General Surgery News : May 2021

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GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

May 2021 • Volume 48 • Number 5

New Antireflux Technique Combines Laparoscopic, Transoral Approaches

By CHRISTINA FRANGOU

A

surgeon and gastroenterologist team from the University of California, Irvine, has developed a new approach for the treatment of antireflux disease.

The procedure, concomitant transoral incisionless fundoplication (cTIF), pairs a laparoscopic hiatal hernia repair with TIF in a single session.

For the fundoplication, physicians endoscopically create a modified surgical antireflux valve, called an omega valve. The valve can be adapted for laparoscopic fundoplication or cTIF. Investigators believe the omega valve forms a durable barrier for reflux, with fewer symptoms than those associated with a traditional Nissen fundoplication.

Investigators hope cTIF and omega fundoplication will lead to better repairs and open the door to endoscopic and surgical treatment for more patients suffering from GERD and hiatal hernias.

Endoscopic view of newly constructed 3-cm omega-shaped valve.

MONEY MATTERS

No Surprises Act Passes, Targeting Unexpected Bills Effect on Private Practice Unknown

By VICTORIA STERN

I

n December 2020, after years of heated debate and mounting anxiety from patients, Congress passed legislation to ban surprise medical bills.

The No Surprises Act provides sweeping protections for patients from these unexpected charges, which reportedly accompany 20% to 44% of elective surgeries or hospital visits, and can range from a few hundred dollars to more than $100,000 (JAMA Intern Med 2019;179[11]:15431550; JAMA 2020;323[6]:538-547).

Continued on page 14

Video Peer Review Offers Objective Rating Of Surgical Technique

Continued on page 20

Deaths After Complex GI Cancer Surgery Lower at ‘Top Hospitals’

Wide Variation Seen for Sleeve Gastrectomy

RESIDENT CORNER

Neverisms, Alwaysisms And the Dangers of Absolutisms in Surgery

By CHRISTINA FRANGOU

By ETHAN COVEY

By BARRET HALGAS, MD

T

he technique a surgeon uses while operating can vary greatly, even among trained practitioners, leading to extensive differences in patient outcomes, according to a new study.

Conducting a peer review of surgical video may be a valuable way to evaluate surgical technique, allowing for targeted education, coaching and quality improvement (JAMA Surg 2021;156[2]:e205532).

“In many years of research on surgical outcomes, we’ve focused on all sorts of factors, such as hospital size, surgeon volume and surgical approach that are related to

P

atients who underwent complex gastrointestinal surgery for cancer at institutions listed in the U.S. News & World Report annual ranking of top hospitals were less likely to die from complications than patients treated at nonranked hospitals, according to a study published this month in the Journal of the American College of Surgeons (2021 Mar 18. doi:10.1016/j.jamcollsurg.2021.02.012).

Overall, top-ranked hospitals had lower in-hospital mortality, at a rate of 1% versus 2.26% at nonranked hospitals.

The study’s findings are in contrast to those

Continued on page 18

F IRST LOOK

4 Updates From the Society of Surgical Oncology IN THE NEWS

8 Woman Contracts COVID-19 From Lung Transplant NE W TECHNOLOG Y

15 Update on the Skin Patch That Measures GI Activity .

facebook.com/generalsurgerynews

@gensurgnews

Continued on page 16

“I

’m just a product of my training.”

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OPINION

MAY 2021 / GENERAL SURGERY NEWS

Celebrating May

By FREDERICK L. GREENE, MD

W

e have a tradition in our country of dedicating specific days, weeks or months during which we celebrate events, concepts, organizations, groups of professionals or any other entity that warrants highlighting and reverence. Certainly, the month of May is no different. In May we celebrate National Nurses Week, National EMS Week, National Hospital Week, National Nursing Home Week and Arthritis Awareness Month. Obviously, many of these days remind and encourage us to recognize those with whom we work in our hospitals, organizational settings and in our daily professional lives. But May also includes a very special recognition: We honor and thank Mom for everything that she has done for us.

In 1912, Anna Jarvis, born in the 1860s in West Virginia, trademarked the term “Mother’s Day” and recommended that the second Sunday in May be a time to remember mothers throughout the United States. Anna Jarvis, who began her campaign to create Mother’s Day after her own mother died, attained her dream in 1914 when former President Woodrow Wilson signed the law officially creating Mother’s Day as a countrywide celebration. It is noteworthy that the singular possessive form of the phrase Mother’s Day was utilized with a specific intent that each individual should honor his or her own mother.

Yes, Mother’s Day has always been so special for me,

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

especially since I lost my mother almost 12 years ago. In 2021, however, we remember all the moms who sadly left us during the pandemic, and many reflect on all the months of quarantine that prevented us from seeing moms, grandmothers and even greatgrandmothers. For those of you who still have your mom, it is my hope that you utilize every opportunity to say “thanks” to her for being there.

For those of you who may be estranged from your mom, perhaps it is time to begin a new relationship. For those, like me, we must stop to reflect on Mother’s Day and be thankful for the times that we had together. All of us need to remember how our moms influenced not only our very being but also our approach to our profession, our patients and to those special relationships we have forged throughout our lives. Perhaps Mother’s Day should be more than a daylong event and celebrated more than once a year.

In addition, each May brings the promise of growth and renewal. The beauty of spring has progressed to 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

Editorial Advisory Board

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

Timothy Lepore, MD Nantucket, MA

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

Robert Lim, MD Tulsa, OK

James Forrest Calland, MD Charlottesville, VA

John Maa, MD San Francisco, CA

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As we reflect on this month, let us also remember the most important and meaningful events and people in our lives. warmth throughout most of our country, except in some Northern climes where snow flurries and cold winds still remind some that global warming may not have become reality! This May will also usher in the excitement, once again, of in-person graduations and the realization for students at all educational levels that in-classroom schooling is an opportunity that should not be taken lightly. For sports enthusiasts, the hoopla of the Final Four has faded, another Masters champion has already been crowned, Major League Baseball has returned, and football with fans is beginning to be a topic of conversation. As we reflect on this month, let us also remember the most important and meaningful events and people in our lives. Yes, the month of May allows us to do all of that.

■ —Dr. Greene is a surgeon in Charlotte, N.C.

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IN THE NEWS

GENERAL SURGERY NEWS / MAY 2021

First Look: The Society of Surgical Oncology International Conference All articles by KATE O’ROURKE

Nivolumab Shows Promise for Resected Esophageal, GE Junction Cancers

Medicaid Expansion Associated With Earlier Diagnosis of Gastric Cancer

DCIS Biological Risk Signature Predicts Recurrence, Radiation Benefit

Adjuvant nivolumab is the first therapy to provide a statistically significant and clinically meaningful improvement in disease-free survival in patients with resected esophageal and gastroesophageal junction cancer. This news comes from research presented at the Society of Surgical Oncology 2021 International Conference on Surgical Cancer Care (abstract 94).

“The risk of recurrence after neoadjuvant chemoradiation therapy followed by surgery (trimodality therapy) remains high in esophageal or gastroesophageal junction cancer and there is no established adjuvant treatment,” said Guillaume Piessen, MD, PhD, of the University of Lille, Claude Huriez University Hospital, in Lille, France, who presented the findings. Nivolumab (Opdivo, Bristol Myers Squibb) offers a new standard of care in these patients, Dr. Piessen said.

The findings come from the CheckMate 577 trial, which is the first global, phase 3, randomized, doubleblind study to report the efficacy and safety of a checkpoint inhibitor in the adjuvant setting after trimodality therapy for esophageal or gastroesophageal junction cancer (N Engl J Med 2021;384:1191-1203).

The trial enrolled 794 adults, of whom 532 received nivolumab and 262 were given placebo. Patients who had resected stage II/III esophageal/gastroesophageal junction cancer and received neoadjuvant chemoradiation therapy and had residual pathologic disease were randomized 2:1 to nivolumab 240 mg or placebo every two weeks for 16 weeks, followed by nivolumab 480 mg or placebo every four weeks. Maximum treatment duration was one year. The primary end point was diseasefree survival.

Approximately 70% of patients had adenocarcinoma and almost 60% had a pathologic lymph node status of ypN1 or higher in both groups. Patients receiving nivolumab were predominantly male (84%) and white (81%), with an Eastern Cooperative Oncology Group (or ECOG) performance status of 0 (58%). They also had predominantly stage III disease (66%) and received a diagnosis of adenocarcinoma (71%). The median age was 62 years.

At a prespecified interim analysis, adjuvant nivolumab was significantly associated with improvement in DFS versus placebo (hazard ratio, 0.69; 96.4% CI, 0.560.86; P=0.0003). Median disease-free survival was doubled. Most treatment-related adverse events were grade 1 or 2. The incidence of serious adverse reactions leading to discontinuation was 9% or lower with nivolumab and 3% with placebo. The majority of treatment-related adverse events with an immunologic etiology were low grade, with grade 3/4 events occurring in fewer than 1% of patients in the nivolumab group.

Based on the promising data from the trial, the FDA accepted the supplemental Biologics License Application for nivolumab for the treatment of patients with resected esophageal/gastroesophageal junction cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy.

The agency also granted the application priority review.

According to research presented at the Society of Surgical Oncology 2021 International Conference on Surgical Cancer Care, Medicaid expansion caused a decrease in uninsured patients and led to an earlier diagnosis of gastric cancer with an associated increase in oneyear survival (abstract 95).

“Increased health care access may be associated with a shift toward earlier diagnosis with improved outcomes in gastric cancer,” said study author Clara Zhu, MD, of Cooper University Health Care in Camden, N.J., who presented the findings.

According to Dr. Zhu, the 2014 Medicaid expansion was intended to improve patient access to care. Some states elected to expand Medicaid, while others opted not to expand the program. Dr. Zhu and her colleagues hypothesized that Medicaid expansion was associated with earlier diagnosis and improved outcomes in gastric cancer.

To find out, Dr. Zhu’s research team turned to the National Cancer Database to identify patients with a new primary diagnosis of gastric cancer between 2006 and 2016. The researchers compared states that expanded Medicaid in 2014 to those that did not, excluding states that expanded earlier or later than 2014 and patients older than 64 years. Her research compared the pre- and post-expansion intervals 2012-2013 and 2015-2016.

The study cohort included 20,639 patients.

Expansion states demonstrated a significant reduction in uninsured patients from 7.0% to 2.7% (P<0.01) compared with non-expansion states (14.2%-10.9%; P=not significant [NS]).

The researchers identified an increase in patients diagnosed with stage 0 to II gastric cancer from 38% to 41.5% (P<0.01) in expansion states, but found no change at 38.9% in nonexpansion states. Patients 50 years of age and older diagnosed with stage 0 to II gastric cancer increased in expansion states from 38.2% to 42.5% (P<0.01), and in non-expansion states from 39.3% to 39.9% (P=NS). Uninsured and Medicaid patients diagnosed with stage 0 to II gastric cancer increased in expansion states from 32.4% to 37.8% (P=0.01), and decreased in nonexpansion states from 29.7% to 27.3% (P=NS).

Patients receiving treatment rose from 91.6% to 92.2% in expansion states (P=0.01) and from 89.6% to 89.7 (P=NS) in non-expansion states.

Rates of treatment for uninsured and Medicaid patients rose in 87.0% to 90.3% in expansion states (P=0.01) and from 83.9% to 84.9% in nonexpansion states (P=NS). Twelve-month survival for patients in expansion states rose from 68.1% to 70.6% (P=0.03), but decreased from 65.2% to 65.1% (P=NS) in non-expansion states.

Women with ductal carcinoma in situ and elevated commercial DCISion scores (DS) had a significantly higher risk for ipsilateral breast events and a greater relative benefit from radiation therapy than women with lower scores. These findings come from research recently presented at the Society of Surgical Oncology 2021 International Conference on Surgical Cancer Care (abstract 5).

Radiation therapy after breast-conserving surgery for DCIS is known to reduce the risk for ipsilateral breast events without altering survival, but its use varies widely due to differing assessments of the risk–benefit ratio.

Precise assessment of postsurgical radiation therapy benefit would allow individualized treatment decisions.

In the new study, Bruce Mann, MBBS, PhD, FRACS, of Royal Melbourne Hospital, in Victoria, Australia, and his colleagues conducted a validation of a commercially available biological risk signature, DCISionRT (PreludeDx), to assess ipsilateral breast events risk after breast-conserving surgery and the benefit of radiation therapy.

Using a retrospective Australian cohort, Dr. Mann identified 183 women with DCIS who met eligibility criteria. Medical records were reviewed to collect data on treatment and outcomes, and tissue specimens were provided to the PreludeDx CLIA lab for blinded testing of a panel of biomarkers (HER2, PR, Ki-67, COX2, p16/INK4, FOXA1 and SIAH2) scored by board-certified pathologists, and determination of the patented DS. The researchers used a multivariate Cox proportional hazards analysis to assess the prognostic effect of DS for ipsilateral breast events risk. They adjusted for adjuvant treatments. The predictive effect of DS for radiation therapy benefit on ipsilateral breast events was assessed by the multivariate analysis, including the radiation therapy‒DS interaction.

Of the 183 women in the study, 72 received radiation therapy and 66 received endocrine therapy. The total cohort had a five-year ipsilateral breast events risk of 10%. By treatment group, women given radiation therapy had a 4% risk and those treated without radiation therapy had a 14% risk. Among patients treated without radiation therapy, those with a low DS had a 7% rate of ipsilateral events, while those with elevated DS had a 23% rate.

After breast-conserving surgery without endocrine therapy, patients with low DS had a nonsignificant difference of 2% with and without radiation therapy, while those with elevated DS had a highly significant 27% difference, indicating tumor radiation sensitivity.

Findings were similar when all patients were included—2% and 20% absolute differences with radiation therapy.

“This validation in a contemporary cohort supports previous findings that DCISionRT provides prognostic and predictive information to allow personalized ■ treatment decisions,” Dr. Mann said.

Dr. Piessen reported no relevant financial disclosures.

Dr. Zhu reported no relevant financial disclosures.

Dr. Mann reported no relevant financial disclosures.

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BULLETIN BOARD

GENERAL SURGERY NEWS / MAY 2021

GSN Welcomes New Board Member, Melissa Red Hoffman, MD

Public Perceptions on Resident Participation

Melissa Red Hoffman, MD, NP, FACS initially trained and worked as a naturopathic physician and yoga teacher. She then attended medical school at Oregon Health & Science University, in Portland; completed a residency in general surgery at Maricopa Medical Center, in Phoenix; and completed a fellowship in surgical critical care at the University of North Carolina at Chapel Hill, and a second fellowship in hospice and palliative medicine through Mountain Area Health and Education Center, in Asheville, N.C. She now practices as an acute care surgeon at Mission Hospital and as an inpatient hospice physician at the John C. Keever Solace Center, both in Asheville.

Dr. Hoffman is an adjunct assistant professor in the Department of Surgery at UNC and serves as the surgery clerkship director for UNC School of Medicine Asheville campus. Her clinical interests are in surgical palliative care, the care of surgical patients with substance use disorder and medical education. She is the founder and host of The Surgical Palliative Care Podcast, and has been a guest on multiple podcasts, including Behind the Knife, the GeriPal Podcast and the EAST Traumacast, discussing the integration of palliative medicine into the care of surgical patients.

Dr. Hoffman authors a bimonthly column in General Surgery News, The Surgical Pause, which focuses on surgical palliative care, and her writing has also appeared in JAMA, KevinMD and Doximity. She is happy to chat with or mentor anyone who is interested in palliative care. You can learn more about her on her website www.redhoffmanmd.com and follow her on Twitter @redMDND and @surgpallcare.

To the Editor: [Re: “Public Perceptions,” March 2021, page 3] I very much enjoyed this most important and insightful editorial by Dr. Frederick Greene on the perceptions of the American public concerning resident participation in surgical care. The well-described wide spectrum of tolerance of trainee participation by patients in their surgical care is an age-old issue, but deserves fresh discussion, particularly in light of the new paradigms in surgical training.

Academic training programs have the immense responsibility of producing a competent, safe and dedicated workforce needed to meet the varied and complex needs of our surgical patients. Over the past few decades, socioeconomic, regulatory and generational pressures have made this task increasingly difficult, mainly through reductions in resident operative experience and autonomy. Surgery, not unlike many other professions, such as airline piloting, is a physical discipline that requires repetitive practice, graded responsibility and autonomy to reach the desired goal of competency. Although the current sophistication of simulators and like teaching aides are helpful, there is absolutely no substitute for real operative experience to gain the skills and judgment needed to safely practice this most complex and demanding art. Any further limitations or reductions of this most critical part of training will significantly limit overall competency and the safe delivery of surgical care to our patients.

I have had the immense privilege of working in both private and academic practice, and have participated in residency operative training at all levels of surgical sophistication. Assuming adequate supervision and a procedure tailored to the level of the resident’s skill, I have found that resident participation is safe, and in no way reduces the quality of the conduct of the procedure. Quite honestly, residents often enhance the quality of the experience with their elevated academic thoughts, questions and perspectives. Furthermore, I am aware of no serious study that has found an increase in complications or diminutive outcome rate with resident participation in surgery.

Therefore, I firmly believe that resident participation in surgery is safe, that it frequently elevates the quality of care, and that it is an essential societal requirement for the production of competent surgeons and the future quality of surgical care for all our patients. I agree with Dr. Greene that our profession needs to undertake a vigorous campaign to educate the populous as to the importance, safety and benefits of resident surgical participation in academic surgical training.

James K. Elsey, MD, FACS Professor of Surgery, Medical University of South Carolina, Charleston

LE T T E R TO THE EDITOR

The Scientific Greats: A Series of Drawings

By MOISES MENENDEZ, MD, FACS

William Thomas Green Morton (1819-1868) William Thomas Morton was an American dentist who first publicly demonstrated the use of inhaled ether as a surgical anesthetic in 1846. The promotion of his questionable claim to have been the discoverer of anesthesia became an obsession for the rest of his life. Of all milestones and achievements in medicine, conquering pain must be one of the very few that has potentially affected every human being in the world. It was in 1846 when one of mankind’s greatest fears, the pain of surgery, was eliminated.

In the autumn of 1844, Dr. Morton entered Harvard Medical School and attended the chemistry lectures of Charles T. Jackson, who introduced Dr. Morton to the anesthetic properties of ether. Dr. Morton then left Harvard without graduating. On Sept. 30, 1846, he performed a painless tooth extraction after administering ether to a patient. Upon reading a favorable newspaper account of this event, Boston surgeon Henry Jacob Bigelow arranged for a now-famous demonstration of ether on Oct. 16, 1846, in the OR of Massachusetts General Hospital (MGH). At this demonstration, John Collins Warren painlessly removed a tumor from the neck of Edward Gilbert Abbott.

News of this use of ether spread rapidly around the world, and the first recorded use of ether outside the United Sates took place in London, by dentist James Robinson in a tooth extraction at the home of Francis Boote, an American doctor who had heard of Drs.

Morton’s and Bigelow’s demonstrations. The MGH OR became known as the Ether Dome, and has been preserved as a monument to this historic event. Following the demonstration, Dr. Morton tried to hide the identity of the substance Mr. Abbott had inhaled, by referring to it as “Letheon,” but it soon was found to be ether.

Dr. Morton had single-handedly proven to the world that ether is a gas that, when inhaled in the proper dose, provided safe and effective anesthesia.

Dr. Morton was in New York City in July 1868. He was riding in a carriage with his wife when he suddenly demanded the carriage to stop, and he ran into the lake in Central Park “to cool off.” This peculiar behavior was attributed to a major stroke (cerebrovascular accident) that he had suffered, which proved fatal soon after.

Dr. Morton was taken to nearby St. Luke’s Hospital. It is reported by his wife that upon recognizing Dr. Morton, the chief surgeon made the following remark to his students: “Young gentlemen, you see lying before you a man who has done more for humanity and for the relief of suffering than any man who has ever lived.”

Sources Fitzharris L. The Butchering Art: Joseph Lister’s Quest to Transform the Grisly World of Victorian Medicine. Farrar, Straus and Grious; 2018:1-304.

Hollingham R. Blood and Guts: A History of Surgery. St. Martin’s Press; 2009:11, 62.

Robinson DH, Toledo AH. Historical development of modern anesthesia. J Invest Surg. 2012;25(3):141-149.

William T.G. Morton. https://en.wikipedia.org/wiki/ William_T._G._Morton

William Thomas Green Morton (1819-1868) Work was done on a Canford gray paper, 11×15, using panpastel, charcoal pencils and white chalks.

Artist: Moises Menendez, MD, FACS

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

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IN THE NEWS

GENERAL SURGERY NEWS / MAY 2021

Woman Contracts COVID-19 From Lung Transplant

By CHRISTINA FRANGOU

A

woman contracted COVID-19 and died 61 days after receiving a double lung transplant from a donor who harbored the SARS-CoV-2 virus, according to a case report published in the American Journal of Transplantation (2021 Feb 10. doi.org/10.1111/ajt.16532).

This is the only confirmed case of COVID-19 transmitted via organ transplant, according to the authors.

A thoracic surgeon who handled the donor lungs and performed the transplant surgery also was infected with the virus, but later recovered.

The donor, a woman who died from a severe brain injury from a car accident, had a negative result on a nasal swab test prior to transplant. Her family said she had no known symptoms of COVID-19 and there was no radiological evidence of infection.

However, three days after the transplant surgery, the recipient developed a fever and hypotension. She struggled to breathe and developed septic shock with cardiomyopathy. A CT scan showed signs of infection.

As the patient’s condition deteriorated, she was tested again for SARS-CoV-2.

Her polymerase chain reaction test came back negative but fluid samples via bronchoalveolar lavage (BAL) were positive.

Concerned about the source of infection, doctors tested BAL fluid obtained from the donor during procurement. This test came back positive for SARS-CoV-2.

The thoracic surgeon tested positive for the virus four days after transplantation. He had prepared the lungs and performed the surgery.

Genetic sequencing confirmed that the recipient and the surgeon acquired SARS-CoV-2 from the donor lungs. Ten other members of the health care team tested negative.

The patient was given remdesivir, convalescent plasma and steroids, but did not recover.

In their report, physicians from the University of Michigan called for more thorough testing of lower respiratory tract specimens of potential lung transplant donors, especially in areas with high SARS-CoV-2 transmission in the community.

“BAL testing should be standard for potential lung transplant donors since asymptomatic patients may have positive BAL testing and negative NP [nasopharyngeal] swabs, and poor recipient outcomes may occur,” said Daniel Kaul, MD, a professor of internal medicine and the director of the transplant infectious disease service at the University of Michigan, in Ann Arbor.

Other centers have reported

near-misses, in which potential donors had negative nasal swab tests but infections were discovered through tests of the lower respiratory tract, he said.

Dr. Kaul advised that surgical teams wear full personal protective equipment for aerosol-generating procedures done during COVID-19. This would include N95 masks and eyeglasses even if patients have tested negative.

In February, the Organ Procurement and Transplantation Network released

an update on donor evaluation and testing based on new evidence on SARSCoV-2. It noted that SARS-CoV-2 testing by nucleic acid test in a lower respiratory sample likely decreases the risk for unrecognized infection in lungs being recovered for transplantation.

SARS-CoV-2 antibody testing has insufficient evidence to support its use for clinical evaluation of donors at this time, the network found.

Despite a sharp drop in deceased

donor transplantation in the spring of 2020, organ transplants from deceased donors hit a new annual record in the United States last year, totalling 33,309.

Unexpected transmission of any infection from donor to recipient is uncommon, occurring in about 0.2% of transplant recipients between 2008 and 2018, according to a study published in February. Infections were the most common donor-derived disease (Am J Trans■ plant 2021;21[2]:689-702).

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IN THE NEWS

MAY 2021 / GENERAL SURGERY NEWS

By ETHAN COVEY

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urgeons who wear clear face masks during patient encounters receive significantly higher marks for communication and trustworthiness, compared with colleagues who wear traditional surgical masks, according to a new study.

The report, which is the first study to evaluate differences in patients’ perceptions of surgeon communication based on their mask type, may have additional

implications as the COVID-19 pandemic recasts the need for mask wearing during physician–patient interactions (JAMA Surg 2021 Mar 11. doi:10.1001/ jamasurg.2021.0836).

“With the changing health care landscape due to the pandemic, masks have become an even

Image Courtesy of JAMA Network® ©2021 American Medical Association

Clear Surgical Masks Lead to Higher Patient Satisfaction more important aspect of surgeon PPE,” said Ian M. Kratzke, MD, a physician in the Department of Surgery at the University of North Carolina (UNC) at Chapel Hill School of Medicine, and lead author of the study. “The findings speak to the importance for surgeons and OR personnel to recognize the barriers that

masks create in effectively communicating and building trust with patients.”

A total of 200 patients were enrolled in the study, recruited from 15 surgeons’ clinics spanning seven surgical subspecialties. Clinic visits were conducted at a single academic medical center, with the patients rating the surgeons on communication, trust, and a number of quantitative and qualitative impressions regarding the two mask options.

Across the board, patient rankings were more positive for surgeons who wore clear masks.

Surgeons wearing clear masks were rated higher for providing understandable explanations (95% clear vs. 78% standard), demonstrating empathy (99% vs. 85%) and building trust (94% vs. 72%). Overall, patients preferred clear over standard masks 100% to 72%, expressed greater excitement for clear masks, and had more frequent complaints regarding interactions with doctors wearing standard masks.

“This study demonstrates that patients prefer to see their surgeons’ faces,” said senior author of the study, Muneera R. Kapadia, MD, an associate professor of surgery at UNC School of Medicine. “Therefore, it is important to identify mask technology that allows this visibility, while maintaining safety standards and providing a comfortable mask-wearing experience.”

Margaret L. (Gretchen) Schwarze, MD, an associate professor of surgery at the University of Wisconsin– Madison School of Medicine and Public Health, who authored a corresponding commentary, agreed.

“We do a lot of things to try to improve patient care,” she said. “This study clearly shows that patients report much higher communication scores when the surgeon is wearing a clear mask. This seems incredibly valuable for our patients, and something we should probably do to support them in their surgical care.”

However, surgeons themselves were less positive in their reviews of clear masks. Only 47% indicated they were likely to choose clear masks for future patient encounters.

In addition, since the COVID-19 pandemic has increased use of masks, patients have grown more accustomed to them being worn during all interactions. Dr. Kratzke noted that while it is difficult to estimate the long-term effect of the pandemic on mask wearing, the study provides key information regarding ways health care professionals may adapt mask usage to satisfy patients. “While the scope of this study did not involve evaluating the situations that masks should be worn moving forwards, masks have and will always serve a role in the health care setting,” he said. ■

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IN THE NEWS

GENERAL SURGERY NEWS / MAY 2021

To Do REBOA or Not to Do REBOA? With Conflicting Study Results, Guidelines and Recommendations Are Difficult to Make

By VICTORIA STERN

A

fter a traumatic injury, a patient with severe internal hemorrhaging faces a ticking clock. Without controlling the bleeding quickly—sometimes within minutes of the injury—the patient may die.

That’s where the resuscitative technique REBOA, or resuscitative endovascular balloon occlusion of the aorta, can come into play. Traditionally used on the battlefield to prevent hemorrhage-related casualties, REBOA has gained traction in the civilian trauma setting over the past few years, with more than 300 hospitals adopting the technique worldwide Despite REBOA’s growing popularity, experts continue to debate when its use is appropriate.The evidence to date provides no clear framework (Am Surg 2021 Jan 31. doi:10.1177/0003134820988813).

“REBOA is one of the most difficult topics to understand because the evidence is inconsistent,” Nikolay Bugaev, MD, the executive director of research in the Department of Surgery and an assistant professor of surgery at Tufts University School of Medicine, in Boston, told General Surgery News.

Some studies, for example, have shown the technique can save lives while others have found the opposite. A 2018 study analyzing registry data reported that patients with penetrating trauma who received REBOA instead of resuscitative thoracotomy had a significantly better rate of survival after the emergency department (63% vs. 44%) and after discharge (9.6% vs. 2.5%) (J Am Coll Surg 2018;226[5]:730-740). Other research found that 280 severely injured trauma patients who underwent REBOA had a higher rate of mortality (35.7% vs. 19%) than a similar group of 140 patients who did not receive REBOA (JAMA Surg 2019;154[6]:500-508).

In 2018, trauma surgeons attempted to clarify the appropriate uses of REBOA in a joint statement without success.

The authors concluded that “no current, high-grade evidence clearly demonstrates REBOA improves outcomes or survival compared to standard treatment of severe hemorrhage” (Trauma Surg Acute Care Open 2018;3:e000154).

Earlier this year, experts from the Eastern Association for the Surgery of Trauma reviewed the latest evidence to see if

they could determine the role of REBOA in trauma care. But even devising the right questions proved a challenge.

“We went back and forth on the questions for a few months,” said Dr. Bugaev, who presented the ‘Looking at the evidence in each EAST committee’s recommendations at the 2021 virtual category, the studies showed diverging meeting. “Our goal was to give results, which meant it was impossible practical recommendations that every surgeon can use in their to make any firm conclusions about daily practice and ultimately, when and where to use REBOA.’ due to the limited literature, we settled on three lines of inquiry.”

—Nicole A. Stassen, MD The questions focused on patients bleeding in the abdodecrease time to the aorta occlusion men or lower extremities in three contexts: and reduce mortality?

• In trauma patients who are • In hemodynamically unstable hemodynamically unstable with nontrauma patients, should REBOA suspected subdiaphragmatic bleeding, be performed prior to definitive should REBOA be performed prior hemostatic procedures to decrease to definitive hemostatic procedures blood transfusion requirements and to decrease time to definitive mortality? intervention, blood transfusion “The committee selected three very requirements and mortality?

• In trauma patients with cardiac arrest, important questions to investigate and their review nicely illustrated the chalshould REBOA or resuscitative lenges of interpreting the REBOA literthoracotomy be used to increase the ature,” said Nicole A. Stassen, MD, the return of spontaneous circulation,

Recent Advances in Hemostatic Resuscitation Reviewed primary coagulopathy is also associated with increases in mortality, blood product requirement, multiple organ failure and hospital length of stay, and is consistent across injury severity, with an increasing prevalence (J Trauma 2003;54[6]:1127-1130).

By CHASE DOYLE

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or the past four decades, hemorrhage has consistently been a major cause of mortality, accounting for approximately 30% to 40% of all trauma deaths. During the 2020 American College of Surgeons Clinical Congress, Jana Macleod, MD, reviewed the literature related to traumainduced coagulopathy and shared recent advances in hemostatic resuscitation.

“Hemorrhaging patients and patients in shock should be treated by a protocolized approach of giving balanced blood products as close to 1:1:1 as possible or whole blood, with limited crystalloid administration, guided by point-of-care testing,” said Dr. Macleod, a professor of surgery at Kenyatta University, in Nairobi, and an adjunct professor of surgery at the University of Pittsburgh. “Future research needs to incorporate the dynamic aspect of trauma-induced coagulopathy and look for ways to inculcate that in our treatment approaches.”

Despite advances in the technical approach to surgical bleeding, including the use of intravascular shunts, damage control laparotomy, interventional radiology adjuncts and even REBOA (resuscitative endovascular balloon occlusion

Massive Transfusion Protocols

of the aorta), coagulopathic bleeding remains a challenge for trauma surgeons. Although uncontrolled bleeding was historically understood to lead to coagulopathy, retrospective data have shown that approximately one-fourth of all trauma patients had coagulopathy at the time of arrival to the hospital (J Trauma 2003;55[1]:39-44). This

Several correlational studies have shown that trauma results in tissue factor release, directly disrupts endothelium, activates platelets, and consumes and activates coagulation factors and protein C, leading to their depletion.

These changes result in hyperfibrinolysis with fibrinogen deficit, and leads to impaired thrombin generation and an overall hypercoagulable state. Although a complete etiologic understanding of coagulopathy is lacking, according to Dr. Macleod, this paradigm has been rapidly adopted in the clinical arena.

“Crystalloids are now discouraged and replaced by early blood product administration for hemorrhaging patients or those in shock,” Dr. Macleod said, who noted that only 1 L of crystalloid is recommended initially and only when blood is not yet available.

With the advent of this new paradigm, both military and civilian trauma

centers have introduced massive transfusion protocols (MTPs) aimed at correcting coagulopathy by giving balanced blood volumes with equal volumes of plasma and platelets along with cryoprecipitate. Retrospective reviews following implementation have shown a reduction in mortality of up to 40% with high ratio replacement.

Measuring Coagulopathy At the same time, interest has grown in a more patient-directed and nuanced approach to resuscitating with MTPs based on coagulopathy measurement. As Dr. Macleod explained, trauma-induced coagulopathy is not a clinically detected abnormality. Overt bleeding may be present, she said, but often it is not.

A randomized controlled trial comparing the use of conventional assays with thromboelastography (TEG) to guide goal-directed MTP resuscitation found that TEG was associated with a significant reduction in mortality, especially early mortality. Currently, TEG is the standard of care for measuring trauma patients’ coagulopathic status and directing blood product usage. Alternatively, smaller trauma centers lacking access to TEG can use the international normalized ratio (INR) with a point-of-care device.

IN THE NEWS

MAY 2021 / GENERAL SURGERY NEWS

director of the Kessler Burn & Trauma Center and Kessler Family Intensive Care Unit and a professor of surgery at the University of Rochester, in New York, who was not involved in the EAST analysis.

After a comprehensive literature review, the committee homed in on 13 studies that explored these scenarios and reported outcomes such as transfusion, time to definitive procedure and mortality.

In the group of patients with traumatic subdiaphragmatic bleeding, the studies showed a significant favorable effect of REBOA versus no REBOA in those who received transfusions of packed red blood cells or platelets, but not fresh frozen plasma. For time to definitive procedure or mortality, REBOA did not show a significant benefit. The committee concluded that based on the “very low quality of evidence, we cannot make recommendations for or against REBOA.” “Looking at the evidence in each category, the studies showed diverging results, which meant it was impossible to make any firm conclusions about when and where to use REBOA,” Dr. Stassen said.

In patients in traumatic cardiac arrest, the evidence from three studies pointed to a survival benefit for those receiving REBOA versus resuscitative thoracotomy. But again, given the limited data and low quality of evidence, Dr. Bugaev and

his colleagues could not recommend one intervention over the other.

In the group of patients with nontraumatic subdiaphragmatic bleeding, a review of five studies exploring transfusion and mortality outcomes led the committee to the same conclusion about REBOA versus no REBOA: No definitive recommendation was possible.

Determining more definitive guidelines will require more data. But, even with the mixed evidence, Dr. Bugaev saw a potential place for REBOA in the civilian setting—namely, for patients with massive bleeding and who don’t have

immediate access to surgical care. A 2020 analysis using the Japan Trauma Databank found REBOA led to improved survival—56.5% versus 31.8% without REBOA—but only for patients who had to wait over an hour for surgery (Am J Surg 2020;220[6]:1485-1491).

Dr. Stassen agreed that “REBOA may show a benefit for patients who can’t get surgical care quickly. Such delays may be more relevant in rural areas, but then we get into questions of who would place the device and maintaining that competence.”

Although the EAST committee ultimately could not make recommendations

for or against REBOA in these three contexts, Dr. Bugaev expressed optimism about REBOA’s role in civilian trauma care.

“I’m not discouraged after doing this review,” Dr. Bugaev said. “Although we still don’t know exactly who will benefit from REBOA and who will not, the technique appears to be feasible and relatively safe to use.” Ultimately, Dr. Bugaev explained, “the message is not avoid this technique; rather, the message is use REBOA if you have the expertise, clinical resources and a patient who you think can benefit.”

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ADVANCING POSTSURGICAL PAIN MANAGEMENT AND RECOVERY Powered by DepoFoam® technology to deliver precise pain control for the critical first few days after surgery

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8 MILLION ADULT PATIENTS HAVE RECEIVED EXPAREL SINCE 2012 1

“INR elevation above the normal range is the original definition of trauma-induced coagulopathy, so at least a patient will be recognized early as a high mortality risk if the INR is performed,” Dr. Macleod said. “Although TEG provides more information on the clot, if blood components to address these findings are not available, then its usefulness can be questioned.”

According to Dr. Macleod, when indicated empirically or with TEG, administration of tranexamic acid within three hours of injury is associated with reduced mortality. In settings where MTPs are not readily available, the ability of tranexamic acid to improve survival is even more pertinent, and its use should always be included where indicated, she said.

“Trauma-induced coagulopathy is a dynamic entity that changes with time, and the literature now supports that different patients will experience different trajectories of their coagulopathy,” Dr. Macleod concluded. “We also know that there are different phenotypes of trauma-induced coagulopathy, and there is a growing interest in moving from a balanced goal-directed correction of the clot abnormality to an individualized patient response to coagulopathy.”

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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, pruritis, 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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GENERAL SURGERY NEWS / MAY 2021

The Dangers of Absolutisms in Surgery continued from page 1

residency, surgery is still learned from surgeons. As such, my mentor’s tools have become my tools. But by the same token, have his biases also become my biases?

In the middle of an M&M write-up pertaining to the use of T-tubes, I again realized the weight of surgical dogma that I inherited in residency. And by dogma, I mean those tenets or principles that are unquestionably upheld, but impossible to unravel. Inside is probably a fragmented truth, but it is wrapped in

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.

layer upon layer of perpetuated bias.

The process of teaching surgery seems always caught between evidence-based medicine and a hodgepodge of experience, anecdotes and dogma. Partly this is inherent to surgery because it is both an art and a science. The truth is, there are actually very few absolutes in surgery. Case in point, we use phases like risks, benefits and indications when we talk about management and treatment.

And we talk about the “principles of the

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)

operation” because we understand that having enough intraabdominal esophageal length in a hiatal hernia repair is more important than the actual technique or instruments used; as the phrase goes, “There’s more than one way to skin a cat.”

In training, especially in the early years, the wires get crossed when principles and preferences are taught with equal zeal. We ask interns to live, breath and internalize an ungodly amount of information that first year. Through no

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.

fault of their own, all of the information is indiscriminately committed to memory. Their education is a confusing blend of textbooks, randomized controlled trials, staff anecdotes and surgical dogma.

In the same day, they are reprimanded for not listening to bowel sounds, learn about the Z0011 trial at a cancer conference, listen to a story about a patient who died from a nasogastric clamping trial, and, finally, in the OR, they are told that Hasan entry is the safest method.

• 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

RESIDENT CORNER

MAY 2021 / GENERAL SURGERY NEWS

The process of teaching surgery seems always caught between evidence-based medicine and a hodgepodge of experience, anecdotes and dogma.

I spent most of my junior residency separating and sorting all of this information just to decide: What is preference and what is principle? But there are many residents who will never see the difference, and so interns continue to be scolded for not waiting six hours for a post-pull chest x-ray, or for not placing a Foley catheter during an appendectomy.

And before long, there is an entire class of interns who unquestionably believe that silk should never be used on small bowel—or any other sort of idiosyncrasy picked up along the way.

This becomes less of a problem over five to six years of interacting with dozens of different surgeons, from different specialties, working within different hospital systems. As time goes on, residents collect these techniques and choose the ones they can safely and consistently perform. As my mentor likes to say, “You can never be a surgeon who knows only one way to do something.” Each technique has its own merits and risks. And I think that this information—the ability to contextualize each technique—is arguably as important as the technique itself. Knowing all the ways of intraabdominal entry is good, but knowing specific situations that would favor one over the other is far better. With that being said, I anticipate that with time in practice, I will pick and choose techniques that I can safely reproduce with maximal efficiency.

But this brings up, I think, the difference between faculty surgeons and for lack of a better word, nonfaculty surgeons. Faculty surgeons have a responsibility to teach surgical principles and techniques—all techniques—along with the pros and cons of each. Knowing that a partner had a bad outcome with a particular technique does not necessarily invalidate that technique, but instead affords an opportunity to discuss potential pitfalls, ways to mitigate and how to deal with complications. And this is where experience is most valuable. I feel like this approach can’t help but create diverse and conscientious surgeons, and not “onetrick ponies.” It reinforces what makes a surgeon a surgeon, and not a technician.

I think it is fair to say that not every

surgeon has to be faculty. It is an incredible responsibility; they have my utmost respect. The process of teaching residents is labor-intensive, time-consuming and anything but efficient. The faculty I have learned the most from are able to put aside their own practice patterns to ensure I experience and adapt to different scenarios. The tune changes from “I never do it that way” to “I typically do it this way because of, … but these are the other ways you can do it as well.” Instead of fixing a hiatal hernia from the patient’s right side, can I also have that same experience standing between the legs? Or this time, can I also modify my port placement and use a different energy device?

I don’t necessarily want the same patterns as my

mentor. Instead, I would like to piecemeal together safe techniques to create my own pattern, and by doing so become comfortable or, at a minimum, familiar with all of them. Surgical residency has moved away from long rotations with a core faculty group to shorter rotations with subspecialists who are either building or supporting their own practice. I wonder if this shift is partly responsible for the “product of my training” phenomenon. It has to be asked: Is the goal of residency to produce copies or products, carrying around the same biases? Or is the goal to produce well-rounded surgeons, capable of oper■ ating in any OR, under any set of circumstances?

—Dr. Halgas is a chief surgical resident in El Paso, Texas.

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14

IN THE NEWS

GENERAL SURGERY NEWS / MAY 2021

Antireflux Technique Combines Laparoscopic, Transoral Approaches continued from page 1

“I think our new innovative approaches will change the way we perform antireflux surgery, and maybe we’ll see a change in acceptance of these procedures similar to the acceptance and growth of bariatric surgery in the early 2000s,” said Ninh Nguyen, MD, the chair of surgery at the University of California, Irvine.

In the Journal of the American College of Surgeons, Dr. Nguyen and Kenneth Chang, MD, a professor and the chief of gastroenterology at the University of California, Irvine, reported the results of cTIF in 60 patients with confirmed GERD and hiatal hernias larger than 2 cm (2021;232[3]:309-318). In this group, 53% were men with a mean age of 59.3 years, and all were treated between 2018 and 2020.

The surgeon first performs laparoscopic hiatal hernia repair, followed by a same-session TIF by the gastroenterologist, for a combined procedure that lasts about 90 minutes.

Although cTIF was technically successful in all cases, one patient experienced an esophageal mucosal tear with subsequent mediastinal inflammation during the TIF portion, which investigators attributed to excessive torquing of the TIF device.

Assessments showed that patients’ symptoms significantly improved six months after treatment. Their scores on the Reflux Disease Questionnaire dropped to around one-third of baseline. GERD health-related quality-oflife scores for gas bloating decreased to 0.25 at six months and 0.5 at 12 months, from 1.4 at baseline. Heartburn also dropped significantly. Proton pump inhibitor (PPI) use fell from 69% to 29% of patients at six months and down to 14% at 12 months.

The results, however, are based on small numbers of patients. Six months after cTIF, only 30% of patients completed the Reflux Disease Questionnaire, and 20% and 18%, respectively, were evaluated with the Reflux Symptom Index and the GERD-Health-Related Quality of Life assessment.

Ambulatory pH monitoring after cTIF was available in five patients, with DeMeester scores improving from 49.1 to 4.9 after the procedure, and mean acid exposure time improving from 12.7% at baseline to 1.28%.

Over the past decade, studies have shown that TIF is a safe antireflux procedure for GERD refractory to medical therapy. It is not as effective as laparoscopic fundoplication for preventing gastroesophageal reflux, and its application is limited to patients without hiatal hernias. But TIF is appealing to patients who prefer to avoid surgery with its

Pre-op endoscopy shows a Hill grade III with no flap valve architecture.

Laparoscopic esophageal lengthening and hiatal hernia repair.

Endoscopy after hiatal hernia repair shows a Hill grade I with initial omega-shaped valve.

Endoscopic transoral fundoplication.

A new 3-cm omega valve flap constructed by cTIF.

Laparoscopic omega partial fundoplication with orientation of the wrap in a reverse-C fashion with an open area along the lesser curvature.

reduced risk for post-procedure pain and overnight hospital stay, and no scar.

Dr. Nguyen said he and Dr. Chang believe the addition of the hiatal hernia repair strengthens the antireflux barrier and increases the length of the intraabdominal esophageal segment to reestablish the gastroesophageal flap valve. It also means that patients with a hiatal hernia can undergo an endoscopic antireflux procedure.

Since their report, Drs. Nguyen and Chang expanded their cTIF eligibility to include patients with hiatal hernias smaller than 2 cm.

In an accompanying editorial, Kyle A. Perry, MD, an associate professor of surgery at The Ohio State University Wexner Medical Center, in Columbus, said cTIF offers the “potential of an elusive high-efficacy, lower side effect management strategy for GERD patients.”

But there are important unanswered questions, he added. The long-term durability of cTIF remains unknown, especially compared with laparoscopic Nissen fundoplication. The side effects need to be examined in more patients, he added.

It’s not clear that cTIF will appeal to clinicians and patients, given that patients still need a surgical procedure. Moreover, the fundoplication is held together with plastic fasteners rather than sutures, noted Ezra Teitelbaum, MD, an assistant professor of surgery at Northwestern University Feinberg School of Medicine, in Chicago.

“I think the big question now becomes what is the comparison between cTIF and other ways of creating the antireflux barrier at the time of surgery,” he said.

“Can it provide the same degree of reflux control? How does it compare with Toupet in terms of dysphagia and gas bloat?”

He said cTIF should be tested headto-head in randomized studies with Toupet fundoplication.

Investigators are trying to get larger studies underway. They are seeking institutional review board approval for a multicenter randomized trial that will compare cTIF with laparoscopic Nissen fundoplication, Dr. Nguyen said. He pointed out that there is a learning curve associated with TIF and cTIF, and these procedures require specialized training.

Michael Ujiki, MD, the Louis W. Biegler Chair of Surgery at NorthShore University HealthSystem in Chicago, agrees with the authors that endoscopy is a critical step in antireflux procedures. But he challenged the suggestion that laparoscopic fundoplication doesn’t afford an endoscopic view.

“Just placing the scope (during laparoscopic fundoplication) does that,”

he said, adding that all surgeons who perform antireflux procedures should employ endoscopy during the operation.

“You can better visualize the valve you’re creating, make sure that you are creating it at the right place on the esophagus, and then also ensure that it has the right compliance—not too tight, not too loose,” he said.

The work of Drs. Nguyen and Chang on cTIF also led to modifications in their construction of the surgical gastroesophageal flap valve, which they hope will improve surgical outcomes.

They describe the omega flap valve in detail in the March issue of Surgical Endoscopy (2021 Mar 11. doi:10.1007/ s00464-021-08416-y). The wrap begins at the angle of His at the 3 o’clock position, with a near circumferential wrap of distal esophagus, leaving open the backstop region along the lesser curvature.

This will allow for physiologic venting and reduce the risk for dysphasia and gas bloat, they wrote.

“We’re not trying to create a new operation. The current fundoplication operations are good operations. All you have to do is change your technique a little bit to improve the formation, and hence the efficacy, of the omega valve,” Dr. Nguyen said.

The omega fundoplication involves two technical differences from conventional approaches: a partial fundoplication with orientation in a reverse C fashion, and the gastric cardia wrap oriented toward the 9 o’clock position rather than the conventional approach of 11 or 12 o’clock position; and placing initial sutures to reestablish the angle of His, followed by using the mid-aspect of the anterior and posterior gastric wall to perform the 300-degree wrap. The omega fundoplication is a partial wrap that leaves a 60-degree area of the esophagus open along the lesser curvature.

This valve may offer a surgical approach to the formation of the omega valve for surgeons who do not want to adopt cTIF, Dr. Nguyen said.

Dr. Teitelbaum said the omega fundoplication has promise as a laparoscopic antireflux procedure. “I think it’s a very interesting idea, especially how they think it might be more reproducible. That makes sense to me,” he said. ■ Dr. Nguyen’s institution received grant funding for evaluating the role of cTIF followed by sleeve gastrectomy, and he received consulting fees from EndoGastric Solutions Inc and Olympus. Dr. Chang receives consulting fees and expenses from Apollo Endosurgery Inc., and his institute receives grant funding from Cook Medical, EndoGastric Solutions Inc., Erbe, and Olympus.

15

MAY 2021 / GENERAL SURGERY NEWS

5 Years Later

Update on GutCheck, a Skin Patch That Measures GI Activity

By MONICA J. SMITH

W

hat can be done with a wireless cutaneous patch that measures gastrointestinal activity? Apparently, quite a bit.

When General Surgery News first reported on the technology in 2016 [https://bit.ly/32uFqP8], early research showed that the GutCheck patch could measure electrical signals from the gastrointestinal (GI) tract noninvasively, and that it could differentiate healthy controls from individuals with GI symptoms based on those signals.

Since then, the small company behind the patch, G-Tech Medical, has investigated the technology in a handful of settings and patient populations.

For instance, in a study of 75 patients undergoing Whipple procedures, researchers could identify patients who would be able to eat sooner rather than later based on gut electrical activity detected by the patch within 36 hours after surgery (Am J Physiol [Gastrointest Liver Physiol] 2018 Oct 17. doi.org/10.1152/ ajpgi.00074.2018).

“We know from ERAS [enhanced recovery after surgery] protocols that one of the most important ways to identify patients who can be discharged sooner is to know when patients can first be fed safely,” said Steve Axelrod, PhD, the president and CEO of G-Tech Medical.

But identifying these patients can be quite hit or miss. “They take into account the patient’s age, how sick they are. They rely on the patient to tell them if they’ve passed gas. It’s very subjective,” Dr. Axelrod said.

“But with our system, you can see how each individual is doing and customize their care.”

Another study showed that the GutCheck patch could predict time to first flatus in patients undergoing open abdominal surgery, which again could be used to identify patients ready for feeding (J Gastrointest Surg 2019;23[5]:982-989). A pilot study of postoperative pediatric patients ranging in age from 5 months to 16 years also found the device feasible of monitoring gut myoelectric signals across this broad age range.

At present, researchers are investigating whether the wireless patch could serve as a noninvasive alternative to high-resolution manometry in children.

“We’re seeing a beautiful correlation between the signals measured internally with pressure sensors and the electrical signals we can read externally that come from the GI organs while they’re contracting. We see much of the same activity,” Dr. Axelrod said. “Very recently, we’ve also seen excellent correlation in a pig model between our patches and internal electrodes placed on the stomach, small intestine and colon.”

They are also doing a study on patients with Crohn’s disease who participated in earlier studies; due to restricted activity during the coronavirus pandemic, this study is being carried out remotely.

“This is very exciting—a whole future avenue of being able to help people with GI problems who don’t want to visit a doctor’s office,” Dr. Axelrod said.

This particular patient population is especially resonant to Dr. Axelrod, whose interest in the technology stems partly from raising a daughter with Crohn’s disease.

“This is very personal. We really want to help people,” he said.

That daughter, Lindsay Axelrod, now holds a master’s

Spectra of a short section (7 minute) of the raw time-series data. Top graph is the signal from an electrode placed on the serosal surface of a pig colon. Lower graph is the signal from one of the G-Tech patch channels at the same time, showing that the external patch faithfully measures the myoelectric activity.

Typical arrangement of three patches on an abdomen.

Spectra for two, three-day tests on a patient.

The orange trace is the baseline, and the blue trace is when patient was taking polyethylene glycol to relive constipation.

degree in translational medicine and is one of the company’s three core full-time employees besides Dr. Axelrod and Anand Navalgund, PhD, a medical engineer and G-Tech’s director of clinical science.

G-Tech, which receives support from the Fogarty Institute for Innovation, plans to submit a 510(k) application to the FDA in May 2021.

“We just want to get it out there for researchers to use, because there are so many different potential applications, from surgery to IBD [inflammatory bowel disease] to patients with constipation or nausea or bloating, or people going through the ER with GI pain,” Dr. Axelrod said.

A gastroenterologist who specializes in gut motility disorders at Cleveland Clinic in Weston, Fla., Alison Schneider, MD, sees how the GutCheck patch could be a useful alternative to the technology currently used to evaluate patients.

Spectra calculated from the time series data showing that there is a peak at 5 cycles per minute in both cases.

“It is very difficult to evaluate small-bowel motility. One of the standard tests is a smart pill, which you swallow, but you’d worry about using that in a surgical patient, where you wouldn’t want to unnecessarily pass a foreign body through a fresh anastomosis,” she said.

Manometry, too, Dr. Schneider noted, is quite invasive and rather limited, being offered by few centers.

“We really don’t have a good diagnostic test for bowel function and motility. Using a little patch externally and noninvasively is an exciting concept and would be pretty useful in a number of clinical settings, beyond surgi■ cal patients.”

Column Editor: Michael A. Goldfarb, MD, clinical professor of surgery, Rutgers University Medical School, in New Brunswick, NJ. Neither Dr. Goldfarb nor GSN has any financial relationship with G-Tech.

16

IN THE NEWS

GENERAL SURGERY NEWS / MAY 2021

GI Cancer Surgery Complications continued from page 1

from a similar study two years ago that looked at surgical outcomes after less complex laparoscopic abdominal operations, including bariatric, colorectal and hiatal hernia procedures (JAMA Surg 2019;154[9]:861-866). The first study showed no difference in patient results between ranked and nonranked hospitals.

“The message is if you are a patient with gallbladder disease, go to your local general surgery provider. But if you need an operation where you might die from the operation, where you might have huge complications that mean you might spend a long time in hospital, go to a hospital that does a large number of these procedures,” said study co-author Ninh T. Nguyen, MD, the chair of surgery at the University of California, Irvine.

Using data from the Vizient clinical database, Dr. Nguyen and his colleagues assessed 6,662 patients who underwent elective esophagectomy, gastrectomy and pancreatectomy for malignances at U.S. academic centers and their affiliated community hospitals in 2018. Forty-two of the top 50 hospitals on the newspaper’s list are in the database.

The investigators compared patient outcomes at the ranked hospitals and those at 198 nonranked hospitals.

Patients experienced serious complications at similar rates at ranked and nonranked hospitals. But when complications occurred, patients at ranked hospitals were far less likely to die: Inhospital mortality after a complication at ranked hospitals was 8.19%, compared with 16.79% at nonranked hospitals.

“It’s not necessarily that your complication risk is lower, but the chance of dying from that complication is much less,” Dr. Nguyen said. “Experts know how to pick up on complications early on, which is key. It might not be because of the surgeon, but the entire team.”

After adjusting for patient characteristics such as severity of illness, death rates were still, on average, lower in the ranked hospitals.

The key factor at ranked hospitals is the high volume of complex cases performed at these institutions, the investigators said.

Ranked hospitals perform an outsized proportion of complex cancer operations in the United States. Nearly half of all GI cancer operations—3,052—took place at the 42 ranked hospitals. Nonranked hospitals, which account for 82% of hospitals in the database, carried out 54% of procedures, or 3,608.

‘If you are a patient with gallbladder disease, go to your local general surgery provider. But if you need an operation where you might die from the operation, where you might have huge complications that mean you might spend a long time in hospital, go to a hospital that does a large number of these procedures.’

—Ninh T. Nguyen, MD Top-ranked hospitals had an average annual case volume for these highrisk conditions four times higher than

GI Cancer Surgery Outcomes Better With High-Volume Anesthesiologists

P

atients fared better in the three months after gastrointestinal cancer surgery if they received care from high-volume anesthesiologists, according to a Canadian study.

Published in JAMA Surgery, the analysis showed that care from high-volume anesthesiologists was independently associated with a 15% lower odds of combined 90-day major morbidity (including mortality) and hospital readmission, after adjusting for patient case mix, institutional volume and surgeon volume (2021 Mar 21. doi:10.1001/ jamasurg.2021.0135).

All patients were treated at high-volume cancer centers.

“Anesthesiology care and perioperative care is becoming more complex, just like surgeries are becoming more complex and patients themselves more complex, and anesthesiology can have important impact on how well patients are going to do after surgery,” said study co-author Julie Hallet, MD, a staff surgical oncologist at Sunnybrook Health Sciences Centre and an assistant professor of surgery at the University of Toronto.

Dr. Hallet and her colleagues used administrative health care data sets to identify 8,096 adult patients in Ontario, Canada, who underwent esophagectomy, pancreatectomy or hepatectomy for cancer between Jan. 1, 2007, and Dec. 31, 2018.

In this study, anesthesiologists had lower volumes than surgeons, with a median of three procedures per year compared with 27 for surgeons. Anesthesiologists were classified as high-volume if they performed six or more of the particular procedure annually in the two years before the index surgery.

Ontario has a highly regionalized system for oncologic surgery. Since 2006, hepatopancreaticobiliary surgery in the province has been concentrated at 10 designated centers of excellence and esophageal cancer surgery at 15. These centers have requirements for institutional annual case volume, surgeon fellowship and perioperative care infrastructure, but not anesthesiology services.

“We may have a different anesthesiologist for every case that we do over a six-month period,” Dr. Hallet said.

The findings suggest patients may benefit if perioperative care were reorganized to increase anesthesiologist volume, Dr. Hallet noted. Large institutions could create specialized anesthesiology teams, while smaller ones could build clinical networks with high-volume anesthesiologists, she said.

In an accompanying commentary, researchers from the Surgical Outcomes and Quality Improvement Center at Northwestern University, in Chicago, said the study offers a rare look at the contribution of anesthesia volume to outcomes (JAMA Surg. 2021 Mar 17. doi:10.1001/jamasurg.2021.0136). As with surgery, volume is a useful proxy for quality, but may reflect factors such as experience, processes of care and team organization, the authors said.

“We commend Hallet et al for their methodical and thought-provoking study, but much work still needs to be done to uncover the true underlying factors associated with improved outcomes,” Rachel Hae-Soo Joung, MD, and her colleagues wrote.

—Christina Frangou

nonranked hospitals (72 vs. 18 cases).

Dr. Nguyen said he believes that patients do better in ranked hospitals because staff members at these institutions have more experience with detecting and managing serious complications, particularly postoperative anastomotic leaks or pancreatic leaks. They’re more likely to respond quickly and in ways that prevent patients from dying after complications, he said.

Many studies have shown an association between case volume and reduced mortality over the past three decades, especially for complex procedures. This study took a novel approach to examining the volume–outcomes relationship by delving into a hospital ranking system that is widely used by patients and heavily marketed by hospitals.

For 31 years, U.S. News & World Report has published its annual list ranking hospitals across 16 specialties. The report lumps gastroenterology and GI surgery into a single specialty. Last year, the three top-ranked hospitals for gastroenterology and GI surgery were Mayo Clinic, Cedars-Sinai Medical Center and Cleveland Clinic.

Surgeons who were not affiliated with the study said the findings validate the U.S. News & World Report ranking system.

“This could potentially be very helpful for patients trying to decide where they might consider surgery. In that regard, it’s an important addition to the literature,” said Andrew P. Loehrer, an assistant professor of surgery at Dartmouth-Hitchcock Medical Center, in continued on page 22

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18

IN THE NEWS

GENERAL SURGERY NEWS / MAY 2021

Peer Review of Surgical Technique continued from page 1

surgical outcomes,” said Karan R. Chhabra, MD, of the Department of Surgery at Brigham and Women’s Hospital, in Boston. “Surgeons talk about their technique all the time, but we rarely have data to back up very common technical decisions. They have been notoriously hard to study, and even harder to standardize.”

Dr. Chhabra and his colleagues reviewed whether it was possible to objectively evaluate surgical technique, and whether variation in surgical technique

would have meaningful association with clinical outcomes.

More specifically, the researchers explored how variations in sleeve gastrectomy surgery can affect patient health.

“Sleeve gastrectomy is becoming one of the most common operations in the U.S., but there are variations in outcomes that we haven’t been able to explain in the usual ways,” Dr. Chhabra said, noting that while one-third of patients have new or worsening reflux after the procedure,

it’s challenging to predict which patients will be affected.

For this study, surgeons from the Michigan Bariatric Surgery Collaborative were asked to submit representative videos of themselves performing a sleeve gastrectomy for morbid obesity. A total of 30 surgeons submitted 46 videos, collected from Jan. 1, 2015, to Dec. 31, 2016.

The videos were then peer reviewed, with the surgeons evaluating each on key technical components of the procedure, and rating the skill level of the surgeon in each video via the Objective Structured Assessment of Technical Skills tailored

for bariatric surgery. Patient outcomes also were obtained from medical records, focusing on results from 30 days, and one, two and three years after surgery.

The team found a wide variance in the use of surgical techniques with corresponding weight loss, levels of gastroesophageal reflux disease and risk for hemorrhage.

‘This approach imposes a “Hawthorne effect” to get it right each time as best as can be done and not accede to the temptation that the performance is simply “good enough.”’

—John C. Alverdy, MD

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“We were surprised to see that our overall hypothesis was right, that a fairly tight-knit community of surgeons in a single state had significant variations in their technique, and that these had meaningful relationships with their clinical outcomes, even when we adjusted for their overall skill level,” Dr. Chhabra said.

Specifically, the results showed that completely dissecting the proximal stomach is associated with better weight loss and reflux outcomes, as well as lower bleeding rates.

Other results surprised the researchers by being somewhat counterintuitive.

For instance, Dr. Chhabra said, “making a ‘tighter’ sleeve by stapling the stomach closer to the bougie was not associated with better weight loss—even though it makes the stomach smaller—but was associated with poorer reflux outcomes.”

The results, and adoption of larger such peer review opportunities, may help improve outcomes for these specific procedures, and allow for more customized education for practicing surgeons.

John C. Alverdy, MD, the executive vice chair in the Department of Surgery at the University of Chicago, who authored an accompanying editorial, agreed (JAMA Surg 2021;156[2]:e205557).

“The paper calls into question whether surgeons can be sufficiently self-aware to judge the manner and method by which they perform an operation,” Dr. Alverdy said. “The authors of this article provide a method to demand peak performance and technical perfection in each case. This approach imposes a ‘Hawthorne effect’ to get it right each time as best as can be done and not accede to the temptation that the performance is simply ‘good enough.’

“Although among surgeons the aphorism ‘the enemy of good is perfect’ is often uttered, perhaps the time has come to consider it no longer applicable,” he said. ■ Dr. Chhabra reported receiving payments from Blue Cross Blue Shield of Massachusetts Inc. outside the submitted work.

IN THE NEWS

MAY 2021 / GENERAL SURGERY NEWS

Findings Suggest Increased Unhealthy Alcohol Use After Bariatric Surgery

By BOB KRONEMYER

P

atients without self-reported unhealthy alcohol use in the two years before bariatric surgery were significantly more likely to develop unhealthy alcohol use three to eight years after the procedure compared with patients without unhealthy alcohol use at baseline who did not undergo bariatric surgery, according to a recent study.

The multisite retrospective study of 2,608 U.S. veterans (75.3% men) who underwent a bariatric surgical procedure at a Department of Veterans Affairs health system between October 2008 and September 2016 consisted of 2,393 veterans who did not have unhealthy alcohol use before surgery and 215 veterans who did (JAMA Network Open 2020;3[12]:e2028117).

The two interventions were laparoscopic sleeve gastrectomy (LSG; n=1,684) and Roux-en-Y gastric bypass (RYGB; n=924).

“In prior VA-funded studies, we had evaluated several of the long-term benefits of bariatric surgery, such as survival, weight loss and medication discontinuation, but had not examined the longterm potential harms of surgery or any mental health outcomes,” said principal investigator Matt Maciejewski, PhD, a senior research career scientist at the Durham VA Center of Innovation and professor at Duke University, in Durham, N.C. For the current National Institute on Drug Abuse–funded study, “we recognized that we had a unique opportunity to examine changes in patient-reported unhealthy alcohol use, because the VA has been conducting mostly annual unhealthy alcohol screening since 2008 throughout its entire system,” Dr. Maciejewski said.

Eight years after LSG, nearly twice as many surgical patients (7.9% vs. 4.5%) had unhealthy alcohol use as control patients.

Likewise, eight years after RYGB, more than twice as many surgical patients (9.2% vs. 4.4%) had unhealthy alcohol use as control patients.

“The ability to evaluate changes in self-reported alcohol consumption in the two years before surgery was novel and confirmed what many had suspected: that reported drinking at the time of surgery was lower than baseline several years earlier,” Dr. Maciejewski said.

“However, additional research is needed to assess whether this finding was due to an actual decrease in consumption; or patients reported lower use, when in

‘These outcomes … suggest that ongoing annual screening after surgery could identify patients who would benefit from additional supports. The VA health system is a leader in screening for unhealthy alcohol use.’

reality there was no change, because patients wanted to maximize their chance of approval for bariatric surgery.”

The results indicate that patients should be screened using a validated measure of alcohol use before surgery, according to co-author Kathy Bradley, MD, MPH, a senior physician investigator at Kaiser Permanente Washington Health Research Institute, in Seattle.

—Kathy Bradley, MD, MPH

continued on the following page

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GENERAL SURGERY NEWS / MAY 2021

No Surprises Act Passes; Effect on Private Practice Unknown continued from page 1

Surprise bills typically occur when a patient with commercial insurance unknowingly receives care at an out-ofnetwork facility or from an out-of-network provider. That facility or provider can bill outside the limits of in-network rates, but if the insurer refuses to cover the charge in full, patients are often on the hook for the balance [GSN, August 2020, page 1. https://bit.ly/3x5V2Xb].

The No Surprises Act goes into effect on Jan. 1, 2022.

It prohibits out-of-network providers or facilities from balance billing patients in both emergency and nonemergency settings, including out-of-network air ambulances but not ground ambulance transport. In other words, patients will no longer be responsible for paying more than the in-network cost-sharing rate, which may include a commercial plan’s deductibles, coinsurance and copayments.

“Essentially, the new law takes patients out of the middle of insurers and health care providers—an outcome everyone can support,” said Patrick Bailey, MD, FACS, the medical director of the American College of Surgeons.

Although the legislation lays out a framework for banning surprise bills, several key details remain unwritten. These unknowns, and their potential consequences to providers’ income, have left some surgeons on edge.

Mit Desai, MD, a general surgeon at Lutz Surgical Partners, in Brooksville, Fla., expressed concern about how the federal legislation will affect his private practice. When Florida passed comprehensive surprise billing legislation in 2016, Dr. Desai’s business came under intense financial strain.

“Insurance companies disputed anything I submitted a claim for and we’d go through a process of negotiating,” Dr. Desai said. “It took nine months from when the Florida bill went into effect and when I first got paid by insurance.”

Dr. Desai ultimately had to hire a full-time employee to handle billing, but often still waits six to nine months for insurance companies to follow through on paying claims.

What We Know Ultimately, the No Surprises Act will protect more than 135 million Americans in employer-based plans regulated under the federal law known as the Employee Retirement Income Security Act (ERISA), and millions more in state-regulated plans in areas with no surprise billing legislation.

However, insurers and providers need a forum to settle payment disputes for out-of-network bills. The law maps out an independent dispute resolution process called “baseball-style arbitration”—an approach that only comes into play when insurers and providers fail to reach a voluntary agreement about a charge after 30 days.

In baseball-style arbitration, each party makes a payment offer and the arbitrator must select one of the two amounts. The losing party subsequently will pay the administrative costs of arbitration.

Alcohol continued from the previous page

“These outcomes also suggest that ongoing annual screening after surgery could identify patients who would benefit from additional supports,” she said.

‘Arbitration and consent waivers will have the biggest impact on surgeons’ income, but it will be a while before we know the nuts and bolts of the legislation and the specific details of those regulations.’

‘In going after these shady billing practices by private equity-backed companies, the little guy is getting slammed. I believe the No Surprises Act will be the last nail in the coffin for private practice.’

—Patrick Bailey, MD, FACS

—Eileen Natuzzi, MD

No payment standard exists, but an arbitrator can weigh a host of factors, including median in-network rates, a surgeon’s training, experience and quality, as well as the complexity of services provided. But the arbitrator cannot consider billed charges or Medicare and Medicaid rates.

The idea here, Dr. Bailey explained, is to encourage insurers and providers to come to an agreement before arbitration and dissuade excessively high or low payment offers during the process.

The No Surprises Act does include an exception to the balance billing protections, called a notice and consent waiver. In specific circumstances, certain out-ofnetwork providers can ask patients for written consent to send balance bills in the nonemergency setting. The notice must include details such as a good faith estimate of the charges, the fact that the provider or facility does not participate in the patient’s health plan, and a list of in-network physicians or facilities where the patient can receive care instead. The law also bars specialties with a history of balance billing from using these waivers.

“These two categories—arbitration and consent waivers—will have the biggest impact on surgeons’ income, but it will be a while before we know the nuts and bolts of the legislation and the specific details of those regulations,” Dr. Bailey said.

What We Don’t Know Surgeons don’t yet know how two key aspects of the legislation will play out in real time.

The first one is arbitration decisions. If arbitrators base their payment picks on the insurer’s median innetwork rates—the amount an insurer pays other local doctors for the same service—health care costs will likely decline, as will physician income.

Calculating median in-network rates depends on many variables, including what constitutes a geographic region and how to deal with newly covered services or providers.

Some providers argue that relying on median in-network rates as a benchmark will give health plans an incentive to reduce these rates, for example, by terminating

“The VA health system is a leader in screening for unhealthy alcohol use.”

Dr. Bradley previously validated the screening and collaborated on its implementation. “These annual screening results provided unique opportunity to be able to track long-term postsurgical

in-network contracts that raise the average rate.

For venture capital‒backed physician groups, which are responsible for the lion’s share of surprise bills, relying on median in-network rates will likely minimize inflated charges. But for the private practice surgeons who have faced declining reimbursement rates for years, a further reduction in reimbursement may mean a death sentence for their business.

“The venture capital groups who have purchased specialty physician groups have killed it for everyone,” said Eileen Natuzzi, MD, an acute care surgeon in California. “In going after these shady billing practices by private equity‒backed companies, the little guy is getting slammed. I believe the No Surprises Act will be the last nail in the coffin for private practice.”

The outcomes of arbitration also may affect health insurance premiums, but it’s unclear in which direction.

The Congressional Budget Office estimates that the federal law will reduce commercial insurance premiums by between 0.5% and 1%, if insurers win in arbitration.

Alternatively, some experts worry that premium costs could rise if insurers lose in arbitration.

The second uncertainty is how exactly the federal law will interact with existing state laws. The answer, Dr. Bailey said, depends on whether a person has a federal-regulated plan or a fully insured state-regulated plan.

For the 18 states that have comprehensive surprise billing legislation, the federal law defers to the state regulations for fully insured plans. However, because states cannot regulate employer-based plans, which fall under ERISA, the federal regulations take precedence. State laws will also remain primary when state-level requirements extend beyond those detailed in the new federal law.

“In states with their own laws, there is a potential for very different outcomes on claims for similar services depending on whether the patient’s plan is subject to state or federal regulations,” Dr. Bailey said. “This could create confusion for the out-of-network surgeon when determining what steps can be taken regarding a payment from an insurer.”

■

alcohol use that is unlike data in any other health system in the world at this point,” she said.

Still, trials are needed to test whether alcohol interventions at the time of surgery can decrease postoperative unhealthy alcohol use, according to Dr. Bradley.

“Also, our study results should be replicated in other settings, in larger samples of women, and assess the development of alcohol use disorders,” she said. “That future research should use biomarkers to determine whether changes in reporting contribute to findings.”

■

CLASSIFIEDS

MAY 2021

GENERAL SURGEON BETH ISRAEL DEACONESS PLYMOUTH The Division of General Surgery at Beth Israel Deaconess Medical Center (BIDMC)/ Beth Israel Lahey Health (BILH) is seeking a general surgeon who will be primarily based at our Beth Israel Deaconess Hospital-Plymouth location in Plymouth, Massachusetts. The surgeon will also hold clinical privileges at Beth Israel Deaconess Medical Center in Boston.

Applicants must be board-certified/board-eligible in general surgery. Candidates with fellowship training or special qualifications in advanced laparoscopy are preferred. The successful candidate for this position may be considered for Harvard Medical School appointment at the rank of Instructor, Assistant Professor or Associate Professor, commensurate with experience, training and achievement in the field.

BIDH-Plymouth is an acute care, 150-bed community hospital serving 12 towns in Plymouth and Barnstable counties and is the largest hospital in the southern region of the South Shore.

Beth Israel Deaconess Medical Center is a part of is part of Beth Israel Lahey Health, a new health care system of academic medical centers and teaching hospitals, community and specialty hospitals with more than 4,000 physicians and 35,000 employees in a shared mission to expand access to great care and advance the science and practice of medicine through groundbreaking research and education.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions or any other characteristic protected by law. Women and underrepresented minorities are particularly encouraged to apply. Applications are made online at www.hmfphysicians.org/careers. Please respond to requisition: 201496

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21

22

OPINION

GENERAL SURGERY NEWS / MAY 2021

When Both Sides Are Wrong

By BRUCE RAMSHAW, MD, FACS

“While many empirical conclusions are, … correct; … the presages of a weatherwise sailor or hunter may be more accurate … than those of a scientist who relies wholly upon scientific observations and tests; while, indeed, empirical observations and records furnish the raw or crude material of scientific knowledge, yet the empirical method affords no way of discerning between right and wrong conclusions. Hence it is responsible for a multitude of false beliefs. The technical designation for one of the commonest fallacies is post hoc, ergo proper hoc; the belief that because one thing comes after another, it comes because of the other.”

—John Dewey, “How We Think” – Chapter 11, 1910

I

n 2005, less than a year after I started as the chief of general surgery at the University of Missouri, I was scanning the contents of that quarter’s Mizzou magazine. An article caught my eye because it highlighted the work of a biological engineer named Sheila Grant.

The focus of the article was her expertise in researching materials designed for implantable medical devices.

Because we use synthetic materials for most adult hernia repairs, I thought she might want to work with our hernia team.

After a brief introduction in our first meeting, Sheila asked me what material we use for hernia mesh. When I told her that the most common synthetic polymer used in hernia mesh was polypropylene, her jaw dropped, and she exclaimed, “You can’t put that in human beings; it’s going to degrade in the body.” I replied, “But we put it in about a million people a year just in the United States alone.”

I was shocked to hear her response, and my initial thought was that she had to be “wrong,” and I was obviously “right” because I’m a hernia expert. But we had just met, and she was nice. I didn’t want to start an argument, so I kept that opinion to myself. We had a nice dialogue, which led to a collaboration and friendship that continues to this day.

The interaction between hernia mesh and the human body was the first complex problem I investigated after learning the need to use systems and data science principles to understand the real world’s uncontrollable biological variability. Sheila and her husband, Dave, a mechanical engineer, decided to work with our hernia team on this complex issue.

We started a materials characterization lab and began to analyze mesh after removing it from patients, usually for symptoms of chronic pain, infection and/or a

GI Complications continued from page 16

Lebanon, N.H., and Geisel School of Medicine, in Hanover, N.H. There are limitations to the study.

The researchers didn’t look at the specific factors are top-ranked hospitals that are associated with improved outcomes, things like nursing ratios or ICU

recurrent hernia. The material removed from the body complex disease such as COVID-19. In the article, he often looked different, and was sometimes hard and notes that the concept of a static, linear scientific methmore brittle, compared with the soft and flexible mate- od—the PRCT—was taken from only one paragraph in rial that comes out of the package. But here’s the inter- the book “How We Think,” by John Dewey, published esting thing: This didn’t occur in all mesh explants, and in 1910. The “method” was simplified to be put into it occurred to different degrees in different patients. It textbooks to teach children how to do science. This was even could be different in different parts of the same never the intent of Dewey, who described many other mesh. ways of learning and discovery. ScienFor a while, this was difficult for tists know that this representation of This kind of false me to understand. I was taught that the scientific method is not how scidichotomy in the face mesh was inert, meaning it would ence works in the real world. not change after being implanted. In in health care, we still attempt of a complex problem is to But my lectures, I said the most imporuse an invalid scientific method to tant part of doing a hernia repair with tragic because it creates deal with complex disease. It doesn’t mesh was the technique. Placing the work, and it leads to the divisiveness an ‘us versus them’ mesh with good technique would lead I described above. We feel we have to health care system and choose between two options: antibito perfect results.

But in our analysis of explanted otics or surgery to treat appendicitis; society. It leads to a mesh, Sheila and I learned that we “I’m pro-mesh or anti-mesh for hernia situation where both were both wrong, at least for some repair”; “I’m pro-mask or anti-mask in patients. For most patients who have places during a pandemic.” This sides are wrong because public a hernia repaired with mesh, the mesh kind of false dichotomy in the face of performs fine. But in some patients, the situation is complex, a complex problem is tragic because the mesh may have been a contriban “us versus them” health and there is no one right itcarecreates uting factor that leads to an uninsystem and society. It leads to a answer, but both sides situation where both sides are wrong tentional complication. When I first learned this, it made my brain hurt. the situation is complex, and believe they are right. because It was hard for me to understand that there is no one right answer, but both the same mesh, placed the same way, sides believe they are right. ts could in two different patients Lower bra brain, reductionist principles undergo vastly different changes lead to frag fragmentation and divisiveand result in different outcomes. comes. ness, nes causing us to believe Before this experience, nce, I we w must prove we’re right. believed that the best, most We need to evolve to a powerful way to learn in health higher brain mindset care was to test a hypothehewhere we are comfortsis using a prospective able with uncertainrandomized controlled ty. We can then work trial (PRCT). The together, using systems PRCT is the reductionand data science principles, ist science gold standard to deal dea with all of our complex, for the scientific methreal-world real-wo problems, including od. The goal is to prove orr this pa pandemic.

■ disprove a hypothesis. But when we use a reductionn—Dr. Ramshaw is a ist tool like this, we cregeneral surgeon and ate a false dichotomy of data scientist from only two options: right or Knoxville, Tenn., wrong. Our lower brain craves and a managing partner at CQInsights. this facade of certainty, but it has a harmful effect—the He is a member of the editorial advisory board of General divisiveness it creates. Our lower brain falsely entices us Surgery News. to pick a side (e.g., for or against mesh).

One science historian, Henry Cowles, recently pub- Editor’s note: Opinions in General Surgery News lished a book and an article that explains why the reduc- belong to the author(s) and do not necessarily reflect tionist scientific method is ill-equipped to deal with a those of the publication.

capacity. If these components were identified, lower-performing hospitals could make changes to improve patient care, Dr. Loehrer noted.

He added that patients consider factors besides operative mortality when deciding where to go for surgery. They weigh variables such as proximity to home and their relationship with the surgical team.

In addition, they don’t necessarily have a

choice of where they can go, he said.

“There’s much more work to be done understanding how we can better improve the access and quality of care for all folks,” Dr. Loehrer said.

Niraj Gusani, MD, MSc, the chief of surgical oncology at the Baptist MD Anderson Cancer Center in Jacksonville, Fla., said the high volume of surgery done at top-ranked hospitals shows

that complex operations have become more concentrated at larger hospitals as the evidence mounted to support a volume–outcomes relationship. That’s good for surgical patients, he said.

“The other key message here is that this is a paper about surgical outcomes but it’s also about cancer, and we need to think about all facets of cancer care,” Dr. Gusani said.

■

Important Safety Information (continued) Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra is also contraindicated in patients with disseminated intravascular coagulation. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT).

Hypersensitivity reactions to Kcentra may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment.

In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

Kcentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

KCENTRA® (Prothrombin Complex Concentrate [Human]) For Intravenous Use, Lyophilized Powder for Reconstitution Initial U.S. Approval: 2013

• Administer reconstituted Kcentra at a rate of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min (~210 units/min).

Pre-treatment INR

BRIEF SUMMARY OF PRESCRIBING INFORMATION

Dose* of Kcentra (units† of Factor IX) / kg body weight

These highlights do not include all the information needed to use Kcentra safely and effectively. See full prescribing information for Kcentra.

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding.

• Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Kcentra in clinical trials and post marketing surveillance. Monitor patients receiving Kcentra for signs and symptoms of thromboembolic events.

• Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra may not be suitable in patients with thromboembolic events in the prior 3 months.

------------------------------------INDICATIONS AND USAGE---------------------------------Kcentra, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with: • acute major bleeding or • need for an urgent surgery/invasive procedure.

-----------------------------DOSAGE AND ADMINISTRATION--------------------------------For intravenous use after reconstitution only.

• Kcentra dosing should be individualized based on the patient’s baseline International Normalized Ratio (INR) value, and body weight.

• Administer Vitamin K concurrently to patients receiving Kcentra to maintain factor levels once the effects of Kcentra have diminished.

• The safety and effectiveness of repeat dosing have not been established and it is not recommended.

Maximum dose‡ (units of Factor IX) *

† ‡

2–< 4

4–6

>6

25

35

50

Not to exceed 2500

Not to exceed 3500

Not to exceed 5000

Dosing is based on body weight. Dose based on actual potency is stated on the vial, which will vary from 2031 Factor IX units/mL after reconstitution. The actual potency for 500 vial ranges from 400-620 units/vial. The actual potency for 1000 unit vial ranges from 800-1240 units/vial.

Units refer to International Units.

Dose is based on body weight up to but not exceeding 100 kg. For patients weighing more than 100 kg, maximum dose should not be exceeded.

---------------------------------DOSAGE FORMS AND STRENGTHS-------------------------• Kcentra is available as a white or slightly colored lyophilized concentrate in a single-use vial containing coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S. --------------------------------------CONTRAINDICATIONS -----------------------------------Kcentra is contraindicated in patients with: • Known anaphylactic or severe systemic reactions to Kcentra or any components in Kcentra including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin.

• Disseminated intravascular coagulation.

• Known heparin-induced thrombocytopenia. Kcentra contains heparin.

----------------------------------WARNINGS AND PRECAUTIONS---------------------------• Hypersensitivity reactions may occur. If necessary, discontinue administration and institute appropriate treatment.

• Arterial and venous thromboembolic complications have been reported in patients receiving Kcentra. Monitor patients receiving Kcentra for signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thrombotic or thromboembolic (TE) event within the prior 3 months. Kcentra may not be suitable in patients with thromboembolic events in the prior 3 months.

• Kcentra is made from human blood and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

-----------------------------------ADVERSE REACTIONS---------------------------------------• The most common adverse reactions (ARs) (frequency * 2.8%) observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. (6) • The most serious ARs were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis.

To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring at 1-866-9156958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Revised: October 2018

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When time is essential, it’s time for Kcentra

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*Effective hemostasis measured up to 24 hours for the Acute Major Bleeding trial and until the end of procedure (up to 24 hours) for the Urgent Surgery/Invasive Procedures trial. Rapid INR reduction to ≤1.3 at 0.5 hours after end of infusion. †In 2 head-to-head trials, Kcentra demonstrated superiority to plasma in 3 of 4 efficacy endpoints. Superior hemostatic efficacy in the Urgent Surgery/Invasive Procedures trial and equally effective hemostasis in the Acute Major Bleeding trial. Faster INR reduction (to ≤1.3 at 30 minutes after end of infusion) in both head-to-head trials. ‡8 hours for Urgent Surgery/Invasive Procedures trial and 12 hours for Acute Major Bleeding trial. Administer vitamin K concurrently to patients receiving Kcentra. Vitamin K is administered to maintain vitamin K-dependent clotting factor levels once the effects of Kcentra have diminished.

Important Safety Information Kcentra is a blood coagulation factor replacement indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Kcentra is for intravenous use only.

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events.

Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events.

Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months.

Please see additional Important Safety Information and the brief summary of full prescribing information on adjacent page.

Kcentra is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC. Kcentra® is a registered trademark of CSL Behring GmbH. Biotherapies for Life® is a registered trademark of CSL Behring LLC. ©2020 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA www.CSLBehring.com www.Kcentra.com KCT-0320-AUG20