General Surgery News (April 2020)

Should Subspecialty Surgery Be Limited to Fellowship-Trained Surgeons in Urban Areas?

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

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April 2020 • Volume 47 • Number 4

Life in the Time of COVID-19

Surgeons Grapple With Unknowns Amid COVID-19 Private Practice Likely To Be Hit Hard by Canceled Cases

By VICTORIA STERN

[Editor’s note: This story went to press on March 31 and information may have changed since then. Readers are encouraged to visit www.generalsurgerynews.com for the most updated information on COVID-19.]

Surgeons From Across the Country Share Their Experiences and Reflections as They Deal With Outbreak

By SAMUEL P. CARMICHAEL II, MD, Trauma Surgeon, Winston-Salem, N.C.

March 22, 2020—World War II witnessed Adolf Hitler’s blitz through the Rhineland and into France as an unprecedented demonstration of modern warfare. It was swift and brash, traveling at such velocities previously considered impossible. Panzer tank divisions consumed the countryside, traversing the Ardennes and bringing the German Army to the center of Paris before an Continued on page 16

Partial REBOA Device Shows Promise in Swine Model Prototype Still in Early Phase; Controversy on REBOA Remains High Among Trauma Specialists

By CHASE DOYLE

A

minimally invasive technique born on the battlefields of Iraq, resuscitative endovascular balloon occlusion of the aorta (REBOA), has saved the lives of countless combat soldiers with traumatic noncomp ressible torso bleeding, but its role in the civilian setting remains limited and somewhat controversial. Despite the need for temporizing measures to slow bleeding en route to surgery, critics of the technique argue that the ischemic complications that ensue from full aortic occlusion are just too damaging.

Continued on page 12

IN THE NEWS

8 Review of Treatments for COVID-19 OP IN ION

24 Artificial Ignorance By Linda Wong, MD 6

Bleeding in Bariatric Surgery .

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@gensurgnews

A

s the number of COVID-19 cases continues to grow at an exponential rate, the demand for hospital supplies, safety equipment, beds and staff is outpacing supplies.

To conserve resources and prepare hospitals for the volume of cases to come, policymakers and surgical societies have issued recommendations to help physicians and hospitals make tough choices.

On March 24, the American College

Continued on page 4

OPINION

Principles and Commitments

By HENRY BUCHWALD, MD, PHD

‘Important principles may, and must, be inflexible.’

—Abraham Lincoln

S

andy Koufax, probably the greatest left-handed pitcher in the annals of baseball, refused to pitch Game 1 of the 1965 World Series for the Brooklyn Dodgers, because the game fell on Yom Kippur, the holiest day in the Jewish calendar. He lost Game 2, won Game 5, and after two days of rest, pitched a three-hit shutout in Game 7 to win the series for the Dodgers.

Continued on page 22

FOR SOME ELITE SOLDIERS, THIS IS ADVANCING. As a general surgeon and officer on the U.S. Army health care team, you will work in cutting-edge facilities as you see and study cases that are not usually encountered in civilian practices. You will also receive benefits that ensure you are taken care of, including student loan repayment programs, paid continuing education, retirement plans and much more. Joining this team will allow you to advance your career and focus on why you became a physician in the first place—to care for your patients.

To see the benefits of being an Army medical professional call 800-431-6717 or visit healthcare.goarmy.com/aiqr

Š2020. Paid for by the United States Army. All rights reserved.

IN THE NEWS

APRIL 2020 / GENERAL SURGERY NEWS

New Guidelines Address Sepsis in Children ‘Substantial Departure’ From Approach to Adults

By CHRISTINA FRANGOU

T

he Surviving Sepsis Campaign has issued the first clinical guideline for the identification and treatment of sepsis in children, from newborn to 18 years of age.

The guideline, which was presented during the Society of Critical Care Medicine’s 2020 Critical Care Congress, differs notably from guidelines for adults with sepsis.

“Children are not simply small adults and the signs of sepsis and its treatment differ, so they need to be assessed and managed differently,” said Scott Weiss, MD, an intensivist at Children’s Hospital of Philadelphia and a co-vice chair of the guideline committee, in a statement.

While adult guidelines recommend that all patients are started on antimicrobial therapy within one hour of recognizing sepsis, the pediatric guidelines recommend a more liberal approach with a two-phase process for assessing children suspected of having sepsis.

Kids who have symptoms of septic shock should be placed on antimicrobial

therapy within one hour of shock rec- needed, and children should be reasognition. Those without symptoms of sessed daily and taken off antimicrobial septic shock should be further evaluat- therapy once they no longer have evied to confirm or exclude a diagnosis of dence of bacterial infection. sepsis and, if results are positive, started “This helps reduce inappropriate antion therapy within three hours of the ini- biotic use, which has become a globtial suspicion or sooner if shock develops al health emergency,” said committee during the evaluation. co-chair Niranjan Kissoon, MBBS, the The guideline recommends obtain- vice president of medical affairs at Briting blood cultures before antimi- ish Columbia Children’s Hospital and crobial therapy if this does not Sunny Hill Health Centre for Children, substantially delay treatin Vancouver, in a statement. ment. The authors—a multidisciplinary panel of 49 international 1.2 million children develop experts, three methsepsis globally every year, odologists and three public members— including more than 75,000 in called for initial use the United States. Nearly 7,000 American of broad-spectrum antimicrobial therachildren die of sepsis annually, making it py to cover all likely more deadly than pediatric cancer. pathogens and narrowing to a more specific therapy once a pathogen has been identified.

The panel stressed that antibiotics should only be used when

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DISCLAIMER Opinions and statements published in General Surgery News are of the individual author or speaker and do not represent the views of the editorial advisory board, editorial staff or reporters.

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While sepsis is more common in adults, 1.2 million children develop the condition globally every year, including more than 75,000 in the United States.

Nearly 7,000 American children die of sepsis annually, making it more deadly than pediatric cancer.

Sepsis and septic shock can be difficult to diagnose in children. The majority of kids who have some sepsis symptoms do not have the condition, making early and accurate diagnosis challenging. For this

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IN THE NEWS

GENERAL SURGERY NEWS / APRIL 2020

Surgeons Grapple With Unknowns Amid COVID-19 Outbreak continued from page 1

of Surgeons published guidelines asking surgeons to restrict elective surgeries in preparation for the cases of COVID-19 “to skyrocket in the next few weeks.” In its guidance, the ACS compiled recommendations from experts in 14 specialties, including operations for cancer and vascular surgery, to help surgeons make the best treatment decisions and identify procedures that can be postponed. These recent guidelines take on a more urgent tone than those issued just a week earlier.

“These current guidelines are not rigid laws or rules. They are there to help people’s thinking and will change as regularly as they need to,” said David Hoyt, MD, FACS, the executive director of the ACS. The CDC and the Society of Gastrointestinal and Endoscopic Surgeons, along with the Centers for Medicare & Medicaid Services and other authorities, have echoed the ACS recommendations to delay nonessential procedures to conserve personal protective equipment (PPE), hospital beds and ventilators.

Given these recommendations, institutions across the United States have been cutting back on nonessential elective

procedures to varying extents. Hospitals in New York—a hot spot for the virus— are in lockdown mode after Gov. Andrew Cuomo (D-N.Y.) issued a directive to cancel all noncritical surgical procedures in the state starting March 25.

For New York, the need to conserve resources is critical. As of March 24, the number of COVID-19 patients in the state exceeded 25,000, with hospitals just days away from running out of ventilators and vital safety equipment. Other states may not be far behind New York if the spread of infection is not contained, which is why many hospitals across the country are preparing for this type of surge.

Cedars-Sinai Medical Center, in Los Angeles, “has tried to perform surgery only when we felt the risk of not performing it was greater than the risk of performing it now,” Gary H. Hoffman, MD, the clinical chief in the Division of Colon-Rectal Surgery, told General Surgery News. “Our surgical centers have gone with reduced operating hours, so surgeons are sharing precious resource time in the OR. But our job has been made easier because many patients have

New CPT Code to Report SARS-CoV-2 Test

By GSN STAFF

The American Medical Association (AMA) announced a new addition to the Current Procedural Terminology (CPT) code set that will help streamline data-driven resource and allocation planning in the battle against SARSCoV-2 as the number of confirmed COVID-19 cases continues to rise in the United States.

“In the face of the COVID-19 pandemic, the CPT Editorial Panel has expedited approval of a unique CPT code to report laboratory testing services that diagnose the presence of the novel coronavirus,” said AMA President Patrice A. Harris, MD, MA. “The new CPT code assigned to the test for the novel coronavirus provides analytical advantages for tracking, allocating and optimizing resources as testing ramps up in the United States.”

For quick reference, the new Category I CPT code and long descriptor are: • 87635 Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique.

• The code is effective immediately for use as the industry standard for reporting of tests for the novel coronavirus across the nation’s health care system. In addition to the long descriptor, CPT code 87635 has short and medium descriptors that can be accessed on the AMA website.

• The CPT Editorial Panel, the independent body convened by the AMA with sole authority to manage revisions to the CPT code set, expedited the code development process for the novel coronavirus test. Development, review and approval of the new CPT code involved broad input from practicing physicians, the CDC and other experts.

‘Everyone is reacting at a different pace depending on their experience, but we’re starting to see reports that more and more hospitals have stopped or are planning to stop performing elective operations.’

—David Hoyt, MD, executive director, American College of Surgeons preferred to put off their procedures, freeing up time for those who really need it.”

William Hope, MD, FACS, said his hospital in Wilmington, N.C., recently made the tough call to cancel nonessential surgeries, despite seeing only a handful of COVID-19 cases so far.

“There are so many unknowns with this virus,” said Dr. Hope, a general surgeon at New Hanover Regional Medical Center. “No one knows how long or how bad it’s going to get here, and if it does get bad, how long it will last.”

In contrast, some facilities continue to perform nonessential procedures, according to several sources. On March 20, Kaiser Health News reported business as usual for the University of California, Davis Medical Center, in Sacramento, with surgeons performing breast augmentations, cataract procedures and hip replacements, while UCSF Medical Center faced a shortage of PPE and ventilators just 90 miles away in the Bay Area.

The Hill and the Washington Post reported similar occurrences at other hospitals.

Health care workers have expressed fears that continuing to perform nonessential operations is using precious hospital resources and potentially spreading the virus to staff and patients. One physician at UC Davis shared his frustrations with Kaiser Health News about the decision that hospital executives had made to continue these surgeries, noting that many of his colleagues “have protested, but they’re falling on deaf ears.”

But according to Dr. Hoyt, this inconsistency in hospitals’ adherence to the surgery recommendations is starting to decrease.

“Everyone is reacting at a different pace depending on their experience, but we’re starting to see reports that more

and more hospitals have stopped or are planning to stop performing elective operations,” he said.

Although limiting operations to the most essential cases allows hospitals to free up equipment and beds for providers on the front lines of COVID-19 care, these actions also come with consequences for patients, surgeons and practices. For example, what constitutes a nonessential procedure is not necessarily clear-cut, and surgeons may be left making difficult decisions about who needs care now and who can wait.

“The guidances have been somewhat vague and because every case is different, it can be a struggle to decide who should get those limited surgical spots,” Dr. Hope said.

As patient visits continue to fall nationwide, physicians’ offices and hospitals are taking a financial hit. “Every office we know has had to downsize from a personnel standpoint,” Dr. Hoffman said.

Dr. Hope is concerned about the impact this decline in surgical procedures and office visits will have on private practices. “Surgery is their major source of income,” he said. “These practices have to pay staff and overhead, which they won’t be able to do with limited to no income coming in. I know some surgeons who are taking out short-term loans to give themselves a cushion.”

The human toll of the COVID-19 pandemic already is clear. The number of people infected will continue to rise but the toll goes beyond those who fall ill.

“The total devastation [wrought] by COVID will not be known for months, even years,” Dr. Hoffman said. “The measuring stick used to calculate the devastation will measure lives lost or altered, jobs lost, and businesses ruined.

But for now, flattening the curve is key and depends on the cooperation of everyone in society.”

■

I M A G I N E WHAT LONGER PAIN RELIEF MIGHT LOOK LIKE

SHOULDN’T WE

EXPECT MORE FROM

LOCAL ANESTHETICS?

When it comes to non-opioid postoperative pain relief, duration is everything. However, because of the body’s local inflammatory process, most local anesthetics—including extended-release formulations—struggle to work beyond 12 to 24 hours.1-4

With severe pain often lasting beyond 24 hours, we rely on opioids to pick up where local anesthetics leave off.5 But opioids come with a cost. Shouldn’t we expect more from local anesthetics?

L EAR N MO R E AT S UR G ICA L PA IN. CO M

References: 1. Berde CB, Strichartz GR. Local anesthetics. In: Miller RD, Cohen NH, Eriksson LI, Fleisher LA, Wiener-Kronish JP, Young WL, eds. Miller’s Anesthesia. Vol 2. 8th ed. Philadelphia, PA: Saunders; 2015:1012-1054.e4. 2. Carvalho B, Clark DJ, Yeomans DC, Angst MS. Continuous subcutaneous instillation of bupivacaine compared to saline reduces interleukin 10 and increases substance P in surgical wounds after cesarean delivery. Anesth Analg. 2010;111(6):1452-1459. doi:10.1213/ANE.0b013e3181f579de. 3. Kim J, Burke SM, Kryzanski JT, et al. The role of liposomal bupivacaine in reduction of postoperative pain after transforaminal lumbar interbody fusion: a clinical study. World Neurosurg. 2016;91:460-467. doi:10.1016/j.wneu.2016.04.058. 4. Becker DE, Reed KL. Essentials of local anesthetic pharmacology. Anesth Progress. 2006;53(3):98-109. doi:10.2344/0003-3006(2006)53[98:EOLAP]2.0.CO;2. 5. Svensson I, Sjöström B, Haljamäe H. Assessment of pain experiences after elective surgery.

J Pain Symptom Manage. 2000;20(3):193-201. doi:10.1016/S0885-3924(00)00174-3.

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PP-HCB-0115 • 02/19

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Bleeding in Bariatric Surgery Alan A. Saber, MD, MS, FACS, FASMBS Professor of Surgery Rutgers New Jersey Medical School Newark, New Jersey Division Director Bariatric and Metabolic Surgery Newark Beth Israel Medical Center RWJ Barnabas Health Newark, New Jersey

Introduction The long staple line required for many bariatric surgical procedures increases the risk for postoperative bleeding.1 To avoid this potentially significant complication, surgeons often reinforce the staple line or use linear staplers with reduced staple height.2,3 Some use clips or biological sealants, with varying degrees of success.2,3 Other approaches for managing bleeding from the staple line include cautery, suturing, and/or the application of adjunctive hemostatic agents.4,5 Ideally, surgeons seek strategies that minimize tissue trauma and achieve hemostasis at the staple line.6 PERI-STRIPS DRY® with VERITAS® Collagen Matrix (PSDV), FLOSEAL Hemostatic Matrix, and TISSEEL represent a growing portfolio of products designed to address intra- and postoperative bleeding.7-9 Alan A. Saber, MD, MS, FACS, FASMBS, a professor of surgery at Rutgers New Jersey Medical School, and division director of bariatric and metabolic surgery at Newark Beth Israel Medical Center in Newark, New Jersey, believes that these products are useful even for surgeons who have been performing bariatric surgery for years. “We all have high-risk patients, and the risk for bleeding is sometimes out of your hands,” he said.

Clinical Need Bariatric procedures represent about 90% of the surgeries in Dr Saber’s practice, and half of these are laparoscopic sleeve gastrectomies (LSGs). Approximately 15% of cases Dr Saber performs are surgical revisions.

“I see an increase in the risk for postoperative bleeding due to a number of factors, including a growing number of redo bariatric procedures and an aging population,” he said. “Many of these patients are on antiplatelet therapy or chronic anticoagulation for cardiovascular comorbidities, and thus require anticoagulation treatment during the perioperative period.”10 Research confirms that bleeding is not an uncommon occurrence.

A recent meta-analysis indicated that sleeve gastrectomy and gastric bypass postoperative bleed rates may be as high as 3.5%.1

6

GENERAL SURGERY NEWS • APRIL 2020

An Effective Approach to Reducing Staple Line Complications PSDV, an implantable biologic tissue prepared from non–cross-linked bovine pericardium derived from US cattle under 30 months of age, is used in conjunction with PERI-STRIPS DRY Gel, which creates a temporary bond between the PSDV buttress and the surgical stapler jaws until the surgeon positions and fires the stapler.7,11 PSDV is approved by the FDA for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement (SLR) is required.7 It is indicated for the reinforcement of staple lines in lung and bronchus resections and during bariatric surgical, gastric, small bowel, mesentery, colon, and colorectal procedures.7 The next generation of PSDV, PERI-STRIPS DRY with VERITAS with Secure Grip Technology (PSDV Secure Grip) (Figure 1), is currently available for Echelon 60 mm surgical staplers. PSDV Secure Grip offers bariatric surgical teams a pre-applied adhesive in lieu of PERI-STRIPS DRY Gel.12 PSDV Secure Grip is 2 times faster to prepare than SEAMGUARD and PSDV with PERI-STRIPS DRY Gel.13

Figure 1. PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with Secure Grip Technology.

Dr Saber describes himself as an early adopter. “I have used PSDV and TISSEEL successfully in thousands of surgical cases, and they are key components of my armamentarium for preventing gastric bleeding and leaks, that also includes FLOSEAL,” he said.8,9 TISSEEL is a fibrin sealant used as an adjunct to hemostasis in adult and pediatric patients for whom bleeding control by conventional surgical techniques (eg, suture, cautery) is ineffective.9 It is particularly useful in surgical patients on anticoagulant and/or antiplatelet therapy. TISSEEL is also indicated to help prevent leaks from colonic anastomoses after the reversal of temporary colostomies.9 FLOSEAL is indicated as an adjunct to hemostasis when

control of bleeding by ligature or conventional procedures is ineffective.8 A combination of patented gelatin granules and human thrombin provides fast, effective hemostasis.8 Dr Saber acknowledged this capability.

“FLOSEAL is very good for focal bleeding,” he said. “It’s amazing how it works.”

The Evidence Multiple clinical studies have demonstrated the advantages of bovine pericardium strips. In a 2010 report, investigators used a canine model to evaluate staple line seam integrity at supraphysiologic intraluminal pressures after ileocolic and colon–colon anastomoses in the immediate postoperative period.14 Colon anastomoses were either buttressed with PSDV (n=15) or did not receive any reinforcement (n=12).14 All nonbuttressed anastomoses burst at the staple line.14 The mean intestinal burst pressure of bowel segments with buttressed staple lines (362 mm Hg) was significantly higher than that of non-buttressed staple lines (204 mm Hg) (P<0.0001) (Preclinical data: results may not correlate to performance in humans).14 Callery et al enrolled 1,073 morbidly obese Rouxen-Y gastric bypass patients, and compared the outcomes of individuals who received bovine collagen matrix reinforcement of the linear and circular gastric staple line (n=568) with patients who received no reinforcement (n=505).15 Collagen matrix reinforcement was associated with a significant reduction in the incidence of abdominal septic events (1% vs 4%, respectively; P<0.001), including frank staple line leakage, purulent drainage, and abscess.15 D’Ugo et al assessed the efficacy of SLR by determining leak and bleed rates in 1,162 morbidly obese LSG patients.5 Patients received no SLR (n=189), oversewing (n=476), PERI-STRIPS DRY SLR (n=312), synthetic polyester reinforcement (n=76), glycolide/trimethylene copolymer reinforcement (n=63), or FLOSEAL Hemostatic Matrix (n=46).5 The highest leak rate was observed in the synthetic polyester group at 7.8%, whereas leaks occurred in 4.8% of those who received no SLR, and only 0.3% in the PSDV group. Furthermore, the PERI-STRIPS DRY and FLOSEAL groups exhibited the 2 lowest postoperative leak rates at 0.3% and 2.2%, respectively.5 None of the patients in the PERI-STRIPS DRY and FLOSEAL groups experienced postoperative bleeding.

A 2011 prospective study of 187 patients undergoing LSG demonstrated that the use of PSDV SLR (n=96) significantly reduced bleeding from the staple line compared with patients who did not receive SLR (n=91) (P=0.012).16 Patients who received SLR also required fewer days of hospitalization.16 A 2015 meta-analysis extracted data from 295 studies

Supported by

Leak Rate, %

4 3

2.45

2 1 0

2.61

2.75

1.28 PSDV

Oversewing

Glycolide Copolymer

No SLR

Figure 2. Leak rate by reinforcement type.

PSDV vs oversewing and no SLR, P<0.001; PSDV vs glycolide copolymer, P<0.01.

PSDV, PERI-STRIPS DRY with VERITAS Collagen Matrix; SLR, staple line reinforcement Based on reference 1.

5

Bleed Rate, %

4

3.45

3

2.69

2 1 0

2.48

1.23 PSDV

Oversewing

Glycolide Copolymer

No SLR

Figure 3. Bleed rate by reinforcement type.

PSDV vs no SLR, P<0.001; PSDV vs glycolide copolymer, P<0.01; PSDV vs oversewing, P≤0.05; glycolide copolymer vs no SLR, P<0.01.

PSDV, PERI-STRIPS DRY with VERITAS Collagen Matrix; SLR, staple line reinforcement Based on reference 1.

The use of PSDV in obese patients can significantly reduce the incidence and severity of postoperative staple line bleeding and leaks.1,3,5,16 Dr Saber believes that PSDV, along with FLOSEAL and TISSEEL, provide an easy, efficient, and effective way to address surgical bleeding.1,8,9 “Considering the increase I am witnessing in bariatric surgery patients at high risk for bleeding, I believe that even experienced surgeons can benefit by reinforcing the staple line,” he said. “Remember these products when you have a problem regarding bleeding or when you know the patient is at high risk for bleeding. They can get you out of trouble.”

PERI-STRIPS DRY with VERITAS Collagen Matrix Indications for Use: PSDV Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed. PSDV Reinforcement can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures, and during gastric, small bowel, mesentery, colon, and colorectal procedures.

Important Risk Information: The use of PSDV reinforcement is contraindicated in patients with known sensitivity to bovine or acrylic material. Discard all open unused components.

Do not use product if there is damage to the pouch or seals.

Rx Only. For sale and proper use of this device, refer to the complete Instructions for Use. FLOSEAL Hemostatic Matrix Indication: FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Contraindications: Do not use FLOSEAL in patients with known allergies to materials of bovine origin.

Warnings: Do not inject or compress FLOSEAL into blood vessels.

For a complete list of all warnings please refer to your IFU.

Hypersensitivity or allergic/anaphylactoid reactions can occur with the use of TISSEEL. Such reactions may especially be seen if TISSEEL is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously.

Aprotinin is known to be associated with anaphylactic reactions.

Even in the case of strict local application of aprotinin, there is a risk of anaphylactic reactions to aprotinin, particularly in the case of previous exposure.

Discontinue administration of TISSEEL in the event of hypersensitivity reactions. Remove remaining product from the application site.

Air or gas embolism has occurred when fibrin sealant was administered using pressurized gas. This can occur if a spray device is used at higher than recommended pressures and in closer than recommended proximity to the tissue surface.

When using the EASYSPRAY device, or an equivalent spray device for open surgical procedures cleared by FDA, TISSEEL must not be sprayed in enclosed body areas and must be sprayed onto only visible application sites.

TISSEEL is denatured when exposing to solutions containing alcohol, iodine or heavy metals. If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of TISSEEL. Apply TISSEEL as a thin layer by dripping or spraying using cannula or spray set. Excess clot thickness can negatively interfere with wound healing.

The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated; its use in this setting is not FDA approved.

TISSEEL is made from human plasma. It may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

References 1.

Shikora SA, et al. Obes Surg. 2015;25(7):1133-1141.

2.

Gagner M, et al. Surg Obes Relat Dis. 2014;10(4): 713-723.

3.

Shah SS, et al. Obes Surg. 2014;24(12):2014-2020.

4.

Shikora SA. Obes Surg. 2004;14(10):1313-1320.

5.

D’Ugo S, et al. Surg Obes Relat Dis. 2014;10(3):450-454.

6.

Feldheiser A, et al. Acta Anaesthesiol Scand. 2016;60(3): 289-334.

Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.

7.

Peri-Strips Dry: instructions for use. St. Paul, MN: Synovis Life Technologies; 2018.

8.

FLOSEAL Hemostatic Matrix: instructions for use. Deerfield, IL: Baxter Healthcare; 2018.

Important Risk Information for TISSEEL [Fibrin Sealant]

9.

TISSEEL Fibrin Sealant [package insert]. Deerfield, IL: Baxter Healthcare Corporation; 2018.

TISSEEL [Fibrin Sealant] Indications Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients.

For Topical Use Only. Do not inject TISSEEL directly into the circulatory system or into highly vascularized tissue. Intravascular application of TISSEEL can lead to intravascular coagulation, can result in life-threatening thromboembolic events, and can increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients. To minimize the risk of intravascular application, exercise caution when using TISSEEL in surgery.

Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin.

Do not use TISSEEL for treatment of severe or brisk arterial or venous bleeding. In these situations, TISSEEL will be washed away in the flow of blood before hemostasis can be attained.

Do not spray TISSEEL where the minimum recommended distance from the applicator tip to the target site cannot be assured.

10. Degirmenci SE, et al. J Visc Surg. 2014;151(2):125-135.

11. Deeken CR, et al. J Am Coll Surg. 2011;212(5):880-888.

12. Peri-Strips Dry Staple Line Reinforcement with Veritas Collagen Matrix with Secure Grip Technology: instructions for use. St. Paul, MN: Synovis Life Technologies; 2019.

USMP/90/20-0004 01/2020

5

Conclusion

13. Data on file. Staple line reinforcement time in motion study report. Baxter.

14. Gaertner WB, et al. J Biomed Mater Res B Appl Biomater.

2010;92(1):48-54.

15. Callery CD, et al. Surg Obes Relat Dis. 2012;8(2):185-189.

16. Stamou KM, et al. Surg Endosc. 2011;25(11):3526-3530.

BB189

with 66,727 patients to assess staple line complications in morbidly obese patients undergoing gastric bypass and LSG, and included 4 treatment arms: no SLR, oversewing, a biocompatible glycolide copolymer, and PSDV.1 More than 40% of study patients had no reinforcement, and experienced the highest leak (2.75%) and bleed rates (3.45%).1 Oversewing was better than no reinforcement (leak rate, 2.45%; bleed rate, 2.69%).

Buttressing with a biocompatible glycolide copolymer yielded the second highest leak rate (2.61%) and a high bleed rate (2.48%).1 In contrast, PSDV reinforcement exhibited the lowest leak (1.28%) and bleed (1.23%) rates, offering strong support for the ability of bovine pericardium to provide substantial clinical benefit to morbidly obese patients undergoing bariatric surgery (Figures 2 and 3).1

Disclosures: Dr Saber is a consultant to Baxter and Medtronic.

GENERAL SURGERY NEWS • APRIL 2020

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IN THE NEWS

GENERAL SURGERY NEWS / APRIL 2020

Treating COVID-19: Available Weapons to Fight the Disease

By CHASE DOYLE

[Editor’s note: This article was first posted online at www.generalsurgerynews.com and last updated for print on March 31.]

I

n less than four months, research scientists and health professionals have identified a novel coronavirus, sequenced its genome, charted the clinical course of disease it causes, and begun trials for investigational vaccines. Unfortunately, in that same time span, the virus has infected hundreds of thousands around the world, wreaking havoc on health care systems and the global economy. Thus far, there are no approved therapies for COVID19, the respiratory illness caused by SARS-CoV-2, but clinicians are exploring a myriad of treatment options, including drugs approved to treat malaria, lupus, rheumatoid arthritis, HIV and Ebola.

Of note, not all people who contract the disease require treatment. According to data presented by Bin Cao, MD, in an American College of Cardiology webinar held in partnership with the Chinese Cardiovascular Association, approximately 80% of confirmed COVID-19 cases involve mild symptoms, ranging from completely asymptomatic disease to mild pneumonia.1 For the remaining cases that progress to severe (14%) and critically ill (5%) status, however, clinicians must be prepared to treat severe pneumonia, respiratory failure requiring mechanical ventilation, shock, and multiorgan failure requiring admission to the ICU.

COVID-19 Is a Systemic Disease Dr. Cao, who has been treating patients on the front lines in Wuhan, China, emphasized that COVID-19 is neither a localized disease nor limited to the respiratory tract. Severe and critical cases are not only associated with pneumonia and acute respiratory distress syndrome but also metabolic acidosis, acute kidney injury and acute cardiac injury.

He cautioned health care providers to watch for the latter in particular.

“We have to keep in mind that severe and critical cases will have acute cardiac injury, and some of these may be complicated with myocardial infarction,” said Dr. Cao, a professor of pulmonary and critical medicine at the China-Japan Friendship Hospital and Capital Medical University, in Beijing. “Keep a close eye on patients with underlying cardiovascular diseases or hypertension because they’re at risk for cardiac complications.”

Another common finding among severe and critical patients is abnormal

coagulation. As Dr. Cao reported, significantly increased levels of D-dimer and fibrinogen/fibrin degradation products have been associated with poor prognosis, and extensive intravascular microthrombosis was discovered in fatal COVID-19 cases on autopsy.2 Because vascular endothelial cells express high levels of angiotensin-converting enzyme 2, anticoagulation therapy should be initiated for patients with severe COVID-19 unless otherwise contraindicated, he said.

Peripheral lymphocyte counts, mainly T cells, also were substantially reduced in patients with severe COVID-19, with severe lymphopenia observed until death in nonsurvivors. For survivors, on the other hand, lymphocyte count was lowest on day 7 after onset of illness and improved during hospitalization. In addition, sepsis occurred in more than half of Wuhan inpatients with COVID-19. Although sepsis is usually associated with bacterial infections, no bacterial pathogens were detected in patients on admission, said Dr. Cao, who theorized that sepsis might be directly caused by SARSCoV-2 infection.

“This is not a lung disease; it’s a wholebody disease,” he explained. “The virus has been detected in nasopharyngeal swabs, sputum, lower respiratory tract secretions, blood and feces using RT-PCR [realtime polymerase chain reaction] and/ or NGS [next-generation sequencing] methods. Thus, it’s not surprising that we see viremia in severe cases because this disease can spread from the lungs to other organs, including the heart.”

According to Dr. Cao, the median duration of viral shedding was 20 days, but it could be as long as 37 days, which has “never been seen before” in an acute respiratory viral infection.

Isolation and Supportive Care The approach established by Dr. Cao and his colleagues in Wuhan has been two-pronged: isolation of confirmed patients in a single room to contain the

spread of the virus followed by treatment. Although the disease is not limited to the lungs, severe disease (seen in 14% of patients) is characterized by dyspnea, hypoxia or greater than 50% lung involvement on imaging within 24 to 48 hours. For the 5% of patients who progress to critically ill status, respiratory failure, shock or multiorgan dysfunction are possible clinical outcomes.

According to a primer drafted by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Acute Care Committee, however, early data suggest that the majority of critically ill patients are suffering from only hypoxia and “only require management of hypoxemia using Positive End Expiration Pressure (PEEP), fraction of ispired oxygen, and possibly prone positioning.” Although other underlying chronic illnesses must be treated accordingly, the effect of COVID-19 appears to be mostly hypoxemia, albeit profound. Lung lesions also are peripheral and ground glass in appearance, the authors of the primer noted.

For providers with no COVID-19 testing available, chest imaging may help with the diagnosis. However, Dr. Cao cautioned that deterioration can occur rapidly—sometimes within a few hours.

“You cannot imagine how fast deterioration can occur,” Dr. Cao said. “We have observed patients in stable condition in the morning progress rapidly to respiratory failure by the afternoon.

Close monitoring of vital signs and lab work is essential.” Equally essential for providers is personal protective equipment to shield themselves from respiratory droplets spread from patients (www.cdc.gov/coronavirus/2019-ncov/ hcp/ppe-strategy/index.html).

According to the SAGES Acute Care Committee, gowns and gloves for contact isolation and face protection will work when intubation is necessary, but patients with COVID-19 often require more than respiratory support. Treating the disease is truly a multidisciplinary effort, said Dr. Cao, who noted that circulatory support, renal replacement therapy, convalescent plasma treatment, blood purification treatment and immunotherapy are commonly used among other therapeutic measures. Most patients hospitalized with COVID-19 are also complicated

with hypoproteinemia, he added, so treatment should be complemented with sufficient caloric intake as well as fluid and electrolyte balance.

Dr. Cao also reported that use of corticosteroids is still controversial and should be reserved only for patients with rapid progressive deterioration of oxygenation and excessive inflammation. According to Dr. Cao, corticosteroids should be limited to short-term use (three to five days) and at a low to moderate dosage, and should not be used in patients with the following contraindications: allergy; uncontrolled diabetes; uncontrolled hypertension; glaucoma; gastrointestinal bleeding; immunodepression; a lymphocyte count of less than 300 cells/mcL; and severe bacterial and/or fungal infections.

While various news reports have stated that the use of nonsteroidal antiinflammatory drugs, such as ibuprofen, could worsen COVID-19 symptoms, the FDA has found no scientific evidence to support these claims.

Finally, for the vast majority of patients who recover from the disease, Dr. Cao recommended the following discharge criteria: resolution of fever for at least 72 hours without the use of fever-reducing medications; improvement in respiratory symptoms; and ensuring that at least seven days have passed since symptoms first appeared. Per the CDC, a test-based strategy for discharge requires two consecutive negative nucleic acid tests for respiratory specimens collected 24 hours apart.

Experimental Interventions Although clinical trials of investigational vaccines for COVID-19 have already begun,3 approval of a vaccine and widespread inoculation could be more than a year away. Finding other medical countermeasures to treat and prevent the disease will thus play a critical role in managing the pandemic.

Chloroquine and Hydroxychloroquine

According to the CDC, there are several hundred clinical trials for COVID19 underway around the world. Two FDA-approved oral prescription drugs, chloroquine and hydroxychloroquine, have shown activity in vitro against SARS-CoV, SARS-CoV-2 and other coronaviruses, with hydroxychloroquine having relatively higher potency against SARS-CoV-2, the virus that causes COVID-19.4 Although chloroquine has been used for malaria treatment and chemoprophylaxis,

IN THE NEWS

APRIL 2020 / GENERAL SURGERY NEWS

hydroxychloroquine is used for treatment of rheumatoid arthritis, systemic lupus erythematosus and porphyria cutanea tarda. In a March 19 press release, the FDA highlighted its collaboration with government agencies and academic centers to determine the effectiveness of chloroquine and hydroxychloroquine in patients with mild to moderate disease to reduce the duration of symptoms and viral shedding. Optimal dosing and duration of either agent for prophylaxis or treatment of SARS-CoV-2 infection have not been identified, but data from multicenter clinical trials conducted in China showed apparent efficacy and safety in treatment of COVID-19-associated pneumonia.5 A small study in France also reported that hydroxychloroquine alone or in combination with azithromycin significantly reduced viral load in nasal swabs compared with a nonrandomized control group,6 although clinical benefit was not assessed.

Per the CDC, some U.S. clinicians have reported anecdotally different hydroxychloroquine dosing: 400 mg twice daily on day 1, then daily for five days; 400 mg twice daily on day 1, then 200 mg twice daily for four days; and 600 mg twice daily on day 1, then 400 mg daily on days 2 to 5. In patients with chronic medical conditions such as renal failure or hepatic disease, the CDC advised caution when considering hydroxychloroquine and azithromycin due to association with QT prolongation.7

Remdesivir Originally developed to treat the Ebola virus, remdesivir is an investigational IV drug that’s also demonstrated in vitro activity against coronaviruses, including SARS-CoV-2. Although remdesivir was found to have no effect against Ebola, a case report published in The New England Journal of Medicine showed improved clinical condition and subsequent recovery in a critically ill Californian patient with COVID-19 who was administered the antiviral on a compassionate use basis.8 Gilead Sciences, the company that manufactures remdesivir, is developing an expanded access program for the United States to meet what the company described as “overwhelming demand” for the experimental drug.

According to the FDA, approximately 250 patients have already been granted access to remdesivir, but controlled clinical trials are needed to determine its efficacy and safety. The CDC listed several options for obtaining remdesivir for treatment of hospitalized patients with COVID-19, including a National Institutes of Health–sponsored adaptive double-blind, placebo-controlled trial of remdesivir versus placebo in patients with pneumonia and hypoxia (https://clinicaltrials.gov/ct2/show/

NCT04280705) and two phase 3, randomized, open-label trials in patients with severe disease (https://clinicaltrials. gov/ct2/show/NCT04292899) or moderate disease (https://clinicaltrials.gov/ ct2/show/NCT04292730).

Lopinavir and Ritonavir Approved nearly 20 years ago for the treatment of HIV, the combination of lopinavir and ritonavir has been shown to inhibit the protease of viruses, including coronaviruses. Recently published clinical trial data from China, however, have not been promising against COVID-19. In a

randomized study of 199 adult patients hospitalized with severe disease, the addition of lopinavir-ritonavir to standard supportive care was not associated with clinical improvement or a reduction in viral loads versus standard care alone.9 Nevertheless, the study authors cautioned that the overall mortality of the trial (22.1%) was substantially higher than rates observed in other studies of hospitalized patients with COVID-19.

What’s more, secondary outcomes demonstrated lower 28-day mortality (19.2% vs. 25.0%) and shorter stays in the ICU (six vs. 11 days) for patients in the

lopinavir-ritonavir group versus standard of care. Because the difference in mortality was also greater among patients treated within 12 days after the onset of symptoms compared with those treated later, the investigators hypothesized that utilization of lopinavir-ritonavir at an earlier stage of illness could lead to better responses.

Despite the Chinese study’s negative outcome, lopinavir-ritonavir is still under investigation in a World Health Organization study. Announced on March 18, the large, international SOLIDARITY trial will compare untested treatments continued on the following page

Peri-Strips Dry

STAPLE LINE REINFORCEMENT WITH VERITAS COLLAGEN MATRIX WITH SECURE GRIP TECHNOLOGY

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Contact your Baxter representative for more information Indications for Use: PSDV-SG is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.

PSDV-SG can be used for reinforcement of staple lines during bariatric, gastric, small bowel, colon, and colorectal procedures.

Important Risk Information: The use of PSDV-SG is contraindicated in patients with known sensitivity to bovine or acrylic material(s).

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Baxter and Peri-strips are registered trademarks of Baxter International Inc. USMP/PER49/20-0012 03/2020

Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 www.baxter.com

9

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IN THE NEWS

GENERAL SURGERY NEWS / APRIL 2020

Sedation or No for Ventilated ICU Patients: Time for Individualized Approach?

By CHRISTINA FRANGOU

I

n a multicenter, randomized controlled trial involving mechanically ventilated ICU patients, mortality at 90 days did not differ significantly between patients who were assigned to a plan of no sedation and those assigned to light sedation with daily interruption.

There were no significant differences in the number of ventilator-free days or in the length of ICU or hospital stay between the two groups.

“The times are changing, and I think we have to move towards individualized medicine on sedation,” said Palle Toft, MD, a professor in the Department of Anesthesiology and Intensive Care at Denmark’s Odense University Hospital, in an email interview with General Surgery News.

Dr. Toft, one of the study authors, presented the results at the 2020 annual meeting of the Society of Critical Care Medicine. It was published in The New England Journal of Medicine (2020 Feb 16. [Epub ahead of print]. doi: 10.1056/NEJMoa1906759).

Sedation was necessary 75 years ago with early-generation ventilators. But that’s not the case with modern ventilators with softer tubes.

“Today we do not need sedation in most of our ICU patients, as long as there is an educated nurse bedside,” he said.

The trial follows on a single-center study from Toft et al that showed a strategy of no sedation for

COVID-19 continued from page 9

in thousands of patients from at least 10 countries. In a media briefing on the pandemic, WHO Director-General Tedros Ghebreyesus, PhD, said, “Multiple small trials with different methodologies may not give us the clear, strong evidence we need about which treatments help to save lives.” As Dr. Ghebreyesus explained, the SOLIDARITY trial is designed to “provide simplified procedures to enable even hospitals that have been overloaded to participate.”

One arm of SOLIDARITY will test lopinavir-ritonavir against standard of care, while another will combine the two antivirals with interferon beta-1b, an anti-inflammatory agent used to treat multiple sclerosis. WHO will also test chloroquine/hydroxychloroquine and remdesivir, although the design of the trial is subject change at any time.

Other Potential Therapies Time may be of the essence to discover more effective strategies against the virus, but the number of potential therapies is not in short supply. Genomic analysis of SARS-CoV-2 has already generated a list of nearly 70 FDA-approved drugs that target human proteins or host factors associated with its viral replication.10

mechanically ventilated ICU patients was associated with significantly fewer days on mechanical ventilation and shorter hospital stays compared with sedation with daily interruption (Lancet 2010;375[9713]:475-480).

In the new trial, 700 patients at eight European centers were randomized to receive a plan of no sedation or light sedation with daily interruption within 24 hours of intubation. The mean Richmond Agitation-Sedation Score in the sedation group increased from –2.3 on day 1 to –1.8 on day 7, and, in the nonsedation group, from –1.3 to –0.8.

Mortality at 90 days was 37% in the sedation group and 42% in the nonsedation group (relative risk, 1.10; 95% CI, 0.90-1.35)—a trend contrary to what investigators hypothesized.

But the depth of sedation did not differ between the groups as much as investigators intended, and this may explain some of the outcomes, the authors said. Patients in the nonsedation group could receive bolus doses of morphine for analgesia and, if needed, medications similar to those in the sedation group.

Twenty-seven percent of patients in the nonsedation group received medication for sedation on the first day and 38.4% at some time during their ICU stay. The main reason for sedation was delirium.

One patient in the nonsedation group (0.3%) and 10 in the sedation group (2.8%) experienced a major thromboembolic event (difference, –2.5 percentage points; 95% CI, –4.8 to –0.7).

In the American College of Cardiology webinar, Dr. Cao presented several options that are being employed: 1. Interferon alpha: 5 million units, atomization inhalation twice daily.

2. Ribavirin: used together with interferon or lopinavir-ritonavir, 500mg IV injection twice or three times daily, but no longer than 10 days.

3. Arbidol: 200 mg three times daily for adults, but no longer than 10 days.

4. Convalescent plasma treatment: infusion dose of 200 to 500 mL (4-5 mL/kg), two infusions.

5. Favipiravir, a Japanese influenza drug approved by China to treat symptoms of COVID-19.

As Dr. Cao acknowledged, there is no solid evidence of efficacy for any of these approaches, and clinicians must be mindful of treatment-related adverse events.

Despite the need for more effective therapeutic measures, there is no shortcut for the scientific method.

“Rigorous clinical trials in the setting of COVID-19 will ultimately delineate ‘pearls’ for any drugs that may be considered for this disease,” said Bonnie A. Falcione, PharmD, BCPS

In most of the participating ICUs, the nurse-topatient ratio was 1:1. The ICU teams sought to individualize sedation according to a patient’s need, based on two-way communication with the patient. “At the moment, we have, for example, a patient who wants to be sedated at night but prefers nonsedation in the daytime and evening,” Dr. Toft said.

In an accompanying editorial in The New England Journal of Medicine, Claude Guérin, MD, PhD, of the Hôpital Edouard Herriot in Lyon, France, pointed out several notable concerns with the trial findings. The results are specific to a somewhat circumscribed population; a high percentage of patients (14.6%) declined to participate, raising questions about patients’ comfort with forgoing sedation; and it may have been underpowered, he said.

But the results are important “because they arouse concern about omitting sedation in mechanically ventilated patients and reinforce the need to monitor sedation clinically, with the aim of discontinuing it as early as possible or at least interrupting it daily.”

■

(AQ-ID), an associate professor of pharmacy and therapeutics at the University of Pittsburgh School of Pharmacy. “Otherwise, contemporary pearls for agents currently being utilized stem from their recognized safety concerns when they have been used for different diseases. These safety-related pearls cannot be compared without data from well-designed comparative clinical trials, may not be relevant for durations of therapy that differ from the diseases they have historically been used for, and certainly cannot be considered as an all-inclusive list.”

That said, Dr. Falcione noted that providers administering hydroxychloroquine to treat COVID-19 should be aware of the potential for cardiotoxicity, gastrointestinal toxicity and retinopathy, while drug interaction, gastrointestinal toxicity and hepatoxicity have been described with lopinavir-ritonavir. Experience to derive pearls with remdesivir, however, is limited because of its investigational and compassionate use to date. Lastly, Dr. Falcione said, in some critically ill patients, absorption of any enterally administered drugs may be compromised or unreliable. Hydroxychloroquine and lopinavir-ritonavir do not have parenteral formulations available to avoid this possible problem, she concluded.

■

References 1. Cao B. Chinese Guideline of Diagnosis and Treatment of COVID-19 (7th Version). ACC/Chinese Cardiovascular Association COVID-19 Webinar 1.

Presented March 18, 2020.

2. Zhou F, Yu T, Du R, et al. Lancet.2020 Mar 11. [Epub ahead of print]. doi: 10.1016/S0140-6736(20)30566-3 3. Clinicaltrials.gov/ct2/show/ NCT04283461?term=mrna1273&draw=2&rank=1.

4. Colson P, Rolain JM, Lagier JC, et al.

Int J Antimicrob Agents. 2020 Mar 4.

[Epub ahead of print]. doi: 10.1016/j. ijantimicag.2020.105932 5. Gao J, Tian Z, Yang Xu.. Biosci Trends.

2020;14(1):72-73.

6. Gautret P, Lagier JC, Parola P, et al. Int J Antimicrob Agents. In press.

7. Yao X, Ye F, Zhang M, et al. Clin Infect Dis. 2020 Mar 9.

8. Holshu ML, Debolt C, Lindquist S, et al. N Engl J Med. 2020;382(10):929-936.

9. Cao B, Wang, Y, Wen D, et al. N Engl J Med.2020 Mar 18. [Epub ahead of print]. doi: 10.1056/NEJMoa2001282 10. Gorden DE, Jang GM, Bouhaddou M, et al. A SARS-CoV-2-human proteinprotein interaction map reveals drug targets and potential drug-repurposing.

BioRxiv.[Epub Mar 22, 2020]. https:// doi.org/10.1101/2020.03.22.002386

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IN THE NEWS

GENERAL SURGERY NEWS / APRIL 2020

Injury and Shock Associated With Different Platelet Phenotypes

By CHASE DOYLE

D

espite the enhanced care delivery of trauma systems, hemorrhage remains a leading preventable cause of death, and approximately 25% of trauma patients have a trauma-induced coagulopathy upon arrival in the emergency department. Scientists continue to work

to identify mechanisms and treatment targets of this coagulopathy to reduce death from hemorrhage. Now, data presented at the 2020 EAST Annual Scientific Assembly suggest novel insights into platelet “dysfunction,” highlighting that improved platelet phenotyping could ultimately help guide drug and transfusion therapies.

Ultimately, the researchers envision a panel of biomarkers that will lead to a precision medicine– based treatment protocol for injured patients.

In the prospective study, blood collected pre-resuscitation from trauma patients and healthy donors showed different patterns of platelet activation and aggregation in injured patients in the presence or absence of shock. Isolated severe injury was associated with a “functional” platelet phenotype, whereas combined tissue injury and shock was associated with a “dysfunctional” phenotype, the study authors reported.

“These results confirmed our hypothesis that in the setting of tissue injury, there is an elevation in the baseline levels of activated platelets,” said Lucy Z. Kornblith, MD, FACS, an assistant professor of surgery, trauma and surgical critical care at Zuckerberg San Francisco General Hospital, University of California, San Francisco (UCSF).

“In severely injured patients with shock, however, we did not see those increased baseline levels. … They’re not activated in the same way that platelets from patients with injury but no shock may be activated.”

As Dr. Kornblith explained, trauma continues to be the leading killer of people up to 45 years of age, and hemorrhage is the main preventable cause.

Various targets have been identified for

treatment of trauma-induced coagulopathy, Dr. Kornblith said, but altered platelet function remains an understudied area, and the mechanisms of this phenomenon are poorly understood.

For this study, Dr. Kornblith and her colleagues compared blood samples collected from 227 pre-resuscitation trauma patients and 27 healthy donors. The researchers measured pre-agonist baseline impedance and platelet aggregation in response to agonists collagen, thrombin receptor-activating peptide-6, arachidonic acid and ristocetin using multiple electrode platelet aggregometry. Patients were stratified by the Injury Severity Score (ISS), with a score greater than 25 representing severe injury, and shock (base excess less than –6).

As Dr. Kornblith reported, patients had a median ISS score of 21, with 23% in shock. Importantly, she said, isolated severe injury was associated with a “functional” platelet phenotype: elevated pre-agonist baseline impedance, but impaired aggregation in response to agonist collagen. Combined injury and shock, in contrast, was associated with a “dysfunctional” phenotype: no significant effect on pre-agonist baseline impedance, but similar impaired

Partial REBOA Device Shows Promise; Prototype Still in Early Phase continued from page 1

According to data presented at the 2020 EAST Annual Scientific Assembly, however, a novel partial REBOA approach could resolve many safety and feasibility concerns, striking a better balance between hemorrhage control and ischemic burden. Results of the swine model study of hemorrhagic shock conditions showed that prolonged partial REBOA at a moderate distal flow rate provided hemorrhage control, improved survival and decreased ischemic injury versus “full” REBOA with prolonged use.

“There’s a lot of skepticism in the trauma community as to whether REBOA should have a place in the overall care of trauma patients, but as we continue to improve the safety of this technology with better catheters and with partial and/or intermittent occlusion techniques to lower ischemic burden, I think we’re going to see broader acceptance of this technology,” said the study’s lead author, Dominic M. Forte, MD, a general surgery resident at Madigan Army Medical Center, in Tacoma, Wash.

As Dr. Forte explained, despite REBOA’s ability to control noncompressible torso bleeding, medical practitioners have been reluctant to use it because of its heavy ischemic burden, and have largely favored aggressive resuscitation. Although partial restoration of aortic flow during REBOA is advocated by some to mitigate distal ischemia, Dr. Forte said, current devices cannot effectively control partial flow.

“A partial REBOA technique used by highly trained medics or Air Evac nurses to limit the amount of blood loss could be a real game changer in rural and austere

environments that are far from the nearest hospital,” Dr. Forte said.

Optimized Bleeding Control And Reperfusion Injury For this study, Dr. Forte and his colleagues used a swine model to test a novel partial REBOA device against full REBOA techniques in hemorrhagic shock conditions.

The researchers placed aortic flow probes and REBOA catheters (zone 1) in 20 Yorkshire swine that were randomized to either solid-organ or abdominal vascular injury. The partial REBOA group (10 swine) underwent full inflation for 10 minutes, followed by deflation to a flow rate of 0.5 L per minute for two hours. The full REOBA group (10 swine) underwent full inflation for 60 minutes, followed by deflation and resuscitation.

“We tested two injury patterns because when a trauma patient comes in, it’s unclear whether it’s a vascular or solid-organ injury,” Dr. Forte said. “To be field ready, this technology needs to function equally well in both regards.”

As Dr. Forte reported, swine treated with full REBOA hemorrhaged less than those in the partial REBOA group, as expected, but survival rates were much higher with partial REBOA. In the partial REBOA group, 60% of swine with solid-organ injuries and 80% of those with abdominal vascular injuries survived to the end of the experiment. In the full REBOA group, however, 20% of swine randomized to either solid-organ or abdominal vascular injuries survived.

In the partial REBOA group: 60% of swine with solid-organ injuries and 80% of those with abdominal vascular injuries survived.

In the full REBOA group: 20% of swine randomized to either solid-organ or abdominal vascular injuries survived.

In addition, serum lactate was higher in the full REBOA group at 60 and 90 minutes, Dr. Forte noted, while surviving animals in the partial REBOA group had higher levels of calcium at 30 minutes and trended toward lower potassium. According to Dr. Forte, prophylactic calcium supplementation could help increase survival in patients receiving partial REBOA. The researchers are currently exploring designs to improve the portability of this technology for better functionality in deployed and rural environments.

Spectacular Technology, Big Controversy Elliott R. Haut, MD, PhD, FACS, in the Johns Hopkins School of Medicine and Bloomberg School of Public Health, in Baltimore, contrasted REBOA’s conceptual strengths with its current, practical limitations.

“The idea behind this technology is spectacular, but

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APRIL 2020 / GENERAL SURGERY NEWS

aggregation responses. In other words, according to Dr. Kornblith, injury and shock confer differential patterns of platelet activation and aggregation, and may be required in combination to drive platelet “dysfunction.”

“It’s possible that platelets circulating in severely injured patients that have a component of shock are truly dysfunctional, a possible explanation of why these patients don’t have elevated levels of baseline impedance in aggregometry,” Dr. Kornblith said. “This is not the first finding that combined tissue injury and shock may be necessary to induce coagulopathic responses.”

The authors noted several limitations in their study. Most importantly, Dr. Kornblith said, whole blood platelet aggregometry is an ex vivo test that may not necessarily reflect the true function of platelets in vivo in the absence of endothelium and flow. Furthermore, sampling of circulating blood may create a bias toward measuring less active or “functional” platelets that were not incorporated into clots at local injury sites. This could exaggerate the identification of platelet “dysfunction” in trauma patients compared with healthy volunteers.

For now, the researchers are continuing to seek out novel ways to study platelets.

there’s still controversy in the trauma world over whether or not it’s beneficial, and if there’s a benefit, who it is good for,” Dr. Haut said. “We will have much more data on this in five or 10 years, but right now, there are places that do it all the time and places that have decided they’re not ready yet. We’ll probably end up doing it at some point, but there’s not very strong data supporting its use in a specific patient population right now.”

Despite the preclinical data supporting the use of partial REBOA in swine, Dr. Forte also cautioned providers against attempting this technique in real practice.

“This is still in early phase,” Dr. Forte emphasized. “This prototype has not been studied in real-world application in humans yet. This device may be available in the future, but the current REBOA catheters are not designed for partial inflation.”

■ Podcast: east.org/education/online/traumacasts Dr. Haut can be reached on Twitter @elliotthaut.

“We’re performing a whole host of assays to analyze platelet function, including using flow cytometry to measure surface receptors at platelet activation,” said Zachary Matthay, MD, a surgical resident at UCSF and co-author of the study. “We’re also collaborating with investigators at Stanford to image morphologic rearrangements in the setting of trauma that may explain some of the underlying mechanisms of platelet dysfunction. Furthermore, we are working upstream in the biology focused on identifying platelet genomic signatures in the setting of injury.”

Ultimately, the researchers envision a panel of biomarkers that will lead to a precision medicine–based treatment protocol for injured patients.

“Injured, bleeding patients may not all look the same biologically,” Dr. Kornblith said. “There are certain to be various phenotypes of coagulation biology in these patients. If we can identify alterations in platelet biology that can be measured from the blood, then those could potentially be targets for platelet-based therapeutics to reduce death from hemorrhage and organ failure in injured patients.”

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Do You Have

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a Story Idea?

Contact the editor at

khorty@mcmahonmed.com.

In High-risk Breast Cancer a

Neoadjuvant Therapy Surgery Together

Preoperative systemic therapy may benefit certain high-risk 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

a

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

b

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.

Copyright © 2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. US-OBR-00106 07/19

OPINION

GENERAL SURGERY NEWS / APRIL 2020

Positive Steps Perioperative Leaders Can Take to Address COVID-19

By DAVID TAYLOR, MSN, RN, CNOR

T

oday’s health care systems are in uncharted waters in relation to the novel coronavirus causing COVID-19. This rapidly evolving infectious disease outbreak is spreading at an unprecedented rate, leaving health care organizations overwhelmed and scrambling to keep up with the demands of affected patients. In the United States, there are an estimated 2.8 hospital beds per 1,000 patients and 160,000 ventilators.1 However, will it be enough as the nation continues to see increasing numbers of sick patients?

In an article published in The New York Times (March 17, 2020), Harvard researchers concluded that hospitals throughout the country will run out of beds. This analysis will depend largely on how fast this virus spreads and who will be hit hardest. Although the prediction is not exact and reflects the worstcase scenario, it does show that if 40% of adults contract the virus in the next 12 months, hospitals would not have the capacity to care for them.2 What about rural hospitals that have closed? Who will serve those communities during this pandemic? If they could be reopened, who would staff them? The crisis in rural areas could have a profound impact on our nation. The shortfall of beds, qualified staff and much-needed equipment makes the closure of rural hospitals a component of this problem that will prove disastrous.

According to the World Health Organization, COVID-19 belongs to a large family of viruses that can cause a variety of illnesses ranging from the common cold to more severe diseases, such as severe acute respiratory syndrome (SARS), which spread globally in 20032004, and Middle East respiratory syndrome (MERS), affecting thousands in that region in 2013-2014. Both were relatively mild compared with the influenza outbreak of 1957, when the number of deaths reached 1.1 million globally with 116,000 deaths in the United States contributing to that number. 3 In 2009, the (H1N1)pdm09 influenza emerged in the United States, killing about 12,000 people, and then quickly spread around the world affecting nearly 61 million. The CDC estimated that the global death toll from April 2009 to April 2010 was in the hundreds of thousands.4 Regardless of where COVID-19 leads us, it deserves our full attention now. As the outbreak continues to evolve, the CDC is closely monitoring its continued spread across the country and modifying its approach. Hospitals are assessing their

preparedness daily or actively responding to an ever-changing situation. On March 14, the U.S. Surgeon General, Jerome Adams, MD, asked hospitals and health care systems to seriously consider stopping all elective procedures during this crisis as concerns of spreading COVID-19 to health care workers become a reality.5 This message was reinforced on March 18, when Seema Verma,

MPH, a White House Coronavirus Task Force member, recommended canceling all nonessential elective surgery including dental procedures as a way to expand the health care capacity nationally.6 Hospital and health-system leaders should take this advice and stop performing elective surgery procedures and refocus their attention on the hardesthit areas. Nurses, technicians and service personnel of the OR can be reallocated to other areas of the hospital to provide

support and even expand services. Doing executive leadership walkabouts will help leaders understand what’s going on in real time in their organization and will allow the reallocation of resources as needed.

This change will give staff remaining in the OR a unique opportunity to perform all tasks that are often overlooked or pushed off because of the highpaced demands of surgical services. Begin by performing a deep cleaning of your department and terminally clean every

S

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OPINION

APRIL 2020 / GENERAL SURGERY NEWS

room in your department. Take an inventory of your supplies, removing outdated items, and clean the shelving and cabinetry housing those supplies. Next, inspect all of your equipment, clean as needed, and take this opportunity to repair equipment that has been overlooked or put in a faroff corner. If elective surgery at your facility has been curtailed, perioperative leaders should take this opportunity to meet oneon-one with their staff. It’s an opportunity to engage with your staff and let them know they are valued. This will also let you review job descriptions with them and ensure your team has the required skills to

The importance of this crisis will set leaders apart from those who just manage tasks.

perform the various specialties your OR performs. Everyone who works for you knows what is expected of them, but this time will allow leaders to reset what those expectations and responsibilities are.

Giving your team some undivided attention will allow you to engage them in different ways. Lastly, take advantage of this time to catch up on education.

Whether it be Health Stream; renewing CPR, ACLS or PALS; or providing in-services and hands-on training, your investment in your team will allow them to feel a sense of ownership about their role and the organization.

Efficient Instrument Sterilization If OR and central sterile processing staff across the country happen to contract the virus, how will hospitals be able to perform surgery when it becomes urgent or emergent? One answer is preoperative leaders can look to vendors to help amplify the staff they do have during these trying times. SteriCUBE is doing just that.

According to Maryellen Keenan and Michele Mauzerall, the “SteriCUBE System is an incredibly efficient and safe way of sterilizing and delivering all the surgical instruments required for a single patient surgery, eliminating multiple steps both in the central sterile processing and OR workflows.” Ms. Mauzerall said that it has allowed staff from both departments to spend needed time on other tasks, freeing them up to focus more on the patient. Ms. Keenan described one hospital in Olympia, Wash., that recently acquired the SteriCUBE technology and reported they were able to handle an unexpected spike in surgeries despite being short-staffed.

They also said they were achieving other efficiencies, too: Not having to use blue wrapper or containers on all those trays saved the hospital money and increased their efficiencies.

No one knows what the impact will be as a result of this pandemic or the numbers of people who will be affected in the coming weeks and months. The importance of this crisis will set leaders apart from those who just manage tasks. Leaders anticipate needs and strategically plan for them, not react to them. A focused approach will enable you to move forward quickly.

■

References

1. Wan W, Cha AE, Sun LH. The Washington Post. March 13, 2020. www.washingtonpost. com/health/2020/03/13/coronavirus-numbers-we-really-should-be-worried-about/.

2. Sanger-Katz M, Kliff S, Parlapiano A. The New York Times. March 17, 2020. www.nytimes.com/interactive/2020/03/17/ upshot/hospital-bed-shortages-coronavirus. html 3. www.who.int/health-topics/coronavirus

4. CDC. Influenza (flu). 1957-1958 pandemic (H2N2 virus). www.cdc.gov/flu/pandemicresources/1957-1958-pandemic.html 5. Luthi S. Surgeon. Politico.com. March 14, 2020. www.politico.com/news/2020/03/14/ surgeon-general-elective-surgeries-coronavirus-129405

6. www.cnn.com/world/live-news/coronavirusoutbreak-03-18-20-intl-hnk/h_66bbf534d3b 14bcaf0966c5b628dc414

—David L. Taylor, MSN, RN, CNOR, is an independent hospital and ambulatory surgery center consultant and principal of Resolute Advisory Group LLC, in San Antonio. You can email Mr. Taylor at David@ResoluteAdvisoryGroup.com.

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Carmichael continued from page 1

international audience. Allied forces were driven to Dunkirk, narrowly escaping the onslaught across the English Channel.

The world, having only closed a chapter 20 years previously to bloody conflict, was faced with it once again. Without question, there were the perceptions of fear, anger and helplessness among those living through this dark time. It suffices to say that no one knew what the future would hold.

COVID-19 has changed our modern landscape in much the same fashion.

What began with reports of a respiratory illness from Wuhan, China, quickly became a global pandemic, sweeping across the world to nearly 150 countries. It has affected young and old, healthy and unhealthy. National health care systems have been overwhelmed by the needs of their citizens, struggling to accommodate those requiring

GENERAL SURGERY NEWS / APRIL 2020

hospitalization. According to a recent report from the United Kingdom, epidemiological data and modeling reveal that roughly 4% of infections will require hospital care, with an estimated 30% needing critical care and 50% mortality rate among the critical care cohort. Even with optimal social mitigation strategies (i.e., home isolation and quarantine, social distancing, and closure of schools/universities), deaths from this disease are predicted to surpass 1 million in the United States (https://doi.org/10.25561/77482).

With the possibility of an effective vaccine 12 to 18 months away, we are left only with suppressive measures to “flatten the curve” for an unclear period of time. Without question, fear, anger and helplessness are among us once again.

The virus has also changed the way we provide care. Patients under investigation require isolation with droplet precaution and increased layers of personal protective equipment, a resource

First COVID-19 Patient

By MELISSA RED HOFFMAN, MD, Acute Care Surgeon, Asheville, N.C.

March 22, 2020—After three days off and way too much time on the internet, I woke with a start this morning, dreaming (literally) about PEEP (positive end-expiratory pressure) and proning. I attempted to quash the anxiety with a ride on Peloton and a hot shower, but was still racked with anxiety as my boyfriend dropped me off at work.

I walked into a very different world today. Yesterday my hospital announced its first COVID-19 patient.

Last night, all visitors were banned, the cafeteria was closed, and all but three entrances were locked down.

But this morning, on rounds, my patients were very much the same.

“How are your spirits?” I asked a mid-20s patient with necrotizing pancreatitis. He shook his head forcefully as his eyes welled up with tears. “This is a lot,” he confessed. “And I’m lonely.”

Next door, a young man with metastatic cancer and a recent intestinal bypass grabbed my forearm and said, “I just need to hold on to someone.” I grabbed his hand and responded, “I get it.”

Rounds reminded me that regardless of what’s going on in the world, or even of what’s going in the hospital, my patients—many of whom are tethered to their beds with lines, drains and tubes—are mostly just concerned with what’s going on in their rooms and within their bodies. They are in pain, frustrated, scared, and are now even more isolated. They need me: to think clearly, to plan thoughtfully, to be their cheerleader, to be their advocate, to be their surgeon and, most importantly, to be their doctor.

And I need them: to remind me that I am currently blessed with health, with economic security, with a resourceful community, and with a purpose that extends far beyond this pandemic. Just for today, that is enough.

■

now in short supply. To mitigate exposure among practices, physicians have adopted rotating schedules, decreasing individual time spent in the hospital to maintain provision of daily services by a group. ORs have limited surgical volumes to perform only urgent and emergent procedures and reduce overall hospital volume. Furthermore, surgical intensivists have made preparations to assist with surge populations requiring critical care after medical ICUs reach their capacity.

World wars and pandemics cause more tragedy than loss of life or economic upheaval. It is only natural that, in times of fear and uncertainty, we are motivated to protect what is ours—to hoard resources we consider finite at the expense of our neighbor. Prioritization of family, friends and loved ones, although important, can be mirrored by an attitude of exclusion, greed and selfishness. If we are to survive and learn from such struggles, it cannot be individually and at the

loss of our humanity and goodwill. With mitigation and suppression as our only tools, collaboration and accord must be our only outlook.

It is not often that the acute care surgeons are called to the obstetrics floor.

Usually, such signals hollow the stomach and sharpen the senses for an unpleasant chain of events. Recently, we received such a call. A young mother required an emergent caesarean delivery, and the obstetricians requested our assistance. We walked into the OR as she was getting positioned. After carefully entering her abdomen, a uterine incision was made and, with a few brisk motions of the obstetrician’s arm, a new life entered the world. I admit it: I fought back tears. There is light to be seen in the darkness and joy in times of war and plague. As we navigate this unclear road, may we not forget our humanity and goodwill, never hesitating to conduct ourselves with a burden of love toward one another.

■

Risk–Benefit Decisions

By JOHN VOSSLER, MD, MS, MBA, Surgical Resident, University of Hawaii, Honolulu

March 21, 2020—As I write this, the state of Hawaii has 48 confirmed or presumed positive cases of COVID-19 with no deaths.

The United States is currently at 23,000-plus cases and 302 deaths. We are, fortunately, at a much earlier point on the curve of infections versus time than the rest of the nation.

Our state and local governments have implemented many of the same public health policies as those on the mainland, such as mandated closures of eatin restaurants, theaters and bars. Some counties have even implemented a curfew. Hawaii’s economy is largely based on tourism. Our domestic and international daily arrivals have plummeted to approximately 25% of what they were at this time last year.

Many businesses have been even more proactive. My wife’s salon is now closed through at least the first week of April.

Our hospitals have responded similarly. Cancellation of elective procedures began earlier this week, and at this point, have almost completely halted. It’s my hope that Hawaii will benefit from our relatively late onset of infection, early start of public health interventions and geographic isolation.

Our general surgery residency program, like many others across the country, was faced with a difficult question: How should we protect our residents and preserve our workforce while still providing the coverage on which our patients depend? Our program, after careful deliberation, has implemented a new resident coverage model to address this issue. I’ve had the privilege of being our program’s administrative chief, and as such, I was given the responsibility of crafting the specifics for how it would be implemented. We have transitioned from a typical rotating 24-hour call schedule to a day/night float system, in which residents switch between stretches of being

on duty and stretches of being off duty. These periods are approximately five to seven days long, and approximately half of our residents are off duty at any given time. The rationale behind keeping a significant number of residents off duty, although they may be well and capable of working, is to limit their exposure and keep a reservoir of residents available to fill gaps if the on-duty residents become ill. Over the past few days, I’ve spent a lot of time thinking about not only the micro-decisions that go into making a call schedule but also the general merits of this new coverage model.

Doesn’t it seem strange that our response to a pandemic has been to decrease the number of residents available to treat patients? Any coverage model that involves the intentional throttling of resident coverage to limit exposure and preserve the workforce exists on a spectrum. At one extreme, there’s full resident coverage, which maximizes our current capacity to care for patients. However, this also maximizes our exposure and risk for illness-related attrition, which could significantly reduce our capacity to care for patients later on. At the opposite extreme is zero resident coverage, which minimizes our exposure and risk for attrition, but eliminates our ability to care for patients. Where’s the sweet spot? Where should we aim to be on this spectrum? This is a risk–benefit judgment. Do the benefits of decreased transmission and preservation of the workforce outweigh the risks of decreased resident coverage? There’s probably an analytic approach to answering this question, but it would certainly depend on a number of variables that are currently unknown and may not be measurable. Although frustrating, this question seems remarkably similar to a question that we answer multiple times per day: Do the benefits of surgery outweigh the risks? We’re experts at making risk–benefit judgments on incomplete and imperfect information. Hopefully, that expertise translates well into policymaking.

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COVID-19 BLOGS

APRIL 2020 / GENERAL SURGERY NEWS

The surgeons’ blogs on pages 16-18 are updated regularly and can be found at

www.generalsurgerynews.com

A Surgical Light on ...Preparing for the Chaos of Corona

By MARIA BAIMAS-GEORGE, MD, MPH, General Surgery Resident, Carolinas Medical Center, Charlotte, N.C.

March 21, 2020—The Chaos of Corona: At first glance, it sounds like a fable from Greek mythology that most likely involves Dionysus, the god of winemaking and drunken revelry. And when you first hear about it, it sort of sounds like one, too. “I’ve never seen anything like this in all my 100 years,” a direct quote from my clearly very old, yet consistently very witty, 100-year-old grandmother. Ranging from travel bans, to empty grocery store aisles, to school shutdowns, to the cancellation of all sporting events, this definitely feels unprecedented. And yet, the weather remains beautiful. The newest set of college graduates still heads to Mexico for spring break, pictured oh so flatteringly ignorant and callous as they state, “Coronavirus isn’t a big deal; let’s drink!” And just as rudely, the traumas keep happening; the appendices keep bursting; the cancer cells keep multiplying; and the bowels keep impolitely twisting and turning into pretzels of obstructions like yoga novices attempting “tripod headstand with lotus legs.” So how can we deal with this? When our ICU beds on a normal day of Dionysus’ debauchery are at full capacity, what will this special chaos bring, and more importantly, how will we deal with it?

In Charlotte, N.C., the first tests are coming back positive. Our curve has started to swoop up like the beast of prey we expected as we ready for its full attack.

As Herb Brooks once said, “Great moments are born from great opportunity. And that’s what you have here tonight.” Now don’t mistake me; COVID-19 is no “great” opportunity. In fact, it’s a tactless little bastard incubating for up to two weeks, waiting to attack young and old lungs alike. However, unlike mass casualty events that suddenly exceed our resources and to which we can only retrospectively plan and react to, we have the opportunity here to see, one could argue, into the future. Presuming a similar pattern and response to what has happened in China and Italy, and now in

several areas of the United States, Atrium Health’s Carolinas Medical Center (CMC) is preparing its battle forces accordingly.

Walking into the hospital, it feels like a ghost town.

Where are all the visitors? The children? The happy faces and the sad ones? With visitation policies heavily enforced, the hallways look eerily reminiscent to night float with only essential personnel present. And with all possible elective surgeries being delayed, the OR board also looks like—no wait. No; it’s still full. Well, that’s a problem. This tertiary care hospital—this Level I trauma center, this epicenter for care and hope—on any given day has an OR wait list. Even with nonessential surgeries canceled, the ORs remain full, the surgical ICU beds remain at capacity, and the residents remain busy. So how can we surgeons, we surgical residents, prepare for further chaos when we often feel like we’re barely staying afloat as is? As many staff will almost certainly fall ill or be quarantined, our workforce and supplies may reach limits never faced before.

With this unprecedented challenge facing us, different hospitals are implementing different contingency and staffing plans. Hearing from my friends and colleagues around the country, no one is doing it quite the same as these uncharted waters start being navigated.

The plan implemented at CMC, as of Friday, March 20—far before the worst of the virus has hit—split the surgery residents into a two-team system. Five days on, five days off. The teams operate in their own orbits: no contact and with virtual sign-out—like the sun and moon or an anesthesiologist and OR. When on five days off, residents are in isolation at home, ready to step in and work if a resident from the other team falls ill or needs to be quarantined. With half staff, we are a skeleton crew, covering only the essential fields that encompass the traumas, malignancies and complications that don’t stop with pandemics. These teams include general surgery, trauma, ICU, pediatrics and night float.

Additionally, there is a float resident to help with surgical oncology cases and other overflow as needed. These

teams also remain separate, as best they can, in their individual orbits. Thus, the ICU, staffed by acute care surgeons, is closed to primary surgical teams, and all care and recommendations will be communicated virtually. High-risk residents, like our lovely second-year resident who is in her third trimester, is screening clinic patients, taking emergency department calls, reviewing imaging—all remotely, keeping her safe, out of the hospital. This plan will remain in place for only 10 days (or even less), at which point it will be reassessed and changed as necessary.

The larger more expansive surgical plan, involving attendings, consults and transfers, is also a fluid, constantly shifting amalgam of patient triage. There are different levels of activation ranging from our current level of “alert” that emphasizes virtual visits and prioritization of only essential cases to Level 0 with battlefield promotions of senior residents and fellows, cancellation of all nonemergent cases, and transfers of urgent cases.

In this final level of activation with extreme facility and system resource exhaustion, hepatobiliary attendings will be called on to help with trauma codes, and bariatric surgeons may round on medical patients. All staff will be expected to be flexible and help cover nonsurgical infected patients. For, as the wise Albus Dumbledore (a “Harry Potter” reference for all you Muggles) once said, “We are only as strong as we are united, as weak as we are divided.” We will support our medical colleagues and our emergency department colleagues as best we can. We who choose to cut, who love to operate, will pick up our stethoscopes and set down our scalpels and fill in the gaps, for we are first, and foremost, physicians.

With this journey into the unknown, this surgical resident will keep reporting their experience to share new experiences, maybe failures, and (fingers crossed) hopefully “successes.” So, to end again on a quote, for the most appropriate words have often already been spoken, J.R.R. Tolkien’s Théoden, King of Rohan once said, “Forth, and fear no darkness! Arise! Arise … a sword day … a red day … ere the sun rises!”

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COVID-19 BLOGS

GENERAL SURGERY NEWS / APRIL 2020

Is the Scene Safe? When Emergency Response Simulation Becomes a Reality

By KRISTEN JOGERST, MD, MPH, surgical education research fellow at The Massachusetts General Hospital, in Boston, and a surgical resident at the Mayo Clinic AZ; and JASON BOWMAN, MD, chief resident in emergency medicine at The Massachusetts General Hospital.

March 22, 2020—In college, I worked as a lifeguard. My partner, Jason, worked as an EMT. This week as the number of COVID19 cases across the United States rose, we reflected on our time as first responders. Jason currently works as a resident in the emergency department (ED), where he still fulfills that role. I have shifted gears into general surgery but use simulation in my research fellowship for teaching surgical trainees.

This week, Jason and I reflected on the intersection of simulation education and emergency response. With growing concerns about personal protective equipment (PPE) shortages, many medical providers are wondering how we are going to manage COVID-19 patients if or when the supplies run out. We talked about how donning PPE to care for a COVID-19 patient is reminiscent of our first responder simulation drills. In the drills, we would practice running into emergent scenarios, much like what providers are preparing to do when COVID-19 patients arrive to their hospitals. Each simulation assessment always begins the same way. The course instructor makes sure the trainee asks upon arrival to the scene: “Is the scene safe?” The simulation instructor then tells you, “Yes. Scene is safe. Please proceed.”

You continue with the rest of the scenario for assessment of your rescue knowledge and technical skills.

Friends and fellow trainees shared their worries about the growing shortages of PPE with me this week.

We shared frustrations and disbelief upon hearing that equipment, such as N95 masks and powered air-purifying respirators (PAPRs), was running out or that hospitals had decided full body suits were too expensive.

They should instead use cheaper supplies, such as surgical masks and gloves. This turned to outright anger when we found out the CDC loosened its recommendations, suggesting bandanas or homemade masks might do. This recommendation was delivered despite prior evidence showing 97% of the time, cloth masks won’t protect you from respiratory particles (BMJ Open 2015;5[4]:e006577). The recommendation left us in disbelief. I tried to reassure friends that living in a country with a lot of healthcare and financial resources and with donations coming in, maybe the PPE stockpiles would change this week. Maybe we would be ready for the inflection point of the epidemiological curve (Washington Post. Mar 14, 2020; https://coronavirus.jhu.edu/).

Maybe more critical care resources would arrive before the case numbers truly surged. I suggested maybe supply chain management would change in response to the social media calls for #getmePPE. I suggested maybe

Pediatric Sepsis continued from page 3

reason, the guideline recommends each institution implement screening and protocols to facilitate timely recognition and treatment in children.

The guideline, published in February in Pediatric Critical Care Medicine (2020;21[2]:e52-e106) and Intensive

it would be OK. A resident friend chimes into the call: “But what if it isn’t? What will we do?” There is a long pause and heavy silence. “I don’t know,” I respond.

But the truth is we both knew; we just didn’t want to say it out loud. Later that night, Jason and I recall that in emergency responder simulations, if the scene wasn’t safe, you didn’t proceed. The simulation was over.

You state that you and your team will work to address the personal safety threat: whether that’s turning off the electricity source to the water the rescue victim is found down in, or waiting for firefighters to evacuate the patient from the burning vehicle before beginning your primary assessment. You work to reduce your personal risk. You do not proceed. A dead or injured first responder saves no one.

For the past decade, I have worked with a nongovernmental organization in Haiti. As a surgical resident, I now assist volunteer surgeons. Whenever we are told by perioperative staff and volunteers that certain supplies are unavailable, we shrug our shoulders, think for a moment, and choose the next best thing.

Don’t have the suture we normally like? OK, what else can you get me? Don’t have normal inhalational anesthesia available? OK, how long can a spinal block last?

We will work efficiently. During our trips to Haiti, my surgical friends and I jokingly started an acronym: TIH. TIH stood for “this is Haiti.” It’s reserved for those times when local resource limitations prevent a surgeon from getting the supplies they want.

It’s reserved for times when you could get frustrated or become creative and flexible. You could cry, or you could laugh and keep going. For example: Don’t have what we want for instruments? Volunteer or local staff: TIH. We share a couple of laughs. OK, what else can you get us?

Never in my surgical training did I predict TIH would apply to one of the richest medical systems in the world. Then COVID-19 happened. Amidst the chaos this novel virus is stirring, I hope it also teaches us a lot. So far it has shown us many of the defects in our medical system: from supply chain management of PPE, to lack of paid sick leave for some employees, to a paucity of funding for disaster preparedness and laboratory and epidemiological research. It taught us what governmental leadership thinks about the value of its health care workers, from the CDC suggestion that health care professionals could use bandanas for PPE, to leaving health care workers out of Congress’s paid sick leave plans (Pillsbury Winthrop Shaw Pittman LLP; Mar 18, 2020). Amidst the frustrations, I try to remind myself, “TIH.” Or in this case: TIUS. “This is the United States.”

Care Medicine (2020;46[2020]:10-67), recommends fluid administration be decided based on the resources available in each hospital. Children at hospitals with ICUs should receive up to 40 to 60 mL/kg bolus fluids in the first hour of treatment, based on cardiac output, and discontinued if they exhibit signs of fluid overload. However, health care systems without ICUs may not have the resources to manage fluid overload and should

Instead of quitting, instead of getting frustrated, it’s time to shrug our shoulders. Not out of apathy but with a willingness to be flexible, to be determined, and to carry on. No, my partner will not be wearing a bandana to his next ER shift when he gears up to intubate a COVID-19 patient. Rather, how can we as a community of hardworking, creative and determined people put our minds together and figure out solutions to these shortages? Don’t have that PAPR that I need?

How can we build one with other supplies that we have? How can more research labs that are temporarily shut down donate supplies (The Harvard Gazette.

March 19, 2020)? Don’t have a rapid test so we can adequately test and quarantine cases to flatten the curve?

How can we support labs to make one (In. Practice/ Education/Research. Rochester, Minn., 2020)? How can we give them resources, and lighten restrictions on sharing intellectual property and reagents? Don’t have enough healthcare personnel to staff the EDs, ICUs or inpatient care teams? Shrug shoulders. How can we utilize teams whose elective surgeries, consults, or research endeavors have been canceled? Let’s increase the pool to decrease the burnout. Don’t have enough critical care resources to provide for patients if they all present within the same week? How can we make social distancing cool? How can we leverage social media, telemedicine and e-learning to encourage this for our patients, family, and friends (Washington Post. Mar 14, 2020)?

For many of you reading this, your hospital leadership, research teams, engineers, and technology specialists have already done many of these measures or are working on them. You have already shrugged your shoulders and gotten flexible and remain determined.

I hope other hospitals will follow your lead. But more importantly, if you are reading this, you and your colleagues are probably on the front lines. I’m thankful you signed the Hippocratic Oath. You might be scared. I’m scared, too. Not because I’m worried all my colleagues and I are going to get COVID-19 without proper PPE. I’m scared because we know how the emergency simulation ends. Not safe to go into the room for the code?

Not safe to proceed? The simulation is over. Those moments spent searching for supplies are opportunity costs in emergency rescue. I hope those in leadership positions are as scared as I am for our patients and what might happen to them when we reach the time point on the inflection curve.

■ The views expressed are those of the author(s) and not those of their employers or associated institutions.

not administer a bolus of fluid unless the child has extremely low blood pressure, the committee advised. In those cases, children should receive maintenance fluids instead.

“This is a substantial departure from the approaches that we use for adults,” said Lewis J. Kaplan, MD, the president of the SCCM and a professor of surgery at the Hospital of the University of Pennsylvania, in Philadelphia.

The guideline also recommends that children receive epinephrine or other vasoactive medication to treat low blood pressure if they continue to show signs of shock despite fluid therapy. Symptoms suggesting warm shock are often unreliable in children and can mask sepsisinduced heart dysfunction.

The Surviving Sepsis Campaign is a joint initiative of SCCM and the European Society of Intensive Care Medicine. ■

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GENERAL SURGERY NEWS / APRIL 2020

Birds, Balance and Burnout

By BARRET HALGAS, MD

‘If you want something done, ask a busy person.’

—Unknown

W

hen I was on my general surgery sub-internship as a fourth-year medical student, the residents advised me to avoid listing hobbies on my curriculum vitae because, in their words, “program directors resent things that take time away from the hospital.”

These are the other things I heard heading into intern year: • “There will be no time for anything other than surgery.”

• “Patients will always come first.”

• “Family can wait until after residency.”

Unfortunately these sentiments are still being perpetuated, causing interns and residents to deprioritize the very things that could protect them in the long run.

A hobby is just one small part of maintaining a balanced life, and the reality is that there is a rich history of surgeons enjoying and contributing to fields outside of the OR. For example, anatomist and surgeon John Hunter was a respected and published naturalist.

Kocher was an artist. Bilroth was a concert pianist. Halsted cross-bred dahlias at his country house. Kelly was a botanist and theologian. Cushing was a lifelong fishing enthusiast. DeBakey was a well-read historian. All contributed something. A few were experts in the field, but most just offered their time and energy while appreciating the wellness and balance it reciprocated. Osler reflected that “no man is really happy or safe without

Burnout seems to exist where ‘being there’ for patients meets the crushing reality of system and administrative burdens, and, unfortunately, the people most affected are often the most committed.

a hobby, and it makes precious little which turns into a busy general surgery difference what the outside interest practice, and still almost 100% of their may be—botany, beetles or butterflies, emotional reserve is spent inside the roses, tulips or irises, fishing, mounhospital and clinic. Exposed, without taineering or antiquities.” the protective insulation of a personThe reason surgeons like to [insert al–professional balance, these surgeons hobby here] is because the pursuit of are at highest risk for burnout. surgery rarely exists within a vacuSurvey-based studies have tried to um. The work ethic, thirst for knowlidentify which intrinsic (personal and edge and obsession with detail that are family values) or extrinsic (specialty, channeled into five years of residenworking conditions, job satisfaction, cy inevitably spreads to other interetc.) variables are statistically differests outside of medicine and surgery. ent among physicians who self-report When the U.S. Army began to push Major General Edgar Erskine burnout. An outside hobby or interwest in the 19th century, physicians Hume, MD, the highestest was rated fifth in importance for and surgeons attached to cavalry reg- decorated medical officer in prevention of burnout.3 In addition iments carefully journaled about the American history, was also to providing a healthy balance, studchanging flora and fauna. This was not an amateur ornithologist. ies have shown that engaging in crejust a few men either; it was hundreds. ative outlets is associated with better The medical corps became famous for their careful and job performance. It’s difficult to say for certain if the precise observations of the landscape of the Southwest. correlation is causal or not. On the one hand, engag(Several bird species are even named after wives and ing in a hobby provides mental relaxation and recovgirlfriends.) ery, which leads to more perspective and potentially A curator at the Smithsonian remarked that “if he transferable skills, all of which can improve on-the-job wanted any information in the domain of natural his- performance. Or it may simply imply that top performtory, ethics or positive science, he could always get such ers have a healthy curiosity paired with an internally information as he wanted from an officer in the Army competitive nature that is reflected through a variety Medical Corps.” Major General Edgar Erskine Hume, of self-expressive pursuits.4 Regardless, the pursuit of MD (1889-1952) created a record of their findings and excellence outside of a single domain seems to provide was an amateur ornithologist (study of birds) himself, an emotional balance that can be crucial to surviving besides being the highest decorated medical officer in the long years of surgical training.

American history. As to why these men were so drawn Interns and junior residents are often corrected in the to other fields of study, General Hume recognized that OR to avoid creating bad habits. What no one is coran active mind will naturally search for outlets that recting is this habit of “delayed gratification” that is ramprovide personal and professional fulfillment. “Medical pant—the habit of postponing activities and ambitions officers were exceedingly well-educated men and when until some other time in the distant, utopian future. The campaigns were not in progress, their spare time was problem is that even years removed from training, those not wasted.”1 What started as a side project became a same doctors and surgeons are still grinding and danpopular coping mechanism during months of drudgery, gerously at risk for burnout. service and political pressure (think: burnout). As it is, I hear stories of residents graduating, now five to six birding is still a widely enjoyed hobby among physicians years older and with more time on their hands, askand surgeons. Identification is very similar to creating a ing, “What kinds of things do I like to do?” In small, differential diagnosis: Signs and symptoms become dis- infrequent but deliberate ways, continue to put time tinctive markings, behaviors and songs. More impor- and energy into your hobbies. They will undoubtedly tantly, it is a reason to be outside and ditch the loupes change in residency, so continually find out what it is for binoculars. that you enjoy learning. Invest in habits that will serve What we now call burnout has reached nearly pan- you long into the future, and your career.

■ demic proportions effecting nearly 40% of U.S. physicians. The exact cause is still poorly understood, and yet References this has not deterred hospitals from shamelessly and 1. Hume, EE. Ornithologists of the United States Army Medical Corps. The Johns Hopkins Press; 1942. reflexively implementing mandatory wellness models.

What is generally agreed upon is that burn- 2. Eschleman KJ, Madsen J, Alarcon G, et al. Benefiting out refers to a clinical syndrome of emofrom creative activity: the positive relationships between creative activity, recovery experiences, and tional depletion and depersonalization performance‐related outcomes. J Occup Organ Psychol. from colleagues and patients. Younger 2014;87:579-598. surgeons seem to be more affected than older surgeons. Of note, there is no corre- 3. Balch CM, Freischlag JA, Shanafelt TD. Stress and lation between burnout and work hours. burnout among surgeons: understanding and managing Burnout seems to exist where “being there” the syndrome and avoiding the adverse consequences.

Arch Surg. 2009;144(4):371-376. for patients meets the crushing reality of system and administrative burdens, and, unfortu- 4. Shanafelt TD, Oreskovich MR, Dyrbye LN, et nately, the people most affected are often the most al. Avoiding burnout: the personal health habits committed.2 and wellness practices of US surgeons. Ann Surg.

From day 1 of residency, surgeons restructure their 2012;255(4):625-633. worldview around the premise that “patients come first,” leading to a lifestyle of delayed gratification and putting —Dr. Halgas is a surgical resident in El Paso, Texas. His off personal fulfillment. Residency turns into fellowship, articles on surgical residency appear every other month.

OPINION

APRIL 2020 / GENERAL SURGERY NEWS

Coronavirus: To Mask or Not to Mask

By FREDERICK L. GREENE, MD

T

he recent emergence of a deadly mutated strain of coronavirus (COVID-19) and its spread across the world has heightened interest in the role of the surgical mask as one possible barrier to a potential pandemic. The media has touted the use of surgical masks and the types of masks that should be worn as a barrier to airborne viral spread.

The need and desire for entire urban populations and travelers to don facial barriers have literally created a worldwide shortage of surgical masks and viral barrier respirator masks. The largest surgical mask provider, Prestige Ameritech, no longer is accepting orders of masks from individuals as it focuses on supplying U.S. hospitals. Not since the SARS epidemic in 2002-2003 has there been such interest in the varieties of mask protection.

Initial interest in the use of masks as protection against infection, especially tuberculosis, began in the late 19th century but did not routinely translate to usage in the OR until the 1920s.

It is reported that Paul Berger, a Parisian surgeon, first began routinely using a mask during surgical procedures in 1897. These early masks were made of fine mesh gauze and used to cover the mouth only. During World War I, the use of gauze masks in military hospitals was introduced to protect patients who were placed in mixed wards with a high incidence of respiratory infections.

During the influenza pandemic of 1918, wearing of gauze masks became commonplace, but sadly in retrospect, masks were not protective in trapping viral particles. Throughout the early 20th century, varieties of masks were introduced to prevent bacterial transmission from OR personnel to patients. With the recognition of viral contamination, this filter concept gained greater importance.

As we began operating on HIV-infected patients with laparoscopic techniques in the late 1980s, the release of a “viral plume“ into the OR from the escape of the carbon dioxide used for creation of a pneumoperitoneum became a concern.

This led to the development of mask filters that would lessen transmission of viral particles and afford increased protection for the operating team. Later improvements would usher in the mask respirator concept now designated as the N-95 mask recommended for protection against viral particles and especially COVID-19.

While wearing of surgical masks during seasons of heightened respiratory illness has been commonplace in Asian

cultures, this protective strategy remains infrequently used in North America. The current spread of COVID-19 is changing all of this. While the wearing of surgical masks may be beneficial in locales with smog or other environmental pollutants, they are woefully inadequate for protection against the mutated coronavirus.

It is both appropriate and beneficial as a public health mandate that surgeons

should have proper knowledge regarding mask protection that could be shared with patients, their families and, when asked, the media.

The assumption that the wearing of a surgical mask is protective for populations at risk from respiratory-mediated viral epidemics should be dispelled. Adequate hand-washing is a better preventive measure than wearing nonprotective facial barriers. While the spread of COVID-19 has rightly engendered fear, the ultimate

antidote against fear is fact, and who is best suited to provide appropriate facts regarding the drawbacks of surgical masks and the benefits of handwashing?

Surgeons—that’s who!

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

Management News The Independent Source of News for Operating Room Managers, Supply Chain Professionals & C Suite

21

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OPINION

GENERAL SURGERY NEWS / APRIL 2020

Principles and Commitments continued from page 1

Koufax’s decision not to pitch on Yom Kippur drew national attention, some condemnation, but mostly approbation. His refusal to abandon his religious principles and his own personal principles of keeping this day sacred has remained a story often told, an example of an individual making an ethical decision, regardless of the potential consequences. My mentor, Richard L. Varco, often said the only face that you must confront in the mirror each morning of your life is your own.

A tragic outcome of following one’s principles within our medical profession was the Chinese government’s response to the first alarm of the emergence of the COVID-19 epidemic raised by Dr. Li Wenliang of Wuhan, China, the epicenter in that country. Dr. Li, an ophthalmologist, was punished for his early warning and forced to recant it before his death from the disease itself. We all know the stories of Ignaz Semmelweis and Joseph Lister, who implored doctors to wash their hands between seeing patients to prevent the spread of infection. They were ridiculed and criticized, greatly delaying acceptance of the principles of antisepsis and asepsis.

Owen H. Wangensteen’s lifesaving use of nasogastric suction and IV support for intestinal obstruction was initially greeted with derision and, twice, by the refusal to publish his work. I lived through the time of opposition to pediatric surgery to repair congenital anomalies (e.g., coarctation of the aorta), open heart surgery, transplantation surgery and bariatric surgery; the pioneers of these disciplines were, at times, sanctioned and ostracized for their dedication to their principles of patient care and medical progress.

I know of many surgeons today who risked and often encountered retaliation for what they believed were ethical decisions that their conscience demanded. Some refused to comply with administrative dictates. Some challenged principles of patient care—for example, who, when and where to admit patients to the hospital; what operations to perform or not to perform; and which support facilities to have available. Some refused to subjugate themselves to a service line or hospital employment.

Some rebelled against fixed hours of care and lack of availability to patients. Some objected to fixed incomes.

Although surgeons have occasionally triumphed in these encounters, commonly they have been penalized for their principles; they have been demoted, limited in autonomy and privileges, and discharged. Yet, surgeons persist, risking their careers. Why? There seem to be certain principles that demand our allegiance. I believe that there are at least three cardinal tenets of our profession: service, independence and responsibility.

I pledge to pursue the practice of surgery with honesty and to place the welfare and the rights of my patient above all else.

I will take no part in any arrangement or improper financial dealings that induce referral, treatment, or withholding of treatment for reasons other than the patient’s welfare.

—Statements on Principles, American College of Surgeons, Fellowship Pledge Service is the hallmark of our profession. We see patients and listen to them, we treat them, and we operate on them, with the expectation that we can make a difference, save lives and enhance well-being. Is this relationship compromised by hours of electronic record keeping, unending mandatory administrative regulations, and the

and group analyses, this abrogation of independence is readily accepted by, and does not seem to impose a moral burden, on today’s surgical graduates.

As surgeons, we acknowledge that we interact with our patients when they are most vulnerable.

—Statements on Principles, ACS, Qualifications of the Responsible Surgeon Surgical care includes providing preoperative diagnosis and care. …

The primary attending surgeon is personally responsible for the patient’s welfare throughout the operation.

The responsibility for the patient’s postoperative care rests primarily with the operating surgeon.

Sandy Koufax

The surgeon will ensure that the surgical patient receives appropriate continuity of care.

Patients usually choose their surgeons, and surgeons, in turn, may accept or refuse patients.

—Statements on Principles, ACS, Relation of the Surgeon to the Patient

What does the future hold for surgeons, as a group, with regard to our ability to follow through on a commitment and in upholding the principles of service, independence and responsibility? determination by others of the way and to whom we can offer our services? Do these impositions impair our ability to serve and have we said no to them?

To find yourself, think for yourself.

—Socrates … Independence now and independence forever.

—Daniel Webster Independence is happiness.

—Susan B. Anthony A job is more than a paycheck. A good job fosters independence.

—James H. Douglas Everything that is really great and inspiring is created by the individual who can labor in freedom.

—Albert Einstein Not that long ago, surgeons or surgical groups were independent contractors, or individual practitioners, governed by their ambitions, talents and allocation of hours—a time when this arrangement was the norm in both private practice and academia. Today, nearly all urban surgeons are employees of a hospital or a health care network, subject to prescribed tasks and hours in exchange for salary, benefits, vacations and management of billing. Dependence on an administrative body includes the potential for being dismissed, not for incompetence but for exercising individual principles. It has been a conundrum to me that based on interviews

I have always believed that the assumption of personal responsibility is the cardinal trait of a surgeon. That is why in the past, patients called their surgeons “my doctor,” and we referred to our patients as “my patient.”

Today’s patient often does not know who his or her surgeon is, because the surgeon has been replaced by a group. Not even the operating surgeon of a group or a service line may be guaranteed to a patient. Various members of the group may be in charge of specific areas of care, and hospitalists take over at night. I have been told that in some institutions, not only the assisting resident but the operating surgeon may be rotated when his or her allocated time is up. To me, these practices renounce personal responsibility for the patients we serve and I believe that in the process, our outcomes will be negatively impacted.

Sandy Koufax risked his career by saying no; however, he did not lose his profession and he maintained his principles. Can we as surgeons do likewise and say no to the loss of our ability to serve, that is, to keep our independence and fulfill our mandate for personal responsibility?

If you shake my hand, that’s for life.

—Jerry Lewis Adherence to principles is essential to the keeping of commitments. My father, a businessman, would often seal a transaction with a handshake. People in his time justified engaging in this form of contractual arrangement by citing the reliability of the other party. I’ve often heard the term, parodied in “The Godfather” movie trilogy, “He is a serious man.” The word “serious” was not meant to be taken as studious but represented “reputable and trustworthy.”

Who today does business on a handshake? No one trusts in a verbal commitment, or for that matter, any commitment. Contracts are signed, witnessed and notarized. Lawyers are involved. Some parties to an agreement, with minimal hesitation, view the violation of the contract as a part of doing business, willing to pay court-won compensatory damages, expenses covered by

OPINION

APRIL 2020 / GENERAL SURGERY NEWS

illegal profits, and not considered an embarrassment.

In academia, I know of instances in which retirement benefits promised on a handshake were not honored, where honest criticism was followed by dismissal in violation of a contract, cases where not only income but also space and privileges were suddenly revoked after a surgeon decreased his hours in the operating room and therefore was not generating a certain level of income for the team and for administration. Age discrimination is illegal but it is practiced. Many attempts have been made by universities to eliminate tenure, the final refuge of academic freedom of speech. Although I have no personal experience in the world of private surgical practice, I have been given to understand that in that realm, “commitment” is also often but a word in the dictionary.

What does the future hold for surgeons, as a group, with regard to our ability to follow through on a commitment and in upholding the principles of service, independence and responsibility? What are our obligations in making that commitment? I believe that all of us would like others to say about us: “She is a serious woman” or “He is a serious man.”

■ Now if I carry out this oath, and break it not, may I gain forever reputation among all men for my life and for my art.

—The Hippocratic Oath —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.

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response

Artificial Ignorance

By LINDA WONG, MD

T

he whole world wants to predict the future, but, like it says on the bottom of every financial report, “past performance is not indicative of future results.” In surgery, we want the ability to give patients the likelihood of death from a procedure; the risk for infection, bleeding or hospital readmission; or other complications. We want to tell them the estimated duration

of the surgery, length of stay and days off work needed to recuperate.

In the past, surgeons would answer these questions based loosely on an article they once read for surgical journal club, while on the plane, or in the bathroom. We would be unable to quote the exact statistics, and even if we did, it was likely the article was limited by being retrospective, a single-center study, or having a smallish sample size. With time, the recollection of specifics becomes fuzzy,

and surgeons would advise patients based on their experience more than anything else. All the numbers were estimates with wide ranges and really forgettable data.

Fast-forward to today. Now we have big data, nomograms, artificial intelligence and risk calculators. I can query online calculators and inform my 65-yearold male patient with a body mass index (BMI) of 24 kg/m2, pancreatic cancer and diabetes that his estimated risk for death after a Whipple procedure is 0.5%, that

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his risk for serious complications is 21%, and his length of stay is eight days. I could then go to an online pancreatic fistula risk calculator and plug in more numbers. If his pancreatic duct is 4 mm, he has a firm pancreas, and blood loss is 500 cc, his risk for having a pancreatic leak is 5.6%.

Armed with all of these data and information, are we much better off than the old-time general surgeon? Furthermore, is every 65-year-old man with diabetes, pancreatic cancer and a BMI of 24 kg/ m2 the same? Sure, we can add in other comorbidities—maybe some laboratory values, vital signs and a few other things— but these calculators are not going to capture everything. The key section that is missing in most surgical calculators and nomograms is the social history.

For those of you electronic health record copy–paste masters, social history is where you write “no alcohol, no smoking.” If you have a smart phrase, an entire section of social history comes up that includes education, occupation, marital status, illicit drug use, military service, living arrangement, foreign travel and incarceration. Many surgeons just gloss over this and default to “unknown,” mostly because we didn’t ask. Why does it matter when the history and physical isn’t that important in 2020? After all, we have the CT scan result, which is pretty much the answer.

Social history actually matters, and risk calculators fail to capture it. You probably use the social history much more than you think—even though you are not documenting it well—when you make subconscious decisions about whether to operate.

Here are two examples.

I walked into a room with a roughly 60-year-old man recently found to have liver cancer. Homeless, thin and rather disheveled, he had been pulled out of a muddy corner of a park after a fall.

He rarely wore shoes, and the bottoms of his feet were brownish black. His breath smelled like the full pack of cigarettes he smoked that day, and he admitted to illicit drug use and alcohol in the past. The trauma team who admitted him noted that he had slightly elevated liver enzymes and was hepatitis C–positive with a 4-cm liver mass on CT scan.

This seemed resectable, and the surgical chief resident was excited at the prospect of getting to do a liver resection.

I asked more questions. The patient had an ex-wife, was estranged from his

APRIL 2020 / GENERAL SURGERY NEWS

children, and had no other family or friends. He lived on the beach and various parks and was in the process of getting medical insurance. He stopped taking his medications for hypertension years ago and had not seen any physician for years. Now, could I safely do a liver resection? I would be discharging him to perhaps a shelter or maybe the street in a few days. Would he even come back to remove the staples or return for longterm follow-up? Will he return to alcohol, drugs and smoking? If I plugged in all those nomograms and calculators, he would not look like a bad resection candidate, but somehow, I did not see this turning out well.

Another case: A roughly 60-yearold massage therapist presented with obstructive jaundice. She was taking 15 different herbal and dietary supplements and was sure that milk thistle would cure jaundice. She had never seen a physician but completely trusted her naturopathic healer. During the course of her workup, she was found to have pancreatic cancer, uterine cancer and breast cancer. However, this workup took months because she missed appointments, refused certain tests, left the hospital against medical advice, disagreed with her physicians, and thought that things would get better if she just changed her diet and did juicing instead of meals. Which cancer do I treat first, and would her outcomes be worse because of the delays in therapy and her noncompliance?

Before we truly predict the future and use AI to guide our therapy, we need to add factors that make each patient unique.

Do we develop a separate psychosocial history calculator or develop a psychosocial index that can be added to a regular calculator? Does the use of milk thistle belong, or is it just a screaming red flag to dig deeper? Perhaps a “milk thistle calculator” might actually allow us to achieve better results, or maybe the patient is in worse shape than we thought.

A psychosocial index will be tough to accomplish. Alcohol history is not just how much patients drink now, but the sum total of what they drank in their lifetime. The true effect of alcohol on a person depends on sex, size, race and other comorbidities. Even if all physicians consistently obtained a detailed alcohol history, many patients forget, lie or underestimate how much they really drink. Ditto for cigarettes, illicit drugs, narcotics, dietary supplements or highrisk behaviors. In addition, a patient’s education, primary language, family, occupation, imprisonment, drug rehabilitation, military service, psychiatric history, any type of abuse or living conditions will affect treatment and outcome. Finally, some patients are just plain difficult for no measurable reason because they are armed with misinformation from Dr.

response Google, Dr. Pimple Popper and reality TV. How are we ever going to put all of that into the calculator?

Think twice before you rely solely on numbers spit out by calculators. Perhaps that prehistoric general surgeon was not that bad after all if he or she made decisions based on the whole patient and not just data from number crunchers. Data output is only as good as the data input, and there are probably five different calculators for everything. Use it as a guide, but not the bible. Quote it in conferences to sound smart, explain the frequency of an event, or perhaps educate

the malpractice attorney. If the estimated mortality and morbidity is high and you do not want to operate on a particular patient, you can use this to support your decision. Use it to explain things to a patient, but don’t let numbers replace common sense. After all, your eyes and ears will sometimes tell you more than the numbers indicate.

While calculators are based on large patient groups, many are based on higherlevel centers that have the ability to collect data, and this may not represent the real world. Past performance is no guarantee of future results. Use your intuition,

your calculator, your modified milk thistle calculator or your older colleague to try to get the best results for your patients.

Don’t be a slave to the data.

■ —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 CedarsSinai Medical Center, and instructor in the Cedars-Sinai colon and rectal surgical fellowship, in Los Angeles.

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Faculty Curtis Choice, MD (Chair)

Assistant Professor Department of Anesthesiology Albert Einstein College of Medicine Director, Division of Ambulatory Anesthesia Director of Anesthesiology Montefiore Hutch Ambulatory Surgery Center Clinical Director, Preoperative Services for Hutch Tower II PAT Clinic Montefiore Medical Center Bronx, New York

Michael Guertin, MD, MBA, CPE, FASA This activity is jointly provided by Postgraduate Institute for Medicine (www.pimed.com) and MedEdicus LLC. This activity is supported by an independent educational grant from Merck & Co., Inc. Distributed via Anesthesiology News and CMEZone

Director, Leadership and Business Anesthesia Fellowship Director, Faculty Leadership Institute The Ohio State University Wexner Medical Center Columbus, Ohio

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Montefiore Medical Center Bronx, New York 1.0 AMA PRA Category 1 Credit™ 1.0 ANCC contact hour (0.2 contact hour of pharmacotherapy credit)

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25

26

Resident Writing Contest The following essays are three honorable mentions from our Resident Writing Contest, and again thank you to all who participated.

TOPIC Y ou have the ability to instantly change one aspect of surgical education as it is currently implemented. What would you change and why?

Essays continue on page 28 & 30.

Specialization and Trade

By JOHN D. VOSSLER, MD, MS, MBA University of Hawaii, Honolulu

W

ith my ability to instantly change one aspect of surgical education, I would immediately implement a 3+X surgical training model in which trainees would complete a threeyear surgical foundation residency followed by an X-year surgical fellowship, where X varies by specialty.

It’s time for surgical training to more closely reflect surgical practice.

No one surgeon will do a mastectomy, a pulmonary lobectomy, a femoral popliteal bypass, a Ladd’s procedure and a Whipple procedure. Those procedures are each done by a different specialty-trained surgeon in most hospitals throughout the country. The days of the true general surgeon are dwindling to a close. Our training system should no longer make this the starting point for all surgeons. Rather, our training system should focus on creating an array of specialist surgeons who understand the nuances of working within a group of specialists. Just as specialization and trade make the economy grow, so also specialization and trade make the profession of surgery grow.

Certainly, a broad foundation of surgical knowledge and experience is essential to any surgeon. A three-year surgical foundation residency will be more than adequate to provide this foundation. It will be designed to expose trainees to all surgical specialties with the goal of establishing the fundamental principles of patient management, operative technique and professionalism. Equal emphasis will be placed on perioperative and operative experience. I envision that all trainees will complete their Fundamentals of Laparoscopic Surgery, Fundamentals of Endoscopic Surgery and other not-yet-implemented fundamental skill courses, such as Fundamentals of Open Surgery, Fundamentals of Endovascular Surgery and Fundamentals of Robotic Surgery (ideas for another writing contest, perhaps). A graduate of a surgical foundation residency will be

equipped with the skills and knowledge necessary to start training in a surgical fellowship program. The length, structure and setting of these fellowships will vary by specialty.

This is not to say that we will no longer train general surgeons. General surgeons are still a vital component of the health care system, particularly in rural and acute care settings. General surgery will itself become a subspecialty that focuses on rural and acute care general surgery. The general surgery fellowship will consist of rotations in urban and rural hospitals and will give trainees broad exposure to “bread and butter” general surgery. General surgery fellows, however, will not be trained to do advanced hepatobiliary surgery, thoracic surgery, vascular surgery, plastic surgery, or any other aspect of what would be considered the realm of other surgical specialists. They, as well as their special-

Honorable Mention

no relevance to their future practice. A 3+X surgical training model efficiently focuses the training experience of all surgical trainees. Future vascular surgeons will no longer spend months learning to resect livers, and future plastic surgeons will no longer spend months learning to resect recta.

While it is true that there is overlap between specialties, this will be accounted for by focused training within the context of one’s chosen specialty. For example, a trauma surgery fellow will need to learn to operate in the thorax, but it is false to assume that experience doing carefully planned, minimally invasive lobectomies for cancer in stable patients extrapolates in any meaningful way to an emergency anterolateral thoracotomy for control of thoracic hemorrhage in an unstable patient. It doesn’t.

Those are two completely different patients, problems, settings and procedures. The trauma surgery fellow needs experience with one and not the other.

Perhaps more valuable than the effect

Open abdominal aortic aneurysm cases will no longer be wasted on future breast surgeons, and redo paraesophageal hernia repairs will no longer be wasted on future colorectal surgeons. … We should make every effort to ensure that the educational value of each clinical experience is used for the greatest good. ist counterparts, will be trained to identify patients who should be referred to another surgical specialist and the urgency with which to do so. This will provide a training experience saturated with the surgical problems that the fellowship-trained general surgeon will spend the rest of their career treating without overexposure to problems that they will rarely, if ever, treat.

An aspiring thoracic surgeon does not need advanced training in trauma surgery, and an aspiring trauma surgeon does not need advanced training in thoracic surgery. Yet, under the current training model, both trainees spend a significant amount of time throughout the course of a five-year general surgery residency doing things that have little to

that the 3+X training model will have at the individual level is the effect that it will have at the health care–system level.

Open abdominal aortic aneurysm cases will no longer be wasted on future breast surgeons, and redo paraesophageal hernia repairs will no longer be wasted on future colorectal surgeons. Clinical experience is a valuable and limited resource.

We should make every effort to ensure that the educational value of each clinical experience is used for the greatest good. Every laparoscopic adrenalectomy should go to a rising endocrine surgeon, and every Whipple should go to a rising hepatobiliary or oncologic surgeon. The current mis-/underutilization of these clinical experiences is a large opportunity for improvement.

The 3+X training model will also enhance our ability to select the right people for surgical training. Our current system does a poor job of identifying people who are ill-suited to be surgeons, whether it be for personality, intelligence or dexterity reasons. A few months as a third- or fourth-year medical student on a surgery clerkship is not enough exposure for the student to know they want to be a surgeon, or for program directors to know if a student is the right fit for a career in surgery. Three years as a surgical foundation resident will be more than enough time to make these assessments.

Now this begs the question: What will be done with the trainees who finish a three-year surgical foundation residency but do not progress to a surgical fellowship? I would also create a new boarded specialty called surgical medicine for which graduates of a surgical foundation residency will be eligible. A surgical medicine–boarded physician will be an independent surgical hospitalist who functions in much the same way that an internal medicine–trained hospitalist functions with the added ability to do simple bedside procedures such as incision/drainage, lines, chest tubes and so on. They could also function in a similar fashion to advanced practice providers by doing things such as first-assisting in the OR, seeing surgical patients in the clinic, and triaging surgical consults in the ER. In addition to enhancing our ability to select the next generation of surgeons and creating a valuable new specialty, this will also be a more empathetic way of handling those who simply aren’t meant to be surgeons. These people will be able to obtain from their training a valuable board certification that they can use as a stand-alone career or as the basis for continued experience treating surgical patients while they wait for an opportunity to reapply for surgical fellowship.

The future of everything is specialization and trade. Surgery is no exception.

A 3+X surgical training model will optimize the training of surgical specialists, including general surgeons, while also creating surgeons who understand the nuances of working within a system of surgical specialization and trade.

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RESIDENT WRITING CONTEST

APRIL 2020 / GENERAL SURGERY NEWS

The Stagnancy of ABSITE A Resident’s Glimpse Into Opportunity for Change

By MARIA BAIMAS-GEORGE, MD, MPH Atrium Health’s Carolinas Medical Center, Charlotte, N.C.

H

ow to create a surgeon? A question that has been thrown about, mulled over and debated for decades. A question that sets fire under our historical counterparts, as the importance of work hours on technical skills and overall aptitude is ferociously deliberated; that raises protracted arguments on raw talent versus practice or on competence versus excellence.

There is no unanimous way to create a surgeon, no tight consensus on the appropriate technique to assist in the metamorphosis of an awkward intern into a slick surgical master in the short half decade allotted. As such, the education regimens across the country and world differ as dramatically as the clinical opinions of our superiors at morbidity and mortality conferences. Medical students touring eagerly use this wide range of curricula that shift hierarchy from simulation to early OR exposure and to autonomy for help with match ranking, all the while not realizing there is no magic formula. There is no program that has calculated the equation to surgical perfection; no instantaneous way to improve the search for an archetypal curriculum. Except what if there was?

Imagine being able to instantly change an aspect of education with a flick of your so-called wand, or with a tip of your surgical cap, to exactly what you wish it to be. As a resident only in my third year, I have barely seen a glimpse of the world into which I will soon be thrust. Residency is the tip of the iceberg of our profession that draws you in and sucks you down, quite willingly, into dark depths of wonder. So, it is with considerable awareness of my own constraints that I pitch forth my two cents—or perhaps, more appropriately, two desolating cranks of a Finochietto retractor—on this topic.

becomes a subsidiary to the exam, unable to independently thrive and blossom spontaneously. Our expert lectures focus on bullet points from a national website rather than innovative techniques that our attendings may actually be practicing. Now, do not misunderstand, it is imperative to know the basics and history of our craft. But allotting time to discuss the constantly shifting and creative art that we all love, without instigating anxiety that with each minute we are losing exam points, is paramount.

Having undergone multiple past iterations, the ABSITE is back to being a singular exam; the same test is taken by the intern, nonphysician and senior residents. Imagine expecting an intern to do the same amount of an esophagectomy as a chief resident. It is laughable. And yet, we expect an intern to take the same test as a chief. The rebuttal will of course cite the adjustment of percentile across class. Valid, yes, but shouldn’t an intern be studying concepts appropriate for their real-world experience—an added, and arguably, more important benefit than improving an in-service exam score? And wouldn’t a more appropriately leveled test improve confidence and conviction rather than popping an intern’s often already quite deflated balloon of emotions that may be quite close to eddying out to sea amidst burnout, demoralization and depression?

Now there are a plethora of data on the ABSITE. Look up “ABSITE and surgery” on PubMed, and you’re met with more than 130 papers. Most of these explore correlations between scores and different study regimens or resources. More importantly, however, this literature shows a correlation between ABSITE scores and a successful first attempt at the written boards—a crucial, legitimate finding. But above what percentile? It is quite implausible and almost preposterous. It’s only 30%. Thirty percent! Was there ever a time when a surgical resident aimed for 30%?

Think back. Was your goal in organic chemistry at least a 30%? Did you hope to be at least better than 30% of your soccer team, or hope to identify at least 30% of your cadaver’s anatomy? The resounding answer to all these is a loud and likely “no,” because we surgical residents aim for perfection.

We strive for a flawlessness in all

Honorable Mention

Standardized tests are, in general, widely applicable and germane. But I think we can do better because excelling at surgery is far from equivalent to excelling at a standardized test.

If I could change one thing, one singular aspect of my training education, it would be to amend the annual standardized testing known as the American Board of Surgery In-Training Examination (ABSITE). Now, I have nothing against tests. They have served me well, encouraged study habits, and helped to homogeneously rank competence between colleagues to allow for appropriate promotion. Standardized tests are, in general, widely applicable and germane. But I think we can do better because excelling at surgery is far from equivalent to excelling at a standardized test.

For those who have happily forgotten, the ABSITE is a 250 multiple-choice examination that forces surgical curricula into focusing primarily on test preparation.

Our educational structure that is supposed to answer that age-old question of how to create a surgeon instead

we do. None of us will never say, “Well, as long as I don’t cut the common duct 30% of the time.” So, the ABSITE should reflect that. Currently, it’s a bit behind the times.

In fact, in tune with this resident’s assessment, the ABS has unveiled a new recertification process to replace its prior “ABSITE-esque” exam. Previously, surgeons took a 250-question standardized test every decade.

With resounding applause from most faculty I know, this exam was supplanted by a 40-question, open book test, of which 20 questions are practice specific. A two-week period is allowed for completion, and immediate feedback is provided with opportunity to answer a question correctly twice. This is a highly relevant, focused and easily accessible process for surgeons to recertify. Instead of having a hepatobiliary surgeon answer questions about women’s breast health, they can focus on their prized right upper quadrant, appropriately. Instead of trying to remember and learn from a test after answering 250 questions without feedback, you can see your error and give it another go—like real life. Instead of having to memorize the pharmacology of vincristine, the open book fashion mimics an Epocrates reality.

In summary, if I could change one thing about surgical education today, it would be to modify our annual in-service exam for in this ever-changing educational paradigm; the ABSITE has sadly remained stagnant and static. While taking a test will never assess personality, performance under pressure, or influence reportable quality or patient-centered outcomes, modifications can serve to improve its quality and function. I would suggest a different exam for each class year. (Let the interns ponder the critical view of safety and the chiefs deliberate a gallbladder carcinoma nodal dissection.) I would endorse a restructuring of the bell curve such that a three-question difference does not reflect a 20% change in score. Perhaps, with that, the aim for 30% or above may shift and hopefully reflect a more appropriate and realistic number for us perfectionists. It would provide instant feedback. Wouldn’t it be nice to learn from the test for which we constantly study? And in doing all this, perhaps we shift the thinking of testing in the era of the modern surgeon such that the written and oral boards start to undergo transformations as well. But alas, that is a topic for another day and time.

■

Coming Next Month We continue to highlight honorable mention essays from our Resident Writing Contest.

Please send comments about the essays to khorty@mcmahonmed.com.

27

RESIDENT WRITING CONTEST

GENERAL SURGERY NEWS / APRIL 2020

From a Time-Based to Merit-Based System: The Training of a 2020 Surgeon

By KRISTEN JOGERST, MD, MPH, The Massachusetts General Hospital, Boston, and The Mayo Clnic, Arizona

Dear Fellow Surgical Trainee,

W

hat would you say if tomorrow we could instantly transport you to a program that allowed you to progress through residency based on the quality of your performance, rather than continuing along in your uniform training program lasting five years? As you complete performance metrics, you will transition from intern to junior to chief resident and then graduate with “boardeligible” status to become adjunct faculty.

Does completing general surgery training in four years instead of five sound appealing? This stepwise progression would be based on your ability to complete level-appropriate, clearly described entrustable professional activities or (EPAs).1 As you complete EPAs and your clinical responsibilities increase, you will receive modest raises instead of waiting for your small salary increase just once per year. You would be able to initiate EPA assessments by scheduling performance reviews with your program’s expert faculty. For instance, once faculty assessed your ability to admit, work up and surgically treat a patient with cholecystitis, and they trusted you as a professional to independently manage cholecystitis, your perioperative and operative cholecystitis EPAs would be complete. In addition, a selection of your videotaped operative cases and mini oral board–style simulated case scenarios would be sent to an external expert review panel. This would ensure program adherence to the local EPA assessments.

After successful completion of all the pre-outlined EPAs and associated surgical cases, you would become board eligible. If this occurred before the traditional five-year general surgery time line, you would be hired locally as adjunct faculty, with associated faculty salary and operating privileges. If you needed more time to learn a certain skill set or acquire knowledge of certain procedures or perioperative care pathways beyond the traditional five-year time line, the program would accommodate it accordingly.

This 2020 general surgery program with merit-based progression might sound farfetched compared with your current general surgery model of time-based training and promotion, but it is not. It is simply proposing one change in surgical education: transitioning from time-based training to a merit-based system. This system

is based on well-accepted educational principles and the understanding that different learners progress along different Ebbinghaus learning curves. Evidence has demonstrated that learners acquire skills and knowledge at different rates (Figure).2,3 This system also uses context-specific assessments, understanding some trainees have difficulty with the transition from factual memorization to clinical context–specific learning and performance.4-6 Such a system might sound too grandiose to implement in 2020, but that has been disproved by our Canadian surgical colleagues.7 Perhaps you are concerned about how your program will provide an adjunct faculty salary if you complete all EPAs and are boardeligible prior to the allotted five-year training time. We can reassure you the extra case volume and RVUs [relative

Honorable Mention

direct care while studying and practicing technical skill training? This is an important concern and must be addressed for the merit-based system to succeed. Nurses and advanced practice providers will work alongside you in this team-based model to help with patient care responsibilities, paperwork and complex system issues to address the education and service balance. In understanding that learning is a collaborative and social process, this will teach you valuable health care teamwork principles.8,9 An interdisciplinary collaboration EPA will be included in your assessments. In addition, these team members will gain recognition and pride knowing they are contributing to training the next generation of entrustable general surgeons.

I am sure there are several aspects of general surgery training you would like to change. Perhaps you want a better balance between the division of learning and the need to complete noneducational service. Perhaps you are concerned about

Fellow trainee, I hope you will join me in advocating for this merit-based system. I hope you embrace the challenge of resident-initiated assessments and the operative autonomy that comes with your future adjunct faculty position.

Targeted Skill Threshold Skill Acquisition

28

Trainee 1 Trainee 2 Trainee 3

Time

Figure. Example Ebbinghaus Learning Curves of surgical trainees' skill acquistion over time. Notice how Trainees 1,2, and 3 eventually all meet the hypothetical targeted skill level (green dotted line), but they reach this trageted metric at different times.

value units] you will bring in as adjunct faculty and the improved OR efficiency your proficient skill set will provide will ensure the chief financial officer’s bottom line remains in the black. The extra patient volume will cover the salary costs of adjunct faculty positions.

As a trainee, you might worry about balancing patient care responsibilities with preparation for the merit-based performance reviews. How will all of the everyday, noneducational activities get completed if residents are away from

autonomy in the OR. Perhaps you perceive unfairness in how formative assessments of trainees are completed. Perhaps you have concerns about proper preparation for summative assessments at the end of residency, such as passing your oral or written boards. Perhaps your program has struggled in the past with a trainee who required probation or even was asked to leave surgery. Perhaps you wonder how we can improve attrition rates nationally so that 20% of all trainees who start out in general surgery do

not leave for a different medical career, amid the growing general surgeon shortage.10,11 Perhaps you are concerned about the need for fellowship or the inability to be ready for independent general surgery practice when you finish.12 The beauty of this one change—transitioning from time-based to merit-based, traineespecific progression—is that it addresses many of these concerns. As our program is held accountable through external expert validation of the EPA assessments, our trainees’ time for skill and knowledge acquisition in addition to nontechnical skill development will be prioritized over noneducational service–related activities.

In turn, each member of the health care team will be held to a higher standard, and patients—the center of the health care team—will receive better care.

Since Halsted’s 1904 address on “The Training of a Surgeon,” surgical educators have argued the time line of general surgery training is too short, and we must use ingenuity to prepare a competent future workforce.13 As the required skill set and knowledge needed to become an entrustable general surgeon continues to expand, I do not think surgical education ingenuity has kept pace. During this time, general surgery has evolved to incorporate minimally invasive techniques of laparoscopy and robotics; rounds have transitioned from reviewing the paper chart at the patient’s bedside to sifting through hundreds of data points in front of a computer; medical and surgical knowledge have grown exponentially, as has the field of medical education.

It is wishful thinking to expect that prior training paradigms will produce trainees ready to operate in a completely different landscape. Medical schools have realized this need for training changes amidst the changing landscape and implemented 13 core EPAs for graduating medical students in 2014.14 It is time for graduate medical education, including general surgery training, to follow suit.

Fellow trainee, I hope you will join me in advocating for this merit-based system. I hope you embrace the challenge of resident-initiated assessments and the operative autonomy that comes with your future adjunct faculty position. Should you take longer than five years to complete the training program, I appreciate your steadfast dedication to becoming a truly entrustable general surgeon and hope that these context-specific objective assessments keep you and your colleagues motivated and deter you from continued on page 30

APRIL 2020 / GENERAL SURGERY NEWS

SECTION 29 CLASSIFIEDS CLASSIFIEDS 29 29

APRIL APRIL 2020 2020

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The incoming Chief of Surgery will have oversight of the delivery of care by CHA’s general surgery and subspecialized surgical services across two hospital campuses in Cambridge and Everett, MA. Incoming Chief will also provide clinical and administrative leadership for our existing surgical teams, which are comprised of more than 20 surgeons and 20 surgical physician assistants.

Ideal candidates will have at least 5 years of progressive leadership experience including a successful track record of recruitment, retention, professional development and mentoring of junior staff, medical students and residents. Demonstrated ability to implement department wide protocols, identify clinical process improvement areas and opportunities for quality initiatives are essential.

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Qualified candidates may apply confidentially at www.chaproviders.org. Alternately, CV and cover letter may be confidentially submitted for consideration via email to ProviderRecruitment@challiance.org. CHA’s Department of Provider Recruitment may be reached by phone at (617) 665-3555 or by fax at (617) 665-3553.

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CLASSIFIED Page 29

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30

RESIDENT WRITING CONTEST

GENERAL SURGERY NEWS / APRIL 2020

Change in Paradigm for Change in Time

By CLAUDEN LOUIS, MD University of Rochester, Rochester, N.Y.

B

ecoming credentialed and becoming successful may require different skill sets after surgical training. Concern remains that current models of surgical training may not be optimized to meet these expectations as currently implemented. Surgical education at the highest level should prepare trainees to have the competency and skills to not only meet expectations, but to adapt.

Residency need not be a race of annual examination, but a strategic component of adult education that taken in all its parts, provides a complete product after training.

The current measures of objective testing for surgical trainees cover content both relevant and obsolete to further stratify examinees. The annual examination measures knowledge but does not correlate with technical skill or operative performance.1,2 When used appropriately, objective testing may allow programs to proactively intervene on behalf of low-performing residents to give them a greater chance for success.3 In contradistinction to the original intentions, objective testing in surgical education is used to promote, defer, suppress and restrain, as opposed to rehabilitate.

graduated responsibility and planned attrition, rendering trainees vulnerable to years of training with no end in sight.

Although this pyramid no longer exists in its truest form, and resident work hours have become a major concern regarding safety measures, only a few additional changes have been made over time in the educational aspect of surgical training. The length of general surgery training has remained at five to eight years despite the need of many institutions requiring subspecialty-trained practitioners. The number of general surgeons performing complex foregut, carotid surgery and oncologic surgery has decreased. As surgical technique and technological advances continue, there are some who point to overlapping practitioners with specialty training as the reason why the general surgeon of old no longer exists. The general surgery resident of today is not like the general surgery resident of old given the breadth of subspecialty programs, such as ENT, ortho, plastic, cardiac, vascular and neurosurgery, which have direct training routes, some of which are no longer attainable after general surgery training.

The attrition exists because many institutions require residents to not only complete five categorical years of training, but some also require one to three years of research prior to being considered for fellowship.

Surgical attrition in the general surgery programs has increased to 20%, according to several studies.4,5 Training length has been cited as one of several reasons for surgical attrition. One can learn from the training models of orthopedic surgery, neurologic surgery, integrated vascular surgery and integrated cardiothoracic surgery.

These subspecialty training programs recruit from medical schools and provide the trainee with an increased service time and exposure to their definitive specialty of practice, with no requirement of being board certified in foundational training specialty. Should one plan on a career in general surgery, a consideration can be made for this individual to continue a fifth year for general surgery boards, but four years of general surgery prior to additional training may provide resolution.

We should refrain from using archaic educational models to train future leaders in this specialty. The current training models have led to attrition and burnout. To improve surgical training, we must consider cessation of the current five-year training model for the future subspecialist whose time in fellowship is much shorter in comparison to that of residency.

Honorable Mention

We should refrain from using archaic educational models to train future leaders in this specialty. … To improve surgical training, we must consider cessation of the current five-year training model for the future subspecialist whose time in fellowship is much shorter in comparison to that of residency.

Based on the current implementation, surgical testing needs restructuring, but this concern is merely a symptom of a larger problem. Surgical training has not evolved to fit what is required for the modern-day resident. William Halsted established graduate medical training for surgeons based on previous international systems of training. At Johns Hopkins, this surgical training modality required residents to be residential inhabitants of their training institutions such.

This same model promulgates pyramidal systems of

Surgeon Training continued from page 28

switching into a nonsurgical career. We look forward to watching you progress along your future Ebbinghaus General Surgery Learning Curve and are hopeful that your training will fill the need for the 2020 entrustable general surgery resident.

Sincerely, Your Fellow Trainee An Advocate for the 21st Century Merit-Based General Surgery Training Program ■

References 1. Ten Cate O. Entrustability of professional activities and competency-bases training. Med Educat.

2005;39:1176-1177.

As general surgery remains the major pathway to a multitude of subspecialties, many programs have limited several service rotations, thus reducing exposure for the very specialties general surgery currently is gatekeeper to. Many residents leave general surgery having rotated on cardiac surgery services, leaving them with little to no exposure.

Leaders must be cognizant of the goals of the fellowship surgeon, as no randomized controlled trial establishes a set number of gallbladder removals to increase the competency of the future cardiac surgeon operating on the beating heart; yet five years, excluding research, are dedicated to the foundation of surgery training and general surgery boarding with only two years to gain mastery in one’s definitive career, which may have been unequally represented in residency.

Out of necessity, other pathways continue to be formed but remain roads less traveled. The official 4-3 program as documented by thoracic surgery training does not formally exist in other specialties. The 4-3 program allows for an internal applicant in general surgery to begin thoracic surgery as a PGY-5 and complete it as a PGY-7.

This paradigm of surgical training maintains board specialization in general surgery while also offering the flexibility of increasing time on planned specialization. In the absence of these opportunities, some surgical graduates continue to be unprepared for practice and seek additional subsequent fellowships to accomplish what could not be done within the formal training period.

The time is now for surgical education retooling with a focus on becoming trainee-oriented. This solution, when implemented, will align the goals of both the trainees and trainers. Previous methods of training surgeons may be less efficient in today’s time given the changes in health care, changes in trainees, and advances in technological innovation.

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References

1. Krishnamurthy S, Satish U, Foster T, et al. Components of critical decision making and ABSITE assessment: toward a more comprehensive evaluation. J Grad Med Educ. 2009;1(2): 273-277.

2. Scott DJ, Valentine RJ, Jones DB. Evaluating surgical competency with the American Board of Surgery In-Training Examination, skill testing, and intraoperative assessment. Surgery.

2000;128(4):613-622.

3. Yost MJ, Gardner J, Bell RM, et al. Predicting academic performance in surgical training. J Surg Educ. 2015;72(3):491-499.

4. Yeo H, Bucholz E, Ann Sosa J. A national study of attrition in general surgery training: which residents leave and where do they go?

Ann Surg. 2010;252(3):529-536.

5. Freischlag JA, Silva MM. Preventing general surgery residency attrition—it is all about the mentoring. JAMA Surg.

2017;152(3):272-273.

6. Durning SJ, Artino Jr AR, Schuwirth L, van der Vleuten C. Clarifying assumptions to enhance our understanding and assessment of clinical reasoning. Acad Med. 2013;88(4):442-448.

2. Wozniak RH. Introduction to memory: Hermann Ebbinghaus (1885/1913). Classics in the history of psychology. 1999.

7. Nousiainen MT, Mironova P, Hynes M, et al.

Eight-year outcomes of a competency-based residency training program in orthopedic surgery.

Medical teacher. 2018;40(10):1042-1054.

3. Grange P, Mulla M. Learning the “learning curve.” Surgery. 2015;157(1):8-9.

8. Lave JW, E. Situated Learning: Legitimate Peripheral Participation. Cambridge University Press; 1991.

4. Durning S, Artino Jr AR, Pangaro L, el al. Context and clinical reasoning: understanding the perspective of the expert’s voice. Med Educat.

2011;45(9):927-938.

5. Durning SJ, Artino AR, Boulet JR, et al. The impact of selected contextual factors on experts’ clinical reasoning performance (does context impact clinical reasoning performance in experts?). Adv Health Sci Educ. 2012;17(1):65-79.

9. Wenger E. Communities of Practice: Learning, Meaning, and Identity. Cambridge: Cambridge University Press; 1998.

10. Williams TE, Ellison EC. Population analysis predicts a future critical shortage of general surgeons. Surgery. 2008;144(4):548-556.

11. Yeo H, Bucholz E, Ann Sosa J, et al. A National

Study of Attrition in General Surgery Training: Which Residents Leave and Where Do They Go? Ann Surg. 2010;252(3):529-536.

12. Mattar SG, Alseidi AA, Jones DB, et al. General Surgery Residency Inadequately Prepares Trainees for Fellowship: Results of a Survey of Fellowship Program Directors. Ann Surg.

2013;258(3):440-449.

13. The Training of the Surgeon. Journal of the American Medical Association.

1904;XLIII(21):1553-1554.

14. Lomis K, Amiel JM, Ryan MS, et al. Implementing an Entrustable Professional Activities Framework in Undergraduate Medical Education: Early Lessons From the AAMC Core Entrustable Professional Activities for Entering Residency Pilot. Academic Medicine.

2017;92(6):765-770.

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1. Gagner M, Buchwald JN. Comparison of laparoscopic sleeve gastrectomy leak rates in four staple-line reinforcement options: a systematic review. Surgery for Obesity & Related Diseases 2014;10(4):713-723. 2. Gagner M, Brown M. Update on sleeve gastrectomy leak rate with the use of reinforcement. Obesity Surgery 2016;26(1):146-150. 3. W. L. Gore & Associates, Inc. Clinical Performance with Staple Line Reinforcement Scientific Literature Analysis (n = 4689 patients). Flagstaff, AZ: W. L. Gore & Associates, Inc; 2019. [Brochure]. AP6010-EN3. 4. Zambelli-Weiner A, Brooks E, Brolin R, Bour ES. Total charges for postoperative leak following laparoscopic sleeve gastrectomy. Presented at Obesity Week 2013: The American Society for Metabolic and Bariatric Surgery and the Obesity Society Joint Annual Scientific Meeting; November 11-16, 2013; Atlanta, GA. A-305-P. See Instructions for Use and goremedical.com for complete information. Products listed may not be available in all markets. GORE, Together improving life, SEAMGUARD and designs are trademarks of W. L. Gore & Associates. © 2019 W. L. Gore & Associates, Inc. AY1461-EN1 October 2019

A Supplement to

1

Should Specialty-Specific Surgery In Urban Areas Only Be Performed

By Fellowship-Trained Surgeons?

This month’s debate focuses on an opinion that may influence the way surgeons practice their trade in the future. It basically questions who should treat patients and how surgeons should be certified as qualified to treat those patients. The question to be debated is: Should specialtyspecific surgery in urban areas only be performed by fellowship-trained surgeons?

The debaters this month have very different opinions, and both support their opinions with data. How you will respond to this debate may be influenced by your own history as a surgeon.

Whether you are an older surgeon and were trained before fellowship pathways, recently trained and opted for fellowship training or not, or are in the midst of your training and deciding if fellowship is necessary, not only will you have an opinion, but patients, hospitals and institutions (government and insurance companies) that fund the surgery may have an opinion and actually control who performs specialty-specific surgery in the future.

At first glance, this month’s topic may not seem to be the most exciting one we’ve covered, but in terms of the future, it is as important as anything we have previously debated. The conclusions we come to as surgeons may not only affect the future of surgery but determine what our friends, the lawyers, consider standard of care.

So, I encourage you to read this debate carefully, come to a reasonable conclusion, and help guide what pathways we choose for the specialty that we call general surgery. If you don’t become involved, others will be making the critical decisions about the direction general surgery will take in the future, and we know that in the past this has not always worked out well.

Edward L. Felix, MD General Surgeon Pismo Beach, Calif.

Yes—Specialty-Specific Surgery Should Be Performed Exclusively by Fellowship-Trained Surgeons

Meredith Duke, MD, MBA Assistant Professor, Division of General Surgery, Vanderbilt University Medical Center, Nashville, Tenn.

M

any of my esteemed colleagues and staff in training opine about the glory days when they would confidently and competently perform Whipples, abdominal aortic aneurysm repairs and the first laparoscopic cholecystectomy at their institution, … looking through the scope … with OB-GYN instruments … by candlelight. My question to you today is, would you prefer your surgeon to be a jack-of-all-trades or a master of one?

The American Board of Surgery made the task of supporting my argument straightforward by defining general surgery as “a discipline

that requires knowledge of and responsibility for [patients] with a broad spectrum of diseases.” It goes on to state that “comprehensive knowledge and management of conditions in these areas generally requires additional training: vascular surgery, pediatric surgery, thoracic surgery, burns, solid-organ transplantation.”1 It is important to have broad exposure during training, although definitive treatment is best provided by specialists. In urban areas where access and travel are not barriers, specialty-specific surgery should only be performed by fellowship-trained surgeons. 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 The ACP used in clinical trials included:

Early diet advancement

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

20

144

HOURS FASTER

120

14 HOURS

26

HOURS FASTER

FASTER

Study 2 ENTEREG (n=160) Placebo (n=142) HR=1.6 (CI, 1.3–2.1)

Study 3 ENTEREG (n=139) Placebo (n=142) HR=1.4 (CI, 1.1–1.8)

Cystectomy Study

32

13

HOURS FASTER

HOURS FASTER

11

Placebo

HOURS FASTER

ENTEREG

96 72 48 24 0

Study 1 ENTEREG (n=317) Placebo (n=312) HR=1.5 (CI, 1.3–1.8)

Study 4 ENTEREG (n=98) Placebo (n=99) HR=1.4 (CI, 1.0–1.9)

Study 5 ENTEREG (n=239) Placebo (n=229) HR=1.3 (CI, 1.1–1.6)

Study 6 ENTEREG (n=143) Placebo (n=134) HR=1.8 (CI, 1.4–2.3)

HR=hazard ratio CI=95% confidence interval

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

a

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 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.

a

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.

Copyright © 2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.All rights reserved.

US-ENT-00235 02/20 entereg.com

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

Copyright © 2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. US-ENT-00235 02/20

GREAT DEBATES

APRIL 2020 / GENERAL SURGERY NEWS

continued from page 1

The shifting trend toward specialty training is a classic example of the law of supply and demand. Patients want specialists providing their surgical care. Up to 80% of recent graduates are choosing to pursue fellowship training, demonstrating that the next generation of surgeons believes specialization is a necessity.2 Yeo and colleagues found that 55% of residents surveyed supported the statement, “the modern general surgeon must become specialty trained in order to be successful.”3 What defines “successful”? Safe? Competent? Competitive? Marketable? It is likely a combination of all of the above. In addition, patients have a desire to be treated at centers of excellence by high-volume surgeons. This desire is driven by the vast amount of literature documenting the inverse relationship between hospital and surgeon volume with patient morbidity and mortality. For decades, multiple specialties and societies have demonstrated that hospital and surgical volume positively correlate with improved morbidity, mortality, readmissions and length of stay, particularly in complex cases.4,5 This has been reproduced in multiple specialties ranging from cardiac and vascular, to hepatopancreaticobiliary, bariatric, esophageal and even emergency general surgery procedures.6-11 Schneider et al demonstrated a potential 20% to 30% reduction in morbidity and mortality and an 8% reduction in hospital patientdays by shifting patient care from intermediate and low-volume centers to high-volume ones.12 Avoiding complications by shifting care to high-volume specialists in urban centers is safer, more cost-effective, and the right thing to do for optimal patient care.

There’s a constant buzz regarding adequate training in the era of the 80-hour workweek. This issue is magnified in light of the massive expansion of basic medical knowledge and technological innovation. It is estimated that the doubling time of medical information in 1950 was 50 years, which dropped to seven years in 1980, 3.5 years in 2010, and is projected to be 0.2 years or 73 days this year. Densen aptly demonstrated in his 2010 paper, “Challenges and Opportunities Facing Medical Education,” the clinical implications of medical doubling time.

A surgical resident who started training in 2010 and completes seven years of training will experience three doublings of knowledge. What was learned in the first three years of school or training will be just 6% of what is known at the end of the decade 2010-2020.13 Without specialization, it is practically impossible to provide current, data-driven care across a broad array of surgical diseases.

Achalasia is an excellent example of the necessity and advantage of specialization. Slightly more than 100 years ago, Ernest Heller documented performing the first extramucosal esophageal myotomy for achalasia.14

The diagnosis was made through clinical history and radiographic examination. Today the diagnosis is made utilizing a variety of modalities, including clinical history, endoscopy with or without catheter-based impedance planimetry, radiology, and manometry. The disease can be treated medically, endoscopically and surgically.

Medical management includes nitrates and calcium channel blockers. Endoscopic treatment options include balloon dilation, Botox (onabotulinumtoxinA, Allergan) injections or peroral endoscopic myotomy. Surgical approaches include open, laparoscopic or robotic Heller myotomy. The disease hasn’t changed, but the diagnosis, pharmacology and procedural therapy is constantly evolving. A patient deserves a foregut specialist who has a standardized treatment algorithm, knowledge of current literature and reproducible surgical outcomes. This is in comparison to a generalist who might perform a single myotomy every few years. Just because you can doesn’t mean you should.

The primary concern of all health care delivery models should first and foremost be patient safety. Specialty surgeons at high-volume centers have demonstrated improved patient outcomes, and these outcomes translate to cost savings for patients, hospitals and the entire health care system. Most residents are electing to pursue specialty fellowship training, making access to specialists in urban areas a nonissue. The only way to maintain and improve patient care in the era of unprecedented medical information growth is narrowing the focus. All signs point to yes, specialty-specific surgery in urban areas should only be performed by fellowship-trained surgeons.

References 1.

2.

3.

4.

5.

6.

7.

8.

9.

American Board of Surgery. www.absurgery.org/default. jsp?aboutsurgerydefined.

Coleman JJ, Esposito TJ, Rozycki GS, et al. J Am Coll Surg.

2013;216(4):764-771.

Yeo H, Viola K, Berg D, et al. JAMA. 2009;302(12):1301-1308.

Dudley RA, Johansen KL, Brand R, et al. JAMA. 2000;283(9):1159-1166.

Luft HS, Bunker JP, Enthoven AC. N Engl J Med. 1979;301(25):1364-1369.

Vemulapalli S, Carroll JD, Mack MJ, et al. N Engl J Med. 2019;380(26):2541-2550.

Nathan H, Cameron JL, Choti, MA, et al. J Am Coll Surg.

2009;208(4):528-538.

Nimptsch U, Haist T, Krautz C, et al. Dtsch Arztebl Int. 2018;115(47):793-800.

Markar SR, Karthikesalingam A, Thrumurthy S, et al. J Gastrointest Surg.

2012;16(5):1055-1063.

10. Zevin B, Aggarwal R, Grantcharov TP. Ann Surg. 2012;256(1):60-71.

11. Santry H, Kao LS, Shafi S, et al. Trauma Surg Acute Care Open.

2019;4e000318.

12. Schneider EB, Ejaz A, Spolverato G, et al. J Gastrointest Surg.

2014;18(12):2105-2115.

13. Densen P. Trans Am Clin Climatol Assoc. 2011;122:48-58.

14. Heller E. Mitt Grenzgeb Med Chir. 1914;27:141-149.

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GREAT DEBATES

GENERAL SURGERY NEWS / APRIL 2020

No— Specialty-Specific Surgery Should Not Be Performed Exclusively by Fellowship-Trained Surgeons An initial problem with the idea that specialty-specific surgery in urban areas should only be performed by fellowshiptrained surgeons is the suggestion that Robert a surgeon’s location should affect the Stovall, MD qualifications required to do a proceGeneral Surgeon, Kaiser dure. Patients in nonurban areas both Permanente, Denver desire and deserve qualified surgeons as much as urban patients. If a surgeon has the appropriate training and experience, the surgeon should be able to perform the procedure whether in an urban area or not. Conversely, if a surgeon is not trained, whether by residency or fellowship, for a particular surgery, then as a rule they should not perform that surgery inside or outside of a city. Fellowship training may help with gaining larger market share in an urban area, but where a surgeon happens to be working now doesn’t change the adequacy of training already received.

Another problem with the proposition being debated is there is no distinct or well-defined category of “specialty.” What constitutes specialty surgery depends on who you ask and remains subjective. No surgeon spends years in training and does not consider himself or herself a specialist, even if other surgeons may disagree. For example, although general surgeons are specialists, a simplistic notion of general surgery is often used as a foil to promote a supposedly “better” specialty option. If there is no clear definition of what specialty surgery is, and it may include any surgery, then arguing that specialty surgery should only be performed by fellowship-trained surgeons is tantamount to arguing that all surgery should be performed by fellowship-trained surgeons. While some may argue this very point because they believe that residency training is inadequate, this opinion denies the capability of the many residency-, and not fellowship-trained, surgeons, both new and old, currently practicing what many would consider specialty-specific surgery with excellent outcomes.

A further difficulty with the proposal under consideration is that restricting surgery to fellowship-trained surgeons assumes that fellowship training is the only way to acquire appropriate training. There is no evidence, however, that training acquired in a fellowship is better than that gained in a residency or through the ongoing skills acquisition that must occur throughout a surgeon’s career. All would agree that surgeons should have appropriate training, but agreement on exactly what appropriate training is and how it is obtained evolves over time.

For example, most would agree that only a neurosurgeon

has the appropriate training to remove brain tumors and an orthopedic or general surgeon does not. In contrast, consensus on what constitutes appropriate training for various operations within the realm of general surgery may not exist. Thyroid surgery is one relevant example.

Many argue that appropriate training for thyroid surgery can be gained in a residency in either general surgery or ENT. Others, however, argue that to be trained to perform thyroid surgery a fellowship is necessary, perhaps a fellowship in endocrine surgery or possibly in head and neck cancer surgery. This one example demonstrates how there may be multiple, overlapping pathways to competency for a given surgery.

In this and other similar examples, if surgery were limited to only fellowship-trained surgeons regardless of the quality of their training and experience, the residency-trained surgeons would be excluded, and patient access to qualified surgeons would diminish.

Also, the assumption that fellowship training is the only way to acquire appropriate training disregards the new knowledge and skills that are acquired throughout a surgeon’s career. With the rapidly changing nature of the practice of medicine today, we cannot limit a surgeon’s training or practice only to what is learned during the formal training years, whether residency or fellowship.

New techniques, new information, new fellowships and other innovations are being developed regularly. Surgeons must be able to adapt to changing techniques as well as to adopt new procedures.

If we were to restrict procedures only to those with fellowship training, then surgeons who acquire new skills and knowledge during their careers would be kept from changing their practice with the evolution of medicine. Robotic surgery is a recent example of this: Many surgeons performing excellent robotic procedures learned these skills many years after completing a residency or fellowship. If a broad consensus exists on what constitutes appropriate training for a given surgery, particular pathways can be agreed upon to guide who performs a given surgery. For many operations, however, there is no such consensus.

Appropriate training is a necessity, in any setting and for any surgery, but the title of where appropriate training is acquired is of little consequence compared with the quality of the care given after the training is complete. “Specialty-specific” surgery in urban areas should not be restricted to fellowship-trained surgeons. Surgery should be performed by well-trained surgeons, irrespective of whether that training was acquired in a fellowship and regardless of where the surgeon is practicing.

GREAT DEBATES

APRIL 2020 / GENERAL SURGERY NEWS

Dr. Duke’s Rebuttal to Dr. Stovall Many of the points Dr. Stovall makes in his argument are well taken. Unfortunately, they don’t summate to support the stance that specialty-specific surgery in urban areas does not need to be performed by fellowship-trained surgeons. All patients, regardless of location, deserve qualified and capable surgeons. I cannot argue this point and I will cede the issue, but I will take it one step further. Patients don’t just deserve a capable surgeon; they deserve an expert surgeon. Many generalists are very capable of performing a wide variety of procedures, but as the recent AT&T commercial aptly pointed out, a surgeon who is “just OK, is not OK.” Dr. Stovall correctly points out that specialty definitions are unclear with significant overlap. My argument is not about which specialty should own each disease, just the fact that fellowship training produces a more qualified expert to address complex surgical issues. It is not feasible to suggest that all surgery should be performed by fellowship-trained surgeons.

There is a growing shortage of all health care workers, particularly surgeons, and more so, general surgeons. While the population is growing and life expectancy increasing, the number of general surgery graduates has dropped from 1,047 in 1981 to 909 in 2008.1 With more of these graduates obtaining fellowship training, the shortage is magnified. There will always be a place for qualified and capable graduates of general surgery residencies. The shrinking pool of graduates best serves our communities by treating a broad variety of routine general surgical issues, usually in rural locations.

My argument does not stand on the concept of surgical competency and its definition. The Accreditation Council for Graduate Medical Education has faced the continuous struggle of identifying and defining competency. It has attempted to quantify competency based on length of training, number of cases, written tests, oral boards and maintenance of certification. None of these objective measures has adequately separated competent from incompetent surgeons, so one should not attempt to use them to define generally competent and specialty competent. One can, however, utilize fellowship training as a proxy for specialty competence. Each residency and every individual graduate within that residency has very different experiences. Some residencies provide its graduates with unique exposure to certain disease processes that is usually obtained in fellowship training. My argument is not meant to restrict these types of graduates from performing the surgery they are experts at performing. The goal is to align patients in need of complex care with those best capable of providing it.

Reference

Dr. Stovall’s Rebuttal to Dr. Duke In our debate on whether or not specialty-specific surgery in urban areas should only be performed by fellowship-trained surgeons, Dr. Duke argues that specialization has benefits and implies that specialization requires fellowship training. No explanation is given for why only fellowship-trained surgeons are capable of specialization.

Dr. Duke goes on to discuss that an increase in volume may be associated with improved outcomes. While this can be true, a surgeon’s volume now is not necessarily related to whether or not they were fellowship-trained. There are many high-volume, residency-trained surgeons who likely reap the proposed benefits of increased volume without fellowship training.

Dr. Duke further points out that the practice of medicine changes and that specializing is one way to help manage this change. Again, this does not explain why fellowship-trained surgeons are the only surgeons capable of specialization.

As discussed before, appropriate training is a necessity; however, the title of a surgeon’s formal training is not related to whether or not a surgeon is capable of specialization in their area of expertise.

In summary, increasing volumes and specialization may indeed have benefits, but it does not follow that only fellowship-trained surgeons are capable of specialization or high volumes.

Specialty-specific surgery in urban areas should not be performed exclusively by fellowship-trained surgeons. Surgery should be performed by well-trained surgeons with high-quality outcomes, regardless of where the surgeon is practicing and whether that training was acquired in a fellowship, a residency, or through the ongoing education required of a practicing surgeon.

1. Sheldon GF. J Gastrointest Surg. 2011;15(7):1104-1111.

Read this column at generalsurgerynews.com

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