August 2022 Print issue

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

August 2022 • Volume 49 • Number 8

Vaccination Status Influences Patients’ Surgery Decisions During a Pandemic

By GINA SHAW

P

atients are more willing to have surgery duringg a pandemic, such as COVID-19, if both they and d the hospital staff are vaccinated, according to a new study from researchers at the University of Chicago and Embry-Riddle Aeronautical University (Vaccine 2022;40[26]:3536-3539).

Patients may choose to delay surgery during a pandemic, even if the procedure is lifesaving, due to fears of viral exposure in a healthcare setting. In March 2020, a retrospective analysis from the Michigan Stroke Treatment Improvement Collaborative found a significant reduction in both ischemic stroke admissions and mechanical al thrombectomy procedures for the most severe ischemic mic strokes compared with February 2020 and March 2019 (Neurosurgery 2020;87[3]:E397-E399).

New Research Links Gallstones, Pancreatic Cancer

By MARCUS A. BANKS

[Editor's Note: This article was originally posted online at www.generalsurgerynews.com on July 18.]

SAN DIEGO—Patients diagnosed with pancreatic ductal adenocarcinoma are more likely to have had gallstones than patients without pancreatic cancer, according to research presented at the 2022 Digestive Disease Week.

“Understanding this association between gallstone disease and pancreatic cancer might be a key to differential diagnosis strategies,” said Teviah Sachs, MD, MPH, the chief of the Section of Surgical Oncology at Boston Medical Center and an associate professor of surgery at Boston University School of Medicine, at a media briefing describing the results. The early symptoms of pancreatic

Continued on n page 12

Practice-Changing Breast Surgery Papers Of 2021 Reviewed Surgeon Continues Her Annual List of Top Research in the Field

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Hospital-Related Resistant Infections Grew 15% During Pandemic

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OP IN ION

5 Algorithms for Good

IN THE NEWS

8 Moral Injury: The Emotional Impact of Complications

NE W TECHNOLOG Y

10 New Device May Improve Outcomes After Cardiac Arrest X

facebook.com/generalsurgerynews

By HENRY BUCHWALD, MD, PhD D

ospital-related resistant infections and deaths increased at least 15% during the first year of the COVID-19 pandemic, pushing back the progress made in the fight against antimicrobial resistance (AMR), according to a new report by the CDC. “This report confirms what previous research has suggested: COVID-19 has not only increased the threat of antibiotic resistance; it has undone years of progress, and on a staggering scale,” said David Hyun, the director, The Pew Charitable

By MARIE ROSENTHAL, MS

related papers of 2021, Helen Pass, MD, the chief of breast surgery and co-director of the Stamford Hospital Breast Cancer Center, in Connecticut, found more than 20,000 English-language clinical articles. She presented those she considered the most compelling at the 2022 annual meeting of the American Society of Breast Surgeons.

“I want to find things that are going to change what you do: research that has significant practice value, landmark studies or something that got a lot of national press,” Dr. Pass said.

The Corruption of Care ike many Americans, I enjoyy taking my children and grand-children to baseball games. I lookk forward to seeing a live game up close and eating stadium food. I buy a limited season pass, allowing me to pick certain games in certain seats well in advance. I select a home game against our team’s most exciting opponents on a day when family can attend.

Let’s say that several weeks before the game, I receive a phone call. A voice says, “Is this Henry?”

I hesitate at this greeting without identification, but I respond, “Yes.” The Voice continues: “Well, Henry,

By MONICA J. SMITH

LAS VEGAS—In her search for the top breast cancer–

OPINION

@gensurgnews

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 a

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.

© 2022 HERON THERAPEUTICS, INC. ALL RIGHTS RESERVED. 4242 CAMPUS POINT COURT, SUITE 200 • SAN DIEGO, CA 92121 • 858-251-4400

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

AUGUST 2022 / GENERAL SURGERY NEWS

Algorithms for Good

By BRUCE RAMSHAW, MD

F

or over 25 years, I’ve been considered an expert in my m field of surgery. I used to think I knew the best treatment for each patient. But as I learned about and then applied the principles of data science to real patient care, I’ve realized how much better our decisionmaking process in healthcare could be if we had a data and analytics infrastructure that could generate not just predictive algorithms but predictive algorithms for good. However, algorithms generated from big data can reinforce discrimination, racism and inequities all too common in our world.

Some algorithms are designed for self-serving purposes, clearly not intended to help all people. Examples include attempting to manipulate voters, maximize the price of an airline seat, maximize the profit from a stock trade and win baseball games. These examples come from companies and organizations that use algorithms in competition to win or make more money. These algorithms do not result in doing good to improve our world. As soon as other

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

competitors develop their algorithms, a competitive advantage is lost. Although they came close to a championship using algorithms described in the book and movie “Moneyball,” the Oakland Athletics never won the World Series using algorithms. As other teams learned to use algorithms and had larger budgets, the smaller market teams, like the Athletics, were less competitive again.

On the other hand, there are many algorithms developed to do good but lack an understanding of data science principles that could benefit all people. No algorithm is perfect, but there are ways to design algorithms that can improve outcomes for all people over time.

TThe he cchallenge hallenge aahead head lies lies in in ethically ethically iimplementing mplementing a data and analytics infrastructure in healthcare that supports the ability of each local clinical environment to produce algorithms that improve outcomes over time.

Decentralize the Data Using a fundamental principle of data science to create algorithms for good in healthcare, we need to start by decentralizing these efforts in each local environment in the context of any whole, definable patient care process. Decentralization is a critical first step because centralized algorithms may contribute to unintended harm by poorly representing populations at the margins of society.

Centralized data sets produce averages but lack insights.

Jarrod Kaufman, MD Brick, NJ

Network Learnings Decentralizing our data in healthcare leads to the ultimate potential— networked or ensemble learning. Once the learnings and algorithms are in the context of each local environment and a whole, definable patient care process, they can be combined with other learnings and algorithms. By combining many

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

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algorithms generated from the same process in different local environments, the predictive ability of the algorithms can be optimized.

Identify What Matters Over time, as learnings are shared with each local clinical team, the goal should continued on the following page

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IN THE NEWS

GENERAL SURGERY NEWS / AUGUST 2022

Diagnostic Balloon-Assisted Enteroscopy Beneficial For Suspected Small-Bowel Bleeds

By MICHAEL VLESSIDES

N

ew research has confirmed that balloon-assisted enteroscopy remains an effective diagnostic and therapeutic modality in patients with suspected smallbowel bleeding.

The retrospective analysis found that the approach yielded higher diagnostic and therapeutic rates in patients presenting with active overt gastrointestinal bleeding and in those who underwent balloon-assisted endoscopy within 30 days of overt gastrointestinal bleeding.

In a presentation at the 2022 Canadian Digestive Diseases Week, investigators from the University of Alberta, in Edmonton, explained that obscure gastrointestinal bleeding is estimated to comprise approximately half of all gastrointestinal bleeds. Among the various diagnostic and therapeutic modalities used to investigate sources of obscure gastrointestinal bleeding is balloon-assisted enteroscopy, which the researchers said has reported diagnostic and therapeutic yield rates of up to 87% and 80%, respectively, in these patients.

To shed more light on the clinical outcomes of patients undergoing balloon-assisted endoscopy for suspected small-bowel bleeding, the researchers reviewed the records of 342 patients who underwent the procedure at the institution between 2016 and 2021 (abstract A116). Of these patients, 116 underwent evaluation for obscure gastrointestinal bleeding.

A host of pre-procedural variables were assessed to

Algorithms continued from the previous page

be to identify “what matters” the most to outcomes that measure the value of care.

I first learned how to develop algorithms for good by applying these principles to real patient care through trial and error with a small, diverse hernia team. As we were learning to apply these data science skills, we found that we were not measuring one of the most important factors predicting outcomes for a surgical procedure: a patient’s neuro-cognitive/ emotional state prior to surgery. When a person suffers traumatic experiences (violence, sexual abuse, financial stress, psychological abuse, multiple surgeries, etc.), there can be a neurophysiologic change in the brain that leads to a chronic stress state. This chronic stress can negatively impact the hormonal and immune systems, and ultimately, increase inflammation in the body. When we measured the impact of that factor, we found it was much more important than many other factors being measured. It was humbling to realize there were factors more

allow for stratification of the data, including patient age and sex, indication for endoscopy, and time since video capsule endoscopy. Endoscopic variables that were used to calculate diagnostic and therapeutic yields included modality, findings and therapeutic interventions. The investigators also analyzed the association between the timing of balloon-assisted enteroscopy after video capsule endoscopy and clinical outcomes such as rebleeding rate, diagnostic yield and therapeutic yield.

Finding the Bleed According to study senior investigator Sergio Zepeda-Gomez, MD, an associate professor of medicine at the University of Alberta, the overall diagnostic yield of the procedure was 70.3%. For patients with active overt bleeding, the yield was 78.6%, which was greater than the 72.5% for patients with occult bleeding or the 64.6% for inactive overt bleeding.

Subgroup analysis revealed that the diagnostic yields of balloon-assisted enteroscopy with and without prior video capsule endoscopy were similar (75.9% and 77.8%, respectively; P=0.605).

The most common findings among all presentations of obscure gastrointestinal bleeding were vascular lesions, including angiodysplasia, arteriovenous malformations and Dieulafoy’s lesions. The majority of lesions were located within the proximal jejunum.

The study also found an overall therapeutic yield rate of 51.1%, although a higher yield was noted in patients presenting with active overt bleeding than in their counterparts with either occult bleeding or inactive overt bleeding. Finally, balloon-assisted

important than my surgical technique in predicting outcomes.

Implement Improvement Via Human-Computing Symbiosis Another critical step requires algorithms to be interactive and curated by small, diverse teams in each local environment. This human-computing symbiosis is how algorithms for good can achieve sustainability in improving any complex healthcare problem and other challenges in our world. Passive algorithms, used to improve performance in rules-based applications, are not sufficient for complex problems. Addressing complex problems will require interactive algorithms be applied in each local environment with the engagement of diverse teams of people dedicated to improving the problem being addressed. Through a human-computing symbiosis, the improvement of any measured outcome for any process is possible.

As our team learned to apply these data science principles, we made many mistakes and overcame many challenges.

As we became more skilled over several

enteroscopy procedures performed within 30 days of overt gastrointestinal bleeding had higher diagnostic and therapeutic rates (80% and 70%, respectively) than procedures performed after 30 days (60% and 30%, respectively).

The findings of the current study largely resemble those of a similar effort by the researchers presented at CDDW 2018 (J Can Assoc Gastroenterol 2018;1[suppl1]:67-68). In that study, they concluded that balloon-assisted enteroscopy “is a useful diagnostic and therapeutic strategy in the management of patients with obscure gastrointestinal bleeding. Luminal evaluation of the small bowel with balloon-assisted endoscopy should be undertaken as soon as obscure gastrointestinal bleeding is suspected, and preferably in proximity to active bleeding.”

A ‘New Frontier’ For Richard S. Zubarik, MD, a professor of gastroenterology at the University of Vermont Medical Center, in Burlington, evaluation of the small bowel is the “new frontier” in the assessment of obscure gastrointestinal bleeding.

“There are several choices to evaluate the small bowel for obscure gastrointestinal bleeding,” Dr. Zubarik said.

“These include push enteroscopy, video capsule endoscopy, balloon enteroscopy and surgically assisted enteroscopy. Factors that determine which technology to use include modality availability, expertise, need for therapeutic intervention, suspected small-bowel site of bleeding and patient comorbidities.

“Balloon enteroscopy has the benefit of routinely evaluating a large portion of the small bowel, having the capability for therapeutic intervention and, as this study shows, a high diagnostic yield.”

■

years, we’ve seen the potential for our healthcare system to be transformed.

The challenge ahead lies in ethically implementing a data and analytics infrastructure in healthcare that supports the ability of each local clinical environment to produce algorithms that improve outcomes over time.

Reframe Ethical Issues The ethical issues about the use of artificial intelligence and machine learning in our world have nothing to do with the technology—they’re about the humans who program the technology. The people who design programs may produce harm that is intentional or unintentional, and when the purposes of the algorithms that permeate our world are opaque and hidden, there is a void of accountability. The ethical solution is transparency and accountability from those who program the data, not only through gaining consent from individuals to use their data. Most importantly, the public must value that transparency and accountability without the rigid judgment of failures.

We are at a critical moment in our world. Will we use our lower-brain mindset, designed for a world of scarcity and imminent physical threats, to use technology for selfish and competitive desires? Or will we use our higher cognitive capacity to create a world of abundance through collaborative uses of technology that result in a better world for all people? It’s up to us.

Do we want to compete to prove we’re right, or do we want to learn to improve and do what is right? As when I closed my TEDx talk in 2012 (“Finding the Hole in Healthcare; www.youtube.com/ watch?v=QPeLIbh0BAw), I still believe the future of our world will be based on each person’s answer to one simple question: Do you care? I do.

■ This article was previously published on the APCO Worldwide blog on May 10, 2021.

—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.

IN THE NEWS

AUGUST 2022 / GENERAL SURGERY NEWS

Male Breast Cancer Patients Often Dissatisfied With Post-op Results

By MONICA J. SMITH

LAS VEGAS—About one-third of male

breast cancer patients are dissatisfied with the cosmetic outcome of their surgical treatment, according to a new study in the Annals of Breast Surgery (2022 July 25). The study found that while a majority of breast surgeons routinely offer breast-conserving surgery to male patients, very few discuss post-mastectomy reconstruction, which presents an opportunity for improving the male breast cancer patient experience.

Anna Chichura, MD, a breast surgical oncology fellow with NorthShore University HealthSystem in Evanston, Ill., and the University of Chicago, in collaboration with her colleagues, administered concurrent online surveys to male breast cancer patients and members of the American Society of Breast Surgeons (ASBrS) in 2020. The surveys were designed to assess male breast cancer patient perspectives about the surgical approach for their treatment, and to compare the patients’ experiences with surgeon recommendations for men with breast cancer.

“The patient survey included questions on patient demographics, surgical choices, a 5-level Likert scale regarding patient comfort with postoperative outcomes and the opportunity for openended responses,” Dr. Chichura said, presenting her study at the 2022 ASBrS meeting. The surgeon survey included surgeon demographics, a hypothetical patient case and questions about recommendations for bilateral mastectomy in men with breast cancer.

Of the 63 male patients who responded to the survey, all but one underwent mastectomy, with 98% having their nipples removed. Only three underwent reconstruction. About one-third of respondents reported feeling somewhat or very bothered by the appearance and feel of their scar after the operation.

“Patient concerns included feeling unbalanced or asymmetric, feeling selfconscious, having an altered sensation of touch, discomfort or skin tightness, and feeling flat, caved or indented. As one patient noted, ‘It looked like a crater in my chest,’” Dr. Chichura said.

Of the 438 out of 2,650 surgeons who responded to the survey (16%), the majority had been in practice for more than 16 years, and most reported treating between one and five male breast cancer patients annually.

“While 60% routinely offered breast conservation to their male patients, only 40% reported ever performing a partial mastectomy on a male patient, and only 20% routinely offer post-mastectomy

reconstruction. At the time of the survey, 36% of surgeons had never even considered it as an option,” Dr. Chichura said.

She noted a few limitations of the study: Although patient advocates and surgeons reviewed the surveys prior to distribution, the researchers did not perform a more rigorous validation process. The response volume of

‘While 60% of surgeons routinely offered breast conservation to their male patients, … only 20% routinely offer post-mastectomy reconstruction. … These findings present an opportunity to optimize the surgical approach to male breast cancer, as well as the patient experience.’

—Anna Chichura, MD

continued on page 17

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IN THE NEWS

Moral Injury: The Emotional Impact of Complications

By MONICA J. SMITH

NASHVILLE, TENN.—Many who read General Surgery News will be familiar with this quote attributed to René Leriche: “Every surgeon carries within himself a small cemetery, where from time to time he goes to pray.” Meditative, elegiac and also incomplete.

“The latter half is, ‘a place of bitterness and regret, where he must look for an explanation for his failures,’” said Sunil Geevarghese, MD, a hepatobiliary and transplant surgeon and an associate professor of surgery at Vanderbilt University Medical Center, in Nashville, Tenn., speaking at the 2022 Southeastern Surgical Congress.

Dr. Geevarghese continued: “I think he was talking about moral injury in 1955.”

First documented in Vietnam War veterans who described unsettling symptoms that differed from classic posttraumatic stress disorder (PTSD), moral injury occurs when individuals witness or fail to intervene in a situation that goes against their moral beliefs.

“Moral injury is a little different from an ethical dilemma because with moral injury, we know the correct ethical action but feel powerless to do it. An example would be that we know a patient needs surgery and would benefit from it, but a delay occurs, which leads to worse oncologic outcomes and patient distress and our own distress,” said Toan T. Nguyen, MD, a breast surgeon and the director of breast oncology at Lakeland Regional Health, in Florida, speaking at the 2022 annual meeting of the American Society of Breast Surgeons.

Moral injury is different from burnout, although it can lead to the latter, Dr. Geevarghese said. It is “like acute kidney injury is not end-stage renal disease.”

Although Leriche’s possible description of moral injury more than 65 years ago suggests it has long been part of the cost of being a surgeon, recent research shows that the COVID-19 pandemic has exacerbated matters, according to Dr. Nguyen (J Gen Intern Med 2022;37:2033-2040).

“This work—which was broadcast on national headline news—showed that healthcare workers, many of us physicians, experience moral injury comparable to veterans. About 50% of us have trouble with moral injury because of someone else’s immoral behavior due to COVID19, and 20% of us have actually had to violate our own morals and values because of pandemic-related restrictions. This led to more PTSD, depression, lower quality of life and burnout,” Dr. Nguyen said.

How Surgeons Experience Moral Injury Preparing for a talk on moral injury,

Dr. Geevarghese came across a paper that described the experience of a neurosurgeon who, after a major complication, yearned for the next case that would have a happy ending. “I think all of us, the morning after a major event, just want to get past it. In reality, it’s really complicated,” he said.

Although moral injury affects physicians across all fields of practice, Dr. Geevarghese thinks it hits surgeons a little differently. As described in a paper

that investigated the emotional impact of complications, surgeons progress through four phases after an adverse event (Med Educ 2012;46[12]:1179-1188).

The kick: a visceral blow to the core.

“I think everyone can attest to how that feels; it’s accompanied by feelings of failure, self-doubt and unworthiness,” Dr. Geevarghese said.

The fall: a sense of spiraling out of control. “If a patient develops a complication, even if it wasn’t your fault,

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IN THE NEWS

‘Identify the problem, gather appropriate facts, turn to each other and build support networks. We find colleagues who share our interests and concerns and share ideas, and it reduces factors leading to moral injury and distress.’

—Toan T. Nguyen, MD

wondering if you shouldn’t have offered them surgery. What would their life had been like if they hadn’t had an operation?”

The recovery: “Almost all surgeons admitted it just took time.”

The long-term impact: “This can be major.

Again, in the words of a surgeon, ‘a piece of me felt taken away with every complication.’”

No surgeon is immune from moral injury. Junior faculty, representing the lauded institutions where they trained while transitioning to new positions, are vulnerable. So are surgeons more advanced in their careers, whose partners and administrators expect more of them as they gain experience.

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The Impact of Surgical Culture On Moral Injury, and How to Change It A recent paper exploring the effect on surgeons of postoperative complications found that their emotional responses may harm their well-being and, if left unaddressed, could represent a threat to the profession (Ann Surg 2022;275:e124-e131).

Calling for a shift in the surgical culture, the authors suggested their readers accept their humanity, destigmatize selfdoubt, “and encourage seeking help when dealing with the burdensome accumulation of a lifetime of complications.”

Part of this shift toward a kinder surgical culture might entail a willingness to mentor junior colleagues in a way that sets them up for success early on. Dr. Geevarghese described some tips that his colleague, Kamran Idrees, MD, the chief of surgical oncology and endocrine surgery at Vanderbilt Health, in Nashville, Tenn., has for mentoring early-career surgeons.

“He gave away his 7:30 a.m. block time.

Dr. Idrees rationalized that if he gave them that OR time, he’d be on the second and third case; if they get into trouble, he can be available. And it’s during daylight hours instead of getting the scraps at 5 p.m., and trying not to be bumped by trauma,” Dr. Geevarghese said.

In an email to General Surgery News, Dr. Idrees noted that historically, new junior faculty cases are scheduled as “addons”—often starting long, complex cases later in the afternoon with random nursing teams, “which is not setting them up for success,” he said.

Dr. Idrees also calls on junior partners to help him out in the OR, stressing that he needs their assistance. “He runs cases by them, rather than just expecting them to run cases by him. This abolishes that stigma of weakness to call for help by making it natural. If my chair is asking me for help, then it’s no big deal if I, as the junior person, ask for help. And he safeguards them by always being available.”

For surgeons at all points in their careers, Dr. Nguyen advises taking steps to alleviate moral injury the way they would address any other emotional or psychological problem. “Identify the problem, gather appropriate facts, turn to each other and build support networks. We find colleagues who share our interests and concerns and share ideas, and it reduces factors leading to moral injury and distress.”

Dr. Nguyen also suggests trying to focus on changing the work environment instead of attempting to fix specific patient factors. “For example, when my patient told me she couldn’t get an MRI for six weeks, I called the radiologist and said I’d send her somewhere else.

Sure enough, 48 hours later, she got her ■ MRI,” he said.

9

10

GENERAL SURGERY NEWS / AUGUST 2022

New Device May Improve Outcomes After Cardiac Arrest

By MONICA J. SMITH

‘We haven’t changed the egardless of setting, cardiac arrest outcomes are dismal. A novel, easy-to-use device that increasbasic way we resuscitate es blood perfusion to the heart and brain when used cardiac arrest patients since in tandem with cardiopulmonary resuscitation (CPR) may prove to be the first breakthrough in a long time.

1960, and it isn’t because we “We haven’t changed the basic way we resuscitate have great outcomes. Cardiac cardiac arrest patients since 1960, and it isn’t because we have great outcomes. Cardiac arrest seemed like arrest seemed like an obvious an obvious and deserving condition for innovation. and deserving condition for We sought to use creative and user-friendly ways to improve outcomes,” said Kristen Quinn, MD, a generinnovation. We sought to use al surgery resident at the Medical University of South creative and user-friendly Carolina (MUSC), in Charleston, and the CEO and co-founder of Heartbeat Technologies, a new mediways to improve outcomes.’ cal device startup.

—Kristen Quinn, MD When MUSC’s Human Centered Design Stu- The SAVER device directs blood to support vital organs during cardiopulmonary resuscitation. dio chairman Prabhakar Baliga, MD, encouraged Dr. Quinn and other participants to consider clinical pain points that could be better optimized, poor car- data in a pig model that shows SAVER increases carot“From there, it should be in every airport, office, stadiac arrest outcomes were identified as an area of focus. id arterial blood pressure. Their next step is to inves- dium and other public spaces, since more than 50% “One of our co-inventors, Dr. T. Konrad Rajab, a pedi- tigate use of SAVER in a pig model during cardiac of cardiac arrest cases occur in the community,” Dr. atric cardiothoracic surgeon, described being nagged by arrest. Brain and heart perfusion will be quantified with Quinn said. this thought throughout his whole training: Why can’t fluorescent microspheres to compare with or without Dr. Baliga, the chairman who encouraged residents to we do something to preferentially perfuse the heart and SAVER as the animal undergoes CPR with an auto- think about human-centered design initiatives, believes the brain during this critical time?” Dr. Quinn said.

Heartbeat Technologies has tremendous potential to mated piston-driven device.

Based on the idea that blood could be better directIf that investigation pans out, Dr. Quinn and her col- make a difference in patient outcomes, “which is the ed to support the vital organs, they developed the Safe- leagues will distribute SAVER to ICUs and emergency whole point of the Human Centered Design Program.” ty Adjunct for Vascular Extremity Occlusion During departments, where many cardiac arrests occur.

SAVER will need further testing “to make sure that Resuscitation (SAVER) device.

“Another thing that makes SAVER innovative is that it’s as effective as we think it is,” Dr. Baliga said, “but I The device consists of an unfolding strapping sys- it can be put on a patient without being activated. If think the premise and rationale behind it make intuitive tem designed to be used while chest compressions are we can identify patients at high risk for a cardiac arrest sense, and that it has tremendous potential to go forongoing, over clothing, by sliding under the patient’s and have SAVER already on them along with the arte- ward.” Dr. Baliga was not involved in the development low back and securing around their legs. rial monitoring devices, we can capture the effects of of SAVER and has no investment or financial stake in Once activated, SAVER deploys pneumatic bulbs SAVER on their pressure and survival,” Dr. Quinn said. Heartbeat Technologies. that apply focal pressure to the femoral vessels, redi“The beauty of this is that it’s coming from our resiFrom there, they plan to start collaborating with recting blood flow from the legs toward the heart and academic medical centers, “because they’re often open dents, from young minds. Some of us get kind of stuck in brain. Sensors in these bulbs give feedback on wheth- to adopting new technologies, furthering the field our ways, but when these fresh young minds examine a er the compressions are generating adequate pressure. of research and participating in clinical trials,” Dr. problem, it’s refreshing to see what happens,” he said. ■ “The idea is that it’s intuitive to use for all comers: Quinn said. inpatient hospital settings, but also out in the commuUltimately, Dr. Quinn and her team want to partner nity, by laypersons and people who have never given with emergency medical services and medical centers Column Editor: CPR before,” Dr. Quinn said. to acquire enough strong data to pitch SAVER to the Michael A. Goldfarb, MD, clinical professor At this point, Dr. Quinn and her colleagues have American Heart Association as standard-of-care thera- of surgery, Rutgers University Medical School, in New Brunswick, N.J. made a minimal viable prototype and conducted pilot py for cardiac arrest.

R

Single-Port Robotic Colorectal Surgery ‘Safe, Feasible,’ With Good Outcomes Single-Surgeon Study of 133 Patients

By KATE O’ROURKE

A

phase 2 clinical trial of single-port robotic colorectal surgery shows it to be feasible and safe with good clinical outcomes, according to new research. The findings were presented at the 2022 annual meeting of the American Society of Colon and Rectal Surgeons (abstract S29).

John Marks, MD, of the Division of Colorectal Surgery at Lankenau Medical Center, in Wynnewood, Pa., described the short- and long-term outcomes of the first phase 2 trial using the singleport robot for colorectal surgery. From

October 2018 to August 2021, researchers selected consecutive patients who underwent single-port robotic surgery at Lankenau Medical Center. Study inclusion required patients to have had a need for colorectal resection. Patients who had emergency surgery, were pregnant, were younger than 18 years of age, had stage IV carcinoma or had an inability to provide consent were excluded from the study. All operations were performed by one surgeon at Lankenau Medical Center.

The study cohort included 133 patients. The mean age was 59.7 years

and 57.9% of patients were women. The mean body mass index was 27.5 kg/m2.

Sixty-five patients had adenocarcinoma, 27 had diverticulitis, 21 had adenoma polyps, seven had ulcerative colitis and the rest had other conditions. The procedure was performed via transanal excision in 57.1% of the cases and an abdominal approach in 42.9%. The single-port colorectal surgery case mix represented a full spectrum of operations.

Single-port colorectal surgery was completed without laparoscopic ports in 96.9% of the cases. There were no conversions to open surgery and four (3%)

to laparoscopy. There were no intraoperative complications and no transfusions were necessary. Median docking time was 6.1 minutes, median console time was 215 minutes and median operative time was 307.0 minutes. The mean abdominal incision was 5.5 cm. Ninety-seven percent were completed with one incision. Overall morbidity was 13.5% and included urinary retention (n=2), anastomotic leak (n=1) and pelvic abscess (n=2). In terms of oncologic outcomes, there were no local recurrences and negative margins were 100%. There continued on page 12

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IN THE NEWS

GENERAL SURGERY NEWS / AUGUST 2022

Vaccination Status and Surgery

Gallstones and Pancreatic Cancer

continued from page 1

continued from page 1

“It’s critical to understand the factors that affect a patient’s decision to have surgery during an infectious pandemic if we want to help reduce deaths and illness.

These factors include the vaccination status of the patient and hospital staff, need for the surgery, length of hospital stay, and urgency of the procedure,” said study co-author Keith Ruskin, MD, a professor of anesthesia and critical care at the University of Chicago, and member of the American Society of Anesthesiologists Committee on Patient Safety and Education. “Having this knowledge could help guide healthcare institutions’ future vaccine resource allocations and policies for vaccine requirements.”

In the study, 2,006 American adults were surveyed about their willingness to undergo a hypothetical surgery during a hypothetical pandemic. Respondents were randomly assigned to one of two experimental conditions: Either the hospital requires all personnel to be universally vaccinated, or the hospital has no vaccine requirements. Consent to undergo surgery was then assessed under several circumstances, including the urgency of the surgery, hospital length of stay, vaccination status of the patient and the hospital’s vaccination policy for staff. For each scenario, study participants rated their willingness to undergo surgery on a Likert scale ranging from –3 (least likely) to +3 (most likely).

Understandably, participants said they were most willing to have surgery if it were a lifesaving procedure, if everyone was vaccinated, and if the procedure was done in an outpatient setting (+1.97). However, even with ‘It’s critical to understand these hypothetical parameters, 15% of respondents were still reluctant to have lifesaving surthe factors that affect gery. “This may reflect distrust in the vaccine, a patient’s decision to in the hospital staff or in surgery itself,” the authors wrote. Participants were least willing have surgery during an to undergo surgery for an elective procedure infectious pandemic if we with an inpatient stay, with both themselves staff unvaccinated (–0.24). want to help reduce deaths and“Making the choice to not have surgery for and illness. These factors an actual health problem could increase the risk of potential illness and disease attributable include the vaccination to pandemic-related fears,” said Anna Clebone status of the patient and Ruskin, MD, a study co-author and an assoprofessor of anesthesia and critical care hospital staff, need for the ciate at the University of Chicago. “This suggests surgery, length of hospital a potential opportunity for public education.”

Dr. Keith Ruskin urged clinicians, includstay, and urgency of the ing surgeons and anesthesiologists, to take a procedure.’ more active role in educating patients about vaccines. “Sadly, there are media platforms —Keith Ruskin, MD that are making a profit out of spreading vaccine-related conspiracy theories,” he said. “We need to learn the same skills to help our patients to explain the advantages of getting vaccinated, particularly if they are considering something like surgery. When someone sees their physician for an annual checkup or meets with a surgeon about an upcoming surgical procedure, that’s a critical time for one-on-one education.”

Funding for healthcare advocates during the pre-habilitation period before surgery could also be useful, Dr. Anna Ruskin said. “You can’t change someone’s mind in a single visit; it takes time,” she said. “When we sense that someone is hesitant to have a potentially needed surgery, we could flag them for a follow-up call from a healthcare advocate who can address their concerns whether they be over vaccination, the safety of the hospital, or other questions about the surgery. That requires funding, but in the long term it could save money.”

In one post hoc analysis of the study data, the authors found that people who were actually vaccinated against COVID-19 were somewhat less likely to choose to have surgery. “One potential explanation is that getting vaccinated against COVID is correlated with a lower risk tolerance in general,” Dr. Keith Ruskin said. “That’s one future research question we want to answer. If you got vaccinated against COVID, are you less likely to, say, ride a motorcycle?”

Nevertheless, there were extremes at both ends of the spectrum. “Some people said that even if they were not vaccinated and the hospital did not require staff vaccination, they would still be willing to undergo elective surgery with an inpatient stay, while others would not undergo even lifesaving outpatient surgery with universal vaccination during a pandemic,” Dr. Keith Ruskin said. “We’re trying to formulate studies now to help us understand why those people made the decisions ■ they did.”

ductal adenocarcinoma (PDAC), the third-leading cause of cancerrelated death in the United States, often mimic those of gallstone disease, Dr. Sachs said, making diagnosis difficult.

To analyze this relationship, Dr. Sachs and his co-investigators examined records from the SEERMedicare database between 2008 and 2015, comparing the experience of 14,643 patients with PDAC and 14,605 patients who did not have cancer (abstract 761).

The team looked for evidence of either gallstone disease diagnosis or gallbladder removal in the 13 months before PDAC diagnosis. Groups were matched with respect to age, sex and race.

Dr. Sachs reported that 4.5% of the PDAC patients and 1.8% of controls without cancer had received a gallstone disease diagnosis in the year before their PDAC diagnosis (odds ratio [OR], 1.36; 95% CI, 1.16-1.60). Patients with gallstone disease were diagnosed at an earlier disease stage (stage I-II) (47.9% vs. 40.5%; P<0.0001) and a higher proportion underwent pancreaticoduodenectomy (17.6% vs. 12.9%; P<0.0001), compared with patients without gallstone disease.

Underscoring that the study does not show gallstones cause pancreatic cancer, Dr. Sachs said, “We can’t be certain at this time ... whether the gallstone disease that we’re seeing is the precursor or the end result of pancreatic cancer. We do know that there’s an association.” Finding patients with possible precursors—such as gallstone disease—can determine who should receive an MRI scan or endoscopic ultrasound to hopefully identify pancreatic cancer before it progresses.

Interpret With Caution Madhav Desai, MD, a gastroenterologist at the Kansas City VA Medical Center, in Missouri, said the findings are important and should inspire further research.

Dr. Desai, who was not involved in the study, cautioned that gallstone disease includes everything from asymptomatic gallstones to gallstones that cause pancreatitis—differences not accounted for by the umbrella term “gallstone disease.”

In response, Dr. Sachs noted that although their data are not broken down by type of gallstone, he expects the proportion of different gallstone types in the cancer population to mirror those in the general population.

Dr. Desai noted that pancreatic ductal obstruction from cancer sometimes causes upstream bile duct obstruction and cholangitis, as consequences rather than causes of cancer.

In addition, Dr. Sachs believes that any screening imaging within a year of PDAC diagnosis that could have identified gallstones also should have been able to spot a pancreatic tumor.

Noting that some risk factors for pancreatic cancer and gallstones overlap, Dr. Desai said, “We should be cautious of interpreting results and avoid any unnecessary concerns for patients with gallstone disease, especially those who are asymptomatic.” ■

Single-Port Robotic Colorectal continued from page 10

was one distant metastasis to the lungs.

“We demonstrate that single-port robotic colorectal surgery is safe, feasible and can achieve good clinical outcomes,” Dr. Marks said.

Rebecca E. Hoedema, MD, MS, FACS, FACRS, of Spectrum Health Medical Group Colon and Rectal Surgery Center for Digestive Diseases, Ferguson Clinic, in Grand Rapids, Mich., was asked to comment on the study and said the findings provided a good overview of the single-surgeon practice. “It is an interesting, singlesurgeon experience that may not translate to all practices,” Dr. Hoedema said. ■ Dr. Hoedema reported no relevant financial disclosures. Dr. Marks has served as a consultant to Applied Medical, Intuitive, Medtronic, Stryker and Virtual Incision; served on the scientific advisory boards of CONMED and Virtual Incision; served on the speakers bureaus of Intuitive, Medtronic, Olympus, Stryker and Virtual Incision; and received an educational grant from Medtronic.

IN THE NEWS

AUGUST 2022 / GENERAL SURGERY NEWS

Anal Cancer Risk Factors and Prevention: What Surgeons Should Know

By MONICA J. SMITH

NEW YORK—Anal cancer is rare. Although the life-

time risk for anal cancer is about one in 500 in the general population, this increases 30- to 100-fold in high-risk groups, and both incidence and mortality have been increasing over the past several decades at a rate of about 2.2% per year.

“That’s a bit of a cause for alarm,” said Rebecca A. Levine, MD, a colon and rectal surgeon at Montefiore Medical Center, and an assistant professor of surgery at the Albert Einstein College of Medicine, in New York City.

At the 2021 Controversies, Techniques and Problems in Surgery meeting, Dr. Levine discussed the risk factors for anal cancer, ongoing research that promises to clarify the topic and what surgeons need to know to prevent anal cancer.

Risk Factors Most anal cancers are squamous cell carcinomas. The disease is more frequent in women, and although more cases occur in absolute numbers in the HIV-negative population, HIV-positive status is the highest risk factor for the disease.

Other risk factors include smoking, any form of irritation (hemorrhoids, fistulas), exposure to HPV, men who have sex with men (MSM) and various forms of immunosuppression.

“But HIV remains the greatest risk factor. In the highest risk groups that risk increases 100-fold,” Dr. Levine said.

Some data show a correlation of anal cancer with lower CD4 counts, but this has been inconsistent; and anal cancer is not an AIDS-defining malignancy.

“In fact, the longer people survive with chronic HIV, the more likely they are to develop anal cancer. And the incidence in this high-risk group is higher than cervical cancer incidence anywhere in the world, including places that don’t have access to screening or vaccine,” Dr. Levine said.

Antiretroviral therapy is not protective against anal cancer. Since the therapy debuted in 1996, the incidence of anal cancer has shot up dramatically, increasing fivefold.

“The bottom line is, antiretroviral therapy is not protective, which makes prevention even more important.”

Etiology Most squamous cell anal cancers are linked to HPV, which tends to adhere to and crawl along the skin, often finding its way to the anus. The theory on HPV’s role in anal cancer is that a break or abrasion in the mucosal barrier allows the virus to enter the epithelium and cause an infection that leads to low-grade dysplasia.

The infection might clear or it might continue, “leading to coinfection with oncogenic subtypes that cause high-grade dysplasia, which is thought to evolve into anal cancer,” Dr. Levine said.

Most studies of MSM and the HIV-positive population have found that nearly all of those patients have HPV. “Unlike cervical HPV, which declines with age, anal HPV levels tend to remain stable, and this is thought to be due to continued exposure through sexual activity,” Dr. Levine said.

Anal intraepithelial neoplasia (AIN) is also most

prevalent in HIV-positive MSM, followed by HIVnegative MSM and then HIV-positive women. One population study of AIN in MSM found high-grade dysplasia in 30% overall; in HIV-positive MSM, the proportion jumped to 43% (Ann Intern Med 2008;149:300-306).

“Why do we care about high-grade dysplasia? Over the years, multiple centers following groups of patients with high-grade squamous intraepithelial lesions [HSILs] have found cases of cancer, which provided some indirect evidence of progression. Most patients with these cancers have coexisting HSIL overlying or adjoining the malignant lesion,” Dr. Levine said.

Most of these lesions will not progress to cancer, es will develop into cancer. but it’s not clear which ones Furthermore, some studiess have found spontaneous regression of HSILs in up to 30% of patients. ons don’t progress “So, if most of these lesions and a huge proportion off them ectiveregress, why not just prospective?” Dr. ly manage these patients?”

Levine asked. dSome retrospective studies support expectant man-m agement, but the long-term data are not yet in from prospective trials such as SPANC (Study of Prevention of Anal Cancer), which is following 617 HIV-positive and early all HIV-negative gay men, nearly with HPV, who are being intensively screened but not treated. The purpose of tural history of the trial is to define the natural ancer.

HPV and progression to cancer.

Baseline data from the SPANC trial has found HSILs far more prevalent in patients who are HIVpositive than in those who are HIV-negative, at 47% and 32%, respectively. Until the final results are in, preventive measures should include HPV vaccination and screening and treatment of precursor lesions.

Screening and Prevention Currently, there are no formal guidelines for screening. Dr. Levine suggests that at-risk patients should be prioritized. “That would include all HIV-positive patients, some women with gynecologic dysplasia and patients with immunosuppression.”

Screening begins with cytology followed by high-resolution anoscopy (HRA) with biopsy if the results are abnormal; low-grade dysplasia is monitored and highgrade dysplasia is treated. Unfortunately, multiple studies have found patients to have high-grade dysplasia on biopsy, even when their cytology was benign; HRA, which magnifies up to 24 times, is the gold standard for screening.

“We stain the mucosa with acetic acid to highlight the HPV changes, and you can use your biopsy tool of choice,” Dr. Levine said. Examining mucosa from the proximal anus to the peri-anus, she uses various descriptors to classify lesions and suspicion of high-grade dysplasia, commenting on the vasculature and uptake of Lugol’s iodine.

“Some low-grade dysplasia is less obvious—flatter and more subtle. High-grade lesions tend to have more prominent vasculature. And while HSIL is generally

invisible and asymptomatic, cancer should be more obvious—palpable and symptomatic,” Dr. Levine said.

The rationale for treatment of HSILs is to prevent progression to cancer. Patients are treated for anal warts if they are symptomatic or if the lesions obscure HRA. There are many options and modalities for treatment, the choice of which depends on the volume of disease, patient preference and other factors.

“Multiple treatments are often needed, and you can also combine modalities. It’s key to rule out cancer before treating because all of these treatment mechanisms destroy the tissue,” Dr. Levine said.

‘Some low-grade lo dysplasia and is less obvious—flatter o more subtle. Highgrade lesions tend to gr have more prominent ha vasculature. And while [a highgrade squamous intraepithelial lesion] is generally invisible and asymptomatic, cancer should be more can obvious—palpable and obv symptomatic.’

—Rebecca A. Levine, MD — Her preferred mode of treatment is to burn off mucosa at the location of the lesion with electrocautery. “You can accomplish a lot in a single session with minimal morbidity and very minimal anesthesia. You do need a smoke evacuator, though, so you don’t inhale HPV particles.” She reserves surgical excision for large, bulky lesions and cases that require inspection by the tissue pathology unit.

There are numerous drawbacks to screening and treating anal dysplasia, Dr. Levine acknowledged; it’s timeconsuming with a steep learning curve and demands a lot from staff. “Though morbidity is mild, it does exert a large psychological toll on patients who have to keep coming back frequently for repeated procedures.”

Therefore, these challenges raise the question: If so many lesions regress, do screening and treatment prevent cancer, or do both cause more harm than good? A couple of small trials suggest that this approach offers a significant protective advantage against anal cancer. This has led to the ANCHOR (Anal Cancer HSIL Outcomes Research) trial, which randomized 4,446 HIV-positive men and women with HSILs to treatment or active monitoring with HRA. Enrollment was halted early in September 2021 due to the high success of treatment.

“This is the cliff-hanger: I cannot share the raw data yet, but it’s quite impressive,” Dr. Levine said. “I think we will finally be able to say, based on level I evidence from a phase 3 trial, that treatment of HSIL significantly reduces progression to anal cancer compared to ■ expectant management.”

13

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GENERAL SURGERY NEWS / AUGUST 2022

LISANDRO MONTORFANO, MD: What is POCUS?

POCUS is an innovative way of using ultrasound. It is performed at the bedside in different prehospital scenarios and in-hospital settings. POCUS is performed by the treating physician as an extension of the physical examination. Its ability for immediate interpretation and clinical integration of the ultrasound findings to the clinical picture help to improve the decision-making process.

DR. L. MONTORFANO: Is there a POCUS

curriculum for surgical trainees?

MIGUEL MONTORFANO, MD:

Point-of-Care Ultrasound for Surgeons

DR. L. MONTORFANO: Can you describe the

Welcome to the August issue of The Surgeons’ Lounge. We dedicate this issue to point-of-care ultrasound for surgeons.

Lisandro Montorfano, MD, the general surgery administrative chief resident at Cleveland Clinic Florida, in Weston, and a World Interactive Network Focused on Critical Ultrasound (WINFOCUS) trainer, interviews Miguel Montorfano, MD, a member of the executive committee of the board of directors and past president of WINFOCUS, and the chair of the Ultrasound Department at Clemente Alvarez Emergency Hospital, in Rosario, Argentina.

Also in this issue, we offer a brief history of point-of-care ultrasound (POCUS).

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

Sincerely, Samuel Szomstein, MD,, FACS Editor, The Surgeons‘ Lounge ounge Szomsts@ccf.org @YANKEEDOC44

Lisandro Montorfano, MD

DR. M. MONTORFANO: Many general surgery programs around the world have integrated POCUS as part of their everyday learning activities for residents, yet there is not a uniform curriculum for all surgical trainees. Based on the results of several publications, it is necessary to integrate POCUS education into all surgery programs worldwide, to improve patient care.

In my personal opinion, the real change of paradigm will happen when all medical schools incorporate POCUS education as part of their curricula.

role of POCUS in surgery?

DR. L. MONTORFANO: Could you discuss some DR. M. MONTORFANO: The first physicians to novel uses of POCUS in surgery? use POCUS were surgeons. The Focused Assessment with Sonography in Trauma DR. M. MONTORFANO: There are several novel uses for Miguel Montorfano, MD (FAST) protocol was developed to assess POCUS in surgery. In trauma patients, POCUS hemoperitoneum and hemopericardium is used for triage, the primary survey (ABCs), a in trauma patients and the very first POCUS protocol. secondary survey from head to toe, to guide procedures and Progressively, this focal approach has become a multifocal for patient monitoring. Surgeons can detect free fluid in approach. Surgeons can evaluate patients from head to the abdomen and pericardium, as well as pleural effusion, toe using POCUS. Currently, POCUS is not limited pneumothorax, bone fractures, soft tissue hematomas and to trauma scenarios. It has been integrated into daily Morel-Lavallée lesions, lung consolidations related to lung surgical practice, from triaging to monitoring critically contusion, intracranial hematomas, and enlargement of the ill patients, as well as guiding many interventional optic nerve sheet diameter related to increased intracranial procedures. pressure, among others.

One of the advantages of POCUS is that it is dynamic, DR. L. MONTORFANO: Which surgical specialties should be like trauma scenarios, and can be rapidly repeated by the using POCUS? surgical team as often as necessary. Regarding patient DR. M. MONTORFANO: All surgical specialties should be using resuscitation, evaluation of cardiac function and the POCUS as an extension of the physical examination to inferior vena cava at the bedside can provide valuable improve patient management and outcomes. The “visual information that allows surgeons to improve fluid management” of the patient is changing the paradigm management for trauma patients. Furthermore, POCUS of surgical care, not only in surgery but in many other Doppler (POCDUS) can be used in trauma scenarios.

In previous publications, we have described the use of specialties.

POCDUS for the evaluation of traumatic vascular lesions DR. L. MONTORFANO: How do you think POCUS affects of the lower extremities and the FAST Doppler protocol surgical training? to rapidly exclude arterial vascular injuries in penetrating DR. M. MONTORFANO: POCUS can have a great impact on trauma. This is especially useful in busy trauma centers as surgical training. It allows residents to evaluate and well as in scarce resource settings.

Another novel use of POCUS is in the field of plastic monitor patients from the time of admission, integrating and reconstructive surgery for evaluation of ruptured the “visual examination” into the decision-making implants, soft tissues and musculoskeletal lesions, and process. POCUS can be used before, during and after surgical procedures, allowing for the detection of early seromas. Recently, very high-frequency devices have been complications and improving patient outcomes. It is employed for evaluation of the depth of penetration of important to emphasize that performing procedures skin lesions. This field is continuously growing, helping under ultrasound guidance has shown to be safer for plastic and reconstructive surgeons with the decisionpatients and decreases complication rates. making process and improving patients’ outcomes.

A Brief History of Point-of-Care Ultrasound

By Mustafa Khan, DO, resident, The University of Texas at San Antonio, and Lisandro Montorfano, MD, chief general surgery resident at Cleveland Clinic Florida, in Weston he past 100 years have seen ultrasonography rapidly transform from a wartime device to a ubiquitously used tool that is crucial in many modern medical practices.1 It now plays a significant role in aiding both point-of-care diagnosis and bedside procedures. The origin of ultrasonography can be traced back to the 1880s when physicists Jacques and Pierre Curie first discovered piezoelectricity, a concept in which electrical charge is generated in proportion to the magnitude of pressure applied to crystals

T

or quartz.2 This principle was the basis on which Paul Langevin, in 1915, developed his ultrasonic submarine detector— an invention that is now considered to be “the original transducer.”3 Ultrasonography first entered the medical field in 1942 when Austrian neurologist Karl Dussik produced neurologic images using ultrasound and suggested that variations in sound wave transmission between different types of soft tissues can be used to detect brain tumors.4 Unfortunately, it was later determined that

these variations noted on the images produced by Dr. Dussik were a result of different bone thicknesses. In 1948, George D. Ludwig, a physician working at the Naval Medical Research Institute, used naval sonar equipment and industrial flaw detectors to successfully visualize gallstones in a canine gallbladder. This work by Dr. Ludwig provided the foundational knowledge on which John Wild and John Reid developed their method for differentiating ultrasonic signals to successfully detect breast tumors from normal tissue.5

SURGEONS’ LOUNGE

AUGUST 2022 / GENERAL SURGERY NEWS

While the advancements made in sonographic technology through the 1940s were revolutionary to the field of medicine, the 1950s and 1960s saw advancements that made its use practical. One of the most significant contributors during this period was English obstetrician, Dr. Ian Donald, who partnered with Scottish engineer Tom Brown to develop the first ceiling-mounted ultrasound scanner.

They used their device for gynecologic and obstetric imaging and became the first to publish a sonographic image of a fetus.6 Their work is widely credited for revolutionizing the field of obstetrics and gynecology and opening the medical field as a whole to the vast possibilities of using ultrasound in daily medical practice.7 Another significant advancement occurred in 1965 when Siemens Medical System of Germany released the Vidoson, the first real-time ultrasound scanner capable of studying moving objects.

This new iteration of ultrasound scanners was revolutionary, as it could display 15 images per second and help in the prenatal setting by evaluating fetal structures.8 This technology revolutionized the way pregnant women were managed, and was quickly adopted by obstetricians as the standard of care for prenatal surveillance and monitoring.

In the 1970s and 1980s, more sophisticated transducers and better image processing technology were introduced, allowing for improved image quality. Where previous models demanded more expertise from users to interpret the images, these newer models opened the possibility for less experienced users to be able to diagnose patients.9 It was during this period of rapid advancement that the medical field began to realize the potential for ultrasonography as a bedside evaluation tool for life-threatening conditions. One of the first emergent applications of ultrasound technology was in the evaluation of trauma patients. This rapid assessment of trauma patients using ultrasonography was incorporated into the Advanced Trauma Life Support guidelines in the 1990s and was coined FAST.10 The 1990s through the 2010s saw ultrasound technology become more portable, accessible and affordable. This innovation encouraged more physicians and other healthcare providers to adopt POCUS into their daily practices.11 Furthermore, multiple studies were conducted during this period demonstrating the improved safety and complication rates associated with employing ultrasound devices for invasive bedside procedures, such as a central venous catheter.12 The results from these studies played a significant role in shaping modern medicine, and have led many prominent professional societies to publish guidelines recommending the use of POCUS in everyday medical practice.

The previous generation of physicians laid the groundwork for making POCUS a mainstay in modern medicine. Over the

past decade, its utility as a bedside tool has been well studied and established.

Specialty societies, like WINFOCUS, have regularly established guidelines and certifications to ensure adequate competency in practicing healthcare providers. Furthermore, POCUS is now becoming widely incorporated into graduate and undergraduate medical curricula to educate physicians early in their core training.13 These initiatives are being put in place to ensure the next generation of healthcare providers are not only proficient in this platform but also equipped to develop even more novel and sophisticated applications for its ■ use in the medical field.

References 1.

Newman PG, Rozycki GS. The history of ultrasound.

Surg Clin North Am. 1998;78(2):179-195.

2.

Zimmerman D. ‘A more creditable way’: the discovery of active sonar, the Langevin–Chilowsky patent dispute and the Royal Commission on Awards to Inventors. War Hist. 2018;25(1):48-68.

3.

3. Hackmann WD. Seek and strike: sonar, anti-submarine warfare, and the Royal Navy, 1914-54. H.M. Stationery Office; 1984.

4.

White DN. Neurosonology pioneers. Ultrasound Med Biol. 1988;14(7):541-561.

5.

Wild JJ. The use of ultrasonic pulses for the measurement of biologic tissues and the detection of tissue density changes. Surgery.

1950;27(2):183-188.

6.

Tansey T, Christie D, eds. Looking at the unborn: historical aspects of obstetric ultrasound. In: Looking at the Unborn: Historical Aspects of Obstetric Ultrasound. Vol 5. Wellcome Witnesses to Twentieth Century Medicine; 2000.

7.

Donald I. Sonar—the story of an experiment.

Ultrasound Med Biol. 1974;1(2):109-117.

8.

The Glasgow man who sketched the ultrasound machine. BBC News. December 1, 2018. Accessed July 13, 2022. https://www.bbc.com/news/ uk-scotland-46386317

9.

Besson A. Imaging from echoes: on inverse problems in ultrasound. Semantic Scholar. 2019.

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10. Rozycki GS. Abdominal ultrasonography in trauma.

Surg Clin North Am. 1995;75(2):175-191.

11. Patel MD, Horrow MM, Kamaya A, et al. Mapping the ultrasound landscape to define point-of-care ultrasound and diagnostic ultrasound: a proposal from the society of radiologists in ultrasound and ACR commission on ultrasound. J Am Coll Radiol.

2021;18(1 pt A):42-52.

12. Arnold MJ, Jonas CE, Carter RE. Point-ofcare ultrasonography. Am Fam Physician.

2020;101(5):275-285.

13. Goodcoff A, Keane D, Bialczak A, et al. Point-of-care ultrasonography integration in undergraduate medical education: a student-driven approach.

J Am Osteopath Assoc. 2019;119(3):e11-e16.

The Essential Oncoplastic Course

The Essential Oncoplastic Breast Surgery Course provides the spectrum of oncoplastic procedures available to breast surgeons. Hands-on education is provided by nationally recognized experts in an individualized method.

Date: March 24-26, 2023

Before and After Techniques Performed

Location: Paris Las Vegas, NV Website: www.breastcare.org/ONCOPLASTIC/ Learn New Skills: Lecturers will demonstrate their techniques followed by all attendees performing the procedures in a “see one, do one” method in the lab.

Techniques most breast surgeons can perform.

Baseline Model 1) Class 3 Ptosis bilaterally 2) Asymmetry of both breasts

Validate Your Skills: The Certificate in Oncoplastic Surgery® is offered by passing the practical performance testing, written testing as well as other requirements (extra charge). Applicants must have prior oncoplastic course(s) attendance and have practical experience.

Right Breast

Left Breast

1) Inframammary Fold Approach 2) Anchor Incision Approach 3) Wise Pattern Markings 4) Superior Pedicle Reduction Mammaplasty

1) Crescent Mastopexy 2) Round-Block / Benelli Mastopexy 3) Wise Pattern Markings 4) Inferior Pedicle Reduction Mammaplasty

Register Early: Course size limited to 50 surgeons.

Course Highlights: 20 Hours of didactic Teaching 7 Hours of hands-on lab over three days National and International Faculty Surgical Procedures on environmentally conscious Mastotrainer Models providing predictable anatomy to perform procedures Earn 17.25 AMA PRA Category 1 Credits™

Sponsored by the National Consortium of Breast Centers

The course is provided within the National Consortium of Breast Centers annual conference. All Attendees of the Oncoplastic Course may also attend the 3 day annual conference at no extra cost.

16

IN THE NEWS

GENERAL SURGERY NEWS / AUGUST 2022

Practice-Changing Breast Cancer Papers of 2021 Reviewed continued from page 1

Performance of the IBIS/Tyrer-Cuzick model of breast cancer risk by race and ethnicity in the Women’s Health Initiative.

(Kurian AW, et al. Cancer 2021;127[20]:3742-3750) The Tyrer-Cuzick (TC) model was developed mainly in non-Hispanic white women, so little is known about its performance in diverse populations. To assess its accuracy across a broad range of ethnic and racial groups, researchers analyzed data from the Women’s Health Initiative to evaluate the TC model’s performance over nearly 20 years. They found the model to be well calibrated overall, but it overestimated cancer risk in Hispanic women.

“We should take this information into account when we’re counseling our Hispanic patients. It has been frustrating to try to adapt one model to a population it was not intended for, so it’s gratifying to see that more models are being developed so that we can be more specific when counseling diverse populations,” Dr. Pass said.

She noted that the researchers used TC version 7; clinicians now use version 8, which includes breast density.

Cryoablation without excision for lowrisk early-stage breast cancer: 3-year interim analysis of ipsilateral breast tumor recurrence in the ICE3 trial.

(Fine RE, et al. Ann Surg Oncol 2021;28:5525-5534) To evaluate the safety and efficacy of cryoablation in women with low-risk breast cancer, researchers conducted a prospective, multicenter, non-randomized trial of 194 women with small (<1.5 cm), unifocal, low- to intermediate-grade tumors with favorable hormone receptor status (i.e., HR-positive, HER2-negative). At a median follow-up of 35 months, 2.4% of the patients had an in-breast tumor recurrence. There were no serious device-related adverse events; 2.4% and 18.4% of patients reported moderate or mild device-related adverse events, respectively. Nearly all patients and physicians were satisfied with cosmesis.

palpable adenopathy and two or fewer nodal metastases, researchers identified 180 women, 78 of whom had two or fewer positive nodes after axillary lymph node dissection (ALND). The patients, who were identified by imaging findings and standard clinicopathologic features, represent a substantial minority of patients with palpable adenopathy and may be candidates for sentinel lymph node dissection (SLND), which is considered acceptable for patients with two or fewer positive nodes.

“In the early trials, palpable adenopathy was a contraindication to sentinel node biopsy, but is that true today? At surgery, 43% of these women had only one or two positive lymph nodes. So, they would be eligible to fall under the [ACOSOG] Z0011 criteria as long as they didn’t have gross extracapsular extension. Palpable adenopathy does not always correlate with bulky disease, or even the presence of disease. Maybe patients with low-volume palpable adenopathy should also be considered for SLND,” Dr. Pass said.

Nodal recurrence in patients with node-positive breast cancer treated with sentinel node biopsy alone after neoadjuvant chemotherapy—a rare event.

(Barrio AV, et al. JAMA Oncol 2021;7[12]:1851-1855) To evaluate nodal recurrence in patients with clinically node-negative (cN0) disease after neoadjuvant chemotherapy (NAC), researchers identified 610 patients with cN1 disease, 550 of whom converted to cN0 after NAC and underwent SLND; 234 patients with three or more negative sentinel nodes also underwent SLND. At a median follow-up of 40 months, one patient had an axillary node recurrence. The findings suggest ALND may potentially be omitted in patients with cN0 disease after NAC and three or more SLNs retrieved.

“Can we extend the Z011 findings to the neoadjuvant patient? In this study, only one patient had an axillary recurrence, synchronous with a local recurrence, and that was in a patient who refused radiation. The unanswered question for me is what to do when the patient has only two sentinel nodes retrieved.”

Management of ipsilateral breast tumor recurrence following breast conservation surgery: a comparative study of re-conservation vs. mastectomy.

Cryoablation.

“This is another important paper you need to know about because percutaneous ablation of breast cancer eventually will be an approved therapy, and as breast surgeons, we need to be involved. In this three-year interim analysis of the cryoablation study, it was overall a very well-tolerated procedure with an excellent cosmetic outcome. Further studies are needed, but these ablative techniques are going to eventually replace surgery. I’m certain of it,” Dr. Pass said.

Palapable adenopathy does not indicate high-volume axillary nodal disease in hormone receptor-positive breast cancer.

(Crown A, et al. Ann Surg Oncol 2021;28[11]:6060-6068) To investigate the proportion of patients with HR-positive, HER2-negative breast cancer with

(Van den Bruele AB, et al. Breast Cancer Res Treat 2021;187[1]:105-112) Mastectomy is generally recommended in women who initially had breast conservation surgery (BCS) with a recurrence in the treated breast. To investigate whether repeat BCS is appropriate for patients who develop an ipsilateral breast tumor recurrence, researchers compared outcomes in 130 patients who underwent BCS and 192 who had mastectomy. At a median follow-up of nearly 11 years, there was no difference between the two groups in terms of overall survival and breast cancer–specific survival.

“In both groups, further events were not uncommon; we already know that biologically, this is a tumor that wants to come back. In the patients who had repeat BCS, another breast event was more common, occurring in 17%; in patients who underwent mastectomy [15% of whom experienced further events], distant disease was more common because chest wall recurrences are still very low. But in patients with very favorable features—older age, longer disease-free survival, smaller

tumor, favorable biological subtypes, ability to achieve negative margins—you can probably consider repeat BCT [breast-conserving therapy],” Dr. Pass said.

Post-discharge nonsteroidal antiinflammatory drugs are not associated with risk of hematoma after lumpectomy and sentinel lymph node biopsy with multimodal analgesia.

(Pawloski KR, et al. Ann Surg Oncol 2021;28[10]:5507-5512) While the reduction of opioid use remains an ongoing public health initiative, there are concerns about the risk for hematoma in patients whose surgery involved ketorolac and are prescribed nonsteroidal anti-inflammatory drugs (NSAIDs). To address this concern, researchers at Memorial Sloan Kettering Cancer Center retrospectively looked at the 30-day hematoma rate in 2,724 patients, 858 (31%) of whom were treated during a period when opioids were prescribed, and 1,866 (69%) were prescribed NSAIDs in a later period. The proportion of patients given intraoperative ketorolac was higher in the NSAID group (78% vs. 63%). There was no difference in risk for hematoma or rebleeding between the two groups.

“The rate of reoperation [in patients who received ketorolac] was 0.7% [in the NSAID group] and 0.1% [in the opioid group], but way under 1% overall. The authors concluded that NSAIDs should be prescribed after lumpectomy with SLND,” Dr. Pass said.

“However, at the same institution, they’ve decided that ketorolac should not be used after a mastectomy.”

(See next paper.)

Intraoperative ketorolac is associated with risk of reoperation after mastectomy: a single-center examination.

(McCormick PJ, et al. Ann Surg Oncol 2021;28[9]:5134-5140) To evaluate the risk for postoperative bleeding associated with intraoperative ketorolac in women undergoing mastectomy, researchers reviewed postoperative bleeding outcomes in 3,469 women who underwent mastectomy, 1,549 (45%) of whom received intraoperative ketorolac. On postoperative day 1 or 2, the reoperation rate for bleeding was 4.8% in the ketorolac group versus 1.8% in the non-ketorolac group.

“Based on this finding, they’ve taken intraoperative ketorolac out of their mastectomy protocol. Patients do not get intraoperative ketorolac; they do get Tylenol [acetaminophen, Johnson & Johnson Consumer],” Dr. Pass said.

Alterations in breast cancer biomarkers following neoadjuvant therapy.

(Mohan SC, et al. Ann Surg Oncol 2021;28[11]:5907-5917) To examine the prevalence of biomarker (i.e., HR and HER2) changes after NAC and its impact on overall survival and disease-free survival, researchers compared survival outcomes in 303 patients treated with NAC: those with no biomarker change, those with insignificant change that did not alter their HR status, and those with a change that significantly altered their HR or HER2 status. Of the 61% who had residual disease, 33% had changes in one or more biomarkers, and one-fifth had changes meaningful enough to alter their course of treatment.

“It should be routine that your pathologists reassess the receptor status in residual disease after NAC. In this trial,

IN THE NEWS

AUGUST 2022 / GENERAL SURGERY NEWS

20% had a clinically significant change in receptor status that influenced their treatment, and that’s enough that it’s worth the money to retest them,” Dr. Pass said.

21-gene assay to inform chemotherapy benefit in node-positive breast cancer (RxPONDER trial).

(Kalinsky K, et al. N Engl J Med 2021;385[25]:2336-2347) To investigate the role of the 21-gene assay-based recurrence score in predicting the benefit of chemotherapy, researchers randomized 5,018 women with HR-positive, HER2-negative, noninflammatory breast cancer, one to three positive nodes and an oncotype score no greater than 25 to endocrine therapy alone or with chemotherapy. At a follow-up of 5.3 years, there was a survival benefit in premenopausal women who underwent dual treatment, but no benefit associated with chemotherapy in postmenopausal women.

“The authors conclude that node-positive, premenopausal women should get chemotherapy regardless of their recurrence score. But in the supplemental material, there’s data on women with a recurrence score of 1 to 10 that suggests the benefit is not nearly as significant. The unanswered question is: Is there a recurrence score low enough in node-positive, premenopausal women that you can omit chemotherapy? And in that subset, is it the chemotherapy alone that’s beneficial, or is it the ovarian suppression from chemotherapy, which you can also get from endocrine treatment?”

Dr. Pass said.

Male Breast Cancer Patient Dissatisfaction continued from page 7

both patients and surgeons was fairly low, which may be partly attributable to the survey having been administered in the first year of the COVID-19 pandemic. In addition, results were limited by selection bias.

Despite the study’s limitations, results indicate that a fair number of men who undergo mastectomy without reconstruction are dissatisfied with their outcomes. Results from the surgeon survey showed that while surgeons rarely perform breast conservation or offer reconstruction to their male patients, they expressed a willingness to do both.

“These findings present an opportunity to optimize the surgical approach to male breast cancer, as well as the patient

experience,” Dr. Chichura said.

Oluwadamilola “Lola” Fayanju, MD, the Helen O. Dickens Presidential Associate Professor and chief of breast surgery at Penn Medicine, in Philadelphia, noted that although a small proportion of patients surveyed were offered breast-conserving surgery, most reported they believed they’d received enough information to make an informed decision.

She requested comment from Dr. Chichura regarding the discrepancy.

Dr. Chichura responded that it is possible men believed they were adequately informed because they were not aware of breast conservation as an option.

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(Bucci LK, et al. Ann Surg Oncol 2021;28[13]:8624-8633) To assess the rate of subclinical lymphedema (SCL) progression in women treated for breast cancer, researchers screened 1,790 patients at baseline and followed them over time. Of the 1,359 patients who underwent SLND, 331 developed SCL, 38 (11.5%) of whom progressed to lymphedema. Proportions were higher in the 431 patients who had ALND; 171 (40%) experienced SCL and 67 (39%) progressed to lymphedema. These findings suggest that patients who experience SCL after ALND are among those most likely to develop lymphedema.

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Mesh and fixation, all in one For more information or to schedule a demonstration, please visit www.deepbluemedical.com/t-line-hernia-mesh or call 833-833-3725 References: 1. Ibrahim et al. Soft Tissue Anchoring Performance, Biomechanical Properties, and Tissue Reaction of a New Hernia Mesh Engineered to Address Hernia Occurrence and Recurrence. J Med Devices. 2019; 13(4): 045002. DOI:10.1115/1.4043740 2. Beeson et al. The T-Line® Hernia Mesh, A Novel Mesh Uniquely Designed to Prevent Hernia Recurrence and Occurrence. Surg Technol Int. 2022; 40: 149-153. PMID:35158403.

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OPINION

GENERAL SURGERY NEWS / AUGUST 2022

The Corruption of Care continued from page 1

we are going to have to move your game a month into the future.” I respond, “Why?” The Voice: “We’ve changed the day you were scheduled for a game between two different teams.” Me: “But I don’t want that. Give me my money back.” The Voice: “We can’t do that.

Your contract entitles you to a game, but not to a date or to choosing the teams that are playing. Have a good day.”

This scenario could never take place.

Major league baseball would go out of business; there would be a great public outcry. Government would step in and pass laws to forbid such shenanigans. Yet, our healthcare system currently “plays” such a game with impunity. The big business of healthcare does not suffer; indeed, it flourishes and is encouraged to place additional impositions on its customers to enhance profits for its administration and stockholders. There is no public outcry. Government does not step in but rather facilitates the subjugation of all of us by paying, in one way or another, for 60% of national healthcare expenses from taxes collected from us, the ill-served populace.

This month, my book titled “Healthcare Upside Down: A Critical Examination of Policy and Practice,” is being published. This book demonstrates the Orwellian use of language to depersonalize medical care and to denigrate the integrity of the doctor‒patient relationship. I trace this transformation through the medical school, the clinic, the hospital and the practice, as well as through the contributions and profiteering of private healthcare insurers, hospital conglomerates, the pharmaceutical industry and medical instrument companies. I discuss the particulars of why in the standard eight global statistics of healthcare performance—such as life expectancy

To turn healthcare right side up, the patient—a designation that refers to all of us at one time or another—must be at the top of the healthcare edifice.

and infant mortality, and six others— the United States is markedly inferior to all comparable industrial nations even though we pay more per capita and in percentage (17%) of our gross national product for healthcare than any other country in the world.

As a nation, we have accepted the current state of affairs, not demanding something better. Most of us have consented to receiving inferior medical care, except for the well-to-do who can afford and are willing to pay for concierge medicine, that is, a personal doctor on call.

Medicine’s big business is booming—a safe and profitable investment, providing 20% of the highest CEO incomes in our country and represented by five of the top 10 Fortune 500 companies. In contrast, the average healthcare recipient—all of us who are the customers of this system—are not getting our money’s worth for the dollars we pay in taxes, for private insurance policies with additional copayments, deductibles and exemptions, and the costs for pharmaceuticals and medical devices. We are being cheated. We, the recipients of healthcare, are victims of this system.

The focus of this column, and what I don’t discuss in my book, is that our cadre of medical professionals, including those of us who are surgeons, also are victims of the “brave new world” of monetized medicine.

I believe that the foundation of being a doctor rests on the one-to-one doctor‒patient relationship, which allows the patient to say, “My doctor,” a designation of trust, and for the doctor to say, “My patient,” thereby accepting responsibility for the well-being of the patient.

In such a relationship, the physician has direct involvement in the outcome of the patient’s care and the patient has

confidence in the therapy recommended and provided. This relationship is embodied in the personal interactions of the doctor and the patient, including office and virtual visits, and telephone conversations. It cannot be replaced by a telephone call with a succession of gatekeepers, starting with a robot, followed by an interrogator who violates HIPAA standards, and subsequently schedulers trained to obfuscate, defer appointments, spout pablum, and conclude by wishing the patient a good day.

In emphasizing the one-to-one doctor–patient relationship, I do not mean to denigrate the advantages of the group approach for the management of certain situations, such as the expertise of a service line of surgeons, radiologists and oncologists in treating breast cancer. A service line, however, should designate one physician to interact with the patient, a communicator of recommendations, someone who actually listens to patient concerns.

In my opinion, the status quo of depersonalized healthcare corrupts our tenets of professionalism and infringes on the concept of medicine as a personal calling.

The definition of professionalism, a doctor’s precepts of behavior, was delineated in Greco-Roman times by Hippocrates and the Roman physician Scribonius Largus. The Charaka Samhita, an ancient Indian code of conduct, states, “He that practices not for money or for caprice but out of compassion for living beings, is the best among physicians.” The seventhcentury Chinese ethicist Sun Simiao stressed that the physician must

exhibit compassion and practice equal treatment for patients. In 1803, the English physician Thomas Percival published a code of conduct for physicians that was adopted by the American Medical Association in 1847. The American Board of Medicine journal subsequently defined six standards of medical professionalism: altruism, accountability, excellence, duty, honor/integrity and respect.

A 1903 dictum by William Osler accurately reflects the essence of professionalism: “The practice of medicine is not a business and can never be one. Our fellow creatures cannot be dealt with as a man deals in corn and coal; the human heart by which we live must control our professional relations.”

A critical examination of current medical practice has to conclude that these principles of professionalism are not being met. Medicine has become synonymous with business. The idea of medicine as a calling that involves patients as fellow creatures has been shunted aside.

I never really knew what I wanted my calling in life to be until my third-year medical school surgical rotation. The life of a surgeon seemed to fit me like a glove: It was my calling. I imagine that a comparable revelation motivates my fellow medical and surgical practitioners. With that sense of commitment, professionalism becomes an everyday reality. A good friend, a monsignor of the Catholic Church who propelled a college into a great university, an educator, an advocate for inclusion and community cohesiveness, responded to my question of how he would like to be remembered by commenting, “I would like people to say, he was a good priest.” In that same spirit, we as physicians would want people to say, “He/she was a good doctor.” Can this statement be reconciled with the lack of a personal calling in today’s physicians?

Some of my fellow physicians may disagree with me. They may believe in and support the current state of healthcare delivery. They may prefer to have a job that provides a steady income without the need to run a business. They may prefer regular daily, weekly and yearly hours; specified times for night and weekend call; patients (clients) covered by hospitalists when they are not on duty; regular, paid vacations; paid maternity/paternity leaves; and other perks.

For some surgeons, a system that offers set operating room hours and the ability

19

AUGUST 2022 / GENERAL SURGERY NEWS

to leave a case and be replaced by another surgeon is preferable to the time-honored tradition of one surgeon in charge from the beginning to the end of the case. These new norms represent a dilution of responsibility for the care of individual patients, changing the practice of medicine to a group effort, thereby eliminating personal triumph or personal guilt for an individual patient’s therapeutic outcomes.

When the practice of medicine is viewed merely as a job that offers a satisfactory income and personal life for the physician, a tranquil home and family life, with more time for leisure pursuits, the patient in the relationship loses relevance and is sacrificed to the welfare of the physician. National statistics, however, indicate an ever-increasing rate of burnout among physicians, starting as early as medical school. This rise in burnout does not present the life of today’s doctor as a contented one. Neither does the decreasing age of retirement, exhibited not only by those of “the old school” but by the new generations as well.

I believe that the structure of healthcare in the United States today is not only askew but upside down, so that the administrators of patient care and services are on top, supported by a compliant middle layer of doctors, all resting on the ultimate payor base of patients, the sick, the needy, the trusting. To turn healthcare right side up, the patient—a designation that refers to all of us at one time or another—must be at the top of the healthcare edifice. Patients should not be treated as pawns for the convenience and for the profits of this system. Patients should be served by the system they pay for. Today, patients are not the beneficiaries but the victims of this healthcare inversion. We, as doctors, the purveyors of healthcare, are also pawns in the current healthcare structure.

Continuing discussions at the personal, state and national levels about healthcare need to focus on who and what is primary for those involved. Stated affirmatively, healthcare should be for patients, conducted by physicians, and facilitated—not dominated—by or for ■ the benefit of the administration.

—Dr. Buchwald is emeritus professor of surgery and biomedical engineering, and the Owen H. and Sarah Davidson Wangensteen Chair in Experimental Surgery, at the University of Minnesota, in Minneapolis. His articles appear every other month.

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IN THE NEWS

GENERAL SURGERY NEWS / AUGUST 2022

Hospital-Related Resistant Infections Grew 15% During Pandemic continued from page 1

Trusts Antibiotic Resistance Project. patients at risk for side effects and create a pathway for “The magnitude of the damage is significant. There resistance to develop and spread, according to the CDC. are steps we must take immediately to protect peoThe impact of the pandemic likely resulted in an ple and save lives, including strengthening systems to increase of healthcare-associated, AMR infections, the improve the way antibiotics are used, and enacting pol- CDC said. During the first year of the pandemic, more icies like the PASTEUR [Pioneering Antimicrobial than 29,400 people died from AMR infections commonly Subscriptions to End Upsurging Resistance] Act that associated with healthcare. Of these, nearly 40% acquired will stimulate the development of urgently needed new the infection during a hospital stay. antibiotics. The need for action in the The total national burden of deaths fight against this serious and growing from resistance may be much highThe COVID-19: U.S. Impact public health threat has never been er, but data gaps caused by the panon Antimicrobial Resistance, more urgent,” Mr. Hyun added. demic hinder that analysis because Special Report 2022 found many clinics and healthcare facilities an increase among seven Threat Within the Threat with limited services served fewer pathogens, including a: The CDC analyzed the state of patients, or closed their doors entireAMR in the United States immely after COVID-19 did not report diately after the 2020 peaks of the resistance data, the CDC said. pandemic. The data show an increase Data are unavailable or delayed for in resistant infections starting durnine of the 18 pathogens listed in the ing hospitalization that the agency CDC’s 2019 report, which estimat78% increase in carbapenemcalled “alarming.” The COVID-19: ed that more than 2.8 million AMR resistant Acinetobacter; U.S. Impact on Antimicrobial Resisinfections occur in the United States tance, Special Report 2022 found each year, with more than 35,000 an increase among seven pathogens, people dying as a result. including a: “The COVID-19 pandemic has • 78% increase in carbapenem-resisunmistakably shown us that antimitant Acinetobacter; crobial resistance will not stop if we let down our guard,” said Michael • 32% increase in multidrug-resis32% increase in multidrugCraig, MPP, the director of the tant Pseudomonas aeruginosa; resistant Pseudomonas CDC’s Antibiotic Resistance Coor• 14% increase in infections in vanaeruginosa; dination & Strategy Unit. comycin-resistant Enterococcus; and “The best way to avert a pandem• 13% increase in methicillin-resisic caused by an antimicrobial-resistant tant Staphylococcus aureus. pathogen is to identify gaps and invest Antifungal resistant threats also in prevention to keep our nation safe,” rose in 2020; Candida auris increased 60% overall, and other Candida spehe added. cies increased 26%.

Denise Cardo, MD, the director Clostridioides difficile is the only of the CDC’s Division of Healthcare 14% increase in infections healthcare-associated pathogen to Quality Promotion, said emphasis in vancomycin-resistant improve in 2020, likely driven in part should be placed on expanding existEnterococcus; and by changes in healthcare-seeking ing prevention strategies that have behavior that resulted in fewer antiproven effective. “The 2021 launch biotics being prescribed. of the Global AR Lab and Response By comparison, a 2019 report Network and the Global Action in showed AMR infections falling Healthcare Network is an example by 27% from 2012 to 2017. These of how aggressively CDC is moving reductions continued in hospitals to combat antimicrobial resistance 13% increase in methicillinuntil the pandemic began. not only in the U.S., but in nearly 50 resistant Staphylococcus The CDC data demonstrate sigcountries across the world. aureus. nificant surges in antibiotic use and “We made significant progress difficulty in following infection prebefore the pandemic, and I’m convention and control guidance during the pandemic. fident that we will make significant progress going Hospitals experienced personal protective equipment forward.” supply challenges, staffing shortages and longer patient The agency said it remains committed to the U.S. stays. Staff also treated sicker patients who required National Action Plan for Combating Antibiotic-Resismore frequent and longer use of medical devices, such tant Bacteria, and will move forward by addressing gaps as catheters and ventilators. in the public health system and exploring investments in Antibiotics were often the first option given to treat U.S. healthcare infrastructure in the following key areas: those who presented with pneumonia-like symptoms • Enhance data systems and sharing. Expanding of fever and shortness of breath, even though many automation of electronic data to allow healthcare patients had SARS-CoV-2 infection, for which antifacilities and systems to have information they need biotics are not effective. From March to October 2020, about antibiotic use and AMR. almost 80% of patients hospitalized with COVID-19 • Infection control. Continuing to offer high-qualireceived an antibiotic. ty infection prevention and control training to every Although some of this prescribing can be approprihealthcare professional and to healthcare facilities ate when risks for related bacterial or fungal infections beyond hospitals, such as nursing homes and other are unknown, this high level of prescribing also can put long-term care facilities. This also means educating

the public on how they can stop the spread of germs and practice infection prevention in the communities where they live and work.

• Antibiotic/antifungal use and access. Optimizing antibiotic use across all healthcare settings and implementing the CDC’s Core Elements across healthcare settings. In addition, working to promote optimal antibiotic and antifungal use and tracking for companion animals and agriculture.

• Environment and sanitation. Expanding the capacity of the National Wastewater Surveillance System to collect AMR data from wastewater treatment plants and healthcare facilities, studying resistance in community and healthcare wastewater domestically and globally.

• Vaccines, therapeutics and diagnostics. Enhancing interagency collaboration to accelerate research for developing new antibiotics, antifungals and therapeutics.

“I applaud this CDC report that highlights the need to stay focused on antimicrobial resistance,” said Debra Goff, PharmD, FIDSA, FCCP, an infectious diseases specialist in antibiotic stewardship at The Ohio State University Wexner Medical Center, and a professor of pharmacy practice in the Department of Pharmacy at Ohio State, in Columbus.

Although the report highlights many ways to address AMR, Dr. Goff stated that, “I think the CDC missed the opportunity to call out the need for antibiotic stewardship programs [ASPs]. They state infection control programs [ICPs], and I agree ICPs are important, but I would have liked to see the CDC report state ASPs need continued funding if we want to avert an AMR pandemic.

“Hospital administrators and CEOs pay attention to CDC reports. ASPs are implied in the statement to ‘optimizing antibiotic use across all healthcare settings,’ but without specifically naming that this critical activity is done by ASP teams, it’s a missed opportunity by the CDC to advocate for ASP. CEOs and hospital administrators will not know who does this work. ASPs will continue to struggle for funding. I am disappointed,” Dr. Goff said.

Daniel P. McQuillen, MD, FIDSA, the president of the Infectious Diseases Society of America, called for systemic changes. “This is no longer a future crisis but one that is at America’s doorstep and needs to be addressed now. Whenever there are high levels of hospitalizations, rates of antimicrobial-resistant infections and deaths will likely further increase unless we take steps to prevent them,” he said, adding that Congress must act.

More federal funding is needed for resistance programs, surveillance and prevention, and Dr. McQuillen reiterated Mr. Hyun’s call for approval of the PASTEUR Act. “Passing the bipartisan PASTEUR Act—which funds the development of new antibiotics as well as stewardship efforts to guide judicious antibiotic use— should be a top priority for Congress,” Dr. McQuillen said in a statement.

“Infectious diseases experts make hospitals safer for patients, but they need the right tools. The U.S. must invest in new antibiotics, smarter antibiotic use, and the recruitment and retention of more ID physicians to lead infection control and antimicrobial stewardship efforts at U.S. health care facilities,” Dr. McQuillen added. ■

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