May 2022 Print issue by McMahon Group

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GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

May 2022 • Volume 49 • Number 5

Factors for Passing Endoscopic Surgery Test: FEC Completion n And Gender

First Post-op Ultrasound Helpful in Determining Risk for Node Basin Recurrence In Melanoma By KATE O’ROURKE

By CHRISTINA FRANGOU

urgical trainees who complete the Flexible Endoscopy Curriculum, or FEC, are more likely to pass the Fundamentals mentals of Endoscopic Surgery, or FES, manual skills test on the first try, according to a study presented at the 2022 annual meeting ng of the Society of American Gastrointestinal and Endoscopic Surgeons. rgeons. One factor, however, proved even more influential than FEC completion in predicting whether trainees would pass the manual nual skills test: gender. Male trainees were three times more likely to pass the skills test on a first attempt compared with female trainees (odds ratio [OR], OR], 3.1; 95% CI, 1.7-5.7; P<0.001), according to the analysis. Male trainees also were more likely to complete the FEC C prior to the

n patients with melanoma, clinical and pathologic factors can be used to predict lymph node recurrence after sentinel lymph node biopsy, but the first postoperative ultrasound may be an important step in determining residual disease in the dissected basin, according to new research. The findings were presented at the Society of Surgical Oncology 2022 International Conference on Surgical Care (abstract 48). The MSLT-II (Multicenter Selective Lymphadenectomy Trial II) resulted in a shift in the management of tumor-positive sentinel lymph nodes from completion node dissection to nodal observation. While there is no apparent survival advantage with completion node dissection, this change in practice leaves some patients with nodal disease in the sentinel lymph node basin.

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SBO Patients Fare Better With Surgical Services, Even Those Managed Medically

MONEY MATTERS

OPINION

Physicians’ Fiscal Fitness: Dispelling the ‘Unsavvy Doctor’ Trope

Better Good Than Lucky

By MONICA J. SMITH

NASHVILLE, TENN.— It has been shown that patients

NASHVILLE, TENN.—Physicians have a reputation

who undergo surgery for small bowel obstruction (SBO) have better outcomes when they’re initially admitted to surgical services. Now, a new study shows even those who can be managed medically fare better when admitted to surgical services. Over the past 20 years, certain changes in care have shifted SBO from a predominantly surgically managed disease to one that often can be managed nonoperatively. The admission of patients is split between surgical and medical services; those with more comorbidities tend to be admitted to the latter.

for being behind their non-medical peers in terms of financial savvy, but new research suggests doctors actually have better financial habits than the general population. “With the additional burdens of practice management, coding and excessive student loans, there’s been increasing interest in financial literacy for trainees,” said Dustin Nowotny, DO, a chief resident at the University of North Dakota, in Grand Forks, while presenting his research at the 2022 Southeastern Surgical Congress.

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By BARRET HALGAS, MD

IN THE NEWS

Highlights From the SAGES 2022 Annual Meeting

12 Lung Transplantation:

A History of Controversies X

OP IN ION

18 Health Information Transparency: How Fast Is Too Fast? facebook.com/generalsurgerynews

@gensurgnews

“Luck is what happens when preparation meets opportunity.” —Seneca

n a 1978 report, psychologist Dr. Pauline Clance shared her observation that highachieving women in the workplace were often reticent to acknowledge their own personal or professional successes. In fact, the people she studied described feelings of phoniness despite actual measurable outcomes of success. Dr. Clance coined the phenomenon “imposter syndrome.” Continued on page 16

ENTER A NEW WORLD OF POSTOPERATIVE PAIN MANAGEMENT With 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 b 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

DISCOVER MORE AT ZYNRELEF.COM

Indication

Contraindications

ZYNRELEF is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.

ZYNRELEF is contraindicated in patients with a 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 CABG.

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.

PP-HTX011-0557 | 01/22

Chondrolysis: Limit exposure to articular cartilage due to the potential risk of chondrolysis. 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.

Use in Speciﬁc Populations 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.

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

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

Drug Interactions

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.

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, volume-depleted, 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 effects.

REDEFINE POSTOPERATIVE PAIN MANAGEMENT

ZYNRELEF® (bupivacaine and meloxicam) extended-release solution, for soft tissue or periarticular instillation use

Dose-Related Toxicity: The toxic effects 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.

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION

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.

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 foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. 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 should not be administered via the following routes: epidural, intrathecal, intravascular or intra-articular, regional nerve blocks, and pre-incisional or 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: As a general guidance in selecting the proper dosing of ZYNRELEF, the following examples of dosing are provided: − Foot and ankle surgical procedures, such as bunionectomy: up to 2.3 mL to deliver 60 mg/1.8 mg. − Small-to-medium open abdominal surgical procedures, such as open inguinal herniorrhaphy: up to 10.5 mL to deliver 300 mg/9 mg. − Lower extremity total joint arthroplasty surgical procedures, such as total knee arthroplasty: up to 14 mL to deliver 400 mg/12 mg.

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 benefits 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: Limit exposure to articular cartilage due to the potential risk of chondrolysis. Intra-articular infusions of local anesthetics have been associated with chondrolysis. 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.

See full Prescribing Information for all important dosage and administration information, preparation instructions and compatibility considerations.

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

CONTRAINDICATIONS

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:

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 potential 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 beneﬁts 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.

ADVERSE REACTIONS

• 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 effects. 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 methotrexateassociated toxicities. Monitor for signs of methotrexate toxicity 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 patients with creatinine clearance 45 to 79 mL/min, monitor for pemetrexedassociated 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.

Manufactured and marketed by: Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA, 92121, USA. Copyright© 2021 Heron Therapeutics, Inc. All rights reserved. ZYNRELEF® is a registered trademark of Heron Therapeutics, Inc. PP-HTX011-0102 12/21

IN THE NEWS

MAY 2022 / GENERAL SURGERY NEWS

Postoperative Undertriage Increases Risk for Morbidity, Mortality By JENNA BASSETT, PhD

nderestimating the risk for postsurgical complications in patients is associated with increased morbidity and mortality, according to a recent study. In the research published in JAMA Network Open (2021;4[11]:e2131669), investigators at UF (University of Florida) Health, in Gainesville, reported that patients at high risk for postoperative complications who are undertriaged after surgery experienced higher morbidity and mortality than a risk-matched control group of ICU admissions. Postoperative triage provides an opportunity to evaluate patients for the risk for complications and to ensure those with high risk are moved to the ICU. However, in some cases, high-risk patients are moved to hospital wards instead, which could result in worse surgical outcomes. “Although it seems intuitive that postoperative undertriage would be associated with worse outcomes, this association had not been previously reported in peerreviewed literature,” said Tyler Loftus, MD, an assistant professor in the UF’s Department of Surgery and lead author of the study. Dr. Loftus and his team evaluated 12,348 hospital ward admissions for inpatient surgical procedures. Using a random forest machine learning algorithm, the researchers identified patients’ risk for hospital mortality or prolonged ICU stay (≥48 hours) and compared patients admitted to hospital wards with risk-matched patients admitted to the ICU.

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

Editorial Advisory Board Gina Adrales, MD, MPH Baltimore, MD Maurice Arregui, MD Indianapolis, IN Philip S. Barie, MD, MBA New York, NY L.D. Britt, MD, MPH Norfolk, VA James Forrest Calland, MD Charlottesville, VA David Earle, MD Lowell, MA Sharmila Dissanaike, MD Lubbock, TX Edward Felix, MD Pismo Beach, CA Robert J. Fitzgibbons Jr., MD Omaha, NE Michael Goldfarb, MD Long Branch, NJ Leo A. Gordon, MD Los Angeles, CA

“The algorithm considered a large set of electronic health record variables (laboratory values, medications, comorbidities, social determinants of health, surgery type, etc.) that were collected during the one-year period before surgery, as well as vital signs and ventilator settings during surgery,” Dr. Loftus said. The algorithm found 10.6% of postoperative ward admissions were undertriaged. “That does seem high, though I imagine it is because postoperative destination is largely determined preoperatively,” commented study co-author Jeremy Balch, MD, a general surgery resident at UF. “There may be subtle shifts in vital signs during the case or unaccounted-for preoperative variables (such as Area Deprivation Index) that did not enter the decision-making process.” Compared with the control group, the undertriaged patients had a higher median age (64 years; interquartile range [IQR], 54-74 vs. 62 years; IQR, 50-73 years; P=0.001), a larger proportion of women (49.7% vs. 44.0%; P<0.001), and more patients with a “do not resuscitate” order before first surgical procedure (4.1% vs. 1.1%; P<0.001). The researchers found the undertriaged group had worse outcomes than the control group—most notably, an increased incidence of hospital mortality (1.5% vs. 0.7%; P=0.04) and elevated risk for morbidity, including a larger proportion of patients with discharge to hospice (1.8%

Jarrod Kaufman, MD Brick, NJ

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. DISCLAIMER Opinions and statements published in General Surgery

Peter K. Kim, MD Bronx, NY

News are of the individual author or speaker and do not represent the views of the editorial advisory board, editorial staff or reporters.

Lauren A. Kosinski, MD Chestertown, MD

DISCLOSURE POLICY We endeavor to obtain relevant financial

Marina Kurian, MD New York, NY

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.

Raymond J. Lanzafame, MD, MBA Rochester, NY

CONTACT THE EDITOR

Timothy Lepore, MD Nantucket, MA

Editorial Staff

Robert Lim, MD Tulsa, OK

Kevin Horty Group Publication Editor khorty@mcmahonmed.com

John Maa, MD San Francisco, CA Gerald Marks, MD Wynnewood, PA Yosef Nasseri, MD Los Angeles, CA Eric Pauli, MD Hershey, PA Richard Peterson, MD San Antonio, TX Ajita Prabhu, MD Cleveland, OH Bruce Ramshaw, MD Knoxville, TN

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Joe Malichio Director, Medical Education jmalichio@mcmahonmed.com

vs. 0.6%; P<0.001), unplanned intubation (3.4% vs. 2.0%; P=0.01), acute kidney injury (26.1% vs. 19.5%; P<0.001), and median hospital length of stay (8.1 days; IQR, 5.113.6 days vs. 6.0 days; IQR, 3.3-9.3 days; P<0.001). Compared with controls, the undertriaged group also had a smaller proportion of admitted patients with prolonged ICU admission (12.6% vs. 57.4%; P<0.001), a similar proportion of admitted patients with prolonged mechanical ventilation (2.5% vs. 2.2%; P=0.60), and an increased proportion of admitted patients receiving postoperative red blood cell transfusion (21.1% vs. 13.7%; P<0.001). In addition, undertriaged inpatients had decreased median total costs per admission ($26,900; IQR, $18,400-$42,300 vs. $32,700; IQR, continued on page 11

NOT RECEIVING GENERAL SURGERY NEWS? All U.S. general surgeons, surgical residents, colorectal surgeons, vascular surgeons, surgical oncologists and trauma/critical care surgeons should receive General Surgery News free of charge. If you are not receiving the publication, or if you are changing your address or name, please follow these instructions: 1) Contact the AMA at (800) 262-3211 or the AOA at (800) 621-1773, and verify with them your name, address and professional specialty. YOU NEED NOT BE A MEMBER OF THE AMA OR AOA. They maintain the ultimate source from which our mailing lists are generated. 2) For added assurance of uninterrupted service, you may also mail or fax a copy of your current mailing label, along with your change of name or address to: Circulation Manager, General Surgery News 545 West 45th Street, 8th Floor New York, NY 10036 Fax: (815) 366-8297 Email: circulation@mcmahonmed.com Please sign and date all requests. If you are not a general surgeon or other specialist listed above and would like to subscribe, please send a check payable to General Surgery News. Please visit generalsurgerynews.com/NewSubscription. Subscription: $105 per year (outside U.S.A., $130). Single copies, $10 (outside U.S.A., $13). POSTMASTER: Please send address changes to General Surgery News, 545 W. 45th St., 8th Floor, New York, NY 10036. Copyright © 2022 McMahon Publishing, New York, NY 10036. All rights reserved. General Surgery News (ISSN 1099-4122) is published monthly for $105 per year by McMahon Publishing.

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IN THE NEWS

FIRST LOOK All Articles by CHRISTINA FRANGOU

Living Donor Robotic Kidney Transplant

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DENVER—Surgeons from the Lahey Clinic presented a technique for a living donor robotic kidney transplant, an approach that leads to a speedier recovery for patients and lower wound complication rates. “We have noted excellent wound healing, lower narcotic pain usage and shorter length of hospital stays following our early cohort of robotic kidk ney transplantation recipients,” said Caro-line J. Simon, MD, the senior staff surgeon and fellowship program director at the Lahey Hospital and Medical Center in Burlington, Mass. Graft function after robotic transplantation is similar to that for conventional kidney transplantation, she said. At SAGES, Dr. Simon showed a video e eo of a robotic kidney transplant performed d on a 53-year-old female patient who received a living donor kidney graft from her daughter. To perform the operation, surgeons made five incisions for four robotic ports and two laparoscopic ports, with one GelPort (Applied Medical) used as both a laparoscopic and robotic port. Robotic dissection was used to prepare the iliac vessels for implantation, while waiting for the living donor nephrectomy procurement. The graft was then inserted via the GelPort in the umbilicus, and the robot was used to perform all anastomoses. Total warm ischemia time is around 40 minutes, she said. The technique was first reported in 2010 by Italian surgeons who performed a robotic kidney transplant in a morbidly obese patient, for whom conventional laparoscopic instruments were unsuitable (Am J Transplant 2010;10[6]:1478-1482). Dr. Simon and her colleagues performed their first robotic kidney transplant in January 2020, after adapting the technique from surgeons at Henry Ford Hospital, in Detroit. Since then, they’ve operated on eight patients using the robotic approach. They expect to increase uptake in the next year after early delays due to the COVID-19 pandemic, she said. “We are hoping to have a fairly rapid expansion, as we have seen good preliminary results,” Dr. Simon said. Open kidney transplantation, first performed in 1954, is associated with high rates of incisional hernias, as well as wound dehiscence and surgical site infections. The first laparoscopic kidney transplant was reported by Spanish surgeons in 2010 (Eur Urol 2010;57[1]:164-167). Surgeons at SAGES said the total robotic approach is promising. “I think there’ll be wound benefits, potentially decreased hernia rates. There’s a lot of potential benefits from converting this to a robotic procedure,” said Jacob Greenberg, MD, a professor of surgery at Augusta University, in Georgia.

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Pre-op Bowel Stimulation Reduces Post-op Ileus

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GENERAL SURGERY NEWS / MAY 2022

The Society of American Gastrointestinal And Endoscopic Surgeons reduced rates of postoperative ileus in patients undergoing elective loop ileostomy closure, according to results from a multicenter, single-blind randomized trial. In the study of 97 patients, only 6% of those who received repeat bowel stimulation in the three weeks before surgery developed postoperative ileus—down from 24.5% of patients in the control arm. “The relative risk reduction with this intervention makes it quite attractive and appealing,” said study co a th co-auth h Richard Garfinkle, MD, a PGY-4 co-author resiid resident in general surgery at Montreal’s M McGill University, during his present tation at SAGES. Investigators recruited adult patients from five hospitals in Canada, one in the United States and another in New Zealand. All p patients previously had a segmentta colectomy or proctectomy with a tal divve diverting loop ileostomy and were randomly assigned to the control or stimulation arm. Patients in the stimulation arm received up to 10 episodes of bowel stimulation performed in an outpatient clinic over the three weeks prior to ileostomy closure. During each session, an 18 Fr Foley catheter was used to intubate the distal limb of the loop of the ostomy, which was infused with a solution of 500 cc of normal saline combined with 30 g of thickening agent. Nearly 80% of patients completed all 10 sessions, 17% completed seven to nine and 4% completed less than seven sessions. Each stimulation lasted an average of 25 minutes, and about 25% of patients reported abdominal cramping. However, only four out of 410 sessions were terminated early due to poor tolerance. There were no major adverse events. Forty-seven percent of patients in the intervention arm had a return of flatus by postoperative day 1, compared with 22.4% in the control arm (P=0.022). Their postoperative length of stay fell to three days, down from four in the control arm (P=0.003). After the presentation, Dimitrios Stefanidis, MD, a professor of surgery at Indiana University School of Medicine, in Indianapolis, called the findings “extremely convincing.” But it’s unclear how many patients would be eligible for this kind of bowel stimulation. The intervention used in the study is time-consuming for both patients and providers and may not be realistic for all patients, Dr. Garfinkle said. As such, he and his colleagues are looking at the potential for patients to perform stimulation at home with the help of community nurses, on their own or with family members, he said. The investigators initially planned to recruit 166 patients, based on sample size calculations indicating that 83 participants would be required in each arm to show a significant effect of bowel stimulation. However, the pandemic affected patient recruitment and study logistics. The investigators performed an interim analysis after 101 patients were randomized. Although the study was stopped early, this remains the largest trial to explore bowel stimulation in these patients and is the first multicenter trial to do so. A 2014 single-center Spanish trial of 70 patients found

ileus fell to 3% from 20% after preoperative bowel stimulation (Dis Colon Rectum 2014;57[12]:1391-1396). The findings are only applicable to patients with residual colon, and not to patients with ileal pouch–anal anastomosis, according to the authors.

U.K.-Based Liver Surgery Scoring System Correlates With U.S. Outcomes DENVER—The Halls/Southampton Laparoscopic Liver Difficulty Score—a model that predicts the risk for intraoperative complications during minimally invasive liver resections—correlates with operative outcomes in North American patients, including estimated blood loss, operative time and length of stay, according to data from eight centers participating in the Americas Minimally Invasive Liver Resection (AMILES) registry. In comparison, the IWATE scoring system did not correlate with operative outcomes or postoperative complication rate in these patients. This may reflect differences in populations in the East and West, the authors said. The IWATE system was developed and revised in Japan where resection for hepatocellular carcinoma is common. The United States, however, has higher rates of resection for colorectal liver metastases, said study co-author Yasmin Essaji, MD, a fellow in hepatobiliary surgery at Virginia Mason Medical Center, in Seattle. The study is based on a retrospective analysis of 1,051 patients in the AMILES registry who underwent a minimally invasive hepatic resection. Patients were scored based on the Halls/Southampton and IWATE scoring systems. The Halls/Southampton score, which was developed in the United Kingdom, categorizes patients in groupings ranging from low, moderate to high. Analysis showed these groupings correlated with estimated blood loss (343, 499 and 681 mL; P<0.001); operative time (116, 225 and 265 minutes; P<0.001) and length of stay (3.53, 6.30 and 7.05 days; P<0.05), respectively. However, there was no statistically significant difference in need for conversion to open and postoperative complication rate. Analysis revealed no significant correlation with IWATE scores and operative or clinical outcomes. Investigators said more research will be needed using a prospective database to better delineate the predictive potential for these scoring systems. But difficulty scoring systems will help surgeons as they develop their skills, Dr. Essaji said. “It really helps to judge the difficulty of minimally invasive liver surgery and resections, and can help surgeons better identify cases where they feel comfortable so that they can start on the lower-difficulty procedures,” she said. Several surgical scoring systems have been proposed, but none are routinely used in practice. A third scoring system developed in France— the Institut Mutualiste Montsouris classification, or IMM—is not as widely validated or accepted as the IWATE and Halls/Southampton scoring systems, and was excluded from this study. The investigators did not differentiate between laparoscopic and robotic-assisted surgery in this analysis, but plan to assess those differences as more centers, especially those with robotic expertise, join the AMILES ■ registry.

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IN THE NEWS

GENERAL SURGERY NEWS / MAY 2022

SBO Surgical continued from page 1

“We wanted to know if surgical services should be admitting patients who are, at least initially, being managed nonoperatively,” said Christopher Thacker, MD, a thirdyear surgical resident at Geisinger Medical Center, in Danville, Pa., who spoke at the 2022 Southeastern Surgical Congress. Dr. Thacker and his colleagues conducted a multicenter, retrospective study of all patients 18 years of age and older, admitted to their health system for SBO from June 2007 to June 2019.They included only patients who did not require any surgical procedure during their admission, and excluded patients admitted initially to the ICU or hematology/ oncology services. The primary outcomes were mortality, length of stay (LOS) and readmission rate. The investigators identified 3,278 patients, of whom 933 (28%) were admitted to surgical services and 2,345 (72%) were admitted to medical services. Of the group, the vast majority was sent

to hospitalist services. “Demographically, there were some significant differences, including [scores on] the Charleston Comorbidity Index,” Dr. Thacker said. Patients admitted to medical services tended to be older (58 vs. 55 years; P<0.001), and were more likely to have diabetes (24% vs. 20%; P<0.015), congestive heart failure (6% vs. 3%; P<0.002) and acute kidney injury (30% vs. 17%; P<0.001). Patients admitted to surgical

services were more likely to have cancer (19% vs. 14%; P<0.001) and more likely to have had surgery in the past 30 days. “The only major comorbidity that did not reach statistical significance was hypertension,” Dr. Thacker said. On univariate analysis, patients admitted to surgical services had lower mortality at their index admission (0.1% vs. 2%; P<0.001), 30 days (1% vs. 7%; P<0.001) and 180 days; The mortality rate was 4.9% in those admitted to surgical services and 13.4% of those admitted to medical services. They also had fewer readmissions at 30 days (8% vs. 12%; P<0.001) and an overall shorter mean LOS, at three versus four days (P<0.001). “We then performed a multivariable analysis controlling for Charleston Comorbidity Index, age, sex and race, as well as all of the individual comorbidities,” Dr. Thacker said. Controlling for all of those variables, patients admitted to surgical services still had a lower odds ratio for admission and 30- and 180-day mortality, and experienced fewer readmissions and a shorter LOS.

Dr. Thacker acknowledged some limitations of the study, such as its retrospective design and the fact that practice patterns vary among institutions. Ultimately, however, the findings showed admission to a surgical service decreases index admission mortality and readmission for nonoperative patients, even after controlling for comorbidities. “Hopefully in the future, we’ll be looking at the impact of surgical consult in patients who are admitted to medical services,” Dr. Thacker said. Deborah Martin, MD, an acute care surgeon at Northside Hospital, in Cumming, Ga., who reviewed the study, pointed out that patients admitted to medical services may be healthier, “and we’re getting them in and out because we don’t do surgery. I’m not sure that means we should admit them all, especially those who have significant medical comorbidities. “But I do think if they’re admitted to the medical service, surgeons need to be consulted in a timely manner and see the patient so that they can decide, as a team, the treatment plan. Both services need to be there,” Dr. Martin said. ■

Social Media Can Be a Boon for Surgeons, When Used Responsibly By KAREN BLUM

ocial media platforms have grown tremendously in popularity among the general public and medical community, but surgeons and other healthcare professionals need to use it responsibly to avoid lawsuits, disciplinary actions and other woes, a panel of surgeons said during the 2021 virtual American College of Surgeons Clinical Congress. “We are clearly living in a post-or-perish era,” said Brian Jacob, MD, FACS, a private practice surgeon in New York City. However, surgeons need to think critically about what they post, he added: “We need to be a little careful about what we do online, because anything you post can and may be used against you at some point.” Social media usage has been exploding, from just under 1 billion users in 2010 to a projected 3.4 billion users in 2023, said Steven Wexner, MD, PhD, FACS, the director of the Digestive Disease Center and chair of the Department of Colorectal Surgery at Cleveland Clinic Florida, in Weston. Physicians and surgeons most commonly use blogs to express their opinions and thoughts, followed by Twitter and Facebook (BMD Med Inform Decis Mak 2016;16:91), whereas the general population is more likely to use Facebook, followed by YouTube and WhatsApp, Dr. Wexner said. The use of social media varies by specialties, he added. Some 82% to 85% of plastic surgeons use social media, versus 28% of academic radiologists, according to a 2017 study that he led (Colorectal Dis 2017;19[2]:105-114). The journal Surgery, under his editorial leadership, launched its digital media efforts about a year and a half ago and now features a digital media and innovations editorial board. The group can now tell authors about alternative metrics, such as how often their article was referenced on Google or LinkedIn or how many blogs mentioned it. Surgeons post information to social media platforms

primarily for a status update, or for educational purposes, to enhance awareness of what’s going on in the surgical field, Dr. Jacob said. However, “the intent to egotistically boast about one’s accomplishments is easily distinguishable from a genuine intent to educate or disseminate to a global audience useful information that might optimize patient outcomes,” he said. Poor judgment when it comes to postings can result in actions such as being fired, having a license suspended or being subject to lawsuits—not to mention damage to your reputation. There are two main areas of concern when it comes to this, he said. One is committing an act that constitutes potential malpractice. The other is the impact of social media use on a potential or pending malpractice proceeding. “If you post a tweet about how nervous you are for an upcoming robotic colon or upcoming hernia case, and that case goes on to have a complication, and the legal team discovers your posts, those posts can be used against you in some form,” Dr. Jacob cautioned. Posting information within private Facebook groups generally is considered safe, he added. However, screen sharing is very commonplace, and those screenshots also could be used by a legal team during the discovery period. A 2019 white paper that he co-authored provides additional information about sharing information in such groups (Surg Endosc 2019;33[1]:1-7). When used responsibly in the surgery realm, social media posts and tweets can provide a newer means of connecting researchers for shared projects or papers, finding mentors or mentees, and finding participants for clinical trials or studies, Dr. Wexner said. “It’s not only where the future is, it’s where the present is, and it’s where our patients are,” he said. “But we have to be very careful with it and follow the rules.” Know that anything posted to social media, even if you hit delete, leaves a footprint in cyberspace that you cannot take back. Never post or send anything until you’re

100% sure you want to do it, he said. You also must be HIPAA-compliant. Do not reveal any information that would potentially reveal any confidential aspect of your physician–patient relationships. Here are some best practices for using social media, from the Icahn School of Medicine at Mount Sinai, in New York City. For more, see bit.ly/3om1vdT. • Take responsibility and use good judgment. You are responsible for what you post. Be courteous, respectful and thoughtful about how others may perceive or be affected by the postings. • Think before you post. Anything you post is highly likely to be permanently connected to you and your reputation. • Protect patient privacy. Disclosing isclosing information about patients without written permission is prohibited at Mount Sinai—and inai—and likely other employers. • Use a disclaimer. Make it clear you are speaking for yourself self and not on behalf of your employer. ployer. • Respect copyright and fairr use laws.

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IN THE NEWS

GENERAL SURGERY NEWS / MAY 2022

Surgeons Call for More Support for Residents During Pregnancy ncy By CHRISTINA FRANGOU

rom the pages of medical journals to the virtual podium at online surgical meetings, surgeons are sounding the alarm over a high rate of pregnancy complications in their profession and calling for widespread changes to support surgeons’ maternal health during pregnancy. Writing in the Annals of Surgery in January, surgeons from the University of Michigan issued a call to action for surgery chairs and program directors. They want residency programs to provide better support to residents who choose to have children during training (Ann Surg 2022;275[1]:e1-e2). “There’s been some progress, but the work has not finished when it comes to creating places where women who desire motherhood and working moms are playing on an even field [with other surgeons],” lead author Michaela Bamdad, MD, MHS, a resident in general surgery and mother of two, told General Surgery News in an interview. She and her co-authors wrote that programs need to create healthy environments for residents who are pregnant. Many policies currently focus on the period after a child is born—primarily by providing better leave policies for new parents—but improvements to support residents during pregnancy are lacking. “Instead of viewing pregnancy during training as a handicap or a hassle, we must view it as promising evidence that the face of surgery is changing,” the authors wrote. “That’s a good thing.” Dr. Bamdad said surgical programs have improved since she had her first child in residency five years ago. But “it’s not happening fast enough or in as much of [an] organized fashion as it should,” she said. Instead of a national organized effort, “it feels like a grassroots de novo sort of operation at each program.” Those concerns were echoed by authors of a study presented at the 2021 Clinical Congress of the American College of Surgeons. They found that female surgeons experience far more pregnancy complications than female partners of their male surgeon colleagues, and these complications have a ripple effect on career satisfaction. Large-scale changes are needed to support surgeons through pregnancy, the authors concluded. “To retain our future workforce, structural changes in training and practice are warranted to optimize maternal health during pregnancy and to provide workplace support to surgeons facing difficult pregnancies,” said the study’s lead author

Manuel Castillo-Angeles, MD, a postdoctoral research fellow at Brigham and Women’s Hospital, in Boston, during his presentation. The findings come from a survey of 692 female surgeons and 158 male surgeons. Surgeons were recruited through five national surgical organizations and social media platforms between November 2020 and February 2021. Another 325 surgeons completed the survey but were excluded from the analysis, mostly

because they or their partner had not been pregnant. Nearly half of female surgeons—45%— had experienced major pregnancy complications, a rate that is far higher than the 27% reported by male surgeons of their childbearing partner. In an unadjusted analysis, participants who experienced major pregnancy complications were significantly more likely to report burnout (40% vs. 28%; P<0.001) and to have a low quality of life

001). (53% vs. 40%; P<0.001). d gone Surgeons who had gnanthrough major pregnancy complications were ikesignificantly less likely to recommend a surgical career to their own child (56% vs. 63%; P=0.015). However, most surgeons, whether

L I

IN THE NEWS

MAY 2022 / GENERAL SURGERY NEWS

they had experienced complications or not, still felt surgery was a career they would be happy to see their children pursue. More than any other variable, being a female surgeon was independently associated with burnout, with a hazard ratio of 2.08 (95% CI, 1.34-3.22; P=0.001). The only other significant independent factor for burnout was having a major pregnancy complication, with a hazard ratio of 1.55 (95% CI, 1.15-2.08, P=0.004). Surgeons were more likely to report a low quality of life if they were female,

worked in an academic setting or had experienced a major pregnancy complication. These patterns may deter women from surgery or cause them to leave the profession prematurely, Dr. Castillo-Angeles said. In the past few years, surgical training programs have taken small steps to support surgical residents during pregnancy or after childbirth. The Accreditation Council for Graduate Medical Education (ACGME) requires programs to provide residents with lactation facilities. Last October, the American Board of Surgery announced a more flexible

family leave policy for general and vascular surgery trainees, allowing six weeks of leave for significant life events. However, these advances do not address health-related issues during pregnancy, Dr. Bamdad said. She and her colleagues set out a guideline to support the well-being of surgical resident parents. It calls for the following: • prenatal health maintenance and access to prenatal visits without stigma or pushback; • support for health and well-being while operating;

• special considerations for work hours and rotation schedules; and • support for non-birthing parents and a culture of support and equity. They also said the ACGME should require programs to directly address the health and safety of pregnant trainees and the American Board of Surgery should comprehensively update their requirements to allow for additional flexibility during training for pregnancy and peripartum periods. “It is time for the traditional surgery training model to change to assure all trainees can flourish,” they concluded. ■

Undertriage continued from page 5

$22,700-$48,500; P<0.001) compared with the control group. The study authors were not surprised by these findings. “The observed associations between postoperative undertriage and morbidity and mortality were not unexpected from a clinical intuition perspective,” Dr. Loftus noted. “Undertriage, by definition, implies these patients are sicker and at higher risk for complications than what was assumed preoperatively. Unfortunately but expectedly, these patients suffered higher rates of complications,” Dr. Balch said. “The vast majority (about 90%) of preoperative decision making was appropriate, implying that surgeons are generally good at predicting where their patients should end up.” From these data, the researchers concluded that while surgeons generally perform accurate postsurgical triage, there remains an opportunity to improve patient evaluation. The authors also noted the importance of the opposite phenomenon: postoperative overtriage of low-risk patients. “The flip side is overtriage, which we have also analyzed and found to be around 5%. I had assumed this would be higher than the undertriage rate, but it appears, at least at our institution, that postoperative triage decisions err on the optimistic side,” Dr. Balch said. Ultimately, postoperative triage presents an important opportunity to improve surgical decision making. “Right now, surgeons can be mindful of the importance of postoperative triage decision making, and critically evaluate their practice patterns and associated outcomes to determine whether there is an opportunity to minimize postoperative undertriage and associated mortality and morbidity,” Dr. Loftus said. ■ Dr. Loftus reported research support from the National Institute of General Medical Sciences of the National Institutes of Health, under Award No. K23 GM140268.

IN THE NEWS

GENERAL SURGERY NEWS / MAY 2022

Lung Transplantation: A History of Controversies By MONICA J. SMITH

NEW YORK—Lung transplantation has been a topic of controversy since day 1. But the nature of these controversies has shifted and changed over time, from questions of feasibility to optimal surgical techniques, to lung allocation and to today’s hot topic: timing in COVID-19 fibrosis. In its earliest days, after the first human lung transplant was performed in 1963, the question was whether lung transplantation should be done at all, said Stephen Forest, MD, the surgical director of Lung Transplantation and Advanced Pulmonary Failure at Montefiore Medical Center, in New York City, at the 2021 Controversies, Problems and Techniques in Surgery meeting. “Survival was dismal, less than a year. Patients were plagued with bronchial dehiscence,” Dr. Forest said. Animal studies in dogs showed lung transplantation was not feasible; animal studies in primate models revealed the opposite. By the late 1970s, many lung transplant programs had stopped altogether due to technical complications. Animal studies showed that despite the regeneration of bronchial blood flow in transplanted lungs, bronchial dehiscence remained a problem. “But in the late 1970s and early 1980s, we were able to show that this was due not only to technical complications but to immunosuppression and rejection,” Dr. Forest said. A modernized immunosuppression regimen plus an advance in surgical technique, omentopexy, led to the first five-year survivor and ushered in an era of success in the 1980s and 1990s. In 1986, the first bilateral thoracic sternotomy incision, or clamshell incision, was performed for bilateral transplant. “Interestingly, this was ‘complicated’ by the need for cardiopulmonary bypass, a tool we regularly use in patients undergoing lung transplant,” Dr. Forest said. Shortly after that first clamshell incision, surgeons began discussing optimal anastomotic technique, endto-end or telescoping, with different single-center experiences claiming one was better than the other. “This controversy over the optimal anastomotic technique continued for decades,” Dr. Forest said.

Moving into the 2000s, controversies in lung transplantation circled around immunosuppression, lung preservation of the donor organ and the lung allocation system. “The lung allocation system was developed in 2005 with two factors in mind: We wanted to decrease death of patients on the waitlist, and we wanted to improve post-transplant one-year survival,” Dr. Forest said. To increase the odds of improvement in both areas, the lung allocation system calculates a lung allocation score using patient characteristics such as demographics, diagnosis, functional capacity and creatinine levels, stratifying patients by degree of illness. “It’s important to note that there’s a window for referral in patients heading toward end-stage lung disease. You don’t want to refer these patients too late, by which point it’s difficult for them to tolerate a lung transplantation. Once patients get to the point where they’re having recurrent exacerbations, hospitalizations and a significant decline in their functional status, we list them for transplantation.”

Trends in Transplant Recipients Internationally, the number of lung transplants has increased dramatically, from about 500 per year in 1990 to 4,500 annually in 2017, with North America performing the majority of those procedures. There’s been a marked increase in the last 15 years alone: from 1,500 to 2,500 per year in the United States. “We suspect that’s in part because of the increase of donors due to the opioid epidemic; it’s also due to the utilization of marginal donors,” Dr. Forest said, such as patients with chronic kidney disease, a history of smoking, peripheral arterial oxygenation less than 400 mm Hg or a less-than-pristine chest radiograph. “Many of our donor offers have lower lobe consolidations, effusions, etc., but with careful evaluation and donor management we’re able to recruit those lungs and increase the donor pool,” he said. And although it would seem to make mathematical sense to increase the donor pool by favoring single-lung transplants over double, that’s not what’s happening. While the volume of single-lung transplants has held steady over time, the volume of double-lung transplants has grown to become a much greater proportion of overall lung transplants. The reason for this is that double-lung recipients survive an average of 7.8 years post-transplant compared with 4.8 years in single-lung recipients. “This is unadjusted; people are constantly trying to readjust it to find equivalent outcomes. But as a global whole, double-lung transplantation is superior,” Dr. Forest said.

Controversial Contraindications In 2021, the International Society for Heart and Lung Transplantation issued a consensus document delineating relative and absolute contraindications for lung transplant candidates, some of which Dr. Forest questioned, for example, the relative contraindication of being older than 65 years of age. “Worldwide, the largest growing group of patients undergoing lung transplantation are patients over 65,” Dr. Forest said.

“If you stratify era of lung transplant by age of recipient, we see that era in conjunction with age is a more significant predictor of mortality than age itself.” The use of extracorporeal membrane oxygenation (ECMO) is another relative contraindication that Dr. Forest examined. “When ECMO is used as a bridge to lung transplantation, patients have far inferior survival compared to patients not on ECMO, which is not surprising—these patients are in organ failure.” Dr. Forest referenced his institutional analysis of data from the UNOS database to support the use of ECMO, rather than mechanical ventilation, as a bridge to transplant. “They actually have better one-year survival rates than patients on mechanical ventilation, so I believe ECMO is less of a relative contraindication than intubation.” He noted that an absolute contraindication is untreatable dysfunction of another organ, excluding patients who will be listed as dual-organ recipients. “Patients undergoing combined liver–lung transplantation actually do superior [to isolated lung transplant] when we look at all patients over a 20-year period. But it’s important to consider that these patients tend to be younger, and their lung pathology is likely cystic fibrosis.” The consensus statement stressed that these patients be treated at a center of expertise.

Lung Transplantation in COVID-19 Fibrosis About once every two weeks, Dr. Forest and his colleagues are consulted on a new patient with advanced lung disease secondary to COVID-19 fibrosis. They have successfully performed lung transplants on several patients with end-stage fibrosis due to COVID-19 infection. “These are patients who were completely normal, and then their lives completely and drastically changed after exposure to COVID-19. They are usually stuck in the hospital with a high level of support, whether mechanical ventilation or ECMO,” said Jamil Borgi, MD, a cardiothoracic surgeon at Montefiore. Lung transplant patients with COVID-19 fibrosis are more likely to be younger, to undergo double-lung transplants and to be on ECMO, and they have a significantly higher lung allocation score due to their acuity, Dr. Forest said. The controversy of lung transplant in these patients is not so much whether it can be done, but whether it should be done and when. “We sometimes see delayed recovery in these patients, meaning that they can separate from aggressive support. It’s a little hard to determine which ones will recover and which will not,” Dr. Borgi said. The literature suggests a minimum of four to eight weeks from recovery after the acute phase of COVID19 infection before consideration of transplantation, but the Montefiore surgeons wait a bit longer. “I think the sweet spot is three months or so before we really begin the evaluation process, but we have to be careful. We don’t want to wait to the point that the patient is nonfunctional and debilitated,” Dr. Forest said. Lung transplant in these patients presents some challenges due to inflammation and adhesions, and the patients tend to bleed more than other lung recipients. “But the outcomes have been similar to patients with■ out COVID-19,” Dr. Borgi said.

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IN THE NEWS

GENERAL SURGERY NEWS / MAY 2022

Factors for Passing Endoscopic Test: FEC Completion and Gender continued from page 1

skills exam: 86.2% of men and 78.6% of women finished all FEC components in advance of the skills exam (P<0.002). The study investigators said the gender gap likely results from a myriad of factors, including a lack of female mentors in endoscopy and the ergonomics of instruments, which are not well designed for smaller hands. Study co-author Dominique L. Doster, MD, a resident in general surgery at Indiana University School of Medicine, in Indianapolis, and a fellow in surgical education research, said surgical residency programs tend to focus on the FES manual skills exam, viewing it as a box

‘FEC completion is strongly associated with passing the FES skills test, and it’s an effective strategy for developing endoscopic skills.’

—Dominique L. Doster, MD

to be checked off on the way to certification. But Dr. Doster and her co-authors would like training programs to emphasize the FEC components as an integral part of training, particularly for female trainees. Women are less likely to have female endoscopists training them, who may better understand the ergonomic challenges that women face in the endoscopy suite. Also, female trainees are often granted less autonomy in the OR, particularly when the attending is male, and this may contribute to their lower numbers of upper and lower endoscopy cases completed in the lead-up to the FES, investigators said.

“Women may be less likely to choose to do endoscopic cases because as a platform, the ergonomics of an endoscope are unfavorable,” Dr. Doster said in an interview with General Surgery News. “As a trainee, it’s easy to gravitate towards the things you are naturally good at. If we could provide female trainees with tips and tricks to mitigate the ergonomic challenges of using endoscopes, we could potentially overcome this barrier to achieving case numbers.” The study is based on a retrospective review of trainees who took the FES manual skills test for the first time between June 2014 and February 2019. Investigators analyzed de-identified data from 2,023 examinees, of whom 40% completed all components of the FEC and 52% completed some. Eight percent completed none of the tasks. Three-fourths of residents completed the upper endoscopy case requirements, and half of residents completed the lower endoscopy case requirements. Completion of the FEC raised the pass rate by an OR of 2.1 (95% CI, 1.5-3.7; P<0.001). It was the only factor to influence the pass rate other than gender. Investigators also performed a multivariable regression analysis after controlling for glove size and gender. The most significant factors were completion of the lower endoscopy case requirements of the FEC (OR, 2.4; 95% CI, 1.3-4.3; P=0.005) and completion of all components of the FEC (OR, 1.6; 95% CI, 1.2-2.1; P<0.001). Trainees who practiced on a simulator did not have higher pass rates, according to the analysis. Dr. Doster and her colleagues are carrying out follow-up studies to explore ergonomics and baseline visuospatial aptitude, and how these factors relate to

performance of FES exam tasks. Based on the results so far, she encouraged trainees to complete all components of the FEC before taking the FES skills test. “FEC completion is strongly associated with passing the FES skills test, and it’s an effective strategy for developing endoscopic skills,” she said. This is the first study to look at the association between FEC completion and pass rate on the Fundamentals manual skills test. The pass rate approached 90% among trainees who had completed all the FEC components, compared with 70% of those who completed none of them. Previous studies showed glove size, gender and height are correlated with score and pass rate, although gender differences remained after controlling for glove size and height (Surg Endosc 2020;34[8]:3633-3643). The study has several limitations, including its retrospective cohort design. Participants were asked to self-report on prior experience and case volumes immediately after taking the FES exam. The upper endoscopy case numbers used in this study are not specific numbers reported by each resident but are based on broad classifications set by SAGES. After the presentation, session moderator Liane Feldman, MD, the president of SAGES and the Edward W. Archibald Professor and Chair of the Department of Surgery at Montreal’s McGill University, said surgeons had hoped that completing standard curricula would overcome gender differences. “And yet, it doesn’t seem to have, which I think represents differences, not necessarily with the test but with the reality of training situations that have been demon■ strated in different contexts,” Dr. Feldman said.

Financially Savvy Physicians continued from page 1

Despite this interest, defined financial curricula are seldom a part of medical training, and there’s been little evaluation of financial literacy in medical trainees and no validated assessment tools. To examine the financial behaviors of medical students and residents, and to assess their financial literacy, Dr. Nowotny developed two surveys and administered them to medical students and residents through the University of North Dakota’s listserv. The surveys were designed to assess demographic characteristics and selfreported behaviors. They included an assessment of financial literacy with questions often used in the financial field, “the Big Three” and “the Big Five,” as developed by Annamaria Lusardi and Olivia S. Mitchell of the Wharton School, that have been validated many times. Of the 461 potential participants, 261 (57%; 65 residents and 196 medical students) responded. The medical students tended to be younger, with two-thirds less than 25 years of age, and carried an expected loan debt of $100,000 to $200,000. Residents were more likely to be over 30 years, be married, and to carry

a debt of $100,000 to $300,000, with 13 respondents having debt in excess of $300,000. “The majority of each group carried less than $1,000 in credit card debt per month, which is very good behavior compared with the average American, who carries more than $6,000 in credit card debt,” Dr. Nowotny said. Overall, the respondents reported sound financial habits, with half of them sticking to a budget and most saving for retirement. Only 28 of the medical students indicated they did not anticipate saving. The findings were the opposite of what Dr. Nowotny expected to find. Only 10 respondents got no or one question right, indicating no or low financial literacy, and many of the incorrect answers were “do not know.” More than half of the respondents—66% of residents and 60% of medical students—got four out of five answers right, “which is considered a high level of financial literacy,” he noted. Both residents and medical students struck out on a question of the effect on bond prices when interest rates rise, with 22% and 14%, respectively, knowing the correct answer. “But all the other

Sample question from “the Big Three”: If you had $100 in a savings account with an interest rate of 2%, how much would you have after five years? A. More than $102 B. Less than $102 C. $102 D. Don’t know

questions were answered correctly by more than 70%,” Dr. Nowotny said. Although nearly half of respondents indicated they felt less knowledgeable and less prepared than non-medical counterparts, and 22% reported no prior financial knowledge, they outperformed the general population on “the Big Three” questions. Only 30% of American adults surveyed in 2009 got all three answers right, but 60% of the doctors aced the questions. James Chambers, MD, of NGPG Surgical Associates Braselton, in Georgia, asked whether offering some financial training in medical school and residency might have a positive downstream effect on physicians’ training.

“If they have a better curricula early on, might that encourage them to take out less money in loans and spend more time in training, perhaps doing a research year or interview for a fellowship, because they’re not in so much debt?” Dr. Nowotny, who plans to start a personal finance program at the University of North Dakota, thought continued training would be helpful in many ways. “The longer you’re in training, you can benefit by taking those loans under forgiveness. Papers show that financial stress contributes significantly to burnout, so if you’re really able to develop your financial habits and financial plan, it will benefit you in the long run.” ■

MAY 2022 / GENERAL SURGERY NEWS

Ultrasound Helps Predict Node Basin Recurrence continued from page 1

Researchers led by Jennifer Keller, MD, a general surgery oncology fellow at Providence Saint John’s Cancer Institute, in Santa Monica, Calif., sought to evaluate prognostic factors for predicting sentinel node basin recurrence. Dr. Keller and participating centers randomized 1,939 patients within the MSLT-II, with 968 patients assigned to nodal observation. Patients were included if they underwent ultrasonography of the sentinel node basin within four months of surgery. The trial excluded those patients who were positive by sentinel lymph node reverse transcription-polymerase chain reaction or if the sentinel lymph node pathologic data were incomplete. The primary tumor, patient and sentinel lymph node characteristics were evaluated. The first postoperative ultrasound was considered abnormal if more than one of the following was present: length-to-depth ratio greater than 2, hypoechoic center or focal subcapsular lesion. Univariate and multivariate analyses were performed to determine independent factors for predicting sentinel node basin recurrence. Of the 737 patients included in the study cohort, 26.2% had sentinel node basin recurrence. There were 73 (9.9%) abnormal ultrasounds: 46 of 147 (23.8%) basins with subsequent recurrence versus 27 of 517 (5%) basins without recurrence had an abnormal ultrasound. On multivariate analysis, a number of factors were significantly associated with sentinel node basin recurrence: age (adjusted odds ratio [aOR], 1.02; 95% CI, 1.0-1.03); increasing Breslow thickness (aOR, 1.14; 95% CI, 1.01-1.28); primary tumor ulceration (aOR, 2.07; 95% CI, 1.42-3.02); and abnormal ultrasound after sentinel node biopsy (aOR, 5.00; 95% CI, 2.97-8.64). “We found that primary tumor location and sentinel lymph node burden were not found to be significantly associated with sentinel node basin recurrence. By combining all the predictive factors, a multimodal model was created to predict sentinel node basin recurrence with an AUC [area under the curve] of 0.76,” Dr. Keller reported. “This study offers important information regarding how we can identify patients at risk of a nodal recurrence with a positive sentinel lymph node biopsy,” said Michael Egger, MD, an assistant professor in the Department of Surgery at the University of Louisville, in Kentucky, who was not involved with the study. “We know from the MSLTII study that survival in these patients is not improved by a completion lymphadenectomy, but they are at increased risk of nodal basin recurrence. In accordance with the trial protocol, we perform nodal

ultrasound surveillance of these patients. This study tells us that the findings of the first postoperative ultrasound can be used to identify patients at high risk of developing lymph node basin recurrences, in addition to the prognostic factors that can be identified from patient and tumor characteristics. “This study tells us to pay attention to that first postoperative ultrasound,” Dr. Egger said. “If there is an abnormal finding, more than half of those patients

may develop a nodal recurrence. What the study can’t tell us is what to do with those patients. Should we alter our surveillance protocol for these patients? If the patient is not being treated with adjuvant therapy, should they be considered for treatment? We simply don’t know the answers to those questions, but based on this study, we should have a heightened awareness for lymph node basin recurrences based on the first post■ operative ultrasound findings.”

MORE THAN 8 MILLION ADULT PATIENTS HAVE RECEIVED EXPAREL SINCE 20121

FEWER OPIOIDS. IMPROVED RECOVERY. Non-opioid EXPAREL® (bupivacaine liposome injectable suspension) delivers safe, extended pain control over the most critical days after surgery ERAS and multimodal protocols with EXPAREL have demonstrated improved clinical and economic outcomes in multiple general surgery procedures:

74%

fewer opioids

31%

were used over 3 days in laparoscopic colorectal surgery2*†

faster return to bowel function

in open ventral hernia repair (P <0.001)3

2 days shorter LOS 4.0 days vs 6.1 days in open ventral hernia repair (P <0.001)3

Connect with us to learn more about how EXPAREL can support your practice ERAS=Enhanced Recovery After Surgery; LOS=length of stay; TAP=transversus abdominis plane. *The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials. † Opioid use was measured by the defined daily dose, with 1 unit equaling 100 mcg of intravenous (IV) fentanyl, 2 mg of IV hydromorphone HCl, 4 mg of oral hydromorphone HCl, 20 mg of oral oxycodone, or 10 mg of oral hydrocodone. For laparoscopic colorectal surgery trial: Retrospective trial comparing patients receiving local infiltration of EXPAREL (n=70) as part of an ERP (enhanced recovery protocol) with those being placed in an ERP (n=70). For open ventral hernia repair trial: Retrospective, observational study comparing patients who received an ERAS protocol with EXPAREL (n=100) with a historical group prior to the introduction of the protocol (n=100).

Indication EXPAREL® (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. Adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via interscalene brachial plexus nerve block were nausea, pyrexia, and constipation. Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia. If EXPAREL and other non-bupivacaine local anesthetics, including lidocaine, are administered at the same site, there may be an immediate release of bupivacaine from EXPAREL. Therefore, EXPAREL may be administered to the same site 20 minutes after injecting lidocaine. EXPAREL is not recommended to be used in the following patient populations: patients <6 years old for infiltration, patients younger than 18 years old for interscalene brachial plexus nerve block, and/or pregnant patients. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Warnings and Precautions Specific to EXPAREL Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, or intravascular or intra-articular use. The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials. Warnings and Precautions for Bupivacaine-Containing Products Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression. Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to dysrhythmias, sometimes leading to death. Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients. Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use. Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use. Please refer to brief summary of Prescribing Information on adjacent page. For more information, please visit www.EXPAREL.com or call 1-855-793-9727. References: 1. Data on file. 6450. Parsippany, NJ: Pacira BioSciences, Inc.; January 2021. 2. Keller DS, Pedraza R, Tahilramani RN, Flores-Gonzalez JR, Ibarra S, Haas EM. Impact of long-acting local anesthesia on clinical and financial outcomes in laparoscopic colorectal surgery. Am J Surg. 2017;214(1):53-58. 3. Majumder A, Fayezizadeh M, Neupane R, Elliott HL, Novitsky YW. Benefits of multimodal enhanced recovery pathway in patients undergoing open ventral hernia repair. J Am Coll Surg. 2016;222(6):1106-1115.

06/21

OPINION

Better Good continued from page 1

As the name implies, individuals (both men and women) in highly competitive fields can struggle to accept that their achievements are merit-based, instead choosing to credit luck or circumstances. But those same people have no problem associating failures with their own personal shortcomings. The combination leaves them feeling unqualified and out of place next to their peers. I remember a moment in residency during a thyroidectomy, at the part of the case

Brief Summary (For full prescribing information refer to package insert) INDICATIONS AND USAGE EXPAREL is indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Limitation of Use: Safety and efficacy has not been established in other nerve blocks. CONTRAINDICATIONS EXPAREL is contraindicated in obstetrical paracervical block anesthesia. While EXPAREL has not been tested with this technique, the use of bupivacaine HCl with this technique has resulted in fetal bradycardia and death. WARNINGS AND PRECAUTIONS Warnings and Precautions Specific for EXPAREL As there is a potential risk of severe life-threatening adverse effects associated with the administration of bupivacaine, EXPAREL should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity. Caution should be taken to avoid accidental intravascular injection of EXPAREL. Convulsions and cardiac arrest have occurred following accidental intravascular injection of bupivacaine and other amidecontaining products. Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL has not been evaluated for the following uses and, therefore, is not recommended for these types of analgesia or routes of administration. • epidural • intrathecal • regional nerve blocks other than interscalene brachial plexus nerve block • intravascular or intra-articular use EXPAREL has not been evaluated for use in the following patient population and, therefore, it is not recommended for administration to these groups. • patients younger than 6 years old for infiltration • patients younger than 18 years old for interscalene brachial plexus nerve block • pregnant patients The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days as seen in clinical trials. ADVERSE REACTIONS Clinical Trial Experience Adverse Reactions Reported in Local Infiltration Clinical Studies The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical site clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 to 532 mg of EXPAREL. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting. The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration were pyrexia, dizziness, edema peripheral, anemia, hypotension, pruritus, tachycardia, headache, insomnia, anemia postoperative, muscle spasms, hemorrhagic anemia, back pain, somnolence, and procedural pain. Adverse Reactions Reported in All Local Infiltration Clinical Studies in Pediatric Patients Aged 6 to Less Than 17 Years The safety of EXPAREL in 110 pediatric patients between the age of 6 and 17 years old undergoing various surgical procedures was evaluated in one randomized, open-label, clinical study in which EXPAREL was administered by infiltration into the surgical site and one single-arm, open-label study in which EXPAREL was administered by infiltration into the surgical site. Patients were administered a weight-based dose of EXPAREL at 4 mg/kg (maximum dose of 266 mg) or bupivacaine HCl 2 mg/kg (maximum dose of 175 mg). In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia. The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration were bradycardia, muscle spasms, tachypnea, hypoesthesia oral, anemia postoperative, dizziness, pyrexia, diarrhea, hypoacusis, hypoesthesia, back pain, hematuria, incontinence, muscular weakness, and visual impairment. Adverse Reactions Reported in Nerve Block Clinical Studies The safety of EXPAREL was evaluated in four randomized, double-blind, placebo-controlled nerve block clinical studies involving 469 patients undergoing various surgical procedures. Patients were administered a dose of either 133 or 266 mg of EXPAREL. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, pyrexia, and constipation. The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration as a nerve block were muscle twitching, dysgeusia, urinary retention, fatigue, headache, confusional state, hypotension, hypertension, hypoesthesia oral, pruritus generalized, hyperhidrosis, tachycardia, sinus tachycardia, anxiety, fall, body temperature increased, edema peripheral, sensory loss, hepatic enzyme increased, hiccups, hypoxia, post-procedural hematoma.

when we were trying to identify the recurrent laryngeal nerve. After testing several candidates, the probe beeped and we knew we found it. The attending chuckled, “Better lucky than good.” I smiled. It was a pretty forgettable exchange, probably because it was the third or fourth time that week that I had heard those words. The phrase has become one of many surgical adages that get perpetuated in training. Now, as a new surgeon building a practice (whatever that means), the saying hits differently. Why was it lucky that we found that nerve? Hadn’t we dissected exactly where the nerve typically runs?

Postmarketing Experience These adverse reactions are consistent with those observed in clinical studies and most commonly involve the following system organ classes (SOCs): Injury, Poisoning, and Procedural Complications (e.g., drug-drug interaction, procedural pain), Nervous System Disorders (e.g., palsy, seizure), General Disorders And Administration Site Conditions (e.g., lack of efﬁcacy, pain), Skin and Subcutaneous Tissue Disorders (e.g., erythema, rash), and Cardiac Disorders (e.g., bradycardia, cardiac arrest). DRUG INTERACTIONS The toxic effects of local anesthetics are additive and their coadministration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity. Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. Patients who are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia:

Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic cyclophosphamide, ﬂutamide, hydroxyurea, ifosfamide, agents rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine Bupivacaine Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2. Non-bupivacaine Local Anesthetics EXPAREL should not be admixed with local anesthetics other than bupivacaine. Nonbupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. There are no data to support administration of other local anesthetics prior to administration of EXPAREL. Other than bupivacaine as noted above, EXPAREL should not be admixed with other drugs prior to administration. Water and Hypotonic Agents Do not dilute EXPAREL with water or other hypotonic agents, as it will result in disruption of the liposomal particles USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are no studies conducted with EXPAREL in pregnant women. In animal reproduction studies, embryo-fetal deaths were observed with subcutaneous administration of bupivacaine to rabbits during organogenesis at a dose equivalent to 1.6 times the maximum recommended human dose (MRHD) of 266 mg. Subcutaneous administration of bupivacaine to rats from implantation through weaning produced decreased pup survival at a dose equivalent to 1.5 times the MRHD [see Data]. Based on animal data, advise pregnant women of the potential risks to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Clinical Considerations Labor or Delivery Bupivacaine is contraindicated for obstetrical paracervical block anesthesia. While EXPAREL has not been studied with this technique, the use of bupivacaine for obstetrical paracervical block anesthesia has resulted in fetal bradycardia and death. Bupivacaine can rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity. The incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus, and neonate involve alterations of the central nervous system, peripheral vascular tone, and cardiac function. Data Animal Data Bupivacaine hydrochloride was administered subcutaneously to rats and rabbits during the period of organogenesis (implantation to closure of the hard plate). Rat doses were 4.4, 13.3, and 40 mg/kg/day (equivalent to 0.2, 0.5 and 1.5 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight) and rabbit doses were 1.3, 5.8, and 22.2 mg/ kg/day (equivalent to 0.1, 0.4 and 1.6 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight). No embryofetal effects were observed in rats at the doses tested with the high dose causing increased maternal lethality. An increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity. Decreased pup survival was noted at 1.5 times the MRHD in a rat pre- and post-natal development study when pregnant animals were administered subcutaneous doses of 4.4, 13.3, and 40 mg/kg/day buprenorphine hydrochloride (equivalent to 0.2, 0.5 and 1.5 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight)

A 2021 survey found that more than 97% of surgery residents reported feelings of moderate to severe imposter syndrome. More interestingly, the authors found no predictive characteristics (J Am Coll Surg 2021;233[5]:633-638). Either this is self-selection in action or there is something intrinsic to the culture or training that contributes to this phenomenon. At its core, the delivery of quality surgical care depends on preventing and avoiding error. When an error does occur, we typically ask ourselves, “Was this an error in technique or judgment?” These questions are necessary for transparency,

from implantation through weaning (during pregnancy and lactation). Lactation Risk Summary Limited published literature reports that bupivacaine and its metabolite, pipecoloxylidide, are present in human milk at low levels. There is no available information on effects of the drug in the breastfed infant or effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EXPAREL and any potential adverse effects on the breastfed infant from EXPAREL or from the underlying maternal condition. Pediatric Use The safety and effectiveness of EXPAREL for single-dose infiltration to produce postsurgical local anesthesia have been established in pediatric patients aged 6 years and older. Use of EXPAREL for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 6 years and older. Safety and effectiveness have not been established in pediatric patients aged less than 6 years old for local infiltration or less than 18 years old for interscalene brachial plexus nerve block. Geriatric Use Of the total number of patients in the EXPAREL local infiltration clinical studies (N=823), 171 patients were greater than or equal to 65 years of age and 47 patients were greater than or equal to 75 years of age. Of the total number of patients in the EXPAREL nerve block clinical studies (N=531), 241 patients were greater than or equal to 65 years of age and 60 patients were greater than or equal to 75 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients. Clinical experience with EXPAREL has not identified differences in efficacy or safety between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Hepatic Impairment Amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity. Therefore, consider increased monitoring for local anesthetic systemic toxicity in subjects with moderate to severe hepatic disease. Renal Impairment Bupivacaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. This should be considered when performing dose selection of EXPAREL. OVERDOSAGE Clinical Presentation Acute emergencies from local anesthetics are generally related to high plasma concentrations encountered during therapeutic use of local anesthetics or to unintended intravascular injection of local anesthetic solution. Signs and symptoms of overdose include CNS symptoms (perioral paresthesia, dizziness, dysarthria, confusion, mental obtundation, sensory and visual disturbances and eventually convulsions) and cardiovascular effects (that range from hypertension and tachycardia to myocardial depression, hypotension, bradycardia and asystole). Plasma levels of bupivacaine associated with toxicity can vary. Although concentrations of 2,500 to 4,000 ng/mL have been reported to elicit early subjective CNS symptoms of bupivacaine toxicity, symptoms of toxicity have been reported at levels as low as 800 ng/mL. Management of Local Anesthetic Overdose At the first sign of change, oxygen should be administered. The first step in the management of convulsions, as well as underventilation or apnea, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to the use of anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine to enhance myocardial contractile force). If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. Endotracheal intubation, employing drugs and techniques familiar to the clinician, maybe indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated. DOSAGE AND ADMINISTRATION Important Dosage and Administration Information • EXPAREL is intended for single-dose administration only. • Different formulations of bupivacaine are not bioequivalent even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL. • DO NOT dilute EXPAREL with water or other hypotonic agents, as it will result in disruption of the liposomal particles. • Use suspensions of EXPAREL diluted with preservative-free normal (0.9%) saline for injection or lactated Ringer’s solution within 4 hours of preparation in a syringe. • Do not administer EXPAREL if it is suspected that the vial has been frozen or exposed to high temperature (greater than 40°C or 104°F) for an extended period.

• Inspect EXPAREL visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer EXPAREL if the product is discolored. Recommended Dosing Local Analgesia via Infiltration Dosing in Adults The recommended dose of EXPAREL for local infiltration in adults is up to a maximum dose of 266mg (20 mL), and is based on the following factors: • Size of the surgical site • Volume required to cover the area • Individual patient factors that may impact the safety of an amide local anesthetic As general guidance in selecting the proper dosing, two examples of infiltration dosing are provided: • In patients undergoing bunionectomy, a total of 106 mg (8 mL) of EXPAREL was administered with 7 mL infiltrated into the tissues surrounding the osteotomy, and 1 mL infiltrated into the subcutaneous tissue. • In patients undergoing hemorrhoidectomy, a total of 266 mg (20 mL ) of EXPAREL was diluted with 10 mL of saline, for a total of 30 mL, divided into six 5 mL aliquots, injected by visualizing the anal sphincter as a clock face and slowly infiltrating one aliquot to each of the even numbers to produce a field block. Local Analgesia via Infiltration Dosing in Pediatric Patients The recommended dose of EXPAREL for single-dose infiltration in pediatric patients, aged 6 to less than 17 years, is 4 mg/kg (up to a maximum of 266 mg), and is based upon two studies of pediatric patients undergoing either spine surgery or cardiac surgery. Regional Analgesia via Interscalene Brachial Plexus Nerve Block Dosing in Adults The recommended dose of EXPAREL for interscalene brachial plexus nerve block in adults is 133 mg (10 mL), and is based upon one study of patients undergoing either total shoulder arthroplasty or rotator cuff repair. Compatibility Considerations Admixing EXPAREL with drugs other than bupivacaine HCl prior to administration is not recommended. • Non-bupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. • Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2. The toxic effects of these drugs are additive and their administration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity. • When a topical antiseptic such as povidone iodine (e.g., Betadine®) is applied, the site should be allowed to dry before EXPAREL is administered into the surgical site. EXPAREL should not be allowed to come into contact with antiseptics such as povidone iodine in solution. Studies conducted with EXPAREL demonstrated that the most common implantable materials (polypropylene, PTFE, silicone, stainless steel, and titanium) are not affected by the presence of EXPAREL any more than they are by saline. None of the materials studied had an adverse effect on EXPAREL. Non-Interchangeability with Other Formulations of Bupivacaine Different formulations of bupivacaine are not bioequivalent even if the milligram dosage is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL and vice versa. Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Do not substitute. CLINICAL PHARMACOLOGY Pharmacokinetics Administration of EXPAREL results in significant systemic plasma levels of bupivacaine which can persist for 96 hours after local infiltration and 120 hours after interscalene brachial plexus nerve block. In general, peripheral nerve blocks have shown systemic plasma levels of bupivacaine for extended duration when compared to local infiltration. Systemic plasma levels of bupivacaine following administration of EXPAREL are not correlated with local efficacy. PATIENT COUNSELING Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

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March 2021

OPINION

is unfortunate because there is something to be said about the psychological wellness that comes from seeing a patient happy and healthy after an operation. The opposite is true when follow-up only consists of readmissions, reoperations, and morbidity and mortality submissions. We are perfectionists—obsessive, sometimes neurotic. We lose sleep, check our phone and check the ER board just to see if the patient we discharged is sitting down there with a complication. Maybe some of this gets better with time; maybe it doesn’t. But I know one thing: I hold on much more tightly to those for accountability, and for personal and professional growth. In his book “Forgive and Remember: Managing Medical Failure,” Charles Bosk reflected that when a poor outcome occurs in a medical patient, the response is often, “What happened?” But when that same outcome occurs in a surgical patient, the response is often, “What did you do?” And we are taught to own these complications; we internalize them. Then, we willingly and publicly discuss them among colleagues to make the system, and ourselves, better. What about our successes? Here I am pausing for literary effect because successes are simply not a part of the culture as I have experienced it. Any and all good outcomes are often credited to luck, chance or good anatomy. Or nothing at all is acknowledged for fear that the universe will conspire and reverse the outcome. Superstition prevents us from saying things like, “glad he recovered and left the hospital so quickly,” because to acknowledge that means the patient is probably sitting down in the emergency department. On the off chance we finally do acknowledge that something good has happened, we celebrate the success as a team effort. And not to minimize the contribution of the OR personnel, surgical nurses, technicians, pharmacists, therapists, dietitians, etc., but sometimes it needs to be emphasized that the patient did well because the surgeon used sound judgment and did a good operation. The only real venue I can think of that celebrates good outcomes is grand rounds, but even this is reserved for visiting surgeons or subject matter experts who discuss their successes over slides of well-lit, well-healed incisions. Where are the grand rounds for interns or residents? When does the resident get to stand in front of peers to discuss the Graham patch that saved their patient’s life? Clinic is a place where some of these successes can be celebrated, and it is probably underutilized for that purpose. Unfortunately, with rotation schedules, resident turnover and more advanced practice providers, residents often never follow up with their postoperative patients. This

follow-up clinic visits. I soak in responses like “no reflux” and “no pain.” I take nothing for granted. I don’t feel like I need a grand rounds to broadcast my successes, because honestly those interactions in clinic are enough. I let myself feel personally responsible for that good outcome— not in an arrogant way, but in a way I never did in training and in a way that validates what I spent six years learning. I realize so much of what we do in the OR is error-avoidant, in other words, performance with the intention of preventing bad outcomes. There is another saying in training: “Work backwards

from the morbidity and mortality conference.” Maybe years of practicing surgery like we’re dodging banana peels in a game of Mario Kart only reinforce what not to do. The data suggest that many up-and-coming surgeons share these sentiments. Some of it will just be growing pains. Some of it comes with the job. But at least right now, I try to encourage residents to see and feel when something goes well. After all, “better good than lucky.” ■ —Dr. Halgas is a general and burn surgeon in San Antonio.

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*Based on data from: Giordano SA, et al. [N=223; RR=6.2%, excluding bridging; AFU=30.5; ADMP=underlay with ACS]; Garvey PB, et al. [N=60; RR=6.4% (3 yr) & 8.3% (5 yr), excluding bridging; AFU=52.9; ADMP=underlay with ACS]; Soares KC, et al. [N=67; RR=3.5%; AFU=8.7; ADMP=sandwich technique or onlay]; Garvey PB, et al. [N=135; RR=6.4%, excluding bridging; AFU=28.1; ADMP=underlay with ACS]; Clemens M, et al. [N=51; RR=3.9%; AFU=18.1; ADMP=underlay with ACS]; Lineaweaver W, et al. [N=15; RR=7.0%, excluding bridging; AFU=18.0; ADMP=onlay with ACS].1-6 ACS= Anterior Component Separation; ADMP=acellular dermal matrix placement; AFU=average followup (months); RR=recurrence rate. References 1. Giordano S, Garvey PB, Baumann DP, Liu J, Butler CE. Primary fascial closure with biologic mesh reinforcement results in lesser complication and recurrence rates than bridged biologic mesh repair for abdominal wall reconstruction: A propensity score analysis. Surgery (United States) 2017;161(2):499-508. 2. 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. 2016;224(3):341-350. 3. Soares KC, Baltodano PA, Hicks CW, et al. Novel wound management system reduces surgical site morbidity after ventral hernia repairs: a critical analysis. Am J Surg. 2015;209(2):324-332. 4. Garvey PB, Martinez RA, Baumann DP, et al. Outcomes of abdominal wall reconstruction with acellular dermal matrix are not affected by wound contamination. J Am Coll Surg. 2014;219(5):853-864. 5. Clemens M, Selber J, Liu J, et al. Bovine versus porcine acellular dermal matrix for complex abdominal wall reconstruction. Plast Reconstr Surg. 2013;131(1):71-79. 6. Lineaweaver W. Improvement of success rates for abdominal component reconstructions using bovine fetal collagen. Ann Plast Surg. 2012;68(5):438-441. Indications SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: • Plastic and reconstructive surgery • Muscle flap reinforcement • Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias Contraindications SurgiMend should not be used in patients with a known history of hypersensitivity to collagen or bovine products.

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SurgiMend, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ©2020 Integra LifeSciences Corporation. All rights reserved. 1035834-2-EN

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OPINION

Health Information Transparency: How Fast Is Too Fast? By PETER CONGELOSI, MD

ost of us are familiar with the idiom “Bad news travels fast.” These n days, however, all news travda els fast. We are flooded with information on our smartphones, tablets and computers throughout the day, every day. News updates, social media posts and email alerts bombard us

with short snippets of information, often raw and unfiltered, which can be as anxiety-inducing as they are entertaining. Until recently, personal health information was absent from this harsh reality of information transmission. In the not-so-distant past, obtaining a copy of one’s medical records required a patient to call their doctor or visit the clinic, to complete a medical records request form, and then to select the specific records they wanted. Even after this effort, it was not

uncommon to wait days to receive them. Now, with the ubiquity of online patient portals and the enforcement of the Interoperability and Information Blocking Rule in April 2021—a key element of the 21st Century Cures Act, requiring the immediate release of medical information—nearly all health data are only a couple of clicks, or taps, away (www.facs.org/ advocacy/quality/information-blocking). The jingle one hears on their smartphone may no longer be a calendar

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reminder, but instead their medical chart application alerting them that the results of their CT scan, which was completed only two hours ago, is now available. Patients will be faced with navigating this confusing information alone without the immediate guidance of their surgeon. This changing paradigm fundamentally alters the way surgeons will need to communicate with patients. Imagine you are a 43-year-old woman with a past medical history of hypothyroidism and obesity who decides to undergo bariatric surgery after numerous failed attempts to lose weight over the previous 10 years. Your preoperative upper endoscopy was normal, and you subsequently undergo a laparoscopic sleeve gastrectomy. You are discharged home the next day. Five days later, you receive an alert on your smartphone indicating there is a new result on your electronic patient portal. You open the app to find a red flag next to “surgical pathology.” You open the report, scroll to the bottom and find that it reads, “welldifferentiated neuroendocrine tumor detected at staple line.” Seeing the word “tumor” induces a dizzying shockwave of fear that radiates out from your chest. You frantically log on to Google and search “neuroendocrine tumor.” After scrolling through the ad results at the top of the page—“carcinoid syndrome diarrhea,” “what is neuroendocrine cancer?” etc.— you find an article from nih.gov that seems reputable. You open the link but soon wish you hadn’t. The information is overwhelming. You strain to decipher what you are reading and struggle to focus, still reeling from the unexpected news. In what feels like a hasty act of desperation, you send a message to your surgeon. All you can do now is wait, resigned that the upcoming hours will feel like days. The description above is a case report published in the Journal of Surgical Case Reports (2020;2020[6]:,rjaa121). The patient’s reaction in this example is hypothetical, but the clinical scenario— and the results one would encounter following the same Google search—is not. Should a patient have to read about their surgical pathology in the same way they scroll through a social media newsfeed? Would you, as a patient, prefer to have heard this news from your surgeon, prepared with an explanation of the pathology report, a referral and, most importantly, a calming voice? Some research on this topic actually indicates that patients are in favor of increased information transparency and that detrimental effects are minimal (JAMA Oncol 2021;7[11]:1609-1610). Although the federal mandate to require

OPINION

MAY 2022 / GENERAL SURGERY NEWS

full open access to one’s electronic medical record did not go into effect until spring 2021, other health systems, such as The University of Texas MD Anderson Cancer Center and Uppsala University Hospital, in Sweden, implemented open notes in 2009 and 2012, respectively (Lancet Oncol 2020;21[9]:1136-1138). In a study by Kayastha et al in 2017, which aimed to describe the experiences of patients with metastatic or incurable cancer who read their cancer care notes, they concluded that access ameliorated uncertainty, relieved anxiety and facilitated control. However, one-fourth of the patients interviewed stated that the notes were emotionally difficult to read or they had compulsions to read their notes, which they later regretted. Furthermore, the researchers only interviewed patients with advanced cancer and did not include patients who were newly diagnosed or in earlier stages of treatment (J Oncol Pract 2018;14[4]:e251-e258). Another study, by Salmi et al, compared oncology patient and clinician attitudes about open note implementation and found that just 4% of patients reported feeling confused by the notes (Cancer Cell 2020;38[6]:767-768). A closer look at the data, however, reveals that on a scale of 1 to 10 of “not confusing” to “extremely confusing,” the 4% represents patients who responded between 8 and 10 on the scale. There is a large subset of patients who found their results at least somewhat confusing who were excluded based on the stratification of the data. Also notable is that both studies looked exclusively at visit notes, which commonly contain a narrative by the physician, complete with integrated data and a formal assessment and plan. Conversely, surgical patients must decipher pathology, imaging and operative reports, which are generally more technical and written to convey information among physicians. Lastly, these studies preceded the Information Blocking Rule, at which time information delays were common. Research on the consequences to patients of open notes is incomplete, and the implementation of the Information Blocking Rule only adds more uncertainty to a poorly understood topic. Looking forward, research in this area will need to do the following: examine how readily patients access their medical data; understand the influence on patient anxiety or changes in interactions with the care team; and explore how surgeons and associate providers alter practice accordingly. Patients are now confronted with technical terms and the medicolegal jargon that populates pathology and radiology reports and operative narratives. The Joint Commission recommends that print materials distributed to patients be at a fifth-grade reading level or below (www.jointcommission.org).

The medical community should expect patients to struggle to understand what they read in their medical record. Radiologists have recognized this issue and have explored changing the language they use in radiology reports, allowing direct communication between radiologists and patients, and have piloted radiology clinics so that patients could discuss results directly with a physician (AJR Am J Roentgenol 2015;205[1]:95-99; AJR Am J Roentgenol 2020;215[3]:673-678; J Am Coll Radiol 2021;18[1 Pt A]:128-132). In the realm of surgical care, surgeons might need to add simplified summaries

to operative reports or provide links to reputable sources for anticipated questions in clinic notes. The delivery of bad news also may need to evolve. This interaction—an essential skill taught in medical school—is predicated on the physician knowing the results before the patient. The new model of information transparency might challenge surgeons’ ability to guide patients through stressful circumstances. The 21st Century Cures Act defines information blocking as a practice that “is likely to interfere with, prevent or materially discourage access, exchange,

or use of electronic health information” (AJR Am J Roentgenol 2020;215[3]:673678). Patients should have the right to review pathology, radiology and operative reports in a timely manner. However, we must carefully monitor this new one-size-fits-all approach to immediate information transparency. In doing so, we can ensure surgical patients are protected from undue uncertainty and additional stress. ■ —Dr. Congelosi is a general surgery resident at Dartmouth-Hitchcock Medical Center, in Lebanon, N.H.

The mission of the Americas Hernia Society is to advance the science and treatment of hernia. The vision of the Americas Hernia Society is to be the worldwide authority on hernia surgery. AHS fulfills its mission and vision by, among other things: • Hosting periodic meetings for open presentation and discussion of scientific material concerning subjects of common interest. • Cooperating in educational endeavors with groups of similar interest throughout the world. • Initiating and cooperating in the publication of a journal and/or newsletter on the subject or hernia/abdominal wall abnormalities. • Undertaking projects of scientific interest to seek information and otherwise serve the mission of the organization. Americas Hernia Society www.americasherniasociety.com (847) 228-3302 | info@americasherniasociety.org

The Americas Hernia society offers a number of benefits to our members. We encourage any surgeon interested in abdominal wall abnormalities to join.

MEMBERSHIP BENEFITS • Discounted meeting registration at AHS/EHSmeetings • Educational Webinars • Online member search for patient referral • Journal Hernia • AHSQC

OPINION

GENERAL SURGERY NEWS / MAY 2022

What Your Heart Desires By MIGUEL A. LOPEZVIEGO, MD, FACS

ver the past few years, a very interesting approach to the practice pra of medicine has emerged in our local hospitals. The methodology seems to mesh very well with the current trend of medical student and resident education that places a great deal of emphasis on “quality of life” issues. We are now seeing the effects of this philosophical shift—in the expectations of our young physicians—manifest in our hospitalbased practices. The practical and economic implications of these changes and their effects on patient care and healthcare spending are likely to be dramatic, and it would be wise for all of us to consider the potential long-term consequences of these fascinating new developments in the way American doctors work. In private practice settings around the country, we are now seeing individual physicians in many specialties (surgery, anesthesiology, critical care and hospital medicine) fall into employed shift work practice models. Established groups of local doctors, hired by hospitals or privately owned corporations, are also participating in similar patterns of business. The hospitals and companies who employ these physicians negotiate “exclusive” rights for them to provide specific services at their home institutions, thus rendering these employed physicians immune to any local business risk or serious competition. This is an interesting and potentially game-changing development in American medicine, and it has become apparent to many physicians who are still involved in more traditional practice arrangements that these employed, shift-working doctors, with exclusive rights to deliver their services, live in an interesting new “privileged” world where they have absolutely no ownership responsibilities. Let me clarify what I mean by the responsibilities of ownership. The traditional American clinician, in private practice, lived day to day, having to perform at an extremely high level to maintain their referral patterns and a sustainable practice. The “owner” physician typically signed long leases for office space, paying huge overhead costs that included employees’ salaries and benefits, malpractice insurance, office supplies, utility costs, continuing medical education fees, annual dues and registration charges, and their staff ’s health insurance on top of their own. These doctors woke up every day knowing they had to deliver medical care at the highest level to be successful in their highly competitive local marketplaces. They were focused on being competent colleagues, excellent communicators, and most importantly, a highly visible and positive influence in their communities. Surgeons would often say, “I am only as good as my last operation” to describe how they always had to be on top of their game. In the world where doctors owned their practices and competition flourished, referring colleagues and patients had choices as to who would manage their cases and thus profit from them. There were no monopolies. Consultants and specialists had to be available, affable and able in the care they delivered, or risk losing referrals and income. Collegiality and building relationships mattered. In this traditional world, doctors were rewarded with busier practices and better remuneration when they excelled, and they were

punished with a shrinking patient caseload and less income when they failed to deliver consistent, quality care with a good attitude. Everyone benefited from this arrangement. Doctors worked long, hard hours delivering healthcare, and also were directly in charge of their own business responsibilities. Taking ownership is a critical component of success in life and social progress. Home ownership is an example. People who own homes tend to take excellent care of their property and fear losing it. The owner tends to invest time, money and energy into improving their home and their community. The same is true

This is not just an economic or lifestyle issue. Quality of care suffers in these modern practice arrangements. Recent studies show the detrimental effect that transition of care—a euphemism for shift work—has on patients undergoing cardiac and noncardiac surgery when anesthesiologists hand over intraoperative care of their patients to another colleague (JAMA Netw Open 2022;5[2]:e2148161; JAMA 2018;319[2]:143-153). Perhaps medical school educators and residency program directors believe that physicians in the workplace are different, long “after the thrill is gone” (as a popular song goes) from other human beings when it comes to the forces that encourage dedication and hard work in individuals. Do we really believe that somehow, just

All physicians, whether employed or independent, should be incentivized in their business agreements to be highly productive and deliver extraordinarily high-quality health care by insisting they “own” both their patients and their referral lines.

of any business, including medical practices. Private ownership demands responsibility and accountability. Along with intense competition in the marketplace, private ownership is the bedrock of the success of all free-market systems. What we are seeing in the United States today, by the elimination of physician ownership and competition, may be the foundation of future socialized medicine in America. The reason you haven’t started worrying about it yet is that even those doctors in the United States who are happily employed in practice models with little or no ownership-related demands are still being paid free-market wages. That, however, may change. Medical schools have always, appropriately, spent a significant amount of time teaching their students compassion and ethics. These are very important faculties for all successful doctors. But I wonder how the salaried corporate doctor will behave when the demand for special attention and extra hours of dedicated, intense, hard work becomes necessary to help a gravely ill patient after the shift is over and no monetary reward is to be gained by staying late.

because someone has an MD or DO after their name and has undergone extensive postgraduate training, they have a different motivation for hard work than most other citizens in society? My experiences over the past 10 years lead me to believe they do not. I believe that most human beings eventually respond to a carrot and a stick. The way shift work medical care is being delivered currently by our well-trained and well-meaning colleagues around the world also supports that impression. The contemporary employed American physician with a contract guaranteeing exclusive rights to provide services at a hospital may feel bold, secure and empowered. They often meet every new case of incremental business they are asked to take on with disappointment or even anger, as it results only in more work and increased responsibility with no significant measurable personal benefit. Without competition and with a solid legal document securing their guaranteed flow of business, they do not worry about catering to their referring doctors or their patients and can live comfortably, absent all the stresses of owning their own practice in continued on page 22

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OPINION

GENERAL SURGERY NEWS / MAY 2022

Heart Desires continued from page 20

a traditional private practice environment. Attitude and performance may become non-issues, and, as a result, they will deteriorate gradually. Their commitment to the hospital’s medical staff, in particular, and to the community in general, is often limited, and the desire to interact and develop relationships with other colleagues is muted as it serves no clear economic benefit. It is a fairly unromantic existence for a physician. In this type of arrangement, they can still enjoy a lucrative income in what appears to be a near-perfect situation. Storm clouds, however, may be on the horizon. Many observers now question why American physicians, practicing in a non-ownership, risk free, non-capitalist medical era, are being paid so much better than their well-educated and highly trained counterparts who deliver care in similar medical practices in Europe, Latin America and Asia. A 2017 article by Dean Baker in Politico asked why American doctors are paid so much more than doctors in Europe when they have nearly identical education and results (www.politico.com/agenda/story/2017/10/25/ doctors-salaries-pay-disparities-000557). Although I do not agree with the author’s point of view, it is nonetheless a valid question. I believe that what made American medicine priceless (and thus expensive) was the fact that the doctor owned his practice and treated both patients and referring doctors like privileged clients whom he was grateful to serve because he was well rewarded for his

dedication and excellent personal care. Doctors are no different from any other human being in the workforce. They respond with passionate hard work to the financial rewards society delivers for excellent medical care. The government and whatever payors remain may soon determine that they will be able to buy shift work‒quality healthcare while slashing doctors’ salaries. Time will tell how our relaxed millennial colleagues will adjust to earning a fraction of the income they now expect and have grown accustomed to when their lack of ownership has its final financial impact on their careers. The modern resident typically desires to graduate from their training program and become employed by an entity that takes care of all their business responsibilities and provides them with a secure, generous, guaranteed salary and benefits along with a steady stream of patients, no threat of competition and an excellent lifestyle. Sounds perfect, doesn’t it? Time will tell. The concern I have with this new workforce arrangement in American medicine is that our citizens are gradually being given the worst possible healthcare scenario—shift work medical attention from their doctors at extraordinarily expensive rates. That is not fair to our patients, our government or our economy. I have no clear remedies or clever recommendations for how to deal with this situation, and I am fairly certain that the ship of traditional, private practice, physician ownership in America has long sailed. Nonetheless, I would insist that doctors, like everyone else in the workforce, perform much better when they have some “skin in the game.” All physicians, whether employed or

independent, should be incentivized in their business agreements to be highly productive and deliver extraordinarily high-quality healthcare by insisting they “own” both their patients and their referral lines, and that they are competing for both on a daily basis in a highly competitive marketplace. Anything less, over the long term, is simply unsustainable. Finally, a caveat before you start celebrating your new employee contract and the salary and lifestyle it promises you. To paraphrase Ralph Waldo Emerson: “Beware of what your heart desires, for you are sure to get it.” The idea of the modern American physician endlessly receiving free-market wages in exchange for salaried medical work and commitment is both illogical and unsustainable, and when the government and private insurers finally decide that they really want to cut costs, I assure you it will not be the big corporations that will be giving up their shareholder profits. It will be the lonely doctor who owns no patients, keeps no charts, has no office phone number, has developed no loyal referral patterns, and is bound by a firm restrictive covenant who will take the hit. ■ —Dr. Lopez-Viego is a vascular and general surgeon, and a clinical professor of surgery at Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, Fla. Editor’s note: Opinions in General Surgery News belong to the author(s) and do not necessarily reflect those of the publication.

Response

Ownership Versus Shift Work: Neither Model Is Sustainable By BRUCE RAMSHAW, MD, FACS B

can appreciate the passion in Dr. LopezV Viego’s opinion article, “What Your Heart Desires.” When I graduated residency in 1994, I joined a small private practice that was a part of the attending faculty at the community residency program where I graduated. My senior partner regularly coached me about being available, affable and able. After eight years in a small private practice, I was recruited to join a well-known private academic medical center where I was in a guaranteed salary position. During my 25-year surgical career, I spent about half my time in a salaried position and half in a private practice, where I had the type of “ownership” that Dr. Lopez-Viego described. Based on my experience and the understanding of the science of complex systems, I can say that both practice structures aren’t sustainable and are potentially harmful. Dr. Lopez-Viego presents a clear picture of the potential harm of the shiftwork, salaried model, but I believe there is an underlying system structural problem that is common to both the hired physician model and the physician ownership

model. Both settings rely on and reward productivity. Even in the hired/salary/ shift-work model, most surgeons do have some element of productivity incentives. For surgeons in the ownership model, they are entirely incentivized by productivity—eat what you kill.

We should be working with others in our clinical setting to measure and improve the most critical intrinsic motivator in healthcare—the value of care we provide in the context of each whole patient care process for which we provide care. Research into extrinsic motivators (carrots and sticks), like financial rewards in a fee-for-service model, clearly shows they work as intended and improve performance when used for simple, mechanical tasks. But when these same extrinsic motivators attempt to incentivize complex tasks, as in healthcare, they result in poorer performance. These extrinsic motivators

take the focus away from doing the challenging work that complex tasks require and shift the focus to what is required to achieve maximal extrinsic rewards (think electronic medical record documentation, coding and billing, double booking clinic, etc.). It took me a majority of my career to realize this, but the volume model is not sustainable and is unintentionally harmful. Compensation determined entirely on billing is one of the top factors correlated with burnout (Ann Surg 2009;250[3]:463-471). This volume model persists in both the private practice/ownership model and employed physician/shift-work model. I first learned about the difference between extrinsic and intrinsic motivators in a book titled “Drive: The Surprising Truth About What Motivates Us,” by Daniel Pink. His research concludes that we are best motivated by autonomy, mastery and purpose. Many physicians have raised the concern about the loss of autonomy due to restrictions on care by payors and from becoming an employee of a hospital. But autonomy is not enough. Responsible ownership includes accountability in addition to autonomy. We should be working with others in our clinical setting to measure and improve the most critical intrinsic

motivator in healthcare—the value of care we provide in the context of each whole patient care process for which we provide care. I have not yet seen a hospital or physician practice demonstrate the ability to measure the value of care they are providing. This is critical to the future of our healthcare system because if we don’t measure it, then we can’t improve it. Until we work together with hospital and physician practice resources to measure and improve the value of care that we provide, we will continue to function in an unsustainable healthcare system regardless of the physician model in which we practice. ■ —Dr. Ramshaw is a general surgeon and data scientist in Knoxville, Tenn., and a managing partner at CQInsights. He is a member of the editorial advisory board of General Surgery News.

KCENTRA® (Prothrombin Complex Concentrate [Human]) For Intravenous Use, Lyophilized Powder for Reconstitution Initial U.S. Approval: 2013 BRIEF SUMMARY OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KCENTRA safely and effectively. See full prescribing information for KCENTRA. WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential beneﬁts of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding. • Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with KCENTRA in clinical trials and post marketing surveillance. Monitor patients receiving KCENTRA for signs and symptoms of thromboembolic events. • KCENTRA was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. KCENTRA may not be suitable in patients with thromboembolic events in the prior 3 months. (5.2) ------------------------------------INDICATIONS AND USAGE---------------------------------KCENTRA, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deﬁciency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with: • acute major bleeding or • need for an urgent surgery/invasive procedure. (1) -----------------------------DOSAGE AND ADMINISTRATION--------------------------------For intravenous use after reconstitution only.. • KCENTRA dosing should be individualized based on the patient’s baseline International Normalized Ratio (INR) value, and body weight. (2.1) • Administer Vitamin K concurrently to patients receiving KCENTRA to maintain factor levels once the effects of KCENTRA have diminished. • The safety and effectiveness of repeat dosing have not been established and it is not recommended. (2.1)

• Administer reconstituted KCENTRA at a rate of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min (~210 units/min). (2.3) Pre-treatment INR 2–< 4 4–6 >6 Dose* of KCENTRA (units† of 25 35 50 Factor IX) / kg body weight Maximum dose‡ (units of Not to exceed Not to exceed Not to exceed Factor IX) 2500 3500 5000 Dosing is based on body weight. Dose based on actual potency is stated on the vial, which will vary from 20 31 Factor IX units/mL after reconstitution. The actual potency for 500 unit vial ranges from 400-620 units/vial. The actual potency for 1000 unit vial ranges from 800-1240 units/vial. † Units refer to International Units. ‡ Dose is based on body weight up to but not exceeding 100 kg. For patients weighing more than 100 kg, maximum dose should not be exceeded.

---------------------------------DOSAGE FORMS AND STRENGTHS-------------------------KCENTRA is available as a white or slightly colored lyophilized concentrate in a single-dose vial containing coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S. (3) --------------------------------------CONTRAINDICATIONS -----------------------------------KCENTRA is contraindicated in patients with: • Known anaphylactic or severe systemic reactions to KCENTRA or any components in KCENTRA including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin. (4) • Disseminated intravascular coagulation. (4) • Known heparin-induced thrombocytopenia. KCENTRA contains heparin. (4) ----------------------------------WARNINGS AND PRECAUTIONS---------------------------• Hypersensitivity reactions may occur. If necessary, discontinue administration and institute appropriate treatment. (5.1) • Arterial and venous thromboembolic complications have been reported in patients receiving KCENTRA. Monitor patients receiving KCENTRA for signs and symptoms of thromboembolic events. KCENTRA was not studied in subjects who had a thrombotic or thromboembolic (TE) event within the prior 3 months. KCENTRA may not be suitable in patients with thromboembolic events in the prior 3 months. (5.2) • KCENTRA is made from human blood and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. (5.3) -----------------------------------ADVERSE REACTIONS---------------------------------------• The most common adverse reactions (ARs) (frequency ≥ 2.8%) observed in subjects receiving KCENTRA were headache, nausea/vomiting, hypotension, and anemia. (6) • The most serious ARs were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis. (6) To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Revised: July 2020

For hemodynamically unstable patients on warfarin

SEVERE GI BLEEDS CALL FOR IMMEDIATE INTERVENTION Act fast in the face of these unstable vitals* PT-INR >2 Moderate-to-severe bleeding Heart rate >100 bpm Blood pressure <90/60 mmHg

Choose Kcentra for urgent warfarin reversal Learn more about Kcentra and GI bleeds at kcentra.com/case-studies

FASTER ACTING† Superior INR reduction at 30 minutes after end of infusion vs plasma

FASTER ADMINISTRATION, LOWER VOLUME

SUSTAINED INR REDUCTION‡

Statistically significant INR reduction sustained ≤1.3 for up to 8 hours vs plasma

Mean infusion time is under 25 minutes ~85% less volume vs plasma

SCAN TO LEARN MORE

*Not inclusive of all symptoms of hemodynamic instability. †In 2 head-to-head trials, Kcentra demonstrated superiority to plasma in 3 of 4 efficacy endpoints. Superior hemostatic efficacy in the Urgent Surgery/Invasive Procedures trial and equally effective hemostasis efficacy in the Acute Major Bleeding trial. Faster INR reduction (to ≤1.3 at 30 minutes after end of infusion) in both head-to-head trials. ‡8 hours for Urgent Surgery/Invasive Procedures trial and 12 hours for Acute Major Bleeding trial. Administer vitamin K concurrently to patients receiving Kcentra. Vitamin K is administered to maintain vitamin K-dependent clotting factor levels once the effects of Kcentra have diminished.

Important Safety Information WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months.

Indications Kcentra is a blood coagulation factor replacement indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K

antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Kcentra is for intravenous use only.

Important Safety Information Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra is also contraindicated in patients with disseminated intravascular coagulation. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT). Hypersensitivity reactions to Kcentra may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment. In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis. Kcentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated. Please see full Important Safety Information on the following page. Please see enclosed full prescribing information, including boxed warning.

Kcentra is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC. Kcentra® is a registered trademark of CSL Behring GmbH. Biotherapies for Life® is a registered trademark of CSL Behring LLC. ©2021 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA www.CSLBehring.com www.Kcentra.com KCT-0122-DEC21

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