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GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

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July 2021 • Volume 48 • Number 7

Ergonomic Injuries in Surgery: A Quiet but Pervasive Problem

Preventing SSIs In General Surgery What the Data Show: An Expert’s Take

By MONICA J. SMITH

D

espite decades upon decades of progress in surgery, surgical site infections are still extremely common, accounting for one-fifth of all nosocomial infections.

The impact on patients ranges from trivial to deadly. And the associated costs, such as increased hospital length of stay, readmissions and admission to ICUs, can be staggering—from $1,500 to $5,000 per day per SSI in the United States.

Over generations, guidelines for SSI prevention have evolved as new methods ds are proposed, put to the test, and ultimatetely accepted or discarded. For now, these are the interventions known to be most beneficial in general

By VICTORIA STERN

I

n July 2019, Talar Tejirian, MD, had surgery to repair a herniated disk at the C5-C6 vertebrae, which provides flexibility and support to the neck. The operation went well. Aside from a stiff neck, she felt pretty good.

However, Dr. Tejirian’s condition soon deteriorated during the physical rehabilitation process. Her physical therapist noted weakness in her right arm and started her on a weight lifting regimen, bypassing standard exercises to improve her range of motion.

She soon developed new, more severe pain in her right arm.

“I knew something was wrong,” said Dr. Tejirian, a general surgeon at Kaiser Permanente in Los Angeles. “I had never before experienced this type of pain.”

A nerve conduction test delineated the problem. The results hit her hard.

Continued on page 30

10-Year Trends in Incisional Hernia Repair European Data Show Intraperitoneal Onlay Declining, Open Sublay on the Rise

Continued on page 24

Inside the Launch of The Surgical Palliative Care Society

Study Suggests Which ich Melanoma Patients May Avoid Sentinel Node Biopsy

By VICTORIA STERN

BY KATE O’ROURKE

A

M

ver the past decade for incisional hernia repair, there has been a significant decrease in laparoscopic intraperitoneal onlay mesh (IPOM) and a corresponding increase in open sublay mesh repair, as well as new minimally invasive techniques including mini less open sublay repair (E/MILOS), extended totally extraperitoneal repair (eTEP), and preperitoneal mesh.

The findings, which were published in Hernia (2021;25[2]:255-265), also showed that 10% of incisional hernias continue to be treated via an open

fter more than a decade practicing surgery, Pringl Miller, MD, FACS, noticed a change in her patients.

Dr. Miller began seeing older and sicker patients, people who required more urgent decision making and symptom management.

“With my patients’ needs shifting, I moved into acute care surgery, but I felt a gap in my ability to provide the advanced communication and supportive care my patients needed,” Dr. Miller said. “As a surgeon, I always aim to mitigate suffering, but these efforts often center on technical skills, not words or touch.”

Continued on page 36

Continued on page 32

By BOB KRONEMYER

O

IN THE NEWS

14 Highlights From the American Society Of Colon and Rectal Surgeons 17 Tips on Being an Expert Witness T H E GREAT DEBATES

34 Roux-en-Y or One-Anastomosis Gastric Bypass: Which Is Better?

A Smart Surgical Stapler: Advantages of FullPowered Functionality PAGE 18

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@gensurgnews

ost patients with newly diagnosed melanoma undergo a sentinel lymph node biopsy (SLNB), in which the sentinel lymph nodes are removed and examined to find whether the cancer has spread beyond the skin. Now, results from a large cohort study indicate that a proportion of stage pT1b-pT2a melanoma patients could potentially avoid SLNB. The findings were presented at the Society of Surgical Oncology 2021 International Conference on Surgical Cancer Care (abstract 59).

“The results of this large cohort study would suggest that, with the new modern treatment paradigm, a proportion of pT1b-pT2a patients could potentially avoid SLNB, since the management of these patients may remain unchanged, Continued on page 38

NOW AP PROVE D F O R 72-HOUR POSTOPERATIVE PAIN RELI E F The First and Only Extended-Release Dual-Acting Local Anesthetic (DALA)1-4 ZYNRELEF redefines postoperative pain management by providing superior pain relief for up to 72 hours, with fewer patients experiencing severe pain, and reducing or eliminating the need for opioids in many patients following surgery versus standard-of-care bupivacaine HCl solution.1-4

SYNERGISTIC MECHANISM OF ACTION1,5,a

SUPERIOR 72-HOUR PAIN RELIEF1-3,b

OPIOID REDUCTION & ELIMINATION1-3,b

NEEDLE-FREE APPLICATION1

BROAD ACCESS PRICING & FAVORABLE REIMBURSEMENT

Synergistic increases in analgesia compared with meloxicam or bupivacaine alone shown in preclinical and Phase 2 studies.1,5 Clinical findings were demonstrated in Phase 3 trials for bunionectomy with osteotomy and open inguinal herniorrhaphy comparing ZYNRELEF to both placebo and bupivacaine HCl solution.1-3

a

b

EXPLORE THE DATA AT ZYNRELEF.COM/SURGERY

Indication

Contraindications

ZYNRELEF is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.

ZYNRELEF is contraindicated in patients with known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to any amide local anesthetic, NSAIDs, or other components of ZYNRELEF; with history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (severe, sometimes fatal, anaphylactic reactions to NSAIDS have been reported in such patients); undergoing obstetrical paracervical block anesthesia; or undergoing coronary artery bypass graft (CABG) surgery.

Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

• ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

• NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/ or GI bleeding are at greater risk for serious GI events.

Warnings and Precautions Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after application of ZYNRELEF. When using ZYNRELEF with other local anesthetics, overall local anesthetic exposure must be considered through 72 hours.

Hepatotoxicity: If abnormal liver tests persist or worsen, perform a clinical evaluation of the patient.

Hypertension: Patients taking some antihypertensive medication may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

Heart Failure and Edema: Avoid use of ZYNRELEF in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.

Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ZYNRELEF in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal failure.

Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.

© 2021 HERON THERAPEUTICS, INC. ALL RIGHTS RESERVED. 4242 CAMPUS POINT COURT, SUITE 200 • SAN DIEGO, CA 92121 • 858-251-4400

PP-HTX011-0213 | 06/21

Use in Specific Populations Methemoglobinemia: Cases have been reported with local anesthetic use.

Serious Skin Reactions: NSAIDs, including meloxicam, can cause serious skin adverse reactions. If symptoms present, evaluate clinically.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): If symptoms are present, evaluate clinically.

Fetal Toxicity: Due to the risk of oligohydramnios/fetal renal dysfunction and premature closure of the ductus arteriosus with NSAIDS, limit use of ZYNRELEF between about 20 to 30 weeks gestation, and avoid use after about 30 weeks.

Hematologic Toxicity: Monitor hemoglobin and hematocrit in patients with any signs or symptoms of anemia.

Drug Interactions Drugs That Interfere with Hemostasis: Monitor patients for bleeding who are using ZYNRELEF with drugs that interfere with hemostasis (eg, warfarin, aspirin, SSRIs/SNRIs).

ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), or Beta-Blockers: Use with ZYNRELEF may diminish the antihypertensive effect of these drugs. Monitor blood pressure.

ACE Inhibitors and ARBs: Use with ZYNRELEF in elderly, volumedepleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function.

Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effect.

Infertility: NSAIDs are associated with reversible infertility. Consider avoidance of ZYNRELEF in women who have difficulties conceiving.

Severe Hepatic Impairment: Only use if benefits are expected to outweigh risks; monitor for signs of worsening liver function.

Severe Renal Impairment: Not recommended.

Adverse Reactions Most common adverse reactions (incidence *10%) in controlled clinical trials with ZYNRELEF are constipation, vomiting, and headache.

Report side effects to Heron at 1-844-437-6611 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For additional information about ZYNRELEF, please refer to the Brief Summary of Prescribing Information on adjacent page.

References: 1. ZYNRELEF [package insert]. San Diego, CA: Heron Therapeutics Inc; 2021.

2. Viscusi E, Gimbel JS, Pollack RA, Hu J, Lee G-C. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: Phase III results from the randomized EPOCH 1 study. Reg Anesth Pain Med. 2019;44(7):700-706. doi:10.1136/rapm-2019-100531.

3. Viscusi E, Minkowitz H, Winkle P, Ramamoorthy S, Hu J, Singla N. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the Phase 3 EPOCH 2 study. Hernia. 2019;23(6):1071-1080. doi:10.1007/s10029-019-02023-6.

4. Lachiewicz PF, Lee G-C, Pollak R, Leiman D, Hu J, Sah A. HTX-011 reduced pain and opioid use after primary total knee arthroplasty: results of a randomized Phase 2b trial. J Arthroplasty.

2020;35(10):2843-2851. doi:10.1016/j.arth.2020.05.044. 5. Ottoboni T, Quart B, Pawasauskas J, Dasta JF, Pollak RA, Viscusi ER. Mechanism of action of HTX-011: a novel, extended-release, dual-acting local anesthetic formulation for postoperative pain. Reg Anesth Pain Med. 2020;45(2):117-123. doi:10.1136/rapm-2019-100714.

REDEFINE POSTOPERATIVE PAIN MANAGEMENT

ZYNRELEF™ (bupivacaine and meloxicam) extended-release solution, for soft tissue or periarticular instillation use BRIEF SUMMARY OF PRESCRIBING INFORMATION WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.

This risk may occur early in treatment and may increase with duration of use • ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events INDICATIONS AND USAGE ZYNRELEF is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.

Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

DOSAGE AND ADMINISTRATION Important Dosage and Administration Information: ZYNRELEF is intended for single-dose administration only. Avoid intravascular administration of ZYNRELEF. ZYNRELEF should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurologic or cardiac toxicity. Avoid additional use of local anesthetics within 96 hours following administration of ZYNRELEF. The safety of concomitant administration of ZYNRELEF and other NSAID medications has not been evaluated. If additional NSAID medication is indicated in the post-operative period, monitor patients for signs and symptoms of NSAID toxicity.

ZYNRELEF should only be prepared and administered with the components provided in the ZYNRELEF kit. See ZYNRELEF Instructions for Use included in the kit for complete administration instructions.

ZYNRELEF is not indicated for the following routes of administration: epidural, intrathecal, intravascular or intra-articular, regional nerve blocks, pre-incisional, and pre-procedural locoregional anesthetic techniques.

Administration Instructions: ZYNRELEF is applied without a needle into the surgical site using a Luer lock cone-shaped applicator attached to the syringe following final irrigation and suction of each layer and prior to suturing. Only apply ZYNRELEF to the tissue layers below the skin incision and not directly onto the subdermal layer or skin. Use only the amount necessary to coat the tissues, such that ZYNRELEF does not leak from the surgical wound after closure.

Dosing Instructions: The recommended dose of ZYNRELEF (bupivacaine/meloxicam) is as follows: − Bunionectomy: up to 2.3 mL to deliver 60 mg/1.8 mg − Open inguinal herniorrhaphy: up to 10.5 mL to deliver 300 mg/9 mg − Total knee arthroplasty: up to 14 mL to deliver 400 mg/12 mg See full Prescribing Information for all important dosage and administration information, preparation instructions and compatibility considerations.

CONTRAINDICATIONS ZYNRELEF is contraindicated in patients with known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to any amide local anesthetic, NSAIDs, or other components of ZYNRELEF; with history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients); undergoing obstetrical paracervical block anesthesia; or undergoing coronary artery bypass graft (CABG) surgery.

WARNINGS AND PRECAUTIONS Cardiovascular (CV) Thrombotic Events with NSAID Use: To minimize the risk of CV thrombotic events, do not exceed the recommended dose. Monitor for serious CV events. Aspirin does not mitigate the risk of these thrombotic events. In patients with a recent MI, avoid the use of ZYNRELEF unless the benefits are expected to outweigh the risk, and if used, monitor patients for signs of cardiac ischemia. The risk of these events following single-dose local application of ZYNRELEF is uncertain.

Gastrointestinal Bleeding, Ulceration, and Perforation with NSAID Use: To minimize the risk of GI bleeding, do not exceed the recommended dose and avoid using more than one NSAID at a time. If additional NSAID medication is indicated in the post-operative period, monitor patients for signs and symptoms of NSAID-related GI adverse reactions. In high-risk patients, evaluate if the benefit outweighs the risk of bleeding, remain alert for GI ulcerations and bleeding, and promptly evaluate and treat suspected serious GI adverse events. In patients using concomitant low-dose aspirin, monitor for GI bleeding.

Dose-Related Toxicity: The toxic effect of local anesthetics are additive. When using with other local anesthetics, overall local anesthetic exposure must be considered through 72 hours. Monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.

Risk of Use in Patients with Impaired Cardiovascular Function: Patients with impaired cardiovascular function may be less able to compensate for the prolongation of AV conduction. Monitor patients closely for blood pressure, heart rate, and ECG changes.

Hepatotoxicity: Bupivacaine should be used cautiously in patients with hepatic disease because of their inability to metabolize local anesthetics normally. NSAIDs are associated with elevations of ALT or AST and rare, sometimes fatal cases of severe hepatic injury. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur, perform a clinical evaluation of the patient. The risk of these events following single-dose local application of ZYNRELEF is uncertain.

Hypertension: NSAID use in patients taking ACE inhibitors, thiazide or loop diuretics may result in impaired blood pressure control.

Monitor blood pressure.

Heart Failure and Edema: NSAID use in patients with heart failure may increase the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retention and edema have been observed with NSAIDs. Avoid use in patients with severe heart failure unless the benefit outweighs the risk of worsening heart failure; if used, monitor for signs of worsening heart failure. The risk of these events following single-dose local application of ZYNRELEF is uncertain.

Renal Toxicity: NSAIDs may cause a dose-dependent reduction in renal blood flow and overt renal decompensation. Additionally, the metabolites of meloxicam are excreted by the kidney which may hasten the progression of renal dysfunction in those with renal disease. Correct dehydration and hypovolemia prior to initiating ZYNRELEF. Avoid use in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.

Anaphylactic Reactions: Meloxicam has been associated with anaphylactic reactions in patients with and without known hypersensitivity to meloxicam and in patients with aspirin-sensitive asthma. Seek emergency help if an anaphylactic reaction occurs.

Chondrolysis with Intra-Articular Infusion: Intra-articular infusions of local anesthetics have been associated with chondrolysis.

ZYNRELEF is not approved for intra-articular infusion.

Methemoglobinemia: Local anesthetics have been associated with methemoglobinemia. Treat with supportive care, and if necessary, methylene blue, exchange transfusion, or hyperbaric oxygen.

Exacerbation of Asthma Related to Aspirin Sensitivity: NSAIDs are contraindicated in patients with aspirin-sensitive asthma. When ZYNRELEF is used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for exacerbation of asthma symptoms.

Serious Skin Reactions: NSAIDs can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, which can be fatal.

If symptoms present, evaluate clinically.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): NSAIDs may cause DRESS. If signs or symptoms are present, evaluate the patient immediately and treat as clinically indicated.

Fetal Toxicity: NSAIDs may cause fetal renal dysfunction leading to oligohydramnios at about 20 weeks gestation and premature closure of the fetal ductus arteriosus at about 30 weeks gestation or later. Limit use between about 20 to 30 weeks gestation, and avoid use after about 30 weeks.

Hematologic Toxicity: NSAIDs may cause anemia due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet agents (eg, aspirin), SSRIs and SNRIs may increase this risk. Monitor these patients’ hemoglobin and hematocrit and for signs or symtoms of anemia.

Masking of Inflammation and Fever: NSAIDs reduce inflammation, and possibly fever, which may diminish detection of infections.

ADVERSE REACTIONS The safety of ZYNRELEF has been evaluated in a total of 1067 patients undergoing various surgical procedures across 7 randomized, double-blind, bupivacaine- and placebo-controlled studies designed to investigate ZYNRELEF to reduce postoperative pain for 72 hours and the need for opioid analgesics. Among 504 patients who received ZYNRELEF in single doses of 60 mg/ 1.8 mg to 400 mg/12 mg via instillation into the surgical site, the most common adverse reactions (incidence greater than or equal to 10%) following ZYNRELEF administration were constipation, vomiting, and headache. The most common adverse reactions (≥ 5% and higher than placebo) in the following 3 studies were: • Bunionectomy: 157 patients received ZYNRELEF 60 mg/1.8 mg and the most common adverse reactions were dizziness, incision site edema, headache, incision site erythema, bradycardia, impaired healing, and muscle twitching. With the exception of muscle twitching, these events were also higher for bupivacaine HCl compared to placebo. A total of four subjects had delayed bone healing (assessed by X-ray on days 28 and 42), with no clinically meaningful difference between treatment groups.

Additional local inflammatory adverse events observed at a higher incidence for ZYNRELEF compared to placebo or bupivacaine HCl included incision site cellulitis, wound dehiscence and incision site infection.

• Herniorrhaphy: 163 patients received ZYNRELEF 300 mg/9 mg and the most common adverse reactions were headache, bradycardia, dysgeusia, and skin odor abnormal. With the exception of skin odor abnormal, these events were also higher for bupivacaine HCl compared to placebo.

• Total knee arthroplasty: 58 patients received ZYNRELEF 400 mg/12 mg and the most common reactions were nausea, constipation, vomiting, hypertension, pyrexia, leukocytosis, and pruritus. With the exception of hypertension, these events were also higher for bupivacaine HCl compared to placebo.

DRUG INTERACTIONS Bupivacaine Drug Interactions: Local anesthetics: In clinical studies, other local anesthetics (including ropivacaine and lidocaine) have been administered before, during, or after application of ZYNRELEF without evidence of local anesthetic systemic toxicity. Administration of ZYNRELEF with other formulations of local anesthetics (ie, bupivacaine liposome injectable suspension) has not been studied. Drugs associated with methemoglobinemia: Bupivicane may increase risk of methemoglobinemia when concurrently used with nitrates, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, and other methemoglobinemia-associated drugs.

Meloxicam Drug Interactions: Drugs That Interfere with Hemostasis: Meloxicam use with anticoagulants has an increased risk of serious bleeding compared to the use of either drug alone. Monitor patients with concomitant use of ZYNRELEF with anticoagulants, antiplatelet agents, SSRIs, and SNRIs for signs of bleeding. ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), or Beta-Blockers: Meloxicam may diminish the antihypertensive effect of these drugs. Monitor blood pressure. ACE Inhibitors and ARBs: Meloxicam use with ACE inhibitors and ARBs in elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, adequately hydrate and monitor for signs of worsening renal function. Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy, including antihypertensive effect. Digoxin: NSAIDs increase the serum concentration and prolong the half-life of digoxin. Monitor serum digoxin levels. Lithium: NSAIDs elevate plasma lithium levels and reductions in renal lithium clearance.

Monitor for signs of lithium toxicity. Methotrexate: NSAIDs use with methotrexate may increase risk for neutropenia, thrombocytopenia, and other methotrexate-associated toxicities. Monitor for signs of methotrexate toxicities. Cyclosporine: NSAIDs use with cyclosporine may increase nephrotoxicity. Monitor for signs of worsening renal function. Pemetrexed: Meloxicam used with pemetrexed may increase myelosuppression, renal, and GI toxicities. In patient with creatinine clearance 45 to 79 mL/min, monitor for pemetrexed-associated toxicities.

OVERDOSE No data are available with regard to overdose of ZYNRELEF. Management of Local Anesthetic Overdose: At the first sign of change, oxygen should be administered. The first step for convulsions, underventilation, or apnea is immediate maintenance of a patent airway and assisted or controlled ventilation capable of immediate positive airway pressure. After assuring airway and ventilation, evaluate and establish adequate circulation as indicated.

Drugs that treat convulsions may depress the circulation. If convulsions persist despite adequate respiration, and if the circulation permits, small increments of an ultra-short acting barbiturate or a benzodiazepine may be administered intravenously. Supportive treatment of circulatory depression may require intravenous fluids and, when appropriate, a vasopressor.

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias, and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. Endotracheal intubation, employing drugs, and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask if maintenance of a patent airway is inadequate or if prolonged ventilatory support is indicated.

CLINICAL PHARMACOLOGY ZYNRELEF contains bupivacaine, an amide local anesthetic, and meloxicam, an NSAID. The contribution of each active ingredient in ZYNRELEF has been studied in clinical studies in herniorrhaphy or bunionectomy, utilizing ZYNRELEF and formulations of meloxicam alone or bupivacaine alone in the ZYNRELEF vehicle. Meloxicam alone provided negligible local analgesia and bupivacaine alone provided greater analgesia compared with placebo through 24 hours post surgery, despite exposure to bupivacaine for approximately 72 hours. Compared with bupivacaine alone in both studies, ZYNRELEF demonstrated greater and longer analgesia through 24, 48, and 72 hours. The instillation of ZYNRELEF into the surgical site results in significant systemic plasma levels of bupivacaine and meloxicam through 96 hours. Systemic plasma levels of bupivacaine or meloxicam following application of ZYNRELEF do not correlate with local efficacy.

PATIENT COUNSELING Inform patients of the risks and mitigations for: CV thrombotic events; GI bleeding, ulceration, and perforation, including the increased risk of GI toxicity with use of NSAIDs in the postoperative period; anaphylactic reactions; serious skin reactions, including DRESS; methemoglobinemia; fetal toxicity; and temporary loss of sensation near the surgical site.

This information is not comprehensive. Visit www.zynrelef.com to obtain the full Prescribing Information, including Boxed Warning. © 2021 Heron Therapeutics, Inc. All rights reserved. ZYNRELEF™ is a trademark of Heron Therapeutics, Inc.

Manufactured and marketed by: Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA, 92121, USA. PP-HTX011-0102 05/21

IN THE NEWS

JULY 2021 / GENERAL SURGERY NEWS

Study Compares Roux Duodenal Switch With SADI-S More Weight Loss With Duodenal Switch but Higher Complication Rate and Similar Comorbidity Resolution

By KATE O’ROURKE

A

ccording to results from a matched cohort study, weight loss is better with Roux duodenal switch compared with single anastomosis duodeno-ileostomy with sleeve gastrectomy (SADI-S), but this weight loss does not translate into better resolution of comorbidities. These findings were presented at the 2021 annual meeting of the American Society for Metabolic and Bariatric Surgery (abstract A001).

According to presenting study author Daniel Cottam, MD, a general surgeon at the Bariatric Medicine Institute, in Salt Lake City, prior to this study, it was unknown whether the long-term outcomes of Roux DS are superior, similar or inferior to those of SADI-S when controlling for similar total bowel lengths. In the new study, researchers at the Bariatric Medicine Institute compared Roux-en-Y duodenal switch patients with a 150-cm Roux limb and 150-cm common channel with SADI-S patients with a 300-cm common channel. The total alimentary limb lengths in both groups were 300 cm.

Data were used for a retrospective matched cohort from 815 patients who underwent a primary laparoscopic traditional DS or primary laparoscopic SADIS from September 2011 through November 2019 by four surgeons. Data were obtained by matching DS patients to SADI-S patients of the same age, sex and body mass index. In addition, only patients who were

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

out at least five years and had a minimum five-year hypertension, obstructive sleep apnea and gastroesophafollow-up were included in the study. There were 30 geal reflux disease were statistically similar between both groups. There also was no statistically significant differpatients in each group.

The researchers found that the total number of ence in nutritional data between the two procedures before and after surgery, but follow-up numbers patients who experienced long-term complications were low. was significantly higher in the DS group (18 vs. six; n According to Dr. Cottam, the nutritionP=0.004). There was no statistically significant differatistically al and complication data with a ence in the short-term (<30 days) complication rate.

30 small cohort should be viewed Of all Clavien-Dindo classification grades, only grade sification skeptically. Dr. Cottam said 3b complications were significantly higher in the DS gnificantly the Roux DS procedure group (P=0.003). with 150 Roux/150 comThe total number of patients ents Duodenal Switch mon channel seems to offer who required long-term m somewhat better weight loss reintervention was significantly higher in the at six years than the SADIS procedure, but the real longDS group (18 vs. nine; term difference between the P=0.019). The total two groups was approximatenumber of patients who ly 15 to 20 pounds without required CT was sigan impact on the comorbidnificantly higher in the ity resolution.

DS group (eight vs. one; ■ P=0.026). At five and six years, the weight loss was siggDr. Cottam is part of the speakers D nificantly better with DS, but the bbureau for Medtronic, and has ending BMI points at five and six years were statisbbeen awarded a research grant tically similar between the two groups. The longby Medtronic for the study of term weight loss failure rate ate was statistically duodenal switch. He also has similar between both groups. ups. The longreceived personal fees from GI term resolution rates of type 2 diabetes, Windows.

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

Peter K. Kim, MD Bronx, NY

Editorial Advisory Board

Lauren A. Kosinski, MD Chestertown, MD

Gina Adrales, MD, MPH Baltimore, MD

Marina Kurian, MD New York, NY

Maurice Arregui, MD Indianapolis, IN

Raymond J. Lanzafame, MD, MBA Rochester, NY

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

Timothy Lepore, MD Nantucket, MA

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

Robert Lim, MD Tulsa, OK

James Forrest Calland, MD Charlottesville, VA

John Maa, MD San Francisco, CA

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.

DISCLOSURE POLICY We endeavor to obtain relevant financial

disclosures from all interviewees and rely on our sources to accurately provide this information, which we believe can be important in evaluating the research discussed in this publication.

CONTACT THE EDITOR

Send letters, article ideas or queries to khorty@mcmahonmed.com.

Editorial Staff Kevin Horty Group Publication Editor khorty@mcmahonmed.com

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IN THE NEWS

GENERAL SURGERY NEWS / JULY 2021

First Look: The American Surgical Association All Articles By CHRISTINA FRANGOU

The American Surgical Association held its 141st annual meeting virtually this year. Here, General Surgery News presents some of the most important papers from the meeting.

The complete manuscripts of these studies and their presentation at the ASA meeting are anticipated to be published in the Annals of Surgery pending editorial review.

Physical Quality of Life Better After Metabolic Surgery, but Not Psychological People who underwent metabolic surgery for treatment of obesity and type 2 diabetes experienced greater improvements in quality of life years after surgery compared with intensive medical therapy, according to a new analysis from the landmark STAMPEDE trial.

The trial randomized 150 patients to sleeve gastrectomy, gastric bypass or intensive medical therapy. In 2017, investigators reported that patients who underwent surgery had greater weight loss and glycemic control, with continued benefits five years later (N Engl J Med 2017;376[7]:641-651).

Throughout study period, 104 patients completed the RAND 36-Item Health Survey and European QoL 5-Dimensions (EQ-5D), as well as a diabetes-specific questionnaire developed by Rand Corp., to assess quality of life.

Patients who had surgery reported more improvements in general health, energy/fatigue, body pain and diabetes-related quality of life compared with medical therapy alone. Independent predictors of improved quality of life weree substantial weight loss and no insulin require-ments at the end of the study. Of note, one-third d of surgical patients had long-term remission of their diabetes and over half had good glycemic control.

Outcomes were similar for people who underwent Roux-en-Y gastric bypass and those who had sleeve gastrectomy.

However, the study showed no differences in psychological, emotional or social aspects of quality of life between patients in the surgical and medical arms of the trial.

Lead author Ali Aminian, MD, the director of the Bariatric and Metabolic Institute and an associate professor of surgery at Cleveland Clinic in Cleveland, said surgery patients may need better psychological screening and continued psychological support to improve outcomes.

“Our findings suggest that psychological well‐being needs may require more attention in metabolic surgical patients,” he said.

He added that the study provides strong Level I evidence that metabolic surgery improves certain domains of quality of life over five years.

The study has a number of limitations. The majority of patients in the study were women (66%) and white (73%), so the results may not be applicable to wider populations. Only 26 patients from the 50 originally in the medical therapy arm completed the surveys. The diabetes-specific question in the study has not been validated in the literature.

The Racial Gap in Liver Transplant Access Widened During the Pandemic Minorities in the United States, especially those with public insurance, experienced a sudden drop in access to liver transplants in the early months of the pandemic, with a twofold decrease in access to transplant surgery compared with whites.

Throughout the pandemic, organ transplantation was classified as a CMS (Centers for Medicare & Medicaid Services) Tier 3b procedure, which should not be postponed.

But an analysis showed that minorities were less likely to be listed for transplant and more likely to be removed from the waitlist in the first three months of the pandemic. In this study, minorities included people who identified as African American, Hispanic, Asian, American Indian or Alaska Native, Native Hawaiian or Pacific Islander, or multiracial.

“We have to be cognizant that when stress hits a system, existing disparities in access to care can be exacerbated, placing vulnerable populations at risk,” said lead author Parsia Vagefi, MD, the chief of surgical transplantation at UT Southwestern Medical Center, in Dallas.

Transplant rates among minorities rebounded by fall 2020, the analysis showed.

Investigators used UNOS STAR file data to compare liver transplants in 2019 and 2020, looking for differences based on minority status, demographics, diagnosis, Model for End-stage Liver Disease (MELD) score, insurance type and transplant center characteristics.

Between March and May 2020, the numbe number of minority patients added to the waitlist for a transplant dropped 14%, compared with 12% for w whites. Minorities underwent 15% less transplants than in 2019, double the rrate of decrease among white patients. Of minority patients who underwent transplantation, they had a higher median MELD score: 23 versus 20 for whites (P<0.001). The likelihood of transplant in minorities was further reduced when compounded with public insurance status, high MELD t scores (>20) and large transplant centers. sco Minorities were removed from the waitlist because of death or being too sick Min more ofte often than wait-listed white patients. They were far more likely to be inactivated on the waitlist because of a COVID-19 precaution; this affected 8.3% of minorities on the wait waitlist compared with 5.5% for white patients (P<0.001).

Among patients who w were publicly insured, minorities experienced the largest drop in access to transplants, down 18.5% over 2019, compared with 8% for whites.

Privately insured minority and white whit patients had similar decreases in rates of liver transplant at the start of the pandemic. By fall 2020, liver transplants among privately insured patients were on the upswing.

Despite the upheaval of 2020, large transplant programs increased the number of transplants over the year, but minority patients accounted for fewer transplants at these programs—down to 27.7% from 31.7% before the pandemic.

Virtual American Board of Surgery Certifying Exam Gets High Marks Future American Board of Surgery (ABS) certifying exams are likely to be offered in a virtual format after a successful first run during the October 2020 exam, according to surgeons on the research committee of the ABS. Last fall, the ABS moved its certifying exam online in order to minimize risk for COVID-19 transmission. Candidates and examiners gave the remote exam high marks in surveys: 85.7% of candidates and 96.4% of examiners said they were highly satisfied with the remote exam.

Three of four candidates said they preferred remote exams in the future, compared with 20% of examiners. Candidates said the exam was fair, organized and carefully planned, although they experienced stress from worrying about technological failure. Examiners noted that they missed the camaraderie of in-person exams.

Lead investigator Herbert Chen, MD, the chair of the Department of Surgery at the University of Alabama at Birmingham and a member of the ABS research committee, said the ABS invested substantial time and money into building a strong infrastructure for a virtual exam, completing two pilot studies of the test.

He said he was not surprised by the positive response to the exam but pleased with the results.

“If you can do a good job of providing a fair exam virtually, people are going to prefer that for the reasons that the examinees stated—no travel, comfort of their home, sleep in their own bed, less stress,” he said.

He noted that his views do not represent the ABS but said virtual exams would be a good option in the future, particularly given the infrastructure is now in place.

“My own opinion is this is where it’s going to be moving forward,” he said.

The ABS set up the exam to take place over Zoom, with one room host to coordinate the flow of the exam, three breakout rooms with a candidate and proctor who carried out a security check, and six examiners who rotated in pairs into the breakout rooms.

The majority of candidates and examiners rated the technology as high, although about 25% of candidates reported concerns with audio or video quality.

Overall, 306 of 308 people who registered for the virtual exam completed it. Two examinees rescheduled for a later day. continued on page 8

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IN THE NEWS

First Look: ASA continued from page 6

The pass rates for the virtual exam were similar to those in previous years: 81.7% of candidates passed compared with 85% of the 1,025 people who took the exam in person in 2019. Pass scores dropped for people repeating the exam: They scored lower on the virtual exam than in person (75% vs. 84.4%), but the difference was not statistically significant.

Courtesy Authorship Continues and Favors Older Male Surgeons Two-thirds of surgeon researchers surveyed continue to engage in courtesy authorship, despite editorial policies from journals that specifically prohibit the practice.

Courtesy authors—individuals who are included in a scientific paper even though they have not made a contribution that meets the criteria as defined by the International Committee of Medical Journal Editors (ICMJE)—are more likely to be older, higher in academic rank and male compared with participatory authors, according to the survey.

“Courtesy authorship preferentially favors late-career males, concentrating academic currency within those who have already achieved academic success,” said lead author Mary Condron, MD, a trauma surgeon at St. Charles Medical Center in Bend, Ore. “Stopping this practice will require changing the culture that perpetuates it,” she said.

The survey follows on a study published in JAMA Surgery in 2019, which found 17% of first and senior authors added courtesy authorship was a common practice (2019;154[12]:1110-1116).

Dr. Condron and her colleagues examined the motivations that drive this practice in academic surgery. They sent an anonymous survey to first and last authors of studies published in eight high-impact surgical journals. Of 2,076 authors approached, 341 completed the survey for a response rate of 16%.

Ninety-two percent of respondents said they understood the ICMJE authorship criteria. Even so, 14% added courtesy authors five or more times in the last year.

When asked why, respondents said they wanted to avoid awkwardness or feared retaliation. In about 25% of cases, surgeons added courtesy authors because they hoped for reciprocal offers or career advancement.

In cases where the courtesy author was not in a position of power relative to the first or senior author, they were twice as likely to be female and nearly twice as likely to be non-white.

Most of the suggestions for courtesy

GENERAL SURGERY NEWS / JULY 2021

authors came from the principal investigator or senior author.

The majority of respondents were male (70%), white (74%) and between the ages of 40 and 59 years. Three-fourths were in academic practice.

Transgastric Debridement For Necrotizing Pancreatitis Needs a Team Approach Patients required fewer interventions, spent less time in the hospital and had fewer readmissions after undergoing

operative rather than endoscopic transgastric debridement for necrotizing pancreatitis, according to one of the largest case series of patients treated for this condition.

But the authors say their results demonstrate that both approaches have a place in management of necrotizing pancreatitis.

Instead of advocating one approach over the other, investigators called for multidisciplinary collaboration in caring for these patients, including clinicians who have

experience in surgical and endoscopic treatment, as well as percutaneous treatment and medical therapy.

“This is a team effort. It takes experienced judgment and multidisciplinary teamwork with GI and surgery to determine the optimal approach to treating necrotizing pancreatitis, whether it’s surgical or endoscopic,” said lead author Nicholas J. Zyromski, MD, a professor of surgery at Indiana University School of Medicine in Indianapolis.

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Some patients treated operatively later received endoscopic and percutaneous treatment, while some treated by endoscopy required subsequent operations, he noted.

The study included 643 patients with pancreatic necrosis who were treated at Indiana University Hospital between 2008 and 2019. In this group, 160 patients underwent transgastric debridement: 59 were treated endoscopically (37%) and 101 operatively (63%).

A multidisciplinary team made the decision on whether to use endoscopy or surgery after considering the patient’s

history, the disease etiology and clinical characteristics.

Patients treated endoscopically required 3.0±2.0 debridements per patient, compared with 1.1±0.5 in the surgical group. Overall, 81% of patients who had endoscopic transgastric debridement required repeat interventions, up from 7% in the surgical group.

The endoscopic approach was associated with longer postoperative lengths of stay in the hospital (13.8±20.8 vs.

9.4±6.1 days; P=0.047). Patients treated endoscopically also had higher rates of readmission (67% vs. 20%; P<0.001).

Surgical transgastric debridement should be the first choice for patients with biliary necrotizing pancreatitis and suitable anatomy, while patients with alcoholic pancreatitis or hypertriglyceridemic pancreatitis may be better suited for an endoscopic approach, Dr. Zyromski said.

More patients died in the endoscopic group (7% vs. 1%), and new-onset organ failure was similar in the two groups at 13%.

Investigators said mechanical intervention for necrotizing pancreatitis should be delayed at least four to six weeks after onset.

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TRENDING Read the five most-viewed articles last month on generalsurgerynews.com.

1

A Response to ‘Guidelines for Avoiding Bile Duct Injury: Beware’

2

Ants to Robotics: 10 Tools of Surgery

3

Eliminating 24-Hour Call: Does It Work? ▼

4

Outcomes of Same-Day Surgery Not Worse in Obese Patients

5

Hospital Major Determinant Of COVID-19 Care, Not Clinical Specifics

HEARD HERE FIRST ‘Surgical site infections are the third most expensive type of health care–acquired infection, costing nearly $21,000 per patient case.

Some estimates raise that cost to $90,000. It’s estimated that the total cost of SSIs to the U.S. health care system ranges from $3.5 billion to $10 billion annually.’

From “Why Surgeons Should Partner With Their Central Sterile Processing Department,” page 25 N

GS

COMING NEXT ISSUE

Look out for our examination of the recently published JACS study “State-Level Examination Of Clinical Outcomes and Costs for Robotic and Laparoscopic Approach To Diaphragmatic Hernia Repair.”

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GENERAL SURGERY NEWS / JULY 2021

Quality of Life Following Elective Sigmoid Resection Versus Conservative Management of Diverticulitis

Diverticulitis, Gallstone Extraction and Hernia Mesh n this installment of “Journal Watch,” we welcome a guest columnist, Brittney Williams, MD, MPH, who is a general surgery resident and research fellow at the University of North Carolina at Chapel Hill. This month, we look at results from the LASER trial evaluating patient quality of life with elective colectomy versus conservative management for the treatment of diverticulitis, the potential use of percutaneous cholecystolithotomy as an alternative to cholecystectomy in high-risk patients, and results of the PRICE trial assessing the use of synthetic versus biological mesh for repair of clean and contaminated ventral hernias.

The hope is that readers will find these topics worthwhile and relevant, with findings to modify and/or support current practice.

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

Brittney Willams, MD, MPH —Guest Columnist

In JAMA Surgery, Santos et al reported the results of the LASER (Laparoscopic Elective Sigmoid Resection Following Diverticulitis) trial (JAMA Surg 2021;156[2]:1-9).

This was an open-label, randomized controlled trial at six centers in Finland, assessing whether elective laparoscopic sigmoid resection improves quality of life (QOL) in patients with recurrent, complicated, or persistent left-sided diverticulitis when compared with conservative treatment. The primary outcome was difference in Gastrointestinal Quality of Life Index (GIQLI) score between baseline and six months. The GIQLI is a QOL measure specific to gastrointestinal symptoms that is scored from 0 to 144, with a higher score indicating better QOL. Secondary outcomes included the 36-Item Short Form Health Survey (SF36) score, recurrence rate, emergency surgery rate, crossover to elective surgery, and, in the surgical group, complication, mortality and stoma rates.

A total of 90 patients with three or more episodes of left-sided diverticulitis within two years, one or more episodes of complicated diverticulitis, and/or persistent pain for more than three months after an episode of diverticulitis were randomized. Patients with the following conditions were excluded: contraindications to elective or laparoscopic surgery, stricture, fistula, malignancy, history of rectosigmoid surgery, active diverticulitis, no colonoscopy or sigmoidoscopy within two years, age less than 18 years or more than 75 years, pregnancy, or inability to complete survey questions.

Ultimately, 85 patients were enrolled in the intention-to-treat analysis of clinical outcomes: 41 to the surgical group (laparoscopic sigmoid resection) and 44 to the conservative therapy group (educational materials and increased fiber intake). The surgical technique was standardized in terms of trocar positioning, proximal and distal transection lines, and stapled anastomosis. Crossover from the conservative to surgical group occurred only if an absolute indication for surgery arose.

The difference in GIQLI score between baseline and six months was greater in the surgical group (11.76±15.89) than the conservative treatment group (‒0.2±19.07), for a mean difference of 11.96 (95% CI, 3.72-20.19; P=0.005). The crude GIQLI score at six months also was higher in the surgical group (114.92±16.77) than the conservative group (101.97±21.74), for a mean difference of 12.95 (95% CI, 3.98-21.92; P=0.005), indicating better GI-specific QOL after surgery.

In terms of the SF-36 at six months, the surgical group had a higher mental component (median, 55.14; interquartile range [IQR], 61.38-57.24 vs. 47.68; IQR, 41.27-56.82; P=0.02), but the physical component was similar in the two groups. The surgical group had a lower recurrence rate (5% vs. 27%; P=0.004). The surgical group had one conversion to open surgery and a 10% rate of Clavien-Dindo grade III complications, including two (5%) postoperative abscesses that required percutaneous drainage and two (5%) anastomotic leaks resulting in reoperation and temporary stoma creation.

Two crossovers occurred from the conservative to surgical group. There were no deaths in either group.

The LASER trial is only the second randomized controlled trial comparing elective sigmoid resection and conservative management of recurrent, complicated or persistent diverticulitis. The authors obtained similar results to the prior DIRECT trial, showing significantly higher GIQLI scores in the surgical group than those conservatively managed, but also lower postsurgical complication rates despite including a higher proportion of recurrent diverticulitis and conservatively managed abscesses (Lancet Gastroenterol Hepatol 2017;2[1]:13-22).

These findings contradict the growing body of evidence, albeit retrospective and/or nonrandomized studies, supporting conservative management of recurrent or complicated diverticulitis (JAMA Surg 2020;155[7]:600-606).

The authors acknowledge several limitations, including the potential placebo effect introduced with lack of sham continued on page 12

Table. Summary of Three Studies Discussed Journal Article

Key Takeaways

Study Limitations

Useful Related Articles

Comparing laparoscopic elective sigmoid resection and conservative treatment in improving quality of life of patients with diverticulitis: LASER (Laparoscopic Elective Sigmoid Resection Following Diverticulitis) randomized clinical trial Santos A, Mentula P, Pinta T, et al. JAMA Surg. 2021;156(2):1-9.

•

•

Small sample size

•

•

Follow-up limited to 6 months

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Strict inclusion criteria restricting recurrent diverticulitis to ≥3 episodes

Van de Wall BJM, Stam MAW, Draaisma WA, et al.

Lancet Gastroenterol Hepatol.

2017;2(1):13-22.

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•

Surgery carried a 10% rate of major complications.

Torney MVS, Moffa G, Kaech M, et al. JAMA Surg.

2020;155(7):600-606.

Safety and efficacy of percutaneous gallstone extraction in high-risk patients: an alternative to cholecystectomy or longterm drainage?

Stirrat J, Patel N, Stella S, et al. J Am Coll Surg. 2021;232(2):195-201.

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PCCL is an effective alternative to cholecystectomy in patients who have undergone cholecystostomy tube placement and remain highrisk due to anesthesia or technical concerns.

•

Retrospective design

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•

Single institution

Riall TS. J Am Coll Surg.

2021;232(2):201-202.

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Unclear reasoning for poor operative candidacy

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Chiverton SG, Inglis JA, Kellett MJ, et al. BMJ. 1990;300(6735):1310-1312.

Almost half of the study population received general anesthesia for PCCL

Preventing recurrence in clean and contaminated hernias using biological versus synthetic mesh in ventral hernia repair: the PRICE randomized clinical trial Harris HW, Primus F, Young C, et al. Ann Surg. 2021;273(4):648-655.

•

Biological mesh had a higher recurrence rate than synthetic mesh in both clean and contaminated ventral hernia repairs.

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Underpowered for subgroup analyses, particularly in hernia size and patient comorbidities

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Carbonell AM, Criss CN, Cobb WS, et al. J Am Coll Surg.

2013;217:991-998.

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Single-center study may have limited generalizability.

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There was no difference in complication rate between biological and synthetic meshes in either clean or contaminated ventral hernia repairs.

Souza JM, Dumanian GA. Surgery.

2013;153:393-399.

•

Multiple surgical techniques with or without separation of components and variable mesh locations make it difficult to guide practice with such small sample size within each technique.

•

Warren J, Desai SS, Boswell ND, et al. J Am Coll Surg.

2020;230:405-413.

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Only one type of biological mesh and two types of synthetic mesh were compared.

Elective laparoscopic sigmoid resection improves quality of life in patients with recurrent, complicated or persistent diverticulitis compared with conservative management.

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Diverticulitis continued from page 10

surgery, a relatively small sample size further exacerbated by lack of QOL data for four patients (9.8%) in the surgery group and nine (20.5%) in the conservative group, and the strict inclusion/exclusion criteria which resulted in including patients largely with multiple recurrent episodes. Despite these limitations, this trial provides valuable evidence on the benefits of elective sigmoid resection in this population. Long-term follow-up results will be useful for shared clinical decision making.

Efficacy of Percutaneous Gallstone Extraction in High-Risk Patients In the Journal of the American College of Surgeons, Stirrat et al presented a retrospective analysis examining the efficacy of percutaneous cholecystolithotomy (PCCL) for definitive management of high-risk patients who have undergone cholecystostomy tube placement (J Am Coll Surg 2021;232:195-201).

This study retrospectively reviewed all cases of PCCL performed at a single center from 2000 to 2017. The primary outcome was the rate of successful gallbladder calculi removal after at least one PCCL. Secondary outcomes included number of PCCLs performed, hospital length of stay, and rates of readmission, complications and mortality.

A total of 75 PCCLs were performed during the study period. All patients were deemed poor operative candidates by the surgical team, largely due to comorbidityrelated anesthesia concerns. Of note, the study included a large proportion of patients with previous biliary procedures, including a subset of aborted cholecystectomies.

The PCCL was performed by Interventional Radiology (IR) at least six weeks after cholecystostomy tube placement. The procedure was standardized to include a cholangiogram, cholecystostomy tube removal, tract dilation, sheath placement into the gallbladder, removal of calculi, and placement of a new cholecystostomy tube for reassessment two weeks after PCCL. Successful gallbladder calculi removal occurred in 68 patients (90.7%), with more than one attempt required in 14 patients (18.6%). Reasons for unsuccessful removal included four stone impactions, three episodes of gallbladder access loss and two technically restricting gallbladders. Readmission rate was 4% at 30 days and 8% at 90 days. Of the 11 patients who were deemed high-risk due to previously aborted cholecystectomies, the success rate of PCCL was 100%. The overall complication rate was 10.4% and all were Clavien-Dindo class I or II, including wound infection, gallbladder hematoma and gallbladder wall perforation. The symptomatic recurrence rate was 6.3% and there were no procedure- or biliary-related deaths.

This study provides the largest series of PCCL cases currently reported in the United States, highlighting an underused alternative for high-risk patients who have undergone cholecystostomy tube placement. Because of its single-center, retrospective design, limitations such as selection bias are introduced. Further, this study lacked key information on the center’s characteristics (such as the number of PCCLs performed each year, experience of the evaluating surgeon and number of cases referred to a hepatobiliary service) as well as the patient selection process that would be needed to aid in practical application of this technique. For example, in an invited commentary, Taylor Riall, MD, observed that 47 patients

(62.6%) were deemed high-risk for cholecystectomy due to concerns of general anesthesia, yet 43 PCCL procedures (45.3%) were performed under general anesthesia (J Am Coll Surg 2021;232[2]:201-202). Finally, as many patients with benign biliary disease do not follow up beyond the immediate postprocedural period, complications or recurrences may have been missed. While the average follow-up period was 2.8 years, this interval was defined using the last documented encounter in the patient’s medical record, which may have been unrelated to their PCCL. Despite these limitations, this series provides support for considering PCCL as a management strategy for patients who are high-risk for both anesthesia and technical concerns of cholecystectomy.

Biological Versus Synthetic Mesh in Clean and Contaminated Ventral Hernias In Annals of Surgery, Harris et al presented the results of the PRICE (Preventing Recurrence in Clean and Contaminated Hernias) trial, a single-blind, randomized controlled trial comparing the relative effectiveness of biological and synthetic meshes for the repair of ventral hernias under usual conditions (Ann Surg 2021;273[4]:648-655).

Despite the high incidence of incisional hernias, the optimal mesh choice for ventral hernia repair (VHR), especially in contaminated settings, remains up for debate. The use of biological mesh in contaminated hernias has gained popularity due to its perceived superiority in an infectious environment; however, evidence of its efficacy is limited and there is burgeoning evidence suggesting synthetic mesh may be safely used in contaminated hernias as well (J Am Coll Surg 2020;230[4]:405-413). The authors sought to compare the recurrence and complication rates of biological versus synthetic mesh for repairing ventral hernias under real-world, both clean and contaminated, conditions.

Adult patients undergoing elective VHR were randomized at a single institution to open repair with a biological (non-crosslinked porcine acellular dermal matrix [Strattice, LifeCell] or synthetic mesh [Barrier-coated Ventralight ST or Soft Mesh, CR Bard]).

Prior to randomization, participants were stratified by comorbidity index, wound class and surgical technique (bridging defect vs. mesh reinforcement) to ensure balanced groups. Standardized surgical techniques were used; however, surgeon discretion was permitted for whether to perform an onlay, sublay or overlay, as well

as unilateral or bilateral rectus myofascial advancement flaps. The primary outcome was hernia recurrence at two years, as identified on clinical exam or imaging study. The secondary outcome was complication rate at discharge, one month and three-month follow-up.

A total of 165 participants were randomized: 82 to biological mesh and 83 to synthetic mesh. At two years, the risk for recurrence was significantly higher in the biological group than the synthetic group (39.7% vs.

21.9%; P=0.018). In the contaminated-wound subanalysis, the increased risk for recurrence among patients with biological mesh persisted (50.0% vs. 5.9%; P=0.041).

There was no significant difference in hospital length of stay, readmission rate or complications between the groups. There was one severe adverse event related to the index admission—an in-hospital death from fungal sepsis after VHR with synthetic mesh. Six mesh explants occurred at an average of 2.2 years postoperatively, one in the biological group for enterocutaneous fistula development and five in the synthetic group for chronic mesh infection.

This study is the first to provide randomized, pragmatic data comparing biological and synthetic meshes in VHR under real-world conditions. The results are in line with other recent retrospective and nonrandomized studies supporting the use of synthetic mesh in contaminated VHR (Hernia 2018;22[6]:1045-1050).

However, there are important limitations to note in this study. The study did not reach its goal sample size of 250 to adequately power its subanalyses by wound contamination, hernia size and patient comorbidities.

Further, there were a number of dropouts within the two-year follow-up period, disproportionately occurring in the biological mesh group. Additionally, while the authors state that surgical technique was standardized, there were a relatively large number of surgical options considering the sample size. Despite no significant difference in technique between groups, the larger proportion of component separation performed in the synthetic mesh group may have clinical relevance.

Finally, the study only evaluated one type of biological mesh and two types of synthetic mesh, limiting generalizability to other brands of mesh with differing mechanical profiles. While additional randomized, pragmatic clinical trials with larger sample sizes evaluating specific surgical techniques and mesh location, with multiple centers, and differing mesh profiles are needed, this study provides further, compelling evidence that synthetic mesh may be a product to consider in the treatment of contaminated ventral hernias.

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1. Christensen E, Birkenkamp-Demtroder K, Sethi H, et al. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients With Urothelial Bladder Carcinoma. J Clin Oncol. 2019;37(18):1547-1557.

2. Reinert T, Henriksen TV, Christensen E, et al. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019.

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IN THE NEWS

GENERAL SURGERY NEWS / JULY 2021

First Look: The American Society of Colon and Rectal Surgeons All Articles by CHRISTINA FRANGOU

The American Society of Colon and Rectal Surgeons (ASCRS) held its 2021 meeting virtually this spring.

Here, General Surgery News presents some of the top papers from the meeting.

The TINGLE Trial: TAP Block With Liposomal Bupivacaine Not Supported A liposomal bupivacaine block does not provide superior or extended analgesia for minimally invasive colorectal surgery, according to results from the first randomized trial comparing liposomal bupivacaine with bupivacaine plus epinephrine and dexamethasone for transversus abdominis plane blocks.

“While the ideal TAP block medication isn’t known, the very expensive liposomal bupivacaine [Exparel, Pacira] doesn’t seem to offer any benefits above our recommended mixture of bupivacaine, epinephrine and dexamethasone, which is highly effective, cheap and readily available,” said author Adam Truong, MD, the chief surgical resident at Cedars-Sinai Medical Center, in Los Angeles.

The study is published in Diseases of the Colon & Rectum (2021;64[7]:888-898).

In the single-center trial, 102 adult patients undergoing minimally invasive colorectal surgery were randomized 1:1 to receive a laparoscopic TAP block with liposomal bupivacaine or bupivacaine with epinephrine and dexamethasone.

There was no difference in the primary end point of total oral morphine equivalents administered within 48 hours after surgery. Patients received 69 mg in the liposomal bupivacaine group and 47 mg in the group with bupivacaine plus epinephrine and dexamethasone (difference

in median 95% CI, –17 to 49 mg; P=0.60).

Emily Carter Paulson, MD, an associate professor of clinical surgery at the University of Pennsylvania, in Philadelphia, noted that the difference in postoperative morphine use could be clinically significant, even though it was not statistically significant. “It seems that a 50% difference in opioid usage is pretty significant,” she said.

The study had 84% power to detect a 15-mg mean difference in 48-hour morphine requirement, Dr. Truong said.

There were no significant differences in pain scores, time to ambulation, time to diet tolerance or bowel movement, length of stay, overall complications or readmission rates between the two groups.

The average wholesale price of liposomal bupivacaine is $336.22 compared with $5.47 for a TAP block with bupivacaine plus epinephrine and dexamethasone.

Dr. Truong said the study could not be conducted in a double-blind fashion, as the investigators were required to document the administered TAP block medication into the medication administration record. In order to conceal the treatment assignment, the team performed several methods, such as employing a single investigator who was not part of the treatment team to manage randomization and handling of medications.

The paper was first presented at the ASCRS in 2020 and received the New England Society of Colon & Rectal Surgeons Award. It was presented this spring as part of the “best of 2020” session.

Gender Differences In Remuneration in Colorectal Surgery Male surgeons perform more highly remunerated procedures in colorectal surgery than their female counterparts, contributing to a gender wage gap in colorectal surgery, according to an analysis of Medicare claims data.

Investigators examined nearly 63,000 Medicare claims submitted by board-certified colorectal surgeons between 2013 and 2017. Of these, only 16.9% were from female surgeons—a rate that increased annually, reaching 22.7% in 2017.

Analysis showed that, every year, male surgeons submitted more claims, submitted more highly reimbursed claims and used a greater number of procedural codes than female surgeons. Men and women were remunerated the same amount for performing the same procedures, but mean submitted charges per female surgeon in 2017 were $2,562 less than that for male surgeons ($16,614 vs. $19,176; P<0.0001). The same year, the average reimbursement for female surgeons was $4,193 compared with $4,962 for male surgeons, for a difference of $1,105 (P<0.0001).

At $689 per procedure, therapeutic endoscopy was the highest remunerated claim. Half of male surgeons who submitted Medicare claims performed therapeutic endoscopies, compared with only one-third of female surgeons (P<0.001).

In 2017, male surgeons submitted claims

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for 675 polypectomies, the most commonly performed therapeutic endoscopic procedure; female surgeons submitted 107.

In comparison, 41.8% of female surgeons obtained the majority of their income from outpatient clinic procedures. These are the lowest remunerated procedures at $189.

The study also showed that male surgeons utilize a higher proportion of procedural codes compared with female surgeons (98% vs. 46%; P<0.0001). Of the 147 unique codes used in 2017, 77 were used only by male surgeons compared with three that were used only by female surgeons.

The study did not look at private practice wage contributions, rank, and seniority of surgeons or academic and educational pursuits.

Lead author Nathalie Sela, MD, an abdominal transplant surgery fellow at the University of Nebraska Medical Center, in Omaha, said the study could not account for factors driving this wage gap. Other studies have shown that female surgeons receive fewer referrals and are quicker to lose referrals after a single negative outcome. They’re also more likely to have smaller clinical networks (Am J Surg 2020;220[1]:69-75).

“Understanding this unique gender equity will allow current surgeons to offer greater support and mentorship for future generations,” Dr. Sela said.

High-Risk Features in Stage II Colon Cancer Portend Worse Survival Than Stage III Disease A new analysis suggests that patients with multiple high-risk features in the presence of stage II colon cancer have worse survival than patients with stage III disease.

High-risk features “have a cumulative effect in stage II colon cancer,” said study author Brian Herritt, MD, a fifthyear resident in general surgery at Louisiana State University Health Sciences Center New Orleans.

These features include T4 lesions, perineural invasion, poor lymph node sampling of 12 nodes or fewer, and poor histologic differentiation.

Using the SEER*Stat database, Dr. Herritt and his colleagues compared the

IN THE NEWS

JULY 2021 / GENERAL SURGERY NEWS

overall and relative survival in five-year intervals of patients with stage II disease who were low risk, had one high-risk feature, or had two or more high-risk features, as well as patients with stage III disease.

The study included 65,828 patients.

As expected, patients with low-risk stage II disease had the highest five-year relative survival at 90%. This dropped to 82% among stage II patients with one high-risk feature. But stage II patients with multiple high-risk features had a marked drop in five-year relative survival—down to 59%—faring worse than stage III patients who had a relative survival of 68% at five years.

“I think this fairly definitely demonstrates that patients with stage II disease and high-risk features warrant additional treatment after surgery with curative intent,” Dr. Herritt said.

No single high-risk feature approached the mortality associated with multiple features. However, the worst survival in the study population for a single highrisk feature was inadequate nodal sampling at 62%.

Dr. Herritt said more research is needed to delineate the role that chemotherapy will play in patients with high-risk stage II disease. Right now, there is no consensus on use of chemotherapy in stage II disease. Multiple regimens have been proposed based on an individual’s risk factors, but there is no agreed-upon strategy.

Dr. Herritt said specific databases should be created to collect data on individual risk factors, clinical and genetic information, and patient outcomes.

The study was recognized with the General Surgery Forum Best Paper Award.

Medicaid Expansion Improved Early Diagnosis of Colon Cancer The adoption of Medicaid expansion led to earlier diagnoses of colon cancer for Medicaid patients, lessening one key cancer disparity between insured and uninsured Americans, according to a new study.

The finding comes from an analysis of the American College of Surgeons’ National Cancer Database for the years 2010 to 2017. Midway through the study period, on Jan. 1, 2014, states had the option to expand Medicaid by increasing eligibility to residents with household incomes up to 138% of the federal poverty level.

During the eight years studied, 162,805 patients between the ages of 18 to 65 years who had private or Medicaid insurance were diagnosed with colon cancer and registered with the database.

Investigators ranked hospitals into low-, medium- or high-adoption

categories based on the percentage of states in each U.S. Census Bureau division that adopted Medicaid expansion.

In areas with a high-adoption rate of Medicaid expansion, the percentage of late-stage colon cancer diagnoses declined, while there was no change in late-stage diagnosis in areas with low rates of Medicaid expansion. The low-adoption rate category consistently showed the highest percentage of latestage diagnoses, averaging over 60%.

Over the same period, people with private insurance were increasingly likely to have a late-stage colon cancer diagnosis,

rising from 47% in 2010 to 52% in 2017.

Analysis was performed to compare Medicaid patients with those with private insurance by eight factors: age, sex, Medicaid expansion, Medicaid adoption rate by division, race, income quartile, facility type and facility setting.

Multivariate analysis showed insurance type was the most significant factor affecting late-stage diagnosis, with an almost 30% increased odds of late-stage colon cancer diagnosis for patients with Medicaid insurance.

“We identified race, socioeconomic status and the rural setting to be factors

that lead to disparities in patient care, despite adjusting for Medicaid expansion,” said study author Mayin Lin, DO, MPH, a colon and rectal surgeon at MercyOne Des Moines Surgical Group, in Iowa.

She called on physicians and surgeons to promote access to care and preventive services for patients. “We can improve colon cancer stage diagnosis by promoting cancer screenings and surveillance,” she said.

The study received the Southern California Society of Colon & Rectal Sur■ geons Award.

NOW AVAILABLE

YOU KNOW THAT FACE. YOU KNOW WHAT IT’S TELLING YOU. AND NOW YOU HAVE A PROVEN OPTION. Barhemsys is the first and only antiemetic approved for rescue treatment of PONV despite prophylaxis.1 Learn more at Barhemsys.com ®

Indications Barhemsys is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist indicated in adults for: prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis • •

Select Important Safety Information Contraindication: Barhemsys is contraindicated in patients with known hypersensitivity to amisulpride.

QT Prolongation: Barhemsys causes dose- and concentration-dependent prolongation of the QT interval. The recommended dosage is 5 mg or 10 mg as a single intravenous (IV) dose infused over 1 to 2 minutes. Avoid Barhemsys in patients with congenital long QT syndrome and in patients taking droperidol. Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders, electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval.

Adverse Reactions: Common adverse reactions reported in ≥ 2% of adult patients who received Barhemsys 5 mg (N=748) and at a higher rate than placebo (N=741) in clinical trials for the prevention of PONV were: chills (4% vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3% vs. 2%), and abdominal distention (2% vs. 1%). Serum prolactin concentrations were measured in one prophylaxis study where 5% (9/176) of Barhemsys-treated patients had increased blood prolactin reported as an adverse reaction compared with 1% (1/166) of placebo-treated patients. The most common adverse reaction, reported in ≥ 2% of adult patients who received Barhemsys 10 mg (N=418) and at a higher rate than placebo (N=416), in clinical trials for the treatment of PONV was infusion site pain (6% vs. 4%).

Please see the Brief Summary of Prescribing Information for Barhemsys on next page.

1. Barhemsys [Prescribing Information], Indianapolis, IN. Acacia Pharma; 2020. Model used for illustrative purposes only.

Delivers when it matters most

™

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16

IN THE NEWS

GENERAL SURGERY NEWS / JULY 2021

AI for Surgeons: Current Realities, Future Possibilities

By VICTORIA STERN

I

n 2012, a patient arrived at Stanford University Medical Center with a large wound on his foot. The man had been walking on it for a month before coming in for care.

Elsie Gyang Ross, MD, quickly recognized the patient had a circulatory condition known as peripheral artery disease (PAD), in which vessels narrow and restrict or block blood flow to the

Delivers when it matters most

limbs. The condition affects an estimated 8 million to 12 million Americans but often goes undiagnosed. If left untreated, PAD can increase the risk for stroke and myocardial infarction or, in this case, lead to a wound that doesn’t heal.

Dr. Ross’ patient had wet gangrene of the foot and, even after antibiotics, debridement and revascularization, he ultimately required a below-knee amputation.

“But a lot can be done to treat patients

™

Brief Summary of Prescribing Information for Barhemsys® (amisulpride) injection See package insert for full Prescribing Information Indications: Barhemsys is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist indicated in adults for: • prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class • treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis Dosage & Administration: The recommended adult dosage of Barhemsys: • Prevention of PONV, either alone or in combination with another antiemetic: 5 mg as a single intravenous dose infused over 1 to 2 minutes at the time of induction of anesthesia.

• Treatment of PONV: 10 mg as a single intravenous dose infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure.

Protect from light. Barhemsys is subject to photodegradation. Administer Barhemsys within 12 hours of removal of the vial from the protective carton.

See full prescribing information for preparation and administration instructions.

Dosage Forms and Strength: Injection: 5 mg/2 mL (2.5 mg/mL) as a clear, colorless sterile solution in a single-dose vial.

Contraindication: Barhemsys is contraindicated in patients with known hypersensitivity to amisulpride.

QT Prolongation: Barhemsys causes dose- and concentration-dependent prolongation of the QT interval. The recommended dosage is 5 mg or 10 mg as a single intravenous (IV) dose infused over 1 to 2 minutes. Avoid Barhemsys in patients with congenital long QT syndrome and in patients taking droperidol. Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders, electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval.

Adverse Reactions: Common adverse reactions reported in ≥ 2% of adult patients who received Barhemsys 5 mg (N=748) and at a higher rate than placebo (N=741) in clinical trials for the prevention of PONV were: chills (4% vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3% vs. 2%), and abdominal distention (2% vs.

1%). Serum prolactin concentrations were measured in one prophylaxis study where 5% (9/176) of Barhemsys-treated patients had increased blood prolactin reported as an adverse reaction compared with 1% (1/166) of placebo-treated patients.

The most common adverse reaction, reported in ≥ 2% of adult patients who received Barhemsys 10 mg (N=418) and at a higher rate than placebo (N=416), in clinical trials for the treatment of PONV was infusion site pain (6% vs. 4%).

Drug Interactions: • Barhemsys causes dose- and concentration-dependent QT prolongation. To avoid potential additive effects, avoid use of Barhemsys in patients taking droperidol.

• ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval (e.g., ondansetron).

• Reciprocal antagonism of effects occurs between dopamine agonists (e.g., levodopa) and Barhemsys. Avoid using levodopa with Barhemsys.

Postmarketing Experience: The following adverse reactions have been identified during postapproval chronic oral use of amisulpride outside of the United States (Barhemsys is not approved for oral dosing or chronic use). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Blood and Lymphatic System Disorders: agranulocytosis; Cardiac Disorders: bradycardia, torsades de pointes, ventricular tachycardia, prolonged QT by electrocardiogram; General Disorders: neuroleptic malignant syndrome; Immune System Disorders: angioedema, hypersensitivity, urticaria; Hepatic Disorders: increased hepatic enzymes; Nervous System Disorders: agitation, anxiety, dystonia, extrapyramidal disorder, seizure; Psychiatric Disorders: confusional state, insomnia, somnolence; Vascular Disorders: hypotension.

Use in Specific Populations: Pregnancy—Risk Summary: Available data with amisulpride use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of amisulpride in rats and rabbits during the period of organogenesis at exposures about 43 and 645 times, respectively, the exposure delivered by the highest recommended human dose (see Data). The estimated background risk of

before we need to consider surgery, such as coronary angiography,” Dr. Ross, an assistant professor of surgery and medicine at the Stanford University School of Medicine, in California, told General Surgery News.

In particular, Dr. Ross said, what if clinicians could use artificial intelligence to diagnose patients sooner or predict who

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. Data—Animal Data: Reproduction studies of amisulpride were conducted in pregnant rats administered oral doses up to 160 mg/kg/day (43 times the exposure based on area under the curve (AUC) at the highest recommended dose of 10 mg) throughout the period of organogenesis. No adverse embryo-fetal developmental effects were observed at any dose level. Maternal animals exhibited a dose-related decrease in overall mean body weight gain. In rabbits administered amisulpride throughout the period of organogenesis, oral doses up to 210 mg/kg/day (645 times the exposure based on AUC at the highest recommended dose of 10 mg) had no adverse developmental effects on the fetus. Maternal animals exhibited reduced mean body weight gain at doses of 100 and 210 mg/kg/day and reduced food intake was observed at 210 mg/kg/day. The pre- and post-natal developmental effects of amisulpride were assessed in rats administered oral doses of 60, 100 or 160 mg/kg/day during the periods of organogenesis and lactation. At 160 mg/kg/day (43 times the exposure based on AUC at the highest recommended dose of 10 mg), maternal animals exhibited a reduction in mean body weight gain and decrease in food intake during lactation. Amisulpride had no effect on maternal pregnancy parameters, litter survival or pup growth, development or maturation at any dose tested.

Lactation—Risk Summary: Based on case reports in published literature, amisulpride is present in human milk at concentrations that are 11- to 20-fold higher than human plasma in patients taking multiple oral doses of amisulpride (200 to 400 mg/day).

The estimated infant daily dose ranged from 5% to 11% of the maternal dose. There are ways to minimize drug exposure to a breastfed infant (see Clinical Considerations).

There are no reports of adverse effects on the breastfed child and no information on the effects of amisulpride on milk production. The pharmacological action of amisulpride, a dopamine-2 (D2) receptor antagonist, may result in an increase in serum prolactin levels, which may lead to a reversible increase in maternal milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Barhemsys and any potential adverse effects on the breastfed child from Barhemsys or from the underlying maternal condition. Clinical Considerations: A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 48 hours after Barhemsys administration to minimize drug exposure to a breastfed infant.

Females and Males of Reproductive Potential—Infertility: In animal fertility studies, administration of repeated doses of amisulpride over a 10-day period to female rats resulted in infertility that was reversible. Pediatric Use—Safety and effectiveness in pediatric patients have not been established. Geriatric Use—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. Renal Impairment—Avoid Barhemsys in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2). The pharmacokinetics of amisulpride in patients with severe renal impairment have not been adequately studied in clinical trials.

Amisulpride is known to be substantially excreted by the kidneys, and patients with severe renal impairment may have increased systemic exposure and an increased risk of adverse reactions. No dosage adjustment is necessary in patients with mild to moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m2).

Overdosage: Doses of oral amisulpride (Barhemsys is not approved for oral dosing) above 1200 mg/day have been associated with adverse reactions related to dopamine-2 (D2) antagonism, in particular: • cardiovascular adverse reactions (e.g., prolongation of the QT interval, torsades de pointes, bradycardia and hypotension).

• neuropsychiatric adverse reactions (e.g., sedation, coma, seizures, and dystonic and extrapyramidal reactions).

There is no specific antidote for amisulpride overdose. Management includes cardiac monitoring and treatment of severe extrapyramidal symptoms. Since amisulpride is weakly dialyzed, hemodialysis should not be used to eliminate the drug.

How Supplied/Storage and Handling: Barhemsys is supplied as follows: Package of 10 cartons (NDC 71390-125-20). Each carton (NDC 71390-125-21) contains one singledose vial of clear, colorless, sterile solution of Barhemsys, 5 mg in 2 mL (2.5 mg/mL).

Store vials at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Patient Counseling Information: QT Prolongation—Instruct patients to contact their healthcare provider immediately if they perceive a change in their heart rate, if they feel lightheaded, or if they have a syncopal episode. Drug Interactions—Advise patients to report to their healthcare provider if they are taking drugs which prolong the QT interval. Lactation—Women may consider reducing infant exposure through pumping and discarding breastmilk for 48 hours after Barhemsys administration.

Barhemsys® is a registered trademark of Acacia Pharma Limited. © 2021 Acacia Pharma Inc. All rights reserved. PP-BAR-1776 04/2021 Acacia Pharma Limited and Acacia Pharma Inc. are wholly owned subsidiaries of Acacia Pharma Group Plc.

BAR HCP BS 03/2020

‘AI is there to make us better.

It should run quietly in the background, catching our blind spots and helping us make more informed decisions about patient care.’

—Elsie Gyang Ross, MD would develop PAD so patients can begin treatment earlier and avoid surgery?

In 2014, Dr. Ross, along with her colleagues at Stanford University’s Center for Biomedical Informatics Research, began evaluating machine learning algorithms to identify patients at risk for PAD. Machine learning algorithms— mathematical tools that help make sense of data—learn from experience. In other words, the more data fed into the algorithm, the more accurate the diagnosis or prediction becomes.

A 2016 analysis described the process of constructing machine learning models using data from 1,755 patients who had undergone elective coronary angiography but whose PAD status was unknown.

Dr. Ross and his team found that the machine learning algorithms could recognize PAD and predict mortality better than standard linear regression models (J Vasc Surg 2016;64[5]:1515-1522.e3). A 2019 study that included 7,686 patients with PAD and incorporated almost 1,000 variables from electronic health records reported that the machine learning models could accurately forecast which PAD patients would develop major cardiac and cerebrovascular events (Circulat Cardiovasc Qual Outcomes 2019;12).

The goal of these models and others, Dr. Ross explained, is not for machine learning or its operationalized counterpart, AI, to take over care or make decisions for surgeons. “AI is there to make us better,” she said. “It should run quietly in the background, catching our blind spots and helping us make more informed decisions about patient care.”

Developing and validating AI and machine learning models takes time and an enormous amount of data before they can be integrated into clinical practice. However, interest in AI technology has ballooned in the past few years, with approvals by the FDA increasing from just two at the end of 2017 to more than

IN THE NEWS

80 by September 2020.

At the 2020 American College of Surgeons Clinical Congress, Dr. Ross, along with Genevieve B. Melton-Meaux, MD, PhD, FACS, and Rachael A. Callcut, MD, FACS, explored the latest advances in surgical AI, highlighting tools that can improve diagnosis, decision making and outcomes in surgery (abstract PS424).

In addition to diagnosing and prioritizing more urgent cases, AI-based tools can help predict outcomes or improve surgeons’ performance in the OR. During her talk, Dr. Ross discussed an imaging platform that guides surgeons during endovascular aneurysm repair. The intraoperative image-based, 3D, fusion CT automates conversion of preoperative scans into 3D models and, in the OR, overlays these images onto the patient’s live fluoroscopy to highlight where the renal arteries are and where a guide wire should go.

“Preliminary use of this technology has decreased important metrics for vascular surgeons, such as radiation exposure as well as fluoroscopy and procedure time,” Dr. Ross said, pointing to a 2018 abstract published in the Journal of Vascular Surgery (2018;67[6]:E61).

As for outcomes, Dr. Melton-Meaux highlighted a risk prediction model called POTTER—Predictive OpTimization Trees in Emergency surgery Risk—that calculates a patient’s risk for 30-day mortality and 18 postoperative complications. Surgeons can use the POTTER app to determine a range of risk factors by answering a series of questions that change depending on the previous response.

An analysis published in Annals of Surgery in 2020 showed that in 29,366 patients undergoing emergency surgery, the model accurately predicted mortality in all patients over 65 years of age, and also septic shock, respiratory failure requiring mechanical ventilation, and acute renal failure (Ann Surg 2020 Dec 23. [Epub ahead of print]).

“It is clear that health care is digitizing rapidly and that AI will permeate it increasingly and in profound ways,” Dr. Melton-Meaux, a professor of surgery and Core Faculty of the Institute for Health Informatics at the University of Minnesota, in Minneapolis, said during her ACS talk.

Despite these trends, Dr. Callcut cautioned that “we’re still in the hype cycle of AI—a lot of excitement but the applications have not been scaled yet.”

Dr. Ross agreed, highlighting other limitations and challenges of AI. “AI is also not going to do robotic surgeries for us. That vision of AI is far off, especially given the technology we have now.”

The advantages of AI center on assisting physicians’ management of their patients by helping to make difficult, time-sensitive diagnoses, prevent postoperative complications, and increase the accuracy and efficiency of surgery.

“We don’t want to do AI for AI’s sake, but if we can make a dent in improving surgical outcomes and decreasing physician burden, investing in AI-based ■ technology is worthwhile,” Dr. Ross said.

Tips on Being an Expert Witness

By MONICA J. SMITH

W

hen medical issues turn into legal ones, attorneys often call on medical professionals—doctors, nurses and operating room managers—to inform the case and help make decisions on how to proceed.

Serving as an expert witness has its perks, but there’s a lot to consider before taking on this responsibility.

At the 2020 OR Manager conference, Rosemary Welde, MBA, BCC, RN, drew on her 30 years’ experience as an expert witness to thoroughly explore the role.

“Either you’re already doing expert witness work and building clients, or you’ve taken a course and gotten certified. Somehow or another, an attorney got your number and contacted you. What do you need to do?” Ms. Welde said.

What Does It Take to Be One, and Why Would You Want to?

The function of an expert witness is to draw from their own expertise in order to express an independent opinion relevant to the case. Some states require physicians testifying in a malpractice case to be of the same specialty, and some require the expert to be licensed in the same state.

“The qualifications include specific on-the-job experience, usually an advanced degree in a particular field; excellent communication, organizational and research skills; and flexibility in your schedule,” Ms. Welde said.

The work pays well, averaging $350 per hour for medical expert witnesses and $500 per hour for medical expert testimony, but this varies by degree and with experience.

“As I’ve gained experience and expertise in multiple areas, I’ve raised my rates,” said Bruce Ramshaw, MD, a managing partner at CQInsights, a health care data analytics firm in Knoxville, Tenn. “Consulting as a medical expert is one of the few areas for physicians in health care where you can be reimbursed what your expertise is worth, whereas most of what we do clinically is negotiate with insurers for rates based on negotiating power rather than expertise or outcomes.”

When You Should Take a Case and When You Shouldn’t There are a number of elements to consider when you’re asked to serve as an expert witness. First and foremost, does your experience apply?

“Usually when I decline a case, it’s because I don’t feel it’s an area of my expertise, and that expertise has changed over time,” said Dr. Ramshaw, whose clinical work has shifted from a broader general surgery practice to primarily focusing on hernia repair in the past 15 years.

Also, be certain you don’t know anyone involved in

the case. “If you know any of the involved parties—the surgeon, nurses or anesthesiologist—legally you cannot serve as an expert,” Ms. Welde said.

Finally, determine whether you will be available for meetings, deposition and, if the case goes to court, trial.

Depositions usually last about two hours depending on the complexity of a case. “But if the case goes to trial, you’ll need to be available for at least two weeks,” Ms. Welde said.

‘Consulting as a medical expert is one of the few areas for physicians in health care where you can be reimbursed what your expertise is worth, whereas most of what we do clinically is negotiate with insurers for rates based on negotiating power rather than expertise or outcomes.’

—Bruce Ramshaw, MD Moving Forward and Preparing Once you’ve decided to take a case, you’ll have to deal with the nuts and bolts of compensation. “The insurance carrier of the attorney’s client will need to approve your CV and fee schedule for you to be an expert in the case,” Ms. Welde said. “Then you’ll need to agree on a billing process.”

Dr. Ramshaw’s approach to reviewing a case starts with a general but thorough overview. “I go through the information available with an open mind, putting myself in the treating physician’s shoes at the time of the treatment. Once I understand that information, I go back and focus on areas I think are really important, to develop a whole story.”

Ms. Welde keeps an eye out for red flags while reviewing preoperative records, anesthesia notes, intraoperative records and postoperative notes. “Some things you’ll want to consider are the length of the procedure, blood loss, number of staff involved and complications.”

Most important, ask yourself if the standard of care was met. “This is absolutely critical and is one thing you’ll be asked at the deposition: What is the standard of care and was it met?” Ms. Welde said.

Often, the case is resolved after the depositions are taken. “In my experience, cases go to trial less than 10% of the time,” Dr. Ramshaw said. “It’s a grueling process for everyone involved, with a lot of potential for secondary victims. Nobody wins emotionally, so both sides are under some incentive not to take it to court.”

■

17

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

A Smart Surgical Stapler: Advantages of Full-Powered Functionality Andrew Wheeler, MD General Surgeon Chief of Metabolic and Bariatric Surgery University of Missouri Health Care Columbia, Missouri

Intelligent Surgical Stapling Surgical staplers continue to evolve, and the more sophisticated devices are notable for their consistency in delivering well-formed and reliable staple lines.1,2 Powered devices were introduced a decade ago to reduce variability in surgical stapling.2,a,b For the last 3 years, Andrew Wheeler, MD, a bariatric surgeon at the University of Missouri Health Care in Columbia, Missouri, has used the landmark Signia™ stapling system because of its advanced features (Figure 1). Dr Wheeler credits the single-handed operation,3,c powered functions,3,c and tissue-sensing technology before and during staple firing.4,5,a

Fewer Malformed Staples Before switching to the Signia™ stapler, Dr Wheeler had a low complication rate in his laparoscopic bariatric surgery practice, but nonetheless encountered intraoperative staple-line bleeding, particularly in sleeve gastrectomies. He was thus drawn by the potential value of the Signia™ system tissue-sensing technology.4,5,a “The hope was that with more consistent staple lines, a level of complete hemostasis would be achieved more reliably,” Dr Wheeler said.

He credits the Signia™ stapler with optimizing staple formation.4,5,a “If the tissue is thick, for example, staples are not reliably driven through to the anvil. When this happens, the staples tend to malform, which is a common concern for surgeons.”

Although malformed staples can occur across tissue thicknesses, manufacturer studies reveal consistently lower staple malformation rates in thick tissue with the Signia™ stapler. In one such preclinical experiment, Signia™ yielded a 2.8% malformed staple rate compared with 19.7% with an alternative contemporary system.6,d,e Another study found that Signia™ produced 3 times fewer malformed staples than a competing powered stapler.7,a,f

Adaptive Firing Speed and Feedback The Signia™ device measures forces on tissue in real time and provides audible and visual feedback when

18

GENERAL SURGERY NEWS • JULY 2021

used with any reload with Tri-Staple™ technology.4,5,8,a,d This tissue-sensing technology optimizes staple formation by adjusting the firing speed when stapling in tissue of variable thickness.4,5,a “Force and tissue thickness are correlated,” Dr Wheeler said. “The Signia™ device measures the firing force which is an indirect measure of tissue thickness.”

An OLED screen readily visible in the handle of the stapler identifies zones based on clamp force measurement.4,5,a The firing speed adapts to these measurements, slowing as tissue thickness climbs from zone 1, the lowest, to zones 2 and 3. The clamp force is measured continuously, providing surgeons with guidance before and during stapling and tissue division (Figure 2).4,5,a “If the measurement moves to zone 3, I have a chance to consider the reason,” Dr Wheeler said. “If unexpected, it could mean I have closed on another staple line or a clip, or the tissue is too thick for that particular staple load. In some cases, I might wait for a few seconds for the edema to decrease at the staple line. Sometimes that’s enough, but this information prevents me from forcing the firing, which threatens the quality of the staple formation.” According to Dr Wheeler, it is this technology that achieves “the shape needed for a secure line.”5,9,10,a,g The value of the smart technology lies in the guidance it provides for achieving the appropriate force and speed of stapling and enabling the surgeon to make informed decisions about staple load selection during a procedure.4,5,8,a,d If the tissue at the staple line is thicker than expected, for example, Dr Wheeler might size up to a more appropriate reload. Although Dr Wheeler had been comfortable with manual stapling devices, he believes the tissue-sensing technology is an unbiased measure and reduces the risk for misinterpreting the feel of the tissue. “With the Signia™ stapler, the resistance that comes with manual clamping is not felt. Instead, the 3-zone dial gives you a relative indication for tissue thickness,” he said.4,5,8,a,d,h The Signia™ stapler will reduce the firing speed when it reaches thicker or variable tissue,4,5,a but Dr Wheeler nonetheless pays close attention to the feedback before firing and as the staple line advances. As the device encounters differences in the varying forces necessary to fire staples, the real-time feedback alerts him to the need for adjustments.4,5,8,a,d He might change his next reload selection, for example, with an elevated compression force reading from the screen.

Dr Wheeler emphasized that smart technology helps

surgeons make informed choices for each patient and recognizes the benefits it brings to his practice.8,d

Fully Powered Features Dr Wheeler said the feedback from the Signia™ stapler helps establish the relatedness of tissue thickness, firing force, and optimal staple formation4,5,a and is therefore useful for training fellows. An appreciation of this relationship, he said, can play a role in preventing potential complications, such as malformed staples and bleeding.2,4,5,a,b In addition, he considers the Signia™ stapler a good training tool because of its single-handed

Figure 1. The Signia™ stapler.

Figure 2. An indicator shows forces on tissue before firing to help assess load selection (left). Visual cues show that firing speeds are adjusting to optimize staple formation in variable tissue thicknesses (right).a Based on references 4 and 5.

Supported by

The Signia™ stapler is compatible with the Endo GIA™ reloads with Tri-Staple™ technology and Tri-Staple™ 2.0 reloads (Figure 3). In addition, cartridges with preloaded buttress material are available, which Dr Wheeler uses for most, but not all, transections.

Tri-Staple™ technology provides 3 rows of variedheight staples in each of the reload cartridge types instead of the 2 rows of uniform-height staples of the predecessor to Tri-Staple™ technology. The lower staple height in the row closest to the closure line means a more secure seal where hemostasis is more important.13-15,d,j Staple heights are incrementally higher in the second and third rows. As the tissue is clamped, the stepped cartridge face delivers graduated compression, reducing stress on the tissue.16,17,k,l The greater height of the 2 adjacent staple rows preserves perfusion.18,k In addition, cartridges are colorcoded for tissue thickness indications. For sleeve gastrectomies, Dr Wheeler commonly starts with black reload cartridges, which are designed for extrathick tissue, but he individualizes the cartridge size for each case. Dr Wheeler thinks Tri-Staple™ technology

1. Chekan E, Whelan RL. Surgical stapling device—tissue interactions: what surgeons need to know to improve patient outcomes. Med Devices (Auckl). 2014;7:305-318.

2. Kimura M, Terashita Y. Superior staple formation with powered stapling devices. Surg Obes Relat Dis. 2016;12(3):668-672.

Figure 3. The Signia™ stapler is compatible with the Endo GIA™ reloads with Tri-Staple™ technology and Tri-Staple™ 2.0 reloads.

3. Data on file. Signia™ stapling system summative usability report. Internal test report #RE00024826 rev D. Medtronic; September 2016.

4. Data on file. ASA verification testing with slow speed force limit evaluation. Internal test report #R2146-173-0. Medtronic; 2015.

5. Data on file. Powered stapling firing speed DOE analysis and ASA parameters. Internal test report #R2146-151-0. Medtronic; 2015.

contributes to the good hemostasis and leak resistance he associates with the Signia™ stapler.13-15,d,j

6. Data on file. Internal test report #PCG-029. Intuitive Surgical™ stapling competitive analysis. Medtronic; June 2017.

Conclusion

7. Data on file. Signia™ stapling system competitive claims. Internal test report #PCG-028. Medtronic; March 27, 2017.

According to Dr Wheeler, the feedback provided by the tissue-sensing technology,4,5,a powered functions, and single-handed operation3,c represent meaningful technological advances and are valuable for ensuring the quality of the staple line.9,10,a,g Staple-line integrity13,14,d,j and increased perfusion18,k are further ensured by the Tri-Staple™ technology with graduated compression and varied-height staples. “Even oozing along the staple line has become an uncommon event with the Signia™ stapler in my procedures,” Dr Wheeler said. “The results I have seen have been reassuringly consistent.”

8. Data on file. Surgeon evaluation testing Signia™ stapling system sensing technology and real-time feedback. Internal test report #RE00055515. Medtronic; August 4, 2016.

9. Data on file. Signia™ stapling adaptive firing technology data calculations and references. Internal report #RE00218740. Medtronic; August 7, 2019.

10. Data on file. 4.5 mm round staple pull-apart analysis report. Internal test report #RE00147607. Medtronic; 2018.

11. Data on file. Signia™ power stapler center of mass.

Based on internal report #RE00027558. Medtronic; 2015.

a

Preclinical results may not correlate with clinical performance in humans.

b

Ethicon™ powered stapler versus manual stapler.

c

Thirty-eight out of 38 surgeons surveyed agreed.

d

Bench test results may not necessarily be indicative of clinical performance.

e

Compared Medtronic Endo GIA™ purple reload with Tri-Staple™ technology with Intuitive™ Surgical’s green staple cartridge.

14. Data on file. In-vitro leak comparison. Internal test report #PCG-002. Medtronic; March 8, 2011.

f

Compared with Ethicon™ powered stapler with GST technology.

g

15. Contini E, Whiffen J, Bronson D. Comparison of endostapler performance in challenging tissue applications. Surg Obes Relat Dis. 2013;9(3):417-421.

Compared with manual and fixed-speed powered staplers.

h

P<0.001

i

Compared with manual staplers or EES Echelon Flex™ during placement.

j

Staple-line strength: Endo GIA™ tan reload versus Echelon Flex™ white reload and Endo GIA™ purple reload versus Echelon™ green, gold, and blue reloads. Leak resistance: in vitro synthetic leak comparison: Endo GIA™ purple reload versus Echelon™ blue and gold.

12. Data on file. iDrive™ Ultra stapler PCR summary report.

Internal report #R0033554. Medtronic; November 2012.

13. Data on file. Tyvek pull-apart test comparing Echelon™ and Tri-Staple™ technology. Internal test report #PCG-001. Medtronic; March 2011.

16. Data on file. Perfusion into clamped media. Internal test report #PCG-007 rev 1. Medtronic; September 2, 2011.

17. Data on file. 2-D FEA of linear staplers. Internal test report #PCG-018. Medtronic; November 2012.

18. Data on file. Final analysis of staple-line vascularity using MicroCT. Internal test report #2128-002-2.

Medtronic; July 2015.

k

Compared with flat-faced cartridges with single-height staples.

Disclosures: Dr Wheeler reported receiving research support from Allena Pharmaceuticals, Ethicon, and Medtronic. He is a consultant to Ethicon and Microline Surgical.

l

Compared with Echelon Flex™ green reload analysis comparing different stapler designs, performance, and impact on tissues under compression using 2D finite element analysis.

This is one surgeon’s experience, results, and recommendations.

Results may vary from surgeon to surgeon. Please see the package insert for the complete list of indications, warnings, and precautions, and other important medical information.

GENERAL SURGERY NEWS • JULY 2021

05/2021-US-ST-2100075

Tri-Staple™ Technology

References

BB213

operation.3,c “It is well balanced and has a good feel in the hand, including for surgeons with small hands,” Dr Wheeler said.11,d Whether for trainees or experienced surgeons, the single-handed operation frees the other hand for other tasks.3,c “If you need to maneuver the device, the free hand is available to hold or pull away tissue, which is more complicated if both hands are occupied,” Dr Wheeler said. “If you are using your left hand when maneuvering tissue to avoid an adjacent organ or for appropriate tissue retraction, you don’t have to let go of that tissue because you can still fire with the hand holding the device.”

The single-handed functionality is made possible by the powered features, including articulation, rotation, clamping, and firing.3,c In Dr Wheeler’s experience, nonpowered devices permit only limited movement in either direction from the midline.

The powered movement provides greater precision and maneuverability,12,i which means less movement of the stapler itself. By positioning the stapler with greater precision, there is an opportunity for better closure with less risk for iatrogenic adverse events.1,12,i “When I am using the stapler where placement is challenging, such as behind the stomach, the power functions are helpful for maneuvering to deliver staples more precisely,” Dr Wheeler said.12,i “For the trainee, the powered articulation and rotation means that there is more forgiveness if the stapler needs to be realigned. You don’t need to pull it away from the tissue but are better able to make the adjustments without repositioning.”12,i

19

20

IN THE NEWS

GENERAL SURGERY NEWS / JULY 2021

Gaps in Pediatric Trauma Care: Meeting the Demands

By VICTORIA STERN

A

fter a traumatic injury—a gunshot wound, severe concussion, broken bone—in a child, emergency care will be needed.

Injuries remain the leading cause of death among children in the United States, accounting for about 30 million or 21% of emergency department visits each year, but about half of these children are not treated by a pediatric-trained emergency physician or in a pediatric trauma center (N Engl J Med 2018;379:2468-2475; GAO report).

A major reason for this situation is infrastructure and access limitations. Of the 6,000 hospitals in the United States, about 170 are Level I or II pediatric trauma centers. Further, most of these centers are concentrated near cities, leaving large expanses of rural areas without pediatric-centered care. In fact, about one in four children live more than an hour by car or plane from a pediatric trauma center.

Limited opportunities to train a pediatric surgery‒specialized workforce also have led to gaps in pediatric emergency care. Pediatric surgeons represent a small fraction of practicing surgeons in the country—estimated at 1,000 compared with 18,000 active general surgeons.

“Trauma is a team sport, but outside of high-level pediatric trauma centers and high-level adult trauma centers that routinely care for children, many providers simply do not have the training or resources to deliver high-quality care to children,” Mary Fallat, MD, a professor of surgery at the University of Louisville in Kentucky, told General Surgery News.

At the 2021 Eastern Association for the Surgery of Trauma Annual Scientific Assembly, Dr. Fallat gave the keynote lecture, tracing the long-standing gaps in pediatric trauma care, and outlined efforts to develop and integrate pediatric standards of care into the blueprint of the U.S. trauma system.

A History of ‘Uneven’ Access In medical school, Dr. Fallat knew pediatric surgery was her calling. Over the next 40 years, she championed pediatric-centered emergency care—starting the first pediatric trauma service in Louisville in 1989, training the latest crops of pediatric surgeons and spearheading leadership roles at the American College of Surgeons to improve pediatric emergency care, and leading the Emergency Medical Services (EMS) for Children Program in Kentucky.

But during this time, Dr. Fallat also saw a glaring problem: As America’s trauma care system developed roots

and standards of care within hundreds of hospitals nationwide, children largely remained on the fringes of the conversation.

A 2006 report from the Institute of Medicine characterized pediatric emergency care in this country as “uneven.” In the report, Dr. Fallat and pediatric subcommittee co-authors detailed a host of deficiencies: a lack of pediatric supplies in the emergency department, inconsistent practice patterns and coordinated

care across institutions and providers, and geographic disparities.

One reason for these deficiencies is that children constitute a small fraction of the patients providers encounter, especially those in rural areas.

“Some hospitals only treat five to 14 children a day and hospital administration may be hesitant to spend the money or allocate resources for pediatric emergencies, if they do not encounter many,” Dr. Fallat said.

However, Dr. Fallat stressed, being pediatric ready—implementing guidelines, tools and training to provide optimal care for children—can save lives. A recent retrospective cohort study, focusing on 20,483 critically ill children up to 18 years of age presenting to 426 hospitals in four states, found that as a hospital’s pediatric readiness scores increased, in-hospital pediatric mortality decreased—11.1%, 5.4%, 4.9% and 3.4% by lowest to highest readiness quartile (Pediatrics 2019;144:e20190568).

For complex hernia repair

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

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

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

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

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

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JULY 2021 / GENERAL SURGERY NEWS

Increasing Pediatric Readiness The first step to improving readiness is to identify where the gaps are.

In 2013, Kate Remick, MD, FAAP, FACEP, FAEMS, an associate professor in the Departments of Pediatrics and Surgery, Dell Medical School at The University of Texas, in Austin, and her colleagues embarked on a large-scale project evaluating the pediatric readiness of thousands of emergency departments across the country. The analysis revealed that 4,146 respondents, representing 82% of U.S. emergency departments, had a median score of 69 out of 100, up from 55 in

2003 (JAMA Pediatr 2015;169[6]:527534). Results showed that emergency departments had improved markedly, but that many still lacked essential tools and training, and less than half reported having pediatric quality improvement processes or disaster plans that include children.

“A particularly striking finding was that a large proportion of pediatric emergency department visits are happening in rural and remote areas, not urban centers where most pediatric trauma centers exist,” said Dr. Remick, the EMS director for the pediatric emergency medicine fellowship at Dell Medical School. “Now

A recent study found that as a hospital’s pediatric readiness scores increased, in-hospital pediatric mortality decreased—11.1%, 5.4%, 4.9% and 3.4% by lowest to highest readiness quartile.

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

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

91.7 7 YEARS %

†

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

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

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

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

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

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

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

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

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

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

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

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

DON’T MESH AROUND

that we’re aware of the needs and resource limitations, we can put strategies in place to drive improvements.”

But launching a quality improvement effort on this scale takes planning and time. To begin enhancing quality, Drs. Fallat and Remick, and a team of experts developed a pediatric readiness tool kit aligned with national guidelines that provides a checklist of equipment, supplies, medications and protocols that physicians, nurses and departments need at their fingertips during emergencies.

To improve access, Dr. Fallat and her colleagues, through the American Pediatric Surgical Association, are also working on an initiative to expand telehealth options for pediatric patients in rural areas, where the majority of pediatric trauma deaths occur and where surgical and trauma specialty care often is not readily available (Health Aff 2019 Nov 20).

Dr. Fallat also recently created a task force to develop pediatric trauma curricula that can be integrated into traditional training.

“Pediatric surgeons, trauma surgeons and pediatric emergency medicine need to lead the charge in establishing training, spreading our knowledge of pediatric trauma care and engaging providers along the continuum of care, including in geographic areas where there are no high-level trauma centers,” Dr. Fallat said.

Dr. Remick agreed: “We need a groundswell, an army of providers willing to stand up and advocate on behalf of children and be pediatric champions on the front lines, and it’s exciting to see a lot of the pieces coming together.”

That support is growing. According to Dr. Remick, 17 states have established a pediatric facility recognition system, a state initiative that recognizes and encourages emergency departments to prioritize and meet established readiness standards.

A 2020 analysis showed that states with such a system in place demonstrated significantly higher pediatric readiness scores (J Pediatr 2020;218:210-216.e2).

“The privilege of my career will be knowing these philosophies are being embraced and that I will be leaving things in good hands when I retire,” Dr. ■ Fallat said.

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GENERAL SURGERY NEWS / JULY 2021

Using New Technology to Improve Surgical Outcomes QUESTIONS for Rafael J. Grossmann, MD From Isabel Elssner, senior pre-med student, University of North Carolina at Chapel Hill

Welcome to the July issue of The Surgeons’ Lounge. In this issue, we feature new technology. Our guest expert is Rafael J. Grossmann, MD, a surgeon, an educator and a health care innovator in Bangor, Maine, who performed the first-ever live surgery using Google Glass, in June 2013.

Check out Dr. Grossmann’s blog at www.RafaelGrossmann.Health.

We look forward to our readers’ questions, comments and interesting cases to present.

Sincerely, Samuel Szomstein, MD, FACS ACS Editor, The Surgeons’ Lounge nge Szomsts@ccf.org

Figure 1. Google Glass.

Figure 2. In the OR with MagicLeap XR Smart Glass.

Figure 3. Varjo 2, the most advanced virtual reality headset.

How have you been using How have you been using technology to improve technology to improve your surgical education? surgical outcomes?

In the field of surgical education, there are several platWhen asked about the use of technology, I always start forms that use VR as a way to train the next generation with a somewhat simple definition: Technology refers to of surgeons. Platforms such as FundamentalSurgery, Prethe skills, methods and processes used to achieve a specif- cisionOS, OssoVR and OramaVR are shaping the future ic goal. It is really the application of scientific knowledge of surgery learning. for something that is practical and impactful.

Simulation in VR to learn and practice the different Just to illustrate this point, let’s talk a bit about crack- steps of a surgical procedure is not new. What is exciting ing skulls. The use of trepanation goes back to the year and innovative is the use of haptic feedback to make that 6,500 B.C. It must have involved some type of technology experience uniquely real. That’s what FundamentalSurin order to do such a craniotomy—a human using his or gery has developed: the possibility of immersing yourself her hands and likely a sharpened rock. If we compare that in the actual surgery and providing a safe, repeatable enviprocedure with the latest advances in surgery today, for ronment to learn. The offer of repetition and damage-free example, robotic or image-guided surgery, the goal is the failures through simulation is a key benefit for learning same. We are trying to have an effect, to improve some- and shows huge value in technology for surgical educaone’s health. tion. It is only with the addition of There is plenty of evidence that surgical The offer of repetition haptics and sophisticated high-fideloutcomes have improved significantly over ity simulation techniques, howevthe past several decades. We have to infer and damage-free failures er, that you can truly understand the that the smart use of technology played a through simulation is a benefits of precise learning, which is key role—from the use of anesthesia, analsomething companies such as Fungesia and antisepsis, to minimally invasive, key benefit for learning damentalSurgery offer. endoscopic and robotic surgery.

Precise learning is a combinaand shows huge value in Today’s technology is advancing in a tion of tracked data points to test a somewhat exponential way. I think that technology for surgical user’s submillimetric accuracy alongtoday’s challenge is how to use these tech- education. side the user’s interactions with the nologies to improve education and diagdifferent tissue textures, all within a nostics, and to achieve equity in global surgical environment. When comaccess to ethical, safe and compassionate care. I think that bining the repetition with not just procedural steps but the current socioeconomic, political and environmental also individual complex steps, muscle memory is built, and landscape is creating a “perfect storm” situation that will skills transfer through “feeling” the virtual body, which is exacerbate an already stressed health care ecosystem. If we a huge step up from some of the current VR simulation look at how the demand for health care services is increas- platforms. ing versus the rapidly decreasing availability, and especially access to safe and affordable health care services, we are Why do you think technological innovation will lead confronting a grave problem. to better surgical care and access to surgical care?

Or how can technology be used to create better How can technology help provide better access to surgical care and access to surgical care? surgical care?

With this highly intuitive system, the platform allows Technology can help. I would argue that the smarter surgeons to experience the same sights, sounds and accuuse of technology can paradoxically create a more empa- rate physical sensations of the human anatomy, enabling thetic and humane health care system. The proper use of them to hone and rehearse skills in a safe and measurable these tools can get us closer to our patients, and, in some environment, dovetailing perfectly with the cadaveric and way, rescue the rapidly fading doctor–patient relationship. assisted/observational learning in the OR, without putOne of the technologies that can enhance educa- ting patients at risk. tion, teaching and learning is immersive media. I’ve been The haptic interactions data also create a personal dashinvolved in this field for close to a decade, sharing clinical board to highlight weaker and stronger areas within each expertise and futuristic insights to help shape its evolution. step of the procedure. Users are able to learn in a fully Immersive technologies refer to platforms (Figures 1-3) immersive environment, where all educational content is such as: both accredited and mapped to Accreditation Council for • virtual reality (VR), in which the user is immersed Graduate Medical Education standards. Following the in a digital, computer-generated environment or a procedure, users can access and review their dashboard, 360-degree video, completely isolated from the surand combined with the data from the @homeVR platrounding real world—think of gaming in an Oculus form, they can learn at their own pace without supervision.

Quest device; Another example of using technology in education • augmented reality (AR), in which the user experiinvolves the live streaming of a surgical procedure. The ences digital content superimposed on the real world, design of some of the current headsets allows the audience viewed through a mobile device or a head-mounted to have a “preferred seat” in the surgical theater. display—think of “Pokémon Go” or the NFL’s magic In June 2013, I performed the first-ever live operation “first down” yellow line; and using Google Glass. All I did was to securely livestream • mixed reality (MR), in which the digital content that surgery to facilitate the experience of the medical stuinteracts with and responds to the physical world as if dents—showing them my perspective, my focal point durit were part of the real surroundings. ing an operation and enabling them to participate in a

SURGEONS’ LOUNGE

JULY 2021 / GENERAL SURGERY NEWS

“virtual,” synchronous fashion, asking and answering questions as if they were physically present. I decided to use that new technology to enhance their educational experience. Obviously, this is not a substitute for being in the OR, but just an alternative, a complement to their surgical education, especially in times when the OR might be too crowded, or when, as in the current pandemic, one cannot be physically present.

Another example is the case of telehealth. According to the Lancet report, it is estimated that approximately 5 billion people do not have access to safe or affordable surgery. This is an unacceptable reality and a problem that can be mitigated by the use of these tools.

The COVID-19 global crisis has shown us the benefits of remote communications and connectivity in every aspect of human endeavor. Health care was no exception, and despite detractors and obstacles, it has made a tremendous difference. The way I see it, telehealth represents another tool to connect with patients and colleagues, just like email, phones, paper and even fax machines. It is a complement, not a substitution, to the physical interaction.

We are seeing more frequent reports of how head-mounted display (or HMD) like Vuzix, Realware, Microsoft Hololens and others have been used to breach geographical and educational barriers, to enable remote surgical assistance (https://journals.sagepub.com/doi/ full/10.1177/1553350619871787).

In the field of AR, the ability to perform teleconsultations with a platform like Proximie, which uses “telestration” to bring the “hand,” skill and knowledge of an expert surgeon to guide a remote colleague, represents a clear example of the smart use of technology to augment surgical care and provide more equitable and inclusive access to global health (https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC5908501/).

In the space of surgical navigation, platforms like MagicLeap and BrainLab have partnered to enable a “mixed reality viewer,” which allows the visualization of holographic, 3D imaging to facilitate and enhance the performance of a surgical procedure. The images are literally “released from the confines of flat screens and taken into your world.” A surgeon in the OR, wearing a MagicLeap headset powered with the BrainLab software, can have access to the patient’s diagnostic imaging in an unlimited number of axes, making the viewing much more intuitive and ergonomic (www.brainlab.com/ surgery-products/overview-platformproducts/mixed-reality-applications/ mixed-reality-viewer/).

Another interesting field in which technology enhances learning is serious

games for health. A platform like Level Ex brings the power and fun of gaming to empower medical learning. It creates video games for doctors that capture the challenges in practicing medicine. It has tapped the convergence of medicine and entertainment, bridging the gaps in the health care industry through state-of-the-art video game technology and design. The intersection of exponential technology, health care and education opens up phenomenal opportunities for us to start solving some of the major problems facing medicine today: access to care, improved quality

of care and training the next generation of caregivers.

Are there any negative aspects to using new technologies in medicine?

How do we ensure that humans are still the ones in control, rather than being controlled by technology?

There are certainly risks in the use of technology. Its improper use could make interactions impersonal, less empathetic and less emotional, more mechanical.

There is a potential risk for violation of patients’ private health information. There are also legal, regulatory and cost barriers

that must be addressed. These issues are real, but they should not be deterrents to the exploration of these tools to improve the way we practice and teach medicine.

These issues are solvable as long as the developers, regulators and users take them into account. The problem is not the technology, but the use we make of it.

It is up to us to wisely harvest this power to ensure that health care and surgery become what they should be at the ■ dawn of the 21st century.

Dr. Grossman is a medical advisor to FundamentalVR, LevelEx and MagicLeap.

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24

IN THE NEWS

GENERAL SURGERY NEWS / JULY 2021

Preventing SSIs in General Surgery: What the Data Show continued from page 1

surgery in the preoperative, perioperative and postoperative settings, with comments by Philip S. Barie, MD, MBA, a professor of surgery and public health in medicine at Weill Cornell Medicine, in New York City, and the executive director of the Surgical Infection Society Foundation for Education and Research.

Preoperative Glycemic control. Glycemic control is not limited to patients with diabetes. Hyperglycemia is associated with an increased risk for an SSI; aim for a preoperative blood glucose level of 110 to 150 mg/dL. “It’s well established that hyperglycemia impairs neutrophil function and wound healing. In patients with diabetes, the risk of infection increases because the neutrophils’ ability to respond to infection is impaired, both in terms of chemotaxis and phagocytosis. Glycemic control is important not just in the preoperative period, but throughout the perioperative and postoperative periods as well.”

Smoking cessation. Current smoking is the highest risk factor for an SSI; counsel patients to refrain from smoking at least four to six weeks before their procedure. Although there is no literature regarding marijuana and e-cigarette use, their discontinuation also is recommended.

“The reason smoking is a risk factor is not just tissue hypoxia, but because nicotine is a vasoconstrictor; it impairs wound healing and also inhibits delivery of antibiotics to the wound. A lot of people won’t be able to stop completely, but if you can get them to cut down even a little bit, it helps.”

Chlorhexidine bath or shower. Antiseptic bathing has been shown to reduce bacterial colonization of the skin for up to 24 hours. Although this has not been proven to reduce SSIs, it may still play a role.

“This is primarily a matter of personal hygiene and accountability; if you’re scheduled for surgery in the morning, you shouldn’t be taking out the garbage before you come to the hospital.”

Perioperative Antibiotic prophylaxis. The role of prophylactic antibiotics is somewhat controversial, and indications vary by procedure. The most recent guidelines of the American College of Surgeons recommend using prophylactic antibiotics only when indicated and discontinuing at the time of incision closure.

“To achieve maximal ‘buy-in,’ the Surgical Care Improvement Project guidelines said to administer prophylactic antibiotics immediately prior to the procedure and for no longer than 24 hours afterward (48 hours

The Jury Is Still Out As the list of potential interventions for SSIs changes, some have fallen out of favor, remain unproven in general surgery or appear promising but haven’t gotten much attention. Philip S. Barie, MD, MBA, offers his expert commentary on these approaches.

Administering 80% supplemental oxygen during procedures performed under general anesthesia and for two hours after the case.

“This is a controversial area. There was a study that showed it was beneficial, but now there have been many that show it is not. We do need to maintain oxygenation, but it doesn’t need to be administered in abnormally high concentrations to achieve this goal.”

Global screening for methicillin-resistant Staphylococcus hylococcus aureus s and nasal mupirocin decolonization in patients who o test positive for S. S aureus. aureus “Nasal decolonization is directed against a single pathogen in MRSA, which is an important but by no means exclusive pathogen in SSI. There are data for nasal decolonization in cardiac surgery and orthopedic surgery; unlike general surgery, neither of those surgical specialties include procedures that enter any hollow viscus, such as the biliary tree or intestinal tract, where the colonizing bacteria are poly-microbial and so, too, the risk of infection. So, screening and decolonization for MRSA as far as SSIs are concerned in surgery really only addresses a small part of the problem, and it’s not really studied.”

Maintaining normal body temperature during a procedure is associated with lower rates of postoperative infection; data also show that directly warming the site of surgery before a procedure reduces SSIs just as well as systemic warming.

“Say you’re going to do a groin hernia repair; while the patient is in the preoperative holding area, you can put a heating pad on the surgical site for 30 minutes and warm the skin while you’re finishing your paperwork. Although this hasn’t caught on yet, it is probably the most innovative new thing in the last 10 years.”

for cardiac surgery). However, the data show clear that a single dose is effective. It’s far more important to redose intraoperatively than postoperatively, especially with short half-life agents such as cefazolin or cefoxitin, if the case is long or if there is a high volume of blood loss.”

Wound protectors. Once controversial, the use of wound protectors is generally supported, particularly in open abdominal surgery and elective biliary tract and colorectal procedures.

“The data aren’t that strong, but surgeons have understood for years that if you minimize contact with wound edges, you’re less likely to inoculate bacteria into the wound.”

Antiseptic sutures. Strong evidence suggests that triclosan-coated antiseptic sutures are superior to standard sutures for decreasing the risk for SSIs, and they are recommended for fascial and subcutaneous closure of clean and clean-contaminated cases.

“The main foil for antiseptic sutures is that they cost 10% more than standard sutures, and some hospitals balk at that. But you can buy an awful lot of triclosancoated sutures for the cost savings of a single infection, which can run to thousands of dollars.”

Postoperative Negative wound pressure. “This is so new it may not even appear in the guidelines yet. But the use of a wound vacuum-assisted closure device [Prevena, 3M Corp.] on closed wounds draws out the fluid that accumulates in wounds and appears to reduce the risk of SSI.” Drain management. Use drains only when necessary and discontinue them as soon as possible. “After 24 hours, drains become a two-way street, just as likely to introduce bacteria as to evacuate them.”

Do not continue prophylactic antibiotics, cover indwelling tubes and drains with antibiotics, or perform antibiotic wound irrigation. “Surgeons learn to do the latter in residency and don’t want to let it go, but it remains unproved.”

■

Sources Ban KA, Minei JP, Laronga C, et al. American College of Surgeons and Surgical Infection Society: surgical site infection guidelines, 2016 update. J Am Coll Surg.

2016;224(1):59-74.

De Simone B, Sartelli M, Coccolini F, et al. Intraoperative surgical site infection control and prevention: a position paper and future addendum to WSES intraabdominal infections guidelines. World J Emerg Surg 2020;15(1):10.

Leaper L, Ousey K. Evidence update on prevention of surgical site infection. Curr Opin Infect Dis. 2015;28(2):158-163.

López-Cano M, Kraft M, Curell A, et al. Use of topical antibiotics before primary incision closure to prevent surgical site infection: a meta-analysis. Sura Infect (Larchmt).

2019;20(4):261-270.

Norman G, Atkinson RA, Smith TA, et al. Intracavity lavage and wound irrigation for prevention of surgical site infection.

Cochrane Database Sys Rev. 2017;10(10):CD012234.

Reiffel AJ, Barie PS, Spector JA. A multi-disciplinary review of the potential association between closed-suction drains and surgical site infection. Surg Infect (Larchmt).

2013;14(3):244-269.

Young P, Khadaroo R. Surgical site infections.

Surg Clin N Am. 2014;94(6):1245-1264.

OPINION

JULY 2021 / GENERAL SURGERY NEWS

Why Surgeons Should Partner With Their Central Sterile Processing Department

O

ver the past decade, hospitals have spent a great deal of time, resources and money to prevent surgical site infections. Properly timed antibiotics, nasal decolonization, skin antisepsis, appropriate hair removal, preoperative bathing and hand hygiene have been some of the measures taken to reduce infection rates. But one critical dimension of infection safety has received comparatively much less attention, and that is the role of the central sterile processing department (CSPD).

Central sterile processing is the first link in the chain of infection prevention.

Its role is to decontaminate, clean, inspect and sterilize instrumentation for future use. However, failure to do so can introduce pathogens into the OR, increasing the risk for SSIs. The major problem is a lack of awareness of just how important this step truly is.

In U.S. hospitals, SSIs are a major problem and a significant patient safety issue.

They affect a significant number of the patients and can have devastating consequences, including long-term disability (http://bit.ly/2OfAsSJ) and worse outcomes (BMJ Open 2016;6[2]:e007224).

Most hospitals have made substantial process changes to improve intraoperative safety, but these gains are vulnerable to weaknesses in the CSPD.

The Financial Issue Nearly 1.5 million surgical procedures were performed in 2019. Cases declined in 2020 because of COVID-19, but experts are predicting a spike this year, with further growth in the surgical market from 2022 to 2025 (http://bit.ly/30uwTe2).

Surgical site infections are the third most expensive type of health care‒ acquired infection (HAI), costing nearly $21,000 per patient case. Some estimates raise that cost to $90,000 (https://bit. ly/3cfPbVB). It’s estimated that the total cost of SSIs to the U.S. health care system ranges from $3.5 billion to $10 billion annually (http://bit.ly/3cfPbVB).

In addition, in 2015, the Centers for Medicare & Medicaid Services began to penalize hospitals for high rates of SSIs along with other health care‒acquired conditions. Because SSIs dramatically increase the risk for rehospitalization, hospitals are more vulnerable to readmission penalties (Table).

These safety and financial issues make a compelling argument for timely preventive action (Langenbecks Arch

Table • Of all inpatient surgery patients, 2% develop an SSI.

to 5%

• Between 160,000 and 300,000 SSIs are estimated to occur every year in this country.

Redefining the Relationship to Decrease Surgical Site Infections

By DAVID TAYLOR III, MSN, RN, CNOR

25

Surg 2011;396[4]:453-459). A surgeon who knows more about CSPD can have a positive effect on their own practice. When surgeons engage directly with hospital leaders to create a strong process for preventing SSIs, patient safety surely will increase.

Going Behind Closed Doors A CSPD orientation program designed to educate surgeons

• On average, hospital LOS increases 7 days as a result of an SSI.

to 11

• There is a 2 to 11 times greater chance of an increase in death associated with SSIs. • It is estimated that up preventable.

to 60% of SSIs are

Sources: Infect Control Hosp Epidemiol. 2014;35(6):605-627; World J Emerg Surg. 2019;14:50.

continued on the following page

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IN THE NEWS

GENERAL SURGERY NEWS / JULY 2021

Hospitals Urged to Strengthen Cybersecurity Systems With Attacks on the Rise

By CHRISTINA FRANGOU

A

s the SARS-CoV-2 virus spread globally over the last year, health care institutions became increasingly vulnerable to another kind of dangerous viral attack—this time, at the hands of cybercriminals.

During the 2021 Critical Care Congress Virtual Event of the Society of Critical Care Medicine, a panel of physicians urged attendees to take steps to protect their hospitals’ cybersecurity systems, pointing out that the health care sector is now the most targeted industry by ransomware in the United States.

These attacks can significantly affect patient care, harm patients and providers and carry an enormous price tag. Medical data breaches alone cost the health care industry more than $5.6 billion annually.

“Hacking in health care is a major problem, with estimated millions of records being breached every year in the U.S. alone,” said L. Nelson Sanchez-Pinto, MD, MBI, a specialist in pediatric critical care medicine and informatics at Ann & Robert H. Lurie Children’s Hospital of Chicago.

This past fall, federal agencies issued a warning that cybercriminals were targeting U.S. health care institutions. The wave of ongoing attacks was designed to lock up hospital health information systems as COVID-19 cases were spiking. Cybersecurity firm Check Point reported that ransomware attacks against American hospitals rose 71% from September to October 2020.

Cyberattacks on health systems come in three forms—phishing, malware and medical data breaches—said Dr. Sanchez-Pinto, who moderated the panel.

Phishing attacks are the most common; they arrive disguised as legitimate-appearing emails that trick the recipient into opening a link or document with malware or into providing personal information.

Malware is software that users inadvertently download onto their devices, which infects the system with a virus. Malware can take control of a computer until a user pays a sum of money, a version known as ransomware; or it silently spies on a computer, sends data or gives access to a hacker.

Medical data breaches have become more frequent in recent years; hackers steal medical records and sell

CSPD continued from the previous page

represents a low-cost, high-impact opportunity that not only drives the alignment between key customers of the OR, but can improve safety and efficiency.

Individual and small group tours are an important start, and can give the surgeon a general overview of the inner workings of the CSPD and how it may affect their practice. To increase the return on investment, a more robust program can be created by taking this concept further and allowing the leaders to present at a Department of Surgery meeting. Once established, the leaders can grow the orientation program and combine it with

them on the dark web. They can fetch up to $1,000 per patient because of the breadth of information in medical records. Information contained in these files can be used for fraud or identity theft, as well as blackmail or extortion. Provider data can also be accessed and used for fraudulent insurance claims or prescription drug fraud.

Dr. Sanchez-Pinto said physicians and their colleagues must create a culture focused on cybersecurity,

Erie County Medical Center, the Buffalo trauma center attacked by a variant of ransomware named SamSam. Credit: D-Day/Wikimedia Commons

although it means some tasks require more time.

“Taking extra security steps online can be annoying because it can seem like they are slowing our workflow, but we owe it to our patients to be safe with their data because it’s extremely vulnerable,” he said.

On April 9, 2017, the Level I trauma center at the University of Buffalo was hit by a variant of ransomware named SamSam. The attack shut down the hospital’s HIS, including all electronic clinical applications, billing and scheduling services, and communication tools.

The hospital decided not to pay the ransom and turned to old-fashioned paper charts and face-to-face communication for two months while the HIS was restored.

In that time, staff lost access to the electronic medical record (EMR), the picture-archiving and communication system, and even the internet.

Physicians could access patients’ historical data,

the introduction of a quarterly surgeon satisfaction survey.

Program components can consist of the following: • Walk through each area of the department.

• Detail the time it takes for accomplishing each step.

• Explain the equipment used in the process.

• Introduce surgeons to the staff responsible for their instruments.

What’s There to Learn?

Efficient turnover of instrumentation can help ensure the surgical team has the necessary equipment to perform its procedures. However, far too often when instrumentation is missing, CSPD gets

including medical records and imaging, through HealtheLink, an electronic clinical information exchange among hospitals in Western New York. Otherwise, patient information was communicated only in writing, by phone and in person.

W. Alan Guo, MD, an acute care surgeon and a surgical intensivist at the University of Buffalo, said trainees struggled with the abrupt switch to a paper-based system as they came to medicine in the era of the EMR. In a study published in 2018, Dr. Guo and his colleagues reported that residents were very stressed by the lack of online resources in the aftermath of the attack (J Surg Res 2018;232:389-397). Some surgical residents said they had less hands-on experience in the OR because limited imaging made cases more difficult.

He urged hospitals to treat ransomware attacks like other disasters and prepare for them as part of disaster planning. Training in paper-based documentation should be included as part of hospital in-service and the graduate medical education curriculum, he said.

“Everything is digital now. So, younger generations need to learn about paper-based documentation in case something happens, because the cyberattack rate is getting higher and higher in this world.”

During the pandemic, health systems have become more dependent on smart devices and telemedicine.

This reliance makes hospitals more vulnerable to major attacks, according to Piyush Mathur, MD, a staff anesthesiologist and critical care physician at Cleveland Clinic in Cleveland. He chairs Cleveland Clinic’s Anesthesiology Institute compliance committee.

“We need to understand that despite telemedicine providing access to a lot of different patient care areas, it has vulnerabilities and we need to be prepared for that,” he said.

Telemedicine systems rely on a network of products that are built in one country, used in another and perhaps serviced in yet another. These systems can be accessed by a global network of people working at multiple points in the chain, including human resources programs, audiovisual intersections and even IV pumps at the bedside.

“These, across the entire nation, are all vulnerable to ■ attack,” Dr. Mathur said.

the blame. When surgeons have a better understanding of the department and its inner workings, they can begin to truly understand where the issues lie.

First and foremost, knowing your set inventory is critical. When a surgeon schedules five procedures for the day and the hospital has only three instrument sets, delays are inevitable. Most organizations require loaner instrumentation to arrive 24 to 48 hours before the surgery to ensure it has been properly inventoried, inspected, decontaminated, reassembled, sterilized and packaged. Also important to note, it takes on average three to four hours for an instrument set to be proper processed, and that’s a low estimate.

In this scenario, it’s called an instrument turnover.

So, when the surgeon asks why their case is delayed and the circulating nurse says the instruments are not ready, it’s easy to see why the CSPD would be blamed.

The truth is the department most likely had requested additional instrumentation to improve processes; however, due to the high cost of instrumentation, the request probably was denied.

Finally, consistent turnover of instrumentation can result in corners being cut and a greater possibility that something was missed, which can have devastating consequences.

■ —David L. Taylor III, MSN, RN, CNOR, is the principal of Resolute Advisory Group LLC, a health care consulting firm in San Antonio.

IN THE NEWS

JULY 2021 / GENERAL SURGERY NEWS

Model Finds Stool Tests Key to Lowering CRC Screening Age

By MONICA J. SMITH

‘We’re seeing an incidence rate in that group similar to what it was in patients 50 and older 20 years ago, so there’s a societal benefit to starting screening in younger patients.’

A

dding to the growing body of research that supports initiating screening for colorectal cancer at 45 years of age, a new modeling study suggests that use of stool-based tests in younger people could reduce the incidence of the disease and save lives, even when adherence is less than perfect.

“One concern of starting screening at age 45 is that we’ll divert colonoscopy, which is not an unlimited resource, from patients 50 and older who are at higher risk for colorectal cancer,” said Deborah A. Fisher, MD, MHS, the lead author of the research. “This model shows that screening with the fecal immunochemical test [FIT] or multitarget stool DNA (mt-sDNA; Cologuard, Exact Sciences) improves all outcomes when screening starts at age 45.”

To estimate the effect that screening younger patients would have on outcomes, Dr. Fisher, an associate professor of medicine at Duke University, in Durham, N.C., and her colleagues applied the CRC and Adenoma Incidence and Mortality (CRC-AIM) microsimulation model to 4 million simulated individuals born in 1975 and who were free of CRC at age 40.

They compared outcomes between those screened between 45 and 75 years of age and those screened between ages 50 and 75. They also looked at how the outcomes changed depending on rates of adherence for the stool tests, whether 100% or rates previously reported in clinical practice, 71% for mt-sDNA and 43% for FIT. CRC-AIM, the same validated model that helped inform the U.S. Preventive Services Task Force to develop guidelines for CRC screening, predicted about 24 life-years gained in individuals who started screening at 45 years of age compared with those who started at 50.

The model predicted a reduction in the incidence of CRC of 64% and 61% in the older and younger cohorts, respectively, using reported adherence rates for mt-sDNA testing, and 54% and 50% using FIT. Reductions in CRC-associated mortality also were greater in the younger screening cohort compared with the older group—72% and 69% with mtsDNA and 63% and 59% with FIT— according to Dr. Fisher’s group, who presented their findings at the 2020 virtual meeting of the American College of Gastroenterology (abstract P0723).

Aasma Shaukat, MD, the chief of gastroenterology at the Minneapolis VA Health Care System and a professor of medicine at the University of Minnesota, in Minneapolis, said the main finding of continued on page 29

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IN THE NEWS

GENERAL SURGERY NEWS / JULY 2021

KRAS Mutation Predicts Response to HAI Pump in Unresectable Colorectal Liver Metastases

By KATE O’ROURKE

I

n patients with unresectable liver metastases from colorectal cancer, mutated KRAS predicts worse response to hepatic arterial infusion (HAI) pump chemotherapy, according to new research. The findings were presented at the virtual Society of Surgical Oncology 2021 International Conference on Surgical Cancer Care (abstract 39).

“Although not practice changing, our results are important when considering whether to offer this particular treatment to potential candidates with KRAS mutation,” said lead study author Hordur Kolbeinsson, MD, a general surgery resident with Spectrum Health/ Michigan State University General Surgery Residency, in Grand Rapids. “Additionally, it suggests that KRAS mutation status should be used as a stratification factor in future trials exploring HAI chemotherapy.”

Previous research showed that KRAS mutation predicts poorer outcomes from resection of colorectal liver metastases and adjuvant HAI pump chemotherapy (Cancer 2014;120[24]:3965-3971). Less is known about the effect of a KRAS mutation on tumor response in patients with unresectable colorectal liver metastases who are treated with HAI pump chemotherapy.

To shed light on this question, Dr. Kolbeinsson conducted a retrospective review to investigate the effects of KRAS mutation on tumor response in patients with unresectable colorectal liver metastases treated with HAI pump chemotherapy. The researchers assessed maximal tumor response and objective response rate (ORR) using CT imaging, and ORR was defined as a cross-sectional reduction in target lesions by greater than 50%.

Dr. Kolbeinsson reviewed cases from 25 patients with unresectable liver metastases from colorectal

‘Data from this abstract suggest that KRAS data can also be used to identify who might benefit the most from HAI therapy. Similar to resection and systemic chemotherapy— perhaps not surprisingly— patients with KRAS wild type status benefited the most from HAI.’ —Timothy Pawlik, MD, MPH cancer who were treated with HAI chemotherapy between August 2017 and May 2019. The median age was 59 years and 52% were male. The median number of liver lesions was 12 and nearly all patients (n=24) had prior chemotherapy before starting HAI pump chemotherapy. The median number of cycles administered via HAI therapy was six.

The researchers observed an overall decrease in liver tumor burden of 63.5% with an ORR of 80%, and 40% of patients converted to resectable status. Eleven patients (44%) had KRAS mutation. When compared with wildtype, KRAS-mutated tumors had a lower rate (64% vs.

100%; P=0.03) and magnitude of response (median,

58% vs. 70%; P=0.04). Fewer patients with KRASmutated tumors converted to resectable status during HAI pump chemotherapy (two of 11 vs. eight of 13; P=0.05).

“It must be noted that even though patients with KRAS mutations had an average smaller tumor burden decrease (58% vs. 70%), their overall response rate was more than acceptable (64%), meaning that patients with KRAS mutations and unresectable liver metastases from colorectal cancer are still going to benefit from the treatment,” Dr. Kolbeinsson said.

Asked to comment on the study, Timothy Pawlik, MD, MPH, the surgeon-in-chief at The Ohio State Wexner Medical Center and chair of the Department of Surgery in The Ohio State College of Medicine, in Columbus, pointed out that previous studies already identified the importance of KRAS status in predicting prognosis in colorectal liver metastases.

“In particular, work from our own research group has demonstrated the importance of KRAS status relative to systemic chemotherapy, tumor burden score, surgical margin status, patterns of recurrence and overall prognosis,” said Dr. Pawlik, who is also the Urban Meyer III and Shelley Meyer Chair for Cancer Research at The Ohio State University Comprehensive Cancer Center‒Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. “The current study builds on this work to demonstrate that KRAS wild type

Aspirin Reduces the Need for Mechanical Ventilation by Nearly Half For COVID-19 Patients

By BOB KRONEMYER

P

atients hospitalized with COVID19 and taking aspirin were nearly half as likely to require mechanical ventilation as those with COVID-19 not taking the drug, according to a study of adult patients.

The patients were admitted to multiple hospitals in the United States between March 2020 and July 2020.

The study’s principal investigator, Jonathan Chow, MD, an assistant professor of anesthesiology and critical care medicine at George Washington University, in Washington, D.C., said: “At the beginning of the pandemic, in March and April of 2020, my colleagues and I observed that all these COVID patients in the intensive care unit began to develop excess clot formation and complications related to blood clots and microclot formation throughout the body.”

Numerous autopsy studies from last spring showed these patients had activation of platelets throughout the body and an excessive number of precursors to platelets, according to Dr. Chow. “That got us thinking, ‘Why don’t we start using an antiplatelet medication, such as aspirin, to treat these patients?’” he said.

“Aspirin has been studied extensively in cardiovascular disease to prevent clot formation, and it is widely available and inexpensive.”

The investigators reviewed the charts of 412 patients, of whom 76.3% did not receive aspirin and the remainder received aspirin within 24 hours after admission or for seven days or more prior to admission (primarily for heart disease).

After adjusting for eight confounding variables including demographics and comorbidities, aspirin tended to provide a protective effect and was independently associated with a 44% decreased

risk for mechanical ventilation, a 43% reduced risk for ICU admission and a 47% decrease in hospital mortality.

In addition, there were no differences in major bleeding or overt thrombosis between the groups. The reason for not observing a lower rate of the latter may be the low number of reported events in each group or reporting bias from avoidance of diagnostic imaging.

“The results of the study do not really surprise us because we know that COVID

causes excess clot formation and we know that aspirin is a very potent blood thinner,” Dr. Chow said. “So when you have a disease that causes clots and a medication that thins your blood, that may lead to the protective effects that we found.”

A disadvantage of giving aspirin to hospitalized COVID-19 patients, however, is the definite risks of a blood thinner, including a significantly increased risk for internal bleeding.

“If the ongoing randomized controlled trials can prove causation between aspirin and improved outcomes, and corroborate our findings, this would be a huge win for those people looking to reduce some of the risks of some of the most devastating effects of COVID-19,” Dr. Chow said.

Peter Papadakos, MD, the director of critical care medicine at the University of Rochester in New York, found the study results unexpected because previous

IN THE NEWS

JULY 2021 / GENERAL SURGERY NEWS

patients had a better response to HAI therapy than KRAS-mutated lesions.

This finding would be what we expect as KRAS-mutated tumor generally have a worse prognosis and are typically more aggressive.”

“While provocative, the data would need to be repeated in a larger trial,” Dr. Pawlik said. “This study only included 25 patients and was retrospective in nature. As such, it is difficult to make any true causal inferences. That said, many clinicians already use KRAS status to help make decisions around treatment with chemotherapy, when/ whether to operate, as well as inform surveillance strategies. Data from this abstract suggest that KRAS data can also be used to identify who might benefit the most from HAI therapy. Similar to resection and systemic chemotherapy—perhaps not surprisingly—patients with KRAS wild type status benefited the most from HAI.” Dr. Pawlik also pointed out that the researchers only reported response to HAI. “While response is an important outcome to measure, the authors should have also reported overall survival,” he said. “Although the response following HAI therapy was different among patients who had KRAS wild type versus mutant tumors, was there a difference in overall survival? In addition, while some centers use pump-based HAI therapy, other centers use catheter-based Y-90 (yittrium-90) locoregional therapy.

Future studies should examine if KRAS status can similarly predict response to ■ locoregional Y-90 radiotherapy.”

CRC Screening continued from page 27

improved outcomes with earlier screening sent a positive message.

“We’re seeing an incidence rate in that group similar to what it was in patients 50 and older 20 years ago, so there’s a societal benefit to starting screening in younger patients,” Dr. Shaukat said.

But she found the study’s projection of adherence rates for the stool-based screening methods a bit presumptive: “We don’t know the adherence rate for the younger cohort because we’ve never

screened this group before, so that’s a weaker part of the analysis.”

Dr. Fisher acknowledged the study’s limitations. “It is a modeling study, and the validity of the output relies on the validity of the input. So much screening is accomplished by colonoscopy in the U.S. that it is difficult to obtain robust data on the actual adherence to FIT,” she said.

“But I think the general principle, that you still have improvements with an earlier initiation age, even when the adherence rates modeled are much lower than 100%, is very supportive and encouraging.”

The findings aren’t immediately

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Other advantages of aspirin as a treatment for COVID-19 are that it is easily available worldwide, is very inexpensive, has a highly impressive safety profile and is already taken by many people prophylactically, said Dr. Papadakos.

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applicable to practice, Dr. Shaukat noted.

“We would want to get some direct patient data; put a group of 45- to 49-year-olds through screening and see if the results of modeling bear out. We would also want to research the best screening modality.”

Also, payors might not reimburse screening in younger patients, at least not yet, Dr. Fisher added. “If the U.S. Preventive Services Task Force guidelines final draft includes at least a grade B recommendation for starting screening at age 45, this study provides evidence for a path forward that might be less resourceintensive and more feasible.”

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IN THE NEWS

GENERAL SURGERY NEWS / JULY 2021

Ergonomic Injuries in Surgery: A Quiet but Pervasive Problem continued from page 1

“The damage to my right arm at that point was irreversible,” she said. “My window of opportunity for the nerve function to fully recover had passed.”

She would never operate again.

To help cope with the news, Dr. Tejirian began researching her injury. She was surprised to learn that work-related injuries, especially along the C5 to C7 vertebrae, are common among surgeons. A 2017 analysis found that most surgeons—up to 90%—experience pain in the back, neck and hands, and almost 28% reported an injury or a chronic condition (J Am Coll Surg 2017;224:16-25.e1). Years of standing in the OR for long procedures, contorted in static positions while maneuvering delicate tools, will eventually take its toll on the body (Surgeons as Educators. Springer; 2017:387-417).

“Surgery is a demanding job and that won’t change, but small problems can add up over time and we can make changes to reduce our risk of injury,” said Scott Hollenbeck, MD, the vice chief of research and an associate professor of surgery in the Division of Plastic, Maxillofacial, and Oral Surgery at Duke University School of Medicine, in Durham, N.C. But few institutions provide ergonomics education and training, and surgeons may be hesitant to get help.

A 2018 meta-analysis, evaluating 40 papers, found that almost 70% of 5,152 surgeons surveyed reported pain from operating—most frequently in the back (50%), neck (48%), and arm or shoulder (43%)—but only 29% sought care (Ann Med Surg 2018;27:1-8).

“As surgeons, we may push through any kind of pain and believe it’s part of the job,” Dr. Tejirian said. “But it doesn’t have to be, if ergonomics and other preventive techniques are built into a surgeon’s life and training.”

Of physicians reporting these injuries, 12% needed to take a leave of absence, restrict or modify their routine or retire early. Physicians also highlighted a lack of awareness and education about ergonomic challenges associated with the job.

These results were confirmed when the authors conducted a survey evaluating the current state of surgical ergonomics education in the United States (Ann Surg 2019;269:778-784). With insights from 130 surgical and medical program directors, the authors discovered that only 33 offered informal information on surgical ergonomics and just two provided formal education.

Almost 70% of 5,152 surgeons surveyed reported pain from operating—most frequently in the: back (50%),

neck (48%),

and arm or shoulder (43%)

A Pervasive Problem Below the Radar In 2012, Dhruv Singhal, MD, was in Taiwan, participating in a craniofacial fellowship.

“When my mentor saw me put on a headlight, he stopped me,” said Dr. Singhal, the director of lymphatic surgery and an associate professor at Beth Israel Deaconess Medical Center, in Boston. “He pointed out how the headlight forced me to crane my neck to move the light where I wanted it. He gave me handheld retractors equipped with lights so I could just manipulate my hands, not my neck.”

The full significance of this informal feedback became clear several years ago, when Dr. Singhal found himself attending more and more lectures on the prevalence and impact of work-related musculoskeletal disorders on surgeons.

The lectures brought him back to this moment in his fellowship. So, when Sherise Epstein, MD, MPH, a medical student at the time, came to him about studying this issue more deeply, Dr. Singhal jumped in.

To understand the scope of ergonomic pain and injury among physicians, Drs. Singhal, Epstein and their colleagues conducted an extensive literature review of studies, published between 1974 and 2016, exploring work-related musculoskeletal disorders. Of the 21 studies analyzed, the authors found a high prevalence of work-related musculoskeletal disorders among more than 5,800 physicians (JAMA Surg 2018;153:e174947).

The most common injuries included degenerative lumbar spine disease (19% or 544 physicians), degenerative cervical spine disease (17% or 457 physicians), rotator cuff pathology (18%), and carpal tunnel syndrome (9%).

—but only 29% sought care.

Source: Ann Med Surg 2018;27:1-8

“I think the data are pretty clear: Work-related pain and injuries are real issues for surgeons,” Dr. Singhal said. “But if surgeons don’t know ergonomics are a problem, they will be way behind the 8-ball when it comes to prevention and treatment.”

An Ergonomics Education By the time Dr. Tejirian found Jarel Russell, OTR/L, an occupational therapist in Glendale, Calif., she knew her days in the OR were over.

During their first session, Mr. Russell asked Dr. Tejirian to share her story.

“Understanding her injury, treatment experiences, where she is in her life and career are essential parts of the therapeutic process,” said Mr. Russell, the clinical director at Flex Motion Physical Therapy who specializes in treating lumbar, thoracic, cervical spine and shoulder pathologies. “Knowing these details helped us build trust and helped me provide a tailored treatment approach.”

Mr. Russell knew Dr. Tejirian faced a long, slow road ahead. He outlined a regimen of targeted exercises to help stabilize the weak points along her spine and back,

and train her to recruit her core—what he calls the gateway to everything—to alleviate strain on her back.

[Next month, Dr. Tejirian details her story and the specific physical therapy regimen created by Mr. Russell.]

Dr. Tejirian is not alone in her predicament. Many of the surgeons whom Mr. Russell treats come to see him after an injury has become chronic.

“By the time you feel pain, something major is already going on,” Mr. Russell said. “That’s why it’s important to regularly condition the body for our daily activities to create balance and prevent injuries. Increasing awareness and detecting potential issues early also means we can correct these problems before surgery and make sure surgeons can continue operating.”

Currently, two surgery programs in the United States have been leading the way on formal ergonomic education—Mayo Clinic in Rochester, Minn., and Duke University.

Duke Surgery launched its program in early 2017, along with the university’s Ergonomics Division. The impetus came from general surgery residents who discovered the source of their neck pain: poorly fitted loupes.

The residents approached the chair of surgery, Allan Kirk, MD, about starting an ergonomics program to increase education on this kind of problem. As part of that program, the residents proposed a loupe-fitting initiative to help reduce strain on their neck and back.

In addition to adjusting tools and technology to prevent injury in the OR, Dr. Hollenbeck highlighted a range of other strategies: taking short stretching breaks during surgery, wearing support stockings or supportive footwear, and varying procedures performed day-to-day.

“But it’s important to remember that no single strategy will solve every ergonomic problem or necessarily work for everyone,” Dr. Hollenbeck said.

That is why Marissa Pentico, an occupational therapist at Duke, began to go to the OR to watch individual surgeons operate, take pictures and meet with them one-on-one.

“After reviewing the pictures with her, you really see yourself differently,” said Dr. Hollenbeck, who learned exercises to counteract the neck pain and finger numbness he began experiencing. “For me, stretching before surgery, just like I would before a run, has made a big difference.”

Although ergonomic education for surgeons has been slow to take hold across the country, Dr. Hollenbeck is starting to observe a shift.

“I’ve seen a growing awareness and urgency surrounding musculoskeletal strain and injury in surgery over the past few years and an openness to discuss these issues,” Dr. Hollenbeck said. “The culture of surgery is changing, and we’re realizing that the old-school approach of ‘never take a break, never complain, never say you’re hurting or weak’ may not be the best way to go through life. Rather, the opposite: Surgeons will be more productive and enjoy a longer career if we address these physical concerns earlier.”

Dr. Tejirian hopes surgeon-specific education and physical training will become non-negotiable elements of surgical training and practice.

“The narrative on musculoskeletal pain and physical injury can change for surgeons,” Dr. Tejirian said. “I can never operate again, I know that. But I hope sharing my experience will help others. I hope I can use my experi■ ence to help prevent other surgeons from injury.”

IN THE NEWS

JULY 2021 / GENERAL SURGERY NEWS

Guideline Leads to Reduction in Opioid Prescribing After Surgery

By BOB KRONEMYER

A

study adhering to a new opioid prescribing guideline in the Journal of the American College of Surgeons found a dramatic decrease in the number of pills prescribed following a broad range of major surgeries, along with a greater than 90% patient satisfaction rate for pain management and the highest compliance rate to date for appropriate disposal of leftover pills.

“We previously showed in 2017, that for mainly outpatient operations, patients were being prescribed more opioids than they used [Ann Surg 2017;265(4):709714],” said principal investigator Richard Barth Jr., MD, a professor and the chief of general surgery at Dartmouth-Hitchcock Medical Center, in Lebanon, N.H. “Patients used only about one-fourth of their opioids.”

Based on these outcomes, Dr. Barth recommended that surgeons in his group practice decrease prescribed opioids.

“This caused patients to start using about only 50% of their opioids, while still very happy with their pain control,” he said.

In another study, Dr. Barth and his colleagues concluded that the best predictor of opioid consumption at home was the amount of opioids that patients took the day before discharge (J Am Coll Surg 2018;226[6]:996-1003).

“The main purpose of the current study was to validate [this] guideline,” Dr. Barth said. “So, it is a very patientcentric guideline. It takes into account the fact that there can be a lot of variability of the pain experience and how much pain individual patients incur, even as a result of the same stimulus.”

The more recent study (J Am Coll Surg 2021 Jan 30. doi:10.1016/j.jamcollsurg.2020.12.057) enrolled 229 adult patients who were admitted to Dartmouth-Hitchcock Medical Center for at least 48 hours after their initial operation, which ranged from thoracic to urologic surgery, between October 2018 and December 2019.

At discharge, patients received prescriptions for acetaminophen and ibuprofen, as well as opioids, based on the guideline.

Patients who took no opioids, which was calculated as zero oral morphine milligram equivalents (MME), were sent home with five oxycodone 5-mg pill equivalents (PEs) on the day before discharge, whereas patients who used up to 30 MME received 15 PEs and patients who used 30 MME or more received 30 PEs. The lower the opioid usage was before hospital discharge, the higher was the level of patient satisfaction with pain management: 99% in the zero-MME

group, 90% in the intermediate-MME group and 82% in the 30-plus‒MME group (P=0.001).

In addition, despite being given an opioid prescription, 73% of the zeroMME group did not use any opioids at home and 85% used two pills or fewer.

“Previous investigators have educated patients about ways to dispose of

their pills, but in the best studies only 20% to 30% of patients dispose of their excess pills in a Food and Drug Administration–compliant fashion,” Dr. Barth said. “In contrast, by supplementing education with a reminder phone call and setting up a convenient drop box in the pharmacy next to the surgeon’s office where the patient visits for a

postoperative check, we increased disposal compliance to 83%.”

A patient questionnaire also enabled patients to take some responsibility for weaning themselves off opioids.

“I was very pleasantly surprised that we were able to get so many patients to responsibly dispose of their excess opioids,” Dr. Barth said. “But none of our results should come as a surprise to clinicians.” continued on page 33

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IN THE NEWS

Palliative Care continued from page 1

Dr. Miller took action. In 2016, she entered a one-year fellowship in hospice and palliative medicine at University of Chicago Medicine.

“I thought to myself, ‘This will be amazing. I’m going to be a better surgeon and have job offers left and right,’” she said.

But, after completing the fellowship in 2017, no such offers materialized. In fact, no jobs combining surgery and palliative care seemed to exist. Dr.

GENERAL SURGERY NEWS / JULY 2021

where surgeons could also be Miller was shocked at the palliative care providers.” lack of opportunities to marry In May 2021, Drs. Millthese specialties. er and Hoffman, along with Melissa Red HoffBuddy Marterre, MD, made man, MD, ND, FACS, also a big move toward that goal. encountered few professional The three surgeons launched opportunities to combine the the Surgical Palliative Care two disciplines.

Society (SPCS; www.SPC“When I first became Society.org), an interdisciinterested in palliative care (From left) Pringl Miller, MD, FACS; Melissa Red Hoffman, MD, FACS; Buddy Marterre, MD. plinary professional forum as a young surgical resident, dedicated to “integrating highI wasn’t sure where to turn,” quality palliative medicine principles and said Dr. Hoffman, an acute care surgeon struggled with finding mentorship and often felt out of step with my surgical colpractices into the care of surgical patients with fellowship training in hospice and leagues.

I really wanted to create a space through mentorship, education, research, palliative medicine, in Asheville, N.C. “I quality improvement and advocacy.”

Bringing Specialties Together

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Despite this surgery–palliative medicine disconnect, the specialties share deep roots. Fifty years ago, Balfour M. Mount, MD, a urologic oncologist, introduced and championed the field of palliative medicine, a specialty that aims to enhance quality of life for patients and families who are facing potentially life-limiting conditions. In the late 1990s, Geoffrey Dunn, MD, and Robert Milch, MD, both general surgeons, brought the concept of palliative medicine to the attention of the American College of Surgeons, and in 2003, the ACS spearheaded a committee dedicated to surgical palliative care (Ann Palliat Med 2015;4[1]:5-9).

Still, palliative care and surgical care rarely intersect in practice. A recent analysis in JAMA Surgery found that although palliative care consultations were “associated with better overall care, communication, and support in the last month of life,” only 3.75% of 95,204 patients undergoing high-risk procedures had a consultation (2020;155[2]:138-146).

Part of this disconnect comes down to the roles both specialties embody.

“How can you hold someone’s hand at the bedside one minute and then put a scalpel to their body the next?” Dr. Miller said.

“Making this transition can be jarring.”

The personal losses of Drs. Marterre and Hoffman as teens made this shift from the OR to the bedside more intuitive.

“When I was 16, I held my father’s hand as he died,”Dr. Marterre said. “As a surgeon, I did complex surgeries—liver transplants, Whipples, major liver resections—but always found myself drawn to the bedside of patients facing their final days. I really got to know these patients intimately and found their bravery amazing.”

At 19, Dr. Hoffman’s father was killed while traveling in Cairo. As she pursued a career in medicine, she found herself wanting to bring comfort to families watching their loved ones die.

“I aspired to embody the kind of surgeon who knows how to make difficult decisions in the OR but who can also hold a family’s hand and weep with

IN THE NEWS

JULY 2021 / GENERAL SURGERY NEWS

them when a surgery does not go well,” Dr. Hoffman said. But, she added, every provider will have their own motivation and way of balancing the role of surgeon and palliative care physician.

Another element of the disconnect falls to training. In the United States, only about 90 surgeons possess dual board certification in surgery and hospice and palliative medicine. Drs. Hoffman, Marterre and Miller—all members of this unique group—wanted to bring more clinicians into the palliative care fold.

In October 2019, the surgeons began making plans over a dinner at the ACS Clinical Congress in San Francisco. By the end of the evening, they had decided to form the SPCS. “Our aim was to bring together a multidisciplinary group of providers, not just surgeons, at all levels of training and collaborate in a way that simply doesn’t exist yet,” Dr. Miller said. “We, as providers, need to support each other in normalizing both high-quality surgical and palliative care in employment opportunities and in daily practice.”

The surgeons envision a group that includes nurses, social workers, chaplains, pharmacists and respiratory therapists. To foster this spirit of inclusivity, the SPCS embraces a nonhierarchical leadership dynamic: no president, just six council members, each with an equal voice.

The surgeons found inspiration for this structure from an unlikely source: honeybees.

Dr. Marterre, a master beekeeper, has spent years watching honeybee colonies at work—thousands of worker bees cooperating to build a nest, find food and raise their young. These colonies organize themselves around swarm intelligence and cooperative behaviors that prioritize the needs of the hive.

“It turns out, if done correctly, this structure is more efficient than a hierarchical one and builds on the principles inherent to palliative care—empathy, active listening and collective decision making,” Dr. Marterre said.

To engage providers, the surgeons plan to host educational webinars and online forums throughout the year, create a mentoring program that bridges the divide between surgery and hospice and palliative medicine. The Society’s first informal gathering will occur on Friday, Aug. 23 at 7 a.m., at the Southeastern Surgical Congress, in Atlanta. Once the American College of Surgeons resumes in-person meetings, the SPCS plans to hold their annual meeting in conjunction with the College’s Clinical Congress every October.

“Momentum towards integrating surgery with palliative medicine is building, as the data proves the patient and family benefit, so we’re hoping to capitalize on this wave of interest,” Dr. Miller said ■ [Am Surg 2020;86(11):1436-1440].

Opioids

and overdose.”

Maureen Hill, MD, a clinical instructor in surgical oncology at Fox Chase Cancer Center, in Philadelphia, said the study confirms that postoperative opioids can be prescribed in a patientcentered fashion, rather than based on procedure alone.

“I am not surprised by these results, as the authors’ previous data was strong and suggested this finding,” said Dr. Hill, who was not part of the current study.

She also said the guideline is applicable to a wide range of surgical patients.

Furthermore, the opioid-dispensing

continued from page 31

The three postoperative medication regimens are easy for surgeons to remember and implement across the country, Dr. Barth said, as is the proper disposal of opioids.

“As surgeons, we need to take ownership and responsibility for the opioids we prescribe,” he said. “By doing this, I believe we are going to minimize the number of patients with repeated opioid prescriptions and even potentially with opioid dependence

guideline is easy to follow, Dr. Hill said, because it is based solely on patient use within the 24 hours prior to discharge. “This is information that is easily obtained in the medical record,” she said. “The conversion to discharge prescription amount is also simple and will take little additional effort on the [part of the] provider to ensure appropriate prescribing based on the investigators’ algorithm.”

The study’s “great success in ensuring appropriate opioid disposal demonstrates that patient education is key to obtaining this goal,” Dr. Hill said.

■

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GENERAL SURGERY NEWS / JULY 2021

The Roux-en-Y Gastric Bypass Is the Superior Operation

T

Roux-en-Y or OneAnastomosis Gastric Bypass: Which Is the Better Bariatric Treatment? s we all get vaccinated, COVID-19 is finally coming under control. Once again, we will be able to meet in person, debate face-to-face, and settle our differences over dinner and perhaps a drink or two. That doesn’t mean, however, that our Great Debates should stop. In fact, this month we are pitting two debaters, both long-time friends of mine and, amazingly, each other, who have been arguing virtually on every online forum during the pandemic. Their debate is on what the best initial anastomotic bariatric treatment may be: the Roux-en-Y gastric bypass (RYGB) or the one-anastomosis gastric bypass (OAGB).

This is not a new debate in the United States. It has been going on for more than 20 years, ever since the mini gastric bypass was first introduced. At first, it was a political battle and not based on legitimate data, but hopefully time has changed all that. Now, the debate should be over interpretation of the data; that is, interpretation of a multitude of studies performed outside the United States, because our societies have previously failed to approve the use of any form of the mini gastric bypass.

Consequently, insurance companies did not reimburse it, essentially blocking legitimate studies in the United States.

As you will see in this month’s debate, our two highly respected and clinically experienced surgeons practice in very different settings (university vs. private practice) and come to very different conclusions from their interpretation of the same available data. Is one right and the other wrong? Can we even answer the question up for debate or is it time to conduct our own well-structured studies in the United States to possibly put this argument to rest?

I am sure our debaters will excite some of you to voice your own opinions on this subject.

I would encourage you to follow up with us at General Surgery News, just as many of you have done with our previous debates like the safe cholecystectomy debate. We can only make progress by agreeing to disagree and listening to the other side’s opinions. nions.

So, let the debate begin!

A

Edward L. Felix, x, MD Editor, The Great Debates es General Surgeon, Pismo o Beach, Calif.

he surgical approach to obesity mana safer perioperative portfolio. In princiagement encompasses a wide specple, the one-anastomosis MGB/OAGB trum of procedures. Metabolic surgeons should be safer than the two anastomoses face a daily challenge of choosing the optiin RYGB, but the data show otherwise.5,6 mal bariatric operation without clear-cut The MGB/OAGB is falsely publicized as a guidance or a definite algorithm. This protechnically feasible operation, while in realcedure selection dilemma exists between ity, it seems to be harder to teach and reprothe Roux-en-Y gastric bypass (RYGB) and duce—both crucial features for the spread Omar the mini or one-anastomosis gastric bypass Ghanem, MD of any successful operation. Furthermore, (MGB/OAGB). Which is the better operif the MGB/OAGB is that easy and that Assistant Professor ation and why? perfect, why the emergence of the various of Surgery Interestingly, the Roux gastrojejunostomodifications of it? Although these deviaMayo Clinic my was introduced in 1977, to resolve bile tions are present in the RYGB, they are not Rochester, Minn. pouch gastritis in the previously described surgery-defining as in MGB/OAGB. loop gastrojejunostomy configuration.1 While the MGB/OAGB is marketHistologically, there were pouch and anased as the impeccable procedure and the tomotic abnormalities in 86% to 91% of the loop solution for every problem, the above characteristics configuration patients (even when an entero-enteros- pin it as an imperfect one—thus a non-endorsement tomy was added).2 While the current MGB/OAGB by the American Society of Metabolic and Bariatric adopters managed to shift attention from bile gastri- Surgeons, and a withdrawal of endorsement from the tis to the “lack” of bile esophagitis in MGB/OAGB, French National Authority of Health. The discrepthe basis of the problem of why the Roux was created ancy between adopters’ claims and the reality witis still there in the current loop configuration. nessed by the governing institutes is a projection of Could this inflammation lead to cancer? In a Japa- one fact: lack of transparency. nese study, 417 patients developed gastric stump carcinoma after Billroth II reconstruction when partial In principle, the one-anastomosis MGB/OAGB gastrectomy was performed for benign causes (time should be safer than the two anastomoses in interval, 33.9 years). Although it might not be appropriate to consider the Billroth II reconstruction itself RYGB, but the data show otherwise.

This non-endorsement leads to lack of reimburseto be oncogenic, the study concludes that gastric ment by insurance companies, but most importantly, stump carcinoma “may come from gastrectomy-relatto a nonexistence of MGB/OAGB data from major ing mechanisms after gastrectomy for original benign 3 registries.

Appreciatively, the short- and long-term diseases.” Bile reflux is not as benign as it is advertised, and only time will tell. Time is a test that sure- risks and outcomes of the RYGB cannot be kept ly the RYGB has passed. While a few cases of cancer secret, providing a superlative tool for advancing both have been reported after RYGB, they remain small the surgery itself and the bariatric field. Learning relative to the very high denominator of the RYGBs from the advantages and liabilities is a must. Findthat have been performed over the past four decades. ing an equilibrium between safety and efficacy is a Additionally, while MGB/OAGB surgeons con- must. Reproducibility is a must. Reimbursement is a stantly undermine pathologic bile esophagitis, 45% must. Transparency is a must. When RYGB satisfies (n=742) of the surveyed surgeons reported revising it all the above checkpoints and MGB/OAGB satisfies at least once for bile reflux.4 none, is there really a debate? One should not conSafety, a major determinant in choosing the ideal fuse enthusiasm and lobbying with realism and data. bariatric procedure, continues to be a vague matter within the MGB/OAGB community. Luck- References ily, the long-term safety of MGB/OAGB has been 1. Buchwald H, Buchwald JN. Evolution of operative procedures for the management of morbid obesity compared to RYGB in the randomized controlled 1950-2000. Obes Surg. 2002;12(5):705-717.

YOMEGA trial (with several MGB/OAGB pioneers 5 on the design team). The MGB/OAGB had a seri- 2. McCarthy HB, Rucker RD Jr, Chan EK, et al.

Gastritis after gastric bypass surgery. Surgery. ous complication rate of 36% (compared with 20% for 1985;98(1):68-71.

RYGB) and an unforgiving 7.7% rate of malnutrition.

Critics of the YOMEGA trial attributed these higher 3. Tanigawa N, Nomura E, Lee SW, et al. Current malnutrition rates to a fixed MGB/OAGB biliopanstate of gastric stump carcinoma in Japan: based on the results of a nationwide survey. World J Surg. creatic (BP) length of 200 cm used in the trial. Being 2010;34(7):1540-1547. a malabsorptive procedure, the MGB/OAGB efficacy depends on this longer BP length. Can MGB/OAGB 4. Haddad A, Bashir A, Fobi M, et al. The IFSO maintain a competitive, noninferior efficacy if the BP worldwide one anastomosis gastric bypass survey: techniques and outcomes? Obes Surg. limb is shorter or if a percentage (rather than a fixed 2021;31(4):1411-1421. segment) of the total bowel length is bypassed? Of course not. The “defective” design of a wider gastro- 5. Robert M, Espalieu P, Pelascini E, et al. Efficacy and jejunostomy, smaller reservoir, and absence of pylorus safety of one anastomosis gastric bypass versus Rouxen-Y gastric bypass for obesity (YOMEGA): a muladded to a longer BP limb is a recipe for metabolic ticentre, randomised, open-label, non-inferiority trial. deficiencies with incidences of anemia of 44%, hypoLancet. 2019;393(10178):1299-1309. albuminemia of 32%, and hypocalcemia of 19% over a period of five years, compared with 17%, 15% and 6. Bhandari M, Nautiyal HK, Kosta S, et al. Comparison of one-anastomosis gastric bypass and Roux-en-Y 8%, respectively, for RYGB.6 gastric bypass for treatment of obesity: a 5-year study.

One can only hope that this humble long-term Surg Obes Relat Dis. 2019;15(12):2038-2044.

MGB/OAGB safety profile is counterbalanced by

THE GREAT DEBATES

JULY 2021 / GENERAL SURGERY NEWS

The One-Anastomosis Gastric Bypass Is the Superior Operation In 2001, an article was published in Obetoward the angle of His. A simple loop sity Surgery, reporting a new operation in a gastrojejunostomy between the jejunum series of 1,274 cases using a single-anastoand distal gastric pouch beginning 150 mosis version of a gastric bypass.1 This simto 200 cm beyond the ligament of Treitz completes the operation. plified version of a Roux-en-Y gastric bypass The OAGB is a simple, reproducavoided creation of a small gastric pouch ible and standardized procedure that is and eliminated the second distal anastoHelmuth employed by the majority of surgeons mosis required in the RYGB. This publiBilly, MD performing bariatric surgery around the cation described what is now known as the President, American world.

In contrast, the RYGB has become one-anastomosis gastric bypass (OAGB), an Society of Metabolic the most nonstandardized, ever-changoperation that has become the most effecand Bariatric Surgeons, ing bariatric operation used in the Unittive and widely performed operation for the California Chapter ed States.

Since its wide adoption as a treatment of obesity around the world.

Director, Bariatric Surgery laparoscopic bariatric operation in 1999Despite an overwhelming body of eviat St. John’s Regional 2000, there are now multiple variations dence and hundreds of publications prov2,3 Medical Center of the RYGB performed. No standarding that OAGB outperforms the RYGB, ization regarding pouch size, alimentary OAGB remains an underused operation in Oxnard, Calif. limb length, BP limb length or even clothe United States. What has become the safsure of mesenteric defects exists. The BP limb lengths est, most effective, reliable, consistent and standardized are now a random assortment of different lengths5— operation for the treatment of obesity in the world is sadly of limited access in the United States. some as short as 20 cm to those reaching 100 to 200 In the most recent randomized controlled trials of cm. Alimentary limb lengths can vary from as short as OAGB versus RYGB, the most important benefits of 50 cm to more than 100 cm. With respect to length and OAGB over RYGB were better glycemic control and a width, the creation of the gastric pouch has no stanhigher type 2 diabetes remission rate. Improved HbA1c dardization. Parietal cell mass is therefore largely pre[hemoglobin A1c] and a spectacular five-year resolution served, affecting rates of marginal ulcers and GERD rate of type 2 diabetes of 70.5% for OAGB, versus a rate following RYGB. of 39.4% with RYGB,4 can no longer be ignored. The OAGB should be recognized and used in the United The lack of standardization of the RYGB States as the better operation for both primary and revisional bariatric operations in the treatment of morbid between practices raises questions about the obesity and its significant comorbid conditions. validity of published data since the variations Over the past 25 years of bariatric surgery, the issue of standardization of procedures has been an important between techniques are not addressed. but elusive clinical goal. In the last 20 years, the OAGB has evolved into a standardized operation using anaThe RYGB resembles a sort of “shape shifter” from tomic landmarks and a technical description that vir- a Harry Potter novel, incorporating many significant tually all OAGB surgeons use to create a consistent changes in technique and limb length that did not and technically identical operation. The only differenc- occur from any evidence-based outcomes. The operaes between the two accepted OAGB techniques remain tion simply changed. As a result, there are very differwhether a side-to-side technique of gastrojejunostomy ent forms of what is universally called the RYGB being (as described by Carbajo) or the end-to-side anasto- performed. The lack of standardization of the RYGB mosis (as described by Rutledge) should be used. Both between practices raises questions about the validity of techniques describe creating a gastric pouch beginning published data since the variations between techniques 1 to 2 cm below the crow’s foot and extending vertically are not addressed.

Dr. Ghanem’s Rebuttal to Dr. Billy While my goal was to elaborate further on some of the distinguishing aspects between the two operations, the copious erroneous claims raised by my frenemy urged me to kick off this rebuttal where I concluded my initial piece: enthusiasm and lobbying versus realism and data. Thus, a fact checker.

Sleeve gastrectomy (and not MGB/OAGB) is the safest and most commonly performed procedure around the world. Although MGB/OAGB was described more than 20 years ago, it still comprises 4.1% of the total bariatric surgeries completed worldwide (vs. 31.2% for RYGB).1 Additionally, biliopancreatic diversion with duodenal switch (and not MGB/OAGB) continues to be the most effective metabolic procedure for weight loss and diabetes resolution.

Few publications (and not hundreds) showed more weight loss and diabetes resolution in MGB/OAGB, but the Level I evidence that takes both efficacy and safety into consideration does not support this misleading “superiority” concept. In fact, YOMEGA was labeled by the MGB/OAGB pioneers as a noninferiority trial due to its modest safety outcomes. The widespread premise of lack of internal hernias in MGB/OAGB was rejected by a recent publication elucidating an incidence of 2.8% after MGB/OAGB.2 The reproducibility claim is denied by the MGB/OAGB gurus , who find a technical defective surgical design in every study that reports reflux after MGB/OAGB.3

In the most recent study describing optimal limb length and OAGB, a BP limb length of 150 to 180 cm was optimal, safe and effective in terms of excess weight loss and comorbidity improvement. Malnutrition effects were low, even in patients with a body mass index greater than 50 kg/m2. The OAGB is now a reproducible and defined operation that has consistent results and is easy to perform.

Unfortunately, to this day, RYGB remains nonstandardized and variable. The issue of how long to make the BP limb remains unresolved and fluctuates between practices. The most recent study of long versus short BP limb compared a 50-cm with a 200-cm BP limb.5 The RYGB group with the 200-cm BP limb has a BP design that is now identical to the OAGB. Weight loss and HbA1c levels were better at 12 months with the longer limb. Better outcomes with the 200-cm BP limb in RYGB is a recognition that the longer BP limb lengths in OAGB have a preferred metabolic and clinical outcome. RYGB may finally incorporate the anatomic design of a long BP limb used for years with the OAGB. Perhaps now, after more than 20 years of discussion and animosity between the RYGB and OABG, we are seeing an evolution of the RYGB into what has always been the standardized design of the OAGB.

References 1. Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001;11(3):276-280.

2. Higa K, Brown W, Himpens J. Editorial: Single anastomosis procedures, IFSO position statement. Obes Surg.

2018;28(5):1186-1187.

3. De Luca M, Tie T, Ooi G, et al. Mini gastric bypass– one anastomosis gastric bypass (MGB-OAGB)—IFSO position statement. Obes Surg. 2018;28(5):1188-1206.

4. Zerrweck C, Herrera A, Sepulveda E, et al. Long versus short biliopancreatic limb in Roux-en-Y gastric bypass: short-term results of a randomized clinical trial. Surg Obes Relat Dis. 2021;S1550-7289(21)00186-6.

5. Lee, W-J, Almalki O, Ser K-H, et al. Randomized controlled trial of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity: comparison of the YOMEGA and Taiwan studies. Obes Surg.

2019;29(9);3047-3053.

The most standardized operation declaration is refuted by Dr. Billy himself as he mentioned two models or modifications (although there exists more) of MGB/ OAGB, as well as him promoting an optimal 150- to 180-cm BP length—a newborn hypothesis that only became popular after the mortifying safety data from YOMEGA. Others preach for tailoring the BP limb length according to BMI,4 so where is the standardization? While Dr. Billy advertises this as a disadvantage, the gorgeousness of RYGB is that standardization (including limb lengths) is not essential for exceptional outcomes.5 When a new procedure is promoted, surgeons expect this “novel” design to seal a practice gap. Which gap is MGB/OAGB trying to fill? Efficacy being promoted as the sole determinant in choosing the optimal bariatric operation takes our field back to the jejuno-ileal bypass era. The RYGB embraces efficacy, safety, comorbidity resolution, teachability and reproducibility. Until science proves otherwise, the RYGB is king and sits on the iron throne.

References 1. International Federation for the Surgery of Obesity and Metabolic Disorders. www.ifso. com/pdf/5th-ifso-global-registry-report-september-2019.pdf 2. Petrucciani N, Martini F, Kassir R, et al. Internal hernia after one anastomosis gastric bypass (OAGB): lessons learned from a retrospective series of 3368 consecutive continued on the following page

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IN THE NEWS

Abdominal Wall Perfusion Predicts Incisional Hernia Development

By JENNA BASSETT, PHD

T

he patency of abdominal wall vasculature appears to influence incisional hernia development among patients undergoing surgery for aortic disease, according to a new study.

Researchers at the University of Maryland School of Medicine, in Baltimore, found that abdominal wall perfusion may be a factor that affects the development of incisional hernias among patients undergoing laparotomy for aortoiliac occlusive disease (Hernia 2021;25[2]:419-425).

Patients undergoing open abdominal aortic aneurysm repair experience higher rates of hernia for reasons that remain unclear.

The study authors hypothesized that the underlying perfusion of the abdominal wall is compromised in some patients undergoing this procedure, and this impediment predisposes patients to hernia development.

A total of 38 patients who had undergone midline laparotomy or a thoracoabdominal approach for aortic disease with at least two years of follow-up were evaluated for abdominal perfusion and subsequent hernia. The researchers used preoperative imaging to assess the patency of abdominal wall vasculature and looked for relationships with hernia development.

Ultimately, 34% of patients (n=13) developed an incisional hernia.

Patients who developed hernias were older and underwent emergency operations more often than those who did not develop hernias.

Factors that predicted hernia development included absent flow in bilateral superior epigastric arteries or ipsilateral superior and inferior epigastric arteries (P=0.013 and 0.011, respectively). Of note, perfusion from the lumbar or deep circumflex iliac arteries was not linked to subsequent hernia development.

“This study introduces patency of the abdominal wall vasculature as a factor that may impact incisional hernia development,” the authors said. “Preoperative assessment of vessel patency may convey the risk of hernia development and help identify a specific patient population that would benefit from fascial closure with mesh rein■ forcement.”

GENERAL SURGERY NEWS / JULY 2021

Incisional Hernia Repair: 10-Year Trends continued from page 1

suture technique, despite all the guideline recommendations to the contrary.

“Considering the increasing concerns about using intraperitoneal mesh in primary and incisional ventral hernia repair, and the development of new techniques with endoscopic placement of the mesh in the retromuscular position, we were interested in knowing how these factors influenced the reality in incisional hernia repair,” said principal investigator Ferdinand Köckerling, MD, a professor and the chair of surgery and minimally invasive surgery at Academic Teaching Hospital of Charité Medical School, in Berlin.

A total of 61,627 patients with primary elective incisional hernia repair in Germany, Austria and Switzerland were enrolled in the Herniamed Registry between 2010 and 2019.

The data showed the proportion of laparoscopic IPOM repairs decreased from 33.8% in 2013 to 21% in 2019 (P<0.001), whereas the proportion of open sublay repairs increased from 32.1% to 41.4% during the same period (P<0.001).

Additionally, use of new minimally invasive techniques rose from 4.5% in 2013 to 10% in 2019 (P<0.001).

“To our surprise, the data from the Herniamed Registry show that surgeons more often returned to performing open sublay repair, despite all studies concluding that there are more perioperative complications for the open compared to the laparoscopic approach,” said Dr. Köckerling, the director of the Herniamed Registry. “On the other hand, the new endoscopic procedures are complex and have a long learning curve. The future will show if and how fast these endoscopic techniques become the standard of care in ventral hernia repair.”

Study co-author Henry Hoffmann, MD, a

The Great Debates continued from the previous page

patients undergoing OAGB with a biliopancreatic limb of 150 cm. Obes Surg.

2021;31(6):2537-2544.

3. Musella M, Vitiello A. The YOMEGA non-inferiority trial. Lancet. 2019;394(10207):1412.

4. Lee WJ, Wang W, Lee YC, et al. Laparoscopic mini-gastric bypass: experience with tailored bypass limb according to body weight. Obes Surg. 2008;18(3):294-299.

5. Ahmed B, King WC, Gourash W, et al. Proximal Roux-en-Y gastric bypass: addressing the myth of limb length. Surgery. 2019;166(4):445-455.

Dr. Billy’s Rebuttal to Dr. Ghanem “Realism and data” versus “enthusiasm and lobbying.” The MGB remains the world’s most overscrutinized bariatric surgery operation. IFSO reviewed more than 16,000 published cases and issued an endorsement for MGB/OAGB. That endorsement included two former ASMBS presidents. Data review must never be selective. The YOMEGA data set included better excess weight loss with OAGB at two years.1 Mean excess BMI lost favored OAGB. Two-year mean percentage total body weight loss was superior for OAGB. Mean operative time was significantly shorter with OAGB. The YOMEGA data set included an eye-opening mean hospital stay of five days in both groups! Five days! American practices are reporting mean lengths

consultant surgeon at ZweiChirurgen GmbH‒ Center for Hernia Surgery and Proctology, in Basel, Switzerland, noted that laparoscopic IPOM is still considered the gold standard for incisional hernia repair. “Our study, though, perfectly mirrors the penetration of the most recent technological developments challenging the supremacy of laparoscopic IPOM,” he said.

The new minimally invasive extraperitoneal techniques, such as eTEP and E/MILOS, “gain incremental acceptance in the surgeon’s daily practice for a good reason: Our registry-based analysis provided good evidence of improved outcomes compared to laparoscopic IPOM,” Dr. Hoffmann said.

The unpopular intraperitoneal mesh position is also avoided, “while keeping all the advantages of the minimally invasive approach,” Dr. Hoffman said. “Scientifically, we certainly need to follow this trend further and invest in surgical education. Our study clearly showed that the conventional open approach had an unexpected revival, with all its negative side effects.”

Regardless of the findings, study bias cannot be excluded because “hospitals and surgeons from the three countries voluntarily participated in the registry,” Dr. Köckerling said.

The existing data on new endoscopic techniques for ventral hernia repair are mainly small case series published by the innovators, according to Dr. Köckerling. “Collection of large case numbers from many surgeons and centers in a hernia registry will allow the comparison of new endoscopic techniques to the open sublay and laparoscopic IPOM procedures,” he said. “This opens the possibility for an early evaluation of these new surgical ■ techniques.”

of stay that are far less.

Cancer concerns? Tens of thousands of published MGB cases and no cancer papers? No associated cancer trend with MGB has been published. Presenting a position that there is a cancer concern without providing a single study linking a connection between MGB and cancer is the very definition of lobbying.

Is YOMEGA with its five-day mean length of stay really an important randomized trial? Why was the 2019 randomized controlled trial by Lee comparing the Taiwan trial and YOMEGA ignored? When including Lee’s data, OAGB remained technically easier, had better glycemic control and patients had less abdominal pain than with RYGB.2 Revisional surgery of OAGB patients in Taiwan? Zero. Malnutrition? Less in Taiwan than in YOMEGA. Surgical complication rate for OAGB? Again, lower in Taiwan. Bile reflux? The incidence of bile reflux was low in OAGB and did not influence the quality of life compared with RYGB. Funny thing about data: It reveals the truth when you consider all of it.

■

References 1. Lee WJ, Almalki O, Ser KH, et al. Randomized controlled trial of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity: comparison of the YOMEGA and Taiwan studies. Obes Surg. 2019;29(9);3047-3053.

2. Gormsen J, Burcharth J, Gogenur I, et al. Prevalence and risk factors for chronic abdominal pain after Roux-en-Y gastric bypass surgery: a cohort study. Ann Surg.

2021;273(2):306-314.

To comment on this Great Debate or to suggest future topics, contact the editor at khorty@mcmahonmed.com.

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JULY 2021

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IN THE NEWS

GENERAL SURGERY NEWS / JULY 2021

Study Suggests Which Melanoma Patients May Avoid SLNB continued from page 1

regardless of sentinel node status,” said lead study author Marc Moncrieff, MD, FRCS, a plastic surgeon from Norfolk & Norwich University Hospital, in Norwich, England.

In the study, Dr. Moncrieff and his colleagues identified 3,515 patients from nine cancer centers in five countries with American Joint Committee on Cancer (AJCC) 8th edition stage IB primary cutaneous melanoma. They analyzed patient demographics, primary tumor characteristics, SLNB status/ details and their association with survival outcomes.

The outcomes of the Multicenter Selective Lymphadenectomy Trial-2 and DeCOG studies, in addition to the maturation of data from recent adjuvant systemic therapy trials, have established the role of SLNB for accurately staging cutaneous melanoma patients, while simultaneously shifting the treatment paradigm from identifying patients for surgical management of the regional lymph nodes to identifying those eligible for adjuvant systemic therapy (N Engl J Med 2017;376:2211-2222; J Clin

A blue stained sentinel lymph node in the axilla. Source: Wikimedia Commons

Oncol 2019;37[32]:3000-3008). Adjuvant systemic therapy is usually not routinely recommended for AJCC IIIA melanoma. Those pT1b-pT2a melanoma patients who are SLNB-positive are mostly mapped to AJCC IIIA, which brings into question the role of SLNB for these patients.

The overall SLNB-positive rate was 11.5%. Virtually all node-positive patients (99.5%) were AJCC IIIA. The 0.1-mm difference in mean Breslow thickness

between the positive and negative biopsies was significant but not clinically relevant (P<0.001). A mitotic rate of 2 mm2 or greater identified 67.5% of all SLNBpositive patients and 74.0% of all stage N2 to N3 and/or extracapsular spread.

The incidence of a mitotic rate of 2 mm2 or greater was 55.8%. A mitotic rate of 2 mm2 or greater was the only significant, independent predictor of relapse-free, distant disease‒free, nodal relapse‒free and disease-specific survival on multivariate

analysis (hazard ratios, 3.78, 3.35, 4.11 and 2.98, respectively; P<0.0001 for all).

Dr. Moncrieff said the role of SLNB for a mitotic rate of 1 mm2 or lower may merit further clarification.

“This is a very interesting study of this common subgroup of patients with stage IB cutaneous melanoma, and it has been presented by excellent investigators globally,” said Craig L. Slingluff Jr., MD, the Joseph Helms Farrow Professor of Surgery and co-leader of the Cancer Therapeutics Program at UVA Cancer Center, in Charlottesville, Va. “The finding that mitotic rate of 2 mm2 or greater identifies most of those with positive nodes does raise an interesting question of whether these clinical stage IB melanomas with one mitosis or less could be spared SLNB. Factors that need to be considered are the interobserver variation in mitotic rate assessment, and the fact that some patients with stage IIIA melanoma are offered adjuvant therapy on clinical trials.”

Dr. Slingluff is also the director of the Human Immune Therapy Center at the University of Virginia.

■

The Scientific Greats: A Series of Drawings

By MOISES MENENDEZ, MD, FACS

Emil Theodor Kocher (1841-1917) At the end of the 19th century and beginning of the 20th century, there was a turn for the good regarding science, especially in medicine. The x-ray was discovered by Roentgen; radioactivity was also discovered and pioneered by Marie Curie; and antisepsis was slowly introduced in hospitals in Europe due to the efforts of Pasteur and Lister.

Kocher, a Swiss physician and medical researcher, was involved in this era and gathered all the latest scientific discoveries. He was able to reduce the mortality rate in surgery, and also received the 1909 Nobel Prize in Physiology or Medicine for his work in the physiology, pathology and surgery of the thyroid gland. He was the first Swiss citizen and the first surgeon to receive a Nobel prize. He was considered a pioneer and leader in the field of surgery in his time.

Kocher studied medicine in Bern and Zurich, Switzerland. Having come into contact with the famous surgeon Theodor Billroth, and having witnessed Thomas Spencer Wells performing Switzerland’s first oophorectomy, he decided to become a surgeon. Before he graduated from medical school, Kocher visited Paris, London, Vienna and Berlin, and learned the newer techniques in surgery.

After graduation, Kocher became the sole assistant in the Surgical Clinic of Bern University (1866-1869) and applied Lister’s antiseptic methods successfully (1867), as confirmed by the clinic’s falling rate of operative mortality.

Kocher contributed to other fields outside of surgery, which put him at a higher level. For instance, he

created a way to reduce shoulder dislocations (Kocher’s III method). Moreover, he designed new techniques and instruments to approach other organs such as the gallbladder. He empowered the existing techniques for inguinal hernia surgery throughout invagination (Kocher’s II method) and introduced improvements in the intervention of organs such as the stomach, lung and tongue.

Kocher is arguably the surgeon with the greatest number of eponyms. It is not uncommon for a surgeon to say to the scrub nurse during surgery, “Give me a Kocher’s,” or a surgeon to tell a resident, “Next, we will Kocherise the duodenum.” Often the student or resident is oblivious to the name behind the instrument or procedure, or the person behind the name. This surgical historical review attempts to discuss the contributions of Emil Theodor Kocher to the field of medicine and surgery, and highlight the surgical eponyms associated with him.

Kocher was one of the most important exponents of thyroid surgery. He inspired a new surgical school based on his refined technique. He transferred his concepts to other recognized surgeons in Europe and America, such as Charles Mayo, who was a pioneer of endocrinologic surgery in America. Other American surgeons who were influenced by Kocher included William Halsted and Harvey Cushing.

■ Sources Tröhler U. Emil Theodor Kocher (1841-1917). J R Soc Med. 2014;107(9):376-377.

Fong ZV, Rosato EL, Lavu H, et al. Emil Theodor Kocher, MD, and His Nobel Prize (1841-1917).

Am Surg. 2012;78(12):1322-1324.

Emil Theodor Kocher (1841-1917) 2017 Work was done on gray-toned paper, 11x14, using Pan pastel and charcoal pencils.

Artist: Moises Menendez, MD, FACS

Franco ML, Acosta N, Chuaire L. Emil Theodor Kocher: an innovator surgeon. Colomb Med. 2009;40(2):231-234.

Koroye OR, Baribote O. Emil Theodore Kocher and surgical eponyms; a story of diligence, hard work and excellence.

Yen Med J. 2021;3(1):3-7.

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GORE® SYNECOR Biomaterial

Versatile, easy-to-use hybrid solution The tissue-building Gore 3D PGA:TMC web scaffold promotes rapid vascularity within seven days1 and tissue ingrowth within one month.2,3

QUALITY OUTCOMES START WITH QUALITY MATERIALS GORE® SYNECOR Biomaterial promotes healing and provides permanent strength.

This latest generation macroporous knit of dense, monofilament PTFE fibers may reduce the risk of bacteria residing within the knit and provide optimum strength for durable, single-stage repairs for your patient.

» Learn more at goremedical.com/synecor.

W. L. Gore & Associates, Inc. | Flagstaff, AZ 86004 | goremedical.com 1. Crawford N. Assessment of Vascularity via Micro CT in Various Patch Devices. Flagstaff, AZ: W. L. Gore & Associates, Inc.; 2016. [Final study report]. 2344TL. 2. Berman A. Evaluation of Plexus with film and ETHICON PHYSIOMESH® in a 30-day rabbit intraperitoneal model. Flagstaff, AZ: W. L. Gore & Associates, Inc.; 2015. [Study protocol]. 2335SC. 3. Berman A. Evaluation of Plexus with no film and ETHICON PHYSIOMESH® in a 30-day rabbit subcutaneous model. Flagstaff, AZ: W. L. Gore & Associates, Inc.; 2015. [Study protocol]. 2336SC. Consult Instructions for Use eifu.goremedical.com

Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available.

Products listed may not be available in all markets.

GORE, SYNECOR and designs are trademarks of W. L. Gore & Associates. © 2020 W. L. Gore & Associates, Inc. AZ1737-EN1 AUGUST 2020