Hopkins Medicine, in Baltimore

When surgeons consider hemorrhage in trauma, it is clear that hemorrhagic shock is the most preventable cause of death,

according to Dr. Sakran. Many physicians struggle with noncompressible torso hemorrhage—the traditional approach to aortic occlusion is resuscitative thoracotomy— but advances in technology have resulted in alternative solutions, with resuscitative endovascular balloon occlusion of the aorta (REBOA) being one of them. Like any new technology, there are always pitfalls to overcome, and in this case it’s incorrect inflation of the balloon in the wrong zone. There are three zones in the aortic occlusion: Zone I is from the left subclavian to the celiac trunk; Zone II is from the celiac trunk to the lowest renal artery; and Zone

III is from the lowest renal artery to the aortic bifurcation. And you typically want to avoid Zone II inflation because this is a perivisceral segment that involves blood supply to the liver and kidneys, etc. A nationwide analysis of REBOA in civilian trauma (JAMA Surg 2019;154[6]:500-508) found no significant difference in four-hour blood transfusion, but the REBOA group had a higher rate of acute kidney injury, lower leg amputation and mortality. This led researchers to needing to better define the specific population. When surgeons consider when to use REBOA, it really

comes down to those injured patients who have life-threatening hemorrhage below the diaphragm and are refractory to resuscitation, according to Dr. Sakran. He also noted that REBOA is contraindicated in the setting of major thoracic hemorrhage or pericardial tamponade. “REBOA should be thought of as a tool that is employed as part of a larger system of damage control, and that’s a really important thing to keep in the back of our minds,” Dr. Sakran said. “As time goes on, we’re going to have a better idea of the specific patient populations where this will be most applicable.” ■

GENERAL SURGERY NEWS / MARCH 2022

Using Gracilis Muscle Flaps In Colorectal Surgery Welcome to the March issue of The Surgeons’ Lounge. In this issue, Lisandro Montorfano, MD, chief general surgery resident at Cleveland Clinic Florida, in Weston, interviews Emanuela SilvaAlvarenga, MD, a clinical associate staff physician in colorectal surgery at Cleveland Clinic Florida, about gracilis muscle flaps in colorectal surgery. Also in this issue, we present another installment of “The Procedure, the Name,” featuring the history of the gracilis flap. We look forward to our readers’ questions, comments and interesting cases to present. Sincerely, Samuel Szomstein, MD, FACS CS Editor, The Surgeons’ Lounge e Szomsts@ccf.org

Figure 1. Thigh incision marking sites.

Lisandro Montorfano, MD: What is gracilis flap surgery? Dr. Silva-Alvarenga: In colorectal surgery, gracilis flap surgery entails harvesting of the gracilis muscle and its use as a rotational flap to reconstruct the perineal area. Due to its long length, substantial bulk and single proximal neurovascular pedicle in most patients, it is a versatile muscle. It can be interposed between the rectum and vagina or urethra, and transposed, without associated skin or as myocutaneous flap, for the treatment of nonhealing perineal wounds. It can also be wrapped around the anus to recreate the anal sphincter.

perineal sinus. The perineal incision is closed using several layers of 2-0 Vicryl suture. All incisions over the thigh are closed with staples.

Dr. Montorfano: What are the most common indications for gracilis muscle flaps in colorectal surgery? Lisandro Dr. Silva-Alvarenga: The gracilis musMontorfano, MD cle has been mostly used for repair of perineal fistulas, perineal nonhealing wounds and to reconstruct the anal sphincter for fecal incontinence. GMI is rarely performed for rectovaginal fistula repairs as an initial surgery. It is customarily performed in tertiary colorectal surgery centers with a Dr. Montorfano: Could you briefly success rate that ranges between 33% and describe the technique you use to har100% for repair of rectovaginal fistula of vest a gracilis muscle flap? all etiologies.1 Emanuela SilvaDr. Silva-Alvarenga: In our departThe treatment of complex anal fistulas Alvarenga, MD ment, the majority of surgeons trained by can be challenging and may require multiple one of our senior surgeons, Dr. Steven D. Wexner— operations. Initial treatment options include endorectal who performs the most gracilis muscle interpositions advancement flap, ligation of the intersphincteric fistula (GMIs)—use a similar technique but with slight mod- tract, fibrin glue injection, tissue interposition flap, videoifications. We advocate for routine fecal diversion prior assisted flap treatment, fistula plug and fistula tract laser to the gracilis interposition, preferably by laparoscopic closure. Proctectomy and permanent intestinal diversion loop ileostomy. The majority of the patients had already are reserved as a last resort, should all else fail. undergone fecal diversion due to various prior failed In the largest published series of 119 GMI procerepairs. Broad-spectrum intravenous antibiotic prophy- dures for complex anal fistulas at Cleveland Clinic Florlaxis is given prior to the induction of anesthesia. Mus- ida—including rectoperineal, rectourethral, rectovaginal cle paralysis is not used. and pouchvaginal—although the initial success rate was The patient is placed in a Lloyd-Davies position using less than 50%, the ultimate success after GMI and other Allen stirrups. The groove between the gracilis muscle subsequent procedures was higher than 90%.2 Patients and the sartorius muscle is identified in either thigh. A must be preoperatively counseled that additional pro4-cm longitudinal incision is made approximately 2 cm cedures will probably be required to achieve successful above the knee joint, and the dissection is deepened fistula closure. through the subcutaneous tissue to expose the fascia Use of the gracilis muscle to interpose nonhealoverlying the tendon of the gracilis muscle. The fascia is ing perineal wounds is not common. Unhealed perithen incised, and muscle is mobilized until all the per- neal wounds from proctectomy generally present with forating vessels are identified. The nerve stimulator can a relatively small skin opening, associated with a large be especially useful during the gracilis mobilization. The presacral cavity. The surgeon’s goal is to accomplish adeperforating vessels can be divided and/or ligated. A tun- quate mobilization without injury of the blood supply nel under the fascia is created by blunt digital dissection, to entirely fill the sinus cavity. Several small series have and a second incision is made proximal to the apex of been published on the management of patients with the tunnel, four to five fingerbreadths distal to the ante- unhealed perineal sinus, after proctectomy for inflamrior superior iliac spine. The fascia is incised, and the matory bowel disease, trauma or cancer, with success muscle is dissected free in a similar fashion; the tendon rates ranging from 57% to 100%.3,4 is identified and disconnected from its insertion near the Use of the gracilis muscle to encircle the anal canal tibial plateau; and the distal muscle is then delivered to and treat fecal incontinence was first described by Pickthe proximal incision. A tunnel is then created from the rell et al in the Annals of Surgery in 1952.4 Small series proximal incision to the perineum. The tip of the tendon (<10 patients) have since been published with reported is exteriorized at the ipsilateral edge of what will become clinical success rates of 38% to 90%.5 Nerve stimulation, or dynamic graciloplasty, was introduced to improve the perineal incision and securely sutured to the skin. The patient is repositioned in prone jackknife on functional results. Long-term success of dynamic a Kraske roll with the thighs fixed, or can be kept in graciloplasty is reportedly between 60% and 75%.6 A lithotomy if undergoing GMI for an anal sphincter multicenter North American trial of dynamic graciloreconstruction. For repair of rectovaginal or rectoure- plasty found that function continued to improve and thral fistulas, the dissection is initiated with a 5- to 7-cm was sustained for up to 24 months after the procedure. anterolateral circumanal incision made through the per- However, dynamic graciloplasty carries high morbidity ineal body and deepened into a plane between the sub- with a revision rate due to major complications of up to cutaneous and superficial portions of the external anal 50%.7 Currently, the procedure is not approved for use sphincter and vagina. Once adequate wide cephalad and in North America but continues to be offered to speciflateral mobilization is accomplished, the edges of the ic patients in Europe and elsewhere. fistula are resected, and the rectal and vaginal or ureteric sides can be closed directly or with an advancement Dr. Montorfano: Is patient selection important at flap. The muscle is then secured to the apex of the dis- the time of performing a gracilis flap? Who is the ideal candidate for gracilis flap surgery? section with interrupted Prolene sutures. Dr. Silva-Alvarenga: Setting realistic expectations is The wound is copiously irrigated. A 15 Fr drain is placed into the bed of the gracilis muscle harvest and a crucial part of the patient selection process. The ideal continued on page 21 a 10 Fr drain is placed along the muscle and into the

SURGEONS’ LOUNGE

MARCH 2022 / GENERAL SURGERY NEWS

The Procedure, the Name: The History of the Gracilis Flap By Ronit Patnaik, MD, general surgery resident, University of Texas, San Antonio, and Lisandro Montorfano, MD, chief general surgery resident, Department of Surgery, Cleveland Clinic Florida, in Weston he first recorded implementation of plastic surgery dates to antiquity. The ancient physician Sushruta’s method of nasal reconstruction, performed sometime between 1,000 and 800 B.C., is the earliest portrayal of flap surgery.1-3 Since then, a plethora of flap reconstruction techniques have been described in the literature. Of these, the gracilis muscle flap has become an essential component of the microsurgeon’s reconstructive armamentarium. In 1952, Pickrell et al published a case series of four children on whom a pedicled gracilis muscle rotational flap was used to address end-stage anal incontinence.4 This was the first description le of the use of the gracilis muscle n this in a reconstructive procedure. In as used scenario, the gracilis muscle was hincter. to return function to the anal sphincter. Miguel Orticochea, MD, first p as a described a gracilis muscle flap 972.5 pedicled myocutaneous flap in 1972. He described a pedicled musculocuulocutaneous gracilis flap to cover a soft tissue defect over the medial mallee flap olus. Four to six weeks after the dicle had been inset, the proximal pedicle ovidof the flap was sectioned off, providfect. ing adequate coverage for the defect. Developing on this work, in 1976, Harii et al published the first case series of three patients who received a gracilis mucocutaneous free flap for reconstruction.6 They described their animal experiments and cadaver dissection prior to the clinical application of this technique to provide soft tissue coverage for the three patients. In 1976, Harii et al also published the first case series of two patients who received a gracilis muscle free flap for dynamic reconstruction of facial paralysis.7 Since these seminal developments, the gracilis muscle has been used extensively in reconstructive microsurgery for wound coverage and as a functional muscle transplant. The gracilis muscle has a constant vascular supply and innervation; furthermore, it leaves behind a negligible functional loss at the donor site. These properties make it a favorite muscle for pedicled and free flap reconstruction. Some authors argue, however, that the muscle is less reliable as a musculocutaneous flap since the vascular supply of the skin overlying the gracilis muscle is quite variable.8 The gracilis muscle is the most superficial of the adductor muscles, originating on the symphysis pubis and pubic arch. Distally, it inserts onto the medial surface of the proximal tibia. The muscle serves to adduct, medially rotate the

hip, and flex the knee and hip.9-11 It is a long strap-shaped muscle with a long distal tendon and is supplied by a long dominant neurovascular pedicle. The muscle is supplied by a dominant vascular pedicle with several minor vascular pedicles along with a single motor nerve, the anterior branch of the obturator nerve.12 Depending on the need, the gracilis muscle flap can be used as a functional or a nonfunctional tissue transfer. It can be used as a functioning free muscle tran transplantation (FFMT) for functionaal restoration. An FFMT involves tr transfer of a fresh gracilis muscl cle along with an intact nerve to the face or limb for a deficit or defect involving major muscle loss or atrophy. It then involves u using microvascular anastomoses fo for muscle revascularization and re reinnervation to allow the transfe ferred gracilis muscle to become a fu functional muscle.13 This technique ca can be used to resolve challengin ing cases such as facial paralysis, ad adult brachial plexus injury, obstetric brachial plexus palsy, Volkm mann’s contracture and several o other maladies. A nonfunctional g gracilis transfer is mainly for soft tis tissue reconstruction. It can be a fre flap or a local flap based on its free arc of rotation for local wound coverage or reconstruction. The gracilis muscle may be transferred as a pedicled flap, free flap or perforator flap. The flap may include the entire muscle, a longitudinal segment or a vertical segment. It may be muscle only or combined with skin (myocutaneous) and can be innervated to act as a functioning muscle. The gracilis muscle is optimally located to be used as a pedicled flap in the perineal area and proximal femoral triangle. As a nonfunctional pedicled flap, it has been described for coverage of exposed femoral vessels after vascular surgery,14 vulvar reconstruction,15 scrotal reconstruction16 and to promote healing of urethral repairs17 and rectovaginal fistulas.18 As previously noted, the gracilis muscle can be used as a pedicled, functional flap to reconstruct anal sphincter continence. The first description of this method was in 1952 by Pickrell.4 Since then, many authors have demonstrated success with this technique, including recent advances in electrical stimulation of the muscle to provide sphincter tone.19 The gracilis muscle has also been used for urethral sphincter reconstruction in urinary incontinence.20 The gracilis muscle is frequently used as a free flap for soft tissue coverage,

particularly for trauma patients. It has been extensively described in attempts at limb salvage of lower extremity wounds.21 It has also found utility as an option for free flap breast reconstruction. The transverse upper gracilis musculocutaneous flap, first described by Yousif et al in 1992, is a popular secondline choice for many breast reconstructive surgeons.22 Due to its smaller size and volume, its popularity is limited. The gracilis has gained widespread popularity for its use as a free flap for functional reconstruction. Since the 1976 description of a gracilis free flap to address facial paralysis, several advances have been made in the technique.7 Currently, the bulk of the gracilis muscle is dramatically reduced, which allows for a more aesthetically pleasing outcome in facial reanimation surgery.23 The gracilis FFMT has gained popularity for restoring elbow flexion in brachial plexus palsy patients, as described in the Kay et al 2010 series.24 Furthermore, the flap may be used in the forearm to develop finger extension or flexion in the brachial plexus palsy patient,25 or a single muscle may be used for more than one function as described in the Doi transfer.26 Similar methods have been described for patients with Volkmann’s ischemic contracture, where a functional muscle replacement is needed.27 The gracilis can also be used to provide hand and upper extremity reanimation in functional reconstructions as a double muscle transfer. In 2010, Terzis et al described the use of the gracilis along with the adductor longus using the common dominant pedicle for the two muscles for functional reconstruction.28,29 This technique was performed on patients with brachial plexus injuries and the gracilis provided elbow flexion while the adductor longus provided shoulder abduction. The gracilis muscle has become an essential component of a plastic surgeon’s reconstructive armamentarium. Since its first description as a pedicled flap for anal reconstruction in 1952, the described uses of the gracilis muscle in reconstruction have grown exponentially. Its popularity comes from its ability to address a variety of reconstructive challenges with minimal donor site morbidity. References 1. Champaneria MC, Workman AD, Gupta SC. Sushruta: father of plastic surgery. Ann Plast Surg. 2014;73(1):2-7. 2. Chari P. Susruta and our heritage. Indian J Plast Surg. 2003.36(4):13. 3. Johnston-Saint P. An outline of the history of medicine in India. J R Soc Arts. 1929;77(3999):843-870. 4. Pickrell KL, Broadbent TR, Masters FW, et al. Construction of a rectal sphincter and restoration of anal continence by transplanting the gracilis muscle: a report of four cases in children. Ann Surg. 1952;135(6):853-862.

5. Orticochea M. The musculo-cutaneous flap method: an immediate and heroic substitute for the method of delay. Br J Plast Surg. 1972;25(2):106-110. 6. Harii K, Ohmori K, Sekiguchi J. The free musculocutaneous flap. Plast Reconstr Surg. 1976;57(3):294-303. 7. Harii K, Ohmori K, Torii S. Free gracilis muscle transplantation, with microneurovascular anastomoses for the treatment of facial paralysis. A preliminary report. Plast Reconstr Surg. 1976;57(2):133-143. 8. Krishnan KG. An Illustrated Handbook of FlapRaising Techniques. Thieme Medical Publishers; 2008. 9. Macchi V, Vigato E, Porzionato A, et al. The gracilis muscle and its use in clinical reconstruction: an anatomical, embryological, and radiological study. Clin Anat. 2008;21(7):696-704. 10. Lyons ME, Goldman JJ. Gracilis Tissue Transfer. StatPearls [internet]; 2021. 11. Netter FH. Atlas of human anatomy. Professional Edition E-Book. Elsevier Health Sciences; 2014. 12. Mathes SJ, Nahai F, Friedman VM. Clinical Atlas of Muscle and Musculocutaneous Flaps. Mosby; 1979. 13. Wei FC, Mardini S. Flaps and Reconstructive Surgery E-Book. Elsevier Health Sciences; 2016. 14. Morasch MD, Albert DS, Kibbe MR, et al. Early results with use of gracilis muscle flap coverage of infected groin wounds after vascular surgery. J Vasc Surg. 2004;39(6):1277-1283. 15. Chen SH, Hentz VR, Wei FC, et al. Short gracilis myocutaneous flaps for vulvoperineal and inguinal reconstruction. Plast Reconstr Surg. 1995;95(2):372-377. 16. Hsu H, Lin CM, Sun TB, et al. Unilateral gracilis myofasciocutaneous advancement flap for single stage reconstruction of scrotal and perineal defects. J Plast Reconstr Aesthet Surg. 2007;60(9):1055-1059. 17. Kua EHJ, Leo KW, Ong YS, et al. Vascularisation of urethral repairs with the gracilis muscle flap. Arch Plast Surg. 2013;40(5):584-588. 18. Troja A, Kase P, El Sourani, et al. Treatment of recurrent rectovaginal/pouch-vaginal fistulas by gracilis muscle transposition–a single center experience. J Visc Surg. 2013;150(6):379-382. 19. Mander BJ, Wexner SD, Williams NS, et al. Preliminary results of a multicentre trial of the electrically stimulated gracilis neoanal sphincter. J British Surg. 1999;86(12):1543-1548. 20. Janknegt RA, Baeten CG, Weil EH, et al. Electrically stimulated gracilis sphincter for treatment of bladder sphincter incontinence. Lancet. 1992;340(8828):1129-1130. 21. Redett RJ, Robertson BC, Chang B, et al. Limb salvage of lower-extremity wounds using free gracilis muscle reconstruction. Plast Reconstr Surg. 2000;106(7):1507-1513. 22. Yousif NJ, Matloub HS, Kolachalam R, et al. The transverse gracilis musculocutaneous flap. Ann Plast Surg. 1992;29(6):482-490. 23. Fattah A, Borschel GH, Manktelow RT, et al. Facial palsy and reconstruction. Plast Reconstr Surg. 2012;129(2):340e-352e. 24. Kay S, Pinder R, Wiper J, et al. Microvascular free functioning gracilis transfer with nerve transfer to establish elbow flexion. J Plast Reconstr Aesthet Surg. 2010;63(7):1142-1149. 25. Terzis JK, Kostopoulos VK. Free muscle transfer in posttraumatic plexopathies part III: the hand. Plast Reconstr Surg. 2009;124(4):1225-1236. 26. Sakai K, et al. Reinnervated free muscle transplantation for extremity reconstruction. Plast Reconstr Surg. 1993;91(5):872-883. 27. Zuker RM, Bezuhly M, Manktelow RT. Selective fascicular coaptation of free functioning gracilis transfer for restoration of independent thumb and finger flexion following Volkmann ischemic contracture. J Reconstr Microsurg. 2011;27(7):439-444. 28. Terzis JK, Kostopoulos VK. Free muscle transfer in posttraumatic plexopathies part 1: the shoulder. Ann Plast Surg. 2010;65(3):312-317. 29. Terzis JK, Kostopoulos VK. Free muscle transfer in posttraumatic plexopathies part II: the elbow. Hand. 2010;5(2):160-170.

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SURGEONS’ LOUNGE

MARCH 2022 / GENERAL SURGERY NEWS

Gracilis Flap continued from page 18

candidate is a patient who does not smoke, has a normal body mass index, has no previous pelvic radiation and has no inflammatory bowel disease, which is normally the exact opposite of a patient who suffers with refractory or recurrent perineal fistulas and nonhealing wounds. Previous operations are usually the norm for most patients, and GMI is as difficult as any prior repair. It may often require additional procedures until the final successful outcome, even in experienced hands, as shown in the literature. Hence, GMI should be performed as a salvage procedure, after first-line approaches have failed, and a proctectomy or diverting ostomy are the only last resources. In addition, GMI should ideally be performed only by, or with the assistance of, experienced surgeons. GMI should be avoided if active infection or inflammation is present within the rectum or perianal tissue; perianal sepsis should be adequately drained. In patients with Crohn’s disease, symptoms should be medically controlled prior to proceeding with GMI. In addition, the patient’s nutritional status should be enhanced, smoking cessation accomplished, and weight loss and normoglycemia should be attained to improve outcomes. Dr. Montorfano: Perineal wounds after abdominoperineal resection can be closed primarily with buttressed muscles. The most frequently used muscles are the rectus abdominus and gluteus muscle. Is the gracilis muscle also an option? Why do you believe this muscle is less frequently used? Dr. Silva-Alvarenga: The gracilis muscle can bring vascularization and volume in the first 6 to 8 cm cephalad to the perineal floor; thus, it can be best employed in small sinuses. Key aspects of the repair include identification and removal of all sinuses. It is important to understand that incomplete filling of the cavity with well-vascularized muscle will result in failure. In cases where there is significant perineal cutaneous tissue loss, the gracilis muscle can be harvested together with an island of skin, subcutaneous tissue and fascia. This method was initially described by McGraw for vaginal reconstruction in the plastic surgery literature in order to create a myofasciocutaneous flap to improve perfusion and minimize tissue loss. This technique has been adapted over the years. The cutaneous area covering the gracilis muscle in the proximal component is harvested with a V-Y incision and rotated in the defect after mobilization of the vascular pedicle. This allows for the most distal portion of the belly of the muscle to be inserted deep into the cavity, a repair best suited for when the perineum or rectal vaginal septum is significantly damaged. Otherwise, large defects may be filled by bilateral gracilis transposition. However, it should be approached by an alternate best method, such as a rectus abdominis myocutaneous flap. Dr. Montorfano: Could you mention some new colorectal surgery advances in the treatment of perineal disease? Dr. Silva-Alvarenga: The use of biologic meshes are reasonably new options for interposition between the rectum and urethra or vagina without the use of flaps. These are acellular collagen matrixes made of biologic tissue. They can be used as “tissue grafts” to promote healing through migration of inflammatory cells and fibroblasts into the mesh, leading to dense fibrosis with gradual absorption of the mesh.

The latest advances are in situ injection of autologous or allogeneic mesenchymal stem cells (MSCs) from bone marrow MSCs or adipose tissue (adipose-derived stem/stromal cells [ADSC]) with or without the standard treatment to treat fistulizing perianal Crohn’s disease. Most of the clinical trials are early phase 1 and 2, and only one phase 3 trial has been completed to date. This trial involved allogeneic ADSCs developed by Takeda (darvadstrocel), and resulted in market approval in Europe.

after 24 and 52 weeks, respectively, compared with 41% and 41.6% for the placebo group, respectively (P=0.064 and P=0.013). The side effects were reportedly similar between the two groups, including mainly anal abscesses and proctalgia. Extension of the original ADMIRE study is being conducted in the United States in combination with a safety and adverse event follow-up. Despite the heterogeneity in the protocol designs, the data from numerous phase 1 and 2 (completed and ongoing trials) are encouraging from a safety and efficacy standpoint.11 ADSCs have also been studied for cryptoglandular fistulas in phase 1 and 2 trials with similar results to those obtained for Crohn’s disease12,13 as well as in smaller studies for refractory rectovaginal fistulas due to Crohn’s disease. However, definitive conclusions could not be drawn from these studies.12,14 ■

References 1.

Pinto RA, Peterson TV, Shawki S, et al. Are there predictors of outcome following rectovaginal fistula repair? Dis Colon Rectum. 2010;53(9):1240-1247.

Yellinek S, Sousa CB, Gilshtein H, et al. Gracilis muscle interposition for treatment of complex anal fistula: experience with 119 consecutive patients. Dis Colon Rectum. 2021;64(7):881-887.

Ruis J, Nessim A, Nogueras JJ, et al. Gracilis trasnposition in complicated perianal fistula and unhealed perineal wounds in Crohn’s disease. Eur J Surg. 2000;166(3):318-322.

Pezim ME, Wolff BG, Woods JE, et al. Closure of postproctectomy perineal sinus with gracilis muscle flaps. Can J Surg 1987;30(3):212-214.

Eccersley AJ, Williams NS. Anorectal reconstruction— restoring continence after abdominoperineal excision of the anorectum. Ital J Gastroenterol Hepatol. 1998;30(5):549-554.

Wexner SD, Ruiz DE, Genua J, et al. Graciis muscle interposition for the treatment of rectourethral, rectovaginal and pouch-vaginal fistulas: results in 53 patients. Ann Surg. 2008;248(1):39-43.

Rao SS. Current and emerging treatment options for fecal incontinence. J Clin Gastroenterol. 2014;48(9):752-764.

Garcia-Olmo D, Gilaberte I, Binek M, et al. Follow-up study to evaluate the long-term safety and efficacy of darvadstrocel (mesenchymal stem cell treatment) in patients with perianal fistulizing Crohn’s disease: ADMIRE-CD phase 3 randomized controlled trial. Dis Colon Rectum. 2021 Dec 7. doi:10.1097/DCR.0000000000002325

Panés J, García-Olmo D, Van Assche G, et al; ADMIRE CD Study Group Collaborators. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn’s disease: a phase 3 randomised, double-blind controlled trial. Lancet. 2016;388(10051):1281-1990.

Figure 2. Division of tendon.

Figure 3. Mobilization of the gracilis muscle bundle.

Most patients in these trials concomitantly received tumor necrosis factor-alpha antagonists and/or immunosuppressants. Diversity of protocol designs among the studies and heterogeneous definitions of response, clinical remission, combined clinical and radiological response, and complete or incomplete closure preclude definitive conclusions to be drawn. Still, in studies with a limited number of patients, the reported complete cure rate ranged from 46% to 90%. In the only controlled phase 3 trial (ADMIRE-CD),8 complete healing of fistulas was significantly higher compared with the placebo group. This pivotal study was conducted with allogeneic ADSCs using a randomized, double-blind, placebo-controlled design, in which 107 patients with Crohn’s disease were treated with allogeneic ADSCs versus 105 with saline (single injection into and around the fistula) for anoperineal fistulas that were initially treated with curettage and seton placement. The assessment was blinded for the gastroenterologists and radiologists for the clinical and MRI examinations, respectively. The primary end point was combined remission such as closure of all treated external fistulous orifices and absence of a collection greater than 2 cm at MRI. A secondary end point was clinical remission alone with 100% closure of external orifices. Two publications report the results at 24 and 52 weeks, respectively.9,10 Combined remission was observed after ADSC injection in 50% and 56.3% of cases after 24 and 52 weeks, respectively, versus 34% and 38.6% for the placebo group, respectively (P=0.024 and P=0.010). Clinical remission alone was observed in 57% and 59.2%

10. Panés J, García-Olmo D, Van Assche G, et al; ADMIRE CD Study Group Collaborators. Long-term efficacy and safety of stem cell therapy (Cx601) for complex perianal fistulas in patients with Crohn’s disease. Gastroenterology. 2018;154(5):1334-1342. 11. Buscail E, Le Cosquer G, Gross F, et al. Adipose-derived stem cells in the treatment of perianal fistulas in Crohn’s disease: rationale, clinical results and perspectives. Int J Mol Sci. 2021;22(18):9967. 12. Garcia-Arranz M, Garcia-Olmo D, Herreros MD, et al; FISPAC Collaborative Group. Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: a randomized clinical trial with long-term follow-up. Stem Cells Transl Med. 2020;9(3):295-301. 13. Dozois EJ, Lightner AL, Mathis KL, et al. Early results of a phase I trial using an adipose-derived mesenchymal stem cell-coated fistula plug for the treatment of transsphincteric cryptoglandular fistulas. Dis Colon Rectum. 2019;62(5):615-622. 14. Lightner AL. Stem cell therapy for perianal Crohn’s. Curr Opin Gastroenterol. 2019;35(4):311-320.

EXTENDED WOUND CARE COVERAGE March 2022

Finding the Right Covering for a Wound Experts Explore the Role Dressings Play in Wound Care By VICTORIA STERN

he ultimate goal of wound care is to accelerate healing and prevent acute wounds from becoming chronic. Part of this process involves choosing a wound dressing that complements the characteristics of the wound. The $6.6-billion market for advanced wound dressings offers dozens of variations. Both alginate dressings, composed of seaweed or kelp, and foam dressings, made of polymer solutions, can absorb exudate and keep wounds moist; collagen or silicone-based dressings help stimulate new tissue and blood vessel growth; and hydrogels and hydrocolloids allow wounds to retain moisture (Front Bioeng Biotechnol 2020. doi:10.3389/ fbioe.2020.00182). Each category of dressing may contain additional substances—calcium, honey or silver, for example—to enhance antimicrobial activity (Cellulose 2020;27:385400. doi.org/10.1007/s10570-019-02795-1). Given the array of possibilities, how do experts choose the best option for each patient? “In an ideal world, the wound dressing literature would help us choose among the many products, but unfortunately, we have minimal evidence to support the use of one product over another,” said Alex Wong, MD, the chief of plastic surgery at City of Hope Comprehensive Cancer Center, just outside Los Angeles. High-quality trials comparing the efficacy of different wound dressings are hard to come by. According to a 2014 review that examined the effectiveness of wound dressings, experts found the literature contained “much conflicting data,” with few randomized controlled trials clearly demonstrating the advantage of particular materials or categories of wound dressings (Adv Wound Care [New Rochelle] 2014;3[8]:511-529). Although the literature provides few definitive answers, “no wound or patient is the same,” and thus no single wound dressing will provide a “magic bullet” for everyone, Dr. Wong said. Like dressings, wounds come in many forms (venous skin and diabetic foot ulcers, pressure sores, radiationrelated injuries, or burns), with a range of characteristics (necrotic or infected tissue, exposed bone, or excessive exudate). Patient factors, including diabetes, peripheral artery disease, cancer and smoking, also affect wound healing. “I can purchase all of the most expensive wound dressings out there, but they won’t help if I don’t know the patient factors contributing to poor wound healing,” said Jeffrey Chang, MD, MS, an assistant clinical professor in the Division of Plastic Surgery at City of Hope. “You have to understand and treat both.” That’s why Dr. Chang begins each visit with a thorough patient exam and history: Does the patient have diabetes or hypertension? Does he have a condition that suppresses his immune system? After identifying patient risk factors, Dr. Chang focuses on the wound itself, relying on four fundamental

principles of wound care to guide his decision making. These principles, developed almost two decades ago, are represented by the acronym TIME: • T issue • I nfection/Inflammation • M oisture • E dges When examining the wound, he looks for dead or infected tissue, moisture content, and how far apart the wound edges are. For infected wounds, Dr. Chang may prefer a dressing with antimicrobial properties. If a wound is too wet, he will opt for a product that can absorb excess exudate. If the edges are far apart, he will use a leg wrap or abdominal binder to help close the wound. “By going through these stages, I can navigate my way to a more optimal dressing,” Dr. Chang noted. Jennifer Powers, MD, an associate professor of dermatology at the University of Iowa Carver College of Medicine, in Iowa City, uses a similar process to determine the most appropriate dressing. “I don’t just zoom in on the wound; I analyze my patient from head to toe to understand the multifactorial reasons for poor healing,” she said. “I look at the skin over the entire body, I do blood work to assess kidney and liver function, as well as other factors, that may cause a wound to fester.” The wound itself can point Dr. Powers toward a particular type of dressing. “I’ve had patients walk into my clinic with a diaper taped to their leg because of the exudate coming off the wound,” she said. In this case, Dr. Powers would likely go for an alginate or foam dressing to help manage the exudate. The question then becomes which variation of alginate or foam dressing is optimal. Alginate dressings, for instance, have dozens of spinoffs—some embedded with silver, others with calcium or zinc calcium. Fortunately, experts do not need to sort through dozens of options. Wound dressing choice is often driven by a hospital’s formulary, which will vary from institution to institution. “Most hospitals will have one to two options in any given class of products because stocking much more than that will be a big financial loss for an institution,” said Geoffrey Gurtner, MD, a professor of surgery and the inaugural vice chairman of surgery for innovation at Stanford University School of Medicine, in California. “I just use whatever wound dressings are available among those options.” Dr. Wong agreed that staying flexible with wound dressing choice is important. “Your hospital may not be willing or able to purchase a specific wound dressing for you, which is why I do not rely on any product in particular,” he said. When choosing among an institution’s offerings, personal experience and cost also may influence decision making. To avoid surgery, Ernest S. Chiu, MD,

Hydrogel burn dressing. a plastic and reconstructive surgeon at NYU Langone Health, in New York City, often uses skin substitutes to treat chronic, slow-healing wounds, but he questions whether the potential to accelerate wound healing by a few days justifies the higher price tag of these products. Skin substitutes can cost hundreds, even thousands of dollars, but it’s not clear whether these products are cost-effective (Adv Wound Care [New Rochelle] 2014;3[8]:511-529). The challenge for the wound care industry will be to veer away from developing more “me-too” products with slight variations and instead focus on pushing the boundaries of wound care. Dr. Chiu highlighted early work that uses artificial intelligence‒based predictive algorithms to help clinicians make diagnoses and predictions about the wound healing process (JAMA Netw Open 2021;4:e217234). Dr. Chang sees promise in biologic dressings. A recent systematic review of 25 studies found that diabetic foot ulcers treated with biologic skin substitutes were 1.67 times more likely to heal by 12 weeks compared with standard-of-care dressings (Ann Plast Surg 2019;83[4S suppl 1]:S31-S44). Other experts are investigating the use of stem cells in wound care. Although the evidence to date focuses on animal models, combining hydrogel dressings with adipose-derived stem cells, for instance, could help accelerate the healing process (J Biomed Mater Res B Appl Biomater 2019;107[2]:278-285). “It’s still early days but I think we’re heading more toward biologic-based wound dressings embedded with growth factors that can help jump-start the wound healing process as well as understanding the molecular basis of a wound in order to optimize the treatment,” Dr. Chang said. However, Dr. Chang added, “even without wound dressing products, as long as the TIME principles are followed—no dead tissue, no infection, moist environment—the body will heal. Having advanced wound dressings in our tool box helps but means we need to find the right balance between a product that is appro■ priate and a cost that is reasonable.” Dr. Wong is a key opinion leader for ACell. Drs. Chang, Chiu, Gurtner and Powers reported no relevant financial disclosures.

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IN THE NEWS

GENERAL SURGERY NEWS / MARCH 2022

Multidisciplinary Approach Best for Managing Chronic Wounds By CHASE DOYLE

s the treatment of nonhealing wounds continues to evolve, multidisciplinary care is playing an increasingly important role in the management of complicated patients. During the 2021 virtual American College of Surgeons Clinical Congress, Nicolas J. Mouawad, MD, the chief of vascular and endovascular surgery at McLaren Health Care, in Bay City, Mich., discussed the benefits of multidisciplinary wound care and how to incentivize institutional collaboration. “Patients with difficult wounds who would often be considered for amputation with a single-specialty approach can now be managed successfully with a multidisciplinary wound team,” he said. As Dr. Mouawad explained, chronic wounds are generally wounds that fail to heal through the body’s natural healing process (less than approximately 30% closure in four weeks). Whether due to anatomic site, concurrent illness or medical comorbidities, the reasons for lack of healing are often complex, with these wounds posing a significant challenge to both patients and providers. “Patients with long-term chronic wound abnormalities, particularly those with venous leg ulcers and diabetic ulcers, can suffer for months or even years, and there are significant costs to the healthcare system,” Dr. Mouawad said. “Based on Medicare data, the management of chronic wounds costs between $28.1 billion to $98.6 billion per year.”

Between 45% and 85% of all lower-extremity amputations can be avoided by using a multidisciplinary approach.’ —Nicolas J. Mouawad, MD The American Diabetes Association and American College of Foot and Ankle Surgeons, for example, promote a team approach, particularly for diabetic

wounds. Importantly, this approach can benefit myriad aspects of healthcare. “The primary outcomes are to increase wound healing rates and ultimately decrease amputation rates,” Dr. Mouawad said. “Secondary outcomes involve patient satisfaction, compliance with orthotic and prosthetic management, and ultimately health-related quality of life.” These outcomes have been repeatedly demonstrated in the global literature. A study showed an improvement

in healing rates from 23% with a single-discipline approach to 82% after the implementation of a team approach in patients with diabetic disease (Acta Derm Venereol 1995;75[2]:133-135). In addition, Gottrup et al showed healing rates of 60% over 12 months for chronic recalcitrant leg ulcers (Arch Surg 2001;136[7]:765-772), while Valdes et al reported an average eight-week healing time for venous ulcers (Ostomy Wound Manage 1999;45[6]:30-36). Finally, a

The Core Problem According to Dr. Mouawad, a major problem affecting treatment is that wounds are not considered an actual disease. This misperception leads to a lack of standardization in wound care management, a lack of reproducibility of clinical and research outcomes, an overwhelming array of similar products, and outdated measurement tools for wound evaluation. Moreover, if chronic wounds are to become a disease entity, he noted, there’s the question of who should manage the patient, given multiple stakeholders. “The management of patients with chronic wounds involves a wide range of specialties,” Dr. Mouawad said. “Taking ownership of the wound requires a multidisciplinary routine approach or a network.”

Multidisciplinary Teamwork The concept of multidisciplinary teamwork in the management of chronic wounds has been around for decades and is supported by numerous professional associations and organizations.

L I

MARCH 2022 / GENERAL SURGERY NEWS

2011 study noted that 72% of patients healed in an average of 12 weeks following a team approach (Wound Pract Res 2011;19[4]:229-233). Many studies have also reported a reduction in amputation rates associated with a multidisciplinary care strategy. In patients with diabetes, for example, the results of a five-year prospective study showed an 82% decrease in major amputations (from 36.4% to 6.7%) with use of a team approach (Diabetes Res Clin Pract 2007;75[2]:153-158). The authors also reported a 45.7% reduction in belowthe-knee amputations and a significant

EXTENDED WOUND CARE COVERAGE

decrease in high-to-low amputation ratio. “We’ve seen this over and over again, not just within the United States, but globally. Involvement of a multidisciplinary team, particularly for the diabetic foot, is associated with a reduction in the incidence of major amputations,” Dr. Mouawad said. “Importantly, between 45% and 85% of all lower-extremity amputations can be avoided by using a multidisciplinary approach.” In addition to clinical excellence, the multidisciplinary team allows for psychosocial factors that are important to patients. Patients have reported increased

quality-of-life scores, particularly in the domains of physical and emotional functioning, when treated with a team approach. A study in Denmark found 91% of patients were satisfied with the quality of technical care and empathy when a multidisciplinary wound team and wound environment was put in place (Int J Low Extrem Wounds 2009;8[3]:153-156). “It’s difficult and involves a lot of people, but multidisciplinary wound teams lead to the best management and the best outcomes for these patients,” Dr. Mouawad concluded. ■

Choosing the Right Dressings for Chronic Wounds Matthew Murphy, MD, PhD, an assistant professor of plastic and reconstructive surgery at Stanford University School of Medicine, in California, noted that choosing the right dressing for chronic wounds can shorten time to healing, relieve pain and suffering, and reduce the economic burden on both the patient and healthcare system. Dr. Murphy highlighted these three types of dressings that can aid the healing process:

1. Hydrocolloids, an occlusive dressing composed of a hydrocolloid matrix bonded to a vapor-permeable film or foam backing, are known to many wound care physicians, and consist of two main types: hydrocolloid and fibrous hydrocolloid (reserved for moderate to severe wounds). Hydrocolloids absorb exudate, provide thermal insulation, promote a moist wound healing environment, prevent bacterial contamination, reduce friction and shear, and promote epithelial migration.

2. Matrices are tissue-engineered products that act as a tissue scaffold and provide a supporting structure into which cells can migrate. Matrices may be sourced from biologic tissue (animal, human or plants), synthetic materials, and composite materials containing two or more components. “The ideal matrix is one that most closely approximates the structure and function of the native extracellular matrix that it is replacing.”

3. Amniotic products are those obtained from normal amnion/chorionic membrane or umbilical tissue of live newborns. These products undergo proprietary processing for sterility, preservation and retention of growth factors. “Within these dressings, there is a host of regulatory proteins, growth factors, cytokines and chemokines that participate in healing.”

IN THE NEWS

GENERAL SURGERY NEWS / MARCH 2022

Life and Limb: Advances in the Management of the Diabetic Foot By CHASE DOYLE

f untreated or unsalvageable, the diabetic foot requires surgical interventions to address the risks to its viability. However, recent advancements in the field suggest that surgeons may not always have to sacrifice a limb to save a life. During the 2021 virtual American College of Surgeons Clinical Congress, Lucas M. Ferrer, MD, described the use of endovascular venous arterialization for limb salvage, and William P. Robinson, MD, discussed the timing of foot amputation after revascularization.

Chronic Limb-Threatening Ischemia According to Dr. Ferrer, an assistant professor of surgery at Dell Seton Medical Center at The University of Texas Hospital, in Austin, approximately 185,000 amputations are performed

annually in the United States, and the primary ‘When the perfusion increase cause is vascular disease after a revascularization is (54%). But for many patients, marginal or the tissue level at the specific vascular disease driving their chron- the amputation is marginal, ic limb-threatening a delayed amputation is ischemia remains unclear. While most studies on recommended to allow the peripheral artery disease maximum perfusion benefit.’ have focused on above—William P. Robinson, MD the-ankle artery disease, for example, less is known about foot artery disease. In a 2018 study, Ferraresi and colleagues hypothesized that and independently associated with critpatients with peripheral artery disease ical limb ischemia, diabetes and dialysis. can be afflicted with both big artery Of the 1,613 patients with symptomatic disease and small artery disease, over- peripheral artery disease who underwent lapping at the foot level (J Cardiovasc angiography, approximately 25% had sigSurg (Torino) 2018;59[5]:655-664). nificant small artery disease. Their retrospective analysis showed “For patients with disease in both that small artery disease was strongly major vessels and small arteries, there

really are no great options, either with an endovascular or open approach,” Dr. Ferrer said. “We need to start looking for new solutions.”

Endovascular Venous Arterialization for Limb Salvage When all classic methods have

10 Things to Know About Hyperbaric Oxygen Therapy By CHASE DOYLE

ith two more indications approved by the FDA in 2021, hyperbaric oxygen (HBO) therapy continues to gain wide acceptance as an adjunct modality for problematic wounds. During the 2021 Symposium on Advanced Wound Care fall meeting, Jayesh B. Shah, MD, the president of South Texas Wound Associates, in San Antonio, shared the top 10 things that every provider should know about HBO therapy. They include the differences between topical and systemic HBO therapy, as well as various indications, contraindications and side effects.

more than the correction of hypoxia. Under normal atmospheric pressure, Dr. Shah explained, hemoglobin binds to oxygen. However, in a hyperbaric environment, resting cellular oxygen requirements can be met by plasma dissolved oxygen alone. As pressure increases, the number of molecules of oxygen in the plasma also increases, which can be extracted by the body to help heal hypoxic wounds.

9. Life Can Exist Without Blood In the 1960s, Boerma et al conducted an experiment that showed that life without blood is possible under hyperbaric conditions. Pigs breathing pure oxygen at 3 ATA (atmosphere absolute) were completely exsanguinated, but the volume of fluid in the circulatory system was maintained, and the oxygen supply remained sufficient (Ned Tijdschr Geneeskd. 1960;104:949-954). After being reinfused with their own blood, the pigs “lived happily ever after,” Dr. Shah said.

8. HBO Is More Than the Correction of Hypoxia Research has demonstrated HBO’s mechanisms are

According to Dr. Shah, infrared spectroscopy may be useful to monitor oxygenation within the wound beds and surrounding tissue. The effect of HBO therapy on diabetic foot ulcers can be documented via near-infrared spectroscopy, said Dr. Shah, who noted that the technology evaluates functional tissue oxygen saturation.

5. Most Approved Indications Are Emergency Indications Although the majority of indications approved for HBO therapy are emergency indications, the number of HBO treatment centers treating emergency indications has decreased. Fewer than 10% of HBO centers with at least one chamber are available for emergency HBO therapy, said Dr. Shah, who noted that electively scheduled patients being treated for wound healing dominate most hospital-based and freestanding HBO facilities.

10. HBO Is Old HBO therapy has been around for more than 150 years in the United States, but its history spans much longer. In fact, the first record of a pressurized chamber used to treat medical conditions dates to 1662 in England. While the popularity of the technique has ebbed and flowed, Dr. Shah said, there are now more than 3,000 centers in the United States, and the list of indications approved by insurance plans continues to expand.

6. Infrared Spectroscopy to Monitor Oxygenation

“The rate at which wounds heal is oxygen dependent,” Dr. Shah said, who noted that all wounds have a hypoxic center of variable size. “Periwound hypoxia alters local responses to infection and local tissue reparative processes, but HBO leads to improved oxygen delivery.”

7. tcpO2 Predicts Failure to Heal Better Than ABI The ankle brachial index (ABI) is the ratio of blood pressure at the ankle to blood pressure in the upper arm and is used to noninvasively check for peripheral artery disease. Transcutaneous oximetry (tcpO2), on the other hand, is the only method to measure the local oxygen released from the capillaries through the skin. “tcpO2 measures oxygen molecules, not saturation,” Dr. Shah said. “It outperforms ABI in predicting the healing of foot ulcers and in predicting limb amputations.”

4. Only 1 Absolute Contraindication The only absolute contraindication to HBO is untreated pneumothorax, which needs to be treated prior to HBO therapy. Relative contraindications include chemotherapy agents and active cancer, pregnancy, a history of middle ear surgery or optic neuritis, pulmonary pathologies, chronic sinusitis, seizure disorder, and viral infections. Physicians also should weigh the risk versus benefit of HBO therapy for patients with confinement anxiety before initiating treatment, Dr. Shah said.

3. HBO Therapy Is Extremely Safe The safety of HBO therapy has long been demonstrated, but patients and providers should be aware of specific side effects. At the 2021 virtual American College of Surgeons Clinical Congress, Ernest S. Chiu, MD, the director of the Helen L. and Martin S. Kimmel Hyperbaric and Advanced Wound Healing Center at

MARCH 2022 / GENERAL SURGERY NEWS

failed or are impossible, Dr. Ferrer noted that arterialization of the distal veins of the foot may be considered a useful revascularization technique for limb salvage. In one study of 60 arterializations, 36 were successful (60%), while the other 24 patients had poor results followed by a major amputation. No deaths were associated with the reversed circulation (Ann Chir 2001;126[7]:629-638). This technique was adapted in the PROMISE I trial. Using a proprietary LimFlow stent-graft system to achieve foot vein arterialization in an endovascular fashion, the investigators demonstrated a limb salvage rate of approximately 70% at 12 months (J Vasc Surg 2021;74[5]:1626-1635). “We observed decreased wound area over time and an increased percentage of completely healed wounds,” said Dr. Ferrer, who acknowledged that the procedure is still in the early stages of development. “The technique still needs more refinement, and there are more questions than answers at this stage.

NYU Langone, in New York City, noted common and reversible adverse effects include barotrauma to the ear and myopia. Serious adverse events are rare but include seizures, congestive heart failure, pulmonary edema and retinal changes. Complications occur in less than 1% of HBO treatments, and the most common complication is ear pain, Dr. Chiu added.

2. Topical Oxygen Therapy Is Not HBO Topical oxygen has gained traction as a technique to facilitate wound healing dynamics, and there is evidence to support its benefits, but the approach should not be confused with HBO therapy, Dr. Shah said. While the latter consists of breathing oxygen at increased atmospheric pressure, topical oxygen involves the placement of a local device that is pressurized with oxygen over an extremity. In the future, topical oxygen may be combined with HBO therapy to facilitate healing, he said.

1. The FDA Just Approved 2 New Indications The FDA approved two new indications for HBO: acute central retinal artery occlusion and idiopathic sensorineural hearing loss. There are now 14 approved indications. “If your healthcare provider recommends HBO therapy, the FDA advises receiving the treatment at a hospital or a facility that has been inspected and is accredited by the Undersea and Hyperbaric Medical Society,” Dr. Shah said. ■

EXTENDED WOUND CARE COVERAGE

“Foot vein arterialization requires dedicated collaboration between vascular surgery, internal medicine, podiatry and wound care to be successful because the learning curve is very steep,” he concluded.

Timing of Foot Amputation After Revascularization For patients with diabetes who require minor amputation of noninfective necrotic tissue and revascularization, the risk for major amputation approaches 50% at one year. According to Dr. Robinson, a vascular surgeon at Southern

Illinois University School of Medicine, in Springfield, time is tissue, and in these situations, “aggressive debridement, including amputation, if necessary,” must be undertaken without delay. Although Dr. Robinson acknowledged a lack of clear, high-level evidence to support definitive recommendations, he emphasized that revascularization should precede definitive minor amputation and closure. “When revascularization provides a good, palpable pulse of the foot and the tissue at the proposed level of amputation is good quality, concurrent amputation is

advised,” he said. “However, when the perfusion increase after a revascularization is marginal or the tissue level at the amputation is marginal, a delayed amputation is recommended to allow the maximum perfusion benefit. “Endovascular perfusion may be different, and in these cases, it probably makes sense to delay the minor amputation, if possible,” Dr. Robinson added. “But clearly given the lack of evidence in this field, we need more research on these outcomes to drive our patient selection and optimize limb salvage in these patients.” ■

GENERAL SURGERY NEWS / MARCH 2022

‘Auf Hinweis’: Translating the Operative Note continued from page 1

people, perhaps “Operationsbericht,” or “Chirurgisch Notiz” would be more appropriate or accurate translations. The German title was used to represent the work our coding professionals do when trying to assign the correct meanings in translating our narrative notes for the procedures we perform. As Dr. Frederick Greene pointed out in his December 2021 editorial [“Templative Operative Reporting: A Caveat,” page 3], synoptic reporting is being revisited to provide the “whole view.” Increasingly, the reality that surgeons’ narrative reports miss elements that affect financial and data extraction functions would seem to suggest we should evaluate the process of procedural documentation. Synoptic reporting has been introduced successfully in other medical disciplines, such as pathology and radiology, to cover elements that could be, and sometimes are, omitted by the recording physician. The Committee on Cancer has adopted the synoptic process for selected malignancies to facilitate data analysis and comparison. Increasingly, surgical subspecialties use registries in pursuit of the capability for comparative analysis. Consider the American College of Surgeons National Surgical Quality Improvement Program (NSQIP),

the Metabolic and Bariatric NSQIP, the Society of Thoracic Surgeons, among many others. In the January 2014 issue of the Journal of the American College of Surgeons common (218[1]:113-118), operative report training—including synoptic style—was evaluated by 441 program directors, who concluded that the synoptic style was not common. Additionally, although teaching operative documentation was considered valuable, it is not widely done. If we separate the functions of the procedural documentation into parts, we could consider several, including but not limited to: • narrative • medicolegal • billing and coding • data retrieval elements The narrative approach is clearly the long-standing technique, dating to the origins of surgery several thousand years ago. This is perhaps because surgeons regarded their work as an art form serving the population. Recording the techniques would be used for teaching purposes and expression of pride in accomplishment. When we look today at narrative procedural descriptions, many different personalities emerge. Although the ranks

Clearly, our survival as surgeons depends in part on improvements and efficiencies that can be elucidated by appropriate data entry and analysis. Many surgeons have a poor understanding of the reimbursements offered by third-party payors to cover the expensive tools we use. Data analysis can help. of documentation minimalists are many, elaborate multiple-page descriptions also exist for similar operations that document elements of operative events in painstaking detail. The medicolegal protection or exposure can be debated, but there is no question the procedural note can be viewed retrospectively, and differing conclusions can be drawn about the conduct and execution of the operation. While some surgeons feel more detail is always better, the documentation minimalist would obviously not share this opinion. The billing and coding function of the operative note has been increasing in importance ever since the American

Medical Association released the Current Procedural Terminology (CPT) coding book in 1966. Surgical coding involves a five-digit code between 10000 and 69990, broken down into the system addressed. Unfortunately, all our narrative descriptions must be translated into one of the existing codes for accurate usage. Some surgeons are quite facile at selecting the appropriate codes that match the narratives produced, whereas others leave the selection to the health information management professionals who read and assign codes based on content. Differences in work relative value units (wRVU) in families of codes can be significant based

Residents on Par With Attendings in ‘Appropriately Selected’ Cases continued from page 1

The investigators would like more residents to perform appropriately selected cases independently before graduating. This, they say, will better prepare residents for independent practice and increase the number of surgeons who go into general surgery rather than subspecialties. “The status quo of decreased autonomy … is not helping residents, not providing an immediate benefit to patients and hurting the patients long term because graduating residents are less prepared for independent practice,” said lead author Joseph B. Oliver, MD, MPH, the chief of general surgery and an assistant chief of surgical services, VA New Jersey Health Care System in East Orange. He is also the residency site director for the general surgery residency program at Rutgers New Jersey Medical School, in Newark. The study is based on a retrospective review of more than 1.3 million surgical procedures recorded in the VA Surgical Quality Improvement Program database between July 1, 2004, and Sept. 30, 2019. Operations performed by surgical residents without an attending surgeon were matched on a 1:1 ratio to those performed by an attending surgeon alone

‘Our recommendation would require every general surgery chief resident demonstrate that they can independently and safely perform appropriate general surgery cases from start to finish by graduation.’ —Joseph B. Oliver, MD, MPH

as well as procedures performed jointly by a resident and an attending surgeon. The analysis included 101,130 pairs of resident- and surgeon-performed procedures, as well as 137,749 pairs of resident-performed and jointly performed procedures. There was no statistically significant difference in patient mortality, all-cause morbidity or length of stay between surgical procedures performed by residents alone versus by attending surgeons alone or in combination. Operations done by residents alone

took longer than those carried out by attending surgeons (median, 80 vs. 70 minutes; P<0.001), but were shorter than those carried out by residents and surgeons together (median, 71 vs. 73 minutes; P<0.001). This is the first study to explicitly compare surgical procedures performed by residents alone with those performed with assistance. Resident autonomy in the OR has steadily decreased over the past four decades, beginning with the death of Libby Zion, who died in 1984 under

the care of residents. Residents’ operating autonomy was further curtailed by a 2002 ruling by the Centers for Medicare & Medicaid Services requiring an attending surgeon to be present during “critical portions” of an operation. Finally, duty-hour restrictions instituted by the Accreditation Council for Graduate Medical Education in 2003 further limited residents’ time in the OR. Today, studies have shown that general surgery graduates report low confidence in their ability to operate independently. As a result, four in five graduating surgical residents pursue a fellowship and become surgical subspecialists. Efforts are underway to address autonomy and skills development in resident training. Almost a decade ago, the American Board of Surgery, or ABS, began mandating cases in which the chief resident operates as a teaching assistant for junior residents, building a system of graduated autonomy. Since then, the number of procedures performed by senior residents serving as teaching assistants increased to 40.3% in 2018, up from 24.4% before the change. But this policy has not led to more residents performing operations

MARCH 2022 / GENERAL SURGERY NEWS

on one word in the narrative. (The wRVU is the reimbursement integer that is consistent regardless of geography.) Many wRVU changes are based on the size of a lesion down to the millimeter, depending on specific location, and others require specific disclosure of the level or depth of surgical dissection, changing the meaning and wRVU. We are charged with producing the operative note immediately after an operation; occasionally this involves a brief note followed later by the complete narrative, and this is shared with other nurses and doctors involved in the case. If changed later, the operative note can be incongruous with that recorded by the others involved. Benchmarks are used to compare surgeons in several hospitals. Perceived quality can be affected by omitting coding details not known by the surgeon or included in the operative note. A diagnosis of appendicitis versus acute appendicitis versus appendicitis with abscess carries a different expected length of stay and severity of illness assignment, which affects hospital reimbursements. The more complicated versions cannot be inferred simply because the patient’s stay is longer or has a persistent fever. The data collection function, which should help us efficiently manage our expenses and the diseases we treat, is disappointingly lacking. A surgical colleague and friend, Dr. Bruce Ramshaw, has

dedicated his surgical career to building tools to help data aggregation. He quipped to me that professional baseball, among other businesses, does a much better job than surgery with statistical analysis based on data entry. More than 25 years ago, elaborate statistical analysis was used in baseball to discern the minutiae necessary to compare performance and efficiency. In medicine, we have so many discordant systems that comparisons are almost impossible to make due to the lack of consistent entry (“garbage in, garbage out”). Clearly, our survival as surgeons depends in part on improvements and

efficiencies that can be elucidated by appropriate data entry and analysis. Many surgeons have a poor understanding of the reimbursements offered by third-party payors to cover the expensive tools we use. Data analysis can help. Data analysis can uncover practices that can be improved for patient benefits. Data analysis can be used to improve facility efficiency and financial stability. Data analysis can help patients trust where care delivery is likely to be superior. Obviously, this is a critical addition that can be bolstered by this function of procedural documentation.

As we work with so many electronic health record tools, clearly tools exist to help. My bias is to continue to develop hybrid tools that allow narrative documentation but also offer a synoptic format to serve coding, billing and data requirements. Surgeons are typically resistant to change, but when change creates benefits that are financially rewarding and helpful, they should be considered. ■ Dr. Newman is a surgeon from Gadsden, Ala. He is the chief medical information officer at Nuance Healthcare and the founder of Nuance SCAPD.

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independently, as the guidelines are vague, Dr. Oliver said. He and colleagues would like the ABS to take a new approach. “Our recommendation would require every general surgery chief resident demonstrate that they can independently and safely perform appropriate general surgery cases from start to finish by graduation,” he said. In an invited commentary, Jonah J. Stulberg, MD, PhD, and his colleagues from the Department of Surgery at the McGovern Medical School, in Houston, argued that residents’ ability to safely complete operations without an attending surgeon is “only the tail end of autonomy.” They said attendings can provide granular information about residents’ skills using tools like the Zwisch scale, a four-part model categorizing the level of guidance provided by faculty to residents, and the System for Improving and Measuring Procedural Learning, a smartphone-based system for evaluating residents after each operation. Even so, they said the study provides reassurance that “providing residents with graduated autonomy does not have ■ to compromise patient care.”

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GENERAL SURGERY NEWS / MARCH 2022

New Society Tackles Issues of Surgical Injury, Ergonomics By MONICA J. SMITH

urgery is a broad and dynamic specialty with an expansive roster of subspecialties. What’s one thing that unites them? Unfortunately, it’s work-related pain and injury. Now there is a professional society, the Society of Surgical Ergonomics (SSE), dedicated to enhancing the well-being of surgeons and other procedure-based specialists by promoting and advancing the scientific discipline of ergonomics. “Surgery is going through a profound cultural and technological change, mainly driven by the business model of medicine that focuses on productivity and output. It’s such a rapid change that it’s hard to convince administrators that it’s about more than this month or even this year’s revenue. They have yet to learn (or accept) that if people get injured at work, it hurts productivity and output,” said Mary L. Brandt, a professor of surgery at Tulane Medical Center, in New Orleans, and senior author of “Working Through the Pain: Surgical Culture and Musculoskelloskeletal Injury” (Curr Surg Rep 2021;9[18]. [18]. doi:10.1007/s40137-021-00295-5). “A workplace should never be designed in such a way that preventable able injuries happen, which is unfortunately ately the world that surgeons live in now,” w,” Dr. Brandt said. “It’s important we tackle this problem together. Ergonomic injuries lead to tremendous pain and suffering, and also increase costs and directly impact patient care. That’s why I’ve been writing about this topic for a while, and why I was delighted to learn that like-minded surgeons took the next step and founded the Society of Surgical Ergonomics.” Dr. Brandt joined the SSE shortly after learning about it on Twitter, which is where the nascent organization got its start in fall 2020. It began with a tweet chat when Geeta Lal, MD, MSc, mentioned an ergonomics curriculum she’d developed for residents after struggling with work-related pain herself. “People started chiming in, saying, ‘You have an ergonomics curriculum? We should be talking about this,’” said Dr. Lal, an associate professor of surgery and pediatrics and an endocrine surgeon at the University of Iowa, in Iowa City, and the inaugural president of the SSE. Before long, they had formed an interest group with surgeons and human factors and ergonomics specialists meeting monthly on Zoom. They developed a charter and pondered how best to advance their mission: Should they be part of another existing surgical society or form one of their own? “We realized that ergonomics issues crossed surgical specialties and that if we wanted funding, we had to be our own entity,” Dr. Lal said. Philip I. Haigh, MD, MSc, an endocrine and oncologic surgeon with Kaiser Permanente Los Angeles Medical Center and the treasurer of the SSE, began researching how to set up a nonPhilip I. Haigh, profit organization. It took a lot MD, MSc of form filing, but within about six

months, the SSE was granted 501c(3) status. Since then, the society has been having regular Zoom meetings and gaining members. The group is planning a virtual conference this September and an in-person conference in 2023. “Going from an interest group to a society to a first conference usually takes four to five years. We’re moving at lightning speed,” Dr. Lal said.

The First Step: Acknowledging There’s A Problem Presentations on ergonomics have become familiar components of surgical conferences, which suggests a ubiquitous need. But surgeons have often felt on their own coping with work-related pain and injury, reluctant to discuss their suffering with colleagues. Dr. Haigh struggled to overcome his own discomfort in asking fellow thyroid surgeons if they suffered from the same intense neck pain he experienced.

‘A number num of people have retired early because they’re in too much pain to do beca their jobs. That’s a detriment to society, thei it’s a detriment to patients who need to see them, and it’s a quality-of-life issue for surgeons.’ —Geeta Lal, MD, MSc “It really wasn’t talked about 10 years ago. But I started asking people at meetings, ‘Do you have pain in your neck when you do thyroids?’ And so many people would say yes.” Susan Hallbeck, PhD, PE, CPE, the Robert D. and Patricia E. Kern Scientific Director for and a professor of health care systems engineering at the Mayo Clinic Kern Center for the Science of Health Care Delivery in Rochester, Minn., and the president-elect of the SSE, has witnessed this reticence time and again in her 20 years’ experience with surgical ergonomics.

‘When I gave talks at surgical societies, it wouldn’t be until someone … said, “I’vee had three cervical laminectomies,” and thenn everyone else acknowledges their own work-related injuries and surgeries. So many people just accept this as the costt of doing business, but this is not OK.’ —Susan Hallbeck, PhD, PE, CPE “When I gave talks at surgical societies, it wouldn’t be until someone, usually the president, said, ‘I’ve had three cervical laminectomies,’ and then everyone else acknowledges their own work-related injuries and surgeries. So many people just accept this as the cost of doing business, but this is not OK,” Dr. Hallbeck said. To Tara Cohen, PhD, CHSE, an associate professor and the director of surgical safety and human factors research at Cedars-Sinai Medical Center, in Los Angeles, and the secretary of the SSE, the personal and

‘Just because you can standd in an awkward position for hours doesn’t mean the environment should allow you to.’ —Tara Cohen, PhD, CHSE institutional acceptance of pain and injury in the workplace runs counter to the fundamentals of physicians’ work: improving patient safety and well-being as well as hospital efficiency. “But how can we expect this if the people doing all the work are in pain or uncomfortable? Just because you can stand in an awkward position for hours doesn’t mean the environment should allow you to.” In the long run, the self-sacrifice many surgeons live with in order to help patients sabotages their ability to do so. “A number of people have retired early because they’re in too much pain to do their jobs. That’s a detriment to society, it’s a detriment to patients who need to see them, and it’s a quality-of-life issue for surgeons,” Dr. Lal said. “No one should have to leave the workforce before they’re ready.”

What It Will Take to Fix the Problem The SSE is multispecialty and multidisciplinary, bringing together surgeons, human factors researchers, occupational medicine experts, and physical and occupational therapists. The society is open to physicians, nurses, physician assistants, scientists, and students and trainees of these disciplines, which is rare for a surgical society. “We need a group of multiprofessional individuals to work together to tackle this problem,” Dr. Cohen said. But that raises the question: Pain and injury have been practically synonymous with surgery since its inception. Can this problem be fixed? “Yes. Is it something we can do in six months? No,” Dr. Hallbeck said. According to organizers, fixing the problem means cchanging a g the culture from one that accepts pain as part of the job to accept one th that challenges it. It means educating surgeons on how to protect themselves from the demands of thems their profession. It means convincing institutions that safeguarding the musculoskeletal health of their workforce is in their best interest. It means working with industry to improve ergonomic design for all the hands that hold their instruments. “It’s going to take a lot of people and a lot of cooperation, but this is the first step,” Dr. Hallbeck noted. “We haven’t had a way to bring all the thought leaders together before, but now we are actually getting the right people together to make coordinated projects across different institutions, and this is how we’re going to move the ball forward.” For more information, visit the SSE’s website at www.societyofsurgicalergonomics.org and follow it on ■ Twitter @SurgErgoGroup.

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MARCH 2022 / GENERAL SURGERY NEWS

Study Addresses Insurance Coverage for Fertility Treatments for Residents By CHRISTINA FRANGOU

ery few general surgery residents have insurance coverage for fertility treatments and/or fertility preservation, according to a study presented at the 2021 American College of Surgeons Clinical Congress. This insurance gap forces residents to pay out of pocket or forgo treatments entirely during training, which overlaps with critical years for fertility. In a survey of residents working at 344 accredited categorical general surgery residency programs and 60 breast fellowship programs, only 7.7% said their insurance covered fertility treatments. Coverage for fertility preservation was even more rare, available to 3.4% of residents. But the number of residents who would pursue fertility preservation, if covered, is nearly 10-fold that number. One-third of residents said they were interested in fertility preservation. Female general surgery residents, especially, wanted fertility preservation, with 43.5% planning to undertake these services if covered. The study’s lead investigator Caiwei (Alison) Zheng, BA, an MD/MPH candidate at the University of Miami, said gaps and delays in insurance coverage can have devastating consequences for a trainee’s family planning goals. Surgeons who delay childbearing until after residency may face increased risk for complications or infertility, research has shown. “We hope our study can be the catalyst to spark a dialogue regarding fertility support and residency programs,” Ms. Zheng said. Breaking down barriers to family planning and fertility preservation will help address an “epidemic of physician infertility,” she added. Ms. Zheng and her co-authors urge surgery program directors and attending surgeons to counsel trainees to undergo fertility assessments as part of their annual physical. “We think that is a low-hanging fruit to get the conversation started and help trainees stay informed,” she said. The survey respondents included 155 female and 75 male trainees. Residents were rarely counseled on fertility planning, but it was more common among women than men (16.8% vs. 4.2%; P=0.009). Female residents were more likely to say their programs were unsupportive, at 16.2% compared with 8% for men. This study is thought to be the first to look at insurance coverage for fertility treatments among surgical residents. Peter Kim, MD, a general surgeon in New York City, who moderated the ACS session where the study was presented, said insurance coverage for fertility

treatments and preservation should be included in the benefits that residents receive during their training. “They require adequate benefits in terms of life insurance, disability urance insurance and health insurance rtable in order to feel comfortable enough to practice good survergery,” Dr. Kim said. Covernts age for fertility treatments and preservation should be made available to

residents, he said. “We need to make sure these needs are being met in order for the doctors to be able to do their jobs and be happy with their careers.” Other research has shown nearly one-third of female physic physicians with infertility say they would have attempted conception co earlier, while 17% would have gone into a different specialty and 7% wish

they had used cryopreservation to extend their fertility (J Womens Health [Larchmt] 2016;25[10]:1059-1065). In the survey presented at the meeting, residents said the decision to postpone having children came down to three main factors: time, career/education goals and cost, cited by 93.2%, 63% and 59.5% of residents, respectively. “These prohibitive factors are modifiable and disproportionately affect ■ women,” Ms. Zheng said.

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OPINION

GENERAL SURGERY NEWS / MARCH 2022

The Importance of Psychological Performance Skills To Surgical Performance By MICHAEL J. ASKEN, PhD; VANESSA A. HORTIAN, DO, MS, LAC; COLBY ELDER, MD; RUSSELL OWENS, MD; and HAROLD YANG, MD, PHD

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ased on articles in the surgical literature, there is a pattern of increasing recognition of and interest in using psychological performance skills as tools to maximize the performance of surgeons.1,2 The focus of this literature is on optimizing surgical skill, but also managing the stresses inherent in surgery and a surgical career, with the overlap being obvious.3 The reasons for this increasing emphasis are not entirely clear. It is suggested that it may have evolved from using visual memory images for learning anatomy.4 Another etiology may be the need for managing the multiple stressors reported by surgeons.5 Most likely, the success of psychological performance skills shown in enhancing performance in other elite and high-stress human endeavors—such as the military, policing, firefighting and athletics—has suggested that these skills have a role in surgery, as was described for emergency medicine.6,7 While the literature promotes the value of such skills, it is not readily apparent what surgeons actually think about those skills or the value of psychological training in general for enhancing surgical performance. An early attempt to assess these attitudes was that of McDonald and colleagues who interviewed 33 practicing surgeons, some of whom were considered “elite” by their peers.4 Among the various aspects of mental skills and surgical excellence that were explored in their study, two areas are of particular relevance to the current trend in the literature. When asked the relative importance of technical, mental and physical preparation for excellence in surgery, the mean responses were 41%, 49% and 10%, respectively. A different assessment approach asked surgeons to describe differences in their feelings about factors that influence successful and unsuccessful procedures, and the greatest (significant) difference was in mental readiness. While these findings seem to support a growing interest in the value of psychological skills for surgeons, the original study is now over 25 years old. Given the evolution of surgery since that time and the increase in relevant articles in this area, we wanted to assess contemporary views held by surgeons on the role of psychological performance skills in surgical performance. We constructed a survey that asked surgeons about their perceptions of the relative contributions of technical skills (speed, precision, etc.), psychological performance skills (focus, anticipation,

managing stress, etc.) and physical skills (physical condition, endurance, etc.) in regard to surgical excellence, source of surgical error and effective response in an emergency situation. The survey also asked whether the surgeons ever received any training in psychological performance skills, whether psychological skills should be a component of ranking applicants to surgical residency programs and to what degree, whether they believed psychological performance skills can lengthen a surgeon’s career, and how important it is to train resident surgeons in psychological performance skills. After institutional review board approval, a sample of 50 surgeons from a university-affiliated health system in Pennsylvania completed the survey. Thirteen different subspecialties were represented. Our results indicated that the mean number of years in practice for this group was 20.4, with a range of one to 44 years. The sample was composed of 45 men (90%) and five women (10%). When asked to report their perceptions of the relative contribution of technical skills, psychological performance skills and physical skills to surgical excellence, the surgeons reported the following (Table 1). Table 1. Surgeons’ Mean Estimation of Relative Contribution of Relevant Skills to Surgical Excellence Technical skills

51.1% (range, 15%-80%)

Psychological skills

31.1% (range, 10%-75%)

Physical skills

17.1% (range, 5%-40%)

When asked to report their perceptions of the relative contribution of technical skills, psychological performance skills and physical skills to the “etiology of surgical errors,” the surgeons reported the following (Table 2): Table 2. Surgeons’ Mean Estimation of Relative Contribution of Relevant Skills to Surgical Error Technical skills

36.4% (range, 5%-80%)

Psychological skills

46.7% (10%-90%)

Physical skills

16.2% (range 0%-50%)

When asked to report their perceptions of the relative contribution of technical skills, psychological performance skills and physical skills to effectively

managing a “surgical emergency,” the surgeons reported the following (Table 3): Table 3. Surgeons’ Mean Estimation of Relative Contribution of Relevant Skills to Management of Surgical Emergencies Technical skills

38.9% (range, 10%-80%)

Psychological skills

46.4% (range, 10%-90%)

Physical skills

14.8% (range, 0%-40%)

When asked to report whether they were ever trained in psychological performance skills for surgery, 43 (88%) responded they had not, while six (12%) reported such training. Of those who described receiving such training, one indicated it was through a national organization and one indicated it was part of psychiatric training. When asked to report whether they believed psychological performance skills could lengthen a surgeon’s career, 39 (78%) indicated “yes”; nine (18%) indicated “maybe”; and two (4%) indicated they “did not know.” None responded “no” to the possibility of psychological performance skills having a salutary effect on a career (Table 4). Table 4. Surgeons’ Opinions on Whether Psychological Performance Skills Can Lengthen a Surgeon’s Career Yes

39 (78%)

0 (0%)

Maybe

9 (18%)

Unsure

2 (4%)

When asked to report whether they believed that psychological skills should be considered in ranking surgical residency program applicants, 44 (90%) reported in the affirmative. Surgeons reported they felt a mean weight of 31% (range, 9%-65%) of the decision to accept an applicant into a surgical training program should be based on psychological skills.

The last question asked surgeons about the importance of residents to be trained in psychological performance skills. Of the responding surgeons, 24 (50%) indicated that such training was “essential”; 21 (44%) indicated it was “important”; and three (6%) indicated it would be of “little value” (Table 5). Zero surgeons responded there would be no value to the training. Table 5. Surgeons’ Estimation of the Importance of Psychological Performance Skills for Surgical Residents Essential

24 (50%)

Important

21 (44%)

Little value

3 (6%)

No value

0 (0%)

Although a small respondent subgroup, the responses from surgeons suggesting that psychological performance skills would be “little value” to residents are interesting. Despite seeing little value in psychological skills training, this group reported that a mean of 16% of surgical excellence was due to psychological performance skills; a mean of 21% contributed to surgical errors; and a mean of 27% of effective response in an emergency situation was attributed to psychological performance skills. So, somewhat perplexingly, psychological performance skills were reported as being an influence in all the various aspects of surgical performance discussed, although training in these skills was seen as being of little value.

Discussion Results from this study should be considered with caution due to the nature and limited size and breadth of the population. However, several results are worth consideration and further exploration. Overall, surgeons reported a perception that psychological performance skills affect the quality of surgical performance in several ways. Almost onethird of surgical excellence (31.1%) is

OPINION

MARCH 2022 / GENERAL SURGERY NEWS

ascribed to psychological skills. While this is somewhat less than that reported in the earlier study (49%) and less than the influence ascribed to technical skills (51.1%), this is a substantial influence.4 Of particular significance is that psychological performance factors are given more weight as a cause of surgical errors than technical skills (46.7% vs. 36.4%). Although specific data are not reported by McDonald et al, in the earlier study, this finding seems to parallel theirs in that the main factor in the difference between a successful and unsuccessful procedure was mental readiness.4 Of note, effective response in a surgical emergency was also reported to be most greatly influenced by psychological factors (46.4%). The potential value of psychological performance skills seen by surgeons is reflected in 78% of this sample endorsing the belief that these skills can lengthen a surgical career. While some surgeons were more equivocal in their responses, none denied any positive influence. Further evidence of a perceived value and role for psychological performance skills is seen in 90% of the surgeons in this group, indicating that psychological skills should be considered when rating surgical residency program applicants. Further, it was suggested that almost one-third (31%) of the acceptance decision should be based on this factor. How to best do this, and especially in the age of COVID19, is worthy of further exploration. Perhaps most telling is that 94% of the surgeons responded that that resident training in psychological performance skills was “essential” or “important” (50% and 44%, respectively). Only three surgeons suggested such training would be of “little value.” This aligns with a study of Canadian surgeons where 88% of residents and 56% of staff surgeons indicated interest in obtaining training in techniques for performing under pressure.8

education. The surgical literature offers approaches to this.9-12 And, surgeons seem willing and interested in such training.13 ■ Special appreciation is expressed to Yijin Wert, MS, for her advice and help with the statistical analysis for this paper.

5. Arora S, Sevdalis N, Nestel D, et al. Surgery. 2010;147(3):318-330.

12. Asken M, Yang H. SIM: The Surgeon’s Imagery Mindset: Performance Enhancing Mental Imagery and the Optimization of Surgical Skill. Amazon Kindle; 2020.

6. Deshauer S, McQueen S, Mobilio M, et al. Ann Surg. 2021;274(1):195-198.

13. Mason V, Balloo S, Upton D, et al. RCS Annals. 2009;4:321-325.

7. Asken M, Kochert E, Wyatt A, et al. Resuscitation. 2020;146:32-33. 8. Percy D, Streith L, Wong H, et al. J Can Chir. 2019; 62 (6): 482-487.

References 1. Asken M, Morgan E, Owens R. General Surgery News. 2021 Dec 28. bit.ly/33ZwO7t. 2. Snelgrove H, Gabbott B. BMC Med Educ. 2020;20:221. 3. Anton N, Lebares C, Karipidis T, et al. J Surg Res. 2021;263:A1-A12. 4. McDonald J, Orlick, T, Letts M.

Contemporary Thought Performance Enhancement. 1994;3:13-32.

9. Anton N, Bean EA, Hammonds SC, et al. J Laparoendosc Adv Surg Tech A. 2017;27(5):459-469. 10. Asken M, Yang H, Aboushi R, et al. Am J Surg. 2020;221(4):775-776. 11. Rosenthal R, Rosales A, Menzo E, et al. Mental Conditioning to Perform Common Operations in General Surgery Training. Springer; 2020.

—Dr. Asken is the director at Provider Well-Being, UPMC Harrisburg, in Pennsylvania. Dr. Elder is a surgical resident at UPMC Harrisburg. Dr. Hortian is a surgical resident at UPMC Harrisburg. Dr. Owens is the chair of the Department of Surgery at UPMC Harrisburg. Dr. Yang is the director of the general surgery residency program at UPMC Harrisburg.

The news you need. Whenever you want.

Conclusion Considerable variation is seen among individual surgeons as to their views of how much psychological performance skills can affect various aspects of surgical performance, with a range from 10% to 90%. However, these results suggest that contemporary surgeons perceive an important influence of psychological performance skills on important aspects of surgical practice. This may be especially true for influence on surgical errors and managing surgical emergencies, where psychological performance skills are rated as more influential than technical skills. Despite this variation, very few surgeons reported any training is these skills and comprehensive psychological skills training is limited. These results suggest the need for greater integration of psychological performance skills in surgical

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IN THE NEWS

GENERAL SURGERY NEWS / MARCH 2022

Getting to the Source of Chronic Groin Pain continued from page 1

how surgeons can better treat patients with pain, General Surgery News interviewed Dr. Jacob. GSN: What spurred this presentation? Dr. Jacob: My career has become super-specialized in treating patients who are suffering from chronic pain and chronic groin pain, and I soon realized that there was so much more needed to help people suffering from chronic pain than just my surgical skill set. GSN: It looked like your presentation focused on nonsurgical approaches to hernia pain. Can you elaborate? Dr. Jacob: In 2021, we published a study in Surgical Endoscopy designed to study the outcomes following hernia mesh removal with robotic technology [2021 Nov 1. doi:10.1007/s00464-021-08835-x]. Even though we do a great surgery to get the mesh out, we are only curing somewhere between 60% and 70% of the patients fully. This means there is a small cohort of patients still suffering chronic pain symptoms that despite mesh going in and then coming out, they still have pain. This cohort of patients is often challenging to manage for a variety of reasons. Those patients are sometimes angry, and very quick to blame the mesh, the mesh companies and the surgeons, but there is always more to their suffering. So, I tried to set up a unique session to address this small cohort of patients. GSN: You mentioned in your talk that surgeons can contribute to the problem of chronic pain after a hernia. Can you explain? Dr. Jacob: One common reason patients get post-op hernia pain is because the surgeon may have repaired a hernia that wasn’t the only cause of the pain. Missing parts of the full history and failing to thoroughly work up the patient before surgery can often be the reason chronic pain continues. The second most common reason patients get postop hernia pain may also, innocently, be our fault. This involves unrecognized intraoperative or postoperative issues, dismissing the patient’s early postoperative complaints; not knowing how to, or having time to, properly and thoroughly work up or treat the patient’s postoperative pain complaints; not believing the surgery could be the source of the pain, when in reality, it probably has to be related. In some cases, patients subjected to that cycle are then experiencing gaslighting. They know the surgery must be related to the new pain, but the doctors keep denying it is possible. When that patient finally gets relief, for example with mesh removal, that patient can then develop new post-traumatic stress disorder from that experience. This can then continue to prolong their pain cycle if not managed with proper interventions or even therapy. There are also people in this unique cohort of chronic pain sufferers who come to the surgical table with preexisting, undiagnosed trauma before they have surgery, and then they can have two hits: 1) trauma from the gaslighting after the most recent surgery, and 2) older trauma from something else that is causing them longstanding, unconscious pain. As surgeons, we may be doing our job really well, but we may not be acknowledging or treating all the ingredients that have gone into that patient’s suffering. The surgery sometimes cures only a piece of the person’s journey toward healing. So, I wanted to introduce some

alternative therapies besides surgery.

studies currently underway looking at the risks and benefits for treating PTSD, eating disorders, depression, anxiety and suicidal ideation (Curr Opin Psychiatry 2022;35[1]:22-29). MDMA was even the focus of a recently published phase 3, double-blind, randomized trial in Nature Medicine in May 2021, that showed MDMA was useful for PTSD (Nat Med 2021;27[6]:1025-1033). The Multidisciplinary Association for Psychedelic Studies (MAPS), led by Rick Doblin, is paving the way for most of this research. Interested readers should check them out. I strongly believe that one day, once legal, more rigorously studied and more widely accepted, these medicines, along with experienced therapists to work with them and the patients who need them, will have a role in helping patients suffering from PTSD after chronic groin pain from hernia repairs and hernia mesh, as well as from any traumatic surgery they may have experienced.

GSN: What are some of these alternative approaches that can benefit patients with chronic groin pain? Dr. Jacob: The first thing, before you get into any of these alternative therapies, is to make sure that you have really truly eliminated all the things that you can cure with surgery. You have to eliminate back, hip and pubic bone sources of pain as well. Finally, you have to eliminate musculoskeletal injuries. But once that is all eliminated, then treatment options include nonmedical and medicine therapy, such as meditation and mindfulness, yoga, Pilates, Reiki, acupuncture, traditional Chinese medicine and, when that is not working, behavioral psychotherapy, and possibly even psychedelic-assisted psychotherapy. My two cents on traditional psychotherapy is that the current medications used today in these patients, including the addictive narcotics and some common anxiolytic and common antidepressants, can mask the existence of the pain, whereas the alternative therapies that I am recommending help the person find the true source of their As surgeons, we may be doing our job really well, but we pain and work through it. In the simplest form, it’s helping may not be acknowledging or treating all the ingredients people achieve self-forgivethat have gone into that patient’s suffering. ness and self-love, as weird as that might sound some—Brian P. Jacob, MD times. Understanding that the source of pain has finally been treated—accepting that you were indeed unheard for a GSN: What is the main message you want to get out period of time, and therefore failed to find definitive about your talk? treatments for many years, and now it’s time for for- Dr. Jacob: The messages I want to get out are threefold: giveness—is important. Working through the sources of 1. Please take a thorough history for all your hernia and pain with a therapist can be very helpful. A lot of peogroin pain patients, even if it seems likely that the ple are angry and they hold onto the pain for that reapain is from the hernia. The days of missing other son. Patients in pain just want their normal lives back causes of groin pain need to wind down sooner than and that sometimes takes time. later. Fixing a hernia but missing the other source only adds a variable for the cause of groin pain, makGSN: Can you explain more about psychedelicing the patient even harder to evaluate. assisted psychotherapy? Dr. Jacob: Within the world of psychedelic-assist- 2. Our patients who are complaining of new pain after ed psychotherapy (PAP), the main modality we have a hernia repair are really in pain; that pain may not today is ketamine-assisted psychotherapy, and the fully resolve and may become chronic (more than results are pretty promising, but not perfect in terms 12 weeks of it); and those patients need reassurancof treating PTSD, depression and anxiety (Am J Psyes that we will stick with them until the pain source chiatry 2021;178[2]:193-202; JAMA Psychiatry is found and managed, no matter how long it takes. 2014;71[6]:681-688). Ketamine for PTSD is becoming If we cannot figure out the source, which does hapmore mainstream. Ketamine clinics [for treating PTSD, pen from time to time, then we should try to help anxiety and depression] are set up now in New York, the patient connect to a surgeon who can continue Toronto, Texas, California, Nevada, Oregon, Baltimore to help further. and a few other places. But there are other very exciting and promising 3. For those pain patients who seem to be spiraling no modalities coming down the pike, like psilocybin- and matter what you do to help them, we need to ask MDMA (3,4-methylenedioxymethamphetamine)them if they want to consider alternative therapies assisted psychotherapy. These novel modalities are to help them work through their experience. There dependent on a dedicated and compassionate therapist is a true benefit if the patient is open to it, and it can ■ experienced in working with these types of medicine, as help them in the short and long term. well as the importance of the integration periods that follow the treatments. The medicines themselves alone Dr. Jacob reported equity in Human Xtensions, will not work. As an empathogen-entactogen, MDMA International Hernia Collaboration and ViaSurgical, has been heavily researched already, with many new and a consultantship with Medtronic.

MARCH 2022 / GENERAL SURGERY NEWS

Surgical Innovation: Taking an Idea All the Way continued from page 1

Brainstorming: Source of Ideas The blinding flash of inspiration is a rare thing. Most ideas are generated through the process of brainstorming, once you’ve identified a clinical need: the problem, the population affected by it and the outcome you wish to achieve. One way to think about this is in the form of “a way to” statement, said Elisabeth Wynne, MD, a pediatric surgeon at Dayton Children’s Hospital, in Ohio, using the example of arteriovenous fistulas and grafts, which are prone to failure. “’A way to’ reliably hemodialyze endstage renal patients that reduces accessrelated complications,” she said. With the needs statement established, identify participants—yourself, colleagues, experts outside your specialty and even outside your industry—who may be able to confer a unique perspective, and a facilitator capable of bringing out the best in each participant. Pick a time of day when your participants will feel most creative; a comfortable room with props that invite fiddling, fidgeting and rapid prototyping (sticky notes, pipe cleaners, Legos); and a spontaneous frame of mind. “As surgeons, we’re used to the analytical mindset. But the generative mindset uses knowledge for inspiration, focusing on multidisciplinary perspectives and waiting to validate ideas,” Dr. Wynne said. Honor the brainstorming rules of deferring judgment, encouraging wild ideas, listening, generating quantity, building on the ideas of others and capturing ideas visually. Once you’ve generated ideas, find a way to organize them. “One of the best ways to do this is mind mapping,” Dr. Wynne said, grouping ideas into the different ways they meet the clinical need. Then build prototypes: representations that “look like,” “act like” or “function/interact like.” “The benefit of prototyping is that it allows you to rapidly cycle through ideas using a rough estimation and moving to the right idea,” Dr. Wynne said. “And then you iterate. You brainstorm and prototype, prototype and brainstorm.”

Patent Protection and Intellectual Property At its essence, a patent prevents competitors from using your idea for their own profit. To get one, you need to show that you have a novel idea—at least one feature that has never been described before—and that you have freedom to operate, meaning that you’re not infringing on another patent without permission. “A lot of what goes into filing a patent

is searching older patents to make sure you don’t infringe,” said Dan E. Azagury, MD, the chief of bariatric and minimally invasive surgery at Stanford University School of Medicine, in California, and the director of education at the Stanford Byers Center for Biodesign. There are two types of patents: a provisional patent, which is an easy-to-file, inexpensive process that protects your idea for 12 months while you file the nonprovisional patent, a more complicated entity that involves lawyers, their fees, dozens of pages of documentation, and review by the U.S. Patent and Trademark Office. If you intend to file a patent, bear in mind timing and public disclosure. “If you’re planning to present your new tool or concept at, for example, the ACS meeting, you have to file a provisional patent before your presentation. Once you present it publicly, it is considered public knowledge and is no longer patentable,” Dr. Azagury said. Also, be aware that if you’re employed by an academic institution, signed an intellectual property document and made more than incidental use of your university’s resources to develop your idea, they own it. “But that is not automatically a bad thing; if you have to defend your patent, having a university back that patent is an immense deterrent to anyone who would like to infringe,” Dr. Azagury said.

Engaging Industry Investment Large medical manufacturers have good reasons to invest in inventors’ ideas: They may be able to accelerate development much more rapidly, building on an inventor’s idea and prototype than generating something organically within their own corporation. Collaboration also helps them mitigate risk if a smaller organization is willing to share the

burden of a development process that might not end in a commercially viable product. “If you as a startup person are willing to take on this journey, that’s important to industry,” said Brian J. Dunkin MD, FACS, the chief medical officer for Boston Scientific, Endoscopy. Before presenting your idea to a large organization, think about why you picked that company. “Because they’ll be asking the same thing. How is your device going to be better in the world because this company can deliver it?” Dr. Dunkin said. You’ll want to think about how your device or idea fits in with their sales process, how manufacturable it will be, how

collaboration with a large corporation might bring down the cost of production and the device’s potential geographic reach. It’s also helpful if you can present an idea that has already reached some level of development. “Large industries will pay a premium for your idea to be taken all the way to a commercial product and brought to market; while ideas are interesting to talk about, they’ll pay much more for something that’s not back-ofnapkin,” Dr. Dunkin said. “Industry and surgeons need each other to collaborate and bring good ideas to life; we need that in order to offer better patient care.” ■

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OPINION

GENERAL SURGERY NEWS / MARCH 2022

Text Without Context: The Downsides of Consumer-Based Medicine continued from page 1

information without explanation and text without context. Indeed, the benefits of taking health into one’s hands ought to lead to motivation to lose weight, increase exercise, get more restful sleep, follow national guidelines for cancer screening and staying updated with vaccinations. Yet, the last 10 years have seen a contrarian rebound of denial and frustrated prerogative with regard to basic healthcare recommendations. Moreover, the all-too-easy access to boundless information of variable quality or utility is slowly eroding and undermining trust in the medical system and physicians. Not only this, but the ability to pick and choose what to read and believe depending on one’s needs creates an extraordinarily skewed perception of medicine. Emboldened by the limitless knowledge of the internet, some patients may go as far as to engage in unfounded arguments about what should and should not be done as part of a screening or treatment plan. One example is the unrestricted access to one’s own medical records, which has led some patients to focus on arbitrary details without an understanding of what they mean. Unexpectedly and without reason, an anesthesiologist may be questioned by a patient’s father regarding the dose of rocuronium used for his child’s induction—a dose that was higher than that suggested on certain medical websites. The anxiety and frustration provoked by such a discovery were not only unprompted and unnecessary but also counterproductive, as it undermined trust in the physician who had adjusted the dose according to experience and physiologic factors unique to that patient. As parts of medicine have shifted toward a consumer mentality, physicians are struggling to stay afloat. The 15 minutes allotted for a meaningful discussion and examination are slowly becoming dominated by an exasperating attempt to “undo” the misinterpretation of the human body provided by so many online resources. Rather than reviewing the risks and benefits of a cholecystectomy, the focus of the discussion is now often shifted on why dissolving the stones is not feasible, practical or recommended despite what some online resources may suggest. To further empower certain individuals, concierge medicine has allowed for a surreptitious bypass of the medical system. The 24/7, 365day availability of an MD who can perform house visits, interpret daily inpatient laboratory results and provide a protective set of eyes from the seemingly predatory system may seem reassuring. The in-house physicians, however, may suddenly find themselves with double the work having to discuss management decisions with the patient and their family, as well as with the personal physician. While having an easily available provider who can translate information to patients may be convenient at times, it can also lead to contradictions and

Years of medical training were suddenly dwarfed by the enormity of the information that I could get from a simple scan—more than I even thought was possible. confusion when there is disagreement about the plan. Furthermore, it also serves as a constant reminder of the unspoken distrust that patients armed with knowledge have against their treating doctors. While browsing titles of online journals, I found myself drawn to the appeal of the $225 same-day fullbody MRI advertisement. The sharp, beautiful, deep blue photograph that inspired reassurance and trust promised to screen for more than 500 cancers and diseases. Years of medical training were suddenly dwarfed by the enormity of the information that I could get from a simple scan—more than I even thought was possible. Enticed by the idea of my personal radiological health concierge and curious to experience the lure that so many of my patients do, I clicked and requested a free quote. Within seconds, I could schedule an appointment with impeccable flexibility that molded into my calendar, not the other way around. I was reassured that there is no insurance copay—a strange relief, considering that the expectation for such exams is an out-of-pocket expense. By contrast, scheduling an ankle x-ray to evaluate for a fracture took all but 17 minutes, several phone calls and rearranging my schedule. The full-body examination promised answers to questions I did not even know I had. The ankle x-ray would instead answer a concrete question on the presence or absence of a fracture. The

thought of a full-body scan was akin to opening Pandora’s box—both tantalizing and intimidating. And to further fuel my intrigue, I knew with near certainty that such a sensitive scan would find something of which I was not aware of in my body. Perhaps an anatomic variant. Perhaps scar tissue. Perhaps retroperitoneal mass that I would never know about. During residency, I had operated on several patients with benign incidentalomas discovered on such recreational scans. Could one say with 100% certainty that what seemed like a benign retroperitoneal fatty tumor was indeed harmless? Certainly not. Scared of the prospect of missing a cancer, we let ourselves be pursued by anxious patients. Not unexpectedly, with every reassuring pathology report would be a minor, but real, postsurgical complication, often just a result of pushing the body just over the edge with a major operation, heavy medications, anesthesia and all the secondary procedures entailed. Knowledge, as tempting as it may be, is not always empowering. At times, it may paradoxically prove to be quite harmful. To push this dilemma even further is to consider the downstream effects of such information. Although a patient may opt to purchase an elective scan with their own resources, once a suspicious finding is identified, the responsibility is suddenly shifted toward the medical system and its own resources to confirm, diagnose and treat the pathology. A healthcare system that is already challenged by limited resources is now forced to chase zebras that were once upon a time invisible and harmless. Albeit written with ardor, this article’s purpose is not to discourage knowledge, transparency or empowerment of patients. Rather, the goal is to stir a discussion regarding an ever-evolving field of medicine in which decisions are being shifted subtly and perhaps involuntarily. The appeal of the internet and limitless resources is palpable and extremely attractive, even to the most educated of us. Before we allow ourselves to slide unconsciously into an entirely different cosmos where medical decisions, screening opportunities and important discussions are made out of anxiety and availability of resources, we ought to stop and acknowledge where we are today, in 2022. The starting step is not the paternalistic medical system. There is no going back to the ways of medicine from a generation ago. Our generation of physicians has a different and much more complex task—that of providing context to meaningless text. ■ —Dr. Baiu is a clinical instructor of general surgery at Stanford University, in California. Editor’s note: Opinions in General Surgery News belong to the author(s) and do not necessarily reflect those of the publication.

PRODUC T ANNOUNCEMENT

Activ Surgical’s Imaging Module, ActivSight™, Available Now Activ Surgical, a digital surgery imaging startup based in Boston, is announcing the commercial availability of its ActivSight™ multimodal imaging module during SAGES 2022. The company is focused on enhanced intraoperative visualization capabilities for surgeons that combine advanced augmented reality, artificial intelligence and machine learning technology. The ActivSight imaging module interfaces with existing vision systems to enable surgeons to view critical physiologic structures and functions, such as real-time blood flow, that cannot be seen with the naked eye while in the operating room. To request a demo of the ActivSight imaging module, contact events@activsurgical.com.

KCENTRA® (Prothrombin Complex Concentrate [Human]) For Intravenous Use, Lyophilized Powder for Reconstitution Initial U.S. Approval: 2013 BRIEF SUMMARY OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KCENTRA safely and effectively. See full prescribing information for KCENTRA. WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential beneﬁts of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding. • Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with KCENTRA in clinical trials and post marketing surveillance. Monitor patients receiving KCENTRA for signs and symptoms of thromboembolic events. • KCENTRA was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. KCENTRA may not be suitable in patients with thromboembolic events in the prior 3 months. (5.2) ------------------------------------INDICATIONS AND USAGE---------------------------------KCENTRA, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deﬁciency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with: • acute major bleeding or • need for an urgent surgery/invasive procedure. (1) -----------------------------DOSAGE AND ADMINISTRATION--------------------------------For intravenous use after reconstitution only.. • KCENTRA dosing should be individualized based on the patient’s baseline International Normalized Ratio (INR) value, and body weight. (2.1) • Administer Vitamin K concurrently to patients receiving KCENTRA to maintain factor levels once the effects of KCENTRA have diminished. • The safety and effectiveness of repeat dosing have not been established and it is not recommended. (2.1)

• Administer reconstituted KCENTRA at a rate of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min (~210 units/min). (2.3) Pre-treatment INR 2–< 4 4–6 >6 Dose* of KCENTRA (units† of 25 35 50 Factor IX) / kg body weight Maximum dose‡ (units of Not to exceed Not to exceed Not to exceed Factor IX) 2500 3500 5000 Dosing is based on body weight. Dose based on actual potency is stated on the vial, which will vary from 20 31 Factor IX units/mL after reconstitution. The actual potency for 500 unit vial ranges from 400-620 units/vial. The actual potency for 1000 unit vial ranges from 800-1240 units/vial. † Units refer to International Units. ‡ Dose is based on body weight up to but not exceeding 100 kg. For patients weighing more than 100 kg, maximum dose should not be exceeded.

---------------------------------DOSAGE FORMS AND STRENGTHS-------------------------KCENTRA is available as a white or slightly colored lyophilized concentrate in a single-dose vial containing coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S. (3) --------------------------------------CONTRAINDICATIONS -----------------------------------KCENTRA is contraindicated in patients with: • Known anaphylactic or severe systemic reactions to KCENTRA or any components in KCENTRA including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin. (4) • Disseminated intravascular coagulation. (4) • Known heparin-induced thrombocytopenia. KCENTRA contains heparin. (4) ----------------------------------WARNINGS AND PRECAUTIONS---------------------------• Hypersensitivity reactions may occur. If necessary, discontinue administration and institute appropriate treatment. (5.1) • Arterial and venous thromboembolic complications have been reported in patients receiving KCENTRA. Monitor patients receiving KCENTRA for signs and symptoms of thromboembolic events. KCENTRA was not studied in subjects who had a thrombotic or thromboembolic (TE) event within the prior 3 months. KCENTRA may not be suitable in patients with thromboembolic events in the prior 3 months. (5.2) • KCENTRA is made from human blood and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. (5.3) -----------------------------------ADVERSE REACTIONS---------------------------------------• The most common adverse reactions (ARs) (frequency ≥ 2.8%) observed in subjects receiving KCENTRA were headache, nausea/vomiting, hypotension, and anemia. (6) • The most serious ARs were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis. (6) To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Revised: July 2020

For hemodynamically unstable patients on warfarin

SEVERE GI BLEEDS CALL FOR IMMEDIATE INTERVENTION Act fast in the face of these unstable vitals* PT-INR >2 Moderate-to-severe bleeding Heart rate >100 bpm Blood pressure <90/60 mmHg

Choose Kcentra for urgent warfarin reversal Learn more about Kcentra and GI bleeds at kcentra.com/case-studies

FASTER ACTING† Superior INR reduction at 30 minutes after end of infusion vs plasma

FASTER ADMINISTRATION, LOWER VOLUME

SUSTAINED INR REDUCTION‡

Statistically significant INR reduction sustained ≤1.3 for up to 8 hours vs plasma

Mean infusion time is under 25 minutes ~85% less volume vs plasma

SCAN TO LEARN MORE

*Not inclusive of all symptoms of hemodynamic instability. †In 2 head-to-head trials, Kcentra demonstrated superiority to plasma in 3 of 4 efficacy endpoints. Superior hemostatic efficacy in the Urgent Surgery/Invasive Procedures trial and equally effective hemostasis efficacy in the Acute Major Bleeding trial. Faster INR reduction (to ≤1.3 at 30 minutes after end of infusion) in both head-to-head trials. ‡8 hours for Urgent Surgery/Invasive Procedures trial and 12 hours for Acute Major Bleeding trial. Administer vitamin K concurrently to patients receiving Kcentra. Vitamin K is administered to maintain vitamin K-dependent clotting factor levels once the effects of Kcentra have diminished.

Important Safety Information WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months.

Indications Kcentra is a blood coagulation factor replacement indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K

antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Kcentra is for intravenous use only.

Important Safety Information Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra is also contraindicated in patients with disseminated intravascular coagulation. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT). Hypersensitivity reactions to Kcentra may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment. In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis. Kcentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated. Please see full Important Safety Information on the following page. Please see enclosed full prescribing information, including boxed warning.

Kcentra is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC. Kcentra® is a registered trademark of CSL Behring GmbH. Biotherapies for Life® is a registered trademark of CSL Behring LLC. ©2021 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA www.CSLBehring.com www.Kcentra.com KCT-0122-DEC21