General Surgery News (June 2020) by McMahon Group

What Is the First Step to Fixing Health Care? (See insert at page 4)

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

June 2020 • Volume 47 • Number 6

Many U.S. Hospitals Already In the Red—Then COVID-19 Hit

ABS Certification Linked to Fewer Disciplinary Actions

Rural Hospitals Particularly Affected; Will Government Relief Be Enough?

By JORDAN DAVIDSON

By ALISON McCOOK

OVID-19 has created a financial crisis for many U.S. hospitals, with no easy way out. The math is simple: During the pandemic, hospitals lost a huge source of revenue from elective surgeries while experiencing a dramatic uptick in costs, as facilities purchase more gear to cope with the surge of infected patients, some of whom are uninsured. “They are Continued on page 8

ertification from the American Board of Surgery is optional, but surgeons are incentivized to obtain it since many hospitals and insurance reimbursements require certification, making it a de facto requisite for many. Certification is not obtained easily, however: Doctors must pass both written and oral exams to demonstrate a thorough understanding of best practices and agility in various surgical situations. Now, a new study has shown that doctors who receive ABS certification are less likely to receive severe disciplinary actions against their medical license. The study, conducted Continued on page 19

Is Surgery Ready For Telemedicine?

Restarting Metabolic And Bariatric Surgery

COVID-19 Pushes Surgeons Toward Virtual Care

Surgeons From U.S., China Share Insights and Lessons Learned

By VICTORIA STERN

By KATE O’ROURKE

he coronavirus pandemic has transformed the use of telemedicine. Before COVID-19 hit, many surgeons did not consider remote visits an option because of poor reimbursement and concerns about HIPAA compliance. But shortly after the U.S. surgeon general and Centers for Medicare & Medicaid Services asked hospitals and health systems to postpone nonessential surgical procedures in mid-March, many surgeons found themselves in a difficult situation. “No one had much warning about COVID-19 or much time to prepare in an intentional way,”

or bariatric surgeons eager to resume a regular surgery schedule, the COVID-19 pandemic presents unprecedented challenges. During a recent American Society for Metabolic and Bariatric Surgery webinar, experts provided tips and advice for restarting metabolic and bariatric procedures. “We are still learning. Every single day, there is more information coming out, and it’s really important that if we think we know something, to keep our ears and eyes open because our collective knowledge and understanding are progressing so

Continued on page 18

J OURNAL WATCH

4 Summary of Recent Useful Studies ON THE SPOT

12 Dueling Debates in Colorectal Surgery OP IN ION

22 Teleflubbies By Linda Wong, MD

Continued on page 16

REPORT

Clinical Experience With a Non-Opioid Local Analgesic Alternative for Postsurgical Pain Management in the Ambulatory Setting See Insert at page 12

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OPINION

Pandemics and Epidemics What’s Been Plaguing Us By HENRY BUCHWALD, MD, PhD

“I wish it need not have happened in my time,” said Frodo. “So do I,” said Gandalf, “and so do all who live to see such things. But that is not for them to decide. All we have to decide is what to do with the time that is given us.” —J.R.R. Tolkien, ‘The Lord of the Rings’

ur time is the time of the COVID-19 pandemic. Daily, even hourly, we are besieged with statistical data, at times inaccurate because of an over- or underestimated variable; sensationalist journalism about an unpredictable death or an astonishing survival; predictions based on assumptions; Continued on page 20

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Philip R. Schauer, MD (Co-Director) John B. Dixon, MBBS, PhD, FRACGP, FRCP, Edin (Co-Director) Cheguevara Afaneh, MD Ali Aminian, MD Eric J. DeMaria, MD Neil Floch, MD

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CVD OUTCOMES OF NEW DIABETES AGENTS: GLP1, SGLT2 Lee M. Kaplan, MD, PhD Harvard Medical School

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IN THE NEWS

JUNE 2020 / GENERAL SURGERY NEWS

PPE and Patient Testing in the Era of COVID-19 By KATE O’ROURKE

s the COVID-19 pandemic continues to plague the world, various groups are issuing guidance on restarting and expanding elective surgeries. During a recent joint webinar from the American Society of Anesthesiologists (ASA) and American College of Healthcare Executives (ACHE), Mary Dale Peterson, MD, the president of the ASA, reviewed recommendations on patient testing and personal protective equipment (PPE). According to the ASA and ACHE, all patients should be screened for COVID19 symptoms before arriving at the hospital, and all patients should undergo nucleic acid amplification testing, including polymerase chain reaction tests, for SARSCoV-2 before nonemergent surgery. Attention should be given to mitigating false-negative tests. If a patient tests positive for SARS-CoV-2, elective surgical procedures should be delayed until the patient is no longer infectious and has demonstrated recovery from COVID19. Policy should contemplate CDC test– based and non–test-based strategies. The ASA/ACHE recommendation states that the evaluation of sufficient

recovery by a patient should include an assessment of the patient’s exercise capacity (metabolic equivalents, or METS), and that antibody testing should not be used for preoperative screening. Antibodies develop in the second week of symptoms, and not all patients who are infected with SARS-CoV-2 will develop detectable antibodies. Dr. Peterson said according to the ASA and Anesthesia Patient Safety Foundation (APSF), regardless of screening and testing, appropriate PPE (masks, eye protection, gowns, gloves) should be worn for all patients. “This is especially true for aerosol-generating procedures (AGPs), which should require an N95 mask or equivalent of that and eye protection (face shields/goggles),” Dr. Peterson said. AGPs include intubation and extubation, bag–valve–mask ventilation, bronchoscopy, electrocautery of blood and gastrointestinal tissue, laparoscopy, endoscopy, and ear nose and throat procedures. “AGPs are anything that would involve a lot of coughing, anything that you are really involved in the airway and could potentially generate these microdroplet aerosols,” Dr. Peterson said. For high-risk patients, those who have

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GENERAL SURGERY NEWS / JUNE 2020

Primary Fascial Closure During Laparoscopic Ventral Hernia Repair

ith a plethora of surgical journals available to readers, it can sometimes be overwhelming to find useful, reliable articles to help guide changes in practice. Journal Watch, a new recurring column in General Surgery News, hopes to provide readers with a quick review of recent journal articles that may be relevant to the scope of a general surgeon’s practice, a discussion of the salient limitations, and pertinent related articles that may be worthwhile on the same topic.

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

Column Editor

Bernardi et al provide evidence for primary fascial closure (PFC) during laparoscopic ventral hernia repair (VHR; Ann Surg 2020;271[3]:434-439). PFC, which is often accomplished in open hernia repairs, is still not a widely adopted practice with laparoscopic repairs despite its purported benefits. More commonly, a laparoscopic VHR is bridged, such that a mesh layer is used to patch across the defect and provide a bridge between the separated muscle/fascia layers, leaving the fascial defect open. In this multicenter, blinded, randomized controlled trial (RCT), 129 patients undergoing an elective laparoscopic VHR with defects measuring 3 to 10 cm were randomized to either mesh hernia repair using a bridged technique or PFC. Follow-up was planned at one month after the operation and then at one and two years postoperatively. The primary outcome was change in quality of life using a validated hernia-specific quality-of-life survey, the modified Activities Assessment Scale (a scale of 1-100), which considers pain, function, cosmesis and patient satisfaction. A total of 107 patients completed the two-year follow-up. There was no difference in secondary outcomes of hernia recurrence, abdominal eventration and postoperative surgical site occurrences (SSOs)—including wound dehiscence, surgical site infections (SSIs),

Article

Journal

Type of Study

Primary Fascial Closure (PFC) During Laparoscopic Ventral Hernia Repair Improves Patient Quality of Life: A Multicenter, Blinded Randomized Controlled Trial

Ann Surg 2020;271(3): 434-439

Randomized controlled trial

Published in March

Key Takeaways • PFC has an on-average higher improvement in quality of life than bridged repairs

seroma and hematoma—between the two groups. Changes in pain scores and chronic pain scores were not different between the two groups. Quality-of-life scores increased for both groups, but those in the PFC group had on average a 12-point higher improvement in quality-of-life score, compared with the bridged group. The study authors should be lauded for carrying out this RCT with the often difficult two-year follow-up in hernia patients. Closure of the fascial defect during hernia repair is often a sticking point for surgeons and a reason to opt for an open versus laparoscopic versus robotic repair. In this study, PFC increased the length of operative time (13 minutes on average) but produced higher improvements in quality-of-life scores (12 points higher on average) than bridged repairs. Strikingly, outcomes such as hernia recurrence and seroma formation, which has been shown to be superior in laparoscopic repairs with PFC in a prior systematic review by the same group, showed no difference in this RCT. Qualityof-life scores improved with laparoscopic VHR, whether a bridged repair or PFC was performed. The higher on-average improvement in quality of life in the PFC group should be a consideration for adopting the PFC technique during laparoscopic hernia repair. Multiple methods of fascial closure during hernia repair, including those described in the article by Palanivelu et al in 2007 using a running intracorporeal suture, by Agarwal et al in 2008 using the “doublebreasted” technique, or by Orenstein et al in 2012 using

Words of Caution When Reading • Both PFC and bridged repairs improve quality of life • The PFC group had lower quality of life at baseline

• PFC increases operative duration by 13 minutes, on average

J Gastrointest Surg

Review article

2020 Apr 13. [Epub ahead of print]. doi: 10.1007/s11605020-04592-9

Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial

JAMA Surg 2020;155(3): 233-242

Safety and Efficacy of Synthetic Mesh for Ventral Hernia Repair in a Contaminated Field

J Am Coll Surg. 2020;230(4): 405-413

• No clear evidence on COVID-19 transmission via laparoscopy or robotic surgery

Nguyen DH, Nguyen MT, Askenasy EP, et al. World J Surg. 2014;38(12):3097-3104

Palanivelu C, Jani KV, Senthilnathan P, et al. Hernia. 2007;11(3):223-228

All recommendations are extrapolated from studies evaluating other viruses

Alp E, Bijl D, Bleichrodt RP, et al. J Hosp Infect. 2006;62(1):1-5

• Large proportion of minimally invasive surgery

Gillis C, Li C, Lee L, et al. Anesthesiology. 2014;121(5):937-497

• Missing follow-up data from almost 50% the rehabilitation group

Barberan-Garcia A, Ubré M, Roca J, et al. Ann Surg. 2018;267(1):50-56

• Type of study may have potential selection bias

Carbonell AM, Criss CN, Cobb WS, et al. J Am Coll Surg. 2013;217(6):991-998

• Case type is not evenly distributed; majority performed open, with myofascial release and permanent synthetic mesh placed in retromuscular position

García-Ureña MÁ, López-Monclús J, Hernando LA, et al. Ann Surg. 2015;261(5):876-881

Ong SWX, Tan YK, Chia PY, et al. JAMA. 2020;323(16):1610-1612

• Multiple safety precautions to reduce virus aerosolization and exposure Randomized controlled trial

• Adherence to a perioperative program was higher in the prehabilitation group • No statistical difference in CCI, LOS, PROs, readmissions, ED visits and 6MWT

Published in April

Agarwal BB, Agarwal S, Gupta MK, et al. J Laparoendosc Adv Surg Tech A. 2008;18(2):222-229

Orenstein SB, Dumeer JL, Monteagudo J, et al. Surg Endosc. 2011;25(5):1452-1457

• No difference in secondary outcomes such as recurrence and surgical site infections What Is the Appropriate Use of Laparoscopy Over Open Procedures in the Current COVID-19 Climate?

Useful Related Articles

Retrospective review from a single center

• Permanent synthetic mesh used in the retromuscular space may provide superior results over biologic and absorbable synthetic mesh use in contaminated settings

• Almost 50% of patients (266) had less than one-year follow-up

López-Cano M, Quiles MT, Pereira JA, et al. Am Surg. 2017;83(6):583-590 Majumder A, Winder JS, Wen Y, et al. Surgery. 2016;160(4):828-838 Breuing K, Butler CE, et al. Surgery. 2010;148(3):544-558

6MWT, six-minute walk test; CCI, Comprehensive Complication Index; ED, emergency department; LOS, length of stay; PFC, primary fascial closure; PROs, patient-reported outcomes

JOURNAL WATCH

JUNE 2020 / GENERAL SURGERY NEWS

the “shoelacing” technique (Table), can be incorporated into practice to provide PFC during laparoscopic hernia repair and potentially improve patients’ quality of life.

Appropriateness of Laparoscopic Surgery During the COVID-19 Pandemic Vigneswaran et al attempt to provide guidance for the appropriate use of laparoscopy over open procedures in light of the growing COVID-19 pandemic (J Gastrointest Surg 2020 Apr 13. [Epub ahead of print]. doi: 10.1007/s11605-020-04592-9). Given the relative infancy and rapid spread of COVID-19, there is a lack of specific clinical knowledge on the virus, its aerosolization and transmission via laparoscopy. The information provided by the authors is derived from the limited published articles on laparoscopy and viral transmission. Based on an 11-patient study of hepatitis B virus and a handful of HPV studies evaluating surgical smoke, the authors conclude: “Historically, there has not been any proven ability for a virus to be transmitted during surgical treatment whether open or laparoscopic.” However, knowing transmission of COVID-19 occurs via respiratory droplets, COVID-19 virus RNA can be found in the fecal matter of patients, and laparoscopy, pneumoperitoneum and surgical smoke can aerosolize known viruses such has HBV, there remains concern for the potential ability of COVID-19 to be transmitted via laparoscopy. The authors review the varying recommendations provided by surgical societies in regard to laparoscopy, and provide a review of the various methods to reduce the risk for viral transmission. Theoretical hazards of virus exposure from energy device usage and benefits of commercial smoke evacuators and “homemade” smoke evacuators are reviewed. Potential modifications, such as lowered intraabdominal pressures and trocar sizing, are also presented. Given the paucity of data on COVID-19 and surgery, the authors make a valiant attempt at extrapolating from prior studies and adapting known precautionary measures to provide useful recommendations in reducing an unknown risk during laparoscopy. In this uncertain time, precautions such as use of appropriate personal protective equipment, minimizing energy devices, lowering pneumoperitoneum, and ensuring closed circuit smoke evacuation should be used at all times.

Prehab Versus Post-op Rehab for Colorectal Cancer Surgery Carli et al describe findings evaluating the effect of preoperative prehabilitation versus the more traditional postoperative rehabilitation on 30-day postoperative complications in frail patients undergoing colorectal cancer surgery in two Canadian hospitals (JAMA Surg 2020;155[3]:233-242). A total of 110 patients underwent surgery with the same in-hospital enhanced recovery pathway. Fifty-five patients underwent a four-week–long prehab program that included attention to exercise (once-weekly inperson session of moderate aerobic exercise, resistance training, and stretching combined with a prescribed home-based program), nutrition, and psychological assessments and interventions. Fifty-five patients in the rehab group underwent treatment for four weeks of the same program, but only after discharge from the hospital. The researchers used the Comprehensive Complication Index (CCI), a validated calculated score

integrating all complications, as a measure of postoperative morbidity as the primary outcome. Secondary outcomes included length of stay (LOS), readmission, emergency department visits, a six-minute walk test (6MWT) and patient-reported outcomes. The majority of the procedures were minimally invasive (76.34% in the prehab group, and 84.8% in the rehab group). Adherence to the overall program was much better in the prehab group compared with the postoperative rehab group (80% vs. 30%). Complete data on the type of operation, CCI, LOS, readmission and emergency department visits were obtained on all 110 patients through the medical record. Although preoperative baseline data were complete on all patients, 6MWT, patient-reported outcomes and four-week postoperative data were incomplete for many patients secondary to missed visits, such that 70.9% in the prehab group and 56.4% in the rehab group completed a four-week postoperative visit. The authors claim that “analysis was conducted using multiple imputation by chained equations and predic-

Prehab into all surgeons’ and health care systems’ preoperative processes before elective surgery should be considered when possible.

tive mean matching under the assumption that data were missing at random” in order to reduce any potential bias from the missing data from missed visits. After analysis, the researchers found there was no statistical difference in primary or secondary outcomes between the prehab and rehab groups. This randomized trial helps to show the difficulty in follow-up of patients enrolled in studies. More than one-third of patients (40) were not evaluated at four weeks. If anything, it demonstrates that patients are highly motivated before surgery, such that adherence to the program was much better in the prehab group. Because the majority of participants underwent minimally invasive procedures, which have been shown to be superior to open surgery in terms of postoperative recovery, pain control and 30-day morbidity, it is difficult to extrapolate the study’s results for all surgical patients and determine whether the type of surgery, rather than the intervention, affects outcomes. Subanalysis of the minimally invasive and open groups may have provided further information. In contrast, other studies (Gillis et al 2014, Barberan-Garcia et al 2018; Table) show the promise of prehab in improving the postoperative recovery of surgical patients. In the ever-present desire to improve patient outcomes, increase efficiency, and lower health care costs, prehab as part of all surgeons’ and health care systems’ preoperative processes before elective surgery should be considered when possible.

Contaminated VHR Outcomes And Type of Closure Warren et al describe their findings comparing the clinical outcomes of 541 contaminated VHRs in a retrospective review from a single institution from 2007 to 2019, based on type of closure: suture repair, permanent synthetic mesh (PSM) repair, absorbable synthetic mesh repair and biologic mesh repair (J Am Coll Surg 2020;230[4]:405-413). Clinical outcomes evaluated included surgical site occurrence (SSO), surgical site infection (SSI), SSO or SSI requiring procedural intervention, operative time, hospital LOS, readmission, reoperation and hernia recurrence. The prospectively maintained Americas Hernia Society Quality Collaborative database along with an internal hernia database for patients before June 2013 were used to obtain patient, operative and outcome details for all VHRs classified as clean–contaminated, contaminated and dirty, with an average follow-up of 55 months. Use of these prospective, surgeon-entered databases provides specifics, such as care management and operative technique, not commonly found in other databases. These granular data are often more useful to surgeons wanting to affect their practice, such as which mesh to choose and where to place it. Detailed tables are provided in the article on patient characteristics, operative details and outcomes. Of the 541 patients, 245 (45.3%) VHRs were clean– contaminated, 214 (39.6%) were contaminated, and 82 (15.2%) were dirty. Evaluation of VHR method revealed the majority of hernias were performed open (472; 87.3%), were repaired with PSM (402; 74.3%), required a myofascial release (428; 79.11%), achieved PFC (515; 95.19%), and had mesh placed in a retromuscular position (406; 75.05%). There was no difference in the rates of SSO and SSI requiring intervention, readmission and need for mesh removal between groups. The rate of hernia recurrence was significantly lower in the PSM group. The rate of reoperation, SSI, wound opening and percutaneous drainage was significantly lower in the PFC and PSM groups. Using multivariate analysis, only chronic obstructive pulmonary disease and dirty wound class were significant risk factors for developing an SSI. Mesh type was not a determinant for developing an SSI. Because this was a single-center, retrospective review of prospectively collected data, there are limitations to the study, such as potential selection bias and a notable preference toward a method of repair: open, retromuscular, PSM. Although the Ventral Hernia Working Group recommended, in 2010, use of biologic mesh when contamination is suspected, this study helps to support prior work demonstrating comparable—if not better—outcomes, with using PSM over biologic and absorbable synthetic materials in contaminated settings (García-Ureña et al 2015, Majumder et al 2016, LópezCano et al 2017; Table). This study should help to better inform surgeons on surgical technique and mesh choice during contaminated VHR, especially with the judicious “use of large-pore, monofilament polypropylene mesh in an extraperitoneal plane, ideally the retromuscular space, for repair of contaminated VHR.” Excitingly, there is an RCT in the works by Michael Rosen, MD, evaluating biologic versus synthetic mesh in clean–contaminated and contaminated VHR, which should prove useful in guiding the practice of mesh use (ClinicalTrials.gov Identifier: ■ NCT02451176).

OPINION

GENERAL SURGERY NEWS / JUNE 2020

Medical History: How the World Responds to Pandemics In Many Ways, Not Much Has Changed Over the Millennia By JUSTIN BARR, MD, PhD

OVID-19 has thus far killed an estimated 375,000 people and infected another 6 million, both numbers gross underestimates expected still to increase. It has reshaped the way we live and die, altered international politics, and caused incalculable economic damage. Yet for all its cataclysmic effects, COVID-19 is but the most recent global pandemic. From Thucydides’s description of the Plague of Athens in roughly 430 B.C.E. to the coronavirus today, a series of infectious diseases have swept around the world, killing millions. Despite their biological differences and chronological separation, these events have elicited remarkably similar medical and social responses. Examining these parallels provides both clarity and perspective on the current pandemic.

The ‘Kübler-Ross’ Stages Of a Society’s Response to Pandemics In 1969, Elisabeth Kübler-Ross published her now-famous model expositing different stages of grief and bereavement. Medical historians such as Charles Rosenberg and Steven Peitzman have elucidated a similar series of stages explaining how societies cope with pandemics such as COVID-19. Like the Kübler-Ross system, this model does not imply a strict progression, but it nonetheless provides a useful framework to help understand how society approaches and responds to a frightening, seemingly existential threat (Figure).

Denial/Delayed Acceptance Throughout history, societies and individual citizens have been slow to accept the arrival of pandemics. Sometimes, this reluctance is strategic: The 1918 Spanish flu got its name because other countries with the disease refused to admit the problem in an effort to maintain military advantage. In other cases, economic reasons predominate, like the slow recognition of the 1897 yellow fever epidemic in New Orleans, in an effort to stave off quarantine and the commercial implications thereof.

1. Denial, delayed acceptance that a pandemic is underway

Denial exists not just at the governmental level but also with individual citizens who fear for their lives and livelihoods. We continue to witness evidence of delayed acceptance. China, after a globally criticized effort to hide the 2002 severe acute respiratory syndrome pandemic, once again downplayed and attempted to mask the extent of COVID-19. Other countries, including the United States, only gradually and begrudgingly accepted that a pandemic was looming; governors declined to mandate stay-at-home orders as late as April, despite epidemiological evidence of their benefits. Individuals continue to defy medical advice, choosing to believe the disease is neither as prevalent nor as serious as public health officials declare. Problematically, the longer it takes to recognize and acknowledge the presence of a pandemic, the greater the difficulty with controlling the disease.

Plague in an Ancient City by Michiel Sweerts, c. 1652.

Panic Viewed historically, pandemics wax and wane. In the immediacy of the attack, however, potentially affected countries and people who have never experienced these events in their lifetimes lack this perspective and respond with the most human of behaviors: irrational panic. This hysteria has led to the almost absurd run on toilet paper, for a disease that rarely causes diarrhea. More commonly, it leads to flight. From Boccaccio’s “The Decameron,” set in 1348 Florence, Italy; to the 1665 Great Plague in London; to cholera infecting New York in 1832; to the coronavirus today, people—mostly the wealthy—have tended to flee cities for the surrounding countryside, presuming the lower population density and bucolic environs will protect them from the scourge. More concerningly, pandemics foster xenophobia. Fearing outsiders spreading disease led to the widespread massacre of Jewish people in 14th-century Europe, exclusion of Italian and Irish immigrants from the United States in the 19th century due to concerns of cholera and typhoid, and recently, scapegoating Asian people for the coronavirus.

2. Panic, terror, chaos, fleeing

Despite extraordinary developments in science over the last few millennia, medicine still has strikingly little to offer to suffering patients in pandemics.

3. Arriving at one or more explanatory frameworks, which might be social, cultural, religious, medical or a combination of all

Figure. Stages of societal response to a pandemic.

While a portion of the population will always respond illogically, composed, purposeful leadership can have a significant impact on calming the masses, restoring order and providing hope. Here, the rapid proliferation of information available in 2020 distinguishes COVID-19 from its predecessors. Never before have those in authority had the ability to reach, almost instantly, the entire population. Never before have people had such immediate and indepth access to information about the disease, enabling, in theory, rational decision making. Yet, this instant, mass communication is a double-edged sword, as misinformation and false doctrines can proliferate with equal rapidity. The challenges of the information age became obvious in the last few years; COVID19 has only reinforced both the advantages and perils of an online world.

Explanations—Social, Cultural, Religious, Biomedical Eventually, society strives to decipher the underlying cause of the scourge it is experiencing. Historically, multiple, often

4. Reestablishment of some order and needed services; enacting public health measures

contradictory, explanations have arisen. Diseases can be sent from god(s), result from environmental conditions, originate from outsiders, be due to the misalignment of celestial bodies, or be caused by germs. These explanations reflect prevailing sociocultural–scientific beliefs of the time. In the 21st century, a biomedical model predominates, with access to scientific tools and techniques unimaginable even a century ago. Whereas it took scientists until 1933 to identify the causative agent of the 1918 flu pandemic, Chinese scientists defined the entire DNA code of the coronavirus by January 2020, only weeks after the first documented case in Hubei Province. Despite this biomedical focus, alternative explanations remain common. As recently as the late 20th century, multiple—albeit mostly fringe—sources proclaimed HIV/AIDS was God’s punishment for “immoral” behavior.

Response These explanatory models powerfully shape the approach to epidemics. If continued on page 9

5. Pandemic endings: attempts to resume normal social life; days of prayer and thanks; sometimes new knowledge; plans for prevention; return to complacency

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IN THE NEWS

GENERAL SURGERY NEWS / JUNE 2020

Hospitals Feel Added Financial Strain Amid COVID-19 Pandemic continued from page 1

increasing unanticipated costs and decreasing any revenue you have to offset it,” said Halee Fischer-Wright, MD, MMM, the president and CEO of the Medical Group Management Association, one of the marquis health care associations in the United States. “I think this is the definition of the perfect storm.” Although the federal government has taken some early actions to flood the health care system with financial relief, experts worry about the long term. “No hospital is going to come through this unscathed,” said Jacqueline Barton True, MSW, MPH, the vice president of rural health programs at the Washington State Hospital Association. “I have a lot of concern about our ability to weather this, and what we look like on the other side. I think it is very possible that without significant help from the federal government, there will be closures.”

Bad Timing Even before COVID-19 hit, many hospitals were struggling, particularly those in rural areas. According to a February 2020 report from the Chartis Center for Rural Health, 19 rural hospitals had to shut their doors in 2019, the largest number of closures in a year since tracking began in 2010 (Figure 1). The analysis identified more than 450 additional facilities in rural areas that are at risk for closure. One of the hardest-hit states is Texas, where 20 rural hospitals have been forced to shut down since 2010, and 50% of the remaining facilities are vulnerable to closure, according to the Chartis report. Thankfully, small and rural facilities in the state haven’t been hit by a surge of COVID-19 patients and some elective surgeries are starting to resume, but they lost a huge source of income from the prolonged pause on those procedures, as well as the usual influx of post-acute care from larger urban facilities, according to Nancy Dickey, MD, the executive director of the Texas A&M Rural and Community Health Institute. “Many rural facilities are, in fact, extraordinarily challenged right now,” she told General Surgery News. Caring for patients in rural areas is often more challenging because they are generally older, have a lower socioeconomic status, and have more chronic diseases than people living in urban areas, according to a report from the Kaiser Family Foundation. What’s more, they are more likely to be uninsured, and that disparity will likely increase, Dr. Dickey said. “When people lose their jobs, they tend to lose their health insurance. So the number of people who are uninsured is probably going to go up across the country.” “What we’re seeing now in this crisis is that 50% of our rural health care centers were already operating in

Corrections In the article “Feet Firmly on the Ground: COVID-19” by Melissa Red Hoffman, MD (May 2020, page 14), a poem by Mary Oliver was mislabeled by the editors. The title of the poem is “Wild Geese,” not “Wild Things.” The algorithm in “Return to Elective Surgery: A Road Map” (May 2020, page 19) contained an error. In the lower right corner, the symbols for positive and negative COVID-19 test results were reversed. The corrected version is shown here. .

the red. This is probably the thing that’s going to push them to close,” Dr. Fischer-Wright said. Even larger urban facilities are struggling, said Kerry McKean Kelly, the vice president of communications and member services at the New Jersey Hospital Association. Northern New Jersey has been a “true hot spot” in the nation for COVID-19 patients, and unexpected costs have risen substantially, as hospitals struggle to purchase more—and more expensive—personal protective equipment and add per-diem staff. “Both of those line items have increased significantly,” she noted. Although there now is a billing code for COVID-19, “I don’t think anybody fully understands reimbursement for those patients,” Ms. Kelly said. “Right now, hospitals are just providing the care.” According to one estimate, each infection results in a median of $3,045 direct medical costs (Health Aff 2020 Apr 23. [Epub ahead of print]. doi: 10.1377/ hlthaff.2020.00426); another suggests the cost of hospitalization to private insurers could reach $20,000 (Figure 2). The larger the hospital, the more likely it is to survive the pandemic, as well as any other waves of cases that appear in the coming months, as stay-at-home orders begin to ease, Dr. Fischer-Wright said. Large facilities likely have bigger cash reserves, and can sell off assets or redistribute costs in a way that isn’t possible at small hospitals, many of which only keep 45 days of cash on hand, she said. “And that is not enough to get through this crisis.”

Some Help, but Not Enough? By the end of April, hospitals were starting to get some relief from the federal government. Starting April 10, hospitals and other providers fighting the pandemic began receiving $30 billion, 30% of the total amount allocated under the $2.2 trillion coronavirus relief bill, to provide them with an immediate influx of cash. To calculate the payments, Congress considered Medicare payments and gave each hospital its portion of that total. (Medicare reimbursements for 2019 were an estimated $484 billion; if a hospital represented 0.5% of all billings, it would receive 0.5% of $484 billion.) More recently on April 23, the government passed an additional $484 billion bill, which includes $75 billion for hospitals. However, Medicare payments are typically half of what providers receive from private insurance. The formula for the first round of payments under the bill also disadvantaged small and rural hospitals, which don’t have the same volume of Medicare patients as larger facilities but still have fixed costs, Ms. True said. One hospital in Washington state told her the funding they received only covered six days of operation. “It was good to get the cash, but it isn’t enough.” The first round of funding also didn’t take into consideration a state’s

2010

2011

2012

2013

2014

2015

2016

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Figure 1. Rural hospital closure. Source: The Chartis Center for Rural Health. 25,000 20,000 15,000 10,000 5,000 0

With major complications or comorbidity

With complications or comorbidity

Without complications

Figure 2. The cost of inpatient admissions for COVID-19 treatment. Source: KFF analysis of IBM MarketScan Commercial Claims and Encounters Database, 2018.

burden of COVID-19 patients, Ms. Kelly said. New Jersey has the second-highest case count in the nation, and the payment formula applied equally to the state with the lowest case count. The rest of the funding allocated to health providers by the end of April—the remaining $70 billion in the bill and the $75 billion from the second bill—aims to help fill the gaps in coverage, focusing for instance on hard-hit areas, uninsured patients and rural areas, but the larger goal of the bailout should be finding ways to make hospitals “whole” enough to survive the crisis over the long term, Ms. True said. “These initial rounds of funding provided just enough to help hospitals limp along. But if each one is just barely making it, what does that do to our viability as a health system and our ability to respond to a future crisis? That’s the concern.” Dr. Fischer-Wright agreed. “The federal support during the initial weeks of the pandemic is certainly laudable, but it will need to continue throughout the remainder of and beyond the pandemic to help our nation’s providers recover and meet patient needs.” “I’m hoping the urgency of the pandemic may help hospitals look at health care as a system, rather than a silo,” Dr. Dickey told General Surgery News. “We need to be better at saying this part of your care can be done at hospital A, and then your rehabilitation or post-acute care can be done at hospital B.” For instance, larger tertiary centers could get patients through the worst of COVID-19, then transfer them to smaller facilities once their needs diminish, but they still need hospital convalescence time. This would free up space at larger facilities and provide smaller hospitals with sources of revenue. “If we can demonstrate the importance of working together during the pandemic, you may be able to carry it forward when the worst is over,” she said. “There is a possibility that post-pandemic we can take a deep breath and say we’ve learned some lessons that can be useful down the road.” ■

OPINION

JUNE 2020 / GENERAL SURGERY NEWS

Pandemics continued from page 6

God caused the disease, then praying to God might end it, hence the groups of flagellants peregrinating around Europe in the 14th century. Environmental etiologies led to the drainage of swamps, razing “unsanitary” districts, and perfuming streets. Debates raged in the 18th and 19th centuries over whether diseases like malaria, cholera and yellow fever were contagious, and societies elected to erect cordon sanitaire accordingly. More recently, belief in biomedicine has led to an international research enterprise laboring to find a cure or vaccine, although historically such successes usually follow the natural waning of these pandemics. Despite extraordinary developments in science over the last few millennia, medicine still has strikingly little to offer to suffering patients. Like the medieval caregivers confronting the Black Death or the early 20th-century physicians combating influenza, doctors in the 21st century provide mostly supportive care and proffer public health solutions, like quarantines, that date back to the 14th century. In times like these, that venerated adage lifted from a tombstone of an unknown 15th-century French surgeon resonates ever more profoundly: “to cure—sometimes; to comfort—often; to care—always.”

Aftermath Eventually, all pandemics end, usually not with a bang but with a whimper. The number of cases dwindles and restrictions like travel bans and stay-at-home orders are lifted. Funerals for those who died can finally take place; memorials to victims are commemorated; and eventually society returns to normal. Memories of the pandemic fade, resulting in the same complacency that contributed to the spread of disease initially.

Conclusion: Pandemic Redux Like the Plague of Athens, the Black Death and the 1918 Spanish flu, COVID-19 will pass. But as long as humans densely crowd together in cities and travel the world by the millions, another pandemic will arise. Many of the lessons and much of the preparedness that result from COVID19 will be forgotten before the next one appears. Undoubtedly, politicians and health care leaders will speak grandly about “preparatory measures” and “matériel stockpiled,” but if history is any guide, they will not be able to maintain that momentum for the years—likely decades—that intervene between major pandemics. Local politics, global economics, seemingly more pressing needs, sheer convenience and false alarms—like

the 1976 swine flu scare—will conspire to deplete the energy, money and motivation needed to maintain these resources. Although perhaps a depressing conclusion, it is realistic, based on human nature, verified by thousands of years of history. If equipment will not be stockpiled and behaviors do not permanently change, then let us at least archive the knowledge derived from this tragedy, as organizations like the National Library of Medicine and American Association for the History of Medicine are actively doing. Let us capitalize on advances

in virology, telehealth and regulatory changes that the coronavirus has stimulated. Let us support scholarship and events, like those associated with the 100-year anniversary of the 1918 Spanish flu pandemic, that will continue to remind us of the challenges these diseases present to society and what measures successfully managed them. And let us hope that when the next pandemic arrives, the world is better equipped and more clear-eyed about the course and consequences of such a disease and the interventions necessary to stymie its course.

Selected Sources Alfred W. Crosby AW. America’s Forgotten Pandemic: The Influenza of 1918. Cambridge University Press; 2003. See this source for one of the most informative histories of the flu. Frank Snowden, a professor emeritus of history at Yale University, in New Haven, Conn., offers a free online course on the history of pandemics in Western society, available at https://oyc.yale.edu/ history/hist-234. ■ —Dr. Barr is a surgical resident at Duke University Medical School, Durham, N.C.

In High-risk Breast Cancer a

Neoadjuvant Therapy Surgery Together

Preoperative systemic therapy PD\ EHQHˋW FHUWDLQ KLJK ULVN breast cancer patients1,2,a

Considerations and Potential Concerns Associated With Neoadjuvant Treatment

Potential preoperative benefits include3,b:

• Consider the potential concerns associated with neoadjuvant treatment for early breast cancer3,5

• Downstaging the tumor • Breast conservation • Assessment of tumor response to systemic therapy

– Risk of disease progression during preoperative systemic therapy • Reduced window of opportunity for fertility preservation5

Potential long-term benefits in neoadjuvant patients who achieved a pCR (vs those who did not) include3,b: • Favorable event-free survival • Favorable overall survival Patients with more aggressive subtypes have been shown to have an increased likelihood of achieving a pCR.2

• Accurate clinical staging at baseline is essential before initiating neoadjuvant treatment3,5 – There is a risk of overtreatment with systemic therapy if patient’s clinical stage is overestimated – There is a risk of undertreatment with certain therapies if patient’s clinical stage is underestimated

Consider Neoadjuvant Therapy for high-risk patients, such as stage II and III TNBC and HER2+ breast cancer patients1,3,a Learn more at WhyNeoadjuvant.com “High-risk” defined as early stage breast cancer patients who have a high risk of distant disease recurrence and death despite use of optimal modern local and systemic adjuvant therapy.4

CTNeoBC pooled analysis: 12 international trials of 11,955 patients with breast cancer treated with preoperative chemotherapy followed by surgery, with available data for EFS, OS, and pCR; pCR was not the primary end point for evaluation. Three most commonly used definitions of pCR were evaluated for their association with EFS or OS. Patients who attained pCR demonstrated improved EFS and OS vs those who had residual disease. The prognostic value was greatest in aggressive tumor subtypes, particularly TNBC and HER2+.2

CTNeoBC = Collaborative Trials in Neoadjuvant Breast Cancer; EFS = event-free survival; HER2 = human epidermal growth factor receptor 2; OS = overall survival; pCR = pathological complete response; TNBC = triple-negative breast cancer.

References: 1. Wirapati P, Sotiriou C, Kunkel S, et al. Meta-analysis of gene expression profiles in breast cancer: toward a unified understanding of breast cancer subtyping and prognosis signatures. Breast Cancer Res. 2008;10(4):R65. doi:10.1186/bcr2124. 2. Cortazar P, Zhang L, Untch M, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014;384(9938):164–172. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.1.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed April 11, 2019. To view the most recent and complete version of the guidelines, go online to NCCN.org. 4. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry. Pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval. www.fda.gov/downloads/drugs/ guidances/ucm305501.pdf. Published October 2014. Accessed April 16, 2019. 5. Cain H, Macpherson IR, Beresford M, et al. Neoadjuvant therapy in early breast cancer: treatment considerations and common debates in practice. Clin Oncol. 2017;29(10):642–652.

IN THE NEWS

GENERAL SURGERY NEWS / JUNE 2020

Elderly Trauma Patients Fare Better at Specialized Facilities Standardization of Geriatric Resources Recommended; ‘Elderly’ Defined as 55 Years or Older By MONICA J. SMITH

New Orleans—Elderly trauma patients in need of surgical management, a patient population that presents significant challenges, may fare better at institutions with dedicated geriatric services, according to a recent multi-institutional study of older patients undergoing damage control laparotomy. “Trauma centers are seeing an increasing influx of elderly trauma patients, who have special needs and considerations that must be taken into account the moment the patient walks into the trauma center or is brought in by emergency medical services,” said Alison A. Smith, MD, PhD, a surgical critical care fellow at UT Health San Antonio. One of the most morbid procedures a patient can undergo, regardless of age, is a damage control laparotomy (DCL), she said. “But there is little evidence in the literature regarding outcomes in elderly patients. Therefore, it is really important to consider what these outcomes are, what can be done to improve outcomes in elderly patients, and what can be taken into account from the institutional standpoint once the patient undergoes DCL.” To evaluate the demographics and LETTER TO THE EDITOR

clinical outcomes in a diverse and elderly patient population undergoing DCL with varying levels of institutional support, Dr. Smith and her colleagues enrolled eight Level I trauma centers, looking at patients aged 40 years and older. They defined DCL as a patient who left the OR with an open abdomen on initial exploratory laparotomy with plans for a second-look laparotomy, geriatric resources as a dedicated geriatric service and/or protocols for guidelines, and elderly as 55 years of age and older. “We know there is a lot of controversy in the literature as to what age should be considered geriatric; some studies suggest a cutoff as low as 40, as the physiologic aging process does occur,” Dr. Smith said. The patients whose outcomes she and her colleagues evaluated ranged in age from 40 to 90 years; looking at fiveyear increments in age, they saw a sharp increase in mortality beginning at 55. “Most people associate 65 with being geriatric, but several studies similar to ours have found that 55 to 57 is where you really see an increased mortality.” The researchers found 379 patients who underwent DCL during the study period, 149 (39%) of whom were 55 years of age and older; the remaining 230 (61%) were 40 to 54. Geriatric resources were available in three centers (38%); 35

of the older patients were seen at those centers, and 114 were treated at centers lacking geriatric services. In terms of specific injuries, large-bowel injuries were more common in younger patients, and vascular injuries were more common in the geriatric group. “This was likely due to mechanisms and to some of the pathology associated with patients’ vascular vessels,” Dr. Smith said. On both univariate and multivariate analysis, age 55 and older was a significant risk factor for in-hospital mortality; twice as many older patients died while in the hospital compared with the younger group. Comparing institutions in terms of geriatric services, those without geriatric resources had higher in-hospital mortality on both univariate and multivariate analyses. She noted that the study had some limitations. “Although it was a multiinstitutional study, all data was reviewed retrospectively, which does introduce inherent bias.” Also, they did not collect data on preexisting comorbid conditions or the use of blood thinners, and did not consider emergent operative interventions that could have played a role in some of the increased mortality in older patients. But as a future direction, Dr. Smith and her colleagues concluded that it will

Age 55 and older was a significant risk factor for in-hospital mortality in trauma patients.

Twice as many older patients died while in the hospital compared with younger patients. be important to standardize geriatric resources at all trauma centers across the United States considering the increasing elderly population. She presented her research at the 2020 Southeastern Surgical Congress (abstract 5). Melissa Hoffman, MD, an acute care surgeon in Asheville, N.C., affiliated with Mission Hospital–Asheville, noted that Dr. Smith’s research is a timely topic as the trauma population continues to age. “Though I will say, with an upcoming birthday, that 55 and older does hurt a bit.” Reviewing the manuscript, Dr. Hoffman encountered the suggestion that a trauma surgeon with geriatric experience should lead the team. “I think the trauma surgeon should be the one taking the lead, but also being involved with the team, which should consist of nurse practitioners, internists and physical therapists—really, a dedicated team that can help this population.” ■

Concerns About Using Cellphones to Combat COVID-19

To the Editor: [Re: “How Our Cellphones Will Tame COVID-19 and Save the World,” by Paul Alan Wetter, MD, May 2020, page 3] Dr. Wetter, thank you for your perspective on cellphones and COVID-19, but I respectfully disagree with it. Having large tech companies work with the government to track people is a bad idea. Let’s also look at the details. Suppose you get an alert on your phone that says you have been close to someone who was close to someone who was close to someone who tested positive for COVID-19. What happens next? Many will ignore the alerts. Some will seek testing, and some of those will find testing too difficult to come by and abandon the effort. If the information cannot identify the individual, there will be no enforcement. And worse, individuals will eventually be identified, as executives and government officials look to improve results for “public safety.” Who could argue against that? Also, I don’t trust the large tech companies to look after me as an individual or our society as a whole. Apple, for instance, refused to cooperate with the FBI to help unlock the phone of a terrorist who murdered and injured 36 people at a Christmas party in December 2015. That certainly wasn’t in the best interest of the community. Google recently removed a news video from YouTube in which two doctors disputed

stay-at-home orders, based on their interpretation of testing data. YouTube’s CEO has stated publicly that they will remove all content that does not conform to World Health Organization guidelines. Facebook’s CEO has stated they will remove all content related to protesting stay-at-home orders, citing “misinformation.” Facebook’s algorithm rejected an ad from my own New England Hernia Center offering support by phone or in person to patients having trouble with their hernias, linking to a Boston Globe article about halting elective surgery, stating the ad was against their policy. These actions are not those of a benevolent master; they are reminiscent of a controlling dictator. So rather than have massive tech companies that already have most of our personal information collude with government to track us under the guise of public safety, I say we should have an integrated medical record that could do much more than that. We are already collecting massive amounts of data for COVID-19 and all other diseases. The problem is, we’re not using that data. If we had access, I am certain we would have the information we need (epidemiological, treatment and vaccine development) to manage the shutdown with a scalpel, rather than a sledgehammer. Simple solutions don’t work for complex problems, and make no mistake, this virus—and health care in general—are complex issues. As H.L. Mencken said, “There is always a well-known solution to every human

problem—neat, plausible, and wrong.” And in my opinion, tracking us on our phones for this purpose is neat, plausible and wrong. David Earle, MD Lowell, Mass. Dr. Wetter’s Reply Thanks for your comments and good points about trust and compliance, Dr. Earle. I understand your concerns. There are so many issues you bring up that relate to trust, government policy, politics and information, which have their own set of issues. I tried to avoid most of these hot-button issues and my own opinions about these, but they do influence how each country has addressed the COVID-19 crisis. Some with good results, some with poor results. We will continually learn from both good and bad. Regarding computer programs and apps, as you know, the first iteration of most of the technology you rely on is often fraught with many issues. But there is the ability to rapidly fix, continually update, change, modify scale and distribute. Functionality issues will be addressed by the tech companies, and how mandatory or invasive it will be by governments. We are already seeing this take place. As with medicine, hopefully both government and tech companies will continue to learn and modify to best practices. Paul Wetter, MD South Miami, Fla.

OPINION

JUNE 2020 / GENERAL SURGERY NEWS

Our Hands-On Culture By FREDERICK L. GREENE, MD

ne of the important ways for me to convey empathy and compassion to patients over the years has been the application of the â&#x20AC;&#x153;laying on of hands,â&#x20AC;? whether it be in the initial handshake, placing a hand on a patientâ&#x20AC;&#x2122;s shoulder, or walking hand-inhand or arm-in-arm to accompany a post-op patient during a hallway ambulation. The need for human beings and many other animal species to connect is found throughout the ages. As we transitioned to the â&#x20AC;&#x153;social distancingâ&#x20AC;? that we all have experienced over the past few months, one of our greatest traditionsâ&#x20AC;&#x201D;joining of handsâ&#x20AC;&#x201D;may be at risk for obsolescence. Of all the various forms of greeting, the handshake is perhaps one of the most ancient. The handshake has existed in some form or another for thousands of years, but its origins are somewhat shadowy. As it is a nonverbal mode of communication, it may have existed before written records. One of the earliest depictions of a handshake is found in a ninth-century (B.C.E.) relief depicting the Assyrian King Shalmaneser III pressing the flesh with a Babylonian ruler to seal an alliance. Many researchers believe that the handshake was an indication of a gesture of peace, demonstrating that the hand held no weapons. By extending their empty right hands, strangers could show they were not brandishing armaments and bore no ill will toward one another. Some even suggest that the upand-down motion of the handshake was supposed to dislodge any knives or daggers that might be concealed up a sleeve! Yet another explanation is the handshake was a symbol of good faith when making an oath or a promise. When clasping hands, people indicated that their word was a sacred bond. The poet Homer described handshakes several times in his â&#x20AC;&#x153; The Iliadâ&#x20AC;? and â&#x20AC;&#x153;The Odyssey,â&#x20AC;? most often in relation to pledges and displays of trust. In ancient Greece, gravestones would often portray the deceased person shaking hands with a family member, signifying either a final farewell or the eternal bond between the living and the dead. In ancient Rome, the handshake was often used as a symbol of friendship and loyalty. Pairs of clasped hands even appeared on Roman coins. From ancient to modern times, the cultural acceptance and method of shaking hands has been taught to us by our parents, and we have passed on this ritual to our children and grandchildren. Today, a handshake is offered upon meeting or

parting. It is an expression of good will, gratitude and congratulations. Many people believe that a handshake reveals something about the character of the person who gives it. Our disposition and temperament are indicated by the nature of our handshake: strength, weakness, insecurity, shyness and so forth. A firm handshake reflects a confident personality while a floppy handshake reveals a shy one.

The concept of the clasping of hands, and now its avoidance, is correctly viewed as a method to both enhance relationships and mitigate the transmission of infection, respectively. Despite our aggressiveness in handwashing frequency and technique, there is a great fear that touching hands, except with our immediate family members, may be anathema. In this modern era of â&#x20AC;&#x153;high-tech, low-touch,â&#x20AC;? characterized by the electronic health record and telemedicine, it is my fervent hope that

our recent requirement for physical distancing does not provoke an avoidance of hands-on contact. This would certainly be a sad legacy of this recent pandemic. This June 25, National Handshake Day, should convey an even greater importance in 2020. It should remind us that this custom, as well as our hands-on tradition in medicine, is one that we certainly cannot â&#x2013; afford to give up. â&#x20AC;&#x201D;Dr. Greene is a surgeon in Charlotte, N.C.

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GENERAL SURGERY NEWS / JUNE 2020

Dueling Debates in Colorectal Surgery 2020 Introduction by Steven D. Wexner, MD, PhD (Hon) s we’ve done since 2010, Dr. Steven Wexner and I have collaborated on the annual “Dueling Debates in Colorectal Surgery.” With special thanks to Dr. Wexner for lending his time, expertise and opinion, I present current debates in colorectal surgery, including COVID-19 related issues in colon surgery, such as use of laparoscopy in infected patients, negative-pressure operating rooms for patients with COVID-19, and COVID-19 testing for patients before elective surgery, as well as whether T1N0 rectal cancers are best treated by endoscopic submucosal dissection. Read on, take a side, access On the Spot online, and share your view with a comment. Also, check out Gut Reaction on page 14 for these surgeons’ candid takes on artificial intelligence, fluorescence imaging, mental conditioning, single port for transanal TME, and the worst complications they’ve seen in their recent cases. Feel free to send me feedback at afe colleen@cmhadvisors.com. Stay safe and healthy, and happy reading!

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

f y

Laparoscopy should be used in patients infected with COVID-19. Abe Fingerhut, MD, FACS (hon), FRCPS FRC (g), FRCS (Ed) (hon), FASCRS (hon) FA Sec Section for Surgical Research, Department of Surgery, Medical University of Graz, o Austria; Department of General Surgery, Ruijin Hospital, Shanghai; Jiao Tong University School of Medicine, Shanghai Minimally Invasive Surgery Center

Art Hiranyakas, MD Director of Bangkok-Phuket Colorectal tal Disease Institute at Bangkok Hospital al Phuket, and Director of Colorectal Surgery Clinic, Bangkok Hospital Headquarters

DR. FINGERHUT: AGREE, but I need a caveat: The word

“should” in the statement might sound like a recommendation, which we cannot make. Let me say this: There is not one scrap of evidence proving that surgical smoke created in laparoscopy is more dangerous than that created by the same energy-driven instruments on

am appreciative that Colleen Hutchinson again asked me to “volunteer” friends to engage in this year’s edition of “Dueling Debates in Colorectal Surgery.” Because of the COVID-19 pandemic, I have selected three of the four topics as germane to COVID-19, leaving the fourth subject as more generic within colorectal surgery. This year’s debates commence with two diametrically opposed views on whether or not laparoscopy can be safely used in patients infected with COVID-19. Dr. Abe Fingerhut, from France, offers his very cogent logic as to not only why, but how, laparoscopy can be safely employed in patients infected with COVID-19. The contrary view is espoused by Dr. Art Hiranyakas from Phuket, Thailand. Dr. Hiranyakas cites excellent evidence about corollary situations, such as human immunodeficiency virus, hepatitis B and papillomavirus, as well as hazardous particulate matter in smoke. Both of these experts are very passionate about their views. The second question was whether negative-pressure operating rooms should be used for patients infected with COVID-19. Dr. Delia Cortes-Guiral, from Madrid, Spain and Saudi Arabia, cites very sound logic as to the reasons for the employment of a negative-pressure OR. The opposing viewpoint is taken by Dr. Amy Lightner, from Cleveland, who invokes the absence of published evidence suggesting that negative-pressure rooms prevent the transmission of the coronavirus. Both of these experts are well versed in the literature and engage in a lively debate. The third topic is whether or not all patients should be tested for COVID-19 infection before commencement of elective surgery. Dr. Aneel Bhangu, from Birmingham, England, notes that the consequences of postoperative COVID-19 pneumonia are “so devastating” that testing is indeed vital. Dr. Jacob Izbicki acknowledges that the German government currently requires routine testing of all patients before elective surgery and indeed concedes that testing can be an effective tool; however, he also cites the literature showing high false-negative rates of these tests and touches on the potential for repeat testing as being needed. The last question focuses on a topic not specific to COVID-19:the treatment of T1N0 rectal cancers. Dr. Emre Gorgun, from Cleveland, presents his view on why endoscopic submucosal dissection is the best treatment for T1N0 cancers, focusing on the organ preservation aspect of that approach. Dr. Dana Hayden, from Chicago, notes that she “wholeheartedly” disagrees. She bases her sentiment on the fact that T1 cancers may have spread to lymph nodes and that these lymph nodes may not be identified on MRI. I thank each of these debaters for their time, expertise and viewpoints. I hope that readers off General Surgery News enjoy their lively comments as much as I did. —Dr. Wexner is the director of the Digestive Disease Center and chairman of the Department of Colorectal Surgery, Cleveland Clinic Florida, in Weston.

the same target organs during laparotomy. No one has ever been able to isolate SARS–CoV-2 in the aerosol (of laparoscopy), and experiments that found that the virus is viable in aerosols were in closed cylinders, not the human body. In contrast to laparotomy, surgical smoke created during laparoscopy is contained within a “closed” abdominal cavity, and as such does not diffuse into the OR during the operation (as is the case for laparotomy). Precautions and strict observance of common sense “should” ensure that the aerosol created during laparoscopic surgery does not escape inadvertently during the operation (airtight trocar incision, air-tight valves in good working condition, no venting during operation to get rid of smoke, careful and steady insertion and withdrawal of instruments, use of one of the modern systems to ensure closed circuit flow and filtered evacuation of laparoscopic carbon dioxide), and, obviously, that the pneumoperitoneum should be completely evacuated before specimen extraction or final withdrawal of trocars for abdominal closure. Accessorily (and perhaps more debatable), there should be low-pressure pneumoperitoneum, short bursts of low-intensity energy. To conclude, if there is no other contraindication, there is no reason why “laparoscopy should not be used in patients just because they are infected with COVID-19.”

DR. HIRANYAKAS: DISAGREE. According to current evidence,

COVID-19 virus is primarily transmitted between people through respiratory droplets (particles >5-10 mcm in diameter) and contact routes. The World Health Organization stated that airborne transmission of COVID-19 may be possible in specific circumstances and settings in which procedures that generate aerosols are performed. It is crucial for surgeons to understand that airborne transmission is different from droplet transmission as it refers to the presence of microbes within droplet nuclei (particles <5 mcm in diameter) that can remain in the air for long periods of time and be transmitted to others over distances greater than 1 m. All energy devices, including electrocautery and ultrasonic in nature, will produce surgical smoke, which is aerosolized when used on tissue. Despite the fact that the respiratory viruses are not known to be transmitted by blood, studies have shown that some activated viruses like HIV, hepatitis B virus and papillomavirus can survive in surgical smoke and be potentially infective (Surg Endosc 1998;12[8]:1017-1019; J Med Virol 1991;33[1]:47-50; Occup Environ Med 2016;73[12]:857863). Although the use of electrocautery in open surgery is potentially hazardous, particle concentration of the smoke in laparoscopic surgery was shown to be significantly higher due to low gas mobility in the pneumoperitoneum (Ann Surg 2020 Mar 26. [Epub

ON THE SPOT

JUNE 2020 / GENERAL SURGERY NEWS

ahead of print]. doi:10.1097/SLA.0000000000003924; J Air Waste Manag Assoc 2020;70[3]:324-332). It is also important to address that the virus may concentrate in the gastrointestinal tract even though the respiratory system is sealed by a closed and filtered respiratory circuit. With the very little evidence regarding the relative risks of minimally invasive surgery versus the conventional open approach specific to COVID-19, the need to protect caregivers from infection and preserve hospital capacity is one of the top priorities of concern. Physicians typically focus on the patient’s risk, not our own. In an infectious disease pandemic, the degree of uncertainty renders calculated risk–benefit analyses impossible. Our calculus must incorporate our own exposure risk, and how exposure would limit the ability to care for future patients.

Negative-pressure operating rooms should be used for patients with COVID-19. Deli Cortés Guiral, MD, PhD, Delia ECPSO ECP Surg Surgical Oncologist, European Certification on Peritoneal Surface Cert Oncology; O Consultant Peritoneal Surface Malignancies and Colorectal Surgeon, King Khalid Hospital, Riyadh, Saudi Arabia

Amy L. Lightner, MD Associate Professor of Colorectal Surgery, Digestive Disease Institute; ute; Associate Professor of Inflammation tion and Immunity, Lerner Research Institute, Cleveland Clinic Disclosure: Consultant for Takeda

DR. CORTES-GUIRAL: AGREE. Protection of caregivers in

the OR has been a major concern since the beginning of the SARS-CoV-2 outbreak and negative-pressure ORs, anterooms and endoscopy suites have been recommended as the safest option to treat COVID-19‒ positive or suspected patients. Negative-pressure rooms protect not only personnel inside, but also patients and personnel in the adjacent areas because the lower air pressure in the OR prevents air to flow from the negative-pressure room to the contiguous ones. Active replication of SARS-CoV-2 has been proven to occur in the stomach, duodenum and rectum, and one case report informed us about the presence of SARS-CoV-2 in the peritoneal fluids; however, further research on contagiousness capability by the virus from smoke or pneumoperitoneum droplets is required. Under the suspicion that coronavirus particles could be released during laparoscopy with carbon dioxide, a number of recommendations for safe laparoscopic procedures have been provided by the main surgical societies (American College of Surgeons, European Society of Surgical Oncology, Society of American Gastrointestinal and Endoscopic Surgeons and others), such as the use of devices to filter released CO2 for aerosolized particles, limiting the intraabdominal pressure, reducing the electrocautery settings, and, accordingly during laparotomy, careful evacuation of the resultant smoke must be ensured. In both cases, a negative-pressure OR obviously looks fundamental to achieve this safety goal. The

moment of extubation is especially risky and it is also recommended to do it in a negative-pressure OR. Interestingly, engineers from Hong Kong have demonstrated that a positive OR could be modified and converted to a negative one, and many guidelines suggest as the optimal location for the negativepressure OR, a corner of the surgical area with separate access. In brief, a negative-pressure OR is a protective measure as essential as personal protective equipment that could effectively protect not only everyone inside, but also other health care workers and patients around. DR. LIGHTNER: DISAGREE. There is no published evidence

DR. BHANGU: AGREE. The consequences of a postoperative

to suggest negative-pressure rooms will prevent the transmission of COVID-19. This reflects much of what we have done—react and quickly implement policy, with the intention of doing all that is possible to keep patients and providers safe. However, if we overreact and implement policies without supporting data, we can also cause secondary consequences. Some hospitals may not have negative-pressure rooms. Should a COVID-19 patient with peritonitis then be transferred to another hospital just for a negative-pressure room? Will we cause more postoperative infectious complications in the non‒COVID-19 patients exposed to negative pressure? Is it practical to convert ORs to negative pressure? While it is certainly reasonable to consider all available options to prevent the spread of COVID-19, there may be simple higher impact changes, such as reducing OR and anesthesia staff changes mid-operation and stopping traffic through the OR that causes repeated opening and closing of doors. These changes may be more effective in reducing spread of COVID-19 and require less infrastructure to implement. Until we have more data, the use of all measures to promote safety is valued, so long as all the secondary consequences are evaluated in parallel.

COVID-19 pneumonia are so devastating that testing in affected areas will become vital. Most postoperative deaths after elective surgery we will see during this era will be driven by postoperative complications, which in turn are driven by SARS-CoV-2 infection. Although their incidence will wax and wane as surges come and go, the effects of just one of these deaths in an elective surgical patient will change practice. Most European Union and North American areas have been hit hard, meaning testing will identify some patients who are asymptomatic carriers and will benefit from deferred surgery. If the rates of community SARS-CoV-2 infection decline to negligible, testing strategies can be relaxed, but we don’t know what the post-peak world holds. There are so many questions around testing that we then need to answer—who, when, where. Bringing a patient into a COVID-hot hospital for a CT scan or swab may expose them to SARS-CoV-2, generating more risk than benefit. I hope all surgeons around the world will start working as broad, networked teams to find local pathways that work.

All patients should be tested for COVID-19 before elective surgery. Aneel B Bhangu, MD, MBChB, PhD NIHR Clin Clinician Scientist in Global Surgery; Honorary Consultant Colorectal Surgeon, University Hospital Birmingham, United Universit Kingdom; Kingdom @COVIDSurg Chief Investigator @C

Jakob Izbicki, MD, FACS, S, FRCS ed. Hon Surgeon in Chief, Chairman of the Department of General, Visceral and Thoracic Surgery,, University Medical Center Hamburg-Eppendorf, Germany

DR. IZBICKI: DISAGREE—by order of the government [in Germany], we are currently obliged to test all patients before elective surgery. Routine testing of all patients can be an effective tool, but its effectiveness depends on the specific regional pandemic situation. In a potential future scenario, with a majority of COVID-19‒positive patients, the routine testing of all patients might not have a beneficial effect; neither might the routine testing in a controlled pandemic situation with a stable reproduction value below 1 be beneficial. In the end, a regional local pandemic status with a doubtful tendency seems to be the most relevant scenario, where routine testing of all patients will be helpful to avoid a spread of COVID-19 within the medical institution. Even in this scenario, we have to remember that the test result is a snapshot of the current situation. Therefore, routine testing of all patients has to be done right before hospitalization for surgery in order to be effective, and the patients have to be isolated until the test results arrive or an admission will take place after a negative test result is assured. Taking into account the incubation time of up to 14 days and the high false-negative test rates (as high as continued on the following page

ON THE SPOT

GENERAL SURGERY NEWS / JUNE 2020

Colorectal Debates

Emre Gorgun, MD, FACS, FASCRS

continued from the previous page

30%), even a negative test does not negate the possibility of an infection (JAMA 2020 Mar 11. [Epub ahead of print. doi: 10.1001/jama.2020.3786). Therefore, a recently published testing recommendation for elective surgery patients includes repeated testing every week of the hospital stay and at discharge (Br J Oral Maxillofac Surg 2020 Apr 13. [Epub ahead of print]. doi: 10.1016/j.bjoms.2020.04.014). In summary, the pandemic situation dictates the necessity of routine testing. If routine testing is carried out, it has to be done before and during hospitalization, and at discharge, to be as effective as possible.

T1N0 rectal cancers are best treated by endoscopic submucosal dissection. DR. GORGUN: AGREE. The treatment of early rectal can-

cer is challenging, since the lymph node involvement can only be verified after oncologic resections. Modalities of local resection are possible treatments in cases where there is little chance of lymph node involvement. Long-term oncologic outcomes are comparable between organ resection techniques and local excisions. Clearly, local resections are superior in terms of morbidities and functional outcomes. Although studies comparing endoscopic submucosal dissection

GUT REACTION

Biggest COVID-19 related challenge right now

Krau Krause-Lieberman Chair in Laparoscopic Colo Colorectal Surgery, Director of Endo EndoLumenal Surgery Center, Lower GI, Clev Cleveland Clinic, Digestive Disease Institute, Cleveland Disclosure: Consultant for Boston Scientific, Cook, Lumendi

Dana Hayden, MD Associate Professor, Colon and Rectal Surgery, Rush University Medical Center, Chicago

(ESD) and other local excision techniques (transanal endoscopic microsurgery and transanal minimally invasive surgery) are limited, ESD has been shown to be an excellent approach, in expert hands, that can overcome some of the limitations of other local excision techniques. Advantages are not only limited in that ESD can be performed under conscious sedation—as well as being effective on lesions located above or near the anal verge—but also, ESD does not destroy anatomic planes since it involves only partial thickness of the target organ. Furthermore, based on the final pathology, if a patient requires reconstructive organ resection (proctectomy/low anterior resection), TME and anastomosis

AI in colon surgery currently

Tool or device in my clinical arsenal I can’t live without

Worst complication I’ve seen in my recent cases

Fluorescence imaging

planes would remain intact. Additionally, for larger laterally spreading tumors covering more than two-thirds of the lumen, extensive tissue resection via ESD provides fast healing of the resection area with excellent “re-epithelialization.” This yields low complication rates and superior functional outcomes compared with other full-thickness local excision techniques. After expertise level has been reached, ESD procedures can be performed in the endoscopy suite under sedation, with results of shorter length of hospital stay and significant cost savings in health care. DR. HAYDEN: I WHOLEHEARTEDLY DISAGREE. My disclaimer: I fully confess to be an “over-treater” and preventative surgeon. I have seen rectal cancers understaged during initial workup. I have seen T1 cancers have node-positive disease indicated on final pathology that was not identified on MRI. Radiation oncology will then recommend adjuvant radiation, as they should, since it is still the standard of care. Then our beautiful, healthy, nonleaking colorectal anastomoses will be exposed to radiation, leading to strictures, poor function and other complications. I do admit, local excision for T1 cancers has a role for poor surgical candidates and patients with extremely low cancers leading to permanent colostomy. However, with submucosal resection alone, the perirectal lymph nodes are not addressed. Then we are left with wishful thinking that our patient will fall into the lower range of potential lymph node metastases for T1 cancers. We have one great shot to treat rectal cancer appropriately and it is best performed at the first treatment. ■

Mental conditioning’s role in the surgeon’s tool kit

Single port for transanal total mesorectal excision

Does perfusion assessment improve outcomes?

Abe Fingerhut, MD

Correct precautions for smoke control

No experience

My brain

Death on the table

Great future

Essential, but not many realize what it means

How else?

Certainly should

Art Hiranyakas, MD

The uncertainty

Our hope

Reliable evidence

Anastomosis gangrene

The reliable evidence on blood supply

Stay calm and be positive.

Really helpful in some cases

Definitely

Delia Cortes-Guiral, MD, PhD

Vaccine; for surgeons, back to “new normal”

AI is changing surgical education in colorectal surgery.

LigaSure Maryland [Medtronic] jaw for laparoscopic peritonectomy

Vascular lesion after lymphadenectomy when replacing a trocar

Good option if positioned at the site of the future stoma

Absolutely, if you tailor your surgery according to the findings

How to reopen

Innovative

Bovie

Pulmonary embolism

Great addition

Critical

Another option

Yes, and why not?

Aneel Bhangu, MD, PhD

Setting up COVIDcold surgical unit

Risk-stratifying patients

Harmonic

COVID-19 postoperative pulmonary complication and death

Needs to prove patient benefits

Do more, talk about it more

Ensure [it is] cost-effective

Unproven against real patient outcomes

Jacob Izbicki, MD

Convince cancer patients not to postpone surgery

Future

Scissor

Portal vein thrombosis after hepatectomy with vascular reconstruction

For low anterior resections and gastric pull-up

Be mentally strong and know your limits; self-reflection

A useful tool in early rectal cancer

Further studies are necessary.

“COVID-related stress syndrome”

Approaching fast. First application will be in screening colonoscopies.

Endoscopic submucosal dissection knife, electrosurgery

Disease progression during total neoadjuvant therapy

Highly crucial in few questionable cases

It is a must and no exceptions.

Only in selected cases indicated

Yes, for questionable cases; alternative is to resect until brisk flash test is positive from marginal artery

Excited to see where it goes

Lube

Repeat admissions for high stoma output

Love it!

Probably the most important part of our training

Adding complicated on top of difficult

I believe it does for left-sided anastomoses

Amy Lightner, MD

Emre Gorgun, MD

Remaining focused and positive in midst of curDana Hayden, MD rent statistics and effects in certain populations

Strong and balanced Here to stay; mental aptitudes are game changer for essential: stop, listen, cytoreductive and think, analyze, oncologic surgery focus, act.

Residency During COVID-19: Business as (Un)Usual By BARRET HALGAS, MD

‘We must advocate that if there is only one physician left on earth, he/she had best be a general surgeon …’ –Stanley Dudrick, MD

he restructuring of university hospitals as a result of COVID-19 forced residency programs across the United States to quickly adapt, in terms of both manpower and academics. The Accreditation Council for Graduate Medical Education responded by permitting continued resident involvement in the care of COVID19‒positive patients, but left the task of figuring out where the new fulcrum point was between clinical and academic requirements. For programs near heavily affected cities, personnel were in high demand and surgical teams quickly became critical care teams to keep up with the growing ICU census. But for the majority of programs, the clinical load quickly dropped. Operative volume dramatically decreased after the American College of Surgeons recommended suspension of elective surgery, citing hospital and resource utilization. For programs that usually run a robust acute care surgery service, these changes were less severe compared with programs that generate most of their volume from elective cases. We found ourselves with more residents than work. To be in accordance with guidelines, we scaled back the teams in order to limit exposure at the hospital, rotating teams in and out to allow time at

home for symptom monitoring. The challenge with this arrangement was that we needed a way to keep accountability of residents during off weeks that also facilitated continued learning. I would like to share a few things that worked for us. After the restructuring, we initially put out a reading curriculum with weekly question banks and a moderated discussion forum, but realized we needed more interaction. This bought us a little time until we were able to broadcast our morning conferences via a virtual meeting platform. There was definitely a learning curve

Coronaviruses are not in the surgical textbooks. So why are surgery residents reading JAMA guidelines and reviewing vent management? Because it is hammered into us that when there is a problem and the consultant is out of town or unavailable (every oral exam), we find a solution. and it took some time to work out the kinks and have everyone comfortable interacting through their phone or computer. The next step was to have a plan for each day of the week, something consistent that could be repeated week after week. The virtual meeting format was ideal. It allowed for maximal participation of staff and residents, both on and off site. The platform let us easily and efficiently disseminate information, since there seemed to

be a new policy or memorandum every day. There was still high visibility of resident learning, and we purposefully chose daily activities that required preparation and participation. The daily meetings were always intended to augment personal reading. Lastly, the format let us reach out to graduated chiefs—now junior faculty at other hospitals—so they could stay engaged as well. We start the week with a surgical debate between two residents of the same year group (similar to “The Great Debates” in General Surgery News). We have each resident present an opposing side of a controversial topic, followed by a series of short rebuttals before the floor is opened up for discussion. The goal is to assign topics that are appropriate for that year group. Some examples are operative versus nonoperative treatment of appendicitis and prophylactic mesh placement for midline laparotomy. I think this format has been hugely successful and something people look forward to now. Every Tuesday, there is a faculty lecture that follows the usual didactic format. Wednesday is standard morbidity and mortality conference. Thursday is our “preoperative conference.” Here we had to get creative since there were fewer and fewer cases on the board. As it stands now, if there is nothing scheduled, the chiefs will assign cases that are again appropriate for that year group. For example, an intern may be assigned laparoscopic cholecystectomy and a more senior resident, distal pancreatectomy. Each resident is assigned a faculty mentor. Again, since these are not actual patients, the continued on page 22

IN THE NEWS

GENERAL SURGERY NEWS / JUNE 2020

Restarting Metabolic and Bariatric Surgery: Lessons Learned continued from page 1

quickly as to how we should optimally treat our patients,” said Clifford Ko, MD, MS, MSHS, the vice chair and a professor of surgery at the University of California, Los Angeles, and the director of the Division of Research and Optimal Patient Care at the American College of Surgeons. “A second thing to be cognizant of is that we should ‘localize’ many things since there are recognized high-prevalence areas and lower prevalence areas, different resource levels, different testing capabilities, etc. When statements, guidelines or suggestions are offered, everyone has to think about what it means for them locally, at their facility and in their community. What may be recommended for a high-prevalence area, for example, might not be the best thing for an area with a lower prevalence.” Dr. Ko gave an overview of the ACS checklist of things to consider when thinking about reopening elective surgery. This guidance focuses on 10 issues in four main categories (Table 1) (www. generalsurgerynews.com/COVID-19/ Article/04-20/Return-to-Elective-Surgery-A-Road-Map-/58124). “In the document, we cite published considerations regarding when facilities might consider resuming elective surgery,” Dr.

Ko said. “As we resume surgery, we need to constantly be aware of the possibility of a second wave.” Finally, for facilities that participate in the ACS’s Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), the data registry will now include COVID-19‒ related variables.

Lessons Learned From China Peng (Charles) Zhang, MD, PhD, the chief of metabolic and bariatric surgery at Beijing Friendship Hospital, Capital Medical University, discussed lessons learned from China, which halted elective surgery on Jan. 25, and resumed elective surgery with COVID-19 screening on March 16. Emergency procedures were allowed, and semi-elective procedures were conditionally allowed during this time period. Patients are divided into three cohorts: • suspected/confirmed COVID-19 patients; • patients under quarantine due to close contact with CoV RNA‒ positive/suspected patients; and • confirmed without coronavirus infection. For patients with suspected/confirmed

Table 1. Guidance From the American College of Surgeons For Resuming Elective Surgery 1. COVID-19 awareness • Know your community’s COVID-19 numbers, including prevalence, incidence and isolation mandates. • Know your COVID-19 diagnostic testing availability and policies for patients and health care workers.

2. Preparedness • Promulgate personal protective equipment policies for your ur health care workers. • Know your health care facility capacity (beds, ICUs, ventilators), including expansion plans (e.g., weekends). • Ensure OR supply chain/support areas (PPE and other). • Address workforce staffing issues. • Assign a governance committee.

COVID-19, only emergency surgery is allowed; elective or semi-elective surgery is canceled or postponed. For patients confirmed without coronavirus infection, surgery is scheduled. For patients under quarantine due to close contact with CoV RNA‒positive/suspected patients, semielective surgery candidates and elective surgery candidates undergo further COVID-19 testing (wait two weeks and rescreen); if patients are confirmed to have no infection, they continue to surgery, but if COVID-19 is detected, surgery is postponed. The COVID-19 screening protocol, Dr. Zhang said, includes travel history, symptoms (including fever, cough, shortness of breath), complete blood count and C-reactive protein tests, a chest CT scan, and a CoV RNA test. China has defined three levels of personal protective equipment (PPE), with level 1 PPE consisting of normal everyday precautions (Table 2). “The goals of protection are to protect our patients, protect ourselves, protect our coworkers, protect our family members and relatives, and protect our communities,” Dr. Zhang said. Close attention, he said, needs to be paid in the emergency room or fever clinic, while transferring patients to the operating room and in the OR, after the operation, during recovery and when patients are discharged. Dr. Zhang emphasized that hospitals should have a designated patient transporting route to the OR. Appropriate PPE should be used during transporting patients, including having the patient fully covered, with a surgical mask, face shield and disposable surgical cap. Transport personnel, he said, should use level 2/3 PPE, which includes a disposable protective coverall suit, shoe covers, double gloves, N95 mask and face shield/eye protection. Spraying disinfectant (500 mg/L chlorine-containing disinfectant) on the route is important, and elevators should be disinfected.

From the OR to Patient Discharge

3. Patient issues • Patient communication • Prioritization protocol/plan

Inside the OR, Dr. Zhang said, a negative-pressure system is strongly recommended, and hospitals should consider avoiding laparoscopy and endoscopy. Other considerations inside the OR include:

4. Delivery of safe and high-quality care • Ensure safe, high-quality, high-value care of the surgical patient across the five phases of the care continuum. Source: www.facs.org/covid-19/clinical-guidance/resuming-elective-surgery

• having a minimal number of personnel in the OR; • using level 2/3 protection; • having surgeons and personnel not needed for intubation remain outside the OR until anesthesia induction and intubation are completed; • minimizing the use of electrocautery and ultrasonic devices (low power setting and avoidance of long desiccation times); • minimizing the use of drainage tubes, urinary catheter, nasogastric/ orogastric tubes and feeding tubes. For laparoscopic surgery, Dr. Zhang said, laparoscopic suction is recommended to remove the surgical plume and desufflate the abdominal cavity (do not vent pneumoperitoneum into the room). Other considerations for laparoscopic surgery include: • using lower intraabdominal pressure (10-12 mm Hg), if feasible; • avoiding rapid desufflation or pneumoperitoneum; • performing specimen extraction with minimal carbon dioxide escape; • minimizing blood/fluid droplet spray or spread; • minimizing leakage of carbon dioxide from trocars (check seals). After the operation, for patients who fall into the cohort who are under quarantine due to close contact with CoV RNA‒ positive/suspected patients, retesting and waiting for CoV RNA results is recommended. If negative, these patients can be transferred back to the ward; if positive, they should be transferred to a designated room or hospital. Dr. Zhang recommended changing PPE when exiting the OR, containing the disposables and using a minimal number of transport personnel. During recovery and going home, a single isolated patient room should be used, and designated personnel should use level 2 PPE. Dr. Zhang recommended an enhanced recovery after surgery protocol. “Do not discharge [a patient] until CoV RNA becomes undetectable for at least two consecutive days,” Dr. Zhang said. As physicians continue to take care of patients, online seminars, teleconsultations and nonsurgical weight loss approaches should be prioritized, he said.

Table 2. Levels of Personal Protective Equipment in China White Coat/ Scrubs

Disposable Surgical Cap

Disposable Gloves

Disposable Shoe Covers

Anti-fog Safety Glasses/Face Shield

Disposable Surgical Gown

Protective Coverall Suit

Level 1

✔

Level 2

✔

Level 3

✔

Disposable Surgical Mask

N95 Mask Or Higher

Full-Face Respirator Or Positive-Pressure Headgear

✔ ✔ ✔

IN THE NEWS

JUNE 2020 / GENERAL SURGERY NEWS

‘We resent the underlying implication that [bariatric/metabolic surgery] is a type of cosmetic procedure. It is only elective in the sense that there is flexibility in scheduling.’ —Eric J. DeMaria, MD

2020;S1072-7515[20]30317-3). Other factors that may come into play as surgeons ramp up their procedures include that patients may have less money for copays and deductibles because of the economic downturn, unemployment which may change health insurance status, challenges completing pre-op requirements, difficulty obtaining new insurance authorization for rescheduled patients who were previously approved, and the fear that some patients may have of COVID-19 infection. “Unfortunately, we may not have as many cases to do as ■ we think,” Dr. DeMaria said.

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Eric DeMaria, MD, the director of bariatric surgery at East Carolina University, in Greenville, discussed considerations for restarting bariatric/metabolic surgery in the United States. Many bariatric surgeons were upset to find that the bariatric procedures including gastric bypass, sleeve, duodenal switch and gastric band fell into the elective surgery category in the ACS guidance. “The ASMBS strongly disagrees with the concept that bariatric surgery is an elective procedure,” Dr. DeMaria said. “We resent the underlying implication that it is a type of cosmetic procedure. It is only elective in the sense that there is flexibility in scheduling. Bariatric surgery is lifesaving surgery, with survival benefit for patients treated by surgery over those treated without surgery.” Dr. DeMaria said during the pandemic, bariatric surgeons have responded admirably to the crisis and prioritized cases based on whether or not harm would occur if delayed, with more urgent cases being triaged ahead of less urgent cases. “However, once we start operating on the ‘flexible scheduling’ category of procedures, how do we prioritize patients?” Dr. DeMaria asked. For cases such as transplant candidates and pseudotumor cerebri, the clock may be ticking and they may need to move forward more rapidly, he said. In terms of surgical risk, surgeons should consider moving forward sooner with patients who are optimized after months of preparation. In terms of COVID-19 risk, according to Dr. DeMaria, obesity, diabetes, hypertension and heart disease increase the risk for bad outcomes. “Do we prioritize the low-risk, low/zero-comorbidity patient?” Dr. DeMaria said. “We have gotten so good at what we do, how would we justify a bad outcome in such a patient when there was no urgency to move forward with surgery? Or do we prioritize the higher-risk/higher-comorbidity patient? This is usually the group we prioritize for treatment because we know they have higher risk without surgery. However, they are more likely to have a bad outcome if COVID infection occurs.” In one study of 34 surgical cases in the early asymptomatic phase of COVID19 who were unintentionally scheduled for elective surgeries in Wuhan, China, 44.1% of them required admission to the ICU during disease progression and 20.5% died after ICU admission (EClinicalMedicine 2020;100331. doi: 10.1016/j. eclinm.2020.100331). In another study of four gastric bypass cases in Iran during the initial phase of the COVID-19 outbreak,

three required readmission to the hospital (two to the ICU), but ultimately survived (Obes Surg 2020 Apr 20;1-4. doi: 10.1007/s11695-020-04617-x). Presenters noted that the gastrointestinal tract is affected by COVID-19, and this presents challenges also for GI surgery. Similar to Dr. Ko, Dr. DeMaria emphasized that local conditions should

The U.S. Perspective: Prioritizing Patients

be the driving factor in restarting elective bariatric operations, including COVID-19 curve flattening; testing status for preoperative patients; hospital status, such as availability of the ICU and ventilators; PPE status; and health care worker status. The likelihood of needing an ICU postoperatively varies depending on surgical site: abdominopelvic minimally invasive surgery (<5%); abdominopelvic open surgery, infraumbilical (5%-10%); abdominopelvic open surgery supraumbilical (10%25%); and head and neck surgery/upper GI thoracic (≥25%) (J Am Coll Surg

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IN THE NEWS

GENERAL SURGERY NEWS / JUNE 2020

Is Surgery Ready for Telemedicine? COVID-19 Spurs Virtual Care continued from page 1

said Catherine Ann Matthews, MD, FACS, FACOG, several months in advance to avoid a backlog and long a professor of urogynecology and pelvic reconstructive delays in care. surgery at Wake Forest Baptist Health, in Winston“Certain patients are much better off with telemediSalem, N.C. cine, including those with limited mobility and who live Recent data from the Commonwealth Fund found far away or need family members to accompany them,” that surgical specialties saw a 66% drop in outpatient she said. “I have an 85-year-old patient whose son has visits and a similar decline in revenue. to take five hours of his day to transport her to and from “We knew if we didn’t introduce a radical new way my office for a 30-minute visit that we could do just as of doing business, it would jeopardize access to patient well over the phone or video.” care and employment for staff,” Dr. Matthews said. In late March, a different way of doing business Expanding Telemedicine became possible when the federal government eased Before the pandemic, Neil Floch, MD, had a boomHIPAA restrictions and increased funding and reim- ing bariatric surgery practice. After the coronavirus hit, bursement for telehealth. As part of the first his patient volume dropped to zero. Elements of a package of the coronavirus aid bill, Congress Like many surgeons, Dr. Floch had never set aside $200 million to fund telehealth and Telemedicine Program really considered telemedicine before, but included $100 billion to expand reimbursevery quickly it became his only option for ment options so health care providers could seeing patients and keeping his business cover medical expenses or lost revenue from afloat. COVID-19. “We all realized we weren’t going to be Several institutions—including the univerable to see patients because they are scared Provider and sities of Arizona, Michigan and Pittsburgh to come in, and we also don’t want them staff training Medical Center—were able to lean on their to come into the office right now,” said Dr. existing telemedicine programs to continue Floch, who runs Fairfield County Bariatrics, providing patient care remotely. a four-surgeon private practice in ConnectBut many surgeons were looking to teleicut. “Suddenly, the only way to see patients medicine for the first time, with no road map and to bill was through telemedicine.” Existing electronic to guide them. After adopting telemedicine and using health record “When faced with immediate stay-at-home the platform for a few weeks, Dr. Floch infrastructure has been able to ramp up remote visits and orders in North Carolina, we quickly made an see 15 patients each day—two-thirds of his executive decision to convert all in-person visnormal patient load before COVID-19. its to telemedicine visits,” Dr. Matthews said. For Dr. Floch, the ability to see patients “But when we tried to look for guidance about remotely has been a lifesaver. how to do this, nothing existed.” Patient education “What we used to do with an in-perDr. Matthews and her colleagues formed son visit, we can now do over the phone or a working group to get telemedicine up and video wherever they are in a HIPAA-comrunning, which involved teaching patients pliant way, which has been incredible,” he how to download and use audio-visual platsaid. “Working remotely has saved patients forms, figuring out billing and patient flow, time and money, eliminates waiting times and educating the office staff on how to Hardware (cellular engage with patients in this new environment. smartphone, telephone, and a lot of overhead costs for private pracdesktop and laptop tice physicians; plus it has allowed me to After building their platform, Dr. Matcomputer, tablet, etc.) work from 9 to 5 and to bill at my normal thews’ team published a tool kit to help other in-office rates.” practices convert to telemedicine more easily For Elizabeth Dovec, MD, the benefits (J Am Coll Surg 2020 Apr 30. [Epub ahead of of telemedicine in surgery come as no surprint]). The tool kit walks providers through prise. Although she did not do traditional eight key factors for adoption, which also Coding and billing telemedicine visits before COVID-19, she include how to integrate telemedicine visintegration has been using a digital education platform its into existing electronic health records and as an essential part of her bariatric practeaching patients how remote visits work. tice for over two years. The digital pro“Through trial and error and teamwork, gram, which is available to patients online we’ve come up with a way to make this proand through a mobile app, substitutes for cess efficient and engage the whole office Institutional the typical in-person visits patients need staff, and we want to share that with others,” IT support before surgery. she said. “We thought about this long before Since launching telemedicine, Dr. MatCOVID-19 and have virtually eliminatthews’ department has done 638 visits over a ed in-person supervised weight loss visits month. Dr. Matthews said translates to about 15 to 20 visits per day for her, compared with Audio–visual platforms prior to surgery for the past few years,” said (MyChart, Doximity, Dr. Dovec, the medical director of GBMC’s about 30 in-person visits before the crisis. A Zoom, FaceTime, Skype, Bariatric Surgery and Comprehensive Obefew patients still come to the clinic, which has Google Duo, etc.) sity Management Program, a three-surgeon remained open with a skeleton staff in case of bariatric surgery practice that’s part of a emergencies. larger 342-bed medical center just north of Although telemedicine doesn’t allow for Baltimore in Towson, Md. the same patient volume, Dr. Matthews said The reason: Bariatric surgery involves a telemedicine has allowed her team to stay Patient and caregiver lengthy preoperative education process. “It’s connected to patients and schedule operations participation

Adapted from Smith WR et al. J Am Coll Surg 2020 Apr 30. Epub ahead of print.

challenging to keep people engaged for several consecutive months before surgery, and there’s typically a lot of attrition during this process,” Dr. Dovec said. To improve retention, Dr. Dovec developed a comprehensive digital program that allows patients to do consultations with her months before they have surgery. The idea is for patients to learn about diet and exercise from the comfort of their homes and to make care more efficient. After initial online consultations in which Dr. Dovec explains insurance requirements and what patients need to do before surgery, the patients embark on a 12-week online education program that includes diet and exercise, as well as strategies to make long-term lifestyle changes. To stay on track, patients take quizzes and log food, exercise and weight through an app. After patients complete this process, Dr. Dovec checks in to determine whether they are ready for surgery. The digital program made her practice worlds more efficient. Since going digital in February 2018, she and her colleagues are able to perform hundreds more bariatric procedures each year. As for reimbursement for these visits, “we may or may not collect copays. We may or may not get paid from insurance for these visits, and the average reimbursement is less than $5.00 total,” Dr. Dovec said. But these visits are essential because preoperative education is crucial from an outcomes standpoint and required by insurance to get the operations approved. “Expansion of telehealth has vastly improved access to care, retention rates and patients’ experience, and has allowed us to continue our digital services uninterrupted during the pandemic,” Dr. Dovec said.

Will Telemedicine Persist Post-Pandemic? Recently, some hospitals have begun preparing to bring patients back for elective or nonessential procedures. The American College of Surgeons, American Hospital Association, American Society of Anesthesiologists and Association of periOperative Registered Nurses issued guidelines for how and when surgeons can start doing elective procedures again (www.generalsurgerynews.com/COVID-19/Article/04-20/ Return-to-Elective-Surgery-A-Road-Map-/58124). North Carolina, for instance, lifted its stay-at-home order on May 8. Dr. Matthews said Wake Forest Baptist Health reopened its outpatient surgery center on May 11 and plans to ramp up to pre-COVID-19 volumes by June 8. But social distancing protocols will still be in place, she said, and all patients will be screened for COVID19 before surgery. Patients will do temperature checks a week before coming in for elective surgery and will be screened when they arrive at the hospital or clinic. Office visits will be spaced out to allow patients to practice social distancing in waiting areas. “We’re also using enhanced recovery pathways to discharge patients more quickly and are expanding our hours to help make up for the backlog of cases,” Dr. Matthews said. Even as some practices ease back into business as usual, Drs. Dovec, Floch and Matthews hope that the changes to telemedicine are here to stay. “Relaxing billing and coding guidelines for telehealth is one of the best things that will come out of these times, and will change medicine in incredible ways,” Dr. Dovec said. ■

IN THE NEWS

JUNE 2020 / GENERAL SURGERY NEWS

ABS Certification continued from page 1

by the American Board of Surgery and published in JAMA Surgery (2020 Mar 18:e200093. doi: 10.1001/jamasurg.2020.0093), also found that initial success on the exam was related to lower risk for disciplinary action over time. These results mean surgeons who passed both the written qualifying exam and oral exam the first time had the fewest strikes against their medical license. “We found the results very encouraging,” said Andrew Jones, PhD, the director of psychometrics and research at the American Board of Surgery, and an author on the paper. “We weren’t sure if we would find a difference between certified surgeons and doctors who tried but failed to obtain certification. Not only did we find a difference, but we showed that each step of our process has utility.” In fact, surgeons who tried but never passed the multiple-choice qualifying exam were nearly five times as likely to face severe disciplinary action against their medical license as doctors who passed both the qualifying exam and oral test on their first attempt. “The results show that board certification matters,” Dr. Jones said. “It acts as a marker of quality. While it remains unclear if board certification causes you to be a better surgeon, this study provides further evidence that it is an indicator of quality.” For the study, Dr. Jones and a team of researchers led by Jason Kopp, PhD, used more than 40 years of test results spanning 1976 to 2017, for surgeons who attempted the qualifying exams. They then compared the results from over 44,000 surgeons with disciplinary data obtained from the Federation of State Medical Boards. “The ABS has an initiative to provide evidence that our programs matter,” Dr. Jones said. “We’re constantly looking to improve the tests and our processes, but we need data to show that our process is working.” To obtain the data, the researchers looked at surgeons’ performance on each part of the exam. They compared the likelihood of disciplinary action among three groups: doctors who passed the first time, doctors who failed one section or the other but ultimately received certification, and doctors who never received certification. The trend was consistent, showing that as performance on the exam decreased, and as doctors needed multiple attempts to pass, the likelihood of severe disciplinary action against their medical license increased. This study shows an association without causal interpretation, so for future research Dr. Jones wants to partner with other groups to link certification with patient outcomes, morbidity and mortality.

In addition, he wants to link board certification data to malpractice claims to see if there is a difference between certified and non-certified surgeons. An invited commentary (doi: 10.1001/ jamasurg.2020.0108) agreed that future steps should explore whether ABS certification is a predictive measure of surgeon quality. It also concluded that the study provides a data point to start targeted measures to help doctors avoid future mishaps.

Surgeons who tried but never passed the multiple-choice qualifying exam were nearly five times as likely to face severe disciplinary action against their medical license as doctors who passed both the qualifying exam and the oral test on their first attempt. “These findings open up a two-way street for both surgeons and hospitals,” said Rachel Kelz, MD, in the Department of Surgery, Center for Surgery and Health Economics at the Perelman School of Medicine, in Philadelphia, who co-wrote the commentary. “While few candidates will actually experience

licensure problems, those who fail the certification exam should recognize they are at an increased risk of ruining their career with egregious, unprofessional behavior. The test result provides a chance to be reflective and seek out resources to fix deficiencies that led ■ to failure.”

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Pandemics and Epidemics continued from page 1

and the casting of blame, often justified but not rewarding. The true, or nearly true, story of our pandemic can and will be told only in the future, based on an analysis of reputable evidence. Until then, an examination of the past may provide us with some knowledge. I have, therefore, chosen to review some of the prominent epidemics and pandemics of history. The following inventory is partially based on an online listing by Owen Jarus, fact-checked against historical sources.

Hamin Mangha/Miaozigou Epidemic (3,000 B.C.) Agent: Unknown Death toll: Unknown Origin: China Story: Excavations of mass burial sites, documented to 3,000 B.C., indicate an epidemic that swept China more than 5,000 years ago.

Plague of Athens (430-425 B.C.) Agent: Unknown, possibly bacterium; Salmonella typhi Death toll: 100,000; the population of Athens at the time was 300,000-400,000 (25%-33%). Origin: Ancient Athens Story: The symptoms of this epidemic were well described by Thucydides and indicate typhoid fever spread by fecal-contaminated food and water. During the Peloponnesian War between Athens and Sparta, Athens was besieged, densely crowded and cut off from outside resources.

Antonine Plague (165-180) Agent: Virus; probably Variola (smallpox) Death toll: 5 million Origin: Parthia (modern Iran) Story: This pandemic was brought back to Rome by Roman armies from the Near East, during the reign of Marcus Aurelius. It contributed to the decimation of the Roman Legions, where there was no social distancing, and was a factor in the downfall of the Roman Empire. The disease was spread to Germanic and Gallic European tribes during war with Rome and probably as far as China by Roman soldiers traveling overland. The medical history of this plague was chronicled by Galen.

Plague of Cyprian (250-271) Agent: Virus; suspected to be a Filovirus (e.g., Ebola) Death toll: Total unknown; the primary site was Rome, where it was stated to have killed 5,000 people a day at its peak in a Roman population of 1 million. Origin: Ethiopia Story: This plague was named after Cyprian, Bishop of Carthage, who described the symptoms in great detail and called this pandemic a signal of the end of the world, a conclusion strengthened by a 40% to 60% mortality rate. This affliction spread throughout the Roman empire, affecting all classes—nobility, workers, farmers and slaves, killing two emperors—and often is cited as the primary cause of the fall of Rome and the loosing of anarchy on the world.

Plague of Justinian (541-542, recurrences until 750)

A medieval plague doctor.

Agent: Bacterium; Yersinia pestis (bubonic plague) Death toll: 25 million to 100 million; 5,000 daily in Constantinople; 20% to 40% of the population of the eastern Mediterranean Origin: Constantinople’s trade with China and India Story: This plague weakened the Byzantine Empire and was a cause of its ultimate collapse; the emperor Justinian himself was stricken but recovered. From its epicenter in Constantinople, it spread north and south, and was the first pandemic to spread to three continents—Asia, Europe and Africa. Death was so common and often so swift that the populace wore name tags to facilitate their identification when they died. The vector of spread was the flea, carried by the black rat, whose preferred dwelling was merchant ships carrying grain.

The Black Death (1346-1353) Agent: Bacterium; Yersinia pestis (bubonic plague) Death toll: 75 million to 200 million; one-third to one-half of Europe and Eurasia Origin: Asia, spread to Europe via the Silk Road Story: The most fatal pandemic in recorded history was spread by fleas living on rodents, passed between humans primarily by airborne droplets, but also by the bite of infected fleas and rats. The disease came to Europe on 12 merchant ships docked in the Port of Messina, in Sicily. Massive social distancing was attempted: Shopkeepers closed their shops and many people fled the cities for the countryside, where it also affected cows, sheep, goats, pigs and chickens. Some doctors refused to see patients. In contrast, the so-called “plague doctors” tended to the sick and the dying. They wore characteristic face masks with a bird-like beak made of leather with eyepieces of glass; the beak was filled with scented herbs that acted as a filter against the airborne spread of infection, believed, at that time, to be caused by “miasmas.” These devices, the first protective masks for medical personnel, were invented about 700 years ago. The most famous work of Giovanni Boccaccio, “The Decameron,” provides a vivid account of these medieval times. A characteristic of all major plagues was the belief by segments of the populace that the plague was a punishment by God for the sins of humankind. To expiate this curse, communities eliminated their “heretics,” which included thousands of Jews who were slaughtered by the populace between 1348 and 1349. This plague also initiated town-to-town processions of flagellants performing penitence by beating themselves and others with leather straps studded with sharp pieces of metal. On a more rational note, Venice started the practice of quarantining all incoming ships for up to 40 days. This bacterium has not been eradicated; today there are still 1,000 to 3,000 cases of this disease annually. Once detected, however, the disease responds readily and rapidly to antibiotics, preventing its spread into an epidemic or a pandemic.

Cocolizli Epidemic (1545-1548) Agent: Bacterium; Salmonella paratyphi C Death toll: 15 million inhabitants of Mexico and Central America Origin: Mexico, spread north and south Story: Cocolizli, translated from the Aztec, means pestilence. This epidemic had manifestations occurring after major regional droughts, followed by a massive increase in the population of the vesper mouse that spread the bacterium causing a hemorrhagic fever. The Aztec world in the 16th century was already weakened by wars with the Spanish conquistadors and the diseases (smallpox, measles, typhoid) they brought with them. In contrast, these New World pandemics had an indigenous origin and were not brought from Europe. This fact was confirmed by the extraction of unique bacterial DNA from a tooth of an Aztec from the 16th century.

Russian Flu Pandemic (1889-1890) Agent: Virus; Influenza A, H3N8 Death toll: 1 million Origin: Bukhara in central Asia, Athabasca in northwestern Canada, Greenland Story: This particular flu poses a great mystery: It seems to have started simultaneously in three separate and distinct locations instead of one area. Even before air transportation, this flu pandemic spread to reach its peak of mortality in five weeks, with a fatality rate of 4%. In the United States, mortality was highest in individuals over 65 years old and predominantly among nursing home residents.

Spanish Flu (1918-1920) Agent: Virus; Influenza A, H1N1 Death toll: 50 million; 500 million infected (10%) Origin: Unknown; China suspected Story: Called Spanish flu because Spain remained neutral in World War I, distributing information without wartime censorship. Among the afflicted was King Alfonso XIII of Spain, who survived. Contrary to many flu viruses, this one was most lethal for young people, possibly due to World War I crowding in the trenches or secondary to cytokine storm, a phenomenon most common in the young. It was also unusual in that it was widespread in summer and fall in the Northern Hemisphere, rather than in winter. The Spanish flu was also unusual because it came in two waves, the second more deadly than the first.

Avian Flu (1956-1958) Agent: Virus; Influenza A, H2N2 Death toll: 2 million Origin: China Story: This flu, and others, was avian in origin, and may have been transmitted to humans from domestic ducks via a pig intermediate.

OPINION

JUNE 2020 / GENERAL SURGERY NEWS

Severe Acute Respiratory Syndrome (SARS) (2002-2004) Agent: Virus; SARS-CoV Death toll: 800 of 8,000 infected (10%) Origin: China Story: This epidemic, minor in numbers, has not reappeared since 2004. The responsible virus is related to the COVID-19 coronavirus and is presumed to reside in bats as a reservoir, transmitted through civet cats.

Middle East Respiratory Syndrome (MERS) (2009-2012) Agent: Virus; MERS-CoV Death toll: 866 of approximately 2,000 infected (43%) Origin: Saudi Arabia Story: This was a zoonotic epidemic. It was carried by camels with a low human infection rate.

Swine Flu Pandemic (2009-2010) Agent: Virus; Influenza A, H1N1 Death toll: 500,000 out of 1.4 billion infected (0.36%) Origin: Asia, probably China Story: This flu infected primarily children and young adults, with a relatively low mortality rate.

West African Ebola Epidemic (2014-2020) Agent: Virus; one of four ebolaviruses Death toll: About 11,000, with an approximately 50% mortality rate Origin: Guinea, South Africa, Congo Story: After its first identification in 1976, these repetitive outbreaks were named for the Ebola River in the Democratic Republic of Congo. This zoonotic epidemic has been isolated and prevented from becoming a pandemic whenever it reappears by isolation, quarantine, travel restrictions and a vaccine. The ebolaviruses appear to originate in primate reservoirs, activated by eating bush meat.

COVID-19 Flu Epidemic (2019- ) Agent: Virus; SARS-CoV-2 Death toll: As yet unknown Origin: China Story: To be told

• Many epidemics and pandemics are zoonotic in origin, passed from unaffected animal hosts to humans, often through an intermediate species. • Social distancing is a tried and true method of disease containment. • Quarantine as a means of containment was introduced in the 14th century. • Protective face masks, initiated in 1346, continue to be a primary means of defense.

What Can We Hope for Regarding the COVID-19 Pandemic? • Benefits from the use of post-recovery plasma infusions of antibodies • Rapid development of a drug(s) that can cure, mitigate and perhaps prevent the disease • Rapid vaccine development • Possibly auto-attenuation apoptosis of the COVID-19 virus

What Are the Most Practical Research Challenges? • Rapid development of post-recovery plasma, antiviral drugs and vaccine therapy • Studies of the zoonotic relationship in order to prevent the future emergence of epidemics and pandemics by source intervention (e.g., outlawing the live animal markets in Asia) • Studies of seasonal virus life cycles to provide insights into their basic viral RNA replication processes • Since viruses cannot replicate themselves but obligate their host cell to replicate their particular molecular structure, by definition they are not living things that have an intrinsic finite life span. Therefore, inducing deactivation of certain of the 29 COVID-19 virus protein spikes can be viewed as a goal for organic chemistry. ■ “By failing to prepare, you are preparing to fail.” —Benjamin Franklin —Dr. Buchwald is a professor of surgery and biomedical engineering, and the Owen H. and Sarah Davidson Wangensteen Chair in Experimental Surgery (emeritus), at the University of Minnesota, in Minneapolis. His articles appear every other month.

CLASSIFIEDS

What Has History Taught Us? • Epidemics and pandemics occurred in prehistoric times and have continued into the present. • During some epidemics and pandemics, great crimes have been committed by religious groups as intended expiation for sins of humankind, without knowledge of the actual cause of disease. • Crowding promotes disease dissemination. • The conditions imposed by war promote the spread of disease; however, travel and commerce are probably the main causes of dissemination. • As a rule, death is highest in older infected individuals, usually aggravated by chronic illnesses, especially present in assisted living or nursing home residents. • Pandemics vary in the population’s age susceptibility. • Bacterial pandemics seem to be more lethal than viral ones, except for the Spanish flu of 1918-1920.

‘Surgical Renaissance in the Heartland’ A New Book by Henry Buchwald In 1960, fresh out of a stint in the Air Force, Henry Buchwald was recruited by Dr. Owen H. Wangensteen to join the Department of Surgery at the University of Minnesota’s medical school. In the culture of innovation created by Wangensteen, Buchwald, who had chafed against the rigidity of East Coast medical practice, found everything an imaginative young surgeon could have asked for. “Surgical Renaissance in the Heartland: A Memoir of the Wangensteen Era” (University of Minnesota Press; 2020, 204 pages, hardcover, $24.95) is the story of a golden era in American surgery, ushered in by Wangensteen’s creative approach to medical practice, told by one who lived it. Buchwald’s account of the Wangensteen era brings to life a medical culture that thrived on debate and the expression of ideas, a clinical practice bound only by the limits of a surgeon’s inspiration and imagination. As entertaining as it is informative, “Surgical Renaissance in the Heartland” effectively conjures the character—and characters—of a time that forever changed medicine and the lives of millions.

For classified advertising, contact Craig Wilson 212-957-5300 x235 • cwilson@mcmahonmed.com

GENERAL SURGERY NEWS / JUNE 2020

response

Teleflubbies By LINDA WONG, MD

n the wake of this entire COVID-19 tragedy, there was this tiny glimmer of hope, and this was the birth of telemedicine. For many years, physicians have tried to make telemedicine a part of routine medical care. Telemedicine has been helpful for patients in remote areas who need consultation from specialists who were not available locally. Studies have also demonstrated that telemedicine has been helpful for routine postoperative care, especially for patients who did not want to travel long distances for a simple hernia wound check. Patients were happy to avoid the drive, and care was not compromised. The major barriers to telemedicine have been the technology and reimbursement. Although we all have smartphone and laptop technology, the more complex machinery is less available, and likely too expensive for everyday use. Although smartwatches can track cardiac arrhythmias, monitor activity, and even record data to a central place, it is not exactly a visit with a physician. There are telerobots and technology that may allow physicians to listen to the heart and lungs with telemedicine stethoscopes. However, remote and rural places will probably not have the capacity for such technology. More mainstream telemedicine with just telephones and computers exists, but companies running these programs have fees, and physicians have been hesitant to invest in these when they may not get reimbursed for their efforts. In terms of reimbursement, insurance providers have been hesitant to support this and have variably set up payment structures, but at a snail’s pace. They are skeptical that the physicians are going to practice medicine adequately and have not put a consistent price on how much doctors should get paid for this seemingly noncontact patient care. Then, pandemic. There was a momentary asystolic pause in medical care while we tried to regroup and

figure it out—and then telemedicine was born. It was a crash cesarean section kind of birth but a birth nevertheless. Our medical center suddenly gave access to a telehealth system for the entire physician staff at “no” charge. They did not want patients coming to the campus or getting near the tents outside the emergency department where workers were screening the symptomatic COVID-19 don’t-wannabes. Everyone stay home. Two days after this started, we received a notice from the billing company listing all of the commercial insurance providers and their billing structure for telemedicine. This was based on “conversation length” to include the number of minutes spent on the phone including base visit (10 minutes), short extended visit, long extended visit and maximum visit (15 minutes) as well as the amount they will reimburse for each visit. We think we are golden. We can lock ourselves in the office, sit down, not wear a mask, and see patients. This should be easy. Yesterday, I saw five or six patients via telehealth and this was anything but easy. Patients were called beforehand, and the staff explained how to download the app on their devices. This was difficult, as the vast majority of my patients were above 65 years of age, frail, non– English-speaking and/or severely technologically challenged. My staff got an earful: Why can’t I just come in? Can you teach me how to download things on my phone? Where is the button to turn on the volume? Why can’t we just FaceTime like I do with my grandkids? I don’t have a smartphone. Can we still do this? My staff had suddenly become IT support or the Apple Store geeks. After the app was downloaded and I invited a patient to participate in this telehealth meeting, there came the wait. (And “wait” is a four-letter word to a surgeon.) This was anywhere from five to 20 minutes, which I have come to define as “tech skills index.” Some patients had

The Resident Corner continued from page 15

resident creates a realistic scenario, reviews the workup and imaging (usually borrowed from another patient), and works through the operative steps. More senior residents and faculty will pose questions about tricks, pitfalls and bail-out maneuvers. Of course, we would like for this conference to be reserved for actual patients, but this has been a valuable substitute. It keeps the interns looking at anatomy, the residents reviewing operative steps and the faculty engaged in education. Lastly, we

to call my office on another phone to get more instructions; some pressed every button until we were fully disconnected; and sometimes by sheer serendipity, the right combination of button pressing yielded both a picture and sound. I had to bring one patient into the office for a 45-minute visit in which I also fixed her phone—no charge. I knew we were in trouble when her first question was, “What’s an icon?” When we begin the telehealth visit, I am happy that the patients can both see me and hear me perfectly. On the other hand, I am mostly looking at their ceilings, the high shelf or light fixture, or perhaps the top of their heads depending on where the phone camera is pointing. Sigh. “Can you please move so I can see you?” “But we don’t know where the camera is!” Patients didn’t feel like they were seeing a physician but more like it was a FaceTime visit with a friend, so they started rambling about their relatives, telling me about their dog—all while seeing half-dressed family members and sometimes a pet in the background. When I asked what medications they were taking, there was a pause, a white screen, and I realized that they had left to find the pill bottles. Then when I asked to see a wound, they tried to point their phone at it, and suddenly I felt like a bar of soap in their shower scanning over their whole bodies. I was thankful this was not a hemorrhoidectomy. For each visit, I took notes, recorded the time, and tried not to be frustrated. Documentation was puzzling. There was not

alternate journal club and trauma/critical care lecture every Friday, led and moderated by a resident. All of this to say that the past few months have forced residency programs to come up with creative solutions. Here we have leveraged remote learning with in-house staffing to still provide care to patients with urgent surgical needs. Despite the growing pains, this period was an opportunity to see the heart behind general surgery education. Coronaviruses are not in the surgical textbooks. So why are surgery residents reading JAMA guidelines and reviewing vent management? Because it is hammered into us that when there is a problem and the consultant

much of a physical exam, since I could not exactly touch anything. I saw some things: The patient seemed to be breathing because they were talking to me; they didn’t look jaundiced despite the weird lighting in the room; and the wound looked OK. I learned some other things: People have a lot of clutter in their homes; two people trying to get into a camera means I’m just seeing the space between them; and it’s tough to draw pictures to explain surgery with this paradigm. More confusing: How will I bill for this? I spent 30 minutes with some patients; 20 minutes of it were spent fighting with the technology on their end. I did hear their voices for some of those minutes, but does that count? Is it face-to-face time? I did not always see a face because they could not seem to figure out where the camera was located. So does face-to-top of head count in those minutes? Telemedicine can be a helpful tool especially in the face of a pandemic. However, its value is best for routine follow-up visits and perhaps those areas of medicine that call for verbal and visual care only. If you have a new problem—bleeding, a new lump, severe pain or something dire—forget telehealth. That computer screen is not going to stop bleeding, drain pus, or determine whether you need an operation. When it comes to surgery, the human touch is important. Even in a pandemic crisis where face-to-face contact is discouraged and social distancing is practiced, some patients just need real surgical ■ care and not a TV doctor. —Dr. Wong is a professor of surgery at the University of Hawaii Cancer Center, in Honolulu. Column editor: Gary H. Hoffman, MD, is surgical director at Los Angeles Colon and Rectal Surgical Associates (www.lacolon.com), attending surgeon at Cedars-Sinai Medical Center, and instructor in the Cedars-Sinai colon and rectal surgical fellowship, in Los Angeles.

is out of town or unavailable (every oral exam), we find a solution. That mindset becomes part of who we are. I began with a quote from Dr. Stanley Dudrick, who sadly passed away this past January. He was most recently chair emeritus at the Department of Surgery at Yale University, but will forever be known for his pioneering work in parenteral nutrition. It is a reminder that when called upon, we are all global surgeons and global physicians, even if on a small scale. ■ —Dr. Halgas is a general surgery resident in El Paso, Texas. His articles on surgical residency appear every other month.

SAGES

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A Supplement to

What Is the First Thing We Need to Do to Fix Our Health Care System? And Will COVID-19 Be the Impetus for This Change? During this coronavirus pandemic, I have been on lockdown at home because I’m considered a senior citizen while many of you have been fighting bravely on the front lines. I have had a lot of time to watch the never-ending parade of news anchors speculate on what we’ve done right and what we’ve done wrong. On television, I have witnessed the tragedy of this pandemic, both in lives lost and the financial suffering. I have participated in many educational Zooms (not the noise a child makes when playing with cars but instead the modern way we can communicate and still socially distance). I and many others have asked the question: Could we, and should we, have done better in handling this pandemic? Why have our medical system and government been so confused on the path to take during this viral pandemic? I have also asked myself: Will we learn anything during the tragedy that will prepare us for future equally tragic events? Who are the experts we should be relying on now and in the future? Finally, as a scientist, I ask: Is there a better way that we should be collecting the data that should be the basis for making decisions in the future? Instead of our usual mano a mano debate, General Surgery News has asked two of its editorial advisory board members to weigh in on the problem. We have asked them: What is the first thing we need to do to fix our health care system? As you will see, they have slightly different takes on the situation; both seem to say the system is broken but there is a way to fix it. You will see from their contributions that both feel our health care system is similar to Babylon in that there has been a breakdown in communication. I hope this month’s debate will make you think of ways we can improve the system. This is not a question for our politicians to answer, but rather for you, the scientists and the ones on the front lines, who are so deeply involved in health care. We cannot leave it to others to solve the problem, or the next pandemic may be the last. If you have thoughts on the subject, contact us so we can continue this thread and perhaps find a solution. You can reach the editor at khorty@mcmahonmed.com. Edward L. Felix, MD Editor, The Great Debates General Surgeon, Pismo Beach, Calif.

The First Thing We Need to Do Is Create an Integrated Electronic Health Record

T David Earle, MD Assoc. Professor of Surgery, Tufts University School of Medicine Director, New England Hernia Center North Chelmsford, Mass.

he goal of health care reform is to improve value by increasing quality and decreasing cost. The Affordable Care Act, passed in 2010, accomplished the opposite by focusing on reducing cost and increasing volume. To accomplish our goal, we first need an integrated electronic health record (EHR). From chaos can come order. In that regard, my hope is that COVID-19 becomes the “Tenerife” of health care. Tenerife is a small Spanish island in the

Canary Islands archipelago off the coast of West Africa. There, on March 27, 1977, two 747 passenger jets collided, resulting in the deadliest aviation accident in history—583 dead, 61 survivors. When KLM Airlines got news of the accident, they looked for their best pilot, Capt. Jacob van Zanten, to investigate the accident. They soon found that their best pilot had hit Pan Am Flight 1736 on the runway during takeoff, and was killed instantly. continued on page 5

If you have suggestions for topics for future Great Debates, contact the editor at khorty@mcmahonmed.com.

In clinical trials, ENTEREG added to an accelerated care pathway (ACP), also commonly called an enhanced recovery pathway (ERP),1,2 was more effective than an ACP alone in helping to

ACCELERATE GI RECOVERY Early diet advancement

The ACP used in clinical trials included:

Early nasogastric tube (NGT) removal

Early ambulation

Indication and Usage

ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.

Important Safety Information WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY Increased incidence of myocardial infarction was seen in a clinical trial of patients taking alvimopan for long-term use. No increased risk was observed in short-term trials. Because of the potential risk of myocardial infarction, ENTEREG is available only through a restricted program for short-term use (15 doses) called the ENTEREG Access Support and Education (E.A.S.E.) Program.

Contraindications ENTEREG Capsules are contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG.

Warnings and Precautions There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic pain. In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of alvimopan, including studies of patients undergoing bowel resection surgery who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established.

For Patients Undergoing Partial Bowel Resections With Primary Anastomosis

Adding ENTEREG to an Accelerated Postoperative Care Pathway Improved Mean Time to GI Recoverya by up to 1.3 Days3 Phase 4 Radical

Mean Improvements in GI Recovery Time vs Placebo, Hours

Phase 3 Bowel Resection Studies

168

144

HOURS FASTER

120

14 HOURS

HOURS FASTER

FASTER

Study 2 ENTEREG (n=160) 3ODFHER Q

HR=1.6 (CI, 1.3–2.1)

Study 3 ENTEREG (n=139) 3ODFHER Q

HR=1.4 (CI, 1.1–1.8)

Cystectomy Study

HOURS FASTER

Placebo

HOURS FASTER

ENTEREG

96 72 48 24 0

Study 1 ENTEREG (n=317) 3ODFHER Q

HR=1.5 (CI, 1.3–1.8)

Study 4 ENTEREG (n=98) 3ODFHER Q

HR=1.4 (CI, 1.0–1.9)

Study 5 ENTEREG (n=239) 3ODFHER Q

HR=1.3 (CI, 1.1–1.6)

Study 6 ENTEREG (n=143) 3ODFHER Q

HR=1.8 (CI, 1.4–2.3)

HR=hazard ratio &, FRQƓGHQFH LQWHUYDO

GI recovery was defined as the time to toleration of solid food and first bowel movement.

Median time to GI recovery was improved with use of ENTEREG by 17 hours (Study 1, Study 2), 15 hours (Study 3), 12 hours (Study 4), and 3 hours (Study 5) in the phase 3 bowel resection studies and 29 hours in the phase 4 radical cystectomy study (Study 6).3 Patient numbers are for modified ITT; dose of ENTEREG used was 12 mg.

Study Design Data are from 5 multicenter, randomized, double-blind, parallel-group, placebo-controlled studies in patients undergoing bowel resection and 1 randomized, double-blind, placebo-controlled study in patients undergoing radical cystectomy (5 US studies and 1 non-US bowel resection study; ENTEREG: n=1096; placebo: n=1058; 54% male; 89% Caucasian). Patients 18 years of age or older (average age: 62 years) who underwent bowel resection surgeries that included primary anastomosis (partial large or small bowel resection surgery or radical cystectomy for

bladder cancer) were administered ENTEREG 12 mg or placebo 30 minutes to 5 hours prior to surgery and twice daily after surgery until discharge, for a maximum of 7 days. There were no limitations on the types of general anesthesia used. The primary endpoint for all studies was time to achieve resolution of postoperative ileus, a clinically defined composite measure of both upper and lower GI recovery. GI2 (toleration of solid food and first bowel movement) represents the most objective and clinically relevant measure of treatment response.

The efficacy of ENTEREG following total abdominal hysterectomy has not been established.

Study Exclusions Patients who received more than 3 doses of an opioid (regardless of route) during the 7 days prior to surgery and patients with complete bowel obstruction or who were scheduled for a total colectomy, colostomy, or ileostomy were excluded. Intrathecal or epidural opioids or anesthetics were prohibited.

Important Safety Information Warnings and Precautions (continued) E.A.S.E. Program for ENTEREG: ENTEREG is available only to hospitals that enroll in the E.A.S.E. ENTEREG REMS Program. To enroll in the E.A.S.E. Program, the hospital must acknowledge that: – Hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use – Patients will not receive more than 15 doses of ENTEREG – ENTEREG will not be dispensed to patients after they have been discharged from the hospital ENTEREG should be administered with caution to patients receiving more than 3 doses of an opioid within the week

prior to surgery. These patients may be more sensitive to ENTEREG and may experience GI side effects (eg, abdominal pain, nausea and vomiting, diarrhea). ENTEREG is not recommended for use in patients with severe hepatic impairment, end-stage renal disease, complete gastrointestinal obstruction, or pancreatic or gastric anastomosis, or in patients who have had surgery for correction of complete bowel obstruction.

Adverse Reactions The most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo among ENTEREG-treated patients undergoing surgeries that included a bowel resection was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%).

Please read the adjacent Brief Summary of the Prescribing Information, including the Boxed Warning about potential risk of myocardial infarction with long-term use. ENTEREG is included in guidelines jointly published by the American Society of Colon and Rectal Surgeons (ASCRS) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).a a

Carmichael JC, Keller DS, Baldini G, et al. Clinical practice guidelines for enhanced recovery after colon and rectal surgery from the American Society of Colon and Rectal Surgeons and Society of American Gastrointestinal and Endoscopic Surgeons. Dis Colon Rectum. 2017;60(8):761-784.

References: 1. Berger NG, Ridolfi TJ, Ludwig KA. Delayed gastrointestinal recovery after abdominal operation—role of alvimopan. Clin Exp Gastroenterol. 2015;8:231-235. 2. Melnyk M, Casey RG, Black P, Koupparis AJ. Enhanced recovery after surgery (ERAS) protocols: time to change practice? Can Urol Assoc J. 2011;5(5):342-348. 3. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package ANES-1149074-0001.

ENTEREG® (alvimopan) capsules 12 mg, for oral use BRIEF SUMMARY OF PRESCRIBING INFORMATION WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY There was a greater incidence of myocardial infarction in alvimopan-treated patients compared to placebotreated patients in a 12-month clinical trial, although a causal relationship has not been established. In short-term trials with ENTEREG, no increased risk of myocardial infarction was observed. Because of the potential risk of myocardial infarction with long-term use, ENTEREG is available only through a restricted program for short-term use (15 doses) under a Risk Evaluation and Mitigation Strategy (REMS) called the ENTEREG Access Support and Education (E.A.S.E.®) Program. DOSAGE AND ADMINISTRATION For hospital use only. The recommended adult dosage of ENTEREG is 12 mg administered 30 minutes to 5 hours prior to surgery followed by 12 mg twice daily beginning the day after surgery until discharge for a maximum of 7 days. Patients should not receive more than 15 doses of ENTEREG. ENTEREG can be taken with or without food. CONTRAINDICATIONS ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG. WARNINGS AND PRECAUTIONS Potential Risk of Myocardial Infarction with Long-term Use There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic non-cancer pain (alvimopan 0.5 mg, n = 538; placebo, n = 267). In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of ENTEREG in patients treated with opioids for chronic pain, nor in patients treated within the surgical setting, including patients undergoing surgeries that included bowel resection who received ENTEREG 12 mg twice daily for up to 7 days (the indicated dose and patient population; ENTEREG 12 mg, n = 1,142; placebo, n = 1,120). A causal relationship with alvimopan with long-term use has not been established. ENTEREG is available only through a program under a REMS that restricts use to enrolled hospitals. E.A.S.E. ENTEREG REMS Program ENTEREG is available only through a program called the ENTEREG Access Support and Education (E.A.S.E.) ENTEREG REMS Program that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of ENTEREG. Notable requirements of the E.A.S.E. Program include the following: ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have enrolled in and met all of the requirements for the E.A.S.E. program may use ENTEREG. To enroll in the E.A.S.E. Program, an authorized hospital representative must acknowledge that: • hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use; • patients will not receive more than 15 doses of ENTEREG; and • ENTEREG will not be dispensed to patients after they have been discharged from the hospital. Further information is available at www.ENTEREGREMS.com or 1-800-278-0340. Gastrointestinal-Related Adverse Reactions in Opioid-Tolerant Patients Patients recently exposed to opioids are expected to be more sensitive to the effects of mu-opioid receptor antagonists, such as ENTEREG. Since ENTEREG acts peripherally, clinical signs and symptoms of increased sensitivity would be related to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea). Patients receiving more than 3 doses of an opioid within the week prior to surgery were not studied in the postoperative ileus clinical trials. Therefore, if ENTEREG is administered to these patients, they should be monitored for gastrointestinal adverse reactions. ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG. Risk of Serious Adverse Reactions in Patients with Severe Hepatic Impairment Patients with severe hepatic impairment may be at higher risk of serious adverse reactions (including dose-related serious adverse reactions) because up to 10-fold higher plasma concentrations of alvimopan have been observed in such patients compared with patients with normal hepatic function. Therefore, the use of ENTEREG is not recommended in this population. End-Stage Renal Disease No studies have been conducted in patients with end-stage renal disease. ENTEREG is not recommended for use in these patients. Risk of Serious Adverse Reactions in Patients with Complete Gastrointestinal Obstruction No studies have been conducted in patients with complete gastrointestinal obstruction or in patients who have surgery for correction of complete bowel obstruction. ENTEREG is not recommended for use in these patients. Risk of Serious Adverse Reactions in Pancreatic and Gastric Anastomoses ENTEREG has not been studied in patients having pancreatic or gastric anastomosis. Therefore, ENTEREG is not recommended for use in these patients. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. The data described below reflect exposure to ENTEREG 12 mg in 1,793 patients in 10 placebo-controlled studies. The population was 19 to 97 years old, 64% were female, and 84% were Caucasian; 64% were undergoing a surgery that included bowel resection. The first dose of ENTEREG was administered 30 minutes to 5 hours before the scheduled start of surgery and then twice daily until hospital discharge (or for a maximum of 7 days of postoperative treatment). Among ENTEREG-treated patients undergoing surgeries that included a bowel resection, the most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%). Adverse reactions are events that occurred after the first dose of study medication treatment and within 7 days of the last dose of study medication or events present at baseline that increased in severity after the start of study medication treatment. DRUG INTERACTIONS Effects of Alvimopan on Intravenous Morphine Coadministration of alvimopan does not appear to alter the pharmacokinetics of morphine and its metabolite, morphine-6-glucuronide, to a clinically significant degree when morphine is administered intravenously. Dosage adjustment for intravenously administered morphine is not necessary when it is coadministered with ENTEREG. Effects of Concomitant Acid Blockers or Antibiotics A population pharmacokinetic analysis suggests that the pharmacokinetics of alvimopan were not affected by concomitant administration of acid blockers (proton pump inhibitors (PPIs), histamine-2 (H2) receptor antagonists) or antibiotics. No dosage adjustments are necessary in patients taking acid blockers or antibiotics with ENTEREG.

USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary: Available data regarding use of ENTEREG in pregnant women are limited, and are insufficient to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. No fetal harm was observed in animal reproduction studies with oral administration of alvimopan during organogenesis to pregnant rats at doses 68 to 136 times the recommended human oral dose, or with intravenous administration during organogenesis to pregnant rats and pregnant rabbits at doses 3.4 to 6.8 times, and 5 to 10 times, respectively, the recommended human oral dose. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Animal Data: Embryo-fetal studies were performed in pregnant rats during organogenesis (gestation days 7 through 19, or 20) at oral doses up to 200 mg/kg/day (about 68 to 136 times the recommended human oral dose based on body surface area) and at intravenous doses up to 10 mg/kg/day (about 3.4 to 6.8 times the recommended human oral dose based on body surface area). A study in pregnant rabbits during organogenesis (gestation days 6 through 18) at intravenous doses up to 15 mg/kg/day (about 5 to 10 times the recommended human oral dose based on body surface area) revealed no evidence of harm to the fetus due to alvimopan. In an intravenous pre- and postnatal development study (gestation day 7 through lactation day 20) in rats, alvimopan did not cause any adverse effect on pre- and postnatal development at doses up to 10 mg/kg/day (about 6.8 times the recommended human oral dose based on body surface area). Lactation Risk Summary: There are no data on the presence of alvimopan in human milk, the effects on the breastfed infant, or the effects on milk production. Alvimopan and its ‘metabolite’ are detected in the milk of lactating rats following intravenous administration. It is unknown if alvimopan is present in rat milk following oral administration. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ENTEREG and any potential adverse effects on the breastfed child from ENTEREG or from the underlying maternal condition. Data: Following intravenous administration of alvimopan to lactating rats at 10 mg/kg/day, concentrations of alvimopan and its ‘metabolite’ in the milk were approximately 15- and 0.11-fold, respectively, the concentration of alvimopan in maternal plasma at 1-hour post-dose. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Of the total number of patients in 6 clinical efficacy studies treated with ENTEREG 12 mg or placebo, 46% were 65 years of age and over, while 18% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment based on increased age is required. Hepatic Impairment ENTEREG is not recommended for use in patients with severe hepatic impairment. Dosage adjustment is not required for patients with mild-to-moderate hepatic impairment. Patients with mildto-moderate hepatic impairment should be closely monitored for possible adverse reactions (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high alvimopan or ‘metabolite’ concentrations, and ENTEREG should be discontinued if adverse reactions occur. Renal Impairment ENTEREG is not recommended for use in patients with end-stage renal disease. Dosage adjustment is not required for patients with mild-to-severe renal impairment, but they should be monitored for adverse reactions. Patients with severe renal impairment should be closely monitored for possible adverse reactions (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high alvimopan or ‘metabolite’ concentrations, and ENTEREG should be discontinued if adverse reactions occur. Race/Ethnicity No dosage adjustment is necessary in Black, Hispanic, and Japanese patients. However, the exposure to ENTEREG in Japanese healthy male subjects was approximately 2-fold greater than in Caucasian subjects. Japanese patients should be closely monitored for possible adverse reactions (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high alvimopan or ‘metabolite’ concentrations, and ENTEREG should be discontinued if adverse reactions occur. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: Two-year carcinogenicity studies were conducted with alvimopan in CD-1 mice at oral doses up to 4000 mg/kg/day and in Sprague Dawley rats at oral doses up to 500 mg/kg/day. Oral administration of alvimopan for 104 weeks produced significant increases in the incidences of fibroma, fibrosarcoma, and sarcoma in the skin/subcutis, and of osteoma/osteosarcoma in bones of female mice at 4000 mg/kg/day (about 674 times the recommended human dose based on body surface area). In rats, oral administration of alvimopan for 104 weeks did not produce any tumor up to 500 mg/kg/day (about 166 times the recommended human dose based on body surface area). Mutagenesis: Alvimopan was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y/TK+/−) forward mutation test, the Chinese Hamster Ovary (CHO) cell chromosome aberration test, or the mouse micronucleus test. The pharmacologically active ‘metabolite’ was negative in the Ames test, chromosome aberration test in CHO cells, and mouse micronucleus test. Impairment of Fertility: Alvimopan at intravenous doses up to 10 mg/kg/day (about 3.4 to 6.8 times the recommended human oral dose based on body surface area) was found to have no adverse effect on fertility and reproductive performance of male or female rats. PATIENT COUNSELING INFORMATION Recent Use of Opioids Inform patients that they must disclose long-term or intermittent opioid pain therapy to their healthcare provider, including any use of opioids in the week prior to receiving ENTEREG. Inform patients that recent use of opioids may make them more susceptible to adverse reactions to ENTEREG, primarily those limited to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea). Hospital Use Only Inform patients that ENTEREG is available only through a program called the ENTEREG Access Support and Education (E.A.S.E.) Program under a REMS that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of ENTEREG. ENTEREG is for hospital use only for no more than 7 days after their bowel resection surgery. Most Common Adverse Reaction Inform patients that the most common adverse reaction with ENTEREG in patients undergoing surgeries that include bowel resection is dyspepsia. For more detailed information, please read the Prescribing Information.

USPI-MK3753-C-1910r001 Revised: 10/2019

GREAT DEBATES

JUNE 2020 / GENERAL SURGERY NEWS

continued from page 1

On Jan. 31, 2020, the U.S. government and multiple airlines banned travel to the United States from China due to a novel coronavirus. Many subsequent actions were taken to “flatten the curve” of rising COVID-19 to prevent overwhelming our health care system, including shutting down the economic engine of hospitals— the operating room. As the pandemic spread, elective surgeries and census numbers plummeted, and hospitals responded by dropping hundreds of employees and dozens of services. Modern data analytics drove us to these decisions. The problem isn’t the analytics, it’s the data. They are incomplete, and maybe inaccurate. As models emerged from the Gates Foundation‒ funded Institute for Health Metrics and Evaluation (IHME), the public lockdown began a metamorphosis, even as the models fluctuated wildly, and were not specific. On May 6, the IHME estimated that 43,511 to 91,454 hospital beds were needed to deal with the pandemic.1 That information, however, is worthless for hospital officials because no action can be taken. But that doesn’t stop elected officials from using it to make decisions. Garbage in, garbage out. The best data analytics can’t overcome incomplete or incorrect data. For a striking example of modern data analysis with poor-quality data, consider the latest robotic systems used to help pilots fly planes. After all, machines can do it better, right? Look at all the marketing for surgical robotics to corroborate that philosophy. In an effort to keep up with rival Airbus, Boeing released its most modern aircraft, the 737 MAX. The larger, more efficient engines could cause the plane’s nose to tilt upward, so data analytics software was used to compensate for this. However, between Oct. 29, 2018 and March 10, 2019, when sensor information was erroneous, incomplete and/or out of context, the software still corrected the plane’s altitude and caused two brand-new aircraft, loaded with a total of 346 passengers and crew, to crash shortly after takeoff, killing all aboard.2 Garbage in, garbage out can kill. God rest their souls. So we do need data analytics, but we can’t do it without the data. The CDC has known for decades the importance of collecting good data, so it created the National Healthcare Safety Network (NHSN) database, a de facto EHR. This single database has modules for diseases, including COVID-19, but it has fatal flaws: 1) it only captures a very limited number of diseases, and 2) it primarily gets data from hospitals and dialysis centers.3 There are no data from outpatient settings, no pharmacy data, no community health clinic data. Also, en route to the CDC, the data are passed along like a story whispered around a campfire, propagating errors along the way. Yes, another incomplete data set, setting public policy. We then heard about promising treatment options

for COVID-19, and how regulatory restrictions would be lowered to speed their legal marketing. Anthony Fauci, MD, of the Presidential Coronavirus Task Force, then stated we must use randomized controlled trials to figure out whether any treatments are effective. And RCTs take time—years. Time is what we don’t have during a pandemic. Consider the number of unique drug combinations using four medications: It’s 24. Then consider timing and dosing variations. A power analysis would reveal that tens of thousands of highly selected patients would be required, which would take years. And that statistical difference may not be clinically relevant. Additionally, RCTs have exclusion criteria, are difficult to interpret and necessarily incomplete representations of the actual data,4 which limits their applicability in the real world where we all work. That is precisely why an RCT will not answer the question about which treatment is best for COVID-19, just as the soup maker Campbell’s discovered there is no best spaghetti sauce in the 1980s.5 This complexity is perhaps one reason the Federal Aviation Administration came out with its “Call to Action” in August 2007, to address aviation runway incursions, with the Tenerife accident playing a prominent role in the decision to proceed with this project. I’ll do the math for you: It’s 30 years after the accident. The solution starts with accurate, timely data. We already collect it in our EHRs, but the data aren’t integrated and the corporate masters won’t give us access. If we had access to accurate and complete data, we subsequently analyze thousands of real-world patient outcomes for COVID-19 treatments to figure out which works best for an individual at a particular location— not a group of patients spread out in different environments. For this, we need an integrated EHR system. With accurate data, we could manage COVID-19 (and all diseases) with a scalpel instead of a sledgehammer. The only thing worse than no data is incomplete or inaccurate data. But the data become dramatically more flawed as assumptions replace real-world data, and we all know what happens when you assume.6 References 1. Institute for Health Metrics and Evaluation. https://covid19.healthdata. org/united-states-of-america. Accessed May 6, 2020. 2. House Committee on Transportation and Infrastructure. The Boeing 737 MAX Aircraft: Costs, Consequences, and Lessons from its Design, Development, and Certification—Preliminary Investigative Findings, March 2020. https://bit.ly/3bS2CsT 3. CDC. www.cdc.gov/nhsn/about-nhsn/index.html. Accessed May 8, 2020. 4. Bauchner H, Golub RM, Fontanarosa PB. JAMA. 2019;322(8):732-735. doi:10.1001/jama.2019.12056 5. Malcolm Gladwell. www.ted.com/talks/malcolm_gladwell_choice_happiness_and_spaghetti_sauce?language=en#t-313902 6. American Broadcasting Company. “The Odd Couple.” 2011. https://youtu. be/svkgOsr7pUc

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JUNE 2020 / GENERAL SURGERY NEWS

GREAT DEBATES

The First Thing We Need to Do Is Develop a Data Analytics Infrastructure Based on Systems and Data Science

n 1944, President Franklin D. Roosevelt sent a letter requesting Vannevar Bush, the director of the Office of ScienBruce tific Research and Development, to proRamshaw, MD pose a plan for applying similar research General Surgeon principles used in the recent war (World Managing Partner, War II) and apply them to the war on CQInsights disease. The Bush report, “Science—The Knoxville, Tenn. Endless Frontier,” led to the development of the National Science Foundation and then the National Institutes of Health. The model that was applied is termed the “linear model of innovation,” and its focus is on basic science using reductionist tools, such as controlled research trials. One example of this reductionist model for innovation is the Norden bombsight. An engineer, Carl Norden, wanted to build a bombsight that improved accuracy to allow bombers to fly at a safer height. He developed a complicated machine, with about 2,000 parts, based on his expertise in gyro stabilization. In controlled testing, the bombsight performed brilliantly. The CEP (a circle into which 50% of bombs would fall) was 75 feet, a fantastic performance for that time. Without testing in the real world, the Norden bombsight was mass produced, and tens of thousands were installed in planes for the U.S. Navy and Air Force at a cost of nearly $10,000 each. When the bombsight was eventually used in realworld conditions, the CEP increased to 1,200 feet, a decay in accuracy of over 90%—about the level of decay in accuracy for our current airport screening process in real-world conditions versus controlled testing. The controlled environment did not account for several factors that might affect accuracy, such as weather conditions, mechanical issues, and the fact that the person operating the bombsight might be getting shot at. The performance was so bad that its usage was abandoned soon after it was introduced into combat. A different model for innovation comes from the principles of systems and data science in real-world conditions, using analytics and feedback loops providing iterative improvement. One example of this is the Wright brothers’ successful achievement of flight. They used real-world conditions, collecting and analyzing data with feedback loops to improve their designs. At one point, they tested dozens of wing surfaces over two months, analyzing the data as results were generated. After their success, one of the Wright brothers wrote: “it is doubtful if anyone would have ever developed a flyable wing without first developing this data.”

If we continue to use reductionist tools for the COVID-19 pandemic, we will continue to require the same management strategies we applied almost 400 years ago during the plague—shelter in place, social distancing, quarantines, etc. And our linear model for innovation, waiting for the results of controlled clinical trials, will result in lengthy delays and unintended waste and harm when treatments are introduced into real-world patient care. Controlled studies attempt to determine whether a treatment works or doesn’t work, and generates recommendations for the average patient. This one-size-fitsall approach is not appropriate for a complex biological system. With an appropriate data analytics infrastructure in place, we could identify different patient subpopulations and apply the optimal variety of treatments matched appropriately to these subpopulations. This is the type of analytics that Netflix uses to present the optimal variety of movies and shows to different subpopulations of people—and thank goodness for Netflix and its algorithms during this pandemic. Many treatments are already being used in clinical settings to improve outcomes for patients with COVID-19, but without a data infrastructure in place that can measure outcomes and assess the value of any treatment in different subpopulations, we are flying blind. We could also use a data infrastructure to identify the factors that lead to a subpopulation that gets the virus and has minimal or no symptoms, one that has moderate symptoms, and another that develops a severe illness and is at risk for dying. The best strategy we have now in the real world is doctors and nurses posting their observations on social media and other forms of communication. But without a data and analytics infrastructure, these stories are just anecdotes. A real-world data infrastructure should include input from the front-line clinical team in each clinical environment. This system would enable a human-computing symbiosis in which the clinical team could identify the most important patient and treatment factors that would influence outcomes that measure the value of care (see “Value Over Volume,” General Surgery News March 2020). The data set could then be uploaded into analytics and visualization tools, and the clinical team could then interpret the results and apply insights to improve measurements and generate ideas to improve outcomes. Each clinical team could be networked with other teams to share their learning and improve algorithms to identify subpopulations for an optimal variety of treatment and preventative measures, termed the “ensemble model continued on the following page for learning.”

GREAT DEBATES

Our health care system has spent billions of dollars for a data infrastructure designed for documentation, coding and billing. We have fragmented EHRs, hundreds of revenue cycle management software products, and armies of coders and billers, guided by the system, in every clinical environment, all focused on getting paid. If we applied a fraction of those resources to a data infrastructure to support the measurement and

GENERAL SURGERY NEWS / JUNE 2020

improvement of value-based outcomes for real-world patient care management, we would have a sustainable health care system globally, and this pandemic would likely be managed and resolved by now. I believe this type of data infrastructure is the most important lesson to learn and apply from the tragedy of this pandemic. Visit Dr. Ramshaw’s blog at www.bruceramshaw.com/blog.

Dr. Earle’s Rebuttal to Dr. Ramshaw Bruce Ramshaw has been speaking about complex systems management for at least a decade. I largely agree with what he has to say, and have realized that literally all aspects of medicine and health care delivery are somehow not using real-world data to continuously improve. In Dr. Ramshaw’s own words, “With an appropriate data analytics infrastructure in place, we could identify … and apply the optimal variety of treatments matched appropriately to these subpopulations.” I agree. But without data, the data analytics infrastructure will be in the next season of television’s “Mysteries of the Abandoned.” Dr. Ramshaw realizes this, stating: “Many treatments are already being used in clinical settings to improve outcomes for patients with COVID-19, but without a data infrastructure in place …, we are flying blind.” Once again, no data means no data analysis. He does acknowledge that “[a] real-world data infrastructure should include input from the front-line clinical team in each clinical environment” and “the best we have now in the real world is doctors and nurses posting their observations on social media and other forms of communication.” As I stated in my argument, we already collect data from front-line clinical teams, we just don’t have access to it. Neither do the elected officials and neither does the CDC. Dr. Ramshaw pointed out the Wright brothers’ statement: “it is doubtful if anyone would have ever developed a flyable wing without first developing this data.” Even the Wright brothers recognized the need for accurate and complete data, before analyzing and acting on it. So, the data we need are collected in software paid for by doctors and hospitals, but doctors and hospitals don’t have access. The FDA doesn’t have access. The CDC doesn’t have access. The multibillion-dollar software companies are hoarding the data. Why? We can only guess, but it’s not to improve health care. This is the true role of government— legislate an integrated EHR [electronic health record]! Give us access to the data we desperately need to apply Dr. Ramshaw’s data analytics infrastructure, protected by all the laws on the books today, such as HIPAA. Our lives literally depend on it.

Dr. Ramshaw’s Rebuttal to Dr. Earle I appreciate the argument presented by Dr. Earle for an integrated EHR. It seems like we should be able to share data across our health care system. But we already have an integrated EHR in the United States, in the Veterans Affairs (VA) system. It is convenient for clinicians and patients to access data throughout that system. But that isn’t how data science works (if it is used to measure and improve outcomes). To achieve value from data and software, a system should be decentralized into each context (definable patient care process) and available in each local clinical environment. A decentralized data system is also the optimal solution for data security. Centralized data is prone to major accidental and intentional data breaches. A couple of years ago, the Veterans Administration announced it would be moving from the current EHR to a new one from Cerner that would cost $10 billion. A couple of months ago, the agency announced delays and the cost is now estimated to be $16.1 billion. Unfortunately, no centralized data repository will ever drive better value into the system (no matter how much we spend). Data access is not the most important solution. Understanding data science and applying it in the real world of patient care is the most important solution (and would be much less costly). This would not be the first decentralized global data infrastructure in our world built on principles of data science; that’s how the internet was designed and built at a total cost estimate of about $125 million. Recently, during a Senate hearing about the lessons learned from our response to COVID-19, Sen. Mitt Romney (R-Utah) asked Dr. Robert Redfield, the director of the CDC: “How is it possible in this day and age that the CDC has never established a real-time system with accurate data?” Dr. Redfield responded, “The reality is there is an archaic system. … This nation needs a modern, highly capable data analytic system that can do predictive analysis. I think it’s one of the many shortcomings that have been identified as we went through this outbreak, and I couldn’t agree with you more, it’s time to get that corrected.” I agree, as well.