February 2022 Print issue by McMahon Group

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

February 2022 • Volume 49 • Number 2

Physical Therapy: An Integral Part of Abdominal Wall Reconstruction

MONEY MATTERS

How Do Surgeons Get Fairly Compensated for Their Work? Exploring Payment Models Outside the Typical Volume-Based Approach

By KATE O’ROURKE

hen many patients undergo abdominal wall reconstruction, usually they do not work with a physical therapist throughout their recovery period. According to Howard Levinson, MD, an associate professor in the Departments of Surgery, Pathology and Dermatology at Duke University Medical Center, in Durham, N.C., this probably should change. At the 2021 annual meeting of the American Hernia Society, Dr. Levinson delivered a lecture on how physical therapy should be an integral part of an abdominal wall reconstruction practice. “When a patient undergoes hand surgery or leg surgery for musculoskeletal disease, they

By MICHAEL VLESSIDES

lthough formulaic compensation models integrating quality and payment are quickly becoming the norm in healthcare systems across the United States, such models may fail to account for the breadth of contributions made by physicians, including surgeons. In a panel session during the 2021 virtual American College of Surgeons Clinical Congress, surgeons representing the academic and rural community settings explored the different models to ensure they and their colleagues are adequately compensated for their efforts. Continued on page 10

Continued on page 8

The State of Telemedicine in Surgery

AI in Surgery: Promise Mixed With Uncertainty

Expert Panel Discusses Current and Future Trends

By MICHAEL VLESSIDES

OPINION

Decisions Forced on Us by COVID-19 By HENRY BUCHWALD, MD, PhD hD

By KATE O’ROURKE

t the 2021 virtual annual American College of Surgeons Clinical Congress, current and future trends in telemedicine in surgery and surgical education were discussed by three experts: Aaron Lesher, MD, an associate professor of surgery and pediatrics at Medical University of South Carolina, in Charleston; Joe Sharma, MD, the vice chair of quality, patient safety and care innovation at Emory University, in Atlanta; and Christopher Schlachta, MD, a professor of surgery at Schulich School of Medicine and Dentistry, in Western University, London, Ontario.

rom complex intraoperative decision support to the automation of robotic tasks, artificial intelligence (AI) may have the potential to forever change the face of modern surgical practice, but the road ahead is peppered with uncertainty. In a panel session during the 2021 virtual American College of Surgeons Clinical Congress, a trio of clinicians discussed the promise and pitfalls of AI, along with its potential future directions. In discussing the potential benefits of AI, Elsie G. Ross, MD, explained that every technology adopted in surgery has its own unique pros and cons. Nevertheless, the advancement of AI may help to address

Continued on page 14

IN THE NEWS

6 Preventing and Managing Parastomal Hernias T H E SURGEONS’ LO U N G E

12 Patient With Partial Gastric Band Erosion T H E SCIENTIFIC G REATS

22 Mary Edwards Walker, MD facebook.com/generalsurgerynews

@gensurgnews

Continued on page 16

he trademark of a surgeon n has been the ability to makee decisions and take responsibili-ty for them. This is a standard of the profession, often involvingg critical, life-and-death choices and outcomes for patients. In addition, a surgeon’s decisions affect coworkers, the institution and professional discipline. Certainly, these decisions are integral to the surgeon’s personal life, family, income and community. Continued on page 18

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IN THE NEWS

FEBRUARY 2022 / GENERAL SURGERY NEWS

Metabolic Surgery Helps Protect Against COVID-19 Complications By CHRISTINA FRANGOU

n people with obesity, weight loss achieved through metabolic surgery was associated with improved outcomes after COVID-19, according to a study published in JAMA Surgery (2021 Dec 29. doi:10.1001/ jamasurg.2021.6496). The finding comes from a retrospective cohort of 5,053 adult patients who underwent weight loss surgery rgery between Jan. 1, 2004, and Dec. 31, 2017, at the Cleveleveland Clinic Health System and 15,159 propensity score– core– matched patients who did not have metabolic surgery. ery. Patients tested positive for SARS-CoV-2 at about ut the same rate in both groups: 9.1% among surgical al patients and 8.7% in the nonsurgical arm. However, individuals who had undergone weight loss surgery had a 49% lower risk for hospitalization, 63% % lower risk for need for supplemental oxygen and d a 60% lower risk for severe disease during a 12-month onth period after contracting COVID-19. The researchers, led by Ali Aminian, MD, the director of the Bariatric and Metabolic Institute at Cleveland Clinic, said the findings “represent the best available evidence on the implications of a successful weight loss intervention for COVID-19 outcomes.” There is an established link between obesity and poor outcomes after COVID-19 infection. But this study demonstrates that obesity is a modifiable risk factor. By losing weight several years earlier with surgery, patients had a reduced risk for adverse outcomes with COVID-19.

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

At the time of their COVID-19 diagnosis, patients in the surgical group had achieved 20.0 kg lower body weight and better glycemic control compared with presurgical levels. They’d lost 18.6% more body weight over time compared with patients who didn’t undergo surgery. Patients with substantial and sustained weight loss “were likely physically and physiologically better equipped to cope with an infection that has the poten-

retrospective design, including unknown confounders, misclassification bias, patients lost to follow-up and control selection bias. Moreover, the study did not compare patients who were actively pursuing medical or behavioral interventions for obesity. It shows only that successful weight loss can be protective against severe COVID-19 complications. In an invited commentary, Paulina Salminen, MD, PhD, of the Department of Surgery at the University of Turku, in Finland, and her colleagues SARS-CoV-2 positive patients who had SARS-CoV argued that metabolic surgery should be considundergone weight loss surgery had a 49% ered medically necessary (JAMA Surg 2021 Dec 29. undergon doi:10.1001/jamasurg.2021.6549). lower risk for f hospitalization, 63% lower At many places around the country, weight loss for supplemental oxygen risk for need n surgery is classified as an elective procedure and was put on hold during surges of COVID-19 to preand a 60% lower risk for severe an serve scarce healthcare resources. disease during a 12-month “As the COVID-19 pandemic continues, health care professionals who make decisions regarding pperiod after contracting health care use must acknowledge the cumulating CCOVID-19. evidence of obesity as a modifiable disease that is a predisposing factor for COVID-19 infection, as supported by this current study,” Dr. Salminen and her tial for multiorgan involvement,” the authors concluded. Three-fourths of patients were female; they were a colleagues wrote. In June 2020, the American Society for Metabolic mean age of 46 years. The study excluded anyone with a history of organ transplant, cancer or precancerous and Bariatric Surgery issued a statement, saying metdiagnosis, alcohol use disorder or alcohol-related medi- abolic and bariatric surgery should not be considered cal condition, dialysis, ascites, cardiac ejection fraction elective (Surg Obes Relat Dis 2020;16[8]:981-982). The organization said these operations are “medically less than 20%, HIV, peptic ulcer disease, or a recent necessary and the best treatment for those with the lifeemergency department admission before surgery. The study has significant limitations due to its threatening and life-limiting disease of severe obesity.”■ 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.

Peter K. Kim, MD Bronx, NY

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BULLETIN BOARD

GENERAL SURGERY NEWS / FEBRUARY 2022

HEARD HERE FIRST

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

1 Mesh Removal: How Much Does

“Regardless of all the burdens thrust upon us by our imperfect system, AI is poised to reduce administrative strains, improve patient outcomes and augment surgical training.” From “AI in Surgery: Promise Mixed With Uncertainty,” pages 1 and 16.

Surgical Approach Matter?

2 Military Surgery: Saving Life, Limb, And Livelihood ▼

SOCIAL MEDIA Follow General Surgery News online at

facebook.com/ generalsurgerynews @gensurgnews

3 Opioid Prescribing for Safe, Effective Postsurgical Pain Management

4 The ‘Difficult’ Gallbladder: Approaches to Different Clinical Scenarios

COMING NEXT ISSUE Surgical Innovation: Taking an Idea All the Way

“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.” — Elisabeth Wynne, MD

Black Race Strongest Predictor of Lymphedema After Axillary Node Dissection By KATE O’ROURKE

lack race and use of neoadjuvant chemotherapy (NAC) are associated with higher rates of breast cancer–related lymphedema, according to the results of a prospective screening study. The study, presented at the 2021 San Antonio Breast Cancer Symposium (GS4-01), involved analysis of 276 patients with breast cancer undergoing axillary lymph node dissection (ALND) and radiation. Enrolled patients underwent measurements of arm volume and body mass at baseline, postoperatively and at six-month intervals. Lymphedema was defined as a relative increase in arm volume of at least 10% from baseline. At trial enrollment, the median age was 48 years and median body mass index was 26.4 kg/m2. Sixty percent of the trial participants were white, 20% Black, 11% Asian and 6% Hispanic. At a median follow-up of 22.6 months, 56 of the trial participants had developed lymphedema. The two-year lymphedema rate was 39.4% in Black women, 27.7% in Hispanic women, 23.4% in Asian women and 20.5% in white women. On multivariable analysis, the

researchers found that Black race was the strongest predictor of lymphedema development, with a 3.5-fold increased incidence of lymphedema in Black women compared with white women (P<0.001). “The etiology for the higher incidence of lymphedema in Black women is largely unknown but may be due to race-based differences in inflammatory reactions, tissue fibrosis and lymphatic function,” according to lead investigator Andrea Barrio, MD, an associate attending physician in the breast service, Department of Surgery, at Memorial Sloan Kettering Cancer Center, in New York City. Hispanic women in the study had a threefold increased risk for lymphedema compared with white women; however, the Hispanic study population was small, and the researchers said further research is necessary to confirm these findings. The researchers also identified a higher incidence of lymphedema in patients who had NAC than in those who underwent up-front surgery, with lymphedema rates of 30.9% and 11.1%, respectively (P=0.017). “We postulate that neoadjuvant chemotherapy may cause fibrosis of

tumor-filled lymphatics as well as lymphatic endothelial damage prior to surgery, resulting in the higher lymphedema incidence observed in our study,” Dr. Barrio said at a press conference during the meeting. “In patient subsets unlikely to achieve a nodal pathologic complete response with NAC, alternatives to NAC to avoid ALND are needed.” Other factors, including older age and increasing time from surgery, were associated with a modest increased risk for lymphedema. “We already know that African American women have a higher rate of triplenegative breast cancer, which is one of the most aggressive breast cancers to treat. Now we are seeing in a very well conducted trial that African American women have a higher risk of lymphedema,” commented Virginia Kaklamani, MD, who was not involved with the study, during the press conference. “I think it’s important for us to recognize this, recognize the symptoms early and treat our patients preemptively so that we can potentially prevent lymphedema in these patients.”

Dr. Kaklamani is a professor of medicine in the Division of Hematology/Oncology at UT Health San Antonio MD Anderson Cancer Center. Rachel Greenup, MD, MPH, the chief of breast surgery at the Breast Center at Yale School of Medicine’s Smilow Cancer Hospital, in New Haven, Conn., said the findings highlight the importance of universal and unbiased screening for breast cancer treatment side effects to identify individuals who will benefit from referral to physical therapy, nutrition and exercise counseling, as well as ongoing follow-up for lymphedema surveillance. “Findings from this study should prompt general and subspecialty surgeons treating breast cancer to have a heightened awareness around the increased risk of breast cancer–related lymphedema in Black women, and may warrant purposeful referral for lymphedema care among women of color.” ■

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IN THE NEWS

GENERAL SURGERY NEWS / FEBRUARY 2022

Preventing Parastomal Hernias: A ‘Silver Bullet’ Remains Elusive By KATE O’ROURKE

t the annual meeting of the American Hernia Society, Richard Lu, MD, gave a presentation on preventing parastomal hernias, which are the most common complication of ostomy surgery. “Some studies suggest that up to 50% of ostomies result in a parastomal hernias,” Dr. Lu said. “In my opinion, all ostomies will develop some degree of herniation if you give them enough time.” Dr. Lu, an assistant professor in the Division of Minimally Invasive and Foregut Surgery, and the James E. Thompson, MD Family Distinguished Professor in Surgical Simulation, Department of Surgery at the University of Texas Medical Branch, in Galveston, said hernia surgeons focus on closing fascial defects, but with ostomies the defect cannot be closed completely. “With ostomy creation, it is pretty much a Goldilocks scenario. You can’t make [the stoma fascial defect] too tight or the ostomy won’t function, and you can’t make it too large or things just herniate through the aperture,” he said. Dr. Lu pointed out that the European Hernia Society guidelines on prevention and treatment of parastomal hernias show there is insufficient evidence to make recommendations on the optimal technique for many aspects of creating stomas (Hernia 2018;22[1]:183-198). The European guidelines found that no recommendation can be made regarding preference for stoma

Ostomy bag, clip and adhesive.

construction by the extraperitoneal over the transperitoneal approach. A meta-analysis of seven retrospective studies favored the extraperitoneal over the transperitoneal approach for ostomy creation with an odds ratio of 0.41, but confidence was limited by the study design (Int J Colorectal Dis 2012;27[1]:59-64). The European guidelines also state that no recommendation can be made regarding preference for stoma construction at a lateral pararectus over a transrectus site. The guidelines suggest keeping the size of the fascial aperture as small as possible to allow passage of the intestine through the abdominal wall without causing ischemia. A study showed that an aperture greater than 3 cm was associated with increased parastomal hernia (J Korean Surg Soc 2013;84[1]:43-47).

The traditional technique to construct a colostomy has been to make a cruciate incision in the rectus fascia during the construction of the stoma. A circular incision instead of a cruciate incision has been suggested as an option. A third approach is to use a prophylactic mesh at the time of colostomy construction. A recent randomized study found no significant differences in the rates of parastomal hernia within 12 months of the index surgery between these three surgical techniques for colostomy construction (Ann Surg 2021;273[4]:640-647). Although the European guidelines recommend using a prophylactic synthetic, nonabsorbable mesh when constructing an elective permanent end colostomy to reduce the parastomal hernia rate, there is contrary evidence from two more recent randomized trials, the STOMAMESH trial, in patients undergoing open colorectal surgery, including creation of a permanent end colostomy, and the GRECCAR7 trial, in patients receiving a first colostomy for an indication other than infection (Ann Surg 2019;269[3]:427-431; Ann Surg 2021;274[6]:928-934). These two trials, which compared patients receiving no mesh and those receiving prophylactic retrorectus mesh, showed no differences in outcomes, lending support for recommending against prophylactic mesh placement in parastomal hernias. Dr. Lu said the jury is still out when it comes to prophylactic mesh and more evidence is needed. “There are discussions about prophylactic mesh placement for end

Treating Parastomal Hernias: Approaches to a Vexing Problem By KATE O’ROURKE

t the 2021 annual meeting of the American Hernia Society, Jenny Shao, MD, gave a presentation on repairing parastomal hernias. In the hernia world, these hernias are some of the most troubling. “Parastomal hernias are really challenging, with high recurrence rates, and potential complications. So, when we choose our patients, we have to choose them wisely, optimize them prior to surgery, and consider the best surgical approach for their goals and quality of life,” said Dr. Shao, an assistant professor of clinical surgery, Division of Gastrointestinal Surgery at the University of Pennsylvania, in Philadelphia. Parastomal hernias are common after ostomy creation and can cause pain, obstruction, leakage and many other complications. “Currently, annually over 100,000 new stomas are created [in the United States] and upwards of 50% of these will develop a parastomal hernia,” Dr. Shao said. “These hernias lead to complications such as difficulty pouching, obstruction, pain and many other issues that ultimately lead to reoperation. Hernia repair after primary suture repair can have recurrence rates of 76%, and as high as 80% after stoma relocation.”

Dr. Shao described the parastomal hernia problem as a Sisyphean challenge. “The parastomal problem is that you can never fully close the fascial defect, as you need to be able to bring the ostomy through the abdominal wall. So, if you make your suture repair too lax and you leave too much room for the ostomy, you have issues with recurrence, herniation, pain, bulging, recurrence and probably another reoperation. If you make your stoma fascial defect too tight, the ostomy can lead to strangulation, obstruction, fistulas and, again, reoperation. But even if you get it just right, the recurrence rates can be high.” Dr. Shao pointed out that there are many surgical options available, including open versus minimally invasive surgery (laparoscopic or robotic), stoma reversal, stoma relocation, primary suture repair and mesh repair. According to the European Hernia Society’s guidelines on prevention and treatment of parastomal hernias, there is insufficient evidence to make recommendations on the optimal technique to create stomas, watchful waiting for parastomal hernias, the optimal surgical technique to repair parastomal hernias or to dictate what type of mesh should be used (Hernia 2018;22[1]:183-198). “What the guidelines did recommend, however, was that mesh repair was

Parastomal hernia.

‘There is no “one size fits all” solution to parastomal hernias. Surgeons need to be comfortable with watchful waiting and a variety of repair techniques.’ —Eric Pauli, MD superior to suture repair,” Dr. Shao noted. “In a systematic meta-analysis (Ann Surg 2012;255[4]:685-695), they found that when compared with mesh, suture repair increased recurrence rates by an odds ratio of 8.9 and [they concluded that] mesh should be used for parastomal hernia repairs.” In the same meta-analysis, in the laparoscopic repair group, the Sugarbaker technique had fewer recurrences

than the keyhole technique (odds ratio, 2.3; 95% CI, 1.2-4.6; P=0.016). In a study of 235 primary elective parastomal hernia repairs performed in five university hospitals and four central hospitals in Finland during 2007-2017, with a median follow-up of 39 months, high recurrence rates were found for the keyhole (35.9%), Sugarbaker (21.5%), sandwich (13.5%), specific funnelshaped mesh (15%) and other techniques (35.3%) (World J Surg 2021;45[6]:17421749). The study found the overall reoperation rate was 20.4%, and complications occurred in 26.3% of patients. In another study that assessed parastomal recurrences, 38 patients underwent 59 recurrent parastomal hernia repairs, postoperative complications occurred following 52.5% of repairs, the recurrence rate was 45.7%, and recurrencefree survival was worse after two or more repairs (Hernia 2021;25[1]:133-140). Dr. Shao emphasized that there is no consensus on the best operative approach for handling parastomal hernias. “If we are going to fix these, discussion of realistic goals preoperatively with the patient in conjunction with consideration of patient preoperative factors and patient-specific factors will ultimately be required to make the best operative decision. If I feel I can benefit the patient by repairing their hernia, then I think about

IN THE NEWS

FEBRUARY 2022 / GENERAL SURGERY NEWS

colostomy creation; however, it raises a huge question on the practicality in the OR as in who is going to do it. Should it be a certain team? Should it just be done by colorectal surgeons, by abdominal wall specialists or someone else? I have not found prophylactic mesh placement to be commonplace in the United States,” Dr. Lu noted. He concluded that the best prevention of parastomal hernias is to not have an ostomy, but if a parastomal hernia occurs, surgeons should advocate for ostomy reversal if possible. The bottom line, Dr. Lu said, is ostomy creation is more of an art, and use of prophylactic mesh needs further evaluation. “There is no ‘silver bullet’ in terms of preventing parastomal hernias in regard to ostomy creation,” Dr. Lu said. According to Eric Pauli, MD, the chief of the Division of Minimally Invasive and Bariatric Surgery, Penn State Hershey Medical Center, who served as the moderator for Dr. Lu’s talk, mesh choice becomes a critical issue and no one has the right answer. “There is no ideal mesh for this operation, just variations that may be better or worse for one particular technique and one particular patient,” Dr. Pauli said. ■

Next Month: Special Wound Care Coverage EXTENDED WOUND CARE COVERAGE

In the March issue, General Surgery News will feature updates on clinically relevant topics in wound care. The following are excerpts from stories that will appear in the issue.

Life and Limb: Advances in Management of the Diabetic Foot If untreated or unsalvageable, the diabetic foot requires surgical interventions to address risks to its viability. Recent advancements in the field, however, 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, experts discussed the use of endovascular venous arterialization for limb salvag eand the timing of foot amputation following revascularization.

Multidisciplinary Approach Beneficial in Managing Chronic Wounds As 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 American College of Surgeons Clinical Congress, Nicolas J. Mouawad, MD, the chief of vascular and

10 Things to Know About Hyperbaric Oxygen Therapy With two more indications approved by the FDA in 2021, hyperbaric oxygen therapy continues to gain wide acceptance as an adjunct modality for problematic wounds. During the Symposium on Advanced Wound Care fall meeting, Jayesh B. Shah, MD, the president of South Texas Wound Associates, 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 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*†

repair. But if they are not symptomatic and I don’t think I can improve their quality of life, then watchful waiting is reasonable. The bottom line is reverse the ostomy when you can, repair it when symptomatic; otherwise, watchful waiting can be employed in the right patient.” Asked to comment on the presentation, Eric Pauli, MD, the chief of the Division of Minimally Invasive and Bariatric Surgery at Penn State Hershey Medical Center, said Dr. Shao’s talk was illustrative of how difficult these operations are and there were several takeaway points. “There is no ‘one size fits all’ solution to parastomal hernias. Surgeons need to be comfortable with watchful waiting and a variety of repair techniques,” he said. “Recurrences are common. Much like a hiatal hernia that has recurred, not every patient needs another operation. Many are improved from before their initial surgery and can be managed nonoperatively.” Dr. Pauli said he considers a number of factors when choosing a surgical approach for patients with parastomal hernias, including whether or not they need to keep the stoma, whether it needs to stay in the same location or needs to be moved, whether there are skin breakdown issues to manage, and whether there are other hernias present or only ■ the parastomal hernia.

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.”

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

GENERAL SURGERY NEWS / FEBRUARY 2022

Physical Therapy: An Integral Part of Abdominal Wall Reconstruction continued from page 1

almost always work with a physical therapist or occupational therapist postoperatively, so it only makes sense for a patient undergoing hernia surgery— which is also a musculoskeletal disease— to also work with a physical therapist postoperatively,” Dr. Levinson said. At Duke University Medical Center, all patients undergoing abdominal wall reconstruction are offered a physical therapy rehabilitation program postoperatively. At the beginning of the

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.

rehabilitation program, patients have an assessment of abdominal wall strength. This involves creating an abdominal wall strength score by scoring trunk-raising and double leg-lowering tests (Figures A and B). Using the strength score and the World Health Organization International Classification of Functioning, Disability and Health for Ventral Hernia, patients are stratified into a low-intensity, medium-intensity or high-intensity rehabilitation program.

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)

‘The benefits of the program that we have developed is that it is mostly independent. We are doing the initial assessment and then really allowing patients to implement excercises on their own.’ —Rebecca Fillipo, PT, DPT

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.

The frequency, time, type and intensity of exercise increases from low to high. Exercises include single-leg hip bridges, modified planks, modified side planks, clam shells and toe raises. “If you have a patient [who] comes in who is a runner or very active, they should be able to tolerate a more aggressive rehab program. Based on the simple physical performance tests, we are likely going to find that they have a stronger score,” said Michael Schmidt, PT, DPT, MHA,

• 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

FEBRUARY 2022 / GENERAL SURGERY NEWS

approaches to help with coping after major surgery and trying to help patients reduce their fear of moving after a surgery. “From an outcomes standpoint, we utilize the PROMISE 29 v2.0 measures of patient-reported outcome measures used in the hernia population,” he said. Mr. Schmidt said clinicians can get more information on their rehabilitation guidelines by contacting him at Michael. Schmidt@duke.edu. According to Richard Pierce, MD, PhD, an assistant professor at Vanderbilt University Medical Center, in the Division of General Surgery, and the director

Figure. Abdominal wall strength score is determined by trunk raising (A) and double leg lowering (B) tests.

the clinical coordinator of rehabilitation services in the Department of Surgery at Duke University Medical Center. “If you have a patient that comes in [who] is very deconditioned or medically unstable, they are likely going to have a weaker core based on the tests, and we would do a more lower-intensity rehab program to improve their conditioning.” Patients are sent home with instructions on how to do their rehabilitation program. “The benefit of the program that we have developed is that it is mostly independent. We are doing the initial assessment and then really allowing patients to implement the exercises on their own. Many of the patients are traveling to Duke for just one visit. As long as patients are adhering to the exercises, we are seeing good benefit,” said Rebecca Fillipo, PT, DPT, a physical therapist at Duke University Medical Center. She said there have been no recurrences to date in patients who have participated in the rehabilitation program since 2019. Ms. Fillipo said when they first started their rehabilitation program for hernia, they only had one protocol for every patient, but they found they weren’t dosing people appropriately. “People weren’t being challenged enough, or it was too challenging and people couldn’t get through the program. Each protocol level now increases in difficulty and is based on what the patient is trying to get back to,” she said. “Patients get moving the very first week after their surgery. The first four to six weeks all look pretty similar, just different repetitions or amount of resistance. But then between week 6 to week 12, we get to more activity-specific or sports-specific exercises. Different from a lot of the other programs, we took away lifting restrictions, with the idea of using a pain-guided approach and letting that dictate how they progress. We say they shouldn’t go past a 2-point jump in their pain when lifting.” Mr. Schmidt said the program incorporates cognitive-behavioral therapy

of the Vanderbilt Center for Hernia Care and Abdominal Core Health, in Nashville, Tenn., the Duke rehabilitation program is only one option for rehabilitation programs after hernia. The Abdominal Core Health Quality Collaborative has published three abdominal core surgery rehabilitation protocol guides on its website (bit.ly/3r3KcA8). There is a patient guide, a guide to be used with a physical therapist, and an in-hospital guide for patients and physical therapists. “The guides are very straightforward. You can print them out and hand them to ■ patients,” Dr. Pierce said.

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How Do Surgeons Get Fairly Paid for Their Work? continued from page 1

“As surgeons, we are often asked to be leaders with various roles within our organizations,” began session co-moderator Jason P. Wilson, MD, MBA, the medical staff president at the Morton Plant North Bay Hospital, in New Port Richey, Fla. “How do we reimburse surgeons for important activities that do not have direct ties to volume-based payment methods? “And as we go down the road of value-based care, how do we measure and reimburse surgeons for these metrics?” Dr. Wilson continued. “How do we choose which measures should impact surgeons’ compensation? And how much of our compensation should be tied to these measures?” L. Arick Forrest, MD, MBA, the vice dean of clinical affairs at The Ohio State University College of Medicine, in Columbus, explored the issue of compensation from an academic perspective, using his institution’s compensation model as a springboard for the discussion. As Dr. Forrest explained, the model considers the four primary responsibilities that comprise an academic physician’s time: clinical, administrative, research and teaching. The clinical component of the model is largely productivity-driven, and measured in work relative value units (wRVUs). Physicians’ salaries are standardized by their specific department or division, and set at a base salary percentile plus 15%. As such, if base compensation is established at the 45th percentile, then the wRVU target is the 60th percentile. These targets are adjusted according to billable clinical full-time equivalents; benchmarks are updated on an annual basis using a three-year rolling average. “There’s still opportunity for supplemental pay,” Dr. Forrest explained. “If you do work above and beyond and it gets approved by a compensation committee, you can get additional pay above your benchmark and your bonus incentive.” With respect to administrative responsibilities, the model seeks to compensate physicians for the value of the time they contribute in this role rather than setting a flat rate. “So, if you’re buying 10% time from a cardiovascular surgeon, it’s a lot different than buying 10% time from an emergency department physician,” Dr. Forrest explained. The compensation model also recognizes research and academic accomplishments for clinicians that contribute to three areas: funded research, investigator clinical trials and team clinical trials. Finally, all faculty at the academic center are expected to engage in mentoring, supervision and teaching activities.

In these cases, expectations are set at the beginning of each academic year, and physicians’ performance against these expectations is reviewed annually to retain appointed positions and protected time. These components come together in an X-Y-Z compensation model, where X represents the physician’s base salary according to academic rank. The Y factor is a supplemental base salary amount, the product of the physician’s specialty, rank and clinical productivity. Together, X

and Y represent the physician’s total base compensation. Finally, the Z component represents incentive bonuses, which are awarded for clinical productivity, quality and academic accomplishments to faculty who exceed external performance benchmarks. For surgeons, incentive bonuses are tied to completing the wound classification at the time of surgery and in critical care by CLABSI (central line–associated blood stream infection) rates, as well as

surgical site infection rates in colon, hip, knee and spine operations. Finally, surgeons are evaluated according to rates of cardiac mortality and kidney injury after cardiac surgery. “So, where are we going with all this?” Dr. Forrest asked. “If you look at the sustainability of healthcare in the United States, it’s simply not sustainable. The government payors and the commercial payors are shifting to value and volume. As surgeons, we’re still going to have to maintain the volume, but now we have to deliver it at a higher value to get the reimbursement we want.

For complex hernia repair

INDICATIONS STRATTICE™ Reconstructive Tissue Matrix (RTM), STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are intended for use as soft tissue patches to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use of these products include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. STRATTICE™ RTM Laparoscopic is indicated for such uses in open or laparoscopic procedures. These products are supplied sterile and are intended for single patient one-time use only. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS These products should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20. WARNINGS Do not resterilize. Discard all open and unused portions of these devices. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. Do not reuse once the surgical mesh has been removed from the packaging and/or is in contact with a patient. This increases risk of patient-topatient contamination and subsequent infection. For STRATTICE™ RTM Extra Thick, do not use if the temperature monitoring device does not display “OK.” PRECAUTIONS Discard these products if mishandling has caused possible damage or contamination, or the products are past their expiration date. Ensure these products are placed in a sterile basin and covered with room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place these products in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. These products should be hydrated and moist when the package is opened. If the surgical mesh is dry, do not use.

MONEY MATTERS

FEBRUARY 2022 / GENERAL SURGERY NEWS

“We feel that our compensation model is fulfilling this mission, while also rewarding all aspects of the academic and clinical mandate here at the medical center.” Danny R. Robinette, MD, the former chief medical officer at Fairbanks Memorial Hospital, in Alaska, offered the perspective of physician compensation in a rural community setting. The basis of Dr. Robinette’s discussion was Foundation Health Partners, a communityowned healthcare foundation comprising a 150-bed hospital, a 60-physician multispecialty clinic, and a 90-bed long- and

‘If you look at the sustainability of healthcare in the United States, it’s simply not sustainable. The government payors and the commercial payors are shifting to value and volume. As surgeons, we’re still going to have to maintain the volume, but now we have to deliver it at a higher value to get the reimbursement we want.’ —L. Arick Forrest, MD, MBA short-term care facility. For physicians employed by the foundation, there are five primary types of compensation: base compensation, bonus compensation, compensation for administrative time, paid time off and benefits.

Base compensation guarantees physicians their lowest possible salary, and is set by each specialty within the organization. “We use a data set from the Medical Group Management Association [MGMA] to determine the base salary

WITH THE STRATTICE™ RTM is designed to be positively recognized, allowing for regeneration and a repair that holds.1,2,* *Correlation of these results, based on animal studies, to results in humans has not been established.

In a recent retrospective evaluation of biologic meshes, including STRATTICE™,

91.7 7 YEARS %

†

OF PATIENTS WERE RECURRENCE-FREE AT POST-OP3,†

Includes porcine and bovine acellular dermal matrices (ADMs) (n = 157). Bridged repair and human ADM were excluded from the study group.

For more information, contact your Allergan Aesthetics representative or visit hcp.StratticeTissueMatrix.com PRECAUTIONS (continued) Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation. Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh. In large abdominal wall defect cases where midline fascial closure cannot be obtained, with or without separation of components techniques, utilization of the surgical mesh in a bridged fashion is associated with a higher risk of hernia recurrence than when used to reinforce fascial closure. For STRATTICE™ RTM Perforated, if a tissue punch-out piece is visible, remove using aseptic technique before implantation. For STRATTICE™ RTM Laparoscopic, refrain from using excessive force if inserting the mesh through the trocar. STRATTICE™ RTM, STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are available by prescription only. For more information, please see the Instructions for Use (IFU) for all STRATTICE™ RTM products available at www.allergan.com/StratticeIFU or call 1.800.678.1605. To report an adverse reaction, please call Allergan at 1.800.367.5737. For more information, please call Allergan Customer Service at 1.800.367.5737, or visit hcp.StratticeTissueMatrix.com. References: 1. Connor J, McQuillan D, Sandor M, et al. Retention of structural and biochemical integrity in a biological mesh supports tissue remodeling in a primate abdominal wall model. Regen Med. 2009;4(2):185-195. 2. Sun WQ, Xu H, Sandor M, Lombardi J. Process-induced extracellular matrix alterations affect the mechanisms of soft tissue repair and integration. J Tissue Eng. 2013;4:2041731413505305. doi: 10.1177/2041731413505305. 3. Garvey PB, Giordano SA, Baumann DP, Liu J, Butler CE. Long-term outcomes after abdominal wall reconstruction with acellular dermal matrix. J Am Coll Surg. 2017;224(3):341-350. STRATTICE™ and its design are trademarks of LifeCell Corporation Corporation, an AbbVie company company. © 2021 AbbVie. All rights reserved. STM147027 05/21

DON’T MESH AROUND

by specialty,” Dr. Robinette said. “We set our base at the 75th percentile of the range of specialty compensation for this data set.” This percentile, he added, can be adjusted to reflect local market conditions. Currently, the base salary is reassessed every three years. Bonus compensation can take one of two forms: physician bonus and productivity bonus. The physician bonus—which is set to the same maximum dollar amount for all physicians—uses an organizational financial target as a door opener, and then adds individual physician amounts, if applicable. These individual amounts are tied to productivity standards, timely medical records, patient satisfaction and departmental quality goals. “As we move forward and payment changes, we would expect to see this bonus become a progressively larger component of the physician compensation plan and more dependent on quality goals,” he explained. The plan’s productivity bonus is not tied to organizational financial targets. Instead, this aspect of compensation is based on RVU production in excess of 60% of MGMA production by specialty. “Some physicians with high productivity are adding an additional 30% to 40% to their income above their base salary,” Dr. Robinette said. Physicians are also compensated for administrative time, as the organization recognizes the need for physicians to perform nonclinical duties that do not directly generate RVUs or revenue. This includes time spent managing other providers, quality and safety functions, peer review, credentialing, and medical direction for a wide variety of service lines. Finally, the compensation package includes paid time off and benefits, which comprise four to six weeks of vacation time, two weeks for continuing medical education (CME), parental leave, and an annual CME allowance of up to $10,000 annually to cover travel and/or registration fees. Employed physicians also receive malpractice insurance for employment-related work, along with health insurance, and retirement benefits. Yet as the clinicians recognized, changing societal expectations will demand flexibility in these compensation models to ensure the financial well-being of the healthcare system as a whole, as well as individual physicians. “We have seen a transition of payment from usual, customary and reasonable fees to the Medicare Physician Fee Schedule or RVU-based compensation,” Dr. Wilson said. “Now, we are seeing a transition from volume-based RVU compensation to more value-based compensation, and many institutions are still early in their journey from volume- to ■ value-based compensation.”

GENERAL SURGERY NEWS / FEBRUARY 2022

QUESTION for Subhash Kini, MD From Francisco Guzman, MD, surgical fellow in MIS and bariatrics, Mount Sinai Medical Center, New York City

A Patient With Partial Gastric Band Erosion Welcome to the February issue of The Surgeons’ Lounge, our first column of 2022. We wish all of our readers a happy and healthy new year! In this issue, Subhash Kini, MS (Clin Research), FACS, FRCS, FRCS (Ed), FRCS(G), the director of the Institute for Bariatric and Minimally Invasive Surgery at Mount Sinai Morningside, New York City, discusses the case of a patient with a partial gastric band erosion. Also in this issue, “The Procedure, the History” returns, featuring a history of the gastric band. We look forward to our readers’ questions, comments and interesting cases to present to our guest experts. perts.

A 57-year-old woman who had undergone an adjustable gastric band placement 18 months ago, presented to the medical service with recurrent left pleural effusion. She had a history of a positive purified protein derivative (or PPD) test. She had undergone repeat thoracentesis and video-assisted thoracoscopic surgery decortication with biopsy. Fluid analysis was predominantly lymphocytic, with no infectious etiology identified, and pathologic analysis showed no malignancy or granulomatous changes, but was suggestive of an exudative inflammatory process. A working diagnosis of fibrinous exudative idiopathic pleuritis was established. The patient was managed with immunosuppressive therapy with methotrexate and high-dose prednisone. Several months into this treatment course, the patient presented to an outside hospital with abdominal pain and fever. A CT scan showed a liver abscess and a collection at her adjustable band port site, prompting transfer to our institution and a surgical consultation. Esophagogastroduodenoscopy showed evidence of partial band erosion (Figure 1). The hepatic collection was percutaneously drained; the abdominal wall collection Figure 1. Top left: CT abdomen pelvis showing was incised and drained; and the band port was the adjustable band and associated left pleural removed. Immunosuppression was stopped and steroids effusion. were tapered a month before the adjustable band Top right: Endoscopic view of partially eroded was ultimately taken down, and a gastrorrhaphy was gastric band. performed via a minimally invasive approach. Bottom left: CT arterial portography showing fluid collection in left liver lobe along course of gastric 1. How could this delay in diagnosis have band tubing system. been prevented?

2. In your experience, when dealing with late band erosions, are there any subtle clues we should keep in mind?

3. What are other clinical presentations to keep in mind when dealing with band erosions? 4. In addition to surgical band removal, is there a role for endoscopy when attempting to remove eroded bands?

Sincerely, Samuel Szomstein, MD, FACS ACS Editor, The Surgeons’ Lounge nge Szomsts@ccf.org

Dr. Kini’s RESPONSE

60 53.8%

Gastric sleeve

50 40 36.7% 30

Gastric bypass 35.4%

23.1%

Lap band

17.8% 10 0

5.7%

Revisions Other 2011

2012

Bottom right: Soft tissue collection around gastric band port system.

2013

2014

Figure 2. Trends in weight loss operations, 2011-2015. Source: American Society for Metabolic and Bariatric Surgery.

2015

Gastric banding, originally approved by the FDA for clinical use in the United States in June 2001, is currently the third most common weight loss operation performed. It is a restrictive procedure that reached its peak of use in 2008, but has steadily fallen out of favor in contemporary practice (Figure 2).1,2 In the past nine years, there have been an estimated 160,000 adjustable gastric bands placed, according to the most recently available data from the American Society for Metabolic and Bariatric Surgery. This presents a particular problem for both general and bariatric surgeons today, given the markedly elevated band failure rates (excess weight loss <25% and/or band removal or conversion in up to 48% of patients).3-6 Despite a lower 30-day adverse outcome rate of 1% compared with gastric bypass at 4.8%, longterm complications (40% vs. 20%) and reoperation rates (27% vs. 13%) with gastric banding are worse than gastric bypass, as was shown in a large, prospective case-matched study with a follow-up of more than five years.5 Long-term complications include band erosion/leak, band slippage, port or tubing malfunction/leakage/

infection, pouch dilation with or without slippage, esophageal dilatation, late food intolerance, reflux and esophagitis. Reoperations include any surgical procedure performed on the port/catheter system, band change, repositioning, removal, or removal with conversion. Of interest to this discussion, band erosion usually occurs about two years after its placement in 1% to 4% of patients and is presumed secondary to pressure necrosis and friction from the band itself, among other local mechanisms. Typical signs may be nonspecific, including infection, weight regain, or nausea and vomiting, and pain. Diagnosis is established by endoscopy. Management can be performed via a laparoscopic or a combined endoscopic and minimally invasive surgery approach. Most often, as the band slowly erodes into the stomach, scar and granulation tissue formation behind it allow safe endoscopic band retrieval combined with laparoscopic tubing extraction. A hiatus of several months should be allowed in case further revisional surgery—Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy, or biliopancreatic diversion with duodenal switch (BPD-DS) for weight loss—is desired.

SURGEONS’ LOUNGE

FEBRUARY 2022 / GENERAL SURGERY NEWS

Ultimately, a high index of suspicion is needed to make the diagnosis of a band erosion/leak whenever patients present with unilateral pulmonary disease, especially after a remote band placement. A history of a positive PPD test along with healthcare status may have misguided this patient’s initial management in lieu of a surgical complication. Careful history taking and a multidisciplinary approach may present the best opportunity to adequately diagnose complex cases. ■

References 1. Kuzmak LI, Yap IS, McGuire L, et al. Surgery for morbid obesity: using an inflatable gastric band. AORN J. 1990;51(5):1307-1324. 2. Belachew M, Legrand MJ, Defechereux TH, et al. Laparoscopic adjustable silicone gastric banding in the treatment of morbid obesity: a preliminary report. Surg Endosc. 1994;8(11):1354-1356. 3. Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009;361(5):445-454.

4. Himpens J, Cadière GB, Bazi M, et al. Long-term outcomes of laparoscopic adjustable gastric banding. Arch Surg. 2011;146(7):802-807. 5. Romy S, Donadini A, Giusti V, et al. Roux-en-Y gastric bypass vs gastric banding for morbid obesity: a case-matched study of 442 patients. Arch Surg. 2012;147(5):460-466. 6. Chapman AE, Kiroff G, Game P, et al. Laparoscopic adjustable gastric banding in the treatment of obesity: a systematic literature review. Surgery. 2004;135(3):326-351.

THE PROCEDURE, THE HISTORY

The History of Gastric Banding as a Weight Loss Intervention By Luis Felipe Okida, MD, PGY-1 general surgery resident, and Lisandro Montorfano, MD, chief general surgery resident, Cleveland Clinic Florida, Weston

Gastric banding was initiated in the United States by Wilkinson and Peloso, who began their surgical weight loss experiments on dogs, and then on human subjects in the mid-1970s. In 1978, Wilkinson developed the concept of placing a small piece of polypropylene mesh around the upper part of the stomach, resulting in a gastric pouch. This would be the prototype of what would later be called adjustable gastric banding, a purely restrictive weight loss operation.1 In 1983, Molina described the gasastric segmentation procedure in which ich a Dacron vascular graft, instead of mesh, was placed around the upper stomach to promote weight loss. Due to the high rate of adherence between the liver and the Dacron material, a polytetrafluoroethylene (PTFE) graft was ultimately used. Also In the early 1980s, Bashour developed the gastro-clip gastroplasty, in which a 10.5 cm polypropylene clip with steel reinforcements was clamped horizontally at the cardia, creating a 50-mL proximal pouch.2 The inability to adjust the diameter of the graft, band or clip at a later occasion caused high rates of weight loss failure as well as numerous complications, such as severe food intolerance and intractable vomiting.3 The idea of an adjustable gastric band came in 1983, when Kuzmak, a Ukrainian surgeon working in the United States, started using a 1-cm silicone band to encircle the upper portion of the stomach, resulting in a 30- to 50-mL gastric pouch. Three years later, this band was modified to provide adjustability of its diameter using an inflatable balloon, and the new band

was shown to have betterr weight weigh loss outcomes and a reduced comed rate of com plications comparedd with the previoussly proposed bandanding techniques. es.4 As gastric banding nding gained popularity, ty, the initial band created by Kuzmak ak underwent several modificationss and then was designated “LapBand,” and,” which was approved by the FDA in 2001. As a restrictive procedure, the gastric band is used to create a small gastric pouch, decreasing food intake and resulting in weight loss. The inflatable table balloon lined with the band is connected to a smalll reservoir that is placed underneath neath the skin, and inflation of the balloon tightens the bandd and creates a smaller gastric pouch, aiding weight loss. Conversely, balloon deflation loosens the band, consequently decreasing weight loss. Gastric band placement can be accomplished through an open or a laparoscopic approach, the latter being preferred because of a lower rate of complications and postoperative pain. However, it was only in 1993 that a group of surgeons from Australia and Italy reported the first placement of a gastric band laparoscopically.3 In fact, laparoscopic gastric banding transformed the outlook for bariatric surgery overall and it was an important initial step to use the laparoscopic approach on other types of weight loss procedures. Overall, adjustable gastric banding has a low rate of major perioperative complications since there is no stomach

resection or anastomosis. Nevertheless, there was a substantial drop in the t number of gastric bands placed in the United States in the past decade. U According Accordin to the American Society of Metabolic and Bariatric SurMeta gery, adjustable gastric ad banding was wa the second-most commonco ly performed weight we loss procedure in the United States in 2011, accounting for 35.4% cases. of all bariatric ba However, this numHoweve ber fell to 0.9% in 2019, becoming almost an obsolete among American surgeons. procedure amo played a role in Many factors f this change, including weight lloss outcomes, remission of comorbidities and band-related complications. com Compared with sleeve gastrectomy, currently the most commonly performed bariatric procedure in the United States, a recent meta-analysis by Li et al showed that excess weight loss was significantly lower at 12, 24 and 36 months after laparoscopic gastric banding when compared with laparoscopic sleeve gastrectomy.5 Gastric banding also has less favorable rates of remission of obesity-related comorbidities. Omana et al demonstrated a greater remission rate of diabetes mellitus (100% vs. 46%; P<0.01), hypertension (78% vs. 48%; P=0.03), and hyperlipidemia (87% vs. 50%; P=0.02) after sleeve gastrectomy when compared with gastric banding.6 Lastly, some studies have documented a substantial number of patients who

required reoperation for long-term complications after gastric banding, such as band erosion, band slippage and band infection.7 Gastric banding is a simple procedure promoting weight loss and remission of obesity-related comorbidities, but due to its inferior weight loss outcomes, high rates of conversions and potential long-term complications, this bariatric intervention will less likely be considered as an option in the near future. However, it will always be remembered as an important step in the history of bariatric surgery. References 1. Wilkinson LH, Peloso OA. Gastric (reservoir)

reduction for morbid obesity. Arch Surg. 1981;116(5):602-605.

2. Bashour SB, Hill RW. The gastroclip gastroplasty: an alternative surgical procedure for the treatment of morbid obesity. Tex Med. 1985;81:36-38. 3. Steffen R. The history and role of gastric banding. Surg Obes Relat Dis. 2008;4:S7-S13. 4. Kuzmak LI, Yap IS, McGuire L, et al. Surgery for morbid obesity: using an inflatable gastric band. AORN J. 1990;51:1307-1324. 5. Li L, Yu H, Liang J, et al. Meta-analysis of the effectiveness of laparoscopic adjustable gastric banding versus laparoscopic sleeve gastrectomy for obesity. Medicine. 2019;98:e14735. 6. Omana JJ, Nguyen SQ, Herron D, et al. Comparison of comorbidity resolution and improvement between laparoscopic sleeve gastrectomy and laparoscopic adjustable gastric banding. Surg Endosc. 2010;24(10):2513-2517. 7. Johari Y, Ooi G, Burton P, et al. Long-term matched comparison of adjustable gastric banding versus sleeve gastrectomy: weight loss, quality of life, hospital resource use and patient-reported outcome measures. Obes Surg. 2020;30:214-223.

IN THE NEWS

GENERAL SURGERY NEWS / FEBRUARY 2022

The State of Telemedicine in Surgery continued from page 1

After the presentations, these experts fielded questions from the co-moderators of the session, Russell K Woo, MD, a pediatric surgeon and professor of surgery at the John A. Burns School of Medicine, University of Hawaii in Honolulu, and Patricia Sylla, MD, a colorectal surgeon and professor of surgery at Mount Sinai Hospital, in New York City. The following is a sample of the questions and answers, which have been edited for brevity.

Q Dr. Woo: Where do you see the telehealth land-

scape settling after the COVID-19 public health emergency ends, specifically with video visits outside of the doctor’s office? Is this something that will stay with us? A Dr. Lesher: I think that remains to be seen. In my view, the main change to telehealth regulations during the public health emergency was lifting the originating-site restrictions. I would hope that we have come so far through this and people have seen the benefits of ambulatory video visits, particularly for rural and underserved patients, that we will be able to maintain ambulatory video visits in the home or noninstitutional setting even after the public health emergency ends.

Q Dr. Sylla: Dr. Lesher, you mentioned that we

don’t have any evidence that telehealth is associated with improved clinical outcomes, and I think that will be an important factor to be able to justify the development and reimbursement of new platforms. But I recently saw an interesting podium presentation where they were talking about the issues that they have with postoperative compliance, specifically with bariatric patients not coming back for their follow-up visits. I thought, what about telehealth visit being a solution, because you might think there might be some psychological components or issues with transportation that interfere with patients coming in for visits. Do you think that telehealth modalities may help increase compliance within the surgical realm relative to in-person visits? A Dr. Lesher: I certainly do think telehealth increases access, and there are good studies demonstrating improved compliance with medical therapy using telehealth. Early on, our telemedicine data were generally focused on usability, patient satisfaction and provider satisfaction. Surely, we are seeing little reports trickle in on things like improved compliance with postoperative visits. I also read a manuscript recently that the access to care improved so much in a foreign country that their no-show rate went to zero after they applied ambulatory video visits, so that by definition will improve outcomes. The onus is on us as the providers to provide those data and prove to the third-party payors that this is really the

way that we should pivot and improve access to care, particularly for people who have impaired access.

Q Dr. Sylla: The feeling from the ACS board of governors survey was that you have improved access with telemedicine. [More than 88% of the board of governors reported being moderately satisfied or extremely satisfied using telemedicine for follow-up appointments.] However, is this among academic centers, rural centers, academic versus community centers? I haven’t seen granular feedback from these different types of practices. Can you comment on that?

‘Telemedicine is going to decrease costs on some levels, certainly to the patients but also to the hospital or providers, because of the decreased nature of using brick-andmortar building.’

—Aaron Lesher, MD

A Dr. Sharma: The board of governors survey is a pret-

ty good representation of practicing surgeons across the country, and it clearly showed that a large segment found telehealth to be useful. But it is not discrete enough for what we really need to answer. There is some early disparity data coming out with the use of telehealth. To put this in best context, we need a level of granularity. Without that level of true attribution of saying where access has been improved and where it has been limited, who it has been limited for, we are not able to answer the disparity in access issue. I think it is going to improve access for a dramatic proportion of our population. However, the ones that need it the most, are we really impacting them? I think about Atlanta, which is an inner-city population, it’s not distance that is keeping people away; it’s access. I always look at it in two ways: there are advantages and disadvantages, and we need to catalog both of them as we move forward.

Q Dr. Sylla: I’ve been really intrigued by the early

data showing disparities [in access to telemedicine]. Are there any thoughts with the ACS to try to tackle this now? Now would be a good time to think about pathways to reduce disparities. A Dr. Sharma: I think part of the mission for us as the board of governors is to do that and encourage research in this area. We are lucky that we don’t have to do the work at times. We have an amazing group of surgeons in disparity committees and access committees that can take these issues head-on. We need to ask people who are truly experts in the field to develop those surveys.

Q Dr. Woo: Do you think third-party payors are

going to get to the point where they need to decrease the reimbursement for telemedicine visits, given the fact that hospitals and clinics are not going to be spending the same kind of money on infrastructure and staff and we are going to see more and more of these visits happening? A Dr. Lesher: We have a very complicated system, where we have disparate payment strategies for different patients and different insurances. I think it would be a mistake on the part of the insurers to try to decrease reimbursement for telehealth, especially at the beginning when we really don’t understand the cost of providing the service. At the federal level, there is bipartisan support for telehealth, but then at the payor level, they are already trying to roll back reimbursement. In the strict fee-for-service reimbursement models that we live under, telemedicine has been disincentivized because of these lower reimbursement strategies. Centers that are part of a delivery network or participate in value-based payment strategies are far more incentivized to use telehealth strategies. Telemedicine is going to decrease costs on some levels, certainly to the patients but also to the hospital or providers, because of the decreased nature of using a brick-and-mortar building. This hasn’t been well studied or well measured, in my opinion.

Q Dr. Woo: As we talk about how things are going

to settle out, what aspects of telelearning and teleproctoring will stay, and are there elements that will go away after the current crisis is over? A Dr. Schlachta: At my own institution and others, by necessity, we are working very hard on trying to shift more to virtual clinical care and away from inperson care. On the education side, there are a few things we have learned. One is that there is a lot of innovation going on right now and we are trying a lot of approaches now that we probably wouldn’t have been as quick to try before. We have embraced technologies and solutions at an accelerated pace that we were certainly going to pursue in the longer run. When we think about the breadth of education, I think this is going to allow us to make rapid progress on the telementoring and teleproctoring front, and certainly on the virtual coaching side as well. As far as medical school and resident training, I don’t think we are going to see a lot of enthusiasm for permanently replacing the handson skill training that we do in the simulation labs. While there has been some necessity-driven clever innovations, I think the personal connectedness is missed. I expect more didactic lectures to persist on Zoom-like platforms, as a flipped classroom, prior to hands-on training. ■

IN THE NEWS

FEBRUARY 2022 / GENERAL SURGERY NEWS

Robotic Surgery in Oncology Gaining Traction By KATE O’ROURKE

t the 2021 virtual American College of Surgeons Clinical Congress, a panel of experts discussed the benefits of robotic surgery in oncology. All panelists said more research was needed in comparing robotic approaches with open approaches. Abhineet Uppal, MD, an assistant professor at The University of Texas MD Anderson Cancer Center, in Houston, pointed out that 86% of patients are operated on at hospitals that don’t have robots. He said surgical complications for colorectal diseases are low regardless of the surgical approach that is used: open, laparoscopic or robotic. “Robotic surgery offers ergonomic and visualization advantages in confined spaces,” Dr. Uppal said. The learning curve for robotic surgery is significant, especially for surgeons without laparoscopic experience, he added. Dr. Uppal said randomized data on the advantages of robotic surgery in colorectal diseases are limited. The results of a meta-analysis revealed that robotic-assisted ventral mesh rectopexy is effective and feasible in the treatment of rectal prolapse (Int J Colorectal Dis 2021;36[8]:1685-1694). A few studies have examined robotics for total proctocolectomy, and found longer operation times, shorter hospital stays and nonsignificant trends for fewer complications with robotic surgery (J Colorectal Dis 2021;36[7]:1345-1356; Dis Colon Rectum 2016;59:201-207). Studies have shown that oncologic outcomes are similar between robotic and laparoscopic total mesorectal excision (Int J Colorectal

Dis 2019;34[6]:983-991). “As the footprint of robots decreases, ease of use will increase,” Dr. Uppal said. Vivian Strong, MD, an attending surgeon at Memorial Sloan Kettering Cancer Center, and a professor of surgery at Weill Cornell Medical College, both in New York City, spoke about the role of robotics for gastric cancer. She said oncologic outcomes were equivalent with robotic and open approaches and there were advantages with a minimally invasive approach. In fact, robotic approaches have distinct advantages for selected patients, she noted. She said not all cases are appropriate for robotic approaches, and surgeons should use caution with diffuse-type tumors where margins are not well visualized and for large/bulky tumors. However, neoadjuvant chemotherapy is not a contraindication if margins can be visualized. Adam Yopp, MD, the Occidental Chemical Chair in Cancer Research and chief of the Division of Surgical Oncology at UT Southwestern Medical Center, in Dallas, spoke about the role of robotic surgery in metastatic colorectal cancer. He said robotic-assisted partial hepatectomy for colorectal liver metastases is safe and oncologically sound in limited series. “Concomitant robotic-assisted colectomy and hepatectomy is efficacious and can avoid second surgical procedures,” he said. Robotic-assisted insertion of a hepatic artery infusion pump in high-volume robotic hepato-pancreato-biliary centers is feasible, with similar complication rates as seen in open procedures (HPB 2017;19[5]:429-435; J Surg Oncol 2016;114[3]:342-347). “Further registry

trials capturing prospective data on robotic-assisted liver surgery [are] needed.” Karim Halazun, MD, an associate professor of surgery with the liver transplantation, hepatobiliary and pancreatic surgery program at Weill Cornell Medicine, in New York City, spoke about robotic surgery for hepatocellular carcinoma (HCC). “Robotic surgery for HCC is safe. Robotic surgery for HCC is oncologically feasible and at least equivalent to open and laparoscopic surgery. There is limited literature specifically examining HCC outcomes, and therefore more data is required,” Dr. Halazun said. He noted that robotic surgery has some technical advantages over laparoscopic surgery, and better transection technology is required. He said the advantages of robotic surgery were visualization with bifocal 3D vision and Firefly; articulating instruments that improve fine hilar dissection; and easier dissection of hepatic veins due to visualization and instrumentation. Disadvantages of robotic surgery, said Dr. Halazun, included no Cavitron ultrasonic surgical aspirator, a variable setup that impedes the learning curve, and operating at a distance from the patient can induce anxiety. According to Melissa Hogg, MD, MS, a surgeon with Northshore University HealthSystem, in Evanston, Ill., surgery has a learning curve, and this concept is revisited with each technique, including robotics. She said formal robotic training can diminish the learning curve for robotic-assisted surgery. In addition, she said, surgeons with laparoscopic experience may be able to overcome the robotic learning curve faster. ■

IN THE NEWS

GENERAL SURGERY NEWS / FEBRUARY 2022

AI in Surgery: Promise Mixed With Uncertainty continued from page 1

several barriers and burdens currently facing surgical practice. Dr. Ross is an assistant professor of surgery and medicine at Stanford University, in California. Among these issues, Dr. Ross said, is the electronic health record (EHR). Developed mainly for billing, the EHR since has been adapted for other purposes, and grown exceptionally burdensome along the way. In fact, one study (J Surg Educ 2020;77[6]:e237-e244) found that surgical residents spent nearly eight months of their five-year training on the EHR. The COVID-19 pandemic exposed a set of health-system vulnerabilities that had previously gone unnoticed by many institutions. There was also a significant loss of opportunities for surgical residents to learn in the operating room. Finally, surgical practice is challenged by an ever-increasing complexity of patients and cases, in both emergent and elective circumstances. Furthermore, although the prospect of such challenges may prove daunting to many, Dr. Ross said AI has the potential to address each one. With respect to the EHR, natural language processing (NLP) algorithms can be employed to improve the efficiency of documentation, coding and billing. “We must completely reimagine the tedious EHR chart review, documentation and ordering process with the addition of AI,” Dr. Ross said. “Suddenly EHRs would not be so burdensome, rather could improve our productivity with automatic transcription that takes our patient visit conversations and converts them into a compliant note format.” AI can also play a role in patient care, Dr. Ross added, particularly by transforming risk stratification into action that both improves outcomes and saves costs for healthcare institutions. Among the studies she cited, Dr. Ross discussed one (J Surg Res 2020;254:408-416), in which an AI deep learning model retrospectively identified opportunities to decrease surgical site infection rates and costs following vascular surgery, compared with a subjective practice strategy. “Another area that AI can be of benefit is in aiding diagnosis,” Dr. Ross noted. Research in this area has examined the potential benefits of real-time AI analysis of endoscopic images. A study (Gastrointest Endosc 2020;92[4]:905911.e1) demonstrated the potential cost benefits of machine learning algorithms that extract polyp features and predict the likelihood of malignancies. Finally, Dr. Ross foresees a time when AI might play an important role in physician education, particularly with respect to enabling practice outside the OR.

Figure 1. Potential roles for AI in surgery. Source: Johnson-Mann CN, Loftus TJ, Bihorac A. Equity and artificial intelligence in surgical care. JAMA Surg. 2021;156(6):509-510. Presented as a slide at the 2021 ACS Clinical Congress.

Figure 2. ‘AI valley of death’ of surgical decision making. Source: Balch J, Upchurch GR Jr, Bihorac A, et al. Bridging the artificial intelligence valley of death in surgical decision-making. Surgery. 2021;169(4):746-748. Presented as a slide at the 2021 ACS Clinical Congress.

“Regardless of all the burdens thrust upon us by our imperfect system, AI is poised to reduce administrative strains, improve patient outcomes and augment surgical training,” Dr. Ross concluded. “We have a long way to go toward developing, testing and integrating these systems into our everyday lives, but I suspect our small wins will eventually snowball into a better system in due time.” Rachael A. Callcut, MD, MSPH, a professor of surgery at UC (University of California) Davis Health, in Sacramento, took the opposing viewpoint, choosing instead to focus on the possible pitfalls of AI in modern surgical practice. Paramount among the problems, Dr. Callcut said, is that despite the explosion in AI-related research in surgery, only two of 2,048 articles published in 2021 were randomized controlled trials. Nevertheless, most surgeons are already using AI in their practice, although most of it goes unnoticed since it tends to deal with issues surrounding efficiencies and predictions of resource demands. Yet despite such widespread adoption, most AI used in healthcare today is not validated and therefore potentially ignores ethnic, clinical and geographic variations. “Most algorithms are designed and developed in very highly constrained patient data sets and patient populations,” Dr. Callcut noted. “When they’re turned into the wild, they don’t perform

the way that they’re intended. It is one of the most concerning things in the field of healthcare AI right now.” Indeed, of 516 studies investigating the performance of AI algorithms for clinical use, only 6% included external validation. Given these shortcomings, reporting standards are extremely important in AI although they are rarely followed. Whether AI is used in digital health, digital medicine or digital therapeutics, Dr. Callcut said the vast majority of algorithms do not fall under regulatory oversight. What’s more, AI algorithms have the potential to propagate biases if the data sources are biased. Misdiagnosis is another very real potential pitfall, and one that opens the door to a host of possible legal and ethical implications. Finally, the use of AI may expose patients to several privacy concerns. “Perception really matters,” Dr. Callcut concluded. “There have been some spectacular artificial intelligence failures outside of medicine, so we have to do this right or the public will be unwilling to accept it. Even though this is an important field with significant promise, it’s clear that we are not quite there yet.” The road forward for AI was discussed by Tyler J. Loftus, MD, an assistant professor of surgery at the University of Florida, in Gainesville. As Dr. Loftus explained, the advancement of AI as a viable part of surgical practice is hampered

by the substantial gap that exists between the development of AI models and the ultimate goal of clinical implementation that improves surgical care. “This gap has been referred to as the ‘AI valley of death,’ in which AI models are hindered by a lack of transparency, physician indifference to low-utility predictions and classifications that are already addressed by standard clinical knowledge and expertise, and time constraints imposed by manual data entry requirements and lack of integration with clinical workflows,” Dr. Loftus said. Addressing such shortcomings can be summed up in what Dr. Loftus described as the ‘desiderata’ for ideal algorithms in healthcare—a cohort of six characteristics that will make AI models more approachable in the future: 1. Explainable: conveys the relative importance of features in determining outputs 2. Dynamic: captures temporal changes in physiologic signals and clinical events 3. Precise: data frequency matches physiology; architecture is aptly complex 4. Autonomous: executes without time-consuming manual data entry 5. Fair: evaluates and mitigates implicit bias and social inequity 6. Reproducible: validated externally and prospectively, shared with research communities “Current surgical care is minimally influenced by artificial intelligence,” Dr. Loftus noted. “But as artificial intelligence applications improve over time, this influence is poised to increase. Furthermore, automation of programmable tasks may allow surgeons to spend less time gathering and analyzing data, and more time interacting with patients and attending to urgent and critical aspects of patient care. “Nevertheless, artificial intelligence is incapable of the important human traits of creativity, altruism, moral deliberation and emotional intelligence,” he added. “As such, it is unlikely that artificial intelligence will ever play a dominant role in surgical care. The surgeon’s role may evolve to interpreting artificial intelligence‒enabled decision support systems and offering wisdom for patients and caregivers who are facing complex surgical decisions, as well as using semiautonomous surgical instruments and robotic platforms in the operating room. “Surgeons should assume active roles in guiding these technologies toward optimal patient care and net social benefit,” Dr. Loftus noted. “If we abdicate this role, then it will inevitably be performed ■ by others.”

IN THE NEWS

FEBRUARY 2022 / GENERAL SURGERY NEWS

Microbiome-Based Enema Effective for Recurrent C. difficile By DAVID WILD

stool-based enema composed of a broad variety of microbes (RBX2660, Rebiotix/Ferring) was up to 84% effective in reducing recurrent Clostridioides difficile infection (rCDI) in a study of more than 720 adults with rCDI. Most responders had no occurrence of diarrhea for up to two years after treatment. “Collectively, these data demonstrate that RBX2660 is consistently and sustainably effective for the reduction of rCDI in adult patients, as early as first recurrence, after receiving standard-ofcare antibiotic treatment,” said investigator Lindy Bancke, PharmD, the head of clinical development at Rebiotix, presenting the data at ID Week 2021. Dr. Bancke’s analysis included data from five prospective studies of the treatment in patients with rCDI (abstract #167). One ongoing study includes patients with rCDI and underlying inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) and immunocompromised status—individuals “that are more typical of standard rCDI clinical practice,” she noted. Three of the studies were open-label while two were randomized and placebocontrolled, with a subsequent open-label phase for patients who did not respond to initial treatment and were provided with a second course of the treatment. The duration of follow-up was 24 months in two studies and six months in three studies. A total of 723 patients with rCDI were evaluable for efficacy and included in the analysis presented by Dr. Bancke. She reported that 50% to 73% of study participants were successfully treated with one dose, compared with 43% to 58% of placebo recipients. Treatment success was defined as an absence of rCDI diarrhea through eight weeks after treatment. Between 50% and 79% of those who did not respond to an initial dose of the agent achieved treatment success after a second dose, leading to overall treatment success rates of 75% to 84%, Dr. Bancke reported. Between 82% and 92% of treatment responders remained free of CDI through six months after treatment in the phase 3 program, with “similar rates observed in the phase 2 program out to 24 months,” Dr. Bancke said. “Additionally, our analyses indicated a consistent safety and efficacy profile for RBX2660 across the expanded populations of patients with IBD, IBS and immunocompromised status,” Dr. Bancke said. The efficacy of RBX2660 is impressive

and falls in line with that of fecal microbiota transplantation (FMT) in rCDI patients, noted Elizabeth Hohmann, MD, an infectious disease physician and the director of Massachusetts General Hospital’s FMT Core laboratory, in Boston, who was not involved the study. Dr. Hohmann said

she administers stool-based, in-house formulated oral capsules to treat her patients with rCDI; although such treatment is effective in most patients, she said a standardized product such as RBX2660 would be preferred.

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“There have been some reports of serious adverse effects using stool that has not been properly screened for pathogens, so we need something that is reliably safe, and I look forward to the FDA’s approval of such a treatment,” she said. Dr. Hohmann noted that infectious disease physicians might find it challenging to administer an enema because “we’re used to prescribing pills, but I hope gastroenterologists would be able ■ to deliver this product.”

OPINION

GENERAL SURGERY NEWS / FEBRUARY 2022

Decisions Forced on Us by COVID-19 continued from page 1

The COVID-19 era has complicated the lives of surgeons and has imposed decisions on them not previously experienced. These new choices often are difficult to make and may involve family decisions as well as one’s surgery practice, the surgical team, and considering institutional mandates, community relations, and ultimately the fundamental doctor–patient relationship.

To Work or Not to Work Should a vulnerable surgeon sit this one out? The severity of COVID disease, hospital and ICU admissions, and death accelerate with age, in particular after 60 years old. At any age, other risk factors include obesity, type 2 diabetes, renal and cardiac disease, chronic obstructive pulmonary disease and asthma, active cancers, and immune deficiency. Many surgeons in active practice fall into one of these risk categories. Some of them, as well as active surgeons without heightened risks, have chosen to retire, and others to stop both operating and patient management on a temporary basis. Most surgeons, however, have not stopped working; many have contracted COVID-19, and some have died. If the surgeon elects to work, what will that work be? The first decision by the individual surgeon, the group or the hospital institution is whether the performance of surgery with the requisite pre- and postoperative care should be curtailed and postponed as being elective, or is it to be considered urgent or emergency, with postponement impossible or likely to cause harm to the patient? Most cosmetic surgery can be delayed; a perforated viscus cannot. Knee replacement could or could not be rescheduled, and cancer surgery rarely should be. In the December 2020 issue of General Surgery News, I wrote an article stating that bariatric surgery was not elective. However, at the beginning of COVID, bariatric surgery was canceled essentially everywhere in the world. Bariatric surgery is metabolic surgery, and, in addition to weight loss, mitigates type 2 diabetes, hypertension, hyperlipidemia and atherosclerotic cardiovascular disease, nonalcoholic steatohepatitis, obstructive sleep apnea, and the numerous debilitating orthopedic complications of obesity. Because obesity per se, and its metabolic complications, increase susceptibility to the severity of COVID-19, metabolic/bariatric surgery becomes an urgent prerogative. If the routine operative practice of a surgeon becomes restricted or halted by the nature of the surgery, or by the loss of nurses and other personnel needed elsewhere in a flood of COVID-19 hospital

If we follow the scientifically proven, common-sense procedures of vaccination, temporary masking and social distancing, and continue the development of therapeutic and prophylactic pharmaceuticals, we will achieve herd immunity with the least human damage, and perhaps even eradicate this virus.

admissions, or institutional emergency policy, the active surgeon may be asked to serve as a physician for COVID-19 management. Many intensivists are also operating surgeons in a surgical discipline; they will likely have to concentrate most of their efforts and extra hours on COVID-19.

The Team Team interactions are reciprocal and the decisions of one party affect all others. As stated, nursing personnel may be pulled out of the OR during a COVID crisis. Alternatively, a surgeon who reduces his or her caseload or stops operating during an increased number of cases can cause unemployment not only of OR nursing personnel, but of many other healthcare and clerical team members in the operating suite, surgical patient admissions, in-hospital care and postoperative follow-up. The work-from-home policy of many institutions during the pandemic is difficult, if not impossible, to employ in taking care of patients. If there are fewer patients, other than those with COVID-19, staffing may be reduced. Thus, a surgeon’s decision to work or not to work, or what work to perform, affects many of the surgeon’s coworkers.

Institutional Mandate Since most surgeons today are employees of a hospital or medical conglomerate, they have abdicated many decisions to the administration of their institutions. Under non-COVID conditions, surgeons can differ with their

institutions on the election of offered patient services and the acquisition of equipment. This ambivalence has been greatly heightened during the pandemic because the stakes are higher. Ordinarily, patient care has several acceptable alternatives, and the surgeon is compensated for surrendering personal independence by lifestyle accommodations and perks. During COVID-19, however, the institution’s decisions—often based on how to use the crisis to maximize profits—can accelerate discord between physicians and the institution, and precipitate a fundamental challenge of ethical principles.

Family These questions—to work or not, what kind of work to do, the hours to work, the facilities to work in, and other considerations—are decisions that surgeons make not only for themselves, but for their families as well. Many surgeons, especially young surgeons recently in practice and practice groups with an extensive payroll, cannot financially sustain prolonged unemployment or restrictions in the number of operations performed. They must work to support their families. At the same time, they need to consider the risk to the family when they work in an environment with many cases of the coronavirus. By working, surgeons may die or become debilitated. The World Health Organization estimates that 80,000 to 180,000 healthcare workers have died from COVID-19 worldwide. More

than 3,600 U.S. healthcare workers, out of 170,000 afflicted, have died from COVID-19, including over 100 physicians. Of those who have recovered, 50% suffer from lingering symptoms for six months, and 20% have long COVID and are unable to work full time or even work at all. Healthcare workers and their families account for one out of six U.S. hospital COVID-19 admissions, and healthcare workers are seven times as likely to have severe COVID-19 as workers in other fields. The surgeon may bring the virus home to the family. A considerable number of surgeons have COVID-susceptible family members. Their lives, therefore, involve constant testing. I know of surgeons who have chosen to live apart from their families in hospital on-call rooms. Their lives resemble a military deployment. I know of surgeons who have rented separate living facilities for susceptible family members so they feel more comfortable going home themselves. Certainly, family gatherings, dinners, vacations have all been severely disrupted. Pleasures such as going to restaurants and movies have been eliminated.

Community The COVID-19 pandemic is the result of infections by several variants of a coronavirus named SARS-CoV-2. This encapsulated RNA virus has spikes that enable cellular penetration for its replication by the host mitochondria. The virus has no political preference; it favors no particular creed, race, nationality or

OPINION

FEBRUARY 2022 / GENERAL SURGERY NEWS

geography; it especially targets the vulnerable population. Yet, many people in the United States and worldwide have endowed this lethal 0.1-micron particle with an agenda, a thought process, so to speak, to carry out the purposes of the believer’s enemies. Others, seeing death and suffering all around them, even in their own families, refuse to acknowledge that this particle can do them harm but can be avoided by ingesting some dangerous bizarre substance. I once believed that if alien creatures from outer space invaded Earth to feast on humans, all people would forget their differences and unite to fight the common enemy. Now, I am not so sure. Herd immunity may be achieved as the result of a devastating death toll, suffering and socioeconomic destruction, as was the case in the Spanish flu pandemic of 1917-1919. Even if virus eradication may never be achieved, a diminution of annual infections, and, in particular, of annual deaths, may become a norm. If we follow the scientifically proven, common-sense procedures of vaccination, temporary masking and social distancing, and continue the development of therapeutic and prophylactic pharmaceuticals, we will achieve herd immunity with the least human damage, and perhaps even eradicate this virus. The decisions of a single or a group of surgeons, and a surgical discipline, may greatly influence a community, large and small. In terms of influencing public opinion, as a body of physicians, we do not have the same effect on public thought and actions as the NFL quarterback who does not get vaccinated. We do not have the same impact as certain elected officials and media commentators who scoff at mask wearing and social distancing. As physicians, however, true to our professional oaths, we must speak out against poor advice. Sadly, even though most of us represent science, public health and a profession we elected as our life’s work, in 2021, the 71 members of the Federation of State Boards of Medicine received an increase in complaints about doctors spreading false or misleading COVID19 information, and 12 boards have taken disciplinary action against physicians who have violated their license by stating medical falsehoods.

protect our tired and diminishing healthcare workers from an unnecessary and possibly fatal risk, and serve the community by emphasizing that one of the prime requisites of a society is to protect the individual’s freedom of choice except when it impinges on the freedoms of others, in particular their freedom to live in good health. The counterargument raised was that this policy voids our creed of offering our knowledge and skills to all in need. After all, we have never refused our services to patients with selfinflicted illnesses resulting from smoking or excessive drinking. We have cared

for enemy soldiers on the battlefield, at times with great personal risk to us and other healthcare personnel. The decision between these alternatives is a personal decision for the individual surgeon, but one that reflects on our discipline and our entire profession. This ambiguity of choice is not limited to surgeons; it involves all physicians.

trademark is to make decisions and take responsibility for them. ■ —Dr. Buchwald is a professor of surgery and biomedical engineering, and the Owen H. and Sarah Davidson Wangensteen Chair in Experimental Surgery (emeritus), at the University of Minnesota, in Minneapolis. His articles appear every other month.

Conclusion I end with the declaration that surgeons and all physicians face heightened decisions during the COVID-19 pandemic. As in the past, a surgeon’s

Editor’s note: Opinions in General Surgery News belong to the author(s) and do not necessarily reflect those of the publication.

The news you need. Whenever you want.

Doctor–Patient Relationship In the final analysis, the decisions that surgeons make in their discipline and their doctor–patient relationships will be the legacy of our profession in the era of COVID-19. Recently, a major, international, metabolic/bariatric surgery society’s senior members engaged in a debate. The proposition was put forth that we should refuse surgery to those who refuse vaccination. The rationale for this action was that it would promote vaccination,

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IN THE NEWS

GENERAL SURGERY NEWS / FEBRUARY 2022

The Scientific Greats: A Series of Drawings

Mary Edwards Walker (1832-1919) By MOISES MENENDEZ, MD, FACS

r. Mary Walker was an American abolitionist, a prohibitionist, a prisoner of war and a surgeon. She was a highly principled and passionate reformer who refused to recognize the oppressive social conventions of 19th-century America, and is the only woman to ever receive the Medal of Honor. Dr. Walker was the youngest of seven children, with five sisters and one brother. Her parents raised her and her siblings in a progressive manner, which was revolutionary for the time. This nontraditional parenting strategy nurtured Dr. Walker’s spirit of independence and sense of justice that she actively demonstrated throughout her life. After finishing primary school, Dr. Walker attended Falley Seminary in Fulton, N.Y. Falley was not only an institution of higher learning but a place that emphasized modern social reform in gender roles, education and hygiene. Its ideologies and practices further cemented Dr. Walker’s determination to defy traditional feminine standards on a principle of injustice. In her free time, she would pore over her father’s medical texts on anatomy and physiology, leading to an interest in medicine at an early age. Dr. Walker worked until she saved enough money for medical school. She attended Syracuse Medical College, in New York, and received her medical degree in 1855. She was the only woman in her class. Shortly after graduating, Dr. Walker married another medical school student, Albert Miller, in November 1855. They started a medical practice together in Rome, N.Y., but the practice did not succeed because of people’s unwillingness to accept a woman as a doctor. At the outbreak of the American Civil War in 1861, Dr. Walker volunteered with the Union army and served as a surgeon at a temporary hospital in Washington, D.C., even though at the time women and sectarian physicians were considered unfit by the Union army examining board. At the start of the war, Dr. Walker, one of the few practicing female doctors at the time, arrived in Washington, D.C., seeking a position as a surgeon in the army. She met with the secretary of war, Simon Cameron, wearing a bloomer-style outfit, which incorporated trousers and represented her interest in equal rights for women. She was offered the role of a nurse, but declined, and chose to volunteer as a surgeon for the army as a civilian. Inspired by her parents’ novel standard of dressing for health purposes, Dr. Walker was infamous for contesting traditional female wardrobe. In 1871, she wrote, “The greatest sorrows from which women suffer today are those physical, moral, and mental ones, that are caused by their unhygienic manner of dressing.” While Dr. Walker was able to successfully push boundaries with her style of dress and occupation, she was never able to become a commissioned officer within the army. However, she secured a paid position as a civilian-contracted assistant surgeon. During

Mary Edwards Walker (1832-1919) 2017 Work was done on velour paper, 9×12, using charcoal pencils and white chalk. Artist: Moises Menendez, MD, FACS

this period, she served at the first battle of Bull Run (Manassas, Va.), and at the Patent Office Hospital in Washington, D.C. She worked as an unpaid field surgeon near the Union front lines, and was happy to see women serving as soldiers, alerting the press to the case of a woman named Frances Hook who served in the Union forces disguised as a man. Dr. Walker was the first female surgeon of the Union army. She wore men’s clothing, claiming it to be easier for the high demands of her work. In September 1863, she was employed as a “contract acting assistant surgeon (civilian)” by the Army of the Cumberland, becoming the first female surgeon employed by the U.S. Army. Dr. Walker was later appointed assistant surgeon of the 52nd Ohio Infantry. During her service, she frequently crossed battle lines and treated civilians. On April 10, 1864, Dr. Walker was captured by Confederate troops and arrested as a spy, just after she finished helping a Confederate doctor perform an amputation. She was sent to Castle Thunder in Richmond, Va., and remained there until Aug. 12, 1864, when she was released as part of a prisoner exchange. While she was imprisoned, she refused to wear the clothes provided her, said to be more “becoming of her sex.” The most notable takeaway is Dr. Walker’s advocacy for dress reform, which included wearing pants

from the start of her career through her death in 1919, and the public criticism she endured for her bravery. After the war, Dr. Walker sought a retroactive brevet, or commission, to validate her service. Former President Andrew Johnson directed Edwin Stanton, the secretary of war, to study the legality of the issue, and he solicited an opinion from the Army’s Judge Advocate General, who determined that there was no precedent for commissioning a woman, but that a “commendatory acknowledgment” could be issued in lieu of the commission. This led Mr. Johnson to personally award the Medal of Honor as an alternative. “The grounds upon which the Medal of Honor could be awarded were broader than they are today and rather ambiguous in a number of cases,” said Edward Lengel, the chief historian for the National Medal of Honor Museum. “It did not necessarily have to be combat service to qualify for the award, i.e., not just wartime service, but service actually under fire. Although, in many cases, Mary Walker came close to that.” And so, Dr. Walker was not formally recommended for the Medal of Honor, and this unusual process may also explain why authorities overlooked her ineligibility, ironically on the grounds of lacking a commission. Dr. Walker’s wartime experiences took their toll, and she never returned to medical practice. For the rest of her natural life, she devoted herself to causes including women’s suffrage, public health, dress reform and temperance; writing books, articles and pamphlets; and giving lectures. Dr. Walker was outraged when, in 1917, her medal was revoked on the grounds that she had not been an active combatant. While in Washington, D.C., two years later, petitioning to have it restored, she fell and soon after died at the age of 86 years, on Feb. 21, 1919, in Oswego, N.Y. Nearly 60 years after her death, in 1977, Dr. Walker’s Medal of Honor was posthumously restored by former President ■ Jimmy Carter.

Sources Ferry G. Mary Edwards Walker: military surgeon who wore the trousers. Lancet. 2020;395(10220):263. Harness C. Mary Walker wears the pants: the true story of the doctor, reformer, and Civil War hero. Bulletin of the Center for Children’s Books. Johns Hopkins University Press; 2013. Kassraie A. Civil War surgeon only woman in history to receive the Medal of Honor: the story of abolitionist, prisoner of war and physician Mary Edwards Walker. AARP. March 23, 2021. Lange K. Meet Dr. Mary Walker: the only female Medal of Honor recipient. DoD News, Defense Media Activity. March 7, 2017. Wikipedia. Mary Edwards Walker.

—Dr. Menendez is a general surgeon and self-taught portrait artist in Magnolia, Ark. Since 2012, he has completed a series of portraits of historical figures, particularly well-known physicians and surgeons.

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