MONEY M AT T E RS
Financial Security: Lessons Not Taught in Medical School Page 22
GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon
GeneralSurgeryNews.com
November 2020 • Volume 47 • Number 11
Antibiotics Found Noninferior to Surgery pp In Randomized Appendicitis Trial
8 Months In: How Private Practice Surgeons Are Faring Durin During COVID-19
By CHRISTINA FRANGOU By VICTOR VICTORIA STERN
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n a large randomized trial comparing surgery with antibiotics in adults with appendicitis dicitis in the United States, antibiotics were nonininferior based on 30-day health status. Seven of 10 adults with appendicitis safely avoided appendectomy for 90 days by receiving a course of antibiotics, according to findings from the ongoing CODA (Comparison of the Outcomes of antibiotic Drugs and Appendectomy) trial. That number fell to six out of 10 for patients with appendicoliths. Of patients nts randomized to antibiotics first, 41% undernderwent appendectomy within three months, s, compared with 25% of those without an appendicolith. ndicolith.
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uss Juno, MD, FACS, a general surgeon in rural Texas, faced a significan significant drop in revenue during the first few months of the pan pandemic. “In April, my income was down 50% from last year,” said Dr. Juno, wh who runs a practice with his wife, OB-GYN Shannon Shanno Juno, MD, FACS, in La Grange, about an hour’s hou drive from Austin. “My staff of six, which includes inclu me and my wife, had to cut pay and hours.” Dr. Juno’s situation situa aligns with that of many private practice practic surgeons across the country. Accordi According to more than 5,200 surgeons su surveyed in May, one in three in pri private practices were at risk for closing cl up shop permanently
Results of Highly Anticipated CODA Trial Seem to Suggest ‘One Size Doesn’t Fit All’
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TIMELY TOPICS IN SURGERY
OPINION
Why Increasing Diversity In Residency Is Good For Our Specialty
Proposed CMS Cuts And the Future of Surgical Education
AI Tool Can Predict Post-op Hernia Complications By KAREN BLUM
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alling for increased diversity in U.S. general surgery residency programs has become ubiquitous on social media platforms b and in our academic journals. It is time, however, to move past the echo chambers and virtue signaling to enact substantive changes in the way we recruit and train surgeons. Enhancing the heterogeneity of surgical residents is only one of the steps necessary to repair the so-called “leaky pipeline” that ends with creating leaders in the surgical community. It is a step, however, in which the opportunity
his August, the Centers for Medicare & Medicaid Services (CMS) proposed a new Physician Fee Schedule (PFS) for the upcoming year starting in January 2021. This new PFS follows a budget neutrality law that would create the largest cuts to surgical reimbursement in over two decades to increase funding to other medical specialties, including outpatient and
n artificial intelligence algorithm could be used to help surgeons determine which hernia patients have complex cases and are best suited for care at larger referral centers, according to new research. When presented with pixels from hernia patients’ preoperative CT images, an AI tool developed by investigators at Carolinas Medical Center, in Charlotte, N.C., learned to predict which patients would require component separation or transfer to the ICU because of pulmonary insufficiency, or develop a surgical site infection
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By JJEREMY LIPMAN, MD
By AHMAD ZEINEDDIN, MD, and HARI B. KESHAVA, MD
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IN THE NEWS
10 First Look: American Association For the Surgery of Trauma 12 Highlights From the Society Of Surgical Oncology J OURNAL WATCH
14 Endovenous Ablation; Appendicitis; s; Incisional Hernia facebook.com/generalsurgerynews
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OPINION
NOVEMBER 2020 / GENERAL SURGERY NEWS
Just OK Is Not OK By FREDERICK L. GREENE, MD
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he advertising world has done a magnificent job over the years of introducing slogans for a variety of products and services that have become ingrained in our collective consciousness, even though we may actually have forgotten the product to which the slogan was attached. Who can forget “Just Do It,” “Where’s the beef ?”, “It melts in your mouth, not in your hands,” and “the breakfast of champions”? Keeping with this theme, you might recognize the title of this editorial from a series of advertisements by AT&T that highlights the concept that we should never settle in choosing a product or service because it reaches only a minimum standard or “low bar.” With this catchphrase in mind, I began to ponder the recent decision by the National Board of Medical Examiners and Federation of State Medical Boards to change the United States Medical Licensing Examination (USMLE) Step 1 examination from a three-digit scoring system to a pass/fail system beginning Jan. 1, 2022. Now, I fully understand that for most of our General Surgery News readership, concerns regarding an examination taken by students at the conclusion of the second year of medical school might not be a priority. For others, especially colleagues involved in the selection and training of future surgeons, this decision may be profound. The decision to use a pass/fail system resulted from concerns that perhaps medical students were spending too much time studying for this examination that tested
My overarching concern is that lessening the role of achieving excellence in favor of merely passing the USMLE Step 1 will ultimately prove detrimental to the very students for whom this decision was meant to benefit.
their understanding of basic medical science. By reducing this “extra” study time, students could concentrate on patient interaction and the ideals of the “art of medicine.” Another reason for the antiscoring move was to level the playing field for all students applying for residency and, perhaps, to put more emphasis on letters of support, overall academic performance or the in-person interview during the prematch process. Although these reasons are laudatory, the practical issue is that the USMLE Step 1 has served as a primary component that governs which students are actually invited for residency interviews. During my almost 35 years of participating in the surgical resident selection process, which included 15 years as a general surgical residency director, having the USMLE Step 1 score as one of several benchmarks for selection was highly beneficial. As you follow my thought process, please know that I am a true believer in egalitarianism, especially as it applies to the selection of our future generations of surgeons. I am also fully aware that some students are better test takers than others and that raw scores on examinations certainly do not necessarily serve as indicators of success or excellence in a surgical career. I am also mindful of the changing beliefs in the value of standardized testing as exemplified by waning interest in the SATs and ACTs for college entrance. My overarching concern is that lessening the role of achieving excellence in favor of merely passing the USMLE Step 1 will ultimately prove detrimental to the very students for whom this decision was meant to benefit. 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.
Senior Medical Adviser Frederick L. Greene, MD Charlotte, NC
Lauren A. Kosinski, MD Chestertown, MD
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DISCLAIMER Opinions and statements published in General Surgery News are of the individual author or speaker and do not represent the views of the editorial advisory board, editorial staff or reporters.
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As an example, consider two students who are applying to a surgical residency program. Both students have done well academically and have glowing support letters from their deans and other faculty. The interview selection committee has also received notification that both students have achieved a pass grade on their USMLE Step 1 examination. Student A is from a top-5 medical school as listed in the recent U.S. News and World Report, while student B has matriculated at an institution that never was listed and from which your training program never selected a student for interview. Guess which is the determinant that will govern the selection process! Since neither student has had an opportunity to excel on the Step 1 exam, but otherwise is an outstanding prospect for surgical training, the main selection criterion might well be the reputation of his or her medical school and not personal benchmarks! I am not so naive as to believe that this argument will delay the inevitable stratification of scoring on standardized tests. I also believe that personal qualities and academic performance are more important than a several-hour examination. I do believe, however, that the rule makers need to examine all the ramifications of their decisions before altering further traditional benchmarks for resident selection. Let us remember, just OK may not be OK! ■ —Dr. Greene is a surgeon in Charlotte, N.C.
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IN THE NEWS
Surgery or Antibiotics continued from page 1
Furthermore, patients with appendicoliths were more likely to have a perforation if they underwent surgery. “The way I interpret these results … antibiotics are reasonable for some patients, probably not all patients. It really helps to figure out what the patient wants when deciding on the different treatment options,” said coprincipal investigator David Flum, MD, a professor and the associate chair of surgery at the University of Washington School of Medicine, in Seattle. “(This) gives information to people so that, based on their characteristics, their preferences and their circumstances, including maybe COVID-19, they can figure out what’s right for them,” Dr. Flum added. He presented the results at the 2020 American College of Surgeons’ Clinical Congress, which was held virtually. The study was published in The New England Journal of Medicine (2020 Oct 5. doi: 10.1056/ NEJMoa2014320). The results of the CODA trial have been highly anticipated since its launch in 2016. The trial is unusually large, with 1,552 adults who underwent randomization and a pragmatic design intended to accommodate the broad range of patients seen in real-world practice environments in the United States. Participants were ethnically diverse, with one-third whose primary language is Spanish. Unlike most other trials of antibiotics to treat appendicitis, patients with appendicoliths and severe disease were included.
The study addressed a question that has long concerned surgeons: Are patients treated with antibiotics at greater risk for perforation and more surgical complications? The answer appears to be no unless they have an appendicolith, but it’s not perfectly clear. The COVID-19 pandemic heightened the urgency for results from the trial, which completed enrollment just as the pandemic was declared. In some places in the United States, health care resources became strained, leading the American College of Surgeons to suggest that hospitals and surgical centers consider nonoperative management when applicable. The ACS noted the limited evidence suggesting that patients with uncomplicated appendicitis can be managed with IV antibiotics. Some patients also wanted an antibiotics-first strategy to avoid time in the hospital, Dr. Flum said. Consequently, the CODA investigators decided to review outcomes from the first 90 days after randomization, a full year earlier than planned. The researchers randomly assigned 776 patients each to undergo appendectomy or receive a 10-day course of antibiotics administered intravenously for the first 24 hours and then as pills on the remaining days. An appendicolith was found on imaging in 27% of the participants. The primary outcome was patients’ health status 30 days after treatment using a measure of general health, the European Quality of Life-5 Dimensions (EQ-5D). Both treatment groups had similarly improved health on the EQ-5D, but each treatment showed advantages and disadvantages. Complications were more common in patients receiving antibiotics, but the difference was attributable to
the presence of an appendicolith. There were 9.3 serious adverse events per 100 participants with an appendicolith who received antibiotics, compared with 3.6 per 100 in the surgery group. Among patients who did not have an appendicolith, complications were similar in the two arms: 2.0 in the antibiotic group and 2.9 in the surgery group per 100 participants. Patients who received antibiotics, on average, missed 3.4 fewer days of work than those undergoing appendectomy (5.3 vs. 8.7 days), but were likelier to need another hospitalization, including for Among patients who did not have an an appendectomy (24% vs. appendicolith, complications were similar 5%). In the antibiotic group, 47% of patients received in the two arms: their initial care in the emergency department and avoided hospitalization for initial treatment. The study addressed a question that has long concerned surgeons: Are patients On average, patients who treated with antibiotics at received antibiotics as greater risk for perforation opposed to undergoing and more surgical complications? The answer appears appendectomy missed to be no unless they have an appendicolith, but it’s not perfectly clear. Patients in the But were likelier to need antibiotic arm had lower rates another hospitalization, of perforation overall (9% including appendectomy: versus 15%), but it was an expected finding given that patients who were not operated on could not be assessed of patients in the antibiotic for perforation. When the analysis was limited to pargroup received their initial care ticipants from either arm who in the emergency department and avoided underwent an appendectomy, hospitalization for initial treatment. perforation was nearly twice as frequent in the antibiotic group: 31% compared with 16%. However, again, this difference was attributable appendectomy. Eight of the neoplasms were carcinomas to the presence of an appendicolith. Overall, the rate and one was a mucocele. of more extensive procedures like small-bowel or colon At the beginning of the trial, researchers were conresection, reoperation or ileostomy was low and similar cerned that increasing antibiotic management in the in the two groups. United States could lead to rare cancers of the appen“Once you control for the presence of an appendi- dix being missed, said Giana H. Davidson, MD, MPH, a colith, there was really no difference in the two groups study investigator and an associate professor of surgery at in terms of the rates of complication. There’s really no UW School of Medicine. They hope this trial will idenreason to think that antibiotics allow a patient to prog- tify radiographic and patient characteristics that place ress to perforation,” said Katherine Fischkoff, MD, a someone in a higher risk category for these cancers. That surgeon at NewYork-Presbyterian/Columbia Universi- information will help clinicians and patients make decity Irving Medical Center, in New York City, one of the sions about treatment options and what to monitor over study authors who spoke at the ACS meeting. time, she said. “Decision makers have to weigh the charAppendiceal neoplasms were identified in nine acteristics, the preferences and circumstances. We found participants, who had a mean age of 47 years (range, one size doesn’t fit all,” Dr. Davidson said. 21-74 years). Of these, seven were in the appendectomy She noted that this report reflects early outcomes and continued on page 6 group and two in the antibiotic group who underwent
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2.9%
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surgery group
fewer days of work
24% vs. 5%
47%
IN THE NEWS
NOVEMBER 2020 / GENERAL SURGERY NEWS
Pediatric Appendicitis Can Be Treated With Antibiotics Only By CHRISTINA FRANGOU
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ost children with uncomplicated appendicitis can be treated successfully with antibiotics alone, according to results from a large controlled intervention study conducted at 10 pediatric hospitals in the United States. Previous studies have shown that a strategy of antibiotics first is effective in many children, but this trial has unique elements. It is the largest to date to examine antibiotics in pediatric appendicitis and, building on an earlier pilot study from the same group, the trial gave caregivers autonomy over the treatment decision, much like they have outside of a clinical trial. In this study, 65% of families chose surgery. They made the decision after a physician outlined the risks and benefits of both treatments, using a standardized script and a one-page decision aid that was put together by a multidisciplinary team. The study, which was published in the Journal of the American Medical Association, involved 1,068 children aged 7 to 17 years, who were diagnosed with uncomplicated appendicitis between May 2015 and October 2018 (324[6]:581-593). The children underwent a laparoscopic appendectomy within 12 hours of diagnosis or initial nonoperative management with antibiotics. Of the 370 children treated with antibiotics, two-thirds did not require
surgery within the next year. The nonoperative approach was associated with significantly fewer patient disability days with one-year follow-up: 6.6 versus 10.9 days for those who underwent immediate surgery. Nonoperative management was also associated with fewer disability days for caregivers. “This arms me with more data to help parents make decisions for their children,” said Janice Taylor, MD, an associate professor of pediatric surgery at the University of Florida College of Medicine, in Gainesville. She was not involved with the study. Some parents consider antibiotic management for appendicitis but they worry about ongoing disruptions to their work– life balance given the unpredictable outcomes, Dr. Taylor said. “Ultimately, if parents choose appendectomy, they don’t have to worry about a treatment [antibiotic] failure rate.” One of the questions in the antibiotics-versus-surgery debate is: What is the standard for success for nonoperative treatment? Is it when 70% of patients avoid surgery at one year? 50%? What about over five years? Study results showed that surgeons have higher expectations for nonoperative treatment than families or other health care providers. At the outset of the study, surgeons defined the minimal acceptable success rate for antibiotic treatment as 70%—meaning that, with
only 67% of patients treated with antibiotics spared from surgery, the trial did not meet the threshold for success. However, the multidisciplinary research group, which was composed of patients, families, pediatricians, emergency medi-
One of the questions in the antibiotics-versus-surgery debate is: What is the standard for success for nonoperative treatment? Is it when 70% of patients avoid surgery at one year? 50%? What about over five years? cine physicians, nurses, patient educators and payors, indicated that 50% would be an acceptable threshold for success. “The study failed from the surgeon’s perspective, but patients would have considered this outcome a success. Whose opinion matters?” wrote Edward H. Livingston, MD, the deputy editor of JAMA and a surgeon at UCLA Medical Center, in an accompanying editorial. Among children who underwent immediate surgery, 7.5% had negative appendectomies. If these cases are considered failures of surgery, the difference in failure rates between the two treatments falls to 25.4%, the authors pointed out. “Taken together, these results support offering nonoperative management
as a treatment option for uncomplicated pediatric appendicitis,” wrote the authors, who represent the Midwest Pediatric Surgery Consortium, a group of pediatric surgeons from academic health centers in seven states. Postoperative outcomes in the surgery group included a 6.9% rate of emergency department visits, 2.9% rate of readmission, 1.1% rate of postoperative infections, and 0.6% rate of reoperation. Support for antibiotic treatment for appendicitis has grown slowly since a pilot study five years ago, but the COVID-19 pandemic pushed some institutions to begin offering medical treatment to patients rather than surgery, said co-lead author Peter Minneci, MD, a professor of surgery at Nationwide Children’s Hospital in Columbus, Ohio. He has received requests from other surgeons for the study’s protocols. “COVID has changed a lot of people’s attitudes because not operating is a way to conserve PPE [personal protective equipment] and minimize risk for the entire staff,” Dr. Minneci said. The study had several limitations, including substantial rates of incomplete follow-up. The one-year rate of patients lost to follow-up in the surgery group reached 25% for patient-reported outcomes and 19% for medical outcomes. In the nonoperative management group, incomplete follow-up was 19% for all ■ outcomes.
IV Acetaminophen Does Not Reduce Post-op Hypoxemia In Randomized Trial BY CHRISTINA FRANGOU
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n patients who underwent abdominal surgery, IV acetaminophen did not reduce the duration of postoperative hypoxemia compared with placebo in a randomized, double-blind trial. In the trial, IV acetaminophen did not significantly reduce postoperative pain, and it reduced opioid consumption by 14%, or 4 mg per day, an amount that was neither statistically significant nor clinically important. “The study findings do not support the use of intravenous acetaminophen for this purpose,” concluded the authors from Cleveland Clinic, led by Alparslan Turan, MD, a professor of anesthesiology and the vice chair of outcomes research at the anesthesiology institute of Cleveland Clinic, in Ohio. “This study has changed our clinical practice,” Dr. Turan said. Cleveland Clinic has eliminated IV acetaminophen from its formulary, he said. The study was published in the Journal of the American Medical Association (2020;324[4]:350-358). Introduced in the United States in 2011, IV acetaminophen does not promote bleeding or delay bone healing and, although expensive, is used to complement
or reduce the use of opioids as postoperative analgesics. However, its efficacy as an analgesic is unclear. Small studies have shown mixed results. The FACTOR clinical trial is the largest randomized trial to examine the use of IV acetaminophen in patients undergoing abdominal surgery. Between February 2015 and October 2018, 580 patients at two Cleveland Clinic institutions were randomized to receive IV acetaminophen at 1 g, or normal saline placebo starting at the beginning of surgery and repeated every six hours until 48 hours postoperatively or hospital discharge. There was no significant reduction in the study’s primary outcome of median duration of hypoxemia (hemoglobin oxygen saturation of <90%) per hour: 0.7 minutes among patients in the acetaminophen group and 1.1 minutes among patients in the placebo group (P=0.29). Analysis revealed no significant difference in secondary outcomes, including nausea and vomiting, sedation, fatigue, active time and respiratory function. Patients had a mean age of 49 years and 48% were women. All of them had an ASA physical status class of I to III, were scheduled for elective open or laparoscopic abdominal or pelvic surgery, and were expected to be
hospitalized for at least two nights. They were randomized in a 1:1 ratio, and stratified based on long-term opioid use and trial site. The study had several limitations. Enrollment was limited to two hospitals belonging to Cleveland Clinic; about 15% of patients in each group used current analgesics; and 10 patients had missing data due to unexpected technical problems. Only abdominal procedures were included because they typically require considerable opioid use. Intravenous acetaminophen may be more effective for less painful procedures, the authors noted. The study results should persuade clinicians to curtail their use of IV acetaminophen for surgical patients, said Elizabeth Wick, MD, a professor of surgery at the University of California, San Francisco School of Medicine. She added that evidence supports the use of nonopioid analgesia, particularly nonsteroidal anti-inflammatory drugs, for abdominal surgery patients as long as they do not have a contraindication. “We need to hold ourselves accountable to practice evidence-based perioperative care, and if the data isn’t there to use IV acetaminophen, we shouldn’t use it,” Dr. Wick said. ■
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GENERAL SURGERY NEWS / NOVEMBER 2020
Wound Care During COVID-19 How the Pandemic Reshaped Vascular Care in New York By VICTORIA STERN
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efore the COVID-19 pandemic, John Lantis, MD, ran a busy vascular surgery department at Mount Sinai West, in New York City. Each week, the five-surgeon team saw about 350 patients with vascular issues— diabetes, critical limb ischemia, peripheral artery disease—and performed around three dozen procedures repairing wounds, removing blood clots, and restoring blood flow. The road to recovery following revascularization—vascular bypass and endovascular surgeries—can be long, often requiring multiple procedures. “We typically do a lot of complex reconstructions over many weeks,” Dr. Lantis, the vice chairman of the Department of Surgery at Mount Sinai West and chief of Vascular and Endovascular Surgery, told General Surgery News. “If, for example, an angioplasty works to restore blood flow to the legs and feet, we may then do a foot resection. If that is successful, we can put artificial skin on the foot. It’s a process, and each step takes time.” In early March, when COVID-19 hit New York City hard, it largely shut down, elective surgeries stopped, and Dr. Lantis’ division got pulled apart. The 25-person team shrank to four, as staff triaged to the ICU or were sent home to work remotely. Outpatient visits dropped from 350 weekly to just 10. But Dr. Lantis faced a big problem: His patients didn’t stop needing care. The 350 people who came through his practice doors before the pandemic still had diabetes, ischemia, and kidney and arteriosclerotic disease, all of which needed continued maintenance. During a talk in late July at the virtual 2020 Symposium on Advanced Wound Care (SAWC) Spring, Dr. Lantis shared how the pandemic disrupted and reshaped his vascular practice. “We had multiple problems trying to deliver appropriate care,” Dr. Lantis said
in his SAWC presentation. First, conducting a physical exam is a bedrock of vascular care. For patients with diabetic foot or ischemic ulcers, for instance, specialists typically use a standard Wound, Ischemia, and foot Infection (WifI) score to assess the likely benefit of a revascularization procedure and to predict a patient’s one-year amputation risk. This evaluation requires an in-person exam. But, facing limited office visits, Dr. Lantis quickly shifted to telemedicine to continue seeing patients while conserving personal protective equipment and limiting patients’ exposure to the virus. But the transition was rocky. Many of his patients needed assistance setting up and using these services. Dr. Lantis relied on the Visiting Nurse Service of New York, a home care agency that makes house calls to vulnerable patients across the city. “But the nurses were getting sick and had limited capacity to visit our at-risk population,” Dr. Lantis said. Another problem, Dr. Lantis said, is telemedicine just can’t replace a physical exam. “A photo or video doesn’t typically capture the reality of what’s going on,” Dr. Lantis said. “Is the wound tan, red, purple? How deep is it? These key features will not necessarily come through.” Dr. Lantis and his team needed a better way to monitor patients’ wounds over telemedicine in order to catch problems before they progressed, especially the 30% of patients with conditions—ischemia or diabetic foot infections—that put them at risk for amputation. A group at Northwell Health in New York, led by Alisha Oropallo, MD, developed the telemedicine version of the WIfI score, making it possible for physicians to assess patients’ wounds remotely. Fever, wound size, wound color, odor and drainage, for instance, were given scores from 0 to 2. If patients had a low score— 2 or less—they could remain on their
CODA Trial continued from page 4
the rate of appendectomy is likely to increase with longer follow-up. The coronavirus infection itself may affect outcomes after surgery, although this was not studied in the CODA trial. In July, the international COVIDSURG Collaborative published a cohort study of 1,128 patients from 235 hospitals in 24 countries who had surgery between Jan. 1 and March 31, 2020, which showed postoperative pulmonary complications occurred in half of patients with preoperative SARS-CoV-2 infection.
A vascular ulcer
‘For patients who needed a complex surgery requiring a 10-day hospital stay and then three to four follow-up operations, it was probably completely impractical during the height of the COVID pandemic to do this.’ —John Lantis, MD current care plan. Patients with a score above 8, however, needed in-person care. “This is something we only instituted towards the end of our experience, but it became very helpful for us to have a way of reading our telemedicine visits and collaborating with our home care nursing to get the patients in the office,” Dr. Lantis said. “We really needed to have metrics that we could say, ‘No, this patient is this ill; we need to have them in the office.’” Fortunately, Dr. Lantis was still able to take care of patients requiring immediate attention—those with diabetic foot sepsis, deeply infected wounds and blood clots related to COVID-19 infection. “But, unfortunately, we did a large number of amputations,” Dr. Lantis said. Before the pandemic, Dr. Lantis said he typically did one major amputation per week, but during the pandemic that number increased to four. “Basically, what happened was patients with wound category 3, or very severe wounds, we actually talked to them about possibly just moving on to primary amputation,” he said. This strategy is not how most vascular experts think about chronic wound care and taking care of these acutely ill patients, Dr. Lantis said, but “for patients who needed a complex surgery requiring
This comorbidity was associated with higher mortality (Lancet 2020;396[10243]:27-38). In an editorial accompanying the COVID-19 trial results, Danny Jacobs, MD, a surgeon and the president of Oregon Health & Science University, in Portland, said he believes that all options must be discussed with a patient, but most providers would still recommend surgical treatment for uncomplicated appendicitis if laparoscopic appendectomy is available. That said, the pandemic will affect people’s decision making, he wrote. “Circumstances do matter, and advantages of antibiotic treatment relative to surgery may be greater during the COVID-19 pandemic or other public health
a 10-day hospital stay and then three to four follow-up operations, it was probably completely impractical during the height of the COVID pandemic to do this.” As New York fought its way out of the COVID-19 surge, Dr. Lantis’ department began ramping up patient visits again, and is now close to normal capacity. But Dr. Lantis knows another surge may happen, and he wants to be ready. To prepare, Dr. Lantis highlighted the importance of allowing patients emergency office-based services to avoid ERs, setting up robust telemedicine services quickly, and having metrics to evaluate patients’ wounds virtually. “If there is a surge part 2, I hope that we can turn on telemedicine and home care services more quickly,” Dr. Lantis told General Surgery News. “I also hope to keep my team from being disbanded, given the complexity of the cases we see and how well we work together.” Dr. Lantis also reflected on the personal toll the pandemic has taken, so far. “We are back, but we are different,” he concluded in his SAWC talk. “We had two medical assistants who were out sick, two techs out sick, one surgeon got sick, and we have lost loved ones to our staff. So, this is a personal fight, and we have to make ourselves partners with ■ our patients.”
emergency in which operating room capacity and other resources are severely constrained,” Dr. Jacobs wrote. It’s important to ensure that people, especially vulnerable populations, are not offered antibiotic therapy preferentially or without adequate education, he added. The study has several limitations, including short follow-up. There was no standard technique for performing an operation or giving antibiotics, nor a standard indication for appendectomy for patients randomized to the antibiotic arm. In addition, women were underrepresented, accounting for one-third of participants. Men and women have a relatively equal chance of appendicitis. ■
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8
THE SURGICAL PAUSE
GENERAL SURGERY NEWS / NOVEMBER 2020
The Dance of Donation By MELISSA RED HOFFMAN, MD
“C
ode trauma. ETA 5 min.” The message flashed across my pager on a Wednesday during morning rounds. As I hustled downstairs to the trauma bay, I called ahead and asked, “What’s coming?” “Mid-30s. Hanging. Ten minutes of CPR with ROSC [return of spontaneous circulation]. Intubated on the scene. Pupils fixed and dilated.” “Damn,” I mumbled as I hung up. This was my third hanging in as many months. The other two had, predictably, not ended well. I arrived in the trauma bay just as the patient was rolling in on a stretcher. The exam was consistent with what I would later describe to the family as a devastating brain injury. The CT scan displayed evidence of anoxia with impending herniation. The patient was admitted to the neurotrauma ICU, but even 72 hours later, despite a Glasgow coma scale of 3T, continued to breathe over the ventilator. Family arrived on Saturday morning, and after I provided them with a brief update, asked, “What’s next?” Rather than launching into a discussion of prognosis
and treatment options, I sat down to chat. I learned this patient had a long history of substance use, but had been clean for several years. I learned they had a long history of depression and that this was not their first suicide attempt. I learned they were spunky, difficult, full of life, and “would never want to live like this.” I inched closer to the patient’s mom and shared, “While it hurts my heart to say this, I need you to know that the likelihood of any sort of meaningful recovery is basically nonexistent.”
And so began what I call ‘the dance of donation.’ … How can I best honor the autonomy of the patient, the grief of the family, and the health and well-being of the greater community, including that of potential organ recipients? When the patient’s mom spoke again, she stated, with resolve, “Stop everything.” And so began what I call “the dance of donation.” I have struggled with this many times: How can I best honor the autonomy of the patient, the grief of the
A Surgeon and His Art
“The Artist in Rockport, Mass.,” a Watercolor by Gerald Marks, MD A good many years ago, I seized the opportunity to visit with a special friend and famed watercolor artist, Dominic DiStefano (1924-2011), in his summer artist retreat, Rockport, Mass. I painted this beachside scene, which became a favorite of mine in the company of a gaggle of professional watercolorists while standing at personal peril partially in the road. I thought I might enjoy repainting the scene with myself in a painting pose to celebrate the memory of that wonderful moment with Dominic. I thought correctly!
Issues in Surgical Palliative Care family, and the health and well-being of the greater community, including that of potential organ recipients? Over the years, I have had many missteps and have crushed several toes, but now, when families ask me “what’s next,” I reply truthfully: “Before we stop any treatment, donor services will approach you about organ donation.” While I realize every physician’s practice is different, for me, offering this “warning shot” feels genuine and kind. The patient’s license indicated they were an organ donor, and, after speaking with donor services, the family eventually chose to proceed with a donation after cardiac death (DCD). Being present at a DCD is unlike witnessing any other death. It is always odd to invite family members into the OR, our secret and sacred temple. Dressed in ill-fitting white bunny suits, with blue bouffant caps on their heads and blue booties on their feet, they shuffle in like aliens, uneasy and awkward. For most people, witnessing a death is like traveling to a foreign country, where the local customs are strange, if not baffling. Witnessing a death in the OR is even worse: No one speaks your language, and the land is cold and austere. In this unknown land, I act as both the interpreter translating the bells and whistles into simple words (“her heart is slowing down and the oxygen levels are falling”) and the tour guide attempting to familiarize the family with local customs (“it’s OK to hold her hand,” and “it’s OK to tell him you love him”), all the while keeping my eyes on both the patient and the clock. When faced with an impending death, I often counsel families that dying is like being born, that folks will often take their time and that ultimately, we need to be patient. In contrast, a DCD—while terribly sad—is also terribly loaded. Everyone in the room wants the dance to cease. I have stood by as family members have fervently willed their loved ones out of this world within the hour, hoping to make some meaning out of the misery. Once the heart stops, the music also stops and the dance comes to an end. The family is hurriedly escorted out of the room while the transplant team quickly scurries in through the back door, the two never crossing paths. The tempo is slow during this “no-touch” period, the requisite five minutes between circulatory arrest and declaration of death. And then the next dance, between scrub tech and surgeon, begins as steel meets skin. The dance of donation reminds me that being a surgeon is holding space for both life and death. It is believing in science and praying for miracles. It is sharing the brutal truth and still maintaining hope. And it is smiling through your tears after leaving the OR, having just watched another surgeon hover expectantly over your patient, scalpel in hand, ready to transform loss ■ into legacy, into life. —Dr. Hoffman is an acute care surgeon and a hospice attending in Asheville, N.C. To listen to the latest installment of her podcast on surgical palliative care, go to https://apple.co/33H6s5w.
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10
FIRST LOOK
GENERAL SURGERY NEWS / NOVEMBER 2020
The American Association for the Surgery of Trauma All Articles by CHASE DOYLE
Life or Limb: Surgeons May Not Have To Choose After All
Pelvic Packing With REBOA May y Provide Lifesaving Hemorrhage Control
The decision to salvage a mangled extremity or amputate is fraught with complexity, as surgeons attempt to balance functional outcomes and quality of life with the risk for complications and mortality. Results of a new study, however, indicate this decision may not affect a patient’s risk for death after all. At the 2020 virtual annual meeting of the American Society for the Surgery of Trauma, Bourke Tillmann, MD, shared data that showed no difference in mortality between patients who underwent early amputation and those treated with the intention of limb salvage (abstract 30). Early amputation also was associated with a shorter hospital length of stay and fewer complications, underscoring the importance of patient input in the treatment plan. “Clinicians worry about putting their patients through the effort of limb salvage if it doesn’t change their long-term outcome, or worse, if it increases their risk of death,” said Dr. Tillmann, of Sunnybrook Health Sciences Centre, in Toronto. “After adjusting for confounding, it was reassuring to see there was no difference in hospital mortality in patients who underwent early amputation in this study. We may not be sacrificing someone’s life in order to save a limb.” For this retrospective cohort study, Dr. Tillmann and his colleagues used data from the American College of Surgeons Trauma Quality Improvement Program and included adult patients who sustained a mangled lower extremity injury and were treated at a Level 1 trauma center between 2012 and 2017. The researchers compared deaths between patients who underwent early amputation, defined as those that occurred within 24 hours of presentation, and those treated with the intention of limb salvage. Secondary outcomes included hospital length of stay, severe sepsis, acute kidney injury and decubitus ulcers. Instrumental variable analysis was used to adjust for possible confounding by patient and injury characteristics. The researchers identified 4,987 patients with a mangled extremity across 209 centers, and 848 (17%) underwent an early amputation. After controlling for confounding, there was no association between early amputation and decreased mortality. Although no difference in mortality was observed, limb salvage is “likely a rougher course,” said Dr. Tillmann, who reported that treatment with the intention of limb salvage was associated with a longer hospital stay and increased odds of developing a decubitus ulcer and severe sepsis. Attempts at limb salvage, therefore, should be reserved for patients with the highest probability of good functional outcomes, he noted, especially given recent improvement in prosthetics and stump rehabilitation. According to Dr. Tillmann, one of the major limitations of the study was the lack of long-term outcomes data. “We’re not able to quantify the impact of the initial treatment strategy on hospital readmissions or other important outcomes that affect patients’ quality of life.”
In patients with unstable pelvic fractures, resuscitative endovascular balloon occlusion of the aorta (REBOA) could be a lifesaving temporizing measure and a bridge for both resuscitation and pelvic packing. Presenting at the 2020 virtual annual meeting of the American Society for the Surgery of Trauma, Clay C. Burlew, MD, reported no deaths from acute pelvic hemorrhage in a cohort of severely injured and physiologically deranged patients (abstract 4). The largest study of strict protocol-driven use of REBOA for a single indication also showed no delays in intervention among patients receiving pelvic packing with adjunctive REBOA. “One of the concerns about using REBOA is that delays real intervention, but our study actually demonstrated that there was not a delay in definitive hemorrhage control,” said Dr. Burlew, a professor of surgery at the University of Colorado School of Medicine, in Denver. As Dr. Burlew explained to General Surgery News, pelvic packing is an operative approach to pelvic fracture that addresses the venous or bony hemorrhage by direct packing of the preperitoneal space into the pelvic hematoma. Dr. Burlew and her colleagues published previous research showing that mortality with pelvic packing as the primary intervention for pelvic fracture bleeding is as good as with angioembolization, if not better, as the primary method. In 2015, they added REBOA to their pelvic fracture management protocol. For patients with systolic blood pressure less than 80 mm Hg, REBOA is considered as an adjunct for temporary hemorrhage control prior to pelvic packing. Between January 2015 and January 2019, 652 pelvic fracture patients were admitted to Denver Health Medical Center. Of those, 78 consecutive patients underwent pelvic packing with adjunctive REBOA. Following pelvic packing, 9% of patients who had continuing bleeding also underwent angioembolization. Patients who received REBOA prior to pelvic packing had a significantly higher injury severity score, lower systolic blood pressure and higher heart rate than those did not. Despite severe injury, there were no deaths from pelvic fracture‒related hemorrhage. “In our experience, pelvic packing with adjunctive REBOA in really severely deranged patients has the lowest mortality that we have demonstrated,” Dr. Burlew said. “This suggests that the combination of REBOA with pelvic packing provides lifesaving hemorrhage control in otherwise devastating injuries.” The researchers plan to evaluate patients prospectively in future studies, but Dr. Burlew noted they do not have pans for a randomized trial. “Patients with very low systolic blood pressure need REBOA,” Dr. Burlew said. “It’s not equipoise to randomize them to a different treatment. We will continue to monitor our protocol and adjust to optimize patient outcomes.” Dr. Burlew acknowledged several limitations to this single-institution study. Although there was general support for placing arterial sheaths for patients with a persistent systolic blood pressure less than 80 mm Hg, not all patients with this recorded blood pressure received REBOA. Placement of the REBOA was ultimately the individual bedside decision of the trauma surgeon, Dr. Burlew said.
Trauma Surgeons Dissatisfied by Work–Life Balance The majority of trauma surgeons are not satisfied with their work‒life balance, according to results of a recent, presented at the 2020 virtual annual meeting of the American Society for the Surgery of Trauma. Findings of the survey, completed by nearly 300 AAST members, showed that 57% of trauma surgeons were dissatisfied with their work‒life balance. Furthermore, this lack of equilibrium appears to be contributing to an alarming rate of burnout among trauma surgeons (abstract 50). In his presentation, Carlos V.R. Brown, MD, reported that trauma surgeons with poor work‒life balance had nearly twice the rate of burnout (77% vs. 39%), and 61% of trauma surgeons overall were burned out. “The lack of work‒life balance for trauma surgeons and the high rate of burnout are very concerning findings,”
said Dr. Brown, a professor of surgery and the chief of acute care surgery at Dell Medical School, University of Texas at Austin. “However, we identified several modifiable factors that were associated with good work‒life balance, and work‒life balance in general.” Having hobbies, a healthy diet and exercising regularly were all shown to be independently associated with satisfying work‒life balance in a logistic regression analysis. The most important modifiable factor appeared to be vacation time off. “Nearly everyone surveyed was allotted a standard four weeks’ vacation,” Dr. Brown said. “While trauma surgeons in the good work‒life balance group actually took four weeks off, however, those reporting bad work‒life balance only took three of those allotted weeks.” According to Dr. Brown, trauma surgeons must take
personal responsibility for many of these modifiable factors and prioritize a healthier lifestyle. For factors like vacation time, however, trauma leaders could help enforce policies that benefit surgical teams in the long run. This also means spending more awake hours at home. “At our institution, the culture is not to stay at work if you don’t have work to do,” Dr. Brown noted. “It’s important to go home and take care of the things that you need to do as a person to maintain your stability.” In addition, fair compensation was associated with satisfying work‒life balance. “Trauma surgeons don’t necessarily need to be paid more money,” Dr. Brown said, “but they need to feel fairly compensated for what they do.” Dr. Brown acknowledged several limitations to the study, including a response rate of only 21%. Because
FIRST LOOK
NOVEMBER 2020 / GENERAL SURGERY NEWS
VTE Prophylaxis in Trauma Patients: Early Initiation S Saves aves L Lives ives Current guidelines for reducing venous thromboembolism in trauma patients recommend initiating prophylaxis within 48 hours. However, according to a large retrospective study, thatâ&#x20AC;&#x2122;s not early enough. Jason Hecht, PharmD, BCCCP, BCPS, reported that chemoprophylaxis within the first 24 hours significantly reduced the risk for VTE in stable trauma patients, even when compared with patients receiving prophylaxis between 24 and 48 hours after hospital presentation. Dr. Hecht presented the data at the 2020 virtual annual meeting of the American Society for the Surgery of Trauma. â&#x20AC;&#x153;These findings challenge the current gold standard in our literature of when to begin prophylaxis,â&#x20AC;? said Dr. Hecht, a clinical pharmacy specialist and pharmacy research director at St. Joseph Mercy Ann Arbor, in Michigan. â&#x20AC;&#x153;By starting chemoprophylaxis within 24 hours, we saw a significant decrease in the rate of VTE during patientsâ&#x20AC;&#x2122; hospital stay. â&#x20AC;&#x153;Conversely, the risk of VTE events skyrocketed in patients who initiated chemoprophylaxis more than 48 hours after hospital presentation,â&#x20AC;? he added. As Dr. Hecht explained, although current guidelines recognize the importance of chemoprophylaxis for VTE, the timing of initiation must balance the risks for thrombosis and bleeding. For this study, Dr. Hechtâ&#x20AC;&#x2122;s team analyzed patient data from the Michigan Trauma Quality Improvement Program taken from 34 Level 1 and 2 trauma centers. Patients who did not receive prophylaxis or who were hospitalized for less than 48 hours were excluded. Three comparison groups were based on timing of initiation of prophylaxis (<24, 24-48, and â&#x2030;Ľ48 hours). Of the 89,165 patients analyzed, 1.9% (1,752) died and 1.8% experienced a VTE complication, Dr. Hecht said. After adjusting for type of prophylaxis and patient factors, the researchers found an increased risk for VTE events
associated with delayed chemoprophylaxis. Although prophylaxis within 48 hours was efficacious, Dr. Hecht said, prophylaxis initiated within 24 hours of hospital presentation was associated with a significantly decreased risk for VTE events. Waiting longer than 48 hours to initiate prophylaxis resulted in increased mortality and thrombotic complications. â&#x20AC;&#x153;The earlier you can get chemoprophylaxis started, the better off the patient is going to be during their hospital stay,â&#x20AC;? Dr. Hecht said. â&#x20AC;&#x153;Balancing the risk of
he ri risk skk ooff a pa p tien ti e t cl lot ot-bleeding versus the patient clotcon onun undr drum um m we we face faace ting is a clinical conundrum stu tud dy all the time. Thiss study tting shows that getting artthat prophylaxis startble le is ed as early as possible ientt going to improve patient outcomes.â&#x20AC;? hAlthough the researchme ers took care to overcome onthe studyâ&#x20AC;&#x2122;s observational design with sensitivity analyses and by accounting for disease severity, Dr.
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they collect self-reported answers, survey studies are also subject to response bias, he said. The biggest limitation is the inability to determine cause and effect. â&#x20AC;&#x153;Do dieting, exercise, having hobbies and taking vacation lead to better workâ&#x20AC;&#x2019; life balance or does having a better workâ&#x20AC;&#x2019; life balance allow you the opportunity to do these things?â&#x20AC;? he said. â&#x20AC;&#x153;All we can say is thereâ&#x20AC;&#x2122;s an association between workâ&#x20AC;&#x2019;life balance and these variables.â&#x20AC;? Dr. Brown and his colleagues are planning to perform a subgroup analysis to see if there are age- and sex-related variables associated with better workâ&#x20AC;&#x201C;life balance.
H He echt cht acknowledged ch a ac Hecht limiitations. itat it tat ations.. Mo M ost importantly, he os Most said sa id id, d, th thee st stud tud udy dy was unable to said, study k at the safety of the practice look like previous resear research has shown. This is a really well-conductâ&#x20AC;&#x153;This ed pilot study with high-quality evidence showing that eearly chemoprophylaxis improves ou outcomes, but l being able to vvalidate the safety and effica efficacy of this practice prospectively in the future would certainly be ideal,â&#x20AC;? â&#x2013; Dr. Hecht concluded.
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11
12
IN THE NEWS
GENERAL SURGERY NEWS / NOVEMBER 2020
Highlights From the Society of Surgical Oncology Annual Meeting All Articles by MONICA J. SMITH
Anastomotic Leak: Predicting Failure to Rescue Using the Modified Frailty Index Age and American Society of Anesthesiologists (ASA) status may be useful in predicting which patients will not survive an anastomotic leak after colectomy for colorectal cancer (CRC), but the addition of other variables associated with frailty do not appear to be of much use, according to new research. “As we all know, predicting which parents will experience an anastomotic leak is notoriously unreliable. Perhaps it’s better to ask then how likely it is that a patient will survive one,” said Richard Spence, MD, PhD, a surgical oncology fellow at the University of Toronto. “This falls under the realm of discussion with regard to the frailty of my patient. There are many definitions of frailty in the literature, but one, of course, is the capacity to overcome the physiological insult of a surgical complication such as an anastomotic leak,” Dr. Spence said in a presentation during the Society for Surgical Oncology’s 2020 virtual meeting. The American College of Surgeons (ACS) National Quality Improvement Program (NSQIP) modified frailty index-5 (mFI-5), which considers functional status, diabetes, hypertension requiring treatment, and a history of chronic obstructive pulmonary disease and congestive heart disease, has not been evaluated in determining failure to rescue in the event of an anastomotic leak after colectomy for CRC. “We wanted to determine the predictive performance of the ACS-NSQIP mFI-5 in determining failure to rescue anastomotic leak following colectomy for CRC,” Dr. Spence said. To do so, he and his colleagues compared the predictive performance of three models (age and ASA status; age, ASA status and mFI-5; and the ACS-NSQIP mortality prediction, which includes more than 150 variables) by analyzing the area under the receiver operating characteristics (AUROC) for each model. Reviewing data on 50,944 patients in the NSQIP database who underwent colectomy for CRC between 2012 and 2016, Dr. Spence and his colleagues identified 1,755 patients (3.46%) who experienced an anastomotic leak, among whom 113 (6.44%) were characterized as failure to rescue (FTR). In this unfortunate group, older age and a median ASA III classification were strongly associated with FTR. About 20% of these patients had diabetes, and more than half were on hypertensive treatment—characteristics associated with frailty according to the mFI5. But analyzing the AUROC, Dr. Spence and his colleagues found no statistical differences in the curves of the three models. “Age and ASA status appear to be the most reliable predictors of FTR and anastomotic leak after colectomy for CRC. The addition of the mFI-5 and all the variables collected by NSQIP don’t significantly improve predictive performance,” he said. Dr. Spence acknowledged some limitations of the research, including its retrospective nature and the fact that they could not confirm that every fatality in patients
with an anastomotic leak was due to the leak itself. He plans further research of prospectively validated risk calculators and variables to better predict FTR anastomotic leaks, including day of postoperative leaks.
Adequate Lymphadenectomy Linked To Improved Survival in Patients With Small-Bowel Cancer Adequate lymphadenectomy in patients with early-stage small-bowel cancer is associated with greater overall survival, according to a new study that adds support to the National Comprehensive Cancer Network’s 2019 recommendation for evaluation of at least eight lymph nodes in this patient population. “Lymph node positivity is one of the most important prognostic factors in gastrointestinal cancers, but small-bowel adenocarcinoma is a rare entity for which the role of lymphadenectomy is less well defined,” said Victor Gall, MD, a graduating surgical oncology fellow at Rutgers Cancer Institute in New Brunswick, N.J. To demonstrate the relationship between adequate lymphadenectomy and OS in stage II small-bowel cancer, and to assess the effect of adjuvant chemotherapy on those outcomes, Dr. Gall and his colleagues conducted a retrospective analysis of data collected between 2004 and 2016 in the National Cancer Database. “Our primary outcome was seven-year OS stratified by the overall lymph nodes examined, and our secondary outcome was OS with and without adjuvant chemotherapy based on the adequacy of the lymph node harvest,” Dr. Gall said. The researchers identified 2,709 patients who met their inclusion criteria. Of the 1,259 patients who had inadequate lymphadenectomy (seven or fewer nodes examined), 610 underwent surgery alone and 417 had adjuvant chemotherapy. Of the 1,450 patients who had adequate lymphadenectomy, 786 had surgery alone and 441 had adjuvant chemotherapy. Overall seven-year OS was 38% in patients with inadequate lymphadenectomy and 56% who had eight or more nodes examined. The impact of chemotherapy was fairly profound in the inadequate lymphadenectomy group—their seven-year OS was 43%; but in patients who had an adequate number of nodes examined, the addition of chemotherapy was associated with an increased OS of only a single percentage point. “When analyzing patients by number of lymph nodes examined, we found that in patients with an inadequate lymphadenectomy, high tumor grade, positive surgical margins and T4 tumors were associated with worse survival. In these patients, the addition of chemotherapy improved survival with a hazard ratio of 0.75,” Dr. Gall said. In patients with adequate lymphadenectomy, only positive surgical margins and T4 tumors were associated with worse OS. In this case, chemotherapy showed no benefit. “Much like in colorectal cancer, this data identifies inadequate lymphadenectomy as a high-risk feature of
stage II disease and supports the use of adjuvant chemotherapy in this situation,” Dr. Gall said. He noted that the study, like all investigations to date on this topic, is limited by its retrospective nature, but that a randomized controlled trial investigating the impact of chemotherapy on survival in this patient population is underway in Europe, and may further delineate which therapeutic agents are optimal. Dr. Gall presented his research at the Society for Surgical Oncology 2020 virtual meeting.
Risk Score Helps Guide Patient Selection for Resection of Sarcoma Lung Metastases On the basis of preoperative characteristics, a novel risk score that stratifies patients with pulmonary metastases may help identify those at highest risk who would benefit from multimodal therapies. First described in the 1970s, lung metastasectomy, which is associated with improved overall survival (OS) in patients with sarcoma lung metastases, remains the standard of care for these patients. “But it stands to reason that some patients may benefit more than others from multimodal therapy,” said Rachel M. Lee, MD, a general surgery resident at Emory University, in Atlanta. Presenting her research at the Society of Surgical Oncology 2020 virtual meeting, Dr. Lee and her mentor, Ken Cardona, MD, observed that several studies have identified factors affecting OS in patients with lung metastases, but that the relative influence and impact of these factors remain controversial, and level I evidence is lacking. “Our aims were to identify preoperative prognostic factors associated with OS in patients undergoing resection for sarcoma lung metastases, and to develop a risk score to stratify patients being considered for lung metastasectomy and multimodality therapy.” To do this, they reviewed information from the U.S. Collaborative Sarcoma Database on 352 patients who met their inclusion criteria. The majority, 270 patients, had truncal/extremity primary tumors, and 49 (15%) had retroperitoneal tumors. “On univariate analysis, age 55 or older, retroperitoneal primary tumor location, R1 resection of the primary tumor, high tumor grade and multiple lung lesions were associated with decreased OS,” Dr. Lee said. On multivariable analysis, all factors excluding high tumor grade were associated with decreased OS. “Because the hazard ratios were essentially equivalent, we weighted these factors equally, and assigned each 1 point, developing an easy-to-calculate risk score from 0 to 4.” Patients with a risk score of 0 have a five-year OS of nearly 60%. That percentage decreases to 48% with a risk score of 1, 17% with a risk score of 2, 9.8% with a risk score of 3, and 0% with a risk score of 4. “We then combined the similar groups to form final low and high-risk score groups. Patients in the low risk score group had a five-year OS of 51% compared to 16% for patients in the high-risk score group,” Dr. Lee said. One study limitation, the small patient population, did not allow the researchers to internally validate the risk score. Dr. Lee noted that external validation with
IN THE NEWS
NOVEMBER 2020 / GENERAL SURGERY NEWS
a larger cohort is necessary to implement the risk score in clinical practice. “But we hope this can improve the informed consent process and inform consideration for multimodality therapy to improve the outcomes for our highrisk score group patients.”
Rectum-Sparing Approach Appropriate for Many Patients After Neoadjuvant Therapy Most patients with rectal cancer who have a complete clinical response (cCR) and many patients who achieve a major clinical response (mCR) after neoadjuvant therapy may be appropriate candidates for rectum-sparing management, according to new research. Prior research has supported the use of watch and wait and local excision in these patients. “But those studies were limited by factors such as small sample size, single center and the variability of methodology used in conducting the studies,” said Gaya Spolverato, MD, a surgical oncologist with the University of Padova, in Italy. At the Society for Surgical Oncology 2020 virtual meeting, Dr. Spolverato presented the preliminary results of reSARCh (Rectal Sparing Approach After Preoperative Radio and/or Chemotherapy in Patients With Rectal Cancer), the first prospective multicenter observational trial to investigate a rectum-sparing approach after preoperative radiation therapy and/or chemotherapy. Dr. Spolverato’s presentation reported short-term outcomes in 176 adult patients enrolled between 2016 and 2019 with adenocarcinoma within 12 cm of the anal verge who had achieved cCR or mCR. Patients who achieved cCR were offered a choice of watch and wait or local excision; those who achieved mCR were offered local excision; the 20 patients who achieved neither cCR nor mCR were referred to total mesorectal excision (TME). Before neoadjuvant therapy, most patients had T3, node-positive disease. After neoadjuvant therapy, the majority had T0-T1, node-negative disease. Among those who achieved cCR, 57 (62%) opted for watch and wait and 34 (37%) chose local excision. In the group that achieved mCR, 63 (97%) underwent local excision and two (3%) watch and wait. Among the 107 patients who underwent local excision, the median interval between radiation therapy and surgery was 15 weeks. “The majority of patients had no complication, and those who did have complications mostly had a grade 1 or 2 complication,” Dr. Spolverato said. TME was required in 30 (28%) patients, mainly due to grade T2 or higher disease. At a follow-up of 15 weeks, 14 of the
66 watch-and-wait patients experienced tumor regrowth. Nearly all of these patients proceeded with TME. Overall, 28 (16%) of patients underwent TME: 16 in the local excision group and 12 in the watch-and-wait group. Overall organ preservation at 13.5 months was 85% (83.5% in the local excision group and 88% in the watchand-wait group). Correspondingly, the rate of definite stoma was low: 9% in the local excision group and 2% in the watch-and-wait group. “The preliminary results of the reSARCh trial are promising. However,
further studies are needed to better define long-term outcomes, and to find an effective definition of clinical response with the ability to predict pathological response,” Dr. Spolverato said. She acknowledged the main limitation of the study is its inability to define the oncologic outcome of the rectum-sparing approaches; these will be evaluated as soon as the study achieves two years’ median follow-up. “In the meantime, we are creating the national registry of patients undergoing rectal-sparing approaches in Italy,” Dr. ■ Spolverato said.
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Early Superficial Ablation For Venous Leg Ulcers
n this installment of Journal Watch, we welcome a guest columnist, Josh Herb, MD, who is a general surgery resident and research fellow at the University of North Carolina at Chapel Hill. We will be evaluating two articles on the antibiotic treatment of appendicitis—the newly published results from the CODA trial along with results evaluating the type of antibiotic to use. We also look at recommendations on the timing of endovenous ablation for superficial venous reflux and timing of incisional hernia repair in relation to ostomy closure. The hope is readers will find these worthwhile topics relevant to the scope of a general surgeon’s practice.
I
—Arielle Perez, MD, MPH, MS S Director of UNC Health Hernia Center and Assistant Assista Professor of Surgery in the Division of General, Acute Care, Divi and a Trauma at The University of North Carolina at Chapel Hill School of Medicine
Column Editor
—Josh Herb, MD Guest Columnist
Article Title
Journal
Study Design
Long-term clinical and cost-effectiveness of early endovenous ablation in venous ulceration: a randomized clinical trial
Gohel MS, Heatley F, Liu X, et al. JAMA Surg. 2020 Sep 23. [Epub ahead of print]
Prospective multicenter randomized controlled trial
Narrow- versus broadspectrum antibiotics for simple acute appendicitis treated by appendectomy: a post hoc analysis of EAST MUSTANG study
Qian S, Vasileiou G, Dodgion C, et al. J Surg Res. 2020;254:217-222.
Retrospective analysis of a prospectively collected multicenter observational study
In JAMA Surgery, Gohel et al published five-year results of the EVRA (Early Venous Reflux Ablation) trial (JAMA Surg 2020 Sep 23. [Epub ahead of print]). This was a prospective, multicenter, randomized controlled trial in the United Kingdom evaluating the healing of venous leg ulcerations with early superficial venous ablation and compression therapy versus compression therapy with delayed ablation. One-year results from this trial have been published previously (Table, Related Articles). The trial included 450 adult patients from 20 centers, recruited from October 2013 to September 2016. Eligible patients had open venous leg ulceration(s) present for at least six weeks and less than six months, who also had evidence of superficial venous reflux, and had an ankle-brachial index over 0.8. Notable exclusions were patients who had deep venous occlusive disease or any other contraindication to superficial venous ablation, ulcerations thought to be from a nonvenous source, or who may need skin grafting. In the early ablation group, patients underwent ablation within two weeks of randomization. In the delayed group, ablation was considered after the ulcer had healed or at six months after randomization if the ulcer had not healed. The method of endovenous ablation therapy (thermal ablation modalities [laser or radiofrequency ablation], ultrasound-guided foam sclerotherapy [the most common modality], or nonthermal nontumescent endovenous interventions performed alone or in combination) was decided by the clinical team. Compression therapy was administered in both groups according to local standard of care. Primary outcomes were time to first ulcer recurrence Key Takeaways
after date of ulcer healing. Primary and secondary end point data were collected via a telephone follow-up conducted between October 2018 and March 2019. Compared with the delayed intervention patients (n=208), those in the early intervention group (n=218) had similar time to first ulcer recurrence from ulcer healing (hazard ratio [HR] for recurrence, 0.82; 95% CI, 0.57-1.17; P=0.28), but slower rate of ulcer recurrence (0.11 vs. 0.16 per person-year; incident rate ratio, 0.658; 95% CI, 0.480-0.898; P=0.003). Early ablation was 91.6% likely to be cost-effective at willingness-to-pay thresholds of $26,283 per qualityadjusted life-year, and 90.9% likely at $45,995. This study adds to the previous ESCHAR randomized trial, also by Gohel et al, which showed surgical correction of superficial venous reflux plus compression did not improve ulcer healing rates at three years, but did reduce the likelihood of ulcer recurrence and increased ulcer-free time (Br Med J 2007;335[7610]:83-87; Table). Limitations of this study include a limited follow-up at a single time point after one year, and the high proportion of patients (20.8%) who did not receive ablation in the delayed intervention group. However, this study adds important long-term follow-up data showing that early endovenous ablation of superficial reflux is a cost-effective method to improve healing time and reduce the incidence of ulcer recurrence in patients with venous ulcerations.
Narrow- Versus ExtendedSpectrum Antibiotics for Uncomplicated Appendicitis In the Journal of Surgical Research, Qian et al published a retrospective analysis examining antibiotic
Study Limitations
Useful Related Articles
• Early endovenous ablation of superficial reflux is a cost-effective method to improve healing time and reduce the incidence of ulcer recurrence.
• Follow-up is limited to a single time point after one year.
Gohel MS, Heatley F, Liu X, et al. N Engl J Med. 2018;378(22):2105-2114.
• A high proportion of patients in the delayed intervention group did not receive ablation.
Gohel MS, Barwell JR, Taylor M, et al. Br Med J. 2007;335(7610):83-87.
• Narrow-spectrum antibiotic use in uncomplicated appendicitis is recommended.
• Observational study leads to inherent selection bias in antibiotic use.
Yeh DD, Eid AI, Young KA, et al. Ann Surg. 2019 Oct 28. [Epub ahead of print]
• Broad-spectrum antibiotics do not confer any benefit over narrowspectrum antibiotics for simple acute appendicitis.
• Patient management with antbiotics >24 hours is contradictory to established Surgical Infection Society recommendations.
Bratzler DW, Dellinger EP, Olsen KM, et al. Surg Infect (Larchmt). 2013;14(1):73-156. Mazuski JE, Tessier JM, May AK, et al. Surg Infect (Larchmt). 2017;18(1):1-76. Cameron DB, Melvin P, Graham DA, et al. Ann Surg. 2018;268(1):186-192.
Should simultaneous stoma closure and incisional hernia repair be avoided?
A randomized trial comparing antibiotics with appendectomy for appendicitis
Oma E, Baastrup NN, Jensen KK. Hernia. 2020 Sep 25. [Epub ahead of print]
Propensitymatched analysis
Flum D, Noninferiority, Davidson G, randomized Monsell S, et al. trial N Engl J Med. 2020 Oct 5. [Epub ahead of print]
• Concurrent stoma and incisional hernia repair have higher risk for future hernia repair than incisional hernia repair only.
• Propensity matching omitted multiple baseline characteristics important to hernia repair. • Matched control group did not have to have a stoma present during incisional hernia repair, making extrapolation of data difficult.
• Antibiotic treatment is noninferior to surgical appendectomy in the short term. • Presence of an appendicolith confers a higher risk for antibiotic treatment failure.
• Two patients in the antibiotic treatment group who crossed over to surgery had neoplastic findings on pathology— foregoing surgery may lead to unintended consequences of missed neoplasm.
Baastrup NN, Hartwig MFS, Krarup PM, et al. World J Surg. 2019;43(4):988-997. Madabhushi V, Plymale MA, Roth JS, et al. Surg Endosc. 2018;32(4):1915-1922. Fischer JP, Tuggle CT, Wes AM, et al. J Plast Reconstr Aesthetic Surg. 2014;67(5):693-701. Salminen P, Paajanen H, Rautio T, et al. JAMA. 2015;313(23):2340-2348. Salminen P, Tuominen R, Paajanen H, et al. JAMA. 2018;320(12):1259-1265. Westfall KM, Brown R, Charles AG. Am Surg. 2019;85(2):223-225.
JOURNAL WATCH
NOVEMBER 2020 / GENERAL SURGERY NEWS
practice patterns and surgical outcomes after appendectomy for uncomplicated appendicitis in patients who received narrow- versus extended-spectrum antibiotics (J Surg Res 2020;254:217-222). This was a post hoc analysis of the prospective Eastern Association for the Surgery of Trauma multicenter observational study of appendicitis (EAST-MUSTANG) study that enrolled adult patients with uncomplicated, perforated and gangrenous acute appendicitis from January 2017 to June 2018 from 28 sites in the United States (Yeh DD et al. Table; Related Articles). In this article, the authors evaluate the uncomplicated acute appendicitis participants from EAST-MUSTANG. The antibiotic spectrum and duration of administration were examined—either narrow-spectrum antibiotics (penicillin, first- or second-generation cephalosporin, and others) or extended-spectrum antibiotics (third- or fourth-generation cephalosporin, piperacillin-tazobactam, and others) before and/or after appendectomy. The primary outcome was surgical site infections, including intraabdominal abscesses. Of 2,336 patients in the analysis, 778 patients (33.3%) received narrow-spectrum antibiotics and 1,558 (66.7%) received extended-spectrum antibiotics. A total of 688 patients (29.5%) received postoperative antibiotics: 24% of the narrow-spectrum group compared with 32% of the extended-spectrum group (P<0.001). Antibiotics continued beyond 24 hours was noted in 23% of patients receiving narrow-spectrum compared with 47% receiving extended-spectrum antibiotics (P<0.001). Narrow- and extended-spectrum antibiotic groups did not differ significantly in any outcomes evaluated in either the index hospitalization or at 30 days. Specifically, at 30-day follow-up, both groups had similar risks for surgical site infection, intraabdominal abscess, secondary intervention, emergency department (ED) visit and readmission. Subgroup analysis based on duration of postoperative antibiotic use was not presented. There are important limitations to note in this study. Although measured baseline characteristics were similar, as an observational study there is an inherent selection bias, with clinically important reasons for which antibiotics were prescribed not accounted for in the data. Additionally, the risk for surgical site infection was low in this study and it may be underpowered to show a true difference. It should be noted that a significant proportion of patients received antibiotics longer than 24 hours, which is contradictory to recommendations by the Surgical Infection Society on the management of intraabdominal infections, which recommend no more than 24 hours of antibiotics unless perforation is noted (Mazuski JE. Table; Related Articles). Nevertheless, these data support narrow-spectrum antibiotic use for uncomplicated appendicitis by the American Society of Health-System Pharmacists, Infectious Diseases Society of America, SIS and the Society for Healthcare Epidemiology of America, which recommend cefoxitin, cefotetan or cefazolin-metronidazole (or a regimen such as metronidazole plus an aminoglycoside for patients with a beta-lactam allergy) (Bratzler DW et al. Table; Related Articles). Limitations of observational studies will only be resolved by a large randomized controlled trial.
Incisional Hernia Repair With And Without Stoma Closure In Hernia, Oma et al report a propensity-matched analysis examining outcomes of elective incisional hernia
repair (IHR) with and without simultaneous stoma closure (Hernia 2020 Sep 25. [Epub ahead of print]). Using the Danish Ventral Hernia Database, the authors identified patients who underwent elective IHR from 2007 to 2017, and with the Danish National Patient Registry identified those who underwent concurrent stoma closure. Of note, parastomal hernia repairs were excluded. The authors used a 1:3 propensity score‒matched control group of patients who underwent IHR only to a cohort of patients who underwent IHR with concurrent stoma closure. Age, sex, defect size, surgical approach and repair technique (mesh vs. suture) were used for propensity matching. With a median follow-up of 6.2 years, the primary outcome was reoperation for hernia recurrence. Secondary outcomes included hospital length of stay, reoperation within 30 days, reoperation for anastomotic leak within 30 days, and readmission within 30 days. A total of 129 patients who underwent stoma closure plus IHR were propensity matched with 387 patients who had IHR alone. Of the stoma closure group, approximately half underwent ileostomy closure and the other half underwent colostomy closure. The fiveyear risk for reoperation for hernia recurrence was 15.9% (95% CI, 9.5%-22.3%) in the concurrent stoma closure group versus 9.6% (95% CI, 6.6%-12.6%) in IHR-only group. The adjusted hazard ratio for recurrence reoperation was 1.72 (95% CI, 1.03-2.87). Restricting to only patients with mesh repair, the risk was still higher but no longer statistically significant (HR, 1.54; 95% CI, 0.852.79; P=0.159). Similar results were seen when excluding patients with anastomotic leakage (HR, 1.62; 95% CI, 0.96-2.75; P=0.074). Not surprisingly, the median hospital stay was longer in the concurrent stoma closure group than the IHR-only group (eight vs. three days). Other secondary outcomes were not significantly different. This study is the first to provide further information on whether IHR should be combined with stoma reversal or staged. Previous studies evaluating other concurrent surgery with IHR have provided conflicting recommendations (Surg Endosc 2018;32:1915-1922; J Plast Reconstr Aesthetic Surg 2014;67[5]:693-701 [Table; Related Articles]). Although propensity matching attempts to create similar groups, multiple hernia-relevant covariates such as chronic obstructive pulmonary disease, immunosuppressed state, body mass index, tobacco use and level of case contamination are missing, making it unclear if the comparison groups are truly equitable. It is unclear whether the study differentiates
reoperation for hernia recurrence at the prior incisional hernia or hernia at the stoma closure site. In fact, the IHR-only group may or may not have had a stoma, making it difficult to extrapolate the results to a staged procedure. Nevertheless, this study may lend support to a staged approach for stoma closure and IHR, particularly in those at high risk for anastomotic leakage. More studies, particularly a randomized controlled trial, may be beneficial to provide more information and guidance.
Antibiotics Versus Surgery For Appendicitis: The CODA Trial In The New England Journal of Medicine, the CODA Collaborative presents results from the CODA (Comparison of Outcomes of Antibiotic Drugs and Appendectomy) trial. This was a pragmatic randomized trial across 25 centers in the United States to assess whether antibiotic treatment is noninferior to surgery for acute appendicitis. The primary outcome was 30-day health status as measured by the European Quality of Life‒5 Dimensions (EQ-5D) score, which combines quality-of-life measures from five dimensions (mobility, self-care, usual activity, pain/discomfort and anxiety/depression) into a single summary score from 0 to 1, with higher scores indicating better health status. A total of 1,552 adult patients with imaging-confirmed appendicitis were randomized: 776 patients to surgical treatment with appendectomy (96% laparoscopic) and 776 patients to 24 hours of IV antibiotics followed by oral antibiotics for a 10-day course. Antibiotics were based on established guidelines (Surg Infect (Larchmt) 2017;18[1]:1-76). The surgical technique was not standardized, and the decision to cross over to surgery in the antibiotics group was left to the treating surgeon. Extensive exclusion criteria included diffuse peritonitis, septic shock, severe phlegmon on imaging, walled-off abscess, free air or more than minimal fluid, and imaging suggestive of neoplasm, and are further mentioned in the study’s methods. It should be noted that an appendicolith was present in 27% of participants. The 30-day EQ-5D score was 0.92±0.13 in the antibiotics arm and 0.91±0.13 in the appendectomy group, for a mean difference (95% CI) of 0.01 (‒0.001 to 0.03), indicating noninferiority for antibiotics. Similar results were found in subgroup analyses of patients with and without appendicolith. Roughly half of patients (47%) in the antibiotics arm did not require hospital admission continued on the following page
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GENERAL SURGERY NEWS / NOVEMBER 2020
8 Months In: How Private Practice Is Faring During COVID-19 continued from page 1
because of the crushing financial hit they over the past four months because of took in the first few months of the pan- COVID-19. Of those, almost 80% were demic. The survey, commissioned by specialists including surgeons. On top of the Surgical Care Coalition, found that that, 4% of survey respondents said they many weathered the financial storm by are planning to shut down in the next year, taking on debt, furloughing employees, citing the pandemic as the cause. or cutting their own salaries. On Sept. 18, Lindsay Fox, MD, FACS, Fortunately, Dr. Juno was able to keep made the decision to close her solo prachis practice open. To help him through tice in Mount Shasta, Calif. Similar to the early financial challenges, he applied Dr. Juno, Dr. Fox had taken a big finanfor a loan through the Paycheck Protec- cial hit in the early months of the pantion Program, part of the demic: Her income Coronavirus Aid, Relief dropped 40%. and Economic SecuriBut the financial strain ty (CARES) Act, geared she experienced over the toward helping small past six months wasn’t businesses continue operultimately the decidations and keep staff on ing factor for shuttering the payroll. her practice. Dr. Fox had Dr. Juno’s loan was already considered this approved in May. The option for several years, $50,000 he received covbut two closely timed ered employee salaries. events over the summer “The loan helped and tipped the scales for her. I’m grateful for it,” Dr. First: Both of Dr. Fox’s Juno said. “It only covered Lindsay Fox, MD, FACS in-laws, who live in Enga small percentage of my land, got COVID-19. losses, but it let me keep my employees Her father-in-law was diagnosed at the covered.” beginning of July. Her mother-in-law Although hospitals and some pri- got sick a few weeks later. After being vate practice surgeons received financial hospitalized for seven days, her motherhelp through the CARES Act, Eileen in-law recovered. But her father-in-law’s Natuzzi, MD, an acute care surgeon in health took a turn. Shortly after falling California, said this assistance “was a ill, he was placed on a ventilator. joke” for private practice surgeons. “After a month on the ventilator, he “Most of that money went to hospi- wasn’t improving,” Dr. Fox said. “It became tals, but private practice surgeons have clear we needed to withdraw care.” faced a tremendous amount of lost revOn Aug. 6, he passed away. enue during the pandemic with no way The second event: In mid-August, Dr. to make it up,” she said. Fox gave birth to her second child, a girl named Bridie Hope. Closing Up Shop “On my first day back at work after For some physicians, the business loss- taking a few weeks of maternity leave, I es during the early months of the pan- cried on and off all day,” said Dr. Fox, who demic pushed them to the breaking figured lingering pregnancy hormones point. were to blame. But the tears continued A survey of more than 3,500 physicians, over the next few days. She knew somepublished in August by the Physicians thing was not right. On her third day Foundation, reported that 8% of respon- back at work, she had a moment of clarity. dents in private practice closed their doors “I’ve been giving my patients the best
Journal Watch continued from the previous page
after diagnosis in the emergency department. Crossover to appendectomy occurred in 29% of patients in the antibiotics arm by 90 days: 41% among patients with an appendicolith and 25% among patients without an appendicolith. Secondary outcomes showed the antibiotics group had fewer days of missed work at 90 days (5.3 vs. 8.7 days) and similar proportions with resolution of symptoms by seven days. However, patients in the antibiotics group had a higher proportion with any hospitalization after index treatment within 90 days (24% vs. 5%) and a higher rate of National Surgical Quality Improvement Program‒defined complications and
patient volumes have almost returned to normal,” Dr. Sarap said. “Our elective endoscopy schedule is pretty filled for the next six weeks. I am seeing a huge backlog of older patients needing cataract surgery, and also a large number of very nasty gallbladder cases and several complicated appendices.” The ramp-up for Dr. Juno has been much slower, largely because of the prolonged shutdown period in Texas. But patients are trickling back in. “By August, I only had 20 patient encounters a week compared to my typical 100,” Dr. Juno said. But the squeeze on private practice surgeons’ income started long before the pandemic. Declining reimbursement rates, in particular, have been hurting these practices for years. “Our reimbursement keeps getting carved down,” Dr. Sarap said. “We’re Changing Tides but Challenges making one-third of what we did 15 Ahead years ago on many procedures, while Like Drs. Juno and Fox, Michael rent, overhead and insurance premiums Sarap, MD, FACS, a general surgeon in have all been going up.” Dr. Fox half joked that if she hadn’t rural Ohio, faced a hefty drop in revenue received call pay at her local hospital over during the early months of the pandemic. the past few years, “I’d His busy three-surgeon probably be living in an private practice went from RV in a parking lot behind a caseload of 1,200 endosmy office.” copies, 300 operations and The future of reim500 smaller in-office probursement isn’t lookcedures each year to no ing any brighter. Starting elective operations and Jan. 1, 2021, surgeons will endoscopies. face a 7% decrease in their “But we still had adeMedicare reimbursement quate PPE [personal prorate. Dr. Juno is concerned tective equipment], so this change will twist the we were able to continue vice on his income even doing more urgent cases like outpatient proce- Michael Sarap, MD, FACS further, given that 60% of his business comes from dures for breast, skin and Medicare patients. But he colon cancer patients who is not ready to give up. couldn’t wait for surgery,” Dr. Sarap said. “I’m going to try to keep fighting,” In June, Dr. Sarap’s business started to bounce back as Ohio eased shutdown Dr. Juno said. “But it feels like death by a thousand paper cuts. My dream was to restrictions. “Every month, our overall hospital be a doctor, not to have to worry about surgical volume has increased and our money.” ■ me,” Dr. Fox said. “Coming home to my family after a long day, I felt I had nothing left to give.” The years of fighting with insurance companies to get paid, declining reimbursement rates, working at breakneck pace, and having no energy when she got home to her family had all taken its toll. She knew the pace of work would never slow down and that she needed to make a change. That evening, Dr. Fox and her husband decided to close the practice and move to England to be near their family. Dr. Fox also decided to take a real break from work—six months off to settle into her new home. “If there’s any time for us to do something big and bold to simplify our lives, it’s now while we have a newborn,” Dr. Fox said.
percutaneous drainage procedures, mainly in the subgroup with an appendicolith. In addition, nine appendiceal neoplasms were identified after surgery: seven in the surgery arm and two who crossed over in the antibiotics arm. The CODA Collaborative should be lauded for undertaking the largest randomized trial to date comparing antibiotics and appendectomy to treat acute appendicitis, which included patients with more severe appendicitis than previous trials and also patients with appendicoliths. The Appendicitis Acuta trial with 530 patients was previously the largest trial, but it excluded those with appendicoliths, had a lower rate of perforated appendicitis, a lower rate of crossover to surgery at 16% after 90 days, and a crossover rate to appendectomy
of 39% after five years (Salminen P, et al. JAMA 2018; Table, Related Articles). Further follow-up is critical to determine the longterm rate of subsequent appendectomy, other complications, and unintended consequences such as missed neoplasms (Westfall KM et al. Am Surg 2019; Table; Related Articles). Additional cost analyses may help summarize the important and conflicting secondary outcomes for antibiotic treatment, such as reduced time away from work but increased rehospitalization, emergency room visits and drainage procedures. Results from the CODA trial can help patients and surgeons in the shared decision-making process for treatment of acute appendicitis, particularly when considering the risks of exposure to COVID-19. ■
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IN THE NEWS
Hernia AI continued from page 1
(SSI), with 64% to 83% accuracy. The work was presented during the Americas Hernia Society virtual annual meeting and received the society’s 2020 Best Paper Award. “Early studies of AI show promising results aiding surgeons in successful identification of malignancy, ocular and skin pathology, and cerebral bleeding. However, the role of AI in general surgical procedures is unknown,” said lead author and general surgeon Sharbel Elhage, MD.
GENERAL SURGERY NEWS / NOVEMBER 2020
“Determining which hernia patients will require complex surgical techniques or specialized postoperative care remains difficult and is often a subjective decisionmaking process. The aim of our study was to develop a machine-learning algorithm that could predict complexity and complications in hernia patients based on preoperative CT imaging alone.” Dr. Elhage’s team pulled in-house data of hernia patients undergoing open abdominal wall reconstruction who had CT scans containing the entire hernia defect. Their outcomes of interest were component separation, defined as
‘These tools, once refined, can allow for objective analysis of hernia patients preoperatively, replacing much of the current subjectivity.’ —Sharbel Elhage, MD transversus abdominis release or external oblique release; pulmonary failure, defined as transfer to the ICU for respiratory complications or intubation; and wound complications, specifically SSIs.
The investigators analyzed images using TeraRecon’s Aquarius iNtuition software and created their tool using the programming language Python and open source Tensorflow and OpenCV frameworks. They standardized all CT images to 150 x 150 pixels, which was analyzed by an eight-layer convolutional neural network to determine the key image characteristics. Next, they batched the images into training and validation sets. Overall, the team assessed images from 233 patients. Hernias had an average defect width of 9.4 cm. Patients had a component separation rate of 46.2%, a pulmonary failure rate of 7.3%, and an SSI rate of 22.5%. The investigators first assessed the AI tool’s ability to predict component separation, Dr. Elhage said. After reviewing CT images 8,000 times while being provided correct information, the algorithm reached 100% accuracy in assessing images in the training set. Next, presented with CT scan images from a validation set of patients, the computer tool accurately predicted whether those patients would require a component separation technique with an accuracy of 74% (P<0.001). Assessing postoperative complications, the tool also reliably predicted patients who would develop pulmonary failure 83% of the time (P<0.001). The AI program also predicted which patients would develop an SSI postoperatively at a rate of 64%, but this did not reach statistical significance (P=0.081). The work demonstrates that “AI can successfully be used to predict complexity and complications in hernia patients solely based on preoperative CT imaging,” Dr. Elhage said. “This is a groundbreaking proof of concept for the entire surgical field, showing that valuable intra- and postoperative information can be garnered by AI analysis. These tools, once refined, can allow for objective analysis of hernia patients preoperatively, replacing much of the current subjectivity involved in the evaluation and risk stratification of hernia patients, and allowing for the creation of a data-driven, tiered hernia referral system that should improve care for hernia patients around the world.” Preliminary testing has shown the program has been more successful than a panel of expert hernia surgeons in predicting which patients will require component separation, Dr. Elhage added. The team is continuing work to optimize the algorithms, through methods such as adding additional patient images, assessing what the algorithm is weighting as most important, and adding database variables such as tobacco use, diabetes status and body mass index, with the goal of testing the tool in multicenter ■ prospective trials, he said.
OPINION
NOVEMBER 2020 / GENERAL SURGERY NEWS
Proposed CMS Cuts and the Future of Surgical Education continued from page 1
telehealth services. These cuts include up to 6% to ophthalmology; 7% to general surgery, vascular surgery and neurosurgery; 8% to thoracic surgery; and 9% to cardiac surgery. This change has led to a strong response from the Surgical Care Coalition, consisting of 12 surgical associations representing more than 150,000 surgeons, arguing against the proposed cuts in light of lower overall reimbursements due to previous CMS interventions and the financial burden that the COVID-19 pandemic has placed on surgical practitioners. As surgical trainees, we bring forward another argument against the proposed PFS: This could hinder the future of surgical education and training. Over the past three to four decades, many studies have sounded the alarm over the future of surgical practice in the United States. When examining the overall number of general surgeons over 25 years (1981-2005), researchers showed a stark decrease (25.9%) in the United States (Arch Surg 2008;143[4]:345-351). This decline extends to all surgical specialties and is projected to continue to a shortage of 17,100 to 28,700 surgeons by 2033, based on the latest workforce report from the Association of American Medical Colleges (www.aamc.org). To the contrary, this decline has not been countered by a response in surgical training positions. Between 1986 and 2016, all 10 of the largest specialties in the national residency match program have experienced growth except for general surgery. We saw a growth of positions offered in emergency medicine by 602%, anesthesia by 242%, and
family medicine by 35%, compared with a 6% decline in categorical general surgery positions offered over those 30 years (Fam Med 2016;48[10]:763-769). Surgical specialties are known for the rigorous and long training with an unpredictable lifestyle even after training. Not only does this make surgical specialties not as appealing as other specialties with more predictable lifestyles, but attrition is extremely high. Up to 18% of trainees leave general surgery with the majority citing an uncontrollable lifestyle as the main reason to change specialties (JAMA Surg 2017;152[3]:265-272). Adding insult to injury, the decrease in future compensation proposed by CMS along with the lifestyle sacrifice will only deter more and more students from pursuing surgery, further exacerbating the need for general surgeons. Aside from that fundamental issue, another point of concern we have as current surgical trainees is the effect any cuts to surgical reimbursements will have on our current education and training in the OR. While the financial benefits of having surgical residents continue to be discussed, with some saying residents cost more time in the OR and inevitably order more tests, residents overwhelmingly benefit the health care system. Surgery residents provide a diverse array of care from the ICU and wards to the OR, all while working 80 hours a week and teaching medical students. During the pandemic, we witnessed the versatility of surgery residents putting patient care above their own health at times. They were willingly redeployed to COVID-19
wards, COVID-19 ICUs and emergency departments, all while performing their usual duties of taking emergency cases to the OR. Although we have continued faith in our surgical teachers and mentors to provide fruitful training opportunities, we cannot help but think about the inevitable financial constraints this proposal will impose trickling down to our education. Surgical training already has many constraints from limited exposure to certain procedures to other non-OR duties that fall on trainees competing with operative training time. The proposed PFS will add to these factors as our educators will have continued pressure from a financial standpoint, forcing them to decrease time for education and teaching. This change will subsequently have a huge impact on patient care due to the decreased training experiences of future surgeons. In the closing days of the public comment period on the proposed PFS, we add our voices to those of our parent organizations in opposition to these cuts. We ask Congress to waive the budget neutrality rule and protect the future of surgical education and practice, while still allowing for well-earned increases in compensation for our colleagues in other specialties. â&#x2013; â&#x20AC;&#x201D;Dr. Zeineddin is a surgical resident in the Department of Surgery, Howard University Hospital, Washington, D.C. â&#x20AC;&#x201D;Dr. Keshava is an assistant clinical professor of surgery and attending thoracic surgeon at the University of California, Irvine.
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TIMELY TOPICS IN SURGERY
Diversity continued from page 1
currently exists to take effective action. A heterogeneous workforce is more creative, nimble and productive, while mitigating the impact of implicit biases (Lyons S. Forbes. Sep 9, 2019. https:// bit.ly/3o4BUED). Diversity in physician teams leads to improved quality of care, higher patient satisfaction, enhanced care for underserved populations, and better patient compliance with treatment plans (J Natl Med Assoc 2019;111[6]:665-673). While there is value in adding providers
from any number of backgrounds and experiences, the shift to virtual resident recruitment and the upcoming changes in United States Medical Licensing Examination (USMLE) reporting provide specific, actionable mechanisms to improve the balance of underrepresented minorities and women in surgery. The diversity of general surgery residency programs in the United States does not reflect the applicant pool or communities those institutions serve. It is for this reason that the term “underrepresented in surgery” is appropriate and the definition used by the Association of American
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Medical Colleges (AAMC). Evaluating the self-identified race or ethnicity of applicants to general surgery programs, Jarman et al found that 12% identified as Hispanic/Latino, 9% as Black/African American and 1% as Native American (J Am Coll Surg 2020;231[1]:54-58). According to the Census Bureau, the U.S. population is estimated to be around 18% identifying as Hispanic/Latino, 13% as Black/African American and 1% as Native American, with 50.8% women. According to the AAMC, 50.5% of medical students are women, yet women make up only 36.9% of general surgery
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training programs. Some may argue that it is out of the residency program’s control to determine who they train, as the complement ultimately relies on the outcome of the match. However, it is incumbent on the programs to make diversity recruitment a priority. The Accreditation Council for Graduate Medical Education recognizes this and has included an obligation for institutions and programs to recruit and retain a diverse, inclusive workforce in its Common Program Requirements. If the rank list does not reflect the diversity desired in the program, it will never be achieved. A robust compendium of strategies to enhance the recruitment, retention and promotion of those underrepresented in surgery has been created by the Association of Program Directors in Surgery, Diversity and Inclusion Committee and is freely available at: https:// bit.ly/2J52GMX This is a rich and very well-designed resource that should be used by all residency programs. Recruitment of a diverse residency program must begin before interview selection. Intentional efforts to encourage applications from those underrepresented in surgery should be undertaken. These should include clear statements regarding the program’s and institution’s value placed on diversity as well as the structure present to support those who train there. Programs also should facilitate communication between underrepresented applicants, current trainees and faculty such that concerns can be allayed and realistic expectations set. Numerous organizations exist specifically in support of diverse trainee groups, such as the Student National Medical Association, National Hispanic Medical Association, Association of Women Surgeons, Society of Black Academic Surgeons and many others. Information about programs can be disseminated to applicants through these channels to ensure student members are encouraged to apply. For a nominal expense, programs can provide stipends to support underrepresented students to do away rotations or visit programs where the financial burden to the applicant would have otherwise precluded this exposure. A holistic approach to application review is imperative. At a recent AAMC
TIMELY TOPICS IN SURGERY
meeting, medical school deans were asked why they thought program directors chose to use the three-digit USMLE score in application review. The largest bubbles in the resulting word cloud that the deans created surrounded “lazy” and “stupid.” Program directors will be forced to move past the number for USMLE Step 1 scores beginning with exams taken in 2022. However, a shift to simply requiring a Step 2 score would only exacerbate the problem. Psychometricians at the National Board of Medical Examiners demonstrated that test takers who were not native, English-speaking, white, male U.S. citizens of average age were likely to score lower on the USMLE exams (Acad Med 2019;94[3]:364-370). Although this difference was at least partially attributable to lower grades and MCAT scores rather than the exam itself, this finding highlights that using the three-digit score is effectively filtering diversity out of the recruitment pool. Admission to the Alpha Omega Alpha (AOA) Honor Society as a medical student affords a higher likelihood of matching into an applicant’s specialty of choice. This is most pronounced in the surgical programs. Even accounting for other educational, leadership and academic covariates, white students have been found six times more likely to be admitted to the AOA than black students (JAMA Intern Med 2017;177[5]:659-665). Holistic application review relies on a broader data set to identify those selected for an interview. It begins with identification of the core values that make a resident successful in a specific program. With this in mind, reviewers can recognize elements of the application that align with these values to select those most likely to succeed there. The challenge with this type of review is the added time required for more thorough review. Many programs rely on USMLE scores, the AOA and other quantitative data to identify a manageable group of applications that will then undergo more thorough evaluation. This approach, however, screens out many otherwise well-qualified candidates, and disproportionately does so to underrepresented applicants. The appropriate mechanism for incorporating a holistic application review will vary based on the resources available to and values of each program. Once the core values are identified, a short training
session can be effective in extending the number of people available to perform application review. Inclusion of current trainees in this process can add value for them, as well. As a result, a larger number of applications can be fully vetted, filtering fewer applications from consideration. Some also have advocated for a program-specific survey of applicants, sometimes referred to as a secondary application, to attain information valuable to the program that may not be available in the standard application (JAMA Surg 2018;153[5]:409-415). The change in USMLE reporting to
pass/fail and the increased reliance of training programs on web-based platforms to promote their residencies provide opportunities to enhance diversity in recruitment of general surgery residents. Now is the time for programs and institutions to reevaluate their application processes and institute changes to intentionally improve the heterogeneity of the workforce. The best efforts of training programs, however, will be lost without an institutional commitment to increased diversity in their faculty recruitment and promotion processes and the development of programs to support and retain
those underrepresented in surgery in their positions. Failure to act now unfairly harms our patients and the future of ■ our specialty. —Dr. Lipman is the program director of the general surgery residency at Cleveland Clinic, in Cleveland. He is an associate professor of surgery at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. Series Editor: Ajita S. Prabhu, MD, associate professor of surgery, Cleveland Clinic Foundation, Ohio
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GENERAL SURGERY NEWS / NOVEMBER 2020
Financial Security: Lessons Not Taught in Medical School By LEX HUBBARD, MD
A
s I write this, we are at some stage of a historical event in the stock market, a dramatic decline resulting from a pandemic. Later on the market managed to recover, but worries persist about further declines, possibly dramatic. My twin brother, Rex, and I have driven the major highways of Texas, Louisiana, Tennessee, Kentucky, Michigan, Pennsylvania, Georgia and more in the last few years. Rex wondered aloud to me, as he marveled at the busy highways, “What could possibly stop this economy?” Now we know. During the last few weeks, my portfolio value has been crushed. I’ve actually enjoyed the trip, not because I’m a stock trader, but because I’m an investor. Portfolio value doesn’t interest me in particular; portfolio income does. After attending the University of Texas Medical Branch in Galveston, I did an internal medicine residency and a pulmonary disease fellowship at LSU Medical Center in Shreveport. Then I went to UT Southwestern Medical Center in Dallas, for another residency, in anesthesiology. I started to practice at Willis-Knighton Medical Center (WK) in 1982, joining many I had known from five years of training at LSU. I could prosper along with WK in association with others building their practices. And like the others, I needed a home, a college savings account and a self-funded “pension.” I had not learned anything about investing to meet financial commitments. In the early, difficult days of being a novice anesthesiologist, I thought, “if I could get $1 million banked, I could retire.” How naive!
Financial Security, Hiccups and All I want to share my journey to financial security. There have been hiccups along the way, but I have 30 years’ experience to share with those willing to create financial security slowly. While on a Boy Scout trip in 1989, Lex, my 9-year-old son, and I met Harvey, a college professor, and Jack, his son. Harvey and I became acquainted. We drifted into a conversation about investing and my suspicion that there was a known strategy for creating financial independence. Harvey was already doing for others what I sought, but mostly for people of better means. From the beginning, he knew Dottie, my wife, and I wanted to learn the basics of investing with the goal of being independent financial managers. Our arrangement was to meet once monthly to create a “dividend reinvestment portfolio.” We paid 1.5% of the portfolio value divided by 12 at each monthly meeting. After 18 months, we took the reins.
Investing in good companies and reinvesting dividends build financial security slowly. I’ve learned a great deal over the years: adventures; misadventures; tax consequences of ordinary dividend and capital gains incomes; the value of diversification; buying stocks that are out of favor; and more.
In 1990, I wrote a personal research paper to confirm that our plan would yield (a good word) shared expectations. The internet was in its infancy, so the effort was more substantial than it would be today. I wrote 100 companies for data on their dividend and price per share on the dividend payment date for up to 15 years. Twenty-four investor relations departments responded. Those 24 companies became my research portfolio. I used spreadsheets to determine the consequence of purchasing 100 shares of each company on the first date of information provided and reinvesting dividends quarterly! I was more interested in portfolio income than portfolio value; both were remarkable, at least to us.
Lessons Learned I retired at age 70. It has been over three decades since starting our little company—a diversified portfolio of dividend-paying stocks—to fund retirement. I can attest to the findings of my research paper—it works. Investing in good companies and reinvesting dividends build financial security slowly. I’ve learned a great deal over the years: adventures; misadventures; tax consequences of ordinary dividend and capital gains incomes; the value of diversification; buying stocks that are out of favor; and more. The details of starting a dividend reinvestment portfolio by requesting delivery of share purchases are complex and no longer necessary. We have had accounts at Charles Schwab since the early 1990s. Using Charles Schwab or other brokers is a great way to start since there are minimal, if any, fees for buying and selling. Dividends can automatically reinvest. It is now easy to do a “what if ” back-test at portfoliovisualizer.com. Consider the possibility that in 1989, I had invested $1,000 ($10,000 total) in each of the following: Caterpillar, Duke Energy, Kimberly-Clark, Lockheed Martin, McDonald’s, PepsiCo, Pfizer, Procter & Gamble, Sysco and Walmart. At the end of 2019, the portfolio value with dividends reinvested would be $460,830, and the annual dividend income would be more than the initial $10,000 investment. Visit the website to do your own investigation using stock names you know and others. So, how to get started? Get a brokerage account like we use at Charles Schwab or one of a number of brokers. Go to the internet for a listing of Dividend Kings, which have increased dividends for at least 50 years, and Dividend Aristocrats and Dividend Champions, which have increased dividends for 25 years (dripinvesting.
org). The Aristocrats are in the S&P 500 and the Champions include companies not in the S&P 500. Build a watch list of these companies at Yahoo Finance, mainly to find those trading “out of favor.” If you plan to buy these companies, why not wait until they are cheap. The way I think about this concept is that I am buying dividends while they are on sale. Buy the stocks you find that are “on sale” and instruct your broker to reinvest dividends. When beginning, you may want to consult Sure Dividend (suredividend.com) and Dividend Growth Investor (dividendgrowthinvestor.com) for direction and reassurance. During the first 25 years after meeting Harvey, I did our investing. Knowing my skill set was limited made me seek professional advice three different times. I fired all three advisors within six months. They either did not do what I asked or they increased risks beyond my comfort zone. While on vacation six years ago, I met an investment advisor who shared my strategy but with better knowledge. I hired him and follow his performance, which has been outstanding. After all this time, I know how to evaluate investment advisors. During the recent market turmoil, while watching our portfolio value decline, our portfolio income has been minimally affected. I have been sanguine. We had cash on the side to invest in companies that were out of favor, and many great companies have been. My investment advisor bought dividends that were cheap by purchasing companies trading at multiyear lows. Some companies have been significantly overvalued, trading at multiyear highs; one was Clorox. We sold it, freeing cash for out-of-favor stocks. The way we invested has not been a secret in our family. I received the following text from one of my daughters recently: “I’m lucky you’re my dad. For many reasons, one of which is that most people don’t teach their kids about investing.” She knows it works. My advice is to have a plan. Research your plan. Write a research paper. Do your own investing to learn. If after you have enough knowledge and assets, you no longer wish to manage your portfolio, find a good investment advisor. Only then will you be able to evaluate his or her performance. ■
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IN COMPLEX HERNIA REPAIR, PATIENT RISK FACTORS AND POSTOPERATIVE WOUND COMPLICATIONS CAN CONTRIBUTE TO THE PERIL OF HERNIA RECURRENCE
STRATTICE™ RTM, a 100% biologic mesh, is a durable solution for abdominal wall reconstruction based on the long-term outcomes of low hernia recurrence rates across multiple published clinical studies1-5 In a recent retrospective evaluation, biologic meshes were shown to have a
CUMULATIVE HERNIA RECURRENCE RATE OF
8.3
% AT
7 YEARS POST-OP1,*
*Inc nclu lude dess po porc rcin inee an andd bo b vi vine ne ace cellllul ular ar der erma m l ma ma matr tric ices ess (AD DMs M ) (n ( =1 =157 57).). 57 Brid Br idge id gedd re repa pair ir and hum uman an ADM wer eree exxcl clud uded edd froom th thee st stud udyy grrou ud oup. p p.
TO LEARN MORE ABOUT STRATTICE™ RTM, SPEAK TO YOUR ALLERGAN REPRESENTATIVE
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-to-patient 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.
PRECAUTIONS (Continued) Place these products in maximum possible contact with healthy, wellvascularized 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. 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 www.StratticeTissueMatrix.com/hcp.
References: 1. 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. 2. Golla D, Russo CC. Outcomes following placement of non-cross-linked porcine-derived acellular dermal matrix in complex ventral hernia repair. Int Surg. 2014;99(3):235-240. 3. Liang MK, Berger RL, Nguyen MT, Hicks SC, Li LT, Leong M. Outcomes with porcine acellular dermal matrix versus synthetic mesh and suture in complicated open ventral hernia repair. Surg Infect (Larchmt). 2014;15(5):506-512. 4. Booth JH, Garvey PB, Baumann DP, et al. Primary fascial closure with mesh reinforcement is superior to bridged mesh repair for abdominal wall reconstruction. J Am Coll Surg. 2013;217(6):999-1009. 5. Richmond B, Ubert A, Judhan R, et al. Component separation with porcine acellular dermal reinforcement is superior to traditional bridged mesh repairs in the open repair of significant midline ventral hernia defects. Am Surg. 2014;80(8):725-731. Allergan® and its design are trademarks of Allergan, Inc. STRATTICE™ and its design are trademarks of LifeCell Corporation, an Allergan affiliate. © 2019 Allergan. All rights reserved. STM122822 04/19