October 2021 Print Issue

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

October 2021 • Volume 48 • Number 10

What Drives Surgeon Burnout Outside the United States?

In a Patient’s Shoes B Breast Surgeon Rethinks What ‘Quality of Care’ Really Means After Becoming a Patient Herself

By MONICA J. SMITH

By VICTORIA STERN

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ix years ago, Elizabeth O’Riordan was a consultant breast cancer surgeon in the United Kingdom with 20 years’ training, a postgraduate diploma in oncoplastic surgery and scores of pleased patients. She prided herself on delivering high-quality care. Then, at age 40, she herself was diagnosed with breast cancer.

“I thought I knew everything. Then I went ffrom being a fit, healthy triathlete to a stage III breast cancer patient overnight. I was going to br have every single treatment that I prescribed my own patients, and I realized I knew almost nothing about patient breast can cancer,” she said, delivering the keynote address at

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hysician burnout remains a persistent problem in the United States. Recent estimates reveal that over 40% of physicians report feeling burned out, a figure that appears to be rising as the COVID-19 pandemic continues to compound chronic job-related stressors.

In the June 2021 issue, General Surgery News highlighted a major contributor to burnout in the United States: work hours [“Eliminating 24-Hour Call: Does It Work?” page 1]. The article captured an acute care surgery team’s effort to alleviate the burden of 24-hour call by instituting a 12-hour shift structure instead.

The change made big waves in the department of surgery gery at Texas Tech in Lubbock.

Continued on page 6

Substance Use and Bariatric Surgery

Continued on page 8

Disability Insurance: What Surgeons Need to Know

What to Look for and How to Counsel Patients

OPINION

Vaccination Penicillin for Pandemics

By HENRY BUCHWALD, MD, PHD

By VICTORIA STERN

By KATE O’ROURKE

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atients presenting for bariatric surgery may consume alcohol or use tobacco, marijuana or opioids. So, what do we know about how these substances affect the outcomes of bariatric surgery or how the surgery affects substance use? Experts discussed these issues at the 2021 annual meeting of the American Society for Metabolic and Bariatric Surgery (ASMBS).

hen Robert Kaplan’s girlfriend entered her pediatric residency in the late 1980s, he wondered what kind of financial protections the institution had put in place for her and her colleagues.

Mr. Kaplan, a certified public accountant at the time, soon discovered that the program did not provide residents with disability insurance—coverage that replaces a physician’s income in case of illness or injury.

Becoming disabled poses a major threat to a physician’s financial stability, according to Mr. Kaplan, who currently lives in Encino, CA.

Continued on page 14

Continued on page 27

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IN THE NEWS

4 First Look: Highlights From the Southeastern Surgical Congress

10 Anatomy of a Lawsuit: Legal Pearls For the Wound Care Provider X

J OURNAL WATCH

16 Latest Published Research With a Focus On Colorectal Surgery facebook.com/generalsurgerynews

@gensurgnews

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n many a fantasy, a time traveler goess to the past, makes an adjustment and d alters the present. In many a fantasy, a time traveler goes to the future, sees es chaos and alters the present to safeguard the future. In real life, we— individually and collectively—can time travel and alter the present based on the past for the good of the future. To go to the past, we have history; to go to the future, we have computerized assumption algorithms for potential outcomes.

Today, the availability, efficacy, rationale and practice of COVID-19 vaccination are the fabric of daily Continued on page 20

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BULLETIN BOARD

OCTOBER 2021 / GENERAL SURGERY NEWS

The History of Robotic-Assisted Surgery, Revisited A Q&A With Edward L. Felix, MD, FACS, FASMBS

By PAUL BUFANO

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eneral Surgery News recently caught up with Edward L. Felix, MD, at the Society of American Gastrointestinal and Endoscopic Surgeons, in Las Vegas, to speak with him about his recent article on the history of robotic surgery (GSN, September 2021, page 1). Below is a slightly edited transcript of the discussion. Video interviews from the meeting, conducted

by Dr. Felix on robotics and other timely topics with experts in the field, can be found at www.generalsurgerynews.com/ Multimedia.

Q: What was the inspiration for your research?

Dr. Felix: As many of you know, I just wrote an article on the history of robotics. Why would I do that? I was never a robotic surgeon and was actually against robotics in the beginning. Yet I began to look at its value and how it has improved, and became extremely interested with how we got to where we are today. So, in my retirement, I decided to sit down and investigate. What I did was look back with Intuitive and review the published literature with the intention to

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

is far advanced. This is one of the questions I posed to the mentors or pioneers of robotics in my history article and they all gave me their opinions. I think robotics today is not going to be what we’re going to see in five or 10 or 15 years from now. My own son who is just starting medical school, and will hopefully end up being a surgeon, will be doing surgery in a very different way Q: What are your thoughts on Edward L. Felix, MD, author of recent history of robotic than we do today—I can’t the cost-effectiveness of robotsurgery article, at the 2021 SAGES annual meeting. even imagine it. I think that the ic surgery?

Dr. Felix: The most frequent question absolutely surgeons who are doing bar- view, the techniques, the instrumentation I kept hearing was “Is there value in iatric and hernia surgeries robotically and the feedback are going to be vastly robotics?” One of my original objections for the same or even less cost than we different. Another major advantage that to robotics was that you were essentially can do laparoscopically. Nevertheless, it’s robotics has, even today, is that teaching taking a Ferrari to go to the grocery store truly dependent on the education of the and learning curves have been greatly up the block. What I realized was that surgeons in the operating room and the reduced because of simulators. Surgeons can now learn in weeks or months to do if you learn to do robotics correctly, the cooperation of the robotic companies. what took us a year in a fellowship to price or cost of that procedure can be the same or even less than its laparoscopic Q: How do you see the field of robotics accomplish. Ultimately, I think robotic surgery is changing the entire platform equivalent. But it takes education and it evolving over the next five to 10 years? takes a level of skill and efficiency of the Dr. Felix: I honestly think we’re still in and therefore thought it was important surgeon. It will also require Intuitive and the infancy of robotics even though it has to document how we got here. Hopefulother companies to somewhat reduce already been 20 years of growth. What ly, someone will carry that history on as the cost of instrumentation. There are the robots will be able to do in the future we move forward.

■ trace robotic surgery from when it began to where it is today. What I learned was that robotic surgery reminds me of a musical group that you think exploded overnight; however, it didn’t happen overnight. Robotic surgery has now taken 20 years to get to where we are today. Although we don’t quite know where it’s going to go, I think it will eventually replace laparoscopic surgery.

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

Peter K. Kim, MD Bronx, NY

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Lauren A. Kosinski, MD Chestertown, MD

Gina Adrales, MD, MPH Baltimore, MD

Marina Kurian, MD New York, NY

Maurice Arregui, MD Indianapolis, IN

Raymond J. Lanzafame, MD, MBA Rochester, NY

Philip S. Barie, MD, MBA New York, NY

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L.D. Britt, MD, MPH Norfolk, VA

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John Maa, MD San Francisco, CA

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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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IN THE NEWS

GENERAL SURGERY NEWS / OCTOBER 2021

First Look: The Southeastern Surgical Congress All articles by MONICA J. SMITH

Survey Captures Patient Attitudes On Surgical Resident Involvement

Older Age and ICU Readmission: A Steep Increase in Mortality

They may not be entirely certain what residents are, but most of the patients of a community general surgery practice support resident involvement in their care, according to the results of a recent survey.

“We wanted to gauge patient understanding of the role of a resident in their care, and use this data to better incorporate resident involvement in the practice,” said James Chambers, MD, PhD, a staff general surgeon with the Northeast Georgia Health System in Braselton.

To do so, Dr. Chambers, who is part of a four-surgeon group serving a 177bed hospital, administered surveys to patients between January and June 2020.

Because many of his patients do not have home internet access, the 26-question surveys were distributed in office.

“We thought we’d be able to capture more people that way,” said Dr. Chambers, presenting his research at the 2021 Southeastern Surgical Congress.

By the end of the study period, 172 patients (73% female) completed the survey. Most were either employed (42%) or retired (30%); education levels were about 28% for high school graduate, some college and college graduate; about 50% had private insurance; and about 30% were covered by Medicare.

The vast majority, 75%, thought residents were medical students. “That was an interesting aspect, because we actually gave them a bit of a crib sheet before the survey that defined what a resident is,” Dr. Chambers said.

In any case, all but seven patients understood that a resident is a doctor in training, and 78% said they would like a resident involved in their care.

“The ones who answered ‘yes’ to that question indicated that they thought it was important that they participate and help train future surgeons,” Dr. Chambers said. “They thought it would add value to our health system.”

Of the 23% who indicated they did not want a resident involved in their care, most noted that they wanted only a doctor involved in their care.

“But I thought this was really important: When we asked if they think a resident will be doing procedures and caring for patients without direct supervision, 91% responded ‘no,’” Dr. Chambers said.

He noted that the research has some limitations; it includes only one practice, and some surveys were incomplete. Nonetheless, although the resident program is relatively new and patients had little prior exposure to residents, the response rate was high (89%).

“In the future, we want to add more patients, internal and external; do a cross-table analysis of the demographic data to see if we can isolate people who may be more receptive to residents’ involvement in their care; and to keep residents involved in the practice,” Dr. Chambers said.

With ICU beds at a premium, efforts are often made to transfer patients out of the ICU as soon as possible, but this could be particularly detrimental for older patients in whom readmission to the ICU is associated with a steep increase in mortality, according to a recent study.

Although geriatric patients comprise about one-fourth of all trauma admissions, geriatric ICU readmission has not been thoroughly studied. To get a better grasp of outcomes in this vulnerable population, Lindsey L. Perea, DO, and her colleagues conducted a retrospective study of all patients aged 40 years and older admitted to accredited Pennsylvania trauma centers between 2003 and 2018.

“We hypothesized that older patients with ICU bounce back (ICUBB) would have greater mortality rates than their younger counterparts. We also hypothesized that older age would lead to higher mortality,” said Dr. Perea, a trauma and acute care surgeon with Penn Medicine Lancaster General Health, in Lancaster, Pa., who presented the study at the 2021 Southeastern Surgical Congress.

Of all patients aged 40 years and older admitted to trauma centers during the 16-year study period, 3,896 (1.1%) met the inclusion criteria for ICUBB (i.e., being transferred to the ICU, then readmitted to the ICU during the same hospital stay). The ICUBB group was older, had a higher injury severity score and had a significantly longer hospital stay than the non-ICUBB population, at 12 and four days, respectively.

The ICUBB group also underwent intubation more frequently, and had a higher incidence of mortality, 12.6%, compared with 5% for non-ICUBB patients. The risk for mortality increased with each decade of age and was most significant in the oldest patients.

“When comparing the bounce-back and non–bounce-back groups, we found alarmingly high increased odds of mortality in our octogenarians and nonagenarians, with an odds ratio of 11.31 in the 80 to 89 group and 35 in the 90-plus group,” compared with those aged 40 to 49 years, Dr. Perea said. In contrast, the odds ratio of mortality in ICUBB patients 50 to 59 was 1.02 compared with those 40 to 49.

Of note, although ICUBB was associated with severe injuries to the head, neck, abdomen and chest, on multivariate analysis the injuries themselves were not associated with increased mortality.

“That raises the question of whether these patients were ready to leave the ICU initially,” Dr. Perea said.

She acknowledged limitations of the paper: Being limited to a single-state database, it may not be generalizable to the greater population, and the researchers were not able to discern the temporal nature of ICU admission.

“But given the profound increase in mortality in our aging trauma patients, it’s imperative to introduce initiatives to address the underlying causes of unplanned ICU readmissions to identify and mitigate risk in this vulnerable geriatric population,” Dr. Perea said.

New Nomogram May Outdo Older Pancreatic Fistula Risk Scores Researchers have developed a new nomogram that may be more accurate than prior fistula risk scores at assessing patient risk for a clinically relevant postoperative pancreatic fistula (CR-POPF).

Although there are a few fistula risk scores available to help surgeons assess patients undergoing pancreatectomy, some have certain drawbacks, such as being based on a small patient population or lacking external validation.

“Currently, there is no universal measure used to predict a CR-POPF,” said Abdimajid Mohamed, a fourthyear Maine Track medical student at Tufts University School of Medicine/Maine Medical Center, in Boston, presenting his research at the 2021 Southeastern Surgical Congress.

“Our project aimed to improve upon those predictive models and to create a tool to increase surgeons’ ability to utilize preoperative care and postoperative assessment.”

To do so, Mr. Mohamed and his colleagues used ACS National Surgical Quality Improvement Program (NSQIP) data on 5,965 pancreaticoduodenectomy

patients, 1,018 of whom had CR-POPF, to compare the original Fistula Risk Score (FRS), Alternative FRS and Samsung Medical Center nomogram, and performed a logistic regression analysis on variable factors from those risk scores.

For example, the Alternative FRS identified body mass index, gland texture and duct size as variables associated with CR-POPF. “What we determined within our NSQIP database is that obese patients are 1.6 times more likely to have a CR-POPF,” Mr. Mohamed said.

Soft gland texture, too, increased risk—by 3.18 times— whereas duct sizes of 3 to 6 mm were protective.

Adding variables from the Samsung nomogram, they found that male patients were 1.59 times more likely to have a clinically relevant fistula, but American Society of Anesthesiologists classification and preoperative albumin had no statistically significant impact on risk.

Ultimately, their multivariate analysis identified male sex, obesity and soft gland texture as variables associated with an increased odds of a CR-POPF; duct size of 6 mm or more, pancreatic adenocarcinoma pathology and

neoadjuvant chemotherapy all appeared to be protective.

Using this information, Mr. Mohamed and his colleagues created the Portland FRS to assess and predict risk.

“Imagine an obese male patient with soft gland texture, pathology other than pancreatic adenocarcinoma, a duct size less than 3 mm and no neoadjuvant chemotherapy; those variables add up to a total point score of 240, which would correlate with a 40% CR-POPF risk,” he said.

With an area under the curve (AUC) of 0.72, the Portland nomogram appears to be stronger than the Alternative FRS and Samsung nomogram, which have AUCs of 0.70 and 0.64, respectively.

Andrew Page, MD, the director of surgical oncology and hepato-pancreato-biliary surgery at Piedmont Healthcare in Atlanta, reviewed the study and was intrigued by the finding that neoadjuvant chemotherapy correlated with decreased CR-POPF. “There is no doubt that the role of neoadjuvant treatment as a risk factor for post-pancreatectomy fistula will continue to be a controversial subject,” Dr. Page said. ■

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IN THE NEWS

How Physician Burnout Differs Outside the U.S. continued from page 1

Catherine Ronaghan, MD, FACS, a professor and the vice chair of the Department of Surgery at Texas Tech, used the word “revelatory” to describe the restructuring. “I noticed a difference immediately in my focus and energy, which allowed me to have much more meaningful experiences with patients,” she said.

In the United States, a growing body of evidence shows that long days on the job can contribute to physician burnout (J Am Coll Surg 2016;223[3]:440-451; Arch Surg 2011;146[2]:211-217). Most recently, Medscape’s 2021 National Physician Burnout & Suicide Report, which included more than 12,000 physicians, found that 37% of respondents cited hours at work as one of the top four factors leading to burnout. Other key factors highlighted by physicians included bureaucratic tasks (58%); lack of respect from colleagues, administrators and staff (37%); and insufficient compensation or reimbursement (32%).

But what about outside the United States? Do work hours affect surgeons in other countries to a similar degree?

Although data are more limited, several reports indicate that work hours do play an important part in surgeon burnout abroad (Royal Coll Surg Eng 2020;102[6]:401407; Arch Surg 2010;145[10]:1013-1016).

An analysis published earlier this year, which surveyed 615 general surgeons in Turkey, reported a prevalence of burnout of 69% and ranked work hours—specifically 60 hours or more per week—as one of the three main contributors to burnout (BMC Health Serv Res 2021;21:39).

The main factors highlighted by Medscape’s 2019 Global Physicians’ Burnout and Lifestyle Comparisons report, which included almost 20,000 physicians spanning the United Kingdom, France, Germany, Portugal and Spain, also largely align with those described in the U.S. survey. Too many hours at work ranked a close second to excessive bureaucratic tasks, especially for physicians in Portugal (51%), Germany (50%), and France (45%). Lack of respect from colleagues, administrators and staff represented the third major stressor, followed by feeling like “a cog in the wheel,” insufficient compensation or reimbursement, and a focus on profits over patients.

However, according to several surgeons who spoke to General Surgery News, long work hours may not actually be a key factor driving surgeon burnout abroad.

Using a relatively simple metric like work hours may miss the more complex stressors that surgeons face on the job.

“Burnout has always been multifactorial and, in Europe, there are broader issues at play than work hours, related to how surgeons are remunerated and valued—or not valued—in the health care

system,” said Neil Smart, a consultant colorectal surgeon at the Royal Devon & Exeter Hospital, in Exeter, England.

The 2021 analysis from Turkey provides a window into that complexity. The study concluded that the top three contributors were long hours at work, employment at a training and research or state hospital, and minimal time for social activities.

But, notably, surgeons’ top 10 suggestions on how to reduce burnout did not match these three major contributors. The three

often cited remedies were implementing a fair salary policy (84%), preventing violence against health care workers (78%), and introducing reforms to reduce medical malpractice lawsuits (75%). Regulating work hours appeared on the list but toward the bottom.

“Surgeon burnout is a big problem in Turkey, and my colleagues and I conducted this analysis to highlight the main sources and what can be done,” said the study’s corresponding author Cihangir

‘Time at work is not just about the total number of hours; it's also about the substance and structure of the work.’

—Neil Smart, MD

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IN THE NEWS

Akyol, MD, a colorectal surgeon at Ankara University, in Turkey. “We found that improving work hours is one solution, but it is likely not the most important one.”

Still, Dr. Akyol did not downplay the role that work hours play in surgeon burnout, which he acknowledged may be on par with surgeons’ experience in the United States, especially considering the increased workload and stressors physicians have faced during the COVID-19 pandemic.

In Turkey, an ongoing threat of physical violence and malpractice accusations from patients, in particular, carry significant

weight for surgeons. For instance, a piece published in January 2020 in the outlet Inside Turkey reported a physician exodus to countries in the European Union (EU) given the harsh working conditions in Turkey—the threat of mass layoffs, mandatory security checks, and ongoing problems including “verbal and physical violence against health care professionals.” According to the Turkish Medical Association, data from the Ministry of Health revealed that about “40 cases of violence are reported daily at healthcare institutions” and in 2018, “more than 15,000 such cases were reported.”

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“These risks to our personal and professional safety make the job especially challenging,” Dr. Akyol said.

In the United Kingdom, Dr. Smart cited elements of the job that create the most stress for him: the changing nature of the work itself and the lack of respect for physicians.

“Time at work is not just about the total number of hours; it’s also about the structure and substance of the work,” Dr. Smart said. “For one, the endless problems and time spent with EMRs [electronic medical records] contribute to feelings of burnout.”

The nature of surgical training has changed with the introduction of shift work in the early 2000s. When the EU’s Working Time Directive capped workweeks at 48 hours including overtime, “the hierarchical mentorship structure and sense of teamwork among trainees and senior surgeons largely went away,” he said.

Regarding professional respect, Dr. Smart has witnessed the rise of the uninformed expert, especially during the coronavirus pandemic. “We saw demonstrations in London recently where an anti-vaxxer compared doctors and nurses to Nazi war criminals,” he said. “That’s a moment when you ask yourself, ‘Why am I doing all this hard work?’”

For Gregorio Maldini, MD, a hepatobiliary surgeon who began his career in Rome and now practices at Straub Medical Center, in Honolulu, burnout in Italy is largely fueled by low pay as well as too much bureaucracy and paperwork. In other words, “when your effort is not correlated to your rewards is when people feel the pain”—what he calls work that is “not morally and financially compensated.”

Although the individual factors contributing to burnout will vary from country to country, the underlying issue remains the same. Whether chronic work-related stress arises from too many hours on the job or with the EMR, a pay structure that does not fairly compensate years of training and level of expertise, or a lack of personal and professional safety and respect, these issues reflect the ways in which health systems around the world do not adequately protect physicians.

Identifying the risk factors and their variations that exist across countries, institutions and individuals will go a long way toward mitigating their impact. But solving such a complex problem will also take considerable time and likely require an overhaul of health care systems. Dr. Akyol was cautiously optimistic that the landscape for surgeons can improve, but he saw a long road ahead.

“I’m currently 45 years old and will likely work 20 more years before I retire, and I’m not sure I’ll see the burnout problem change in that time. But the more we talk about this issue and study it, the better equipped health care workers will be to solve it,” Dr. Akyol said. ■

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IN THE NEWS

GENERAL SURGERY NEWS / OCTOBER 2021

Breast Surgeon Finds Insights From the Patient’s Perspective continued from page 1

the 2021 virtual meeting of the American Society of Breast Surgeons.

Before her diagnosis, Dr. O’Riordan’s focus was largely on outcomes—leaving undetectable scars and minimizing complications as much as possible—a mindset that is not uncommon among physicians.

“We are trained and taught to focus on outcomes, and sometimes, because we know a particular treatment has the best outcome, we tend to glaze over possible side effects,” said Jill Dietz, MD, the director of Breast Growth and Strategy and chief transformation officer at Allegheny Health Network Cancer Institute, in Pittsburgh. “But true shared decision making is where you go over the outcomes of a particular intervention and then discuss the most common side effects and the cost, as well as other treatment options to decide together what’s best for that particular patient.”

The lump that Dr. O’Riordan initially suspected was a benign cyst was in fact a large, mixed ductal and lobular, estrogen receptor (ER)-positive, HER2-negative cancer that put her through some of the most invasive and extensive treatments breast cancer patients endure.

She underwent neoadjuvant chemotherapy, mastectomy with reconstruction (a subpectoral implant she later had removed), and radiotherapy. Three years later, she had a locoregional recurrence that required more surgery and radiotherapy. A side effect of the latter—reduced range of motion in her left arm—forced Dr. O’Riordan to retire from surgery at the age of 43.

What she learned since that initial diagnosis made Dr. O’Riordan rethink what quality care really looks like, and what patients need beyond good outcomes to maintain a satisfactory quality of life.

“It’s not just clinical effectiveness, safety, doing the right thing to the right person at the right time. There is also the patient experience,” Dr. O’Riordan said. “My practice changed so much in the year between my diagnoses, and I want to share the lessons I’ve learned that may be able to help you improve the already impressive care you give your patients.”

Sudden Menopause: Its Side Effects and Impact on Sex Natural menopause is problematic for many women, but the medically or surgically induced overnight change of life by can be particularly cruel.

“I used to tell my patients, ‘you’ll be fine, the odd hot flash.’ I had no idea how devastating it could be, especially for younger women,” Dr. O’Riordan said.

No one on her care team discussed the management of menopause symptoms, which for Dr. O’Riordan included hot flashes, weight gain, sleep-disrupting night sweats and distressing gynecologic discomfort.

She had no idea what to do until a friend suggested she try clonidine, which can improve hot flashes, or venlafaxine, which has been shown effective in improving menopause-related quality-of-life issues.

“Wouldn’t it be great if, in addition to telling our patients what the side effects of their treatments are, we tell them how to manage these side effects,” Dr. O’Riordan noted.

Another rarely discussed topic is the effect of medical or surgical menopause on a woman’s sex life. “I never talked about it as a consulting surgeon, and I rarely heard my colleagues talk about it. But it’s awful when you’re young to suddenly have no libido, or find that sex can be so painful you never want to do it,” Dr. O’Riordan said.

‘Wouldn’t it be great if, in addition to telling our patients what the side effects of their treatments are, we tell them how to manage these side effects.’

—Elizabeth O’Riordan, MD

“You need to make sure someone on your team is talking to patients about the impact menopause can have on their sex life, and what they can do about it.”

Like other menopausal symptoms, gynecologic dryness, pain and irritation can be managed by those who know what options are out there: dilators, lubricant and vaginal estrogen. Breast cancer care physicians might be leery about the last one, but it’s worth a discussion.

“I was very wary of this, and didn’t want to give anyone with ER-positive disease extra estrogen. But we know breast cancer comes back in a third of our patients despite full treatment, and a tiny dose of absorbed vaginal estrogen is not going to have a big impact. However, the impact it will have on a patient’s quality of life is huge, and it should be her choice,” Dr. O’Riordan said.

The Importance of Exercise Just as no one on her care team discussed management of menopausal side effects, no one suggested to Dr. O’Riordan that she should continue to exercise. But she wanted to. Inspired by an extremely active woman with metastatic breast cancer she discovered on Twitter, Dr. O’Riordan kept on exercising—she completed a sprint triathlon halfway through chemotherapy.

“I was one of the slowest people to finish, but the sense of achievement was amazing. For a few hours, I was no longer Liz the cancer patient; I was just Liz,” she said.

She credits exercise with mitigating some of the physical and mental side effects of chemotherapy, and the year she spent lifting weights at home during lockdown returned Dr. O’Riordan to a body she feels comfortable in.

And there’s this boon: Exercise may reduce the risk for recurrence by 50%.

“That’s five-zero. Exercise halves the risk of recurrence and it’s something patients can do for themselves that helps them feel in control,” she said.

Guidelines from a multidisciplinary roundtable recommend 30 minutes of aerobic exercise three times per week and 30 minutes of resistance training twice weekly for cancer survivors (Med Sci Sport Ex 2019;51[11]:2375-2390). Dr. O’Riordan suspects resistance training may be even more important than aerobic exercise.

“Chemotherapy can cause muscle fatigue and wasting, and if you can get your patients doing gentle exercises at home—squats while they’re brushing their teeth, push-ups against a kitchen counter five minutes here and there will do them so much good.

“Promise me one person on your team will tell every patient to exercise,” Dr. O’Riordan said.

Looking for What No One Wants to Find Breast cancer comes back in one-third of these patients, but some are in the dark about this possibility. “You’d be amazed how many women think they’re cured; they don’t know what to look for,” Dr. O’Riordan said.

Recurrence is something she didn’t discuss at length with her patients. “I don’t think I ever told patients what the signs for recurrence are; it was a leaflet tucked into a pile of other leaflets I hoped they would read. But if they don’t know what the signs are, and if their primary care physicians don’t know the warning flags, we’re doing our patients a disservice,” Dr. O’Riordan said.

Every patient should be informed that their cancer can come back. They need to know what to look out for, and who to see for the appropriate scan to determine whether or not it is a recurrence.

Finally, find out what your patients think about and what they need. “Eric Topol, a cardiologist in the U.S., says, ‘The patient is the single most unused person in health care,’ and I think he’s right,” Dr. O’Riordan said.

“Every once in a while, go read a patient forum, go read a blog. Find out what it’s like to be in our shoes so you can provide the best quality care.”

■

Adjust Your Perspectice Using the da Vinci Firefly Imaging System The da Vinci Xi® and da Vinci X™ surgical systems with integrated fluorescence imaging capability provide you with real-time endoscopic visible and near-infrared fluorescence imaging.

This fluorescence imaging capability provides you with the opportunity for visual assessment of at least one of the major extra-hepatic bile ducts, as well as the cystic artery during cholecystectomy procedures performed using the da Vinci® system. It can also be used to assess vessels, blood flow, and related tissue perfusion during cases across your da Vinci Total Practice* when indicated.

White Light Imaging Firefly imaging is not visible in white light imaging mode.

Standard Firefly Mode In Standard mode, the image is displayed as a fluorescent green overlay on a black and white background view. The closer the endoscope is to the tissue, the stronger (more intense green) the signal appears.

Sensitive Firefly Mode In Sensitive mode, the system attempts to automatically adjust the signal intensity and brightness to be consistent, whether the endoscope is moved closer or farther away from the tissue.

Note: Sensitive Firefly mode is only available with Endoscope Plus.

Scan to learn more about the evolution of surgery

Images above show porcine pelvic vasculature using the da Vinci Xi Endoscope Plus. * Total da Vinci Practice refers to the transferable value of da Vinci surgery across procedures in surgeon’s minimally invasive surgery (MIS) practice. It is at the surgeon’s discretion to determine when a patient is a candidate for MIS surgery and whether da Vinci surgery is an option.

Firefly Fluorescence Imaging The da Vinci fluorescence imaging vision system (Firefly® fluorescence imaging) is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci fluorescence Imaging vision system enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow, and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.

recommended. Anaphylactic deaths have been reported following ICG injection during cardiac catheterization.

Total ICG dosage should not exceed 2 mg/kg per patient.

Anaphylactic or urticarial reactions have been reported in patients with or without histories of allergy to iodides.

Fluorescence imaging of biliary ducts with the da Vinci fluorescence imaging vision system is intended for adjunctive use only, in conjunction with standard of care white light and when indicated, with intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Da Vinci Xi/X system precaution statement The demonstration of safety and effectiveness for the specific procedure(s) discussed in this material was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.

Intuitive’s ICG packs are available for sale in the U.S. ONLY. Intuitive’s ICG packs are cleared for commercial distribution in the U.S. for use in combination with the fluorescence-capable da Vinci HD vision system and Firefly integrated hardware.

Intuitive-distributed ICG contains necessary directions for use of ICG with Firefly fluorescence imaging. Using generic ICG with Firefly fluorescence imaging is considered off-label and is not

Important safety information For Important Safety Information, indications for use, risks, full cautions and warnings, please refer to www.intuitive.com/safety.

© 2021 Intuitive Surgical, Inc. All rights reserved. Product and brand names/logos are trademarks or registered trademarks of Intuitive Surgical or their respective owner.

See www.intuitive.com/trademarks.

1089596-US RevA 09/2021

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10

IN THE NEWS

GENERAL SURGERY NEWS / OCTOBER 2021

Anatomy of a Lawsuit: Legal Pearls for the Wound Care Provider

By CHASE DOYLE

W

ith more than 17,000 lawsuits for pressure injuries alone each year, legal action can be a very real consequence of practicing clinical medicine, especially for wound care providers.

During the Symposium on Advanced Wound Care (SAWC) Spring meeting, Lee C. Ruotsi, MD, ABWMS, CWS-P, UHM, and Joyce Black, PhD, RN, discussed treatment and documentation strategies to reduce the risk for litigation, and to defend the treatment provided in a legal setting, should that become necessary.

Dr. Black, a professor at the University of Nebraska Medical Center, in Waterloo, noted that to win a lawsuit, a patient’s lawyer must prove the following elements: • a professional duty owed to the patient; • breach of such duty; • injury caused by the breach; and • resulting damages, including wound, pain, disability and medical costs.

An attorney may not file a lawsuit if they do not see proof of all four elements on initial review.

According to Dr. Black, proper documentation is a critical piece in avoiding litigation. Typical consultation notes include history of the present illness, review of systems and the physical exam, followed by a diagnostic impression and treatment plan. If the patient’s condition is believed to be misclassified, the provider should document what the etiology is per the assessment and include supporting data.

Failure to accurately identify the etiology of the wound can sometimes come at the demand of the administration.

Because treatment of pressure injuries is not reimbursed, Dr. Black said, there may be pressure to instead diagnose the condition as a diabetic foot wound, for example. However, the treatment that follows is not the same, which could present serious problems during litigation.

Another question that arises frequently in legal discussions is whether the condition was present on admission or unavoidable. Present-on-admission documentation allows for deep-tissue pressure injuries that are identified as evolving at the time of admission. For deep-tissue pressure injuries to be classified as “unavoidable,” said Dr. Black, the skin condition needs to be examined at the time of admission, but this is not limited to a 24-hour period, as these types of pressure injuries are not visible for 48 hours. Accurate assessment of risk, an appropriate plan of care and documentation of care are also required by the Centers for Medicare & Medicaid Services to establish a condition as unavoidable.

Costly Mistakes According to Dr. Black, the ability to speak to patients openly and honestly is an essential skill for a wound care provider and may even protect a provider from medical malpractice. When healing cannot occur, for example, it is imperative that the patient or family be “kept in the loop,” she said.

“A family is going to be pretty upset if they thought a wound was minor or small and the patient ends up in the emergency

room,” Dr. Black said. “If a family is taking pictures of the wound, then you should be taking pictures of the wound because those photographs will come into play.”

Although mistakes in the electronic health record rarely lead directly to patient harm, she added, those errors frequently result in lawsuits. Red flags in the EHR include changes in the record, gaps in time and information, improper wound measurements and incorrect wound terminology.

Finally, if a lawsuit goes to deposition or trial, the attitude of the provider can have a significant effect on the outcome. According to Dr. Black, a wound care provider should come across as caring and compassionate and express sincere concern about patient injuries.

“Lawyers pick up on even the most subtle hints of apathy and will exploit them,” Dr. Black noted. “You must have [the] right attitude in your chart, in your deposition and at trial.”

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Important Safety Information WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS • Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer Byfavo.

• Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation.

• Byfavo has been associated with hypoxia, bradycardia, and hypotension.

Continuously monitor vital signs during sedation and through the recovery period.

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• Concomitant use of benzodiazepines with opioid analgesics may result in profound sedation, respiratory depression, coma, and death.

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11

OCTOBER 2021 / GENERAL SURGERY NEWS

Under Pressure According to Dr. Ruotsi, the medical director at Saratoga Hospital Center for Wound Healing and Hyperbaric Medicine, in Saratoga Springs, N.Y., pressure injury is the single leading source of medical-legal litigation, and longterm care facilities and hospitals are the main targets. Common pitfalls of pressure injury include the following: • Failure to perform and document initial skin exam • Failure to establish accurate staging (staging drives dressing and surface choices)

• Failure to implement proper wound care • Failure to evaluate and implement plan for nutrition • Failure to implement proper pressure redistribution surface(s) • Failure to implement and document turning and repositioning schedule • Delay in recognition and intervention for worsening wound “It is useful and instructive to base your care and documentation on a hypothetical review of your own chart,” Dr. Ruotsi said. “If you reviewed your chart, would you be satisfied with your care?”

With this approach, providers should consider the things that they would not want to see in a chart, such as missing or incomplete initial skin exam, inappropriate or missing wound care orders, and failure to address skin issues in a timely fashion.

“At the end of the day, what we’re looking for is simply good-quality, well-documented patient care,” Dr. Ruotis said.

“Do the right thing; document that you did it; and be sure that your charting reflects your policies and procedures.” ■

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severe hepatic impairment, the dose of Byfavo should be carefully titrated to effect. Depending on the overall status of the patient, lower frequency of supplemental doses may be needed to achieve the level of sedation required for the procedure. All patients should be monitored for sedation-related cardiorespiratory complications.

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12

IN THE NEWS

GENERAL SURGERY NEWS / OCTOBER 2021

Research Examines Effect of Age on Pathologic Complete Response After Neoadjuvant Chemo No Difference Seen in Study Of Women With Stage I to III Breast Cancer

By MONICA J. SMITH

I

n clinical trials of neoadjuvant chemotherapy, younger women tend to have higher rates of pathologic complete response (pCR), which is linked with a

better prognosis. New research, however, finds no difference in pCR in a range of age groups, and similar rates of downstaging in the breast and axilla.

To examine the impact of age on pCR and downstaging, Francys Verdial, MD, MPH—who, at the time of the research, was a fellow at Memorial Sloan Kettering Cancer Center (MSKCC) in New York City—and her colleagues evaluated outcomes on 1,385 women with stage I

to III breast cancer who had undergone neoadjuvant chemotherapy. (Dr. Verdial is currently a surgeon at Massachusetts General Hospital, in Boston.)

The researchers stratified the patients into three groups: those aged 40 years and under (300 patients), 41 to 60 (772 patients) and those over 60 (311 patients).

“In the case of triple-negative tumors, we also examined the association of

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tumor-infiltrating lymphocytes [TILs] in BRCA status with pCR,” Dr. Verdial said in a presentation at the 2021 meeting of the American Society of Breast Surgeons.

The distribution of receptor subtypes was similar across age groups. Patients in the youngest cohort were significantly more likely to have ductal histology, poorly differentiated tumors and BRCA mutations than older patients.

As would be expected, among the

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IN THE NEWS

OCTOBER 2021 / GENERAL SURGERY NEWS

entire cohort, pCR was more frequent in patients with HER2-positive or triple-negative tumors than in those with hormone-positive, HER2-negative tumors, but the rate of pCR (34%) did not differ across age groups.

Comparing the rate of pCR by age group across subtype, younger women achieved pCR more frequently among those with triple-negative disease, but there were no differences by age in other subtypes.

“Exploring the potential reasons behind the differences in pCR by age in triple-negative tumors, we looked at BRCA status and TILs in this subgroup, and found young women significantly more likely to have a BRCA mutation compared with

‘I think a lot of it has to do with understanding why the patient is making the decision she’s making, and how you can provide her with the information she needs.’

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—Francys Verdial, MD, MPH

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women in older age groups,” Dr. Verdial said.

“Among women with a BRCA mutation, 67% of young women had a pCR compared to 44% and 0% of older women. Among those who were BRCAnegative, the rate of pCR did not differ significantly by age.”

Consistent with the literature, women with tumors high in stromal TILs had significantly higher rates of pCR than women without TILs, but stratified by age, the association between TILs and pCR was significant only in the 41- to 60-yearold cohort. “This may be at least partly explained by sample size,” Dr. Verdial said.

After neoadjuvant chemotherapy, about half of the women initially ineligible for breast-conserving surgery became candidates for it, and this conversion rate was seen across all ages. “Despite similar rates of downstaging, however, young women were significantly more likely to opt for bilateral mastectomy than older patients,” Dr. Verdial said.

Downstaging of the axilla after neoadjuvant therapy was higher in women 40 years of age and younger, of whom 94% with biopsy-proven cN1 disease were clinically node-negative after chemotherapy, compared with 89% and 85% in patients aged 41 to 60 and 60 years and older, respectively. More than half of the younger patients (52%) were able to avoid an axillary dissection, compared with 39% and 37% of women in the older cohorts.

Preeti Subhedar, MD, FACS, an assistant professor of surgical oncology at Emory University School of Medicine, in Atlanta, pointed out that even when young women are eligible for breast-conserving surgery, many continue to choose bilateral mastectomy regardless of their response to neoadjuvant chemotherapy.

“The message that overall survival is not different between breast-conserving surgery and mastectomy doesn’t seem to be getting across, especially to younger patients. Maybe we should reframe the conversation; instead of thinking about less treatment, which sounds negative, we should talk about reducing morbidity from procedures they don’t need, which is more positive.”

Dr. Verdial said she’s observed that her surgical colleagues at MSKCC are particularly adept at swaying patients away from larger and potentially more morbid procedures when they are good candidates for breast-conserving surgery.

“I think a lot of it has to do with understanding why the patient is making the decision she’s making, and how you can provide her with the information she needs. This sometimes takes a little extra work, but it’s very important that we understand where patients are coming from, what information they’re using to make their decisions, and what their ■ priorities are,” she said.

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GENERAL SURGERY NEWS / OCTOBER 2021

Substance Use and Bariatric Surgery: What to Look for, What to Do continued from page 1

Tobacco Ivy Haskins, MD, an assistant professor of surgery at the University of Nebraska Medical Center, in Omaha, pointed out that smoking cessation is often a requirement for bariatric surgery at many medical centers or by insurance. Landmark articles have detailed the increased risk for early pulmonary and wound morbidity events in current smokers in both open and laparoscopic bariatric surgery, Dr. Haskins said. A recent systematic review describes the short- and long-term effects of smoking on bariatric surgery outcomes (Surg Endosc 2021;35[6]:3047-3066). In addition to early pulmonary and wound events, this review showed that active smokers also experience an increased rate of marginal ulcer formation and vitamin and mineral deficiencies. Guidelines from the American Association of Clinical Endocrinology, The Obesity Society and ASMBS state that tobacco use should be avoided at all times by all bariatric surgery patients (Surg Obes Relat Dis 2013;9[2]:159-191).

“Some studies have shown that patients who have had a longer period of time between smoking cessation and bariatric surgery are more likely to abstain from smoking over the long term, and perhaps requiring a longer period of smoking cessation preoperatively may decrease the likelihood of resuming smoking postoperatively,” Dr. Haskins said. She noted that a multimodal approach to smoking cessation works best, and clinicians should watch for addiction transfers, such as a patient quitting smoking and then becoming a sugar craver.

Although one in seven adults smoke cigarettes the year before undergoing weight loss surgery and nearly all successfully quit at least a month before their operation, smoking prevalence steadily climbs to presurgical levels within seven years after surgery (Ann Surg 2020 Feb 20. doi:1092SLA 0000000000003828). “There are likely many explanations for this observation, but one that I think that is worth highlighting is patient counseling,” Dr. Haskins said. “According to an American College of Surgeons statement, only 13% of general surgeons provide smoking cessation counseling to their patients. Additionally, many surgeons do not know the resources available to their patients either within their own hospital system or because of differences in insurance coverage for these types of programs. One program that may offer guidance is the Quit Smoking Before Surgery program, which is offered through the American College of Surgeons and has resources for both physicians and patients.”

Dr. Haskins said at the University of Nebraska Medical Center, smoking history is part of the bariatric intake process, and is discussed at every subsequent visit that occurs at the bariatric center. She said bupropion is often the first-line medication used to assist with smoking cessation. “When counseling bariatric surgery patients, it is important that they understand that smoking cessation is part of their lifelong lifestyle change, and that the success of their operation not only depends on the changes in their eating and exercise habits, but also on avoidance of smoking, which can negatively impact the long-term success of their surgery,” she said.

Marijuana According to Allyson Diggins, PhD, an associate staff psychologist at the Cleveland Clinic Bariatric and Metabolic Institute, in Cleveland, between 6% and 8.3% of all individuals who are pursuing bariatric surgery

endorse marijuana use. “There is a lot of debate about Sockalingam said. “We know that the initial prescripwhether marijuana is a contraindication for bariatric tion of opioids after surgery for pain management can surgery,” Dr. Diggins said. “When we look specifical- lead to more persistent and continued use.” ly at bariatric surgery, we see that studies have demIn a study involving 56,183 bariatric surgery patients, onstrated an increased risk in two different areas: pain preoperative opioid use was an independent risk facmanagement as well as problematic eating behaviors.” tor for adverse events including severe complications A study of 434 bariatric surgery patients found (odds ratio [OR], 1.67), reoperation (OR, 1.87), length that 8.3% endorsed marijuana use. Those patients of stay (relative risk, 1.11) and readmission (OR, 1.70) who endorsed marijuana use had significantly high- (Surg Obes Relat Dis 2021;17[7]:1256-1262). Risk facer perioperative opioid requirements (natural log mor- tors for continued or post-surgery initiated opioid use phine equivalents of 3.92 vs. 3.52; P=0.0015) (Perm J are more pain at baseline or less pain improvement, 2018;22:18-002). Another study found that patients continued benzodiazepine use, subsequent bariatric who used marijuana after surgery were more like- procedures, improvement in mental health after surly to have disordered eating (Surg Obes Relat Dis gery, and history of orthopedic surgery (Surg Obes Relat 2016;12[1]:171-178).

Dis 2017;13[8]:1337-1346). In a recent study involving But there are no randomized trials examining wheth- 27,779 patients undergoing bariatric surgery, 21% had er marijuana is a contraindication for bariatric surgery. presurgical opioid use, and the rate of new persistent “In the studies that we do have, we see that there is no opioid use after bariatric surgery was 6.3% (Surg Endosc increased risk in short-term or 90-day complications 2019;33[8]:2649-2656). [with marijuana]. There is no difference in weight loss at two weeks to three years after surgery. We also find that there is sim‘It is important that [bariatric patients] ilar surgical site infections as well as similar understand that smoking cessation is part of 30-day readmissions and similar 30-day ED [emergency department] visits. Of note, in their lifelong lifestyle change, and that the a lot of these studies, we don’t see the longsuccess of their operation not only depends on term effects of marijuana and what happens after that two-year point,” Dr. Diggins said. the changes in their eating and exercise habits, Dr. Diggins said there is a dearth of but also on avoidance of smoking, research exploring marijuana use in bariatric surgery, and there are more questions than which can negatively impact the answers on this topic.

long-term success of their surgery.’

Alcohol Scott Engel, PhD, the director of behavioral research at Sanford Health in Fargo, N.D., said it is well established that bariatric surgery increases the risk for alcohol disorders. In one study of 2,348 patients who underwent Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB), 20% of patients reported incident alcohol use disorder (AUD) symptoms within five years of undergoing RYGB, and undergoing RYGB versus LAGB was associated with twice the risk for incident AUD symptoms (Surg Obes Relat Dis 2017;13[8]:1392-1402). Numerous other studies highlight the risks for AUD after bariatric surgery (Obesity 2013;21[12]:2444-2451; JAMA Surg 2013;148[4]:374377). “We find that after bariatric surgery, patients become much more intoxicated, and we see significant changes in the pharmacokinetics of alcohol after surgery,” Dr. Engel said.

According to the ASMBS, patients undergoing bariatric surgery should be screened and educated about AUD and bariatric surgery, and active AUD is a contraindication for weight loss surgery.

Opioids According to Sanjeev Sockalingam, MD, a professor of psychiatry at the University of Toronto, and vice president, education and clinician scientist, at the Center for Addiction and Mental Health, and the director of the Bariatric Surgery Psychosocial Program, University Health Network, opioid use post-surgery is a concern and can lead to surgical and psychosocial sequelae.

“In the U.S., 38 people die every day from overdoses involving overdoses of prescription opioids,” Dr.

—Ivy Haskins, MD

According to Traci Speed, MD, PhD, an assistant professor of psychiatry and behavioral sciences and the chief psychiatrist of the personalized pain program at the Johns Hopkins University School of Medicine, in Baltimore, patients undergoing bariatric surgery who are on chronic opioids have decreased quality of life, worse clinical outcomes, less weight loss, worse body image and a higher rate of depression.

“Broadly speaking, risk factors for opioid use disorder include individuals with a family history of substance use, less education or who are unemployed, certain personality traits such as impulsivity or being antisocial, having a mood disorder or anxiety disorder, as well as those with exposure to trauma or stress early on in life,” she said.

Dr. Speed said there is evidence that patients who have undergone bariatric surgery tend to get prescriptions of opioids in excess of what they actually use.

An approach to minimizing opioid exposure during the perioperative period is to use collaborative care approaches, such as the enhanced recovery after surgery protocol, or ERAS. “Those who receive higher doses and a greater duration of opioids are going to be at greater risk for developing a disorder. In the bariatric surgery population, we know that opioid-naive patients are at risk of developing persistent opioid use, and that is true for about 4% of the population. Those on preoperative opioids are at risk of continuing postoperative opioids, and that is true ■ for 50% to 75% of the population.”

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GENERAL SURGERY NEWS / OCTOBER 2021

Focus on Issues in Colorectal Surgery n this installment of Journal Watch, we welcome guest columnist Rebecca Brown, MD, an assistant professor of surgery at the University of Maryland School of Medicine, in Baltimore, who specializes in colon and rectal surgery.

Dr. Brown evaluates two studies focused on postoperative pain—one on nerve blocks for hemorrhoidectomy, and the other on extraction site after robotic colon surgery. She also reviews two randomized controlled trials—one on ostomy creation preventing parastomal hernias, and another on anastomotic technique for resection of ileocecal Crohn’s disease affecting subsequent recurrence.

The hope is readers will find these recently published findings worthwhile and relevant to a general surgeon’s expertise and be able to use the information to alter and/or reinforce current practice.

I

Arielle Perez, MD, MPH, MS Director of UNC Health Hernia Center and Assistant Professor of Surgery in the Division of General, Acute Care, and Trauma Surgery at the University of North Carolina at Chapel Hill School of Medicine —Column Editor

Rebecca Brown, MD Assistant Professor of Surgery at the University of Maryland School of Medicine, in Baltimore —Guest Columnist

Pudendal Nerve Block in Traditional Hemorrhoidectomy In Diseases of the Colon & Rectum, Mongelli et al published their systematic review and meta-analysis evaluating the effect of pudendal nerve blocks (PNB) on postoperative pain in patients undergoing traditional hemorrhoidectomy (Dis Colon Rectum 2021;64[5]:617-631).

The researchers scoured major research databases (PubMed, Google Scholar, Cochrane Library and Web of Science) through December 2020, and identified randomized trials comparing PNB and any other treatment without PNB in patients undergoing surgical management for hemorrhoidal disease. Studies evaluating nonhemorrhoidal disease or with a sample size of fewer than 10 patients were excluded. The authors then used a random effects model to evaluate opioid consumption, pain on the Visual Analogue Scale, hospital length of stay and readmission rate. This approach allows for variable treatment effects identified in individual studies included in the meta-analysis to influence the average treatment effect identified in the meta-analysis. The approaches to PNB (nerve stimulation, ultrasound guidance and anatomic landmarks), type of anesthetic used, open versus closed hemorrhoidectomy, and control groups (placebo PNB vs. no PNB), varied among the studies. Postoperative pain values or opioid consumption were provided by all included studies.

The authors identified 14 eligible studies with a total of 1,214 patients (565 PNB vs. 649 no PNB) to be included in their analysis. The overall difference in opioid consumption was 7.2 mg of morphine equivalents in favor of the PNB group (P<0.001), with a marked decrease in the number of patients requiring any opioids (22% PNB vs. 65% no PNB; P<0.001).

Postoperative pain scores also were lower in the PNB group in all cases. Patients who received PNB also experienced less frequent postoperative complications, including urinary retention (2.9% vs. 23.4%; P<0.001), and postoperative nausea and vomiting (1.6% vs. 15.4%; P<0.001), as well as a shorter hospital stay (17.4 vs. 29.5 hours; P<0.001) and a lower readmission rate (1% vs. 10.7%; P=0.037). There was no difference in operative time or fluid administration between the two groups.

This systematic review and meta-analysis demonstrated that PNB reduces opioid consumption, postoperative pain, complications, hospital length of stay and readmissions in patients undergoing hemorrhoidectomy. The meta-analysis is based on good-quality trials and supports wider use of PNB in hemorrhoidectomy. No major differences were found in opioid

consumption related to approach (nerve stimulation vs. anatomic vs. ultrasound-guided) or type of anesthetic used.

As with all meta-analyses, this publication is subject to limitations related to publication bias and heterogeneity. However, based on the high-quality data used and similarity of included studies, these are likely to have minimal effect on the overall recommendation in favor of use of PNB for patients undergoing hemorrhoidectomy. This study strongly supports the use of PNB in hemorrhoidectomy—traditionally described as one of the most painful operations performed by colorectal and general surgeons—to assist in postoperative recovery, and should be considered by surgeons who perform this procedure as an adjunct to postoperative pain control.

Preventing Parastomal Hernias During Colostomy Creation In Annals of Surgery, Marinez et al share the results of their randomized, multicenter trial comparing three different surgical techniques (circular incision, cruciate incision, prophylactic mesh placement) on one-year parastomal hernia rates from three hospitals in Denmark and Sweden (Ann Surg 2021;273[4]:640-647).

Patients electively scheduled to undergo end colostomy creation, regardless of indication for surgery, were included in the study. They were randomized intraoperatively just before stoma creation. Postoperative blinding was not possible as the chart was available for review.

A majority of participating surgeons were colorectal

surgeons, with all performing more than 50 colostomy procedures before study participation. Each surgeon received instructions on how to perform all three study procedures. Patients underwent clinical examination and a CT scan in the prone position at one year after surgery to detect parastomal hernias. Complications, readmissions, reoperations, and demographics and risk factors also were collected. The author’s power calculation suggested that enrolling 62 patients per arm would allow for a true difference of 20% to be detected.

A total of 209 patients were enrolled in the study, with similar demographics in the three groups. Overall, 185 completed their one-year clinical and radiographic evaluations (15 died of disease, six declined participation and three were lost to follow-up). The one-year parastomal hernia rate was 50.8% (n=32) in the cruciate incision group, 37.5% (n=24) in the circular incision group, and 39.7% (n=23) in the prophylactic mesh group. The authors found no significant differences in the parastomal hernia rate between the cruciate and circular groups (risk ratio [RR], 1.25; 95% CI, 0.83-1.88; P=0.571) or between the cruciate and mesh groups (RR, 1.22; 95% CI, 0.81-1.84; P=0.701] in unadjusted or adjusted analyses. Postoperative complications, readmission and reoperations were similar in all groups, and were noted to be associated with the index operation rather than related specifically to the stoma (i.e., PNA, abscess, ileus, perineal wound, etc.).

Increasing age and increasing body mass index were found to be associated with the development of a parastomal hernia.

Overall, the authors found no statistically significant differences in the rates of parastomal hernia development at one year among cruciate incision, circular incision or prophylactic mesh placement, suggesting that these three techniques can be considered equal in the creation of an end colostomy. These results were similar to those published in the recent STOMA-MESH trial, which found no decrease in the incidence of parastomal hernia when prophylactic mesh was used. (See Table, Useful Related Articles, page 18.) The overall hernia rate detected in this study is high (37%-50%), but in line with reported rates of parastomal hernias up to 80% as reported by the 2014 Janes study with five-year follow-up. This higher detection rate can also be attributed to the combination of using clinical and radiographic imaging for diagnosis.

The number of symptomatic parastomal hernias is not reported in this study, but only one patient (in the cruciate group) required surgical intervention for parastomal hernia during the study period. Additionally, the authors considered a difference in hernia rate of 20% to be clinically relevant, so they did not continued on page 18

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JOURNAL WATCH

GENERAL SURGERY NEWS / OCTOBER 2021

Post-op Pain continued from page 16

detect any significant difference in their study population, even though the cruciate group demonstrated a more than 10% higher rate of hernia compared with the circular and prophylactic mesh groups. Lastly, follow-up of longer than one year may demonstrate a greater difference in hernia formation as the abdominal and fascial contours change. Nevertheless, this welldesigned randomized controlled trial with adequate size to detect potential differences shows no clear advantage to the use of prophylactic mesh in the creation of an end colostomy within one year of surgery.

Extraction Site Location Does Not Affect Postoperative Pain in Robotic Colorectal Surgery [Editor’s note: Rebecca Brown, MD, guest columnist, is the author of this study.]

In this retrospective cohort study published in Diseases of the Colon and Rectum, Brown et al evaluated differences in postoperative pain scores as well as inpatient and outpatient opioid use based on extraction site location in robotic colorectal surgery (Dis Colon Rectum 2021;64[6]:735-743).

Extraction site incision is typically the longest in robotic surgery, and thus thought to contribute the most to postoperative pain scores and resultant opioid use.

Extraction site location may be determined by operative approach (intra- vs. extracorporeal anastomosis) or surgeon preference and experience. Adult patients

undergoing elective robotic colon or rectal resections without a history of long-term opioid use over the 15-month study period were included. Patients were cared for in a well-established enhanced recovery after surgery (ERAS) program incorporating preadmission classes that included opioid-reducing pain management strategies as well as a pharmacist-led inpatient and outpatient pain management strategy individualized to each patient. An assessment of pain levels using numeric pain scores (range, 0-10) and opioid use was included both during the hospitalization and at the early postdischarge clinic visit that occurred within one week of hospital discharge. Postoperative pain scores and inpatient and outpatient opioid consumption were collected and compared.

During the study period, 193 patients underwent robotic colorectal resections, with 137 (70.9%) undergoing Pfannenstiel extraction site and 56 patients (29.0%) having either an off-midline (n=49) or midline (n=7) extraction site. Incision length was similar in the two groups (5.03 vs. 4.7 cm; P=0.134). Operations were performed at a single institution by one of four surgeons in the Division of Colorectal Surgery. There was no difference in the use of transversus abdominis plane, or TAP, blocks or epidurals between the two groups, and an intracorporeal anastomotic technique was used in a majority (93.8%) of cases. The authors used propensity score weighting to adjust for the observed covariates in the two groups and decrease treatment selection bias in the analysis of their data. In the propensity-weighted analysis, there was no significant difference in postoperative pain scores or inpatient (5.73 vs. 5.71 morphine milligram equivalents; P=0.893) or outpatient opioid

use (2.93 vs. 2.41 5-mg oxycodone tablets; P=0.592) between the Pfannenstiel and non-Pfannenstiel groups.

Hospital length of stay, postoperative complications and readmissions were similar in the groups.

This is the first published study to evaluate the effect of extraction site location in colorectal surgery on pain and opioid use. The authors found no difference in postoperative pain scores or opioid consumption based on the location of the extraction site in robotic colorectal resections. Interestingly, the patient cohort had a very low opioid consumption after discharge (on average, fewer than three 5-mg oxycodone tablets), which may be attributable to the ERAS pathway, and should be considered by prescribing physicians during discharge medical reconciliation.

The study is limited by its single-institution patient population with a well-established ERAS program that contains elements and support not available at all hospitals. Based on this study, location of extraction site can be based on factors such as patient body habitus, anastomotic technique and surgeon preference without affecting pain and opioid use.

A Novel Anastomotic Approach to Decrease Crohn’s Disease Recurrence In Annals of Surgery, Luglio et al published their randomized controlled trial comparing the rates of endoscopic anastomotic recurrence between a KonoS anastomosis and stapled side-to-side anastomosis in patients undergoing ileocolic resection for Crohn’s disease (Ann Surg 2020;272[2]:210-217).

Table. Summary of Four Studies Discussed Article Title

Key Takeaways

Study Limitations

Useful Related Articles

Pudendal nerve block in hemorrhoid surgery: a systematic review and meta-analysis.

• Pudendal nerve block decreases postoperative pain, opioid use and complications in patients undergoing hemorrhoidectomy.

• Pooled RCT data

• Sammour T, Barazanchi AW, Hill AH; PROSPECT group (Collaborators). Evidence-based management of pain after excisional hemorrhoidectomy: a PROSPECT review update. World J Surg. 2017;41(2):603-614.

Mongelli F, Treglia G, La Regina D, et al. Dis Colon Rectum.

2021;64(5):617-631.

Methods of colostomy construction: no effect on parastomal hernia rate: results from Stoma-const— a randomized controlled trial.

Marinez AC, Bock D, Erestam S, et al. Ann Surg. 2021;273(4):640-647.

• No change in operative time

• No statistically significant difference in hernia at one year: – Cruciate: 50.8% – Circular: 37.5% – Prophylactic mesh: 39.7% • Age and body mass index were associated with development of parastomal hernia.

Postoperative pain after enhanced recovery pathway robotic colon and rectal surgery: does specimen extraction site matter?

• No difference in pain scores or opioid use for Pfannenstiel versus other location (midline, off-midline) of extraction site

Brown RF, Brockhaus K, Rajkumar D, et al. Dis Colon Rectum.

2021;64(6):735-743.

• Similar postoperative complications and readmission in groups

Surgical prevention of anastomotic recurrence by excluding mesentery in Crohn’s disease: the SuPREMeCD Study—a randomized clinical trial.

• Lower rate of endoscopic recurrence seen at six and 18 months; clinical recurrence at 24 months in Kono-S versus conventional group

Luglio G, Rispo A, Imperatore N, et al. Ann Surg. 2020;272(2):210-217.

• No difference in clinical recurrence at 12 months or surgical recurrence at 24 months between groups • No difference in perioperative factors (surgery duration, LOS) or postoperative complications

LOS, length of stay; PNB, pupendal nerve block; RCT, randomized controlled trial

• No standardization of PNB approach • Comparison with multimodal pain control not specifically reported

• One-year data • Powered to detect 20% difference in hernia rates • High hernia rates in all groups

• Joshi GP, Neugebauer EA; PROSPECT collaboration. Evidence based management of pain after haemorrhoidectomy surgery. Br J Surg.

2010;97(8):1155-1168.

• Odensten C, Strigard K, Rutegard J, et al. Use of prophylactic mesh when creating a colostomy does not prevent parastomal hernia: a randomized controlled trial—STOMAMESH. Ann Surg.

2019;269(3):427-431.

• Symptomatic hernias not reported

• Antoniou SA, Agresta F, Garcia Alamino JM, et al.

European Hernia Society guidelines on prevention and treatment of parastomal hernia. Hernia.

2018;22(1):183-198.

• Single-institution study

• Samia H, Lawrence J, Nobel T, et al. Extraction site location and incisional hernias after laparoscopic colorectal surgery: should be avoiding the midline?

Am J Surg. 2013;205(3):264-267.

• Long-term complications (i.e., hernia) not included

• Single-institution study, small study population • No power calculation included to determine if study size was sufficient • Two-year follow-up performed instead of typical five-year follow--up • Postoperative medical management was not standardized.

• Kono T, Ashida T, Ebisawa Y, et al. A new antimesenteric functional end-to-end anastomosis: surgical prevention of anastomotic recurrence in Crohn’s disease. Dis Colon Rectum.

2011;54(5):586-592.

JOURNAL WATCH

OCTOBER 2021 / GENERAL SURGERY NEWS

The Kono-S anastomosis is an antimesenteric, end-to-end, hand-sewn anastomosis as described by Kono et al in 2011. (See Table, Useful Related Articles.) Patients requiring surgical intervention for ileocolic Crohn’s disease at a single tertiary referral institution were recruited for participation between March 2015 and September 2017. After enrollment, they were randomly assigned in a 1:1 ratio to Kono-S or conventional side-to-side anastomosis, controlling for age, sex, smoking duration, previous surgery and Crohn’s disease activity. Surgeons performed extracorporeal anastomoses in all patients using a standard technique, and all patients received postoperative care including one month of postoperative metronidazole.

Initiation of medical strategies to prevent postoperative recurrence was tailored based on patient risk profile and clinical judgment. Patients underwent surveillance colonoscopy six months after surgery, and endoscopic recurrence based on a Rutgeerts score of i2 and higher was recorded as the primary end point. Secondary end points included short-term outcomes (surgery duration, days to bowel function, hospital length of stay), perioperative complications, clinical disease recurrence at 12 and 24 months (based on Crohn’s Disease Activity Index [CDAI] score ≥200), endoscopic recurrence at 18 months, and surgical recurrence at 24 months.

A total of 79 patients undergoing ileocolic resection for Crohn’s were enrolled in the trial, with 36 assigned to the Kono-S anastomosis group and 43 to the conventional side-to-side anastomosis group. There were no significant differences in baseline patient characteristics or disease features between the groups. Duration of surgery (approximately 165 minutes), days to return of bowel function (about three days), hospital length of stay (about seven days), and postoperative complications, including an anastomotic leak rate of 0% in both groups, were similar in the two groups. There was no difference in use of postoperative biologics or azathioprine.

The endoscopic recurrence rate was higher in the conventional group than the Kono-S group (62.8% vs.

22.2%; P<0.001), and severe postoperative recurrence (Rutgeerts ≥i3) also was higher in the conventional group (34.8% vs. 13.8%; P=0.03). The endoscopic recurrence rate at 18 months was also higher in the conventional group than the Kono-S group (67.4% vs.

25%; P<0.001). Binary logistic regression found the Kono-S anastomosis to be the only variable associated with reduced risk for endoscopic recurrence

(odds ratio, 0.19; 95% CI, 0.08-0.74; P<0.001). No significant difference was observed in the clinical recurrence rate at 12 months (18% conventional vs. 8% Kono-S; P=0.2), but a difference was seen in clinical recurrence at 24 months, with 30.2% of patients in the conventional group versus 11.1% in the KonoS group demonstrating a CDAI score of greater than 200 (P=0.04). There was no difference in surgical recurrence at two years between the groups (4.6% conventional vs. 0% Kono-S; P=0.3).

The authors of this randomized controlled trial reported a higher incidence

of anastomotic recurrence, increased severity of endoscopic recurrence and increased clinical recurrence in patients with a conventional side-to-side stapled anastomosis compared with the relatively new end-to-end antimesenteric handsewn Kono-S anastomosis. These data are similar to the original Kono study that demonstrated a lower chance of surgical recurrence in a retrospective study comparing the Kono-S anastomosis and conventional side-to-side.

Although interesting data and results are presented here, this was a small study at a single institution with a

relatively short follow-up period of two years versus the standard five years typically used to judge clinical and surgical recurrences in Crohn’s disease. The primary outcome was endoscopic recurrence. While we believe that endoscopic recurrence precedes clinical and surgical recurrences, the time line of this process is unclear. Additionally, there was no standardization of postoperative medical management. Although there was no difference in the use of postoperative biologics, the timing of initiation and medications used could influence ■ this outcome.

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8 MILLION ADULT PATIENTS HAVE RECEIVED EXPAREL SINCE 2012 1

LEARN MORE AT WWW.EXPAREL.COM Indication EXPAREL® (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks.

routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, or intravascular or intra-articular use.

The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials.

Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia.

Adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via interscalene brachial plexus nerve block were nausea, pyrexia, and constipation.

Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia.

If EXPAREL and other non-bupivacaine local anesthetics, including lidocaine, are administered at the same site, there may be an immediate release of bupivacaine from EXPAREL. Therefore, EXPAREL may be administered to the same site 20 minutes after injecting lidocaine.

EXPAREL is not recommended to be used in the following patient populations: patients <6 years old for infiltration, patients younger than 18 years old for interscalene brachial plexus nerve block, and/or pregnant patients.

Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease.

Warnings and Precautions for Bupivacaine-Containing Products Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression.

Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to dysrhythmias, sometimes leading to death.

Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients.

Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use.

Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use.

Warnings and Precautions Specific to EXPAREL Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL is not recommended for the following types or ©2021 Pacira BioSciences, Inc. Parsippany, NJ 07054 PP-EX-US-6517 03/21

Please refer to brief summary of Prescribing Information on adjacent page.

For more information, please visit www.EXPAREL.com or call 1-855-793-9727.

Reference: 1. Data on File. 6450. Parsippany, NJ: Pacira BioSciences, Inc.; January 2021.

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OPINION

Vaccination continued from page 1

recommendations, conversations and societal movements, as well as the determinants of life and death, national and personal economics, freedom of action, and violence. Can past history and future projections help us choose the most rational and optimal of the alternatives before us? Can we as surgeons, as physicians, as scientists, lead the way to fulfilling the Hippocratic credo of “Where the art of medicine is loved, there is also a love of humanity.”

Brief Summary (For full prescribing information refer to package insert) INDICATIONS AND USAGE EXPAREL is indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.

Limitation of Use: Safety and efficacy has not been established in other nerve blocks.

CONTRAINDICATIONS EXPAREL is contraindicated in obstetrical paracervical block anesthesia.

While EXPAREL has not been tested with this technique, the use of bupivacaine HCl with this technique has resulted in fetal bradycardia and death.

WARNINGS AND PRECAUTIONS Warnings and Precautions Specific for EXPAREL As there is a potential risk of severe life-threatening adverse effects associated with the administration of bupivacaine, EXPAREL should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity.

Caution should be taken to avoid accidental intravascular injection of EXPAREL. Convulsions and cardiac arrest have occurred following accidental intravascular injection of bupivacaine and other amidecontaining products.

Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL has not been evaluated for the following uses and, therefore, is not recommended for these types of analgesia or routes of administration.

• epidural • intrathecal • regional nerve blocks other than interscalene brachial plexus nerve block • intravascular or intra-articular use EXPAREL has not been evaluated for use in the following patient population and, therefore, it is not recommended for administration to these groups.

• patients younger than 6 years old for infiltration • patients younger than 18 years old for interscalene brachial plexus nerve block • pregnant patients The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days as seen in clinical trials.

ADVERSE REACTIONS Clinical Trial Experience Adverse Reactions Reported in Local Infiltration Clinical Studies The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical site clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 to 532 mg of EXPAREL. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting. The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration were pyrexia, dizziness, edema peripheral, anemia, hypotension, pruritus, tachycardia, headache, insomnia, anemia postoperative, muscle spasms, hemorrhagic anemia, back pain, somnolence, and procedural pain.

Adverse Reactions Reported in All Local Infiltration Clinical Studies in Pediatric Patients Aged 6 to Less Than 17 Years The safety of EXPAREL in 110 pediatric patients between the age of 6 and 17 years old undergoing various surgical procedures was evaluated in one randomized, open-label, clinical study in which EXPAREL was administered by infiltration into the surgical site and one single-arm, open-label study in which EXPAREL was administered by infiltration into the surgical site. Patients were administered a weight-based dose of EXPAREL at 4 mg/kg (maximum dose of 266 mg) or bupivacaine HCl 2 mg/kg (maximum dose of 175 mg). In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia.

The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration were bradycardia, muscle spasms, tachypnea, hypoesthesia oral, anemia postoperative, dizziness, pyrexia, diarrhea, hypoacusis, hypoesthesia, back pain, hematuria, incontinence, muscular weakness, and visual impairment.

Adverse Reactions Reported in Nerve Block Clinical Studies The safety of EXPAREL was evaluated in four randomized, double-blind, placebo-controlled nerve block clinical studies involving 469 patients undergoing various surgical procedures. Patients were administered a dose of either 133 or 266 mg of EXPAREL. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, pyrexia, and constipation.

The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration as a nerve block were muscle twitching, dysgeusia, urinary retention, fatigue, headache, confusional state, hypotension, hypertension, hypoesthesia oral, pruritus generalized, hyperhidrosis, tachycardia, sinus tachycardia, anxiety, fall, body temperature increased, edema peripheral, sensory loss, hepatic enzyme increased, hiccups, hypoxia, post-procedural hematoma.

The Past Bubonic Plague Before vaccination, there was the bubonic plague, commonly called the Black Death. It is caused by the bacterium Yersinia pestis, carried by fleas and spread by small animals, primarily rats.

There have been three major recorded pandemics of bubonic plague. The first—the Justinian plague, 541-542, with recurrences to 750—destroyed the Byzantine Empire, with a death toll of

Postmarketing Experience These adverse reactions are consistent with those observed in clinical studies and most commonly involve the following system organ classes (SOCs): Injury, Poisoning, and Procedural Complications (e.g., drug-drug interaction, procedural pain), Nervous System Disorders (e.g., palsy, seizure), General Disorders And Administration Site Conditions (e.g., lack of efficacy, pain), Skin and Subcutaneous Tissue Disorders (e.g., erythema, rash), and Cardiac Disorders (e.g., bradycardia, cardiac arrest).

DRUG INTERACTIONS The toxic effects of local anesthetics are additive and their coadministration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity. Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. Patients who are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia:

Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic cyclophosphamide, flutamide, hydroxyurea, ifosfamide, agents rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine Bupivacaine Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2.

Non-bupivacaine Local Anesthetics EXPAREL should not be admixed with local anesthetics other than bupivacaine. Nonbupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. There are no data to support administration of other local anesthetics prior to administration of EXPAREL. Other than bupivacaine as noted above, EXPAREL should not be admixed with other drugs prior to administration.

Water and Hypotonic Agents Do not dilute EXPAREL with water or other hypotonic agents, as it will result in disruption of the liposomal particles USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are no studies conducted with EXPAREL in pregnant women.

In animal reproduction studies, embryo-fetal deaths were observed with subcutaneous administration of bupivacaine to rabbits during organogenesis at a dose equivalent to 1.6 times the maximum recommended human dose (MRHD) of 266 mg. Subcutaneous administration of bupivacaine to rats from implantation through weaning produced decreased pup survival at a dose equivalent to 1.5 times the MRHD [see Data]. Based on animal data, advise pregnant women of the potential risks to a fetus.

The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

Clinical Considerations Labor or Delivery Bupivacaine is contraindicated for obstetrical paracervical block anesthesia. While EXPAREL has not been studied with this technique, the use of bupivacaine for obstetrical paracervical block anesthesia has resulted in fetal bradycardia and death.

Bupivacaine can rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity. The incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus, and neonate involve alterations of the central nervous system, peripheral vascular tone, and cardiac function.

Data Animal Data Bupivacaine hydrochloride was administered subcutaneously to rats and rabbits during the period of organogenesis (implantation to closure of the hard plate). Rat doses were 4.4, 13.3, and 40 mg/kg/day (equivalent to 0.2, 0.5 and 1.5 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight) and rabbit doses were 1.3, 5.8, and 22.2 mg/ kg/day (equivalent to 0.1, 0.4 and 1.6 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight). No embryofetal effects were observed in rats at the doses tested with the high dose causing increased maternal lethality. An increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity.

Decreased pup survival was noted at 1.5 times the MRHD in a rat pre- and post-natal development study when pregnant animals were administered subcutaneous doses of 4.4, 13.3, and 40 mg/kg/day buprenorphine hydrochloride (equivalent to 0.2, 0.5 and 1.5 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight)

25 million to 100 million. The second was the Black Death, 1346-1353, which decimated Europe, with a death toll of 75 million to 200 million—one-third to one-half of Europe and Eurasia. The third started in Yunnan, China, about 1894 and surfaced in the United States in 1900, and periodically reemerged until 1959, with a death toll of 15 million.

Other episodes of bubonic plague have occurred worldwide to the present day.

As a bacterium-caused disease, bubonic plague today is susceptible to antibiotic therapy, with a reduction in mortality from 90% to 10% (not quite acceptable

from implantation through weaning (during pregnancy and lactation).

Lactation Risk Summary Limited published literature reports that bupivacaine and its metabolite, pipecoloxylidide, are present in human milk at low levels. There is no available information on effects of the drug in the breastfed infant or effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EXPAREL and any potential adverse effects on the breastfed infant from EXPAREL or from the underlying maternal condition.

Pediatric Use The safety and effectiveness of EXPAREL for single-dose infiltration to produce postsurgical local anesthesia have been established in pediatric patients aged 6 years and older. Use of EXPAREL for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 6 years and older.

Safety and effectiveness have not been established in pediatric patients aged less than 6 years old for local infiltration or less than 18 years old for interscalene brachial plexus nerve block.

Geriatric Use Of the total number of patients in the EXPAREL local infiltration clinical studies (N=823), 171 patients were greater than or equal to 65 years of age and 47 patients were greater than or equal to 75 years of age. Of the total number of patients in the EXPAREL nerve block clinical studies (N=531), 241 patients were greater than or equal to 65 years of age and 60 patients were greater than or equal to 75 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients. Clinical experience with EXPAREL has not identified differences in efficacy or safety between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment Amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity. Therefore, consider increased monitoring for local anesthetic systemic toxicity in subjects with moderate to severe hepatic disease.

Renal Impairment Bupivacaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. This should be considered when performing dose selection of EXPAREL. OVERDOSAGE Clinical Presentation Acute emergencies from local anesthetics are generally related to high plasma concentrations encountered during therapeutic use of local anesthetics or to unintended intravascular injection of local anesthetic solution.

Signs and symptoms of overdose include CNS symptoms (perioral paresthesia, dizziness, dysarthria, confusion, mental obtundation, sensory and visual disturbances and eventually convulsions) and cardiovascular effects (that range from hypertension and tachycardia to myocardial depression, hypotension, bradycardia and asystole).

Plasma levels of bupivacaine associated with toxicity can vary. Although concentrations of 2,500 to 4,000 ng/mL have been reported to elicit early subjective CNS symptoms of bupivacaine toxicity, symptoms of toxicity have been reported at levels as low as 800 ng/mL. Management of Local Anesthetic Overdose At the first sign of change, oxygen should be administered.

The first step in the management of convulsions, as well as underventilation or apnea, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to the use of anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine to enhance myocardial contractile force).

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted.

Endotracheal intubation, employing drugs and techniques familiar to the clinician, maybe indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated.

DOSAGE AND ADMINISTRATION Important Dosage and Administration Information • EXPAREL is intended for single-dose administration only.

• Different formulations of bupivacaine are not bioequivalent even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL. • DO NOT dilute EXPAREL with water or other hypotonic agents, as it will result in disruption of the liposomal particles.

• Use suspensions of EXPAREL diluted with preservative-free normal (0.9%) saline for injection or lactated Ringer’s solution within 4 hours of preparation in a syringe.

• Do not administer EXPAREL if it is suspected that the vial has been frozen or exposed to high temperature (greater than 40°C or 104°F) for an extended period.

• Inspect EXPAREL visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer EXPAREL if the product is discolored.

Recommended Dosing Local Analgesia via Infiltration Dosing in Adults The recommended dose of EXPAREL for local infiltration in adults is up to a maximum dose of 266mg (20 mL), and is based on the following factors: • Size of the surgical site • Volume required to cover the area • Individual patient factors that may impact the safety of an amide local anesthetic As general guidance in selecting the proper dosing, two examples of infiltration dosing are provided: • In patients undergoing bunionectomy, a total of 106 mg (8 mL) of EXPAREL was administered with 7 mL infiltrated into the tissues surrounding the osteotomy, and 1 mL infiltrated into the subcutaneous tissue.

• In patients undergoing hemorrhoidectomy, a total of 266 mg (20 mL ) of EXPAREL was diluted with 10 mL of saline, for a total of 30 mL, divided into six 5 mL aliquots, injected by visualizing the anal sphincter as a clock face and slowly infiltrating one aliquot to each of the even numbers to produce a field block.

Local Analgesia via Infiltration Dosing in Pediatric Patients The recommended dose of EXPAREL for single-dose infiltration in pediatric patients, aged 6 to less than 17 years, is 4 mg/kg (up to a maximum of 266 mg), and is based upon two studies of pediatric patients undergoing either spine surgery or cardiac surgery.

Regional Analgesia via Interscalene Brachial Plexus Nerve Block Dosing in Adults The recommended dose of EXPAREL for interscalene brachial plexus nerve block in adults is 133 mg (10 mL), and is based upon one study of patients undergoing either total shoulder arthroplasty or rotator cuff repair.

Compatibility Considerations Admixing EXPAREL with drugs other than bupivacaine HCl prior to administration is not recommended.

• Non-bupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more.

• Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2.

The toxic effects of these drugs are additive and their administration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.

• When a topical antiseptic such as povidone iodine (e.g., Betadine®) is applied, the site should be allowed to dry before EXPAREL is administered into the surgical site. EXPAREL should not be allowed to come into contact with antiseptics such as povidone iodine in solution.

Studies conducted with EXPAREL demonstrated that the most common implantable materials (polypropylene, PTFE, silicone, stainless steel, and titanium) are not affected by the presence of EXPAREL any more than they are by saline. None of the materials studied had an adverse effect on EXPAREL. Non-Interchangeability with Other Formulations of Bupivacaine Different formulations of bupivacaine are not bioequivalent even if the milligram dosage is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL and vice versa.

Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Do not substitute.

CLINICAL PHARMACOLOGY Pharmacokinetics Administration of EXPAREL results in significant systemic plasma levels of bupivacaine which can persist for 96 hours after local infiltration and 120 hours after interscalene brachial plexus nerve block. In general, peripheral nerve blocks have shown systemic plasma levels of bupivacaine for extended duration when compared to local infiltration.

Systemic plasma levels of bupivacaine following administration of EXPAREL are not correlated with local efficacy.

PATIENT COUNSELING Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly.

Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

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

5,766,627

8,182,835

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

March 2021

OPINION

OCTOBER 2021 / GENERAL SURGERY NEWS

Vaccination against polio is mandatory for children entering public schools in all 50 of the United States, in addition to vaccination against diphtheria, pertussis, tetanus, influenza type B, measles, mumps, rubella and chickenpox.

by modern standards). The Black Death led to the initiation of public health measures of quarantine, social distancing and masking for health care providers—the famous Plague Doctors of the 14th century with their bird-like beak masks of leather with eyepieces of glass filled with scented herbs that acted as a filter against airborne spread of infection.

Vaccines against Yersinia pestis have been developed from time to time with serious flaws in safety and efficacy. If there is another pandemic outbreak of bubonic plague, no recommendable vaccines are available. In essence, our vaccine weapon against such a pandemic would be nonexistent. We would, as a global community, be no better equipped to arrest the pandemic than we were at the outset of COVID-19.

Why did the major bubonic plague pandemics end? We are not sure. The infectious agent could intermittently lose its potency to attack humans. More likely, herd immunity contributed, or the mass death toll of the disease depleted a primary vector for dissemination. Certainly, over time, public health measures of sanitation and vermin control had a major impact. Today, the squalor and poverty, lack of sanitary facilities, and crowding engendered by the mass migrations of refugees in South and Latin America, and in the Near East, have provided the social milieu for the breeding of rats and fleas in close proximity to people.

Smallpox True vaccinations started with smallpox, a disease caused by a virus with two variants—Variola major and Variola minor. The death toll of the infected population was 30%. The World Health Organization (WHO) certified the global eradication of the disease in 1980. The cause of this unique victory over smallpox was vaccination.

Smallpox is an old disease with visual evidence of its presence dating back to the mummy of Ramses V, who died in 1157 BC. It is estimated that 400,000 people died annually from smallpox in Europe in the 18th century, and 500 million died in the 100 years prior to its

eradication. Yet, it was halted and eliminated by vaccination everywhere, from East to West, South to North, in the rich and the poor, in all races, creeds and religions.

Smallpox, we hope, is forever gone.

Variolation immunization with live smallpox virus started in China in the 10th century AD. Lady Mary Wortley Montagu promoted the procedure in England in 1718.

George Washington, who survived smallpox in his youth, in 1777, as commander-in-chief of the Continental Armies, ordered all of the

troops to be immunized. The variolation approach could, however, lead to active, contagious smallpox with a 0.5% to 2.0% mortality rate.

In 1796, Edward Jenner produced smallpox immunity with a cowpox preparation and coined the term “vaccination” from the word “vacca,” for cow. The source of vaccine became Vaccinia virus in the 19th century, a genetically distant relative of cowpox and variola. The vaccine was 95% effective, with an 0.1% incidence of non‒life-threatening side effects and a fatal response in 0.000198%. Vaccination against smallpox spread rapidly

21

and soon was made mandatory by many nations. Between 1843 and 1855, the individual states of the United States required smallpox vaccination for all of their citizens. Because humans are the only natural hosts for smallpox and there is no zoonotic reservoir, herd immunity was facilitated. As global immunity became universal, smallpox vaccinations were discontinued in the 1970s.

Polio I do not need a time machine to visit the polio era. I was there. It is stored in continued on the following page

February 23-25, 2022 Snowmass, CO Accepting Abstracts for Poster Presentations VACCINATIONS S REQUIRED

Presented by y Columbia Hernia Center

WWW.HERNIASUMMIT.COM

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OPINION

Vaccination continued from the previous page

my memory. Polio season started in the summer and was at its most contagious during the hottest mid-summer. In New York City in the 1940s, before window air conditioners became common, there were two refuges from the heat where mothers sent their children: municipal swimming pools and the movie matinees in an air-cooled theater. As polio infections increased, both of these outlets were less frequented and at times closed. The movie matinees, when available, occupied children the entire afternoon. They consisted of three full-length features, two short features, at least two cartoons and always the news of the day. After the encouraging stories of our armed forces winning World War II, this feature traditionally showed the “fortunate” children with withered legs, receiving hot packs and massages at the Sister Kenny Institute in Minneapolis; President Franklin D. Roosevelt taking the baths at Warm Springs, Ga., to sooth his polio-decimated legs; and row upon row of children in iron lungs, negative pressure ventilators, smiling from the steel cages that compensated for the loss of their respiratory muscles.

One afternoon, I was playing ball with a close childhood friend when he declared that he was tired. We went to his apartment. We played a board game. I ate dinner with his family. My friend was very tired and went to bed; I went home.

The next morning, I called to see how he was. His father answered the phone and told me that he had died during the night from bulbar polio.

The next summer, I was vacationing with my family at a farm. One day, I was extremely tired and had a headache and fever; the next day, my legs would hardly move. I spent the following week in bed, only able to go to the bathroom with help. As I slowly recovered, my granduncle, concerned about me, came out to the farm to take me for daily walks in the woods—first one mile, then a mile and a half, and so on. I was fortunate; I made a full recovery. My family doctor assured my mother throughout that I did not have polio, which was a term dreaded as much as “cancer” at the time. I believed then that I had polio, and I certainly believe it now.

Polio, or poliomyelitis, is caused by the poliovirus and primarily affects the nervous system, resulting in a flaccid paralysis, most commonly of the legs. It occurs mainly in children, with a 5% mortality rate; if it affects an adult, mortality can be as high as 30%. The virus is limited to humans and generally is spread by the oral or fecal route. Polio paralysis is depicted in ancient Egyptian steles of 1402-1365 BC; however, major polio

GENERAL SURGERY NEWS / OCTOBER 2021

epidemics are relatively recent 20th-century phenomena. The 1940s and 1950s epidemics paralyzed or killed 500,000 people annually. Type 2 wild poliovirus was declared eradicated by the WHO in 2015, and type 3 wild poliovirus in 2019.

Type 1 wild poliovirus is still endemic in Pakistan and Afghanistan.

How has nearly worldwide control of polio been achieved? How have American summers become free of the dread of polio infections, death, lifetime crippling? Vaccination!

The first polio vaccine was developed

by Hilary Koprowski at the Lederle

Anti-vaxxers make a decision not only for themselves but for their neighbors, their fellow citizens, their families; they violate the underpinning of public safety and basic societal responsibility.

Ironically, they bring disease, hospitalization and death, most of all to their fellow antivaccination advocates.

Laboratories in 1950, based on a live attenuated virus. The inactivated poliovirus was developed by Jonas Salk at the University of Pittsburgh, in 1955. The injectable inactivated poliovirus (IPV) preparation required three doses to achieve 99% immunity. In 1961, Albert Sabin, at Cincinnati Children’s Hospital, developed the three-dose oral vaccine, with 95% immunity for all three polioviruses. The oral Sabin vaccine was selected for standard global use in developing countries. On rare occasions (one in 2.7 million), however, the virus multiplied in the gut and caused paralytic polio. Since

For complex hernia repair

INDICATIONS STRATTICE™ Reconstructive Tissue Matrix (RTM), STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are intended for use as soft tissue patches to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use of these products include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. STRATTICE™ RTM Laparoscopic is indicated for such uses in open or laparoscopic procedures. These products are supplied sterile and are intended for single patient one-time use only.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS These products should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20.

WARNINGS Do not resterilize. Discard all open and unused portions of these devices. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.

Do not reuse once the surgical mesh has been removed from the packaging and/or is in contact with a patient. This increases risk of patient-topatient contamination and subsequent infection.

For STRATTICE™ RTM Extra Thick, do not use if the temperature monitoring device does not display “OK.” PRECAUTIONS Discard these products if mishandling has caused possible damage or contamination, or the products are past their expiration date. Ensure these products are placed in a sterile basin and covered with room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place these products in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. These products should be hydrated and moist when the package is opened. If the surgical mesh is dry, do not use.

OPINION

OCTOBER 2021 / GENERAL SURGERY NEWS

2000, the United States returned to the IPV given in four separate doses. Vaccination against polio is mandatory for children entering public schools in all 50 of the United States, in addition to vaccination against diphtheria, pertussis, tetanus, influenza type B, measles, mumps, rubella and chickenpox.

The Future For essentially any combination of test variables for artificial intelligence computer modeling of community incidence of mortality or morbid events, based on known COVID-19 data, vaccination will

statistically significantly predict a favorable outcome. A simple example not requiring computer modeling is the calculation of probable events based on the percentage of the United States population having been vaccinated: There have been about 40 million COVID-19 cases reported in the United States, essentially all in unvaccinated people, with about 2.7 million (7%) hospitalized and about 632,000 (1.64%) dead. One adjusted data analysis for age, etc., predicts a 37-fold excess (29-fold unadjusted) in hospitalizations in unvaccinated patients versus vaccinated patients, and a 67-fold

adjusted (15-fold unadjusted) excess in deaths. About 50% of the U.S. population is fully vaccinated. If the other 50% were to be vaccinated, and if protection after the delta variant was 65%—not the original 95%—then using these adjusted statistics, only 14 million, instead of 40 million, cases would be reported in the future, with 73,000, instead of 2.7 million, hospitalizations, and less than 10,000, instead of 632,000, dead. That would still be tragic for those afflicted, but it would be a national triumph for public health.

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

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

91.7 7 YEARS %

†

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

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

For more information, contact your Allergan Aesthetics representative or visit hcp.StratticeTissueMatrix.com PRECAUTIONS (continued) Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation.

Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh. In large abdominal wall defect cases where midline fascial closure cannot be obtained, with or without separation of components techniques, utilization of the surgical mesh in a bridged fashion is associated with a higher risk of hernia recurrence than when used to reinforce fascial closure.

For STRATTICE™ RTM Perforated, if a tissue punch-out piece is visible, remove using aseptic technique before implantation.

For STRATTICE™ RTM Laparoscopic, refrain from using excessive force if inserting the mesh through the trocar.

STRATTICE™ RTM, STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are available by prescription only.

For more information, please see the Instructions for Use (IFU) for all STRATTICE™ RTM products available at www.allergan.com/StratticeIFU or call 1.800.678.1605.

To report an adverse reaction, please call Allergan at 1.800.367.5737.

For more information, please call Allergan Customer Service at 1.800.367.5737, or visit hcp.StratticeTissueMatrix.com.

References: 1. Connor J, McQuillan D, Sandor M, et al. Retention of structural and biochemical integrity in a biological mesh supports tissue remodeling in a primate abdominal wall model. Regen Med. 2009;4(2):185-195. 2. Sun WQ, Xu H, Sandor M, Lombardi J. Process-induced extracellular matrix alterations affect the mechanisms of soft tissue repair and integration. J Tissue Eng. 2013;4:2041731413505305. doi: 10.1177/2041731413505305. 3. Garvey PB, Giordano SA, Baumann DP, Liu J, Butler CE. Long-term outcomes after abdominal wall reconstruction with acellular dermal matrix. J Am Coll Surg. 2017;224(3):341-350.

STRATTICE™ and its design are trademarks of LifeCell Corporation Corporation, an AbbVie company company. © 2021 AbbVie. All rights reserved. STM147027 05/21

DON’T MESH AROUND

The Present Our time travel to the past and future must reach the conclusion that vaccination is rational, it is most successful when mandated, it is the best means to achieve herd immunity and it is the only hope for disease eradication.

Yet, so many people have opposed vaccination in the past and so many continue to do so in the present. In 1802, the British cartoonist James Gillray published a depiction of cowpox vaccination with cows emerging from different parts of young women’s bodies. In the 1800s, there were anti‒smallpox vaccination leagues in England and the United States. Today’s COVID-19 anti-vaxxers cite for justification of their opposition the infringement of personal liberty, religious beliefs, conspiracy theories of government microchip implantation, and political party motivations.

Whatever their stated reasoning, they are in opposition to the fundamental law and order necessary for a society to function. The basis of community law is to safeguard life and minimize risk for death or harm. Anti-vaxxers make a decision not only for themselves but for their neighbors, fellow citizens and families; they violate the underpinning of public safety and basic societal responsibility.

Ironically, they bring disease, hospitalization and death, most of all to their fellow anti-vaccination advocates.

Conclusion Yes, we can time travel. We can go to the past for its history, and to the future using algorithms, and alter the present.

We, as physicians and scientists, must lead the way to implement vaccination against COVID-19. Some people may be able to be persuaded by scientific data, some by logic, some by their religious belief that preservation of life is sacred, some by economics, some by ensuring the most rapid return to schools and other mass assemblies without masks and without fear, some by love of country, and some by self-preservation.

As health care advocates and providers, although frustrated and fatigued, we cannot give up trying to educate and to persuade. Hippocrates said it all: “Where the art of medicine is loved, there is also a love of humanity.”

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

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

23

OPINION

GENERAL SURGERY NEWS / OCTOBER 2021

Climate Change, Health and Surgery: A Call to Action

By AMY COLLINS, MD, AMANDA DILGER, MD, and NEELU TUMMALA, MD

C

limate change is one of the biggest global public health threats of the 21st century.1 Addressing global warming and mitigating its impact on health are essential to improving and protecting health worldwide.

The health care sector is on the front line of the climate crisis, with patients bearing the increasing burden of disease attributable to a changing climate, along with injuries, illnesses and displacement related to extreme weather events. The sector also has a significant climate footprint,2 responsible for 8.5% of U.S. greenhouse gas emissions and the loss of 388,000 disability-adjusted lifeyears in 2018.3 Recognizing this, health professionals are increasingly taking action to promote climate solutions, including climate-smart surgery, which is essential to protect public health and our future.4 The effects of climate change on surgical patients and the role of surgeons in advocating for climate change solutions have not been adequately addressed in the majority of surgical training programs or continuing medical education. For this reason, it is rare to see surgeons involved in sustainability efforts, despite having a trusted voice within the health care system. Surgeons have a critical role to play as leaders for sustainability solutions inside and outside of the OR through research, education and promoting climate-smart health care.

Table. Opportunities for Surgeons to Take Action Action

Opportunities

Education

Integrate education about the intersection of climate change, health and surgery throughout the medical education continuum, including in grand rounds, conferences and departmental talks.

Research

Perform health care emissions research including life cycle assessment.

Evaluate how climate affects the health of surgical patients and influences surgery outcomes.

Discuss research articles about the climate footprint of surgery in journal clubs.

Advocacy and public policy

Advocate for policies that advance climate solutions at local, state and national levels.

Engagement and leadership Connect with the physician sustainable health care community.

Ask your surgical society to issue a climate and health policy paper or position statement.

Start or join a surgical society climate and health interest group.

Ask your surgical society to join The Medical Society Consortium on Climate and Health Increasing awareness

Raise awareness about the intersection of climate, health and health care by writing letters to the editor and op-eds, providing interviews, writing blogs or other articles, by contributing to podcasts and highlighting issues on social media.

In the hospital

Start or join your hospital sustainability committee.

Ask your leadership to join Practice Greenhealth or the Health Care Climate Challenge

In the OR

Start or join your OR sustainability committee.

Work with supply chain and service line leads to eliminate unneeded items in OR kits, review preference cards and products for environmental considerations.

Request reusable medical devices (patient positioning devices, tourniquets, OR light handles, surgical gowns, drapes, towels, caps).

Use reprocessed medical devices.

Climate Change and the Health Of Surgical Patients Climate change contributes to worsening air quality, adverse impacts on food and water supply and quality, and extreme heat, all of which negatively affect health, especially for the most vulnerable populations—children, older adults, outdoor workers, people with preexisting medical conditions, those from low-income communities and people of color. Although there are few studies directly linking climate change to surgical outcomes, it is reasonable to postulate that the health consequences of climate change will increase the risk for perioperative complications based on existing data.

For example, higher temperatures have been found to correlate with higher surgical mortality, particularly in elderly patients,5 as well as increased rates of surgical site infections6 and traumatic injury including assault.7 In addition, rising levels of carbon dioxide are making staple crops, including rice and wheat, less nutritious— putting millions of people at risk for zinc and protein

Use alternative materials to single-use disposable plastic (upcycled bio-based content).

Suggested resources can be found in the online version at www.generalsurgerynews.com.

deficiency by 2050.8 These nutritional deficiencies can impede postoperative wound healing and contribute to periprocedural complications, such as venous ulcers.

Extreme Weather and Surgical Care

SEA R

G SIN S EAEVEL L

EME TR EX THER A

TEM R P

Extreme weather disasters, from droughts to severe storms to flooding, are increasing in frequency and severity. In 2020, the United States experienced a total of 22 unprecedented weather and climate disasters, including the historic wildfires along the West Coast, setting a new annual record.9 Overall, these events resulted in the deaths of 262 people and cost the nation a combined $95 billion in damages, according to the Office for Coastal Management. Such disasters can lead to mortality and morbidity from injuries and illness, and adversely impact the health of surgical patients and the ability to provide safe operative care. Dr. Brian Chesebro, an Oregon anesthesiologist, recalls significant perioperative challenges during the 2020 megaImpact of Climate Change on Human Health fires: “The hospitals’ air-handling systems Injuries, fatalities, Asthma, and our facilities’ staff were at their limit to mental health impacts cardiovascular disease manage the abysmal air quality, while clinical leaders were forced to consider which Air Severe Malaria, dengue, Pollution Weather patients were strong enough to commit to Heat-related illness encephalitis, hantavirus, and death, Rift Valley fever, surgical care, concerned that poor air qualcardiovascular failure Lyme disease, MO NG URES R Changes WE E ISI RAT ity could complicate healing and recovery.”

Extreme chikungunya, E in Vector Heat West Nile virus Ecology Extreme weather can affect surgical care in other ways. In October 2012, Superstorm Sandy caused a 14-foot storm surge EnvironIncreasing mental Allergens in New York City, resulting in power loss, Forced migration, Degradation Respiratory civil conflict, allergies, asthma flooding and the forced evacuation of 322 mental health impacts patients at NYU Langone Medical CenWater Water and Food Quality Impacts Supply Impacts ter.10 Afterward, due to infrastructure damCholera, age, surgery was suspended for two months Malnutrition, cryptosporidiosis, diarrheal disease and hundreds of providers sought privilegcampylobacter, leptospirosis, harmful algal blooms es at other hospitals. Temporary closure NG ELS ISI LEV

2

IN CO CR

24

Source: Centers for Disease Control and Prevention (bit.ly/3tqiZqS)

of other New York City hospitals and relocation of patients caused delays in scheduled surgeries.11 During the cold weather freeze in parts of Texas in February this year, hospitals canceled urgent and nonurgent surgeries12 because of heat and water issues related to the unexpected conditions. Health care leaders can protect against disruptions in health care delivery and improve the organization’s financial viability by preparing10 their facilities for climate impacts and building climatesmart, resilient hospitals.

The COVID-19 pandemic raised awareness of the vulnerabilities13 in the health care supply chain and the sector’s dependence on single-use disposables. Weather events can also disrupt health care supply chains, which can hinder surgical care. Puerto Rico is home to major pharmaceutical, medical device and supply manufacturing plants. After Hurricane Maria devastated the island in 2017, U.S. hospitals faced a shortage of normal saline IV bags, pharmaceuticals and surgical devices including hernia mesh, Medtronic surgical staplers, scalpels, Stryker orthopedic instruments and products used in cataract surgery.14 Lessons learned from the pandemic and weather events can help advance supply chain resiliency.

Climate-Smart Surgery Despite having a small physical footprint, ORs make an outsized contribution to a hospital’s climate footprint.

Surgery is very energy-, resource- and waste-intensive, requiring sterilization processes, lighting, cooling and ventilation. ORs consume three to six times more energy per square foot than anywhere else in the facility and generate 30% of a hospital’s overall waste, including twothirds of its regulated medical waste.15 The surgical supply chain is large and expensive, responsible for 40% to 60% of a hospital’s supply chain costs, with recent studies continued on page 26

26

OPINION

GENERAL SURGERY NEWS / OCTOBER 2021

Call to Action

safety or quality.17 Recognizing the a successful Greening the OR program opportunity to reduce the climate impact requires action from all members of the HVAC SETBACK continued from page 24 of surgical services and reduce costs, many surgical team, surgeons are key stake$2,500 LED SURGICAL ANESTHETIC finding that 71% to 82% of health care hospitals are taking action and “greenholders to involve.

LIGHTING GAS REDUCTION $2,593 $121 emissions are derived from the supply ing the OR.” Practice Greenhealth estiLife cycle assessment (LCA) is an chain.2,3 In addition, volatile anesthetic mates that hospitals implementing important tool to quantify health Hospitals that pursue these programs could see gases, particularly desflurane and nitrous programs such as single-use device care emissions and allow surgeons FLUID MEDICAL annual savings of MANAGEMENT DEVICE oxide, are potent greenhouse gases that reprocessing and reusable medical to make evidence-based device use SYSTEM REPROCESSING $20,060 per can be responsible for 51% of an OR’s products could see median annual and clinical decisions. As an exam$3,389 $6,206 operating room greenhouse gas emissions at an average savings of $20,06015 per OR. ple, a 2015 LCA study by Thiel U.S. hospital.16 While surgery’s immense Clinicians are concerned about the et al20 compared emissions associatREUSABLE environmental impact is often considered footprint of the OR, with surveys finding ed with four different surgical approachOR KIT STERILIZATION REFORMULATION CONTAINERS necessary to provide high-quality care, the majority of surgeons and OR nurses es—abdominal, vaginal, laparoscopic and $1,098 REUSABLE $1,742 studies have shown the impact can be feel that OR waste is excessive and more robotic—used for hysterectomy. They MEDICAL PRODUCTS reduced without compromising patient supplies should be reused.18,19 Although found that robotic hysterectomy produced $2,411 the most waste, and using environmentally preferable anesthesia and reducing anesthetic gas flow rate could reduce emissions associated with vaginal and abdominal hysterectomy by 65% to 95%. Single-use supplies accounted for the largest share of emissions and recycling did very little to offset these emissions, suggesting single-use items should be avoided or reused Digestive Disease & Surgery Institute presents… when possible. LCA, therefore, provides an understanding of the sources of health care emissions and interventions that can help reduce health care’s footprint.

The single largest factor driving health care pollution is clinical care.21 The choices that surgeons and anesthesiologists make—from device use to selection of an anesthetic agent to surgical approach— along with minimizing unnecessary surgeries, tests, interventions and medications can help reduce surgery’s impact.

All health professionals have a role to play in minimizing the most harmful effects of climate change and health care’s contribution to the climate crisis.

Vail Marriott Mountain Resort, Vail, Colorado As among the most trusted and respected health professionals, surgeons have many opportunities to leverage their influence and health expertise to advance climate ACTIVITY DIRECTOR COURSE DESCRIPTION solutions, including climate-smart surgery Michael Rosen, MD along with education and research about Technology for general surgery is constantly evolving. This course Professor of Surgery, the intersection of climate change, surgery will provide an interactive and comprehensive experience focusing Cleveland Clinic Lerner College of Medicine and the health of patients (Table).

■ on management and treatment options from a general surgical

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Director, Comprehensive Hernia Center Department of General Surgery Digestive Disease and Surgery Institute Cleveland Clinic, Cleveland, OH

EDUCATIONAL OBJECTIVES After completing this educational activity, the participant will be able to do the following: • Describe the management of common general surgery emergency cases • Describe the indications and contraindications for managing various cases of ventral and inguinal hernia repairs.

• Rationalize patient management and treatment options for patients with breast and skin disease.

• Discuss evidence-based and cost-effective diagnostic approach for patients with common benign and malignant colorectal cases.

• Review and provide update on current enhanced recovery protocols.

perspective.

The goal of the Cleveland Clinic presents Updates in General Surgery is to provide an atmosphere to foster collaboration, innovation and sharing a cost-effective diagnostic approach for patients with complex general surgery cases involving hernia, colorectal and trauma surgery. Surgical oncology topics will also be discussed, along with a variety of topics affecting the rural/ community surgeon.

We will cover what is new in enhanced recovery protocols and offer interactive sessions consisting of cases and questions and answers. American Board of Surgery (ABS) Maintenance of &HUWLÀFDWLRQ 02& VHOI DVVHVVPHQW FUHGLWV ZLOO EH RIIHUHG Great refresher course for ABSITE training exam.

TARGET AUDIENCE This interactive, comprehensive event is designed for general surgeons, fellows, residents and other medical professionals.

EARLY REGISTRATION encouraged. Register online at ccfcme.org/UpdateGENSUR

References can be found in the online version at www.generalsurgerynews.com.

—Dr. Collins is an emergency medicine physician and a senior clinical advisor for physician engagement at Health Care Without Harm, in Boston. Dr. Dilger is a facial plastic and reconstructive surgeon at Massachusetts Eye and Ear Infirmary, in Harwich, and an instructor of otolaryngology–head and neck surgery at Harvard Medical School, in Boston. Dr. Tummala is an ENT physician and clinical assistant professor of surgery at the George Washington University School of Medicine and Health Sciences, Washington D.C. Editor’s note: Opinions in General Surgery News belong to the author(s) and do not necessarily reflect those of the publication.

IN THE NEWS

OCTOBER 2021 / GENERAL SURGERY NEWS

Disability Insurance: What Surgeons Need to Know continued from page 1

“Physicians can lose millions of dollars over their careers if they become disabled and can no longer practice in their chosen specialty,” he told General Surgery News.

Mr. Kaplan estimates that roughly 70% to 80% of physicians likely have some type of disability insurance— either through their employer, professional society or an individual plan—and although most doctors who buy a policy never expect to use it, the likelihood of filing a claim for more than 90 days is 30% or higher for workers in their 30s.

In 1990, Mr. Kaplan started his own accounting firm, Kaplan Financial, to help physicians plan for their financial future.

“Over the years, I’ve seen doctors make hundreds of claims, and, in my experience, surgeons are even more likely to become disabled and file claims,” he said.

But wading through the complexities of disability insurance can be a headache.

Policies typically include confusing language and a maze of loopholes and addon features. Before purchasing a policy, Mr. Kaplan recommends seeking guidance from an independent professional, someone with no ties to a specific insurance carrier who can help surgeons navigate this landscape.

Here, Mr. Kaplan highlights what surgeons should consider when purchasing disability insurance to maximize their benefits.

remain predictable over time, whereas those for group policies—which are age banded—get more expensive every five years.

2. Contract benefits. One safeguard all individual policy contracts must include, according to Mr. Kaplan, is language stating that the policy is “noncancelable and guaranteed renewable.” That means an insurance company cannot modify the contract language, cancel the policy

or raise premiums before 65 years of age.

Group plans, on the other hand, can modify language, raise premiums or cancel policies for a class of physicians, or even for an entire group with a 30-day notice.

3. Defining disability. Another musthave for an individual policy, Mr. Kaplan noted, is a “true own-occupation” definition of total disability. This definition is particularly important for surgeons who

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A Strategy for Picking Your Plan Although surgeons will have minimal bandwidth to shop for disability insurance during residency, Mr. Kaplan recommends getting a jump on locking down a policy.

“The sooner a surgeon purchases a policy, the lower the rates will be,” he said.

Surgeons can typically choose from two types of plans: individual and group.

In almost all circumstances, Mr. Kaplan recommends an individual plan over a group one. Individual policies are more expensive initially, but they also come with a host of advantages and safeguards that group plans—often provided by an employer or medical association—lack.

“Overall, when someone is insured by a group policy, that person is considered a certificant and not a policyowner,” Mr. Kaplan said. “The owner decides what happens to the policy, if and when changes are to be made, while a certificant is only entitled to receive benefits.”

Here are four key reasons surgeons should opt for individual as opposed to group plans.

1. Stable plan premiums. Premiums for individual plans are guaranteed and

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are often more procedure based than other specialties. Mr. Kaplan advises including the wording “if you have limited your occupation to the performance of the material and substantial duties of a single medical specialty, we will deem your specialty to be your occupation.”

4. The payout. Individual policies will pay surgeons up to their monthly salary, whereas a group plan will only continued on page 30

27

28

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Board certification is required or board eligible status for newly or recently trained physicians who will eventually become certified. You must eligible for licensure in the Commonwealth of Massachusetts. LHMC, an American College of Surgeons Level I Trauma Center, is a member of the Boston Medflight helicopter consortium and receives undesignated trauma transfers with the other Level I trauma programs in the Boston area.

This highly desirable area offers superb educational opportunities and an abundance of cultural, social, and recreational amenities making it a truly wonderful location in which to practice and live.

Interested candidates should forward CV and cover letter to David Brams, Chair, General Surgery, david.m.brams@lahey.org and to Kathryn Schnabel, Sr. Physician Recruiter, at kathryn.a.schnabel@lahey.org.

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30

IN THE NEWS

GENERAL SURGERY NEWS / OCTOBER 2021

The Scientific Greats: A Series of Drawings

By MOISES MENENDEZ, MD, FACS

Daniel Hale Williams, MD (1856-1931) Daniel Hale Williams, MD, was a Black general surgeon, who in 1893 performed a documented, successful open-heart surgery in the United States to repair a stab wound. He is considered the most prominent Black surgeon at the turn of the 20th century.

On July 10, 1893, Dr. Williams repaired the torn pericardium of a knife wound patient, James Cornish. Cornish had been “stabbed directly through the left fifth costal cartilage, injuring the internal mammary vessels, and wounding the pericardium and heart,” according to his operative report, and had been admitted the previous night. Dr. Williams decided to operate the next morning in response to continued bleeding, cough and shock. During the surgery, after opening the left chest, he found a damaged left internal mammary artery and sutured it. A laceration in the pericardium was found and he sutured that. He undertook a second procedure to drain fluid from the chest. About 50 days after the initial procedure, Cornish left the hospital. He survived many years thereafter.

The case was not reported until 1897. Dr. Williams revealed the reasons why this case was not reported earlier. At that time, people were not accustomed to seeing Black doctors, let alone Black surgeons. Black physicians dealt with distrust and misperceptions for more than a century, and very few Blacks were trained physicians or surgeons, and medical education was not open to people of color in the United States. Those seeking medical careers as physicians most often received their education in Canada or Europe, and a few from medical schools in the North.

After completing high school at age 20, Dr. Williams became an apprentice to a former surgeon general for Wisconsin. Dr. Williams studied medicine at Chicago Medical College. He began his studies of medicine

Insurance continued from page 27

provide a percentage of that income.

For instance, surgeons earning $10,000 per month after taxes will receive the full $10,000 per month on an individual plan, whereas surgeons on a group plan may collect half their monthly take-home income.

One caveat, Mr. Kaplan explained, is that certain preexisting conditions— including arthritis, cancer, depression—may make people ineligible for individual coverage. In that instance, he recommends surgeons purchase a group plan because, although “group coverage typically contains caveats, having some coverage is better than no coverage at all.”

The order in which surgeons purchase a plan also matters. “Starting with a group plan limits the individual coverage you can purchase later because it can be difficult to opt out, and insurance companies will not want to overinsure you,” Mr. Kaplan said.

as an apprentice under Dr. Henry Palmer, a prominent surgeon. Dr. Palmer had three apprentices, and all were accepted in 1880 into a three-year program at the Chicago Medical School, which was affiliated with Northwestern University. It was considered one of the best medical schools in the country. Dr. Williams graduated with an MD degree in 1883.

After his internship, he went into private practice in an integrated neighborhood on the South Side of Chicago. He soon began teaching anatomy at Chicago Medical College and served as a surgeon to the City Railway Co. In 1889, the governor of Illinois appointed him to the state’s board of health. In 1890, Reverend Louis Reynolds, whose sister Emma was refused admission to nursing schools because she was Black, approached Dr. Williams for help. This led to the founding of the Provident Hospital and Training School for Nurses in 1891.

After months of hard work, he opened Provident Hospital and Training School for Nurses on May 4, 1891, the country’s first interracial hospital and nursing school.

In 1894, Dr. Williams became chief surgeon of Freedmen’s Hospital in Washington, D.C., the most prestigious medical post available to Black physicians at that time. There, he made improvements that reduced the hospital’s mortality rate. In 1895, he helped to organize the National Medical Association for Black professionals, who were barred from the American Medical Association. Dr. Williams returned to Chicago and continued work as a surgeon. In 1913, he became the first Black surgeon to be inducted into the American ■ College of Surgeons.

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

3 Tips for Optimizing Your Policy Disability insurance is typically sold with a handful of optional features known as riders, each of which provides additional benefits but comes with additional costs.

‘Starting with a group plan limits the individual coverage you can purchase later because it can be difficult to opt out, and insurance companies will not want to overinsure you.’

—Robert Kaplan, CPA Clients always ask Mr. Kaplan: Should I spend money on this rider or not?

Instead of tacking on more and more features, Mr. Kaplan advises clients focus on a few more essential riders and otherwise opt for a plan with a larger base benefit.

“There are tons of riders out there, and adding certain bells and whistles—student

Daniel Hale Williams (1856-1931) Work was done on a toned paper, 11x14, using charcoal pencil and white chalk. 2021.

Artist: Moises Menendez, MD, FACS

Sources Box L, McDuffie TE. Daniel Hale Williams: (1865-1931).

Science Activities. 1982;19(2):16-17.

Cobb WM. Daniel Hale Williams—Pioneer and Innovator.

J Natl Med Assoc. 1944;36(5):158-159.

Jefferson AJ, McKenzie TS. Daniel Hale Williams, MD: “A Moses in the profession.” American College of Surgeons Clinical Congress poster competition; 2017:25-33. Accessed September 20, 2021. https://www.facs.org/~/media/files/ archives/shg%20poster/2017/04_daniel_hale_williams.ashx

loan, retirement and catastrophic disability riders, in particular—can be expensive and unnecessary,” Mr. Kaplan said.

These are three must-have riders: 1. Partial/residual disability. According to Mr. Kaplan, this rider may be the most important feature to include in a disability insurance policy. If a surgeon becomes partially disabled— for instance, they can only operate four hours each day, four days per week— they could lose a lucrative part of their practice. Without this rider, they would only be eligible for benefits if they are completely disabled and cannot operate.

“The partial rider provides a sliding scale of benefits and often includes a recovery benefit, if a surgeon is no longer disabled but still experiences a loss of income from complications due to pregnancy or a strained wrist from surgery,” Mr. Kaplan said.

2. Inflation rider. This rider indexes a physician’s benefits to inflation—an

estimated 3% increase in benefits compounded annually.

“I recommend this rider for anyone buying a policy in their 20s to 40s,” Mr. Kaplan said. “After that, you can probably skip this rider because the policy is only going to increase the value of your benefits until you are 65.”

3. Future purchase option rider. This rider allows surgeons to buy more coverage as their income increases based on their original health status at the time of purchase. Young surgeons making $200,000, for instance, can only buy so much insurance, but as their income increases over the years, they can add to their coverage, regardless of changes in their health as they age.

“This option allows you to buy a larger benefit at a later date without any potentially disqualifying questions about your health or hobbies,” Mr. Kaplan said. “If you are a resident and cannot yet afford as much disability insurance as you may want or need, I recommend adding this rider.”

■

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1. Gagner M, Kemmeter P. Comparison of laparoscopic sleeve gastrectomy leak rates in five staple-line reinforcement options: a systematic review. Surgical Endoscopy 2020;34(1):396-407.

2. Nguyen NT, Longoria M, Welbourne S, Sabio A, Wilson SE. Glycolide copolymer staple-line reinforcement reduces staple site bleeding during laparoscopic gastric bypass. A prospective randomized trial.

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