September 2021 Print Issue

CONVENTION ISSUE

The Americas Hernia Society

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

September 2021 • Volume 48 • Number 9

Using Machine Learning to Predict Surgical Site Infections

Management of GI Emergencies In the Hernia Patient

Results of Two Studies Conflict On Generalizability of Algorithms

Expert Discusses Nonoperative Approaches To Several Different Clinical Emergencies

By MONICA J. SMITH

By CHASE DOYLE

W

hile most health systems are at the beginning of the journey in using artificial intelligence and machine learning to predict surgical complications, surgeons at the forefront of this science are expanding our knowledge by investigating ways to overcome the obstacles to AI, as described in two recently published studies “These articles pose different questions, but what they have in common is that they’re both examining the challenges of bringing AI to bear on the problem of surgical site infection,” commented Philip S. Barie, MD, MBA, a professor

O

utcomes of emergency versus elective ventral hernia repair can differ dramatically, including increased rates of mortality, reoperation and readmission when a ventral hernia is managed in the emergency setting.

During MedStar Georgetown University Hospital’s Abdominal Wall Reconstruction 2021 Conference, Brent Matthews, MD, reviewed nonoperative management strategies for acute appendicitis, small bowel obstruction, diverticulitis, acute cholecystitis and perforated ulcer in patients with a complex ventral hernia or history of abdominal wall reconstruction.

“The goal is to manage patients’ acute GI surgical

Continued on page 18

Malpractice: How to React to a Lawsuit

Continued on page 24

OPINION

Surgery Is a Contact Sport

The History of RoboticAssisted Surgery

A Guide on Injury Prevention for Surgeons

By MONICA J. SMITH

By EDWARD L. FELIX, MD, FACS, FASMBS

By TALAR TEJIRIAN, MD, FACS

A

lmost no physician goes into practice thinking about how they will deal with a malpractice suit. It’s not covered in training, and your mind is on the actions and responsibilities of your practice. But some level of forethought is advisable: How you deal with a lawsuit early on can have an influence on its resolution.

Although claims against physicians can arise at any point in their career, the risk for being sued climbs with age and practice volume. It varies by specialty, and general surgeons are particularly vulnerable. According to the American Medical Association, 63% of general surgeons face a malpractice suit at least once, and 50% are

t was several months after my C5-C6 spine disk replacement surgery when I learned that it is commonplace for surgeons to have C5-C7 cervical spine problems. Interesting.

Why had I never heard of this before?

Not once during training, during my time as an attending or after participating in numerous surgical conferences had I ever come across this information. But clear as day, to others, my problem was not unique. I was just another surgeon suffering the same spine problems that so many before me had suffered. If I am not the first, then I surely will not be the last. We must stop ignoring surgeons’ physical health and actively promote prevention.

Continued on page 26

Continued on page 28

I

IN THE NEWS

11 Bariatric Surgery Decreases Diastolic Heart Failure Admissions

14 Can C-Reactive Protein Levels Help Predict

EXTENDED WOUND CARE COVERAGE

Anastomotic Leak?

20 The Most Compelling Breast Surgery Papers of 2020 PAGE 16 facebook.com/generalsurgerynews

@gensurgnews

A

s a child, I was fascinated with robots, reading about a robots, watching i robot cartoons like the Jetsons, and collecting toy robots. The only problem was I loved to take the robots apart to see what made them work, but I wasn’t ever very successful reassembling them. Maybe that’s why I eventually became a surgeon instead of an engineer. Today, after a 50-year career as a surgeon, I am once again intrigued by robots—this time wondering how and why they Continued on page 8

E N T ER A NE W WO R L D O F 72-HOUR POSTOPERATIVE PAIN RELI E F 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 Clinical findings were demonstrated in Phase 3 trials for bunionectomy with osteotomy and open inguinal herniorrhaphy comparing ZYNRELEF to both placebo and bupivacaine HCl solution.1-3

a

b

EXPLORE THE DATA AT ZYNRELEF.COM/SURGERY

Indication

Contraindications

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

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

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

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

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

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

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

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

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

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

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

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

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

PP-HTX011-0557 | 07/21

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

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

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

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

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

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

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

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

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

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

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

Severe Renal Impairment: Not recommended.

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

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

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

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

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

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

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

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

REDEFINE POSTOPERATIVE PAIN MANAGEMENT

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Monitor blood pressure.

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

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

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

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

ZYNRELEF is not approved for intra-articular infusion.

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

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

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

If symptoms present, evaluate clinically.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

OPINION

SEPTEMBER 2021 / GENERAL SURGERY NEWS

A Society to Enhance Surgical Palliative Care

By FREDERICK L. GREENE, MD B

I

am sure that the title of this editorial conjures up disparate definitions and concepts. As surgeons, we have all provided surgical care for patients who were not destined to survive their illness, but needed relief from pain, bowel obstruction, airway compromise and many other maladies that affect quality of life. One of the beliefs that continues to linger is that palliative care equates with hospice care. One of my goals during a career in surgical oncology has been to dispel the notion that palliative care is synonymous with end-of-life supportive care in cancer patients. The standards developed by the American College of Surgeons (ACS) Commission on Cancer Accreditation Program have also sought to support this differentiation.

For many years, surgeons have been at the forefront of palliative care and alleviation of suffering for many diseases, not only cancer. Surgeons in every discipline have had multiple opportunities to participate, through operative and nonoperative means, to relieve pain and to enhance quality of life. In fact, the concept of “palliative medicine” was started by the Canadian surgeon and urologic oncologist, Balfour Mount. Surgeons exemplified

by Geoffrey Dunn, Robert Milch and Anne Mosenthal have promoted the ideals of surgical palliative care in the United States, and have encouraged its importance through the ACS and other surgical organizations.

Over the past several years, surgeons have incorporated palliative care concepts into their practices. In fact,

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

approximately 90 surgeons in the United States have become board certified in Hospice and Palliative Medicine. These driving forces merged during the 2019 ACS Clinical Congress, when a small group met over dinner to create a new movement that would further enhance the principles of surgical palliative care. These “thought leaders” laid the foundation for a new society—the Surgical Palliative Care Society (SPCS).

Three surgeons, Melissa Red Hoffman, Pringl Miller and Buddy Marterre, all boarded in Hospice and Palliative Medicine, formulated a plan to create an interdisciplinary organization devoid of disciplinary boundaries that would embrace the spectrum of the health care team, including surgeons, nurses, social workers, chaplains and pharmacists who had interests in banding MISSION STATEMENT OF GSN It is the mission of General Surgery News to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for discussion and opinions, from all viewpoints, on the issues most important to surgeons.

Peter K. Kim, MD Bronx, NY

Editorial Advisory Board

Lauren A. Kosinski, MD Chestertown, MD

Gina Adrales, MD, MPH Baltimore, MD

Marina Kurian, MD New York, NY

Maurice Arregui, MD Indianapolis, IN

Raymond J. Lanzafame, MD, MBA Rochester, NY

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

Timothy Lepore, MD Nantucket, MA

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

Robert Lim, MD Tulsa, OK

James Forrest Calland, MD Charlottesville, VA

John Maa, MD San Francisco, CA

DISCLAIMER Opinions and statements published in General Surgery

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

DISCLOSURE POLICY We endeavor to obtain relevant financial

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

CONTACT THE EDITOR

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

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

James Prudden Group Editorial Director Elizabeth Zhong Senior Copy Editor

David Earle, MD Lowell, MA

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Gary Hoffman, MD Los Angeles, CA

David M. Reed, MD New Canaan, CT

Melissa Red Hoffman, MD Asheville, NC

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Van Velle, President, Partner

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together to promote the surgical palliative care movement. The SPCS would have, as its principal goals, mentorship, education, research and advocacy in surgical palliative care. This overall mission would be a driving influence to mandate early promotion of surgical palliative concepts into every disease managed by surgeons.

Now, you may be thinking: Why another surgical organization? Why not intercalate palliative medicine principles into other existing organizations? In my view, although every specialty surgical organization should embrace these concepts, the importance of palliative care in surgery deserves its own mission-driven organization.

I salute these dedicated surgeons who have worked diligently to teach and advocate for surgical palliative care.

The principles they champion should be inculcated into every surgically related organization and residency training program. The Surgical Palliative Care Society is just the group to see that it happens!

■ —Dr. Greene is a surgeon in Charlotte, N.C. Correction In the article “Should Disappearing Colorectal Liver Metastases Be Resected?’

(August 2021), Dr. Laleh Melstrom’s first name was misspelled in one instance (page 28). The editors apologize for the error.

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GENERAL SURGERY NEWS / SEPTEMBER 2021

Bile Duct Injury Prevention Debate: Final Thoughts The following letters from Guy Voeller, MD, and Michael Brunt, MD, et al, respectively, conclude an ongoing debate about bile duct injury prevention that began with the Great Debates column in the December 2020 issue. The debate between Dr. Voeller and Dr. Brunt centers on the issue of guidelines, their role and their value, and how they are disseminated to the surgical community.

To the Editor: After reading the response of Dr. Michael Brunt et al [General Surgery News, June 2021, page 1], I will borrow the line from ”Hamlet,” spoken by Queen Gertrude, and say, “the gentlemen and ladies doth protest too much, methinks.”

The guideline madness will continue since many of the people who do these things believe they are smarter and better than the practicing surgeon. It reminds me of our politicians who think they know better than their constituents. Below, I incorporate some of the responses that I received from practicingg surgeons. su geo s.

Dr. Brunt freely admits dmits that it took the committee 2.5 years ars to review the literature and the best they could muster is a set of recommendaations that carry littlee to no evidence to support any of the claims. They even n conclude their article by admitting the poor qualityy of evidence and the high h risk for bias for manyy key questions (Ann n Surg 2020;272[1]:3-23; co-publication Surg rg Endosc 2020;34[7]:2827:28272855). Despite the overall lack of evidence,, they d with have plowed forward ndations very rigid recommendations cuff the practicthat limit and handcuff ing surgeon. delines” are not To say that “guidelines” mandated or in any way enforced is completely disingenuous. In fact, the committee says they want them disseminated everywhere. Every plaintiff attorney sees “guidelines” as the standard of care, I can promise you.

I just finished testifying in a bile duct injury trial for which the committee’s guidelines were front and center as the standard of care.

If one reads the original paper by Strasberg and Soper (J Am Coll Surg 1995;180[1]:101-125), there are acceptable variations from the critical view. In this paper, the domedown approach, which is disparaged by the committee, is considered an acceptable alternative to achieving the critical view. In addition, clipping and cutting the cystic artery prior to completing the dissection of the cystic duct is also acceptable. These

Dr. Brunt et al Response To Dr. Voeller

alternatives are not mentioned. They are things that practicing surgeons do all the time in performing safe and successful cholecystectomy.

Performing a subtotal gallbladder removal might be the lesser of two evils for some surgeons. It is certainly not true for most experienced practicing surgeons. Leaving the patient with a diseased gallbladder or biliary fistula is not best for the pat e tw e aan ope o patient when open ccho-

We are failing young surgeons by not teaching them how to properly do an open cholecystectomy or a proper difficult lap chole, and that is failing our patients by condemning them to a biliary fistula and continued gallbladder problems. lecystectomy or a well-done lap chole can remove many of these gallbladders that the committee says should not be removed. We are failing young surgeons by not teaching them how to properly do an open cholecystectomy or a proper difficult lap chole, and that is failing our patients by condemning them to a biliary fistula and continued gallbladder problems due to a suboptimal operation.

Shame on us.

Brunt et al end their response by saying, like it or not, we live in an era of evidence-based medicine. I don’t

LE T T ER TO THE EDITOR

know w what that has to do with the guidelines since ev even they admit the ev evidence is terrible at lev level IV for most all of their “guidel “guidelines.” They also conclude that out in the real world, surgeons need gui guidelines, not dictums and mandates. T They, for some reason, fail to see that what they are doing with “guideline “guidelines” are dictums and mandates when viewed by nonsurgeons. I cannot believe they are this naive.

For me, as I sa said in the original column regarding b bile duct injury guidelines, I applaud all the hard work done by the co committee. There are some wonderfu wonderful educational points for the practicing surgeon. I do not applaud the rigidity and arrogance and the effort to disseminate these “guidelines” as they say, “to hospitals, health care systems, healthcare plans, malpractice insurance, and patient safety organizations.”

Lastly, I want to end by saying that every point we have made is for the patient, so that they have the best result possible. The most important person for the patient in that equation is the surgeon, and we should help the surgeon do the best possible operation to cure the patient of their disease. In those few rare instances when a gallbladder cannot be safely removed, the alternatives may be considered.

Guy Voeller, MD, Professor of Surgery at the University of Tennessee Health Science Center, Memphis.

We thank General Surgery News for the opportunity to reply regarding the bile duct injury guidelines follow-up commentary. We previously replied in detail to Dr. Voeller’s comments and criticism of the consensus conference guideline and will not rehash those here, since there is nothing substantively new in his most recent commentary. Undoubtedly, we wish the same goals, that is the best outcome for our patients and application of sound surgical judgment and technique.

The guidelines provide a rigorous and highlevel review of the best available evidence for enhancing safety around cholecystectomy, heightened awareness of the risks, possible pitfalls one may encounter, strategies to help achieve the best possible approach under difficult circumstances, and some approaches to get out of trouble when encountering challenging or unsafe situations or pathology. The fact that the committee took 2.5 years, on a volunteer basis, only serves to demonstrate the dedication of these surgeons to patient safety.

Raising the level of awareness of this topic is a start, and some of us have already witnessed the result of independent surgeons reaching out for advice intraoperatively or perioperatively, because of awareness of the guidelines.

The public trusts us to set and keep high standards of care, even when they are not “popular.” The goal of these, and any, guidelines is not to defend the surgeon at all costs (although they can), but to put forth standards that are reasonable and should, indeed, be weighed in the context of sound surgical judgment and decision making.

We must collaborate and all be on the same team, regardless of practice environment, helping each other along, encouraging others to ask for advice/coaching/help, and keep moving the needle forward with these types of discussions to advance the healing art of surgery in a safe, expert and sound manner. If we are not willing to be open to change and adapt, then the problem of bile duct injury will not diminish to the detriment of our patients and the surgical community alike.

Respectfully submitted, L. Michael Brunt, MD, Professor of Surgery, Washington University School of Medicine, St. Louis.

Marian McDonald, MD Dana Telem, MD, MPH Dan Deziel, MD Taylor Riall, MD, PhD Steven Strasberg, MD Dimitrios Stefanidis, MD, PhD

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8

OPINION

GENERAL SURGERY NEWS / SEPTEMBER 2021

The History of Robotic-Assisted Surgery continued from page 1

have invaded my operating room, which I thought was the surgeon’s domain. It turns out they are not here to harm us as I once thought, but rather to assist us in our endeavor to deliver better health care.

As most of you are probably aware, the number of the robot invaders is increasing daily in our hospitals and an ever-increasing number of surgeons are combining forces with this relentless army of mechanical surgical assistants. Like the evolution of our favorite bands, the robot invasion didn’t happen overnight. It has taken more than 20 years. As one who witnessed the laparoscopic revolution in surgery, I recently became intrigued by how the robotic one was mirroring it in many ways. The pathway by which robots became surgical assistants in today’s operating theater was sometimes tortuous and arduous.

It is worth reviewing to understand how we as surgeons may continue to develop and change the future.

We should not be the specialists of Gropius, the founder of Bauhaus Architecture, who said “specialists are people who always repeat the same mistakes.” As you follow the tale of robotics, it should remind you of how in the past surgeons at first ridiculed, then fought and finally accepted changes in surgery (e.g., laparoscopy, lumpectomy for breast cancer, mesh for hernia repair and other paradigm shifts). Instead, we should listen to Quavo, an American rapper: “History repeats itself. So, you may want to pay attention.”

The Robot’s Journey to the OR

To begin the robot’s trip into today’s OR, we need to go back to the collision of two research groups, one originally from our government and the other at the Stanford Research Institute. Their initial aim was to build a system that could aid the wounded on the battlefield.

In 1987, Richard Satava, MD, a surgeon and colonel in the U.S. Army, joined with the Stanford team to begin development of a “telepresence surgery system” that at first was meant for open surgery. After viewing a video of Dr. Jacques Perrisat performing a laparoscopic cholecystectomy in 1989, Dr. Satava suggested the Stanford group switch their research to use the laparoscopic platform instead of conventional open surgery. He felt the telepresence system was ideally suited for the laparoscopic platform because it solved the fulcrum effect of conventional laparoscopic instruments and could improve surgeon performance with its stereoscopic vision, improved dexterity and tremor reduction. Unfortunately, as you will see, it took some time before Dr. Satava’s predictions became reality.

It took two groups that, at first, worked independently, then competitively, and eventually as one company.

In 1990, Yulun Wang, MD, from the Origins of the Robot University of California, Santa BarbaIf we look at the original meaning and origin of the ra, founded the company Computer robot, it makes sense why a robot would be a perfect Motion. His first endeavor was a robotsurgical assistant. In 1921, Karl Capek, a Czech play- ic endoscope holder that responded to the surgeon’s wright, coined the term “robot” to refer to mechanical commands, and eliminated assistant tremor and the men who were built to work on an assembly line; in his need for a human assistant. As an ego-building bonus, play, they rebelled against their masters. Isaac Asimov, a if asked, the system would even verbally compliment science fiction writer, in 1942 took a more positive atti- the surgeon. Aesop, as the system was called, was the tude toward his fictional robots, making them helpful first FDA-approved surgical robot and the first voicerather than evil. He proposed three “laws of robots,” of controlled equipment to be used in the OR. which two surely apply to our modern concept of medImportant to the development of robotics in the OR ical robots: was that Computer Motion used the • Law 1—A robot may not injure FDA’s 510(k) process, which allowed a human being or, through inacrobotics to reach the OR and surgeons tion, allow a human being to years sooner, and it set the precedent come to harm. for the robotic invasion to come. In • Law 2—A robot must obey the 1996, Computer Motion introduced orders given it by human beings Zeus, a robotic system that combined except where such orders would the camera holder with laparoscopic conflict with the first law. instrumentation. Its first target speThe first advanced modern robot cialty was cardiothoracic surgery, and appeared in 1958, at the Stanford although revascularization of a heart Research Institute. Although it was had been achieved by Douglas Boyd named Shakey because of its wobin Ontario in 1999, difficulties in this bly clattering movements, it might arena were encountered because of the be considered the great-grandparenclosed space. In 2001, a transatlanent of today’s steady-handed medtic cholecystectomy was performed ical robots. Three robot systems using Zeus, proving that telesurgery have been developed: employing a robot system was, in fact, 1. active, which work possible. autonomously; Isaac Asimov's 1942 novel, Almost simultaneously, Fred Moll, “I, Robot,” proposed the 2. semi-active, which are preproMD, one of the pioneers of laparoscopthree "laws of robots," which gramed but allow the operator ic instrumentation—including trocars resonate with modern medical to complement the actions; and and laparoscopic hernia balloons and robots.

3. master–slave systems, which staplers—became interested in robotlack preprogramming and ic applications for laparoscopy. In early depend on the operator. This type of system is the 1990, however, there were two major hurdles to overcontemporary model for today’s surgical robots, but come before the robots could begin their march into our this may change in the future.

ORs: raising money and FDA approval. Although there

Above: promotional photograph of Computer Motion’s Zeus robot. Below: An early Intuitive model.

was government funding because the military had a keen interest in treating casualties remotely, private or venture capital investment was initially lacking. Dr. Moll, recognizing that a robotic platform might reduce some of the drawbacks of conventional laparoscopy, tried to convince Guidant, a leader in endoscopic instrumentation, to invest, but he was unsuccessful.

Not discouraged by industry’s failure to see the benefits of a robotic platform, he approached the venture capital firm Mayfield Fund, which had been a backer of Origin, his previous endoscopic company. Again, the promise of robotics was not evident to investors, but, confident in his predictions, he continued to build a team. In 1995, Fred Moll, John Freund and an engineer named Robert Younge acquired the intellectual property from the Stanford Research Institute, received venture capital funding and founded Intuitive Surgical.

Surgical Robotic ‘Firsts’ On March 3, 1997, in Belgium, Dr. Jaques Himpens performed the first robotic-assisted operation in a living patient, a cholecystectomy using Intuitive Surgical’s robot, called Mona. A human assistant held the endoscope since this system did not have a camera holder.

Unfortunately, the paper documenting this event was rejected by two prestigious journals, The New England Journal of Medicine and Lancet. The robot did not receive its first publication until 1998, when the placement of a gastric band robotically was published in Obesity Surgery by Cadiere and Himpens (1999;9[2]:206-209). The system did have several shortcomings, which included fragile instrument coupling, less than adequate visualization, and a difficult and prolonged setup. These problems would be addressed in the next modification of the system, da Vinci, which began human trials in 1998 in Mexico, Germany and France. By 2001, there were 146 procedures—including antireflux, gynecologic, inguinal hernia and cardiac surgery—performed using the Intuitive robotic platforms.

In the United States, FDA approval for a true robotic assistant was not immediate. In 1997, the da Vinci

by Intuitive was approved, but only for visualization and extraction, severely limiting its usefulness. It was not until 2000 that the FDA approved the da Vinci system for general surgery—including cholecystectomy and fundoplication—fully utilizing the benefits of the robotic platform. The approval was granted through

SEPTEMBER 2021 / GENERAL SURGERY NEWS

hysterectomies in the United States and would later publish the first series.

Despite the initial denial of its value by the American College of Obstetricians and Gynecologists, its adoption has grown rapidly to more than 30% for benign and more than 65% for oncologic disease by 2020, a pattern that seems to repeat itself in other surgical disciplines.

Not all the robotic invasion has been in a forward direction. To capture laparoscopic biliary surgery, Intuitive Surgical and robotic surgeons experimented with single-site, robotic-assisted cholecystectomy. There was early adoption by some, but without articulation—one of the major advantages of robotics over conventional laparosIntuitive's da Vinci Xi robotic platform was designed to overcome copy—and with an increase in trocar many of the perceived problems identified with earlier models, site hernias due to the larger port site, such as providing a “third arm” equipped with tools for the most abandoned this robotic platform surgeon, eliminating the need for an assistant. for use in biliary surgery. Surgeons the 510(k) pathway by claiming equivalence to previous learned that the robotic platform must technology, allowing Intuitive to begin to expand from be equal to, or have advantages over, the laparoscopic the international market into the United States. platform, and be cost-effective, if it is to have value and At this point, there were two robotic armies, Com- sustain or increase its use by the surgical community. puter Motion and Intuitive Surgical, competing for the same battleground with different software and differ- Robotic-Assisted Surgery in Subspecialties ent hardware. The war that ensued, however, was in the The rest of the robotic invasion is fragmented and courts and not the OR. It dragged on for three years, with should be broken down by surgical subspecialties. each company suing the other over patent infringements. Although many of the first cases other than cardiac were In 2003, the companies merged—Zeus, the Computer general surgical in nature—cholecystectomy, inguiMotion robot, was phased out and some of its unique nal hernia repair, antireflux surgery and even bariatric elements were incorporated into future da Vinci robots. surgery—surgeon adoption was slow compared with Although the first cases that were part of a trial in urology and gynecology. The added value of a robotic Mexico and Europe were performed by general and car- assistant was not apparent to the majority of academdiac surgeons, the first procedures to gain serious credi- ic and private practice general surgeons. However, there bility in the United States were performed by urologists. were a few pioneers in each discipline who attempted Only isolated cholecystectomies, inguinal hernia repairs to demonstrate the platform’s value, and influenced not and fundoplications were attempted in early 2000 in only robotic history but helped determine its direction the United States, while robotic radical prostatectomy and ultimately increased its value. was gaining rapid acceptance by the urologic community. After the first robotic prostatectomy was performed What is evident through the different

by Dr. J. Binder in Germany, Mani Menon, MD, at the surgical disciplines is that a concerted Vattikuti Institute in Detroit, reported a series of cases in 2002, and, more importantly, a way to successfully effort to develop new and improved teach the robotic approach to surgeons who had previmethods of teaching became an integral ously only performed open radical prostatectomy. The first studies demonstrated that the robotic procedure part of the robotic invasion and increased was safe and effective but initially took longer than conthe rate of adoption. ventional open prostatectomy. As data from randomized studies accumulated, the robotic-assisted approach seems to decrease hospital stay and blood loss—imporColorectal surgery is one example where a few surtant parameters—but whether it decreases long-term geons led the way. The first colon resection on record, a morbidities or has oncologic benefit is still debated. sigmoid resection, was performed by Guillermo Gomez, After 20 years, however, the preference of surgeons and MD, in Texas in 2000, and within a few months was patients has resulted in more than 85% of radical pros- followed by Mark Talamini, MD, at Johns Hopkins tatectomies being performed using the robotic platform. University and Pier Giulianotti, MD, in Italy in 2001.

The next group of surgeons to widely adopt a robot- The cases were performed with the original da Vinci ic-assisted approach were gynecologists. Unlike the robot from Intuitive, but adoption was slow because of urologic surgeons who were laparoscopic-naive, this docking logistics and the need to use conventional lapgroup had extensive experience with laparoscopic pro- aroscopic staplers and energy sources. This prompted cedures, but most had not mastered certain advanced the industry to develop the next generation of robots laparoscopic skills, such as suturing. Because the robot- with improved docking, thereby decreasing operative ic platform simplified learning this skill, thus facili- time and including instruments that would make the tating an MIS approach to hysterectomy, many were procedures completely robotic-assisted. Both professors eager to adopt the robotic approach. In 2001, Arnold moved—Dr. Talamini to UC San Diego Medical CenAdvincula, MD, while at the University of Michigan, in ter and Dr. Giulianotti to the University of Illinois at Ann Arbor, performed one of the first robotic-assisted Chicago, to become the respective chairman of surgery,

OPINION

where they would continue to advance robotic investigation and establish research and training centers.

What is evident through the different surgical disciplines is that a concerted effort to develop new and improved methods of teaching became an integral part of the robotic invasion and increased the rate of adoption, especially by nonlaparoscopic surgeons.

Initial Resistance to the Surgical Robot Many of us, including myself, initially resisted the robotic platform because an assistant at the table had to perform some of the essential and important tasks that were traditionally performed by the surgeon of record.

Although the robot answered what many of us in the early days of laparoscopy said would be a perfect laparoscopic surgeon, “one with three arms,” it failed to allow the surgeon to have complete control of the operating field. In 2014, the da Vinci Xi robotic platform was introduced largely for general surgery to overcome many of the problems uncovered by the first adopters of the robotic assistant and to answer the questions of the nonbelievers. The Xi not only allowed the surgeon to have a third arm as did earlier robots, but equipped the arm with the essential tools necessary to be a complete assistant, eliminating the need for a surgeon assistant. The surgeon was now in total control of the operating field from retraction to visualization to stapling and energy for hemostasis.

In addition to the added control, because the boom of the Xi robot could rotate, the need for redocking was no longer necessary when the field of dissection was changed—for example, going from the pelvis to the upper abdomen as in mobilization of the splenic flexure.

Early growth in robotic-assisted colectomy has been slow, just as it was with laparoscopic colectomy, but it has reached a level of approximately 18% use since the introduction of the Xi platform. Some surgeons have even adopted extraction techniques first promoted by laparoscopic pioneer Morris Franklin, MD, of Texas, to further advance its minimally invasive value.

Foregut procedures, including antireflux and bariatric, were some of the first robotic-assisted procedures performed, but their value was seriously questioned because of the limitations of the original robotic platform. In 2000, Santiago Horgan, MD, at the University of Illinois at Chicago, performed the first robotic-assisted gastric bypass and, in 2001, the first Heller myotomy in the United States. At The Ohio State University, from 2000 to 2002, Scott Melvin, MD, performed the first robotic-assisted pancreatectomy, Whipple procedure and esophagectomy, while Dr. Giulianotti in Italy was the first in Europe to accomplish it during the same period.

I remember well the videos of these feats and others being presented at national meetings like the American College of Surgeons, but other than amazement, most of the audience did not seem impressed. This reaction was similar to what early adopters of laparoscopy experienced from the academic community in the early days of laparoscopy. The value was not appreciated, and many thought it was a novelty not worth pursuing. As with robotic-assisted colon resection, it took improvements in the robotic platform and a second wave of pioneers to demonstrate the value of robotics in foregut and hepatobiliary and pancreatic surgery.

Robot’s Effectiveness in Complex Cases Just as important as numerous studies showing safety and data were in establishing the value of the robotic assistant, was the benefit it demonstrated for surgeons continued on the following page

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OPINION

History of Robots continued from the previous page

already skilled in advanced laparoscopy. Skilled laparoscopic surgeons like Steve Scott, MD, Eric Wilson, MD, Carlos Galvani, MD, and others have stated that the robotic assistant stands out especially when performing the most challenging cases—operations on superobese patients or those requiring complex procedures. At first, these robotic surgeons felt limited by available robotic instrumentation just like the colorectal surgeons, and had to combine robotic and laparoscopic approaches.

The development of new robotic instruments, especially staplers and energy sources, permitted them to fully utilize the possible benefits of robotics. Now there is an increasing number of procedures including bariatric sleeve gastrectomy, bypass and revisions, as well as foregut procedures including Heller myotomy, antireflux and paraesophageal hernia repair being done with robotic assistance.

In the past, the most difficult thing for even these expert laparoscopic surgeons was passing on their skills to the next generation of surgeons. By using robotic simulators and dual consoles, they have demonstrated that they can pass on their skills to their trainees safely and efficiently just as urologists have done. They have shown that an added advantage of the robotic platform is its ability to facilitate teaching and shorten the learning curve for trainees, which will indirectly improve access to care by increasing the number of experts available.

General Surgery: Recent Growth

GENERAL SURGERY NEWS / SEPTEMBER 2021

hernia repair. For the first time in more than 20 years, the adoption of a minimally invasive approach began to grow, due to the growth of the robotic approach. Today the minimally invasive approach has grown to approximately 50%, with the majority of those procedures being robotic.

Simultaneously with revitalized interest in MIS inguinal hernia repair using the robotic platform, was the ongoing study of new approaches to abdominal wall hernias. Closure of hernia defects laparoscopically as part of an intraperitoneal onlay mesh (or IPOM) technique, first popularized by Morris Franklin, came back into favor and the use of open retrorectus placement of mesh as well as the transabdominal release (TAR) procedure, proposed by Yuri Novitsky, MD, grew. Robotic surgeons like Dr. Ballecer saw the advantage of the wristed action of the robot in suturing defects and ease of dissecting off the peritoneum to keep the mesh outside the peritoneal cavity. He introduced a robotic TAPP repair of abdominal hernias including umbilical, small incisional and Spigelian. For the larger incisional hernias, Alfredo Carbonell, MD, introduced the robotic TAR using the Si robot (Intuitive Surgical) and a double-docking technique. During the same period Igor Belyansky, MD, was developing a modification of Dr. Daes’ extended totally extraperitoneal (eTEP) repair first introduced for inguinal hernias to accomplish the TAR laparoscopically. He began to train on the robot, and in 2017, developed the eTEP TAR. These procedures were uploaded to social media platforms and YouTube, quickly influencing the growth of robotic hernia repair. The simultaneous appearance of new surgical techniques, a robotic platform that could facilitate their application, a social media platform to spread the word, surgeons willing to mentor other surgeons, and industry support were a perfect storm for the robotic invasion, which resulted in the rapid growth of robotics for general surgeons.

The specialty in general surgery that has shown the most recent growth in robotics is repair of abdominal wall hernias—inguinal, ventral and incisional. The first surgeon in the Americas to employ the robotic assistant to repair inguinal and abdominal wall hernias was Barry Only the Beginning Gardiner, MD, in 2000, as part of a ‘The future will be based pilot study. It was not until approxIt should be understood that we have imately 2008 that the first signifionly seen the beginning of the robotic on lessons we learn from invasion. An ever-increasing number cant accounts of a robotic approach the past, so let history to inguinal hernia repair were reportof robotic platforms are in developed. The repairs were done in conment or have already been released be your mentor.’ junction with robotic prostatectomy. outside of the United States. In the Multiple studies appeared in the United Kingdom, Cambridge Medi—Edward Felix, MD peer-reviewed literature describing cal Robotics (CMR) has launched a the safety and efficacy of combining robotic system and has already trained these two robotic procedures. surgeons and has approximately 30 Although several surgeons in private pracunits installed across Europe. In 2017, Meere, tice began performing robotic-assisted transa South Korean company, released a fourabdominal preperitoneal (TAPP) inguinal armed robot similar to Intuitive’s da Vinci Si. hernia repair as a stand-alone procedure, its Five years ago, Verb Surgical was founded as value was seriously debated by hernia sura joint venture between Google and Johngeons, including myself. As the robotic son & Johnson to develop a robotic surgiapproach became standardized and cal system. Although Verb Surgical has mimicked closely the TAPP lapyet to release a general surgery robot, it aroscopic approach, however, it has made several acquisitions to further has gained acceptance as an its advance into the robot wars, includalternative minimally invasive ing Auris Health, a developer of robotic approach. Because of video technologies with its founder and CEO Fred Moll. Dr. Moll, you will rememteaching and mentoring by ber, was the founder of Intuitive Surgical. surgeons such as Conrad Ballecer, MD, and TransEnterix entered the robot competition laparoscopic experts like Jorge Daes, MD, in 2016, with a robot called Surgibot, but David Chen, MD, David Lourie, MD, and initially failed because it was denied FDA others on the International Hernia Colapproval.

TransEnterix soon introduced a laboration—a social media platform for new robot system called Senhance Surgisurgeons started by Brian Jacob, MD, cal Robot System, which was approved by in 2012—there has been widespread the FDA in 2017. Still another company, acceptance of robotic-assisted inguinal

Titan Medical, in Canada, has developed a single-port robotic system with no external moving parts, but it is still in the testing phase.

As more competitors come to the market and the original robotic platform evolves, it is obvious we are only at the beginning of a new era in surgery. What will future robotic systems bring to the OR? How will it harness the power of computers, artificial intelligence and internet communication to enhance the surgical experience for the patient and surgeon? Can robotic systems maintain value by decreasing overall cost while increasing benefit? These are all questions that patients, surgeons, hospitals and payors continue to ask. I have therefore asked some of the leaders of the robotic invasion—past and present—to predict the future. Here is what they had to say: Yulun Wang, MD: “Robotic surgery is really the computerization of surgery, where the power of the computer is placed between the surgeon’s intent and the surgical manipulators. The robotic surgical system will become more and more of an information and communication hub for the surgical procedure. The surgeon’s role will likely become more and more strategic, as opposed to focusing on the precise manipulations, which will be handled more and more by the robot.”

Gary Guthart, PhD [CEO of Intuitive Surgical]: “As robotic-assisted surgery continues its growth and acceptance, the focus moves to not only advancing core robotic capability but also integrating tools, data and services around robotic systems that drive toward better, more predictable patient outcomes, better experiences for patients, better experiences for their care teams, and ultimately, a lower total cost of care.”

Mark Talamini, MD: “I believe we will migrate to more cost-efficient robots designed for specific types of procedures in specific anatomic regions as opposed to one general machine assisting with all types of surgery.

Surgery will also be enhanced by more powerful and real-time imaging modalities and artificial intelligence‒ driven automation, but this will come in stages.”

Steve Scott, MD: “The robot will be ideal for bariatrics because it removes the constraints of the thick abdominal wall, improving the precision of every movement.

I see the ever-increasing information feedback with instrumentation and visualization giving a surgeon the ability to decrease complications, improve outcomes and change the way they approach patients.”

Conrad Ballecer, MD: “Robotic surgery will completely change the game for residents and postgraduate trainees, enabling them to become proficient in MIS procedures ranging from the most basic to the most complex procedures.”

Edward Felix, MD: “The future will be based on lessons we learn from the past, so let history be your mentor.” ■ —Dr. Felix is a general surgeon in Pismo Beach, Calif., and an editorial advisory board member of General Surgery News.

Dr. Felix is a lecturer for Intuitive Surgical and Medtronic.

Editor’s note: Opinions in General Surgery News belong to the author(s) and do not necessarily reflect those of the publication.

IN THE NEWS

SEPTEMBER 2021 / GENERAL SURGERY NEWS

Bariatric Surgery Decreases Hospital al Admissions for Diastolic Heart Failure

By KATE O’ROURKE

B

ariatric surgery decreases the number of hospital admissions for diastolic heart failure in severely obese patients, according to new research presented at the 2021 annual meeting of the American Society for Metabolic and Bariatric Surgery (abstract A008).

According to David Funes, MD, a research fellow at Cleveland Clinic in Weston, Fla., who presented the research, for more than 16 years, the objective of medical therapy in diastolic heart failure has been to decrease hospital admissions and mortality. Unfortunately, all randomized trials have failed to demonstrate efficacy of medical therapy in these important clinical outcomes.

Dr. Funes said the only medication that has proven modest impact to prevent hospitalizations in this patient population is candesartan.

In the new study, the researchers’ primary objective was to evaluate the hypothesis that bariatric surgery is associated with a decrease in hospital admissions for diastolic heart failure in severely obese patients. The researchers conducted a retrospective analysis of the National Inpatient Sample database from the years 2010 to 2015, dividing patients into those with and without a history of bariatric surgery. They analyzed all covariates associated with morbidity and mortality for diastolic heart failure including hypertension, diabetes mellitus, smoking, coronary artery disease, race, age and sex.

The multivariate logistic regression analysis demonstrated that the patients who did not undergo bariatric surgery were at a significantly higher risk for being admitted for acute and chronic diastolic heart failure. “Patients in the control group with no history of hypertension were almost five times more likely to be admitted for acute diastolic heart failure,” Dr. Funes said. “Furthermore, the odds of prevalence for chronic diastolic heart failure were two times higher in the control group when compared to their counterparts in the control group. … The multivariate logistic regression analysis demonstrated that the odds of hospitalization for diastolic heart failure, specifically for patients with a history of coronary artery disease, was almost three times higher in the control group when compared to the surgical group.”

Tammy Kindel, MD, PhD, an associate professor and the director of the bariatric surgery program at the University of Wisconsin–Milwaukee, who served

as the discussant of the study, pointed out h that heart failure with preserved ejection fraction (HFpEF) is closely associated with obesity and w hypertension and is now representing 50% of casess of heart failure. She said it

is a distinct pathophysiologic phenotype from heart failure with reduced ejection fraction.

“HFpEF has significant morbidity and mortality, as mentioned, and there really is no effecti tive medical treatment cap capable of reducing heart

failure–related mortality,” Dr. Kindel said. “Although it would seem that obesity treatment would be essential, there really are minimal studies demonstrating that weight loss, in any form, can modify diastolic dysfunction in HFpEF patients.

Your group has really added an important article to the literature where there is a true void and considerable knowl■ edge gap.”

ADVANCING POSTSURGICAL PAIN MANAGEMENT AND RECOVERY Powered by DepoFoam® technology to deliver precise pain control for the critical first few days after surgery

MORE THAN

8 MILLION ADULT PATIENTS HAVE RECEIVED EXPAREL SINCE 2012 1

LEARN MORE AT WWW.EXPAREL.COM Indication EXPAREL® (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks.

routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, or intravascular or intra-articular use.

The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials.

Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia.

Adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via interscalene brachial plexus nerve block were nausea, pyrexia, and constipation.

Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia.

If EXPAREL and other non-bupivacaine local anesthetics, including lidocaine, are administered at the same site, there may be an immediate release of bupivacaine from EXPAREL. Therefore, EXPAREL may be administered to the same site 20 minutes after injecting lidocaine.

EXPAREL is not recommended to be used in the following patient populations: patients <6 years old for infiltration, patients younger than 18 years old for interscalene brachial plexus nerve block, and/or pregnant patients.

Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease.

Warnings and Precautions for Bupivacaine-Containing Products Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression.

Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to dysrhythmias, sometimes leading to death.

Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients.

Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use.

Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use.

Warnings and Precautions Specific to EXPAREL Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL is not recommended for the following types or ©2021 Pacira BioSciences, Inc. Parsippany, NJ 07054 PP-EX-US-6517 03/21

Please refer to brief summary of Prescribing Information on adjacent page.

For more information, please visit www.EXPAREL.com or call 1-855-793-9727.

Reference: 1. Data on File. 6450. Parsippany, NJ: Pacira BioSciences, Inc.; January 2021.

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12

IN THE NEWS

GENERAL SURGERY NEWS / SEPTEMBER 2021

Bariatric Surgery Benefits Patients With Poor Glycemic Control

By KATE O’ROURKE

P

atients with higher preoperative hemoglobin A1c (HbA1c) levels experience a similar benefit from bariatric surgery without higher complication rates as those with controlled levels, according to results from a new study.

“Patients with poor glycemic control should still be considered eligible candidates that will strongly benefit from bariatric surgery without the need to delay

Brief Summary (For full prescribing information refer to package insert) INDICATIONS AND USAGE EXPAREL is indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.

Limitation of Use: Safety and efficacy has not been established in other nerve blocks.

CONTRAINDICATIONS EXPAREL is contraindicated in obstetrical paracervical block anesthesia.

While EXPAREL has not been tested with this technique, the use of bupivacaine HCl with this technique has resulted in fetal bradycardia and death.

WARNINGS AND PRECAUTIONS Warnings and Precautions Specific for EXPAREL As there is a potential risk of severe life-threatening adverse effects associated with the administration of bupivacaine, EXPAREL should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity.

Caution should be taken to avoid accidental intravascular injection of EXPAREL. Convulsions and cardiac arrest have occurred following accidental intravascular injection of bupivacaine and other amidecontaining products.

Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL has not been evaluated for the following uses and, therefore, is not recommended for these types of analgesia or routes of administration.

• epidural • intrathecal • regional nerve blocks other than interscalene brachial plexus nerve block • intravascular or intra-articular use EXPAREL has not been evaluated for use in the following patient population and, therefore, it is not recommended for administration to these groups.

• patients younger than 6 years old for infiltration • patients younger than 18 years old for interscalene brachial plexus nerve block • pregnant patients The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days as seen in clinical trials.

ADVERSE REACTIONS Clinical Trial Experience Adverse Reactions Reported in Local Infiltration Clinical Studies The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical site clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 to 532 mg of EXPAREL. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting. The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration were pyrexia, dizziness, edema peripheral, anemia, hypotension, pruritus, tachycardia, headache, insomnia, anemia postoperative, muscle spasms, hemorrhagic anemia, back pain, somnolence, and procedural pain.

Adverse Reactions Reported in All Local Infiltration Clinical Studies in Pediatric Patients Aged 6 to Less Than 17 Years The safety of EXPAREL in 110 pediatric patients between the age of 6 and 17 years old undergoing various surgical procedures was evaluated in one randomized, open-label, clinical study in which EXPAREL was administered by infiltration into the surgical site and one single-arm, open-label study in which EXPAREL was administered by infiltration into the surgical site. Patients were administered a weight-based dose of EXPAREL at 4 mg/kg (maximum dose of 266 mg) or bupivacaine HCl 2 mg/kg (maximum dose of 175 mg). In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia.

The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration were bradycardia, muscle spasms, tachypnea, hypoesthesia oral, anemia postoperative, dizziness, pyrexia, diarrhea, hypoacusis, hypoesthesia, back pain, hematuria, incontinence, muscular weakness, and visual impairment.

Adverse Reactions Reported in Nerve Block Clinical Studies The safety of EXPAREL was evaluated in four randomized, double-blind, placebo-controlled nerve block clinical studies involving 469 patients undergoing various surgical procedures. Patients were administered a dose of either 133 or 266 mg of EXPAREL. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, pyrexia, and constipation.

The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration as a nerve block were muscle twitching, dysgeusia, urinary retention, fatigue, headache, confusional state, hypotension, hypertension, hypoesthesia oral, pruritus generalized, hyperhidrosis, tachycardia, sinus tachycardia, anxiety, fall, body temperature increased, edema peripheral, sensory loss, hepatic enzyme increased, hiccups, hypoxia, post-procedural hematoma.

surgery for tighter preoperative glycemic control,” said Eileen Bui, MD, a resident in the Division of General Minimally Invasive and Bariatric Surgery at Loma Linda University Health, in Loma Linda, Calif., who presented the research at the 2021 annual meeting of the American Society for Metabolic and Bariatric Surgery (abstract A007).

Dr. Bui pointed out that bariatric surgery has been shown to improve diabetes, as evidenced by decreases in HbA1c

Postmarketing Experience These adverse reactions are consistent with those observed in clinical studies and most commonly involve the following system organ classes (SOCs): Injury, Poisoning, and Procedural Complications (e.g., drug-drug interaction, procedural pain), Nervous System Disorders (e.g., palsy, seizure), General Disorders And Administration Site Conditions (e.g., lack of efficacy, pain), Skin and Subcutaneous Tissue Disorders (e.g., erythema, rash), and Cardiac Disorders (e.g., bradycardia, cardiac arrest).

DRUG INTERACTIONS The toxic effects of local anesthetics are additive and their coadministration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity. Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. Patients who are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia:

Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic cyclophosphamide, flutamide, hydroxyurea, ifosfamide, agents rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine Bupivacaine Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2.

Non-bupivacaine Local Anesthetics EXPAREL should not be admixed with local anesthetics other than bupivacaine. Nonbupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. There are no data to support administration of other local anesthetics prior to administration of EXPAREL. Other than bupivacaine as noted above, EXPAREL should not be admixed with other drugs prior to administration.

Water and Hypotonic Agents Do not dilute EXPAREL with water or other hypotonic agents, as it will result in disruption of the liposomal particles USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are no studies conducted with EXPAREL in pregnant women.

In animal reproduction studies, embryo-fetal deaths were observed with subcutaneous administration of bupivacaine to rabbits during organogenesis at a dose equivalent to 1.6 times the maximum recommended human dose (MRHD) of 266 mg. Subcutaneous administration of bupivacaine to rats from implantation through weaning produced decreased pup survival at a dose equivalent to 1.5 times the MRHD [see Data]. Based on animal data, advise pregnant women of the potential risks to a fetus.

The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

Clinical Considerations Labor or Delivery Bupivacaine is contraindicated for obstetrical paracervical block anesthesia. While EXPAREL has not been studied with this technique, the use of bupivacaine for obstetrical paracervical block anesthesia has resulted in fetal bradycardia and death.

Bupivacaine can rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity. The incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus, and neonate involve alterations of the central nervous system, peripheral vascular tone, and cardiac function.

Data Animal Data Bupivacaine hydrochloride was administered subcutaneously to rats and rabbits during the period of organogenesis (implantation to closure of the hard plate). Rat doses were 4.4, 13.3, and 40 mg/kg/day (equivalent to 0.2, 0.5 and 1.5 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight) and rabbit doses were 1.3, 5.8, and 22.2 mg/ kg/day (equivalent to 0.1, 0.4 and 1.6 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight). No embryofetal effects were observed in rats at the doses tested with the high dose causing increased maternal lethality. An increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity.

Decreased pup survival was noted at 1.5 times the MRHD in a rat pre- and post-natal development study when pregnant animals were administered subcutaneous doses of 4.4, 13.3, and 40 mg/kg/day buprenorphine hydrochloride (equivalent to 0.2, 0.5 and 1.5 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight)

levels. On the other hand, she said, diabetes and poor glycemic control are also associated with higher rates of complications, as seen in studies in vascular, cardiac and emergency general surgery. “Even in elective surgery, it has been proposed that preoperative diabetes measurements may improve clinical outcomes, with some institutions wanting to delay surgery to achieve tighter glycemic control,” Dr. Bui said. “Therefore, we sought to address whether patients with higher

from implantation through weaning (during pregnancy and lactation).

Lactation Risk Summary Limited published literature reports that bupivacaine and its metabolite, pipecoloxylidide, are present in human milk at low levels. There is no available information on effects of the drug in the breastfed infant or effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EXPAREL and any potential adverse effects on the breastfed infant from EXPAREL or from the underlying maternal condition.

Pediatric Use The safety and effectiveness of EXPAREL for single-dose infiltration to produce postsurgical local anesthesia have been established in pediatric patients aged 6 years and older. Use of EXPAREL for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 6 years and older.

Safety and effectiveness have not been established in pediatric patients aged less than 6 years old for local infiltration or less than 18 years old for interscalene brachial plexus nerve block.

Geriatric Use Of the total number of patients in the EXPAREL local infiltration clinical studies (N=823), 171 patients were greater than or equal to 65 years of age and 47 patients were greater than or equal to 75 years of age. Of the total number of patients in the EXPAREL nerve block clinical studies (N=531), 241 patients were greater than or equal to 65 years of age and 60 patients were greater than or equal to 75 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients. Clinical experience with EXPAREL has not identified differences in efficacy or safety between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment Amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity. Therefore, consider increased monitoring for local anesthetic systemic toxicity in subjects with moderate to severe hepatic disease.

Renal Impairment Bupivacaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. This should be considered when performing dose selection of EXPAREL. OVERDOSAGE Clinical Presentation Acute emergencies from local anesthetics are generally related to high plasma concentrations encountered during therapeutic use of local anesthetics or to unintended intravascular injection of local anesthetic solution.

Signs and symptoms of overdose include CNS symptoms (perioral paresthesia, dizziness, dysarthria, confusion, mental obtundation, sensory and visual disturbances and eventually convulsions) and cardiovascular effects (that range from hypertension and tachycardia to myocardial depression, hypotension, bradycardia and asystole).

Plasma levels of bupivacaine associated with toxicity can vary. Although concentrations of 2,500 to 4,000 ng/mL have been reported to elicit early subjective CNS symptoms of bupivacaine toxicity, symptoms of toxicity have been reported at levels as low as 800 ng/mL. Management of Local Anesthetic Overdose At the first sign of change, oxygen should be administered.

The first step in the management of convulsions, as well as underventilation or apnea, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to the use of anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine to enhance myocardial contractile force).

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted.

Endotracheal intubation, employing drugs and techniques familiar to the clinician, maybe indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated.

DOSAGE AND ADMINISTRATION Important Dosage and Administration Information • EXPAREL is intended for single-dose administration only.

• Different formulations of bupivacaine are not bioequivalent even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL. • DO NOT dilute EXPAREL with water or other hypotonic agents, as it will result in disruption of the liposomal particles.

• Use suspensions of EXPAREL diluted with preservative-free normal (0.9%) saline for injection or lactated Ringer’s solution within 4 hours of preparation in a syringe.

• Do not administer EXPAREL if it is suspected that the vial has been frozen or exposed to high temperature (greater than 40°C or 104°F) for an extended period.

pre-op hemoglobin A1c levels or more poorly controlled diabetes experience a higher or lower benefit from bariatric surgery and whether the risk of complication changes.”

Dr. Bui and her colleagues conducted a retrospective study from 2012 to 2019 by identifying patients at Loma Linda University Health who underwent either laparoscopic sleeve gastrectomy or Rouxen-Y gastric bypass, and who had preoperative HbA1c levels taken (N=1,612).

• Inspect EXPAREL visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer EXPAREL if the product is discolored.

Recommended Dosing Local Analgesia via Infiltration Dosing in Adults The recommended dose of EXPAREL for local infiltration in adults is up to a maximum dose of 266mg (20 mL), and is based on the following factors: • Size of the surgical site • Volume required to cover the area • Individual patient factors that may impact the safety of an amide local anesthetic As general guidance in selecting the proper dosing, two examples of infiltration dosing are provided: • In patients undergoing bunionectomy, a total of 106 mg (8 mL) of EXPAREL was administered with 7 mL infiltrated into the tissues surrounding the osteotomy, and 1 mL infiltrated into the subcutaneous tissue.

• In patients undergoing hemorrhoidectomy, a total of 266 mg (20 mL ) of EXPAREL was diluted with 10 mL of saline, for a total of 30 mL, divided into six 5 mL aliquots, injected by visualizing the anal sphincter as a clock face and slowly infiltrating one aliquot to each of the even numbers to produce a field block.

Local Analgesia via Infiltration Dosing in Pediatric Patients The recommended dose of EXPAREL for single-dose infiltration in pediatric patients, aged 6 to less than 17 years, is 4 mg/kg (up to a maximum of 266 mg), and is based upon two studies of pediatric patients undergoing either spine surgery or cardiac surgery.

Regional Analgesia via Interscalene Brachial Plexus Nerve Block Dosing in Adults The recommended dose of EXPAREL for interscalene brachial plexus nerve block in adults is 133 mg (10 mL), and is based upon one study of patients undergoing either total shoulder arthroplasty or rotator cuff repair.

Compatibility Considerations Admixing EXPAREL with drugs other than bupivacaine HCl prior to administration is not recommended.

• Non-bupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more.

• Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2.

The toxic effects of these drugs are additive and their administration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.

• When a topical antiseptic such as povidone iodine (e.g., Betadine®) is applied, the site should be allowed to dry before EXPAREL is administered into the surgical site. EXPAREL should not be allowed to come into contact with antiseptics such as povidone iodine in solution.

Studies conducted with EXPAREL demonstrated that the most common implantable materials (polypropylene, PTFE, silicone, stainless steel, and titanium) are not affected by the presence of EXPAREL any more than they are by saline. None of the materials studied had an adverse effect on EXPAREL. Non-Interchangeability with Other Formulations of Bupivacaine Different formulations of bupivacaine are not bioequivalent even if the milligram dosage is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL and vice versa.

Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Do not substitute.

CLINICAL PHARMACOLOGY Pharmacokinetics Administration of EXPAREL results in significant systemic plasma levels of bupivacaine which can persist for 96 hours after local infiltration and 120 hours after interscalene brachial plexus nerve block. In general, peripheral nerve blocks have shown systemic plasma levels of bupivacaine for extended duration when compared to local infiltration.

Systemic plasma levels of bupivacaine following administration of EXPAREL are not correlated with local efficacy.

PATIENT COUNSELING Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly.

Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

Pacira Pharmaceuticals, Inc. San Diego, CA 92121 USA Patent Numbers: 6,132,766 5,891,467

5,766,627

8,182,835

Trademark of Pacira Pharmaceuticals, Inc. For additional information call 1-855-RX-EXPAREL (1-855-793-9727) Rx only

March 2021

IN THE NEWS

SEPTEMBER 2021 / GENERAL SURGERY NEWS

Table. Hemoglobin A1c Levels Pre-op

1 month

3 months

6 months

12 months

Controlled

5.6

5.4

5.3

5.3

5.2

Elevated

6.5

6.3

5.9

5.7

5.6

Superelevated

9.1

8

6.7

6.2

6.6

in Greenville, S.C., and president of the ASMBS, congratulated the authors for reviewing their institutional outcomes on this important topic. He pointed out that it was a retrospective review and thus suffers from the limitations of this type of analysis. He also pointed out that no raw outcome data were presented. “Studies like these challenge one’s clinical decision making around perioperative optimizations of specifically HbA1c, as some studies support the authors’ conclusions and others actually show a higher complication rate in patients with higher HbA1c levels preoperatively,” Dr. Kothari said. ■

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4

They then stratified patients into one of three groups: controlled (HbA1c ≤6; n=364); elevated (HbA1c >6 to <8.5; n=207); and superelevated (HbA1c ≥8.5; n=41). The researchers analyzed the complication rate at one month, as well as the efficacy of the surgery, as demonstrated by changes in weight loss, HbA1c and improvements in obesity-related comorbidities. They collected information on excess body weight loss (EBWL), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides and C-reactive protein (CRP).

Baseline characteristics were similar between the three groups, with a slight predominance for men in the groups with higher HbA1c levels. Individuals in the groups with higher HbA1c levels were also more likely to have a higher rate of comorbidities including hypertension, coronary artery disease and hyperlipidemia. Individuals in the controlled and elevated groups were also more likely to undergo sleeve gastrectomy (73% and 65%, respectively), whereas 66% of the superelevated group underwent a Rouxen-Y bypass. Follow-up was 87.8% at one month, 78.6% at three months, 64.2% at six months and 46.4% at 12 months.

“We first looked at the rate of complications at one month, which included readmissions, infections and re-interventions,” Dr. Bui said. “For most, the rates were comparable. We only found a significant difference in length of stay and rates of urinary retention, with the elevated group having slightly higher rates of retention (controlled, 3.4% vs. elevated, 8.2% vs. superelevated, 2.4%). Clinically, however, even the length of stay was similar: two versus 2.5 versus 2.4 days.”

All three groups improved their HbA1c levels compared with preoperative levels (Table). All patients achieved slight improvements in their blood pressure by 12 months, with no significant differences between the groups at that time point. Elevated pre-op HbA1c levels did not inhibit the weight loss achieved through bariatric surgery, as all groups demonstrated weight loss at nearly every time point. No significant difference was found between body mass index or percentage of expected body weight loss at each time point. By 12 months, the controlled group achieved 62% meeting EBWL, with the elevated group achieving 66% and superelevated group reaching 75%. LDL levels demonstrated slight improvement postoperatively, with no difference between

groups. HDL levels increased over time in all three groups, with the superelevated group experiencing less significant change. Triglycerides improved in all three groups. “Triglyceride levels in the controlled group were significantly different from elevated and superelevated, but the difference was present at baseline. At 12 months, the difference is no longer present. CRP levels generally decreased,” Dr. Bui said.

Serving as the discussant for the study, Shanu Kothari, MD, the vice chair of medical staff affairs at Prisma Health Systems,

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IN THE NEWS

GENERAL SURGERY NEWS / SEPTEMBER 22021

C-Reactive Protein Levels: Ready for Prime Time In Assessing Anastomotic Leak?

By ETHAN COVEY

T

racking levels of C-reactive protein (CRP) in the body may help health care professionals to determine whether anastomotic leakage is occurring in patients who have recently undergone colorectal surgery.

According to a pair of recent studies, monitoring CRP levels may signal leakage, thus acting as an easy, early indicator appearing before other radiological and clinical signs (Sci Rep 2020:10[1]. doi:10.1038/s41598-020-58780-3; Br J Surg 2020:107:1832-1837).

“Anastomotic leakage is an undesirable complication of colorectal surgery, resulting in increased length of hospitalization, increased treatment costs, delayed return of intestinal homeostasis and decreased survival,” wrote the authors of a Brazilian study published in Scientific Reports.

“Because vital signs and leukocyte numbers are slow in responding, it is important to identify tools to detect early leakage.”

Despite advances in surgical techniques, the mortality rate among patients with anastomotic leakage is estimated to approach 30% (J Am Coll Surg 2009;208:269-278), and delayed diagnosis has been found to increase mortality by 18% (J Am Coll Surg 1999;189:554-559).

The Brazilian study focused retrospectively on patients who underwent elective or emergency colorectal surgery with primary anastomosis at Carapicuíba General Hospital. The 90 patients were divided into two groups: 11 who experienced anastomotic leakage and 79 who did not.

Serum CRP level was evaluated on each of the first seven postoperative days (PODs), as were other clinical parameters such as abdominal pain, volume, return of bowel function and/or appearance of abdominal drainage.

Overall, surgical outcomes in patients who developed anastomotic leakage were far worse than in those who did not.

Postoperative mortality was 18.2% in the group with leakage versus 1.3% in those without it; median hospital length of stay was 15 days for the leakage group compared with seven days in the nonleakage group; and 91.9% of patients in the group with leakage underwent surgical treatment.

When looking specifically at CRP level, the researchers found no significant differences during the first three days after surgery. However, starting on POD 4, patients with leakage experienced significant increases in serum CRP level.

Peak CRP level occurred five days after surgery among patients with leakage. In contrast, in patients without leakage, CRP level peaked on POD 2 and fell from that point on.

“Serum CRP levels can be routinely analyzed in patients who undergo elective or emergency colorectal surgery. Decreased CRP levels after POD 2 can exclude anastomotic

‘The liver is the sentinel of the body, tapping into bad things which may be happening in other parts of the body.’

—Peter K. Kim, MD

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Request a Sample | VectorSurgical.com | +1 (262) 798-7970 Vector Surgical, the Vector Surgical Logo, MarginMarker and CorrectClips are trademarks of Vector Surgical LLC. Reg U.S. Pat & TM Off | © 2021 Vector Surgical LLC | References (1) Molina MA, Snell S, Franceshchi, D, et al. Breast specimen orientation. Ann Surg Oncol. 2009; 16:285-288. (2) Altman AM, Nguyen DD, Johnson B, et al. Intraoperative inking is superior to suture marking for specimen orientation in breast cancer. Breast J. 2019;00:1-7. (3) Singh M, Singh G, Hogan KT, Atkins KA, Schroen AT. The effect of intraoperative specimen inking on lumpectomy re-excision rates. World J Surg Oncol. 2010;8-4. (4) Van Den Bruele AB, Jasra B, Smotherman C, et al. Cost-effectiveness of surgeon performed intraoperative specimen ink in breast conservation surgery. Journal Surgical Research. 208;441-447 | MMCC SPREAD GSN SEP OCT 2021

IN THE NEWS

SEPTEMBER 2021 / GENERAL SURGERY NEWS

leakage because they are not influenced by factors such as individual inflammatory response, type of approach or surgical indication,” the team of researchers concluded.

The liver produces CRP as an acute phase protein, so such a signal may be the fastest way to detect potential anastomosis in a patient.

“The liver is the sentinel of the body, tapping into bad things which may be happening in other parts of the body,” commented Peter K. Kim, MD, an associate professor in the Department of Surgery at Albert Einstein College of

Medicine, in Bronx, N.Y. Dr. Kim told General Surgery News that he has been tracking CRP levels among his patients as an early identification system for the “devastating complication” of anastomotic leak. He has found tracking CRP levels to be a simple, reassuring way of monitoring his patients. “CRP is not a difficult test—most hospitals have access to it,” he said.

Dr. Kim added that he focuses on other clinical and laboratory markers such as fever, heart rate, complaints of pain, return to bowel function and white blood cell count, but he noted that they

can often be “soft signs of anastomotic leaks,” and may not appear until leakage is well underway. “You want to know earlier on whether patients are in trouble or not,” he said.

Dr. Kim did note, however, that the Brazilian study had a downside, in that it was a retrospective, single-institution study with relatively small numbers.

The second study in the British Journal of Surgery addresses many of those concerns.

This prospective study involved 833 patients recruited from 20 hospitals in Australia, New Zealand, England and

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Scotland between March 2017 and July 2018. Level of CRP was measured before operation and for five days after surgery.

Of the patients, 4.9% had anastomotic leakage with a median hospital length of stay of 16 days, compared with six days in the group without leakage.

The researchers determined that an increasing CRP level between any consecutive PODs had a sensitivity for predicting anastomotic leak, and a negative predictive value of 0.99.

The authors found the results to be less definitive than those from retrospective studies, but commented that “there was evidence of value in CRP testing.”

“This large prospective analysis of the accuracy of CRP testing in diagnosing anastomotic leakage has shown that, although CRP trajectory and cutoff points are not as accurate as expected when subjected to a large multicenter study, they certainly have value in diagnosing and excluding this significant surgical condition,” the investigators added.

Despite these data, Yosef Nasseri, MD, a colorectal surgeon and the founding partner of Surgical Group LA, based at Cedars-Sinai Medical Center, in Los Angeles, cautioned that identifying anastomotic leak is a complicated task.

“Diagnosis of an anastomotic leak requires an astute clinical judgment that takes into account patient’s vital signs, clinical appearance and exams, various laboratory values including WBC [white blood cell count], neutrophils, lactic acid, creatinine and blood gases, and imaging modalities—most commonly CT scan of the abdomen and pelvis,” Dr. Nasseri said. “CRP is certainly not specific to an anastomotic leak, and a rise in CRP can be due to various other reasons for fever and/or infection postsurgically including urinary tract infection, pneumonia, DVT [deep venous thrombosis], pulmonary embolism and others.”

Either way, Dr. Nasseri noted that a significant change in CRP level over a 24-hour period “can be suggestive of a significant acute infectious issue which can raise suspicion for an anastomotic leak, leading to other more definitive investigatory workup.” Additionally, he commented that the “specific cutoff value for a concerning CRP and/or change in CRP should ideally be validated by others before it makes its way into standard practice.”

Yet, Dr. Nasseri said, monitoring CRP levels may, indeed, be beneficial when used in combination with other markers.

“Fortunately, it is a cheap test and can certainly help in conjunction with other parameters so long as it does not lead to unnecessary pursuit of expansive workup ■ that can be exhaustive and costly.”

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EXTENDED WOUND CARE COVERAGE Burn Care 101: Determining the Best Treatment Plan Tips for the Non-Burn Professional

By MONICA J. SMITH

G

eneral surgeons may not see burn patients every day, but burns are a major public health concern, afflicting more than 1 million people in North America every year. The injuries range from mild to life-threatening, and although they share similarities with any wound a surgeon might treat, they also present unique challenges.

“It’s really important for health care professionals to be able to diagnose and treat burns as quickly as possible,” said Maria Goddard, MD, CWS, a burn and wound care specialist at Goddard Medical, LLC, in Overland Park, Kan. “Large burns have the potential to create systemic physiological changes in patients; they don’t behave like your typical wound patients because of that systemic inflammatory response,” she noted.

Burn Types and Degree Burns fall into several categories: thermal (exposure to flame, scalding liquid, contact with hot surfaces), chemical (acid, alkali, organic compounds), electrical (lightning, high voltage, low voltage), and inhalation. Each type has its own concerns and considerations.

“With chemical burns, you’ll want to identify the chemical involved. For instance, patients exposed to hydrochloric acid will have pain out of proportion to the injury, and you’ll want to treat them with calcium gluconate,” Dr. Goddard said, speaking at the 2021 Symposium on Advanced Wound Care virtual spring meeting.

Patients with electrical burns may have hidden injuries and will most likely be seen in an acute care setting, while patients with inhalation injuries need to be checked for carbon monoxide exposure.

First-degree burns, such as sunburns, are superficial and unlikely to need a surgeon’s care. Second-degree burns are subdivided into superficial dermal, which present with blisters and pain, and deep dermal, in which patients might have some diminished sensation due to nerve damage.

“You’ll want to watch second-degree burns closely, as they can go either way—healing on their own or progressing toward coagulation and requiring intervention,” Dr. Goddard said.

Full-thickness third- and fourth-degree burns cause damage to all layers of the skin. “If it goes beyond the subdermis, you may see underlying structures, like bone and muscle,” Dr. Goddard said. “These patients will be at risk for fluid loss and will lose their ability to thermoregulate. We need to monitor these patients for infection as well, which is one of the most common complications.”

“It’s probably the easiest to remember and is relatively straightforward. Nothing’s 100% accurate, but it’s a good starting guide and will help you with your fluid resuscitation,” he said.

The rule of nines breaks down the body into proportions corresponding to the head, trunk and extremities (e.g., one arm represents 9%). If less than an entire portion is burned, you’d want to take that into rior account. “Say the burn is only to the anterior portion of the arm, you’d make it 4.5%, or iff it’s a smaller area, 2%,” Dr. Goddard said.

Fluid resuscitation comes into the picture when the TBSA is 20% or more. “About 20% is where hypovolemic shock can occur and typically where we would start resuscitation,” Dr. Howard said.

“These patients need a lot of fluid, but the pathophysiology is different than what you’d see with a splenic or liver laceration. You can’t just throw fluid at them, but you need to keep up with their ongoing fluid losses.

Sometimes without doing calculations people who don’t often see burn wounds will just give liter after liter, but there really is a ‘Goldilocks spot’ with resuscitation.”

The Parkland formula, 4 mL per hour per percent TBSA, is the calculation most commonly used for determining the volume of lactated Ringer’s needed. “For example, if you have a 20% TBSA, you’ll multiply that by the fluid rate in milliliters and also multiply that by the patient’s weight in kilograms,” Dr. Goddard said.

But this amount may vary a bit. The American Burn Association (ABA) recommends 2 mL per hour for flame burns, 3 mL per hour for pediatric patients and 4 mL per hour for electrical burns.

“The key is to monitor the patient’s urine output and gauge whether you need more or less,” Dr. Goddard said.

Another concern unique to burn patients is their nutritional needs. They may experience a hypermetabolic phase that could last months, even years. “They’ll need greater intake in the acute phase, when they’re the most hypermetabolic. These nutritional needs are reassessed at different stages,” Dr. Goddard said.

Patients who can’t consume adequate nutrition orally may need supplemental nutrition via nasogastric tube, but this raises another problem seen in burn patients: securing any type of tube or line.

“That’s a challenge for every burn center,” Dr. Howard said. “When you can’t secure an IV with tape because the wound is too weepy, suturing is the best and easiest thing to do. Endotracheal tubes can also be difficult—sometimes tying it around the patient’s head with an endotracheal tie is the easiest thing.”

Treatment Details Calculating Burn Extent and Fluid Needs Once you know the mechanism of injury, you’ll want to estimate the total burn surface area (TBSA), and there are a few methods for calculating it. James Howard, MD, a general surgeon in Kansas City, Kan., who is board certified in burn and wound and critical care, favors the rule of nines.

The initial management of a burn wound is a nonlinear cluster of events: removing clothing and jewelry, cooling the wound with warm water (not cold), covering the wound to manage pain and reduce the risk for infection, and optimizing pain control.

“Start with oral medications before you proceed to IV. You’ll want to have frequent discussions with patients

‘Start with oral medications before you proceed to IV. You’ll want to have frequent discussions with patients regarding their pain level.’

—Maria Goddard, MD, CWS

regarding their pain level,” Dr. Goddard said.

The mainstay of nonmajor burn care is topical treatment such as silver sulfadiazine (SSD) or mafenide. Prophylactic antibiotics are not recommended.

Dressings are handled as for any wound: Manage exudate, use dressings that reduce infection risk, and consider patient economics and access to care. “Make sure you have adequate pain control to tolerate the changes, and avoid wound cleansers like hydrogen peroxide that could be cytotoxic,” Dr. Goddard said.

Reevaluate within 24 to 48 hours to see if the wound is likely to heal on its own or if excision will be needed.

“For wounds that won’t heal, consider enzymatic debridement before surgery to remove some of the top layer before you need to perform sharp excision. Excision and skin graft placement can be performed in single or multiple steps,” Dr. Goddard said.

“In a patient with a larger TBSA burn where you’ll be limited for donor sites for skin grafting, you’ll want to be more cautious, especially if it’s in the early stages. If your patient can’t go to the operating room, you can use cellular or tissue-based products to aid with the closure of fourth-degree burns,” Dr. Goddard said.

Transfer to Burn Center Most surgeons would be comfortable managing second-degree burns and doing a skin graft, “say, a 5% or 10% burn on a nonfunctional or noncosmetic area,” Dr. Howard said.

Beyond that, the ABA has identified specific populations of burn patients who should be seen at a burn center: partial-thickness burns greater than 10% TBSA, all full-thickness burns, pediatric burns, inhalation injury, electrical or chemical injury, special anatomic areas (face, hands, joints), burns in combination with trauma, and patients with multiple medical comorbidities.

“Burn wounds are a constant threat to our community, so make sure that even the patients you see in clinic are keeping their water temperatures at appropriate levels and checking their smoke detectors, because we want to protect as many people as possible with prevention,” Dr. Goddard said.

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EXTENDED WOUND CARE COVERAGE

SEPTEMBER 2021 / GENERAL SURGERY NEWS

Targeted Nutrition Therapy: Key Ingredients to Support Wound Healing

By CHASE DOYLE

T

ime may not be able to heal wounds, as the saying goes, but the body can—with proper medical and nutritional support, according to recent data for targeted nutrition therapy.

During the Symposium on Advanced Wound Care Spring 2021 virtual meeting, Maritza Molina, RDN, and David G. Armstrong, PhD, DPM, of the Keck School of Medicine of USC, in Los Angeles, discussed how incorporating nutrition as part of the overall treatment plan can promote healing, decrease treatment duration and improve patients’ overall quality of life.

muscle mass in the groups that received HMB (Arch Gerontol Geriatr 2015;61[2]:168-175).

• Collagen protein: Hydrolyzed collagen protein stimulates internal collagen production, which has been shown to increase the rate of wound healing.

In addition to these ingredients, Ms. Molina noted the following micronutrients that support the wound healing process: • Zinc: important for skin integrity, mucosal membranes and immune response; • Vitamin C: promotes collagen synthesis for tensile strength, modulates immune function and acts as an antioxidant;

Nutrition Assessment and Treatment As a registered dietitian at USC, Ms. Molina’s primary role is nutrition optimization, which means improving wound healing through a nutrition-focused approach.

With tools such as nutrition-focused physical assessment, 24-hour recalls and lab work, Ms. Molina assesses the overall nutritional status of patients before and after surgery and manages nutrition-related diseases like diabetes and renal disease through intervention and education.

These macronutrient and micronutrient plans are individualized based on disease state and/or malnutrition risk. Ms. Molina noted the following key ingredients to support wound healing: • Arginine: A conditionally essential amino acid and precursor of nitric oxide, arginine is involved in vasodilation and blood flow support and plays a role in collagen synthesis. In combination with vitamin C, oral nutritional supplements containing arginine have led to greater improvement in pressure injury healing.

• Glutamine: Another conditionally essential amino acid, glutamine plays a role in collagen production, supports nitrogen metabolism and supports the immune system. A study of 40 patients with burns showed that supplemental glutamine led to improved healing and fewer wound infections (J Parenter Enteral Nutr 2003;27[4]:241-245).

• HMB (beta-hydroxy-beta-methylbutyrate): A metabolite of leucine, HMB slows protein breakdown, enhances protein synthesis and stabilizes the muscle cell membrane. A systematic review of seven randomized controlled trials of patients 65 years of age and older demonstrated greater

‘It’s important not to overwhelm patients with nutritional information. Remember to use your clinical judgment and take it one step at a time.’

—Maritza Molina, RDN • Vitamin E: plays a role in immune response and inflammation; and • Vitamin B12: important in the maintenance of red blood cells and supports wound strength.

Although there are clinical data to support each individual micronutrient, said Ms. Molina, when taken together, there is likely a better balance in tissue repair, wound healing and remission.

These macronutrients and micronutrients also have been shown to support wound healing at every stage of the healing process, including the hemostasis/inflammatory,

proliferative and maturation phases. However, vitamin therapy should only be provided when deficiencies are present or there is poor oral intake, Ms. Molina said.

Providers should consider conducting a 24-hour nutrition recall to determine whether more than 75% of estimated oral intake needs are being met.

“It’s important not to overwhelm patients with nutritional information,” Ms. Molina added. “Remember to use your clinical judgment and take it one step at a time.”

The Diabetic Foot: Common, Complex and Costly Dr. Armstrong, a professor of surgery and the director of the Southwestern Academic Limb Salvage Alliance at USC, reported that lower extremity complications in diabetes have become more expensive than the five most expensive cancers in the United States. Diabetic foot ulcers also are associated with similar rates of fiveyear mortality (approximately 30%).

According to Dr. Armstrong, the best available data have shown that after one year of follow-up, approximately 40% of patients will experience another foot ulcer, and at five years, nearly 75% of patients will develop another one.

“We’re speaking at a wound healing meeting, but can we really heal anyone in this patient population in the big scheme of things?” Dr. Armstrong said. “Even when these patients are supposedly healed, recurrence is likely.”

One strategy proven to be effective in diabetic foot ulcers, however, is oral nutritional supplementation. A randomized study of Juven (Abbott), a unique blend of HMB, arginine, glutamine, hydrolyzed collagen protein and other macronutrients, demonstrated significantly improved wound healing of stage 1A diabetic foot ulcers in patients at risk for poor limb perfusion and/or low albumin levels (Diabet Med 2014;31[9]:1069-1077).

No differences in healing were identified with supplementation in nonischemic patients or those with normal albumin levels.

“When we looked at the addition of this supplement as an adjunct to standard of care, it appears that the more [the patient] needs, the better it starts to work, which is usually the opposite of what we see in many clinical trials,” Dr. Armstrong said.

“It’s time to start paying attention to nutrition and measuring what we manage,” he added. “We’ve ignored this issue for far too long.”

■

Updated Skin Antisepsis Guidelines Aim to Reduce Surgical Site Infections

By BOB KRONEMYER

S

ince its introduction in the 19th century, skin antisepsis has helped to reduce the incidence of health care– associated infections.

Updated guidelines from the Association of periOperative Registered Nurses (AORN) now offer new evidence to help interdisciplinary teams make decisions and standardize preoperative skin antisepsis protocols.

“Standardization eliminates variability, resulting in less waste, fewer errors and improved quality outcome,” said lead

author Karen deKay, MSN, RN, CNOR, CIC, a perioperative practice specialist at AORN, in Denver. “Skin antisepsis is a broad term that includes several interventions to reduce the microbial load on the patient’s skin and inhibit rapid rebound growth of microorganisms from the skin where the incision will be made.”

Skin antisepsis is important because the removal of soil and transient microorganisms, as well as the reduction of resident microorganisms, minimize the number of bacteria on the skin near the surgical site, according to Ms. deKay. “The intervention most perioperative

personnel are familiar with is surgical site preparation. When an incision is made, it compromises our body’s coat of armor and increases the likelihood of introducing microorganisms internally,” she said.

“Hence, reducing the number of microorganisms near the incision site decreases the chance of skin microorganisms entering the surgical site through the incision, thereby decreasing the change for a surgical site infection [SSI].”

Clinical practice guidelines for SSI prevention from various health agencies and professional societies recommend decolonization, alcohol-based skin

antiseptics and bundles to decrease the incidence of SSIs. “Most clinicians are aware of the benefit of decolonization in reducing SSIs,” Ms. deKay said. “However, they may not be aware that decolonization is not indicated for all surgical patients and that community, hospital and procedure risk factors need to be evaluated by an interdisciplinary team to determine which surgical population would benefit the most from decolonization.”

Likewise, clinicians are mindful of the need to decolonize for colonization continued on the following page

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EXTENDED WOUND CARE COVERAGE

GENERAL SURGERY NEWS / SEPTEMBER 2021

Using Machine Learning to Predict Surgical Site Infections continued from page 1

emeritus of surgery at Weill Cornell Medicine, in New York City, and the executive director of the Surgical Infection Society Foundation for Education and Research.

“Studies of SSI prevalence are challenging to perform and interpret if not done prospectively, using trained observers inspecting each incision,” Dr. Barie told General Surgery News. “Retrospective studies always leave doubt as to what exactly was observed, whether patients were omitted inadvertently because of sporadic reporting from the outpatient setting, or if data reporting is incomplete. Moreover, thousands of patients are required to achieve adequate statistical power to study clean operations owing to the low prevalence of infection.”

One study, conducted by researchers at Mayo Clinic in Rochester, Minn., addressed the problem of missing data, which can skew retrospective analyses and subsequent prospective predictions of SSIs. “The nice thing about machine learning is that it allows the system to refine a model as it evolves, as long as you can get data for the system to look at; we wanted to know what the impact of missing data is on the ability to model infections,” said Robert Cima, MD, a professor of surgery at Mayo Clinic College of Medicine and Science, in Rochester, Minn.

“What we found is that unless you do certain corrections, your model is going to suffer from it.”

To evaluate a method for handling missing data, Dr. Cima and his colleagues compared a Bayesian-Probit regression model with multiple imputation (BPMI) with a generalized linear model (GLM) in predicting colorectal deep organ-space SSIs (C-OSIs, e.g., postoperative intraabdominal abscess).

Among the 2,376 elective colorectal resections performed at Mayo Clinic between 2006 and 2014, the C-OSI rate was 4.6% (108). The BPMI model identified 57 of these patients: a sensitivity of 56%, compared with the GLM’s sensitivity of 47%. The BPMI model lost its advantage when the model was built to use extrainstitutional data (i.e., based on the American College of Surgeons National Surgical Quality Improvement Program), which reduced its sensitivity to 47%.

They concluded that for optimal performance, the BPMI model should be built using “data specific to the individual institution” (Surg Infect 2021;22[5]:523-541).

“We’re going to be seeing more and more of these models, and people need to understand the limitations of them,

and how to use them in their institution,” Dr. Cima said.

‘We’re at the beginning of an “My concern is that someacceleration of having machine body will develop a big learning and AI used more model based on a very heterogeneous data set that may widely in health care, but the not reflect the risk profile work to validate models isn’t or the patient profile of an individual hospital. I’d hate always done optimally. In many to see them penalized or instances, we expect it to be like made to look like they’re not performing well when the a “plug-and-play” technology, model was never designed where you install the solution in to be used in their environand it works.’ ment,” Dr. Cima said.

Because retrospective chart —Genevieve Melton-Meaux, MD, PhD review is cumbersome, other investigators have sought to automate the process using machine learning and natural-language processing. The Surg 2021;232[6]:P963-P971). other study, which specifically investigated the gener“Currently there is no standard way SSIs are docalizability of SSI-detection machine learning–gener- umented in the EHR that would make it easier for a ated algorithms, found that machine learning models person to extract the data—if they are documented at designed at one center worked just as well at another. all. Here, they’re using machine learning and AI to go “We’re at the beginning of an acceleration of having through records looking for certain terms that correlate machine learning and AI used more widely in health with the presence of an SSI, saying that the process of care, but the work to validate models isn’t always done screening might be automated, with a particular advanoptimally. In many instances, we expect it to be like a tage that the need to manually review low-risk cases ‘plug-and-play’ technology, where you install the solu- might be eliminated,” Dr. Barie commented. tion in and it works. But the truth is, in some cases there “Basically, they’ve developed a tool that makes it easis a degradation in performance or the need for more ier for the surveillance people to find these SSI cases optimization,” said Genevieve Melton-Meaux, MD, accurately.”

PhD, a professor of surgery and Institute for Health So, what explains the discrepancy in generalizability Informatics core faculty at the University of Minnesota between the two papers? Both Drs. Cima and Melton Medical School, in Minneapolis. suspect it has to do with characteristics of the instituTo do so, Dr. Melton and her colleagues tested auto- tions, the types of patients they see and the way their mated SSI-detection algorithms developed and vali- surgeons practice, and the questions that each of the dated using electronic health record (EHR) data from algorithms are designed to answer.

8,883 patients at their institution, and then applied “In our case, it appears that what we used to build those algorithms to 1,473 patients at the University of the model is robust and good, but it’s unclear if that California, San Francisco. would scale across the country. These were both acaLooking at the detection of superficial, incisional, demic health systems; it might be different at a smallorgan-space and total SSI complications, the research- er center, or with different patient populations or over ers found no difference in area under the curve for any time as surgical practices change,” Dr. Melton said. outcome. They concluded that the algorithms devel“These are important questions that we’re going to ■ oped at one site are generalizable to another (J Am Coll need to be able to answer more and more.”

Antisepsis continued from the previous page

of methicillin-resistant Staphylococcus aureus (MRSA). “However, they may not be cognizant of the need to also decolonize for methicillin-susceptible Staphylococcus aureus colonization,” Ms. deKay said. “Patients with both methicillin-susceptible and methicillin-resistant S. aureus in their nares or on their skin are more likely to develop Staphylococcus aureus SSIs.” Bernard Camins, MD, the medical director of infection prevention for the Mount Sinai Health System, in New York City, and a member of the AORN Guidelines

Skin antisepsis is important because the removal of soil and transient microorganisms, as well as the reduction of resident microorganisms, minimize the number of bacteria on the skin near the surgical site.

Advisory Board, noted the guidelines will decrease the risk for developing infections after surgery, “therefore decreasing the risk of death, hospitalization, prolonged recovery and even long-term complications. By reducing complications, the guideline promotes patient safety.”

Dr. Camins said the current and previous versions of the AORN guidelines “provide clinicians the tools necessary to reduce the bioburden found on the skin to avoid contamination of the surgical wound.

Skin antisepsis is one of the most important measures to prevent infections during surgery.”

Following the recommendations of the guidelines and the manufacturer’s

instructions for using antiseptic solution carefully “will result in a lower risk for the development of SSIs,” he said.

However, one potential obstacle in implementing the guidelines is the time and resources required to form an interdisciplinary team or using a facility’s current SSI prevention task force “to take a closer look at how preoperative patient skin antisepsis elements can contribute to a reduction in the facility’s SSIs,” Ms. deKay said. And if these elements are already part of a facility’s SSI bundle, “you need to provide the resources necessary to establish a process that will closely monitor adherence to these practices, as regular observation of processes can identify inconsistencies and areas for improvement.”

■

Adjust Your Perspectice Using the da Vinci Firefly Imaging System The da Vinci Xi® and da Vinci X™ surgical systems with integrated fluorescence imaging capability provide you with real-time endoscopic visible and near-infrared fluorescence imaging.

This fluorescence imaging capability provides you with the opportunity for visual assessment of at least one of the major extra-hepatic bile ducts, as well as the cystic artery during cholecystectomy procedures performed using the da Vinci® system. It can also be used to assess vessels, blood flow, and related tissue perfusion during cases across your da Vinci Total Practice* when indicated.

White Light Imaging Firefly imaging is not visible in white light imaging mode.

Standard Firefly Mode In Standard mode, the image is displayed as a fluorescent green overlay on a black and white background view. The closer the endoscope is to the tissue, the stronger (more intense green) the signal appears.

Sensitive Firefly Mode In Sensitive mode, the system attempts to automatically adjust the signal intensity and brightness to be consistent, whether the endoscope is moved closer or farther away from the tissue.

Note: Sensitive Firefly mode is only available with Endoscope Plus.

Scan to learn more about the evolution of surgery

Images above show porcine pelvic vasculature using the da Vinci Xi Endoscope Plus. * Total da Vinci Practice refers to the transferable value of da Vinci surgery across procedures in surgeon’s minimally invasive surgery (MIS) practice. It is at the surgeon’s discretion to determine when a patient is a candidate for MIS surgery and whether da Vinci surgery is an option.

Firefly Fluorescence Imaging The da Vinci fluorescence imaging vision system (Firefly® fluorescence imaging) is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci fluorescence Imaging vision system enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow, and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.

recommended. Anaphylactic deaths have been reported following ICG injection during cardiac catheterization.

Total ICG dosage should not exceed 2 mg/kg per patient.

Anaphylactic or urticarial reactions have been reported in patients with or without histories of allergy to iodides.

Fluorescence imaging of biliary ducts with the da Vinci fluorescence imaging vision system is intended for adjunctive use only, in conjunction with standard of care white light and when indicated, with intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Da Vinci Xi/X system precaution statement The demonstration of safety and effectiveness for the specific procedure(s) discussed in this material was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.

Intuitive’s ICG packs are available for sale in the U.S. ONLY. Intuitive’s ICG packs are cleared for commercial distribution in the U.S. for use in combination with the fluorescence-capable da Vinci HD vision system and Firefly integrated hardware.

Intuitive-distributed ICG contains necessary directions for use of ICG with Firefly fluorescence imaging. Using generic ICG with Firefly fluorescence imaging is considered off-label and is not

Important safety information For Important Safety Information, indications for use, risks, full cautions and warnings, please refer to www.intuitive.com/safety.

© 2021 Intuitive Surgical, Inc. All rights reserved. Product and brand names/logos are trademarks or registered trademarks of Intuitive Surgical or their respective owner.

See www.intuitive.com/trademarks.

1089596-US RevA 09/2021

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20

IN THE NEWS

GENERAL SURGERY NEWS / SEPTEMBER 2021

The Most Compelling Breast Surgery Papers of 2020 Surgeon Continues Her Annual List of Top Research in the Field

By MONICA J. SMITH

S

earching PubMed for breast cancer‒related papers in 2020, Helen Pass, MD, the chief of breast surgery and co-director of the Stamford Hospital Breast Cancer Center, in Connecticut, found 14,000 in English alone. Dr. Pass presented the ones she considered most compelling at the 2021 virtual meeting of the American College of Breast Surgeons.

“I tend to select those that are landmark studies, have clinical value, or were a source of patient inquiries or national media attention,” Dr. Pass said.

The Tyrer-Cuzick Model Inaccurately Predicts Invasive Breast Cancer Risk in Women With LCIS (Valero MG, et al. Ann Surg Oncol 2020;27[3]:736-740) The Tyrer-Cuzick (TC) model has been found to overestimate the risk for breast cancer in women with atypical ductal hyperplasia. To assess the accuracy of the TC model in women with lobular carcinoma in situ (LCIS), researchers conducted a retrospective review of 1,192 women, of whom 128 developed invasive breast cancer. Their 10-year cumulative incidence was 14%, but the median 10-year TC score was 20%. The authors concluded that the model may overestimate the risk for invasive cancer in women with LCIS and should not be used in this high-risk group.

“An editorial accompanying this paper concluded that the population estimate of 1.5%-per-year breast cancer risk after the diagnosis of LCIS is probably the most accurate data to use. This means that at five years, everyone with LCIS would have a lifetime risk of 7.5%, making them eligible for chemoprevention; and at 20 years, the risk would be 30%, above the screening threshold for MRI. No matter what model we use, LCIS is recognized as a high-risk condition, and these options should be offered to patients,” Dr. Pass said.

Breast Cancer Screening Recommendations: African American Women Are at a Disadvantage (Rebner M, Pai V. J Breast Imaging 2020;2[5]:416-421) The authors of this paper make the case that guidelines for breast cancer screening are disadvantageous to African American women based on the fact that breast cancer is more common before age 50 in Black women than non-Black women, that triple-negative cancer is more common in Black women, that BRCA mutations are more common in Black women than in white women except for those of Ashkenazi Jewish ancestry, and that breast cancer mortality has decreased to a lesser degree in Black women since 1990.

“Although the reasons for the above are multifactorial, one simple step may be to modify screening recommendations based on risk—which the U.S. Preventive Services Task Force states we should do—but, more importantly, to incorporate race into the risk calculators,” Dr. Pass said.

Survival Outcomes of Screening with Breast MRI in Women at Elevated Risk of Breast Cancer (Bae MS. J Breast Imaging 2020;2[1]:29-35) To compare combined MRI plus mammography with mammography alone, researchers evaluated cancer detection rates and overall survival in 3,002 women with an

increased lifetime risk for breast cancer. The cancer detection rate was higher in the MRI plus mammogram group (1.4% vs. 0.5%), as was overall survival. The authors concluded that combined MRI and mammography in women with elevated risk improves both end points.

“These results differ from the previous study that showed no difference, probably because the two groups compared were contemporaneous instead of sequential. For high-risk populations, the addition of MRI to mammogram is beneficial; however, the role of MRI in screening women with a personal history of breast cancer remains controversial,” Dr. Pass said.

this difference—less than 10 points on a scale of 0 to 100 at six, 12 and 48 hours—was not clinically meaningful. Gabapentinoid use was also associated with a significantly lower level of opioid use, but again, this was not clinically meaningful, and there was no effect on long-term opioid use.

Gabapentinoids were associated with a host of negative effects, such as dizziness, balance disorders, visual disturbance, sedation and cognitive impairment, and postoperative pulmonary complications up to and including mechanical ventilation, and hence increased length of stay. The authors concluded that the available

Fertility Preservation Before Breast Cancer Treatment Appears Unlikely to Affect Disease-free Survival at a Median Follow-up of 43 Months After Fertility-Preservation Consultation (Letourneau JM. Cancer 2020;126[3]:487-495) Another in a series of articles showing that fertility preservation is unlikely to affect disease-free survival, this retrospective review of 329 patients, 207 of whom had fertility preservation and 122 who did not, found no difference in overall disease-free survival over a median follow-up of 43 months. This study included women with estrogen receptor‒positive cancer who underwent neoadjuvant chemotherapy with their tumor in situ during their fertility preservation treatment.

“The strengths of this study compared to others are that it was large, it used modern fertility preservation techniques and had a longer follow-up. It was also more aligned with real-world use, with the inclusion of neoadjuvant chemotherapy (NAC) patients, those who were younger and those with more aggressive disease. So, again, I think we can reassure our patients that fertility preservation is safe and should be offered to women desiring future fertility,” Dr. Pass said.

literature does not support the routine use of gabapentinoids for postoperative pain prevention or treatment.

“The French Society of Anesthesia and Intensive Care Medicine now states that gabapentinoids should not be used systemically or in outpatient surgery as part of ERAS protocols, and it calls into question our ERAS protocols. Personally, I think a greater emphasis on preoperative teaching and expectation setting is needed, as many patients expect no pain after surgery.

“I also recommend reading the accompanying editorial by the editor-in-chief of Anesthesiology, as it makes many important, salient points,” Dr. Pass said.

Perioperative use of gabapentinoids for the management of post-operative acute pain: a systematic review and meta-analysis (Verret M, et al. Anesthesiology 2020;133[2]:265-279.

See also the accompanying editorial, “Perioperative gabapentinoids: deflating the bubble.”)

In this review of gabapentinoids as a pain treatment after surgery (comprised of 281 randomized controlled trials and 24,682 adult subjects), researchers found gabapentinoids to be associated with significantly lower pain intensity compared with control treatment. But

Accuracy of post-neoadjuvant chemotherapy imageguided breast biopsy to predict residual cancer (Tasoulis MK, et al. JAMA Surg 2020;155[12]:e204103) In this assessment of image-guided breast biopsy to predict residual cancer in the breast after NAC, researchers reported a false-negative rate of 18% in 159 of the 166 post-NAC breast cancer patients for whom the core biopsy was representative. But when selection was limited to patients who did not have lobular cancer, whose residual imaging abnormality was 2 cm or less, and those who’d had at least six vacuum-assisted core specimens taken, the false-negative rate fell to 3.2%. The authors concluded that a standard protocol using at least six representative samples in patients with less than or equal to 2 cm of residual imaging abnormality can help reliably identify patients after NAC with no residual disease.

“I think many of us are skeptical that we can accurately select a cohort of patients after NAC in whom the ultimate surgical deescalation could occur, and I have to applaud Henry Kuerer for championing this trial,” Dr. Pass said. continued on page 22

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22

IN THE NEWS

Breast Papers continued from page 20

Impact of Surgical Margins in Breast Cancer After Preoperative Systemic Chemotherapy on Local Recurrence and Survival (Wimmer K, et al. Ann Surg Oncol 2020;27[5]:1700-1707) In this retrospective review of 406 women with a median follow-up of 84.3 months, researchers found no difference between narrow and wide margins in relation to local recurrence‒free survival or disease-free survival, and patients with a pathologic complete response had the best local recurrence‒free and diseasefree survival.

“What this tells us is that the ‘no ink on tumor’ definition of a negative margin remains appropriate even after NAC, that removing normal tissue is not beneficial,” Dr. Pass said.

Surgical Margins and Adjuvant Therapies in Malignant Phyllodes Tumors of the Breast: A Multicenter Retrospective Study (Neron M, et al. Ann Surg Oncol 2020;27[6]:1818-1827) In this multicenter review of 212 patients with malignant phyllodes tumors, wide margins (≥8 mm) were not superior to narrow margins (3-7 mm), and mastectomy improved local recurrence‒free survival but not overall survival. The authors concluded that surgery remains the cornerstone of treatment; that a margin of 3 mm or greater seems optimal; that when needed, a second surgery should be performed to obtain these margins; and that breast conservation is a viable option for appropriate tumors.

“Historically, a 1-cm margin has been advocated for malignant phyllodes tumors. This large study with accurate information on margin width supports the use of at least a 3-mm margin. It also supports the use of breast-conserving therapy in appropriately selected patients, and it made the note that although preoperative diagnosis of malignant phyllodes tumors is difficult, it does facilitate proper surgical planning,” Dr. Pass said.

Microscopic Extracapsular Extension in Sentinel Lymph Nodes Does Not Mandate Axillary Dissection in Z0011-Eligible Patients (Barrio AV. Ann Surg Oncol 2020;27[5]:1617-1624) To determine the necessity of axillary dissection in patients with microscopic extracellular extension (mECE), researchers compared outcomes in 811 patients with or without mECE treated with sentinel lymph node biopsy alone.

All patients were clinically T1 or T2, node-negative, and prospectively managed according to Z0011 criteria; mECE

GENERAL SURGERY NEWS / SEPTEMBER 2021

was identified in 31% of the 685 patients with positive nodes who did not undergo complete axillary dissection. At a median follow-up of 41 months, mECE did not affect the five-year rate of nodal recurrence, local recurrence or distant recurrence. The authors concluded that in Z0011 eligible patients, the presence of mECE should not be considered an indication for complete axillary lymph node dissection.

“To me, this data is very reassuring. However, remember that patients with gross ECE have traditionally not been offered SLN [sentinel lymph node] biopsy and this distinction is important,” Dr. Pass said.

Omitting Radiotherapy Is Safe in Breast Cancer Patients 70 Years Old After Breast-Conserving Surgery Without Axillary Lymph Node Operation (Zhong Y, et al.

Sci Rep 2020;10[1]:19481) Previous studies have shown that omitting radiotherapy after breast-conserving surgery with axillary surgery is safe in elderly patients. But can both lymph node surgery and radiation be avoided in women over 70? This retrospective analysis of 481 older patients, with a median follow-up of five years,

found a higher in-breast tumor recurrence in the 302 patients who had neither nodal surgery nor radiation, but no difference in disease-free survival, breast cancer‒specific survival or distant metastasis rate compared with patients who underwent more extensive treatment.

“I always felt like I struggled between omitting a sentinel lymph node biopsy or omitting radiation therapy, and I found it very reassuring that we may be able to omit both of these treatments for women with early-stage, hormone receptor‒positive, HER2-negative disease who are 70 ■ years of age or older,” Dr. Pass said.

For complex hernia repair

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

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

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

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

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

SEPTEMBER 2021 / GENERAL SURGERY NEWS

Clinical Pearls in Hernia Repair: Avoiding Errors

By CHASE DOYLE

H

ernia repairs can be a challenging surgical problem, even for experienced surgeons. During MedStar Georgetown University Hospital’s Abdominal Wall Reconstruction 2021 Conference, Jeffrey A. Blatnik, MD, noted several tips and tricks for avoiding errors when performing these complex procedures.

According to Dr. Blatnik, an associate professor of surgery at Washington

University in St. Louis, the most important step is to understand the limits of the hernia, the patient and the hospital, respectively, before the procedure. This means considering the patient’s age, medical conditions, the size of the hernia, complications from prior operations and several other factors.

“Having these limitations in the back of your mind when you start to evaluate complex hernia patients can help you avoid making the first error of operating

on somebody that you or your facility lack the resources to take care of,” Dr. Blatnik said.

Dr. Blatnik shared the following clinical pearls:

Getting Access Surgeons should develop a plan to get into the abdomen by studying the CT scan and abdomen. Previous repairs and the presence of old mesh are complicating factors for hernia repair.

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

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

91.7 7 YEARS %

†

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

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

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

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

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

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

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

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

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

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

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

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

DON’T MESH AROUND

“I try to get into the abdomen away from previous surgery,” said Dr. Blatnik, who noted that this is primarily done via sharp dissection. “I use a scalpel to feel the fibers of the old mesh as I divide them, and I like to open the entire midline before dissecting out laterally.”

With respect to lysis of adhesions, Dr. Blatnik recommended “finding a plane out lateral and circling back.” He also advised “staying on the bowel side of things” to avoid inadvertently mobilizing the colon or injuring the peritoneum.

Dealing With Old Mesh Old hernia mesh is not only incredibly painful for patients but is the greatest predictive factor of challenges. Dr. Blatnik recommended dividing the mesh down the middle while opening the abdomen and then freeing underlying adhesions first.

“When removing old mesh, the lateral edge of old mesh is key,” he said. “If the mesh ends medial to linea semilunaris, you can usually salvage the posterior sheath. If it ends lateral to the linea semilunaris, however, you’re going to lose some peritoneum.”

Dr. Blatnik advised leaving old mesh in position while doing a release and removing it at the end. He also suggested using landmarks, such as tacks or sutures, when working around old mesh to mark borders.

“Mesh is not always a nice flat piece that can easily peel away,” he said. “I will not compromise the abdominal wall to remove every centimeter, especially if I’m not there for infection. Take care of unnecessary damage to the abdominal wall.”

Transversus Abdominis Release For complex hernia, transversus abdominis release is the most common approach. There are several places to start, including mid-rectus, over the transversus abdominis, below the arcuate line and the falciform ligament.

Choosing the right place depends on the patient’s history and the part of the peritoneum or posterior sheath that is most preserved.

“Medial tension is key,” Dr. Blatnik said. “I do this with three clamps, evenly spaced, with cautery along the way.” continued on page 25

24

IN THE NEWS

GENERAL SURGERY NEWS / SEPTEMBER 2021

GI Emergencies continued from page 1

emergency nonoperatively so that abdominal reconstruction does not have to be done simultaneously or violate a previous successful ventral incisional hernia repair,” said Dr. Matthews, a professor and the chair of surgery at the University of North Carolina and the surgeon-in-chief at Atrium Health, in Charlotte.

Acute Appendicitis According to Dr. Matthews, NOTA (Non-Operative Treatment for Acute

Appendicitis) was one of the first studies to define short- and longterm outcomes of nonoperative treatment for acute appendicitis, demonstrating a one-year ffailil ure rate of approximately 30% (Ann Surg 2014;260[1]:109-117).

“In an emergency involving a complex ventral hernia, this may provide adequate treatment to take care of patients in an elective fashion,” said Dr. Matthews,

who noted that a scoring syste system is being developed to pre predict which patients will fail and which ones will be successful with nonoperative treatment.

The CODA COD (Comparison of Outcomes of Antibiotic Drugs and trial showed d Appendectomy) A d that patients with an appendicolith have approximately double the failure rate (30%) at 90 days of patients who do not have an appendicolith, suggesting one possible way to stratify patients (N Engl J Med 2020;383[20]:1907-1919).

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Small Bowel Obstruction For cases of small bowel obstruction, water-soluble contrast studies can help predict which patients will be successful with nonoperative treatment. According to Dr. Matthews, prospective randomized trials have shown reduced operative rate and time to resolution of obstruction as well as rshorter hospital stays with contrast studies (World J Surg 2008;32[10]:2293-2304).

Dr. Matthews and his colleagues perform a CT scan of the abdomen/pelvis during initial assessment to examine peritoneal fluid, small bowel thickening, differential enhancement and pneumatosis intestinalis.“If contrast appears in the colon within 24 hours and there’s been no clinical changes of concern, we’ll continue with conservative management,” he explained. “If contrast fails to appear in the colon within 24 hours, however, this is typically diagnostic of a complete obstruction that requires surgical intervention.”

“This is still a difficult area to manage patients because there is a significant amount of clinical judgment that is required,” he added.

Diverticulitis

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As Dr. Matthews explained, besides appendicitis, there is probably no other surgical condition that has been studied with more rigor than diverticulitis, and there are several management guidelines available.

A prospective randomized trial of elective resection versus observation in diverticulitis with extraluminal air or abscess initially managed conservatively found that only 20% of patients randomized to observation had a recurrence within one year, and many of these patients could still be managed nonoperatively (Br J Surg 2018;105[8]:971-979).

“This study showed that the majority of patients observed following conservative management of diverticulitis with local extraluminal air do not require elective surgery,” Dr. Matthews said.

“These patients can be managed nonoperatively and avoid exploration, whether laparoscopic or open, and violation of the hernia … during a contaminated procedure.”

Acute Cholecystitis According to Dr. Matthews, there is a growing body of literature supporting the value of percutaneous cholecystostomy tube placement to treat acute cholecystitis. A recently published study of 70 patients treated with percutaneous cholecystostomy tube alone found that 12.9% developed recurrent biliary sepsis necessitating readmission following initial resolution of symptoms and tube removal (J Gastrointest Surg 2020;24[3]:627-632).

IN THE NEWS

SEPTEMBER 2021 / GENERAL SURGERY NEWS

Hernia Errors continued from page 23

Dr. Blatnik encouraged surgeons to gain experience differentiating the peritoneum from the transversalis fascia, a thin aponeurotic membrane that lies between the inner surface of the transverse abdominis and the parietal peritoneum. This is an important distinction, especially in the subcostal region where the peritoneum can be very thin, he said.

When doing a release, Dr. Blatnik underscored going laterally around thin or challenging areas before working back.

“There’s a perception that that rate is much higher and that these patients will require elective cholecystectomy in the postoperative period,” said Dr. Matthews, who noted that no difference in survival was observed between patients receiving percutaneous cholecystostomy tube alone and subsequent interval cholecystectomy.

“Unfortunately, management of percutaneous cholecystostomy tubes can be fairly labor-intensive and involve both surgery and interventional radiology,” he acknowledged. “A large number of patients will require multiple interventions to be managed successfully.”

Perforated Ulcer A study of nonoperative treatment for perforated ulcer, first published in 1989, demonstrated a mortality rate that was similar between immediate surgery and nonoperative treatment (N Engl J Med 1989;320[15]:970-973). According to Dr. Matthews, however, the key is selecting those patients who are appropriate for nonoperative treatment, because many patients are not in that category.

A study that looked at stratifying high-risk patients into nonoperative treatments showed a reduction in mortality from 8.9% to 3.5% among patients who underwent an aggressive approach with peritoneal drainage (World J Surg 2007;31[12]:2341-2344).

“There is certainly a lot more to understand about who will be successful with nonoperative treatment of perforated peptic ulcer,” said Dr. Matthews, who noted that several studies have also looked at endoscopic therapies as well as using endoscopy to diagnose these patients.

A recently published pilot study to evaluate the effectiveness and safety of urgent endoscopy for gastroduodenal perforation showed that patients with a perforation diameter less than 5 mm were more likely to be successful with nonoperative treatment (Surg Endosc 2021 May 19. doi:10.1007/s00464-021■ 08555-2).

If a difficult closure is anticipated, use the hernia sac as part of posterior closure, he said.

Closing the Posterior Sheath For patients with a straightforward midline hernia without a hernia repair history, closing the posterior sheath can be a straightforward process. For many patients, however, this part of the surgery may require creativity, Dr. Blatnik said.

For a posterior sheath that won’t close, Dr. Blatnik advised getting lateral and saving the part with the greatest tension for last. By removing the safety towel at

that point, some of the tension can be relieved. “It’s also important not to rely on suture to pull the edges together, and if it still won’t close, then patch,” he said.

Dr. Blatnik also recommended using omentum for small holes and absorbable mesh for larger holes. Lateral holes in the posterior sheath should be closed transversely to avoid additional midline tension. “If peritoneum is tearing, then incorporate omentum,” he explained.

“Divide the rectus fascia and flap out lateral to fill space. If you need to repair the posterior sheath with mesh, try to do it midline.”

Closing the Fascia Run primarily with long-term absorbable suture. As the tension increases, however, surgeons should transition to figure 8 sutures, and if there is a big lateral defect from a transverse incision, a barbed suture is recommended. Dr. Blatnik also advised keeping an eye on airway pressures as the fascia is closed.

“Ultimately, do everything you can to preserve the peritoneum,” Dr. Blatnik concluded. “And when the going gets tough, get lateral and work your way back to the midline.”

■

25

26

IN THE NEWS

Malpractice continued from page 1

sued twice or more.

“Unfortunately, it’s just part of medicine. If you do enough surgery, you will almost inevitably get sued,” said Frank J. Borao, MD, who specializes in foregut and bariatric surgery and has been the director of minimally invasive surgery at Monmouth Medical Center, in New Jersey, for 20 years.

The reasons for litigation are not always tied to poor outcomes. “It could be a matter of poor communication with a patient, a misunderstanding of something you discussed or an unrealistic expectation of the surgical outcome. You’re not always sure why someone sues you,

but you do want to figure out why this event occurred so you can avoid it in the future,” Dr. Borao said.

The Nuts and Bolts of a Malpractice Suit The first thing to do when you learn you are facing a lawsuit, either through an attorney’s request for medical records or by being served a complaint, is to notify your employer—if you have one—and call your malpractice insurer to put them on notice.

“Do this as soon as you can, because sometimes there is an opportunity to settle the case before it’s even filed,” said Svetlana Ros, a partner and the chair of the Health Care Practice Group with Pashman Stein Walder Hayden, a law firm headquartered in Hackensack, N.J.

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According to the American Medical Association, 63% of general surgeons face a malpractice suit at least once, and 50% are sued twice or more.

Upon learning of the claim filed against you, your insurer will appoint an attorney who will contact you, review records, begin to consult experts and try to determine the strengths and weaknesses of the case.

“Generally, the answer—the response from the defense—is due within 35 days of being served,” Ms. Ros said. Thus, it is important to put your malpractice carrier on notice quickly, so that counsel can be assigned, and ensure timely filings of appropriate response to the complaint.

Then the discovery period begins, with the two sides exchanging interrogatories (i.e., written questions and answers), document requests, expert reports and depositions.

“The plaintiff has an opportunity to research the defendant; the defendant has an opportunity to build their case against the plaintiff. Simply put, it’s the period when both sides can dig deeper to decide the strength of each other’s case. It’s usually an extensive period of time, during which a lot of cases settle,” Ms. Ros said.

The deposition is a formal, sit-down, question-and-answer meeting in which the defense, plaintiff, experts and witnesses give sworn testimony. Although depositions do not involve a judge, they are given under oath and include a court reporter who transcribes the meeting; this material is admissible in court.

During the discovery period, both sides identify their expert witnesses.

“With regard to the medical care rendered, this will be someone in your specialty or subspecialty who will be able to give their opinion on the standard of care and whether or not you followed it,” Ms. Ros said.

“The search for experts will start pretty early on, because a lot of what happens is contingent on the plaintiff finding a credible expert. If they don’t have a strong expert, the plaintiff might be willing to accept less money to settle, and your lawyer will likely seek an order from the judge to dismiss the case. “Once the discovery is over, technically you would go to trial, but very few cases do.”

IN THE NEWS

SEPTEMBER 2021 / GENERAL SURGERY NEWS

Taking Care of Yourself and Your Case: Dos and Don’ts Figure out what happened. Dr. Borao advises surgeons facing a lawsuit, which he did himself about five years into practice, to find out what went wrong. This can take a bit of digging if you followed the standard of care and it isn’t obvious.

“Review the records, look at the hospital course, the documented discussions you had with the patient,” he said, noting that it’s good policy to record every exchange you have with a patient, discussions of various treatment options (including no treatment) and the possible outcomes of each.

“Because after the fact, when it’s time to go to trial, it can’t be ‘he said/she said’; in the world of law, if it’s not documented, it didn’t happen.”

It goes without saying: Never alter a record. “Always stick with the facts, with what’s documented,” Dr. Borao said.

Know your malpractice coverage. The type of malpractice insurance you have is usually based on the type of practice you have. “If you work for a private practice, you usually have a consent policy, which means you have to give consent in order for the case to settle. If you work for a large hospital or a hospital that’s selfinsured, you may have a non-consent policy, meaning that the hospital and the carrier don’t need your permission to settle if they think it’s in their best interest to do so,” Ms. Ros said.

Stay engaged with the case. Lawsuits can drag on for years, and you may feel you don’t have the time, or desire, to stay on top of the details of your case. But it’s in your best interest to keep informed with regular updates.

“Ask your malpractice attorney to provide you status reports, which they are consistently providing to the malpractice carrier. Especially if you have a non-consent policy, it’s vital to be engaged from the beginning because you probably have less of a driver’s seat than you would have with a consent policy,” Ms. Ros said.

Prepare thoroughly for deposition. Everything that comes up in a deposition is recorded, so accuracy is crucial. “If you’re not prepared and you say something that’s potentially harmful to you, it’s there, under oath, transcribed. If your case gets investigated by the board of medical examiners, that could hinder you before the licensing agency,” Ms. Ros said.

“My biggest piece of advice for doctors is to meet with your malpractice attorney and spend a few hours going over practice questions. You also want to go over the medical record and not rely on memory; review the record as if you were professionally critiquing someone else’s record,” Ms. Ros said.

Also, be aware that the deposition is not an opportunity for resolution, no matter how strong your case. “You’re not there to prove anything. You’re there to answer the questions as precisely as possible and just give those facts, nothing else. You’re not at trial,” Dr. Borao said.

Be nice. Everything in a case is being assessed, and that includes you.

“A lot of times, physicians take a very abrupt position that they have done nothing wrong, and they can be very confrontational. That’s probably not the best way to go,” Ms. Ros said.

“You could be the best surgeon, providing the best care, but if you come off as an unpleasant individual, nobody’s going to hear what you have to say. Likability is huge in a case.”

Try to keep things in perspective. “Initially you’re upset. A lot of surgeons feel they failed the patient, or they may take it personally. And then you get angry.

You work hard, do the best you can, and now you have to deal with this litigation, which is very time-consuming and could take years,” Dr. Borao said.

“But you can’t let it consume you. If

27

it becomes all-encompassing, you can’t focus on your work. It’s either going to get dropped, settled or go to trial, and all you can do is move forward with taking the best possible care of your current patients.”

Although defense is generally advised not to discuss their case with anyone besides their attorney, discussing what you’re going through—sans details—may be helpful, Ms. Ros said. “Talking to peers they trust, recognizing that they are not the only one. This is not going to go away quickly, so whatever doctors can do to find ■ peace of mind, they should do.”

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OPINION

GENERAL SURGERY NEWS / SEPTEMBER 2021

Surgery Is a Contact Sport continued from page 1

It was this realization that jogged my memory from surgical internship. “Surgery is a contact sport.” Almost 20 years ago, I first heard this statement from my senior resident. It was said many times throughout my residency, and I probably repeated it to interns and junior residents as I progressed in my training. It is possible that many of you have also heard this statement or repeated it to others. But until now, I did not fully comprehend what it meant.

Surgery is a mentally, emotionally and physically demanding profession. We spend countless hours in the OR for many years acquiring skills to operate safely and care for our patients. We learn disease processes, treatments and surgical techniques with increasing complexity and responsibility. We are expected to stand for hours—bodies contorted—to get the correct exposure, to perfect the dissection and complete the operation with the patient’s physical well-being as the main goal. But what we rarely take into consideration is the surgeon’s physical well-being.

Without a doubt, the patient’s welfare is the foremost consideration for every operation. But ignoring surgeons’ physical well-being does a disservice to our patients and our profession.

“Surgery is a contact sport” because surgeons are the endurance athletes of medicine. Athletes physically train their bodies to be able to maximally perform and avoid injury. So, why it is that, as surgeons, we don’t train our bodies to endure the repeated physical demands of our job?

In surgery, ergonomic modifications are helpful, but have their limitations, especially with challenging operations. Surgery-specific physical endurance training and body mechanics retraining can make a difference. Just as athletes train, continuously and without fail, surgeons should physically train. Regular, scheduled physical training with very specific body mechanics and strength training for surgeons can help to lower the chances of surgeon-specific physical problems.

Body mechanics for surgeons is rarely discussed.

Body mechanics is defined as “the study of the action of muscles in producing motion or posture of the body” (Farlex Partner Medical Dictionary, 2012). There are techniques of body mechanics retraining that can help minimize the chances of physical injury, especially during lengthy and difficult cases. These techniques are the ally of correct ergonomics; the two fields are necessary and collaborative. By applying correct body mechanics and using larger muscle groups, stress can be off-loaded away from the neck, back and arms of a surgeon. But this type of massive change to physical behavior is not intuitive. It requires surgeon-specific body mechanics and strength training and retraining, along with continued regular maintenance during dedicated time.

It is time we bring the importance of surgeons’ physical well-being to the forefront of practice. We must recognize that the problem exists, then quickly, as a community of surgeons, make the concerted effort to maximize prevention, set aside regular time for body

mechanics and strength training, and not be hesitant to seek medical attention if any pain or problems are ongoing. We are the endurance athletes of medicine, and we must start acting as such. Together, we can improve physical health and increase career longevity for all surgeons. Together, we can ensure the future of surgery— resolute with enduring strength and health.

Below, we highlight some techniques that can help surgeons get started on their body mechanics and strength training routines. Jarel Russell, OTR/L, is a doctor of occupational therapy with certifications in orthopedic manual therapy, concussion rehabilitation and advanced hand therapy. He specializes in treating surgeons.

Dr. Russell has developed Elite Prehab, an individualized program for surgeons to improve specific body mechanics, functional strengthening, postural retraining and neuromuscular reeducation. The goal is to maximize career longevity and minimize career-related physical injuries. Dr. Russell has a background in the prehabilitation/rehabilitation of combat athletes and blood flow restriction therapy.

As with any other physical training program, a thorough evaluation and skilled progression through a treatment program with a specialist is best to maximize therapeutic results and prevent further injury. For surgeons with current neck, back or arm pain, please do not ignore or disregard the problem; get evaluated and maximize correction and treatment as much as possible. ■

Surgical Injuries: The Problem, the Solution, the Prevention

By JAREL RUSSELL, OTR/L

T

he C5-C7 cervical spine segment is frequently affected by poor posture and highly susceptible to pathologic diseases such as degeneration, disk herniation, radicular pain and trauma. By design, the C1-C2 segments are the load-bearing joints during upright activity. However, when surgeons are performing open operations, the C5-C7 cervical segments function as high load-bearing joints. These segments provide flexibility and support to much of the neck while in an operating posture. Not having adequate muscle balance while operating results in pathology of these spinal segments.

Pain is a precursor that signals the beginning of a problem. If pain is ignored, the disease process progresses.

Key concepts of pain science explain the interaction of pain and prolonged operating posture. The three key concepts are: • trauma • muscle imbalance • compensatory movement patterns Each of these key components feeds into the other.

The figure below illustrates that it does not matter which event occurs first. Prolonged operating posture is a hidden component that can lead to further advancement along the pain continuum.

Pain

Core Muscle Complex External (But also internal) obliques

Rectus Abdominis

Diaphragm Multifidus

Pelvic Floor Muscle

Erector Spinea

Quadratus Lomborum

Transversus Adbominis

Trauma Altered Movement Patterns

While the research does not support the ideology of “perfect posture,” every individual has an ideal posture that can aid in the prevention of injuries. The foundation to optimal posture is built upon a strong core. The concept of the “core” muscles is more extensive than most people realize and encompasses numerous muscle groups, as illustrated below. The core plays a role in almost every movement the body makes. From walking to running to sitting, picking up objects from the floor or top shelf, to maintaining a prolonged posture during a surgical procedure, your core is activated and supporting you during all these activities. A strong core can help prevent forward head posture to stabilize the C5-C7 cervical segments for surgeons.

Muscle Imbalance

The other two muscle groups that stabilize the cervical spine are the periscapular and deep neck flexor muscles. Weak periscapular muscles often lead to muscle

imbalance and upper crossed syndrome. With upper crossed syndrome, the shoulder, chest and neck muscles are imbalanced with some being weak and others tight.

The syndrome is a component of poor posture of the shoulders and upper back. The deep neck flexors help to maintain neck stability and are an essential component of good posture. Research shows that 70% of people with chronic neck pain have weak deep neck flexor muscles (J Phys Ther Sci 2016;28[1]:269-273). Strengthening these muscles involves a neuromuscular reeducation program that should be completed with a specialist.

I would like to stress that therapy should be used for both prevention and recovery. Typically, the underlying pathology is complex, and stretching alone is not a good treatment. However, it is useful when combined with an individualized program consisting of strengthening and orthopedic manual therapy techniques. This is the premise behind the Elite Prehab program for surgeons.

Elite Prehab involves individualized orthopedic evaluation using differential diagnosing, postural analysis and neurodynamic assessment. The goals are twofold. The first goal is to uncover the underlying reason for pain and muscle imbalances to fully understand the pathology impeding performance. The second goal is prevention of any future problems that commonly plague surgeons.

Each surgeon should have a customized program for their unique situation. The exercises can be easily incorporated into normal daily routines. The goal of the program is to maximize performance of essential job-related tasks, while improving function of everyday activities. It is skilled progression through a treatment and prevention program with neurodynamic cervical stabilization and strength/balance restructuring that

OPINION

SEPTEMBER 2021 / GENERAL SURGERY NEWS

can prevent problems, relieve pain and allow surgeons to maximize career longevity in the context of optimal physical health.

Common Exercises Prescribed for Home Exercise Plans Deep Neck Flexor Activation Deep neck flexor activation is an essential neuromuscular reeducation component to improve cervical spine strength and posture to improve deep neck flexor muscle activation.

To activate your deep neck flexors, you must perform a chin tuck.

1. Sit upright with the ears directly over the shoulders looking straight ahead.

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2. Place a finger on the chin.

3. Do not move your finger and pull the chin and head straight back until you feel a stretch at the base of the head and top of the neck. (Make a double chin.)

4. Hold for five seconds, if possible, and repeat 10 times.

5. You may have mild discomfort, but your shoulders should not experience moderate to severe pain.

Overhead Pull-Downs Overhead pull-downs with bands are a good exercise to strengthen the posterior shoulder and upper back. Broad strengthening involves the latissimus, lower trapezius, rear deltoid and core stabilizer muscles.

1. Start with your arms overhead, your thumbs facing back and hands slightly wider than shoulder width apart.

2. Perform the chin tuck (as above) to activate the deep neck flexors.

3. Perform a posterior pelvic tilt. (To perform a posterior pelvic tilt, flatten your lower back by tucking in your tailbone as much as possible without pain or discomfort.)

4. Perform abdominal drawing by contracting your core and drawing your belly inward toward your low back (i.e., “suck in your gut”). This will activate the

transversus abdominis and core stabilizers and help prevent rib flare and compensatory lumbar spine extension.

5. Maintain the chin tuck, posterior pelvic tilt and abdominal drawing during the entire exercise.

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OPINION

GENERAL SURGERY NEWS / SEPTEMBER 2021

Surgical Injuries

for a more natural stretch of the targeted muscles whether it is the scalene, upper trapezius or levator scapulae muscle.

2. Perform the chin-tuck maneuver to activate the deep neck flexors and relax the cervical paraspinal musculature.

3. Perform a side bend to the opposite side of the stabilized shoulder by trying to touch the ear to the opposite shoulder.

4. Hold for 30 to 45 seconds. (In this position, you will target the scalene and upper trapezius muscles.)

continued from the previous page

6. Pull down the band with one arm while the other stays overhead. As you bring the arm down, you are going to pull the elbow toward the opposite back pocket and squeeze at the end for maximum muscle contraction. Alternate and repeat as prescribed.

The Quadruped Scapular Push-up This type of push-up is a good exercise to improve strength of the serratus anterior and deep neck flexors.

The Bilateral External Rotation Strengthening Exercise With Bands This is a good exercise for the postural muscles and posterior shoulder.

3. Keeping one arm straight as the stabilizing arm, begin to reach through with your non-stabilizing/ moving upper extremity, allowing your upper trunk to rotate as you reach through. Bend your stabilization arm as needed for comfort.

4. Hold the end position for three to five seconds.

5. Return to the starting position, and place your moving hand on the back of your head.

6. With the stabilizing arm, push into the bed. While pushing, rotate your upper body and neck, looking toward the ceiling. Repeat the exercise as prescribed.

1. Start in the quadruped position with your knees under your hips and hands in line with the shoulders vertically, and slightly wider than shoulderwidth apart horizontally.

2. Perform a posterior pelvic tilt to keep the spine in a neutral position and prevent excess lumbar extension.

3. Keeping your arms straight, pinch your shoulder blades together.

4. Next, detract your shoulder blades apart by pushing into the bed.

5. Perform abdominal drawing and the chin-tuck maneuver while pushing away from the bed or floor while exhaling.

6. Hold the extended position for three to five seconds; then relax, allowing your arms to stay extended and your shoulder blades to retract together while maintaining the neutral spine. (Repeat as prescribed.)

Thread-the-Needle Maneuver “Threading the needle” is a thoracic mobility exercise to improve spine mobility and decrease stiffness and pain.

1. Start in the quadruped position with your knees under your hips and hands in line with the shoulders vertically, and slightly wider than shoulderwidth apart horizontally.

2. Perform a posterior pelvic tilt to keep the spine in a neutral position and prevent excess lumbar extension. It is important to keep the head and hips aligned to avoid lateral spine flexion.

Stretching Stretching is a good way to reduce cervical stiffness and muscle tightness during the day as you perform your essential job duties. Often, stretching is performed incorrectly without stabilizing the correct structures or overloading the cervical joints with overpressure.

1. Start in the standing position, and perform a posterior pelvic tilt and abdominal drawing maneuver to activate the core stabilizers and maintain a neutral spine.

2. Retract the shoulder blades together.

3. Perform a slight chin-tuck maneuver.

4. Keep the elbows bent and down by your side. Perform external rotation by moving the hands away from each other. Squeeze at the end range for maximum muscle contraction.

5. You should feel this in the shoulder blade and posterior shoulder. Repeat exercises as prescribed.

Important Terms Defined Posterior pelvic tilt: A maneuver in which you flatten your back by tucking in your tailbone area.

Abdominal drawing: A maneuver in which you “suck in ■ your gut.”

—Dr. Tejirian is a general surgeon in Los Angeles.

1. Start by stabilizing the shoulder girdle on the same side as the muscles to be stretched. This allows the first rib and shoulder girdle to be stable, allowing

—Dr. Russell is a doctor of occupational therapy with certifications in orthopedic manual therapy, concussion rehabilitation and advanced hand therapy, in Los Angeles.

He specializes in treating surgeons.

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