June 2022 Print issue

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

June 2022 • Volume 49 • Number 6

What’s in That Mesh?

Biologics Not Associated With Infectious Complications Postoperatively in IBD

Hernia Expert Urges Surgeons to Look More Closely at Meshes They Use and How The Materials Behave in Individual Patients

No Need to Hold Biologics Before Surgery

By CHRISTINA FRANGOU

By KATE O’ROURKE

BELÉN, COSTA RICA—Surgeons who perform hernia

E

xposure to biologic agents within 60 days before surgery for inflammatory bowel disease is not associated with postoperative infections, surgical site infections or anastomotic leak, according to new research. The findings, presented at the 2022 annual meeting of the American Society of Colon and Rectal Surgeons (abstract SP11), suggests that biologics do not need to be held before surgery for IBD. This is the largest study by far on this topic.

According to lead study author Stefan Holubar, MD, MS, the IBD surgery section chief, and director of research in the Department of Colorectal Surgery, at Cleveland Clinic, after major surgery for IBD, the effect of preoperative exposure to biologics on postoperative outcomes is controversial.

In the new study, researchers assessed the risk for infectious

repairs must understand the characteristics of different meshes, including the inflammatory response associated with each product in order to select the best mesh for the patient in front of them, said Eric Pauli, MD, the David L. Nahrwold Professor of Surgery and chief of minimally invasive and bariatric surgery at Penn State Hershey Medical Center.

At the 2022 International Hernia Collaboration meeting, Dr. Pauli said hernia surgery has changed enormously over the past two decades, with an explosion in surgical techniques and mesh choices. In contrast, there has not been enough education about how these meshes work once placed in the body, he said.

Continued on page 20

OPINION

Continued on page 26

OPINION Cut It Out? Factors of Questionable Indications Curing Diabetes Mellitus For Surgery Explored

By HENRY BUCHWALD, MD, PhD

Feedback Overdose

By LINDA WONG, MD

Feedback noun

History

By CHASE DOYLE

T

1. information about reactions to a product, a person’s performance of a task, etc. which is used as a basis for improvement.

2. a screeching or humming sound resulting from the return of a fraction of the output signal from an amplifier, microphone, or other device to the input of the same device.

According to Oxford Languages, there are two definitions of feedback. The first is what we provide to enhance performance, promote

he decision to operate is not always clear-cut, nor is it based on medical factors alone. Rather, surgeons are increasingly required to uphold institutional practices that conflict with their own professional duties and responsibilities to patients.

During the 2021 virtual American College of Surgeons Clinical Congress, Michael J. Nabozny, MD, and Megan Applewhite, MD, FACS, discussed external factors that influence the decision to operate outside of a specific diagnosis, including relative value unit (RVU) expectations, OR utilization, expectations of referring physicians and patient preferences.

Continued on page 22

Continued on page 14

IN THE NEWS

4, 6 Highlights From the ASCRS And ASBrS Annual Meeings MONEY MATTERS

15 Retirement: Why Worry About It Now? T H E SURGEONS’ LO U N G E

POWERSEAL™ Sealer/ Divider Curved Jaw, Double-Action: Utility In Bariatric Surgery PAGE 10

18 A Patient With Recurrent Diverticulitis facebook.com/generalsurgerynews

@gensurgnews

D

iabetes (“to pass through” in Greek) mellitus (“sweet, like honey” in Latin) was described in the Egyptian Ebers Papyrus of 1550 b.c. as “to eliminate urine which is too plentiful,” that is, polyuria. In the fifth century b.c., Indian surgeon Sushruta, in his work Samhita, described diabetes as “madhumeha” (honey-like urine) with a sweet taste and sticky to the touch that attracts the attention of ants. In the second century, Aretaeus of Cappadocia first named the disease “diabetes,” and accurately described its symptoms of polyuria, polydipsia, weight loss, inanition and early death. In the Continued on page 24

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IN THE NEWS

JUNE 2022 / GENERAL SURGERY NEWS

SAGES President Announces Initiatives to Improve Surgery

By CHRISTINA FRANGOU

DENVER—Dr. Liane Feldman, in her outgoing address as the president of the Society of American Gastrointestinal and Endoscopic Surgeons, announced a series of initiatives designed to modernize surgical education and improve patient care.

The initiatives—a mix of new and ongoing programs—include efforts aimed at bettering surgical data science, testing artificial intelligence‒based models, and improving training for residents, fellows and practicing surgeons.

“This is the work of SAGES, the work that people have done on Zoom, despite the pandemic. It moves the society toward fulfilling our mission to innovate, educate and collaborate,” said Dr. Feldman, the Edward W. Archibald Professor and Chair of Surgery at McGill University, in Montreal.

Here are SAGES’ initiatives that will be available to surgeons within the next year.

CVS Challenge Kicks Off The SAGES Artificial Intelligence Task Force has launched its first Critical View of Safety Challenge, calling for surgeons to donate 1,000 videos of lap cholecystectomies. The task force plans to annotate the videos and provide this information to outside experts who are developing AI models with the goal of improving the safety of laparoscopic cholecystectomy.

Companies and academic groups have already created AI models for laparoscopic cholecystectomy, but

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

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

these tools require testing on large, diverse data sets before they can be validated. Data from SAGES will help to evaluate AI tools, and ultimately may lead to effective solutions to help surgeons assess the critical view of safety in laparoscopic cholecystectomy, Dr. Feldman said. “This alone will represent a significant contribution toward the development of AI tools of surgical value.”

Dr. Feldman said AI-based algorithms may, one day, augment surgical decision making and safety.

This is the first global challenge to assess algorithms designed to detect the critical view of safety in real time and will lay the foundation for future challenges of tasks related to laparoscopic cholecystectomy safety. Surgeons who are interested can contribute videos or volunteer to annotate them at www.cvschallenge.org.

Last summer, SAGES established a Surgical Data Science Task Force to explore the potential to create a shared global repository for surgical data. Organizers hope that society members will be able eventually to access the data for research, education and quality improvement initiatives.

Fundamentals of Surgery 2.0 In the coming months, SAGES will launch an updated version of its Fundamentals of Laparoscopic Surgery program, originally started in 2004. The new program, called FLS 2.0, will include web-based interactive didactics, a new curriculum founded on Entrustable Professional Activities and an updated multiple-choice examination with new questions. The virtual testing

Jarrod Kaufman, MD Brick, NJ

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

DISCLAIMER Opinions and statements published in General Surgery

Peter K. Kim, MD Bronx, NY

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

Lauren A. Kosinski, MD Chestertown, MD

DISCLOSURE POLICY We endeavor to obtain relevant financial

Marina Kurian, MD New York, NY

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

Raymond J. Lanzafame, MD, MBA Rochester, NY

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Dr. Liane Feldman delivers her presidential address at the 2022 annual meeting of SAGES.

option, first rolled out during the COVID-19 pandemic, will remain.

The skills exam portion of FLS 2.0 will no longer include the extracorporeal knot task, among other changes.

Moving Forward With Video Assessments The SAGES Video Based Assessment (VBA) Task Force is currently setting the parameters for a pass/fail score for its first VBA for fundoplication—a score that continued on page 8

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IN THE NEWS

FIRST LOOK

GENERAL SURGERY NEWS / JUNE 2022

The American Society Of Colon and Rectal Surgeons

All Articles by KATE O'ROURKE

Outcomes of Colorectal Surgery Worse in Patients With Psychiatric Disease TAMPA, FLA.—Psychiatric diagnosis is an independent risk factor for adverse postoperative outcomes after colorectal operations, according to new research. The findings were presented at the 2022 annual meeting of the American Society of Colon and Rectal Surgeons.

The retrospective case–control study identified people who underwent colectomy, proctectomy and rectal prolapse repair using the American College of Surgeons National Surgical Quality Improvement Program database. Patients were divided into two groups: patients with a preexisting psychiatric diagnosis at the time of surgery and those without a psychiatric diagnosis. Patients with a preexisting psychiatric diagnosis were identified using ICD-9 and -10 (International Classification of Diseases) codes for anxiety, panic disorder, depression, bipolar disorder, schizophrenia and schizoaffective disorder.

The primary study outcomes were hospital length of stay, mortality, organ-space surgical site infection (defined as an abscess at the site of operation), unplanned return to the OR and anastomotic leak. The study cohort included a total of 1,447 patients: 402 patients with a preexisting psychiatric diagnosis (90.3% [n=363] colectomy patients and 9.7% [n=39] proctectomy patients) and 1,045 without a psychiatric diagnosis (91.8% [n=959] colectomy patients and 8.2% [n=86] proctectomy patients).

Compared with patients without a psychiatric diagnosis, those with a preexisting psychiatric diagnosis were more likely to be female, have a higher body mass index (29.12 vs. 28.22 kg/m2; P=0.031), and be current smokers within one year of surgery (20.9% vs. 15.2%; P=0.009).

On univariate analysis, patients with a preexisting psychiatric diagnosis had more postoperative organ-space surgical site infections (10.2% vs. 6.1%; P=0.009) and unplanned returns to the OR (9.5% vs. 6.4%).

Patients with a preexisting psychiatric diagnosis showed no differences in 30-day mortality (2.99% vs. 3.35%; P=0.97) and anastomotic leak (3.7% vs. 3.4%; P=0.75) compared with those without a psychiatric diagnosis. Patients with a history of psychiatric disease were more likely to have a hospital length of stay of more than seven days (34.8% vs. 29.0%; P=0.04). On multivariate analysis adjusted for BMI, being a current smoker, gender and ASA physical status, patients with a preexisting psychiatric diagnosis had more unplanned returns to the OR (odds ratio [OR], 1.53; 95% CI, 1.02-2.80) and more organ-space surgical site infections (OR, 1.82; 95% CI, 1.25-2.66).

On multivariate analysis adjusted for body mass index, being a current smoker, gender and ASA physical status, patients with a preexisting psychiatric diagnosis had more unplanned returns to the OR and more organ-space surgical site infections.

“Our data and previous literature show that patients with a psychiatric disease represent a vulnerable patient population,” said presenting study author Alexis Webber, MD, of the Department of Surgery at Albany Medical College, in New York. “Other fields, such as bariatric surgery, have addressed this by implementing psychiatric [evaluation] as part of their preoperative workup. Perhaps we could adopt a similar model through expansion of our enhanced recovery after surgery protocol.”

The researchers said the study was limited in that it was a single institution with a limited sample size.

High Complication Rate After Early Ileostomy Closure Prompts Study’s Halt TAMPA, FLA.—In a prematurely stopped trial, ulcerative colitis patients with ileal pouch– anal anastomosis (IPAA) who underwent early closure of their diverting loop ileostomy experienced an unacceptably high rate of postoperative complications. The findings, reported at the 2022 annual meeting of the American Society of Colon and Rectal Surgeons, suggest that early closure of the ileostomy in this setting is not recommended, even when clinical and radiological assessment of the IPAA indicates that restoration of bowel continuity may be safely performed.

The SLIRPS (Short Versus Long Interval to Ileostomy Reversal After Pouch Surgery) trial was a multicenter, prospective, randomized trial that tested early (seven to 12 days) compared with late (eight weeks or more) closure of the diverting ileostomy after two- or three-stage IPAA in adults with ulcerative colitis. The trial was conducted by colorectal surgeons in the Crohn’s and Colitis Foundation surgical research network and led by Jon Vogel, MD, a colorectal surgeon at UCHealth in Aurora, Colo.

Table. Complications After Loop Ileostomy Closure Early Closure (n=10)

Late Closure (n=12)

P Value

Ileus/small bowel obstruction

5

2

0.095

Venous thromboembolism

2

0

0.104

Enterocutaneous fistula

2

0

0.014

Bacteremia/sepsis

1

0

0.262

Ileal pouch–anal anastomosis leak

1

0

0.262

Ascites

1

0

0.262

Acute adrenal insufficiency

1

0

0.262

Acute kidney insufficiency

0

1

0.350

Adapted from slide presented at the 2022 ASCRS annual meeting.

Patients who passed both a clinical and radiological assessment of their IPAA were randomized to early or late closure of their diverting ileostomy. The primary outcome was the comprehensive complication index at 30 days after ileostomy closure. Secondary outcomes were total complications, complication severity, reoperation and readmission at 30 days after ileostomy closure.

The trial was stopped prematurely after interim analysis revealed a high rate of complications in the early closure group. Among 36 patients analyzed, one patient had an unplanned proctectomy with end ileostomy. Of the remaining 35 patients who underwent IPAA and diverting ileostomy, 28 (80%) were clinically eligible for early closure and underwent radiological IPAA assessment. Among these patients, there were three radiological failures including two with abscess/leak and one with pelvic hematoma. Of the 25 patients who passed both clinical and radiological assessment, 22 (88%) were randomized to early (n=10) or late closure (n=12), and 12% were excluded due to protocol violations. Median complication index was 14.8 and 0 after early and late closure, respectively (P=0.02).

One or more complications occurred in 70% of patients after early closure and 25% after late closure (P=0.035), and were severe in 30% and 0% of patients, respectively (P=0.041). Reoperation was required in 20% of the early closure cohort compared with 0% in the late closure cohort (P=0.10). Readmission was required in 70% in the early closure cohort and 8.3% in the ■ late closure cohort (P=0.003). The full list of complications can be seen in the Table.

VIDEO GSN editorial board member, Eric Pauli, MD, interviews the leaders and attendees of the 2022 International Hernia Collaboration meeting, including program co-coodinator, Talar Tejirian, MD (pictured). To view the series of interviews, visit generalsurgerynews.com/Multimedia.

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IN THE NEWS

FIRST LOOK

GENERAL SURGERY NEWS / JUNE 2022

The American Society Of Breast Surgeons

All Articles by MONICA J. SMITH

In Young Patients, Breast-Conserving Surgery as Effective as Mastectomy LAS VEGAS—Despite often presenting with more aggressive breast cancer than older

patients, young women experience similar survival rates regardless of which type of surgical treatment they receive—mastectomy or breast-conserving surgery—according to a new study.

For the most part, complications such as bleeding, wound infection and chronic pain are more frequent with mastectomy, and young breast cancer patients who undergo breast-conserving surgery report better quality of life regarding breast satisfaction and psychosocial and sexual well-being than those treated with mastectomy.

“However, a national trend toward mastectomy in young women continues to persist,” said Christina V. Pestana, MD, a breast surgical oncology fellow at Atrium Health’s Levine Cancer Institute at the Carolinas Medical Center, in Charlotte, N.C., in presenting her research at the 2022 annual meeting of the American Society of Breast Surgeons.

She conducted the research with the support of senior author Lejla Hadzikadic-Gusic, MD, the co-director of the Young Women’s Breast Program.

The reasons for this upward trend in mastectomy are likely multifactorial, Dr. Pestana said. Consensus guidelines on the management of breast cancer are derived from clinical trials that excluded young women, so providers may be hesitant to extrapolate those data to younger patients.

“Patient factors include concerns about cosmesis after lumpectomy, apprehension toward radiotherapy, and a sense of peace of mind with the removal of all breast tissue due to fear of cancer recurrence,” Dr. Pestana said.

To investigate the association between type of surgery and survival in young women, she and her colleagues reviewed data on 591 patients younger than 40 years who underwent surgery at their center between 2010 and 2019.

“Not surprisingly, 64% of our patients underwent mastectomy compared with 35% who underwent breast conservation,” Dr. Pestana said.

The patient profile was consistent with breast cancer in young women, in that most had HER2-positive disease. The follow-up period was 67 months and the median age was 37 years. Overall, 72 patients (12.8%) died during follow-up.

The type of surgery had no effect on overall survival regardless of cancer molecular subtype. Multivariable analysis showed only the absence of the initiation of hormone therapy was significantly related to survival in hormone receptor‒positive, HER2negative patients, with a 2.9% increased risk for death in patients who did not start hormone therapy (P=0.02). Mortality was also higher in Black women with triple-negative cancer, who had a 5.7-times increased risk for death.

“This highlights the importance of counseling patients regarding outcomes and attempts to reduce unnecessary morbidity from more extensive surgical procedures. In addition, we also need to focus our attention on racial outcome disparities in young women,” Dr. Pestana said.

Tracy-Ann Moo, MD, a breast surgical oncologist at Memorial Sloan Kettering Cancer Center, in New York City, who moderated the plenary session, welcomed these findings. “It’s always reassuring to see that it’s OK for us to do breast conservation in young women,” she said.

Sentinel Node Status Not Best Guide For Chemo Decisions In Older Breast Cancer Patients LAS VEGAS—Nodal status is often used to guide decision making about chemo-

therapy in breast cancer patients. However, new research on the correlation between nodal status and a genomic score suggests sentinel lymph node (SLN) biopsy in women over 70 years of age may not be particularly useful for that purpose.

The “Choosing Wisely” guideline, published by the American Board of Internal Medicine in 2012, and later endorsed by the Society of Surgical Oncology and American Society of Breast Surgeons (ASBrS), recommends against SLN biopsy in women older than 70 with early-stage, hormone receptor (HR)positive, HER2-negative invasive breast cancer. However, many physicians continue to perform SLN biopsy to guide chemotherapy decisions.

“We wanted to determine if Oncotype Dx [Exact Sciences] scores are a better way to differentiate which patients over the age of 70 will benefit from adjuvant chemotherapy,” said Kyra Nicholson, MD, a general surgery resident at the University of Chicago School of Medicine. She presented the study at the 2022 annual meeting of the ASBrS. To do so, Dr. Nicholson and her colleagues analyzed data on 28,338 patients over 70 years of age with HR-positive, HER2-negative breast cancer, and a known Oncotype Dx score.

They first looked at the distribution of patients with an Oncotype Dx score greater than 26; a score of 26 or higher typically means chemotherapy should be considered. They found the proportion of node-negative and node-positive patients with a score greater than 26 was nearly identical—14.7% and 13.1%, respectively.

Next, the researchers conducted a multivariable analysis to determine tumor factors associated with an Oncotype Dx score greater than 26. “We found the strongest independent factor was having a tumor grade of 3 for both nodepositive and node-negative patients,” Dr. Nicholson said. Negative progesterone status also was associated with a higher Oncotype Dx score in both node-negative and node-positive patients.

“Finally, tumor size greater than 2 cm was associated with having an Oncotype Dx score greater than 26. Of note, the number of positive nodes was not associated with a higher score,” Dr. Nicholson said.

Describing the study’s limitations, she observed that the decision to obtain an Oncotype Dx score is up to the clinician’s discretion, which can lead to a biased patient sample.

The research does suggest that nodal status may not be the best guide for chemotherapy decision making in elderly women with HR-positive breast cancer.

“Sentinel node biopsy may not be helpful for adjuvant chemotherapy decisions in this patient population. However, certain tumor factors, such as grade, size and [progesterone receptor] status may be helpful in making decisions regarding chemotherapy,” Dr. Nicholson said.

LYMPHA Reduces Rates of Lymphedema After Axillary Node Dissection LAS VEGAS—Patients who undergo a lymphatic

microsurgical preventive healing approach (LYMPHA) at the time of axillary lymph node dissection (ALND) develop lymphedema at less than half the rate in patients who undergo ALND alone, according to new research.

To assess the effectiveness of LYMPHA, which involves the creation of a lymphatic-to-venous bypass during ALND, Omar Qutob, MD, a fellow in breast surgical oncology at Henry Ford Health System, in Detroit, and his colleagues conducted a prospective longitudinal study in breast cancer patients, comparing the incidence of lymphedema between those who had ALND alone and those who underwent ALND and LYMPHA. “Patients were seen preoperatively by a therapist and

followed up at regular intervals postoperatively. We measured the circumference of both the affected and unaffected limb, and created the circumference to a volume measurement,” said Dr. Qutob. He presented his research at the 2022 annual meeting of the American Society of Breast Surgeons.

The investigators defined lymphedema as a difference of at least 10% between the two limbs, or based on patient reports of swelling, heaviness or changes in sensation.

In the cohort of 139 patients, 35 underwent ALND alone and 104 had ALND and LYMPHA, which involved the participation of plastic surgeons and added 30 to 45 minutes to operating room time. The lymphedema rate in the ALND-alone group was 57%, compared

with about 20% in those who underwent ALND and LYMPHA. The study’s follow-up period was two years.

The only significant difference between the two groups was a higher rate of diabetes in the ALNDalone group, at 26%, compared with 11% in those who underwent LYMPHA at the time of ALND. “Our data supports the use of LYMPHA at the time of ALND as a means of preventing upper extremity lymphedema, and demonstrates the importance of monitoring patients’ symptoms and measuring postoperatively as symptoms can precede changes in volume,” Dr. Qutob said.

He acknowledged that the rate of lymphedema in the ALND-only group was substantially higher than the rate

IN THE NEWS

JUNE 2022 / GENERAL SURGERY NEWS

Disease-Specific Survival High in DCIS Regardless of Type of Surgery LAS VEGAS—There have been concerns about the ability of breast-conserving surgery without radiation to reduce mortality in patients with ductal carcinoma in situ (DCIS), but a review of a National Cancer Database special study suggests choosing locoregional surgical treatment does not decrease disease-specific survival (DSS).

“The state of the literature on DCIS survival is based on many early evaluations of surgical treatment outcomes from invasive breast cancer, which were then inferred to be the same for DCIS,” said Sabrina Wang, MD, a fourth-year medical student at Duke University School of Medicine, in Durham, N.C., noting other limitations in DCIS research, such as the use of incomplete or inaccurate data from national cancer registries.

To get a more accurate assessment of the effect of surgical choice on DSS outcomes in DCIS, Dr. Wang and her colleagues used the National Cancer Database (NCDB) Special Study Database, which supplements the NCDB with 62 new data fields that encompass pathology, treatment and outcomes data for patients diagnosed with DCIS. “Notably, the special study is able to study longitudinal recurrence data as well as DSS, which the traditional NCDB is unable to do,” Ms. Wang said.

In the team’s analysis of 18,983 patients with biopsy-confirmed DCIS between 2008 and 2014, treatment consisted of breast-conserving surgery alone in 4,236 (22%) patients, breast-conserving surgery and radiation in 10,051 (53%), and mastectomy in 4,696 (25%).

Overall survival was lowest among patients who underwent breast-conserving surgery alone, and highest among those who underwent breast-conserving surgery and radiation or mastectomy. In contrast, for DSS, there was no significant difference among the three groups.

Notably, DSS was very high in all three treatment groups, exceeding 99% after eight years.

of 20% to 25% often reported in the literature, which is the rate the team found in their ALND and LYMPHA group.

“It’s true; we noted that. But our collection of data was very sensitive, so even patients who had transient swelling, within a month of surgery, were documented as having lymphedema. Also, we had a low number of ALND-only patients—35— so any incidence magnified the percentage,” Dr. Qutob said. Furthermore, 70% of patients received radiotherapy, which is a risk for lymphedema.

“There is literature that reports lymphedema in up to 60% of patients who undergo radiotherapy,” Dr. Qutob said.

“So far, this is the most up-to-date evaluation of survival in a large population database following locoregional treatment in DCIS. The biggest limitation of this study is the small number of disease-specific events. There were only 41 deaths out of almost 19,000 patients,” Ms. Wang said.

Given there appeared to be no difference in DSS related to surgical treatment, she suggested that clinical values should drive the treatment decision.

“Overtreatment may bring on psychosocial and financial distress for

patients, which both contribute to a decreased quality of life, in addition to factors like scarring and breast sensation changes. Furthermore, risk reduction associated with radiation therapy must be weighed against the rare but serious risk of cardiopulmonary disease and radiation-induced malignancies,” Ms. Wang said.

She added that treatment decisions should be patient-centered, taking into account patient age, comorbidities and life expectancy. “Patients should feel

comfortable choosing a treatment option without fear of compromising their survival outcomes.”

Ms. Wang presented her research at the 2022 annual meeting of the American Society of Breast Surgeons on behalf of her colleagues, including her mentor, Shelley Hwang, MD, the Mary and Deryl Hart Distinguished Professor of Surgery at Duke University School of Medicine, and Marc D. Ryser, PhD, an assistant professor in population health sciences and mathematics at Duke University. ■

MORE THAN 8 MILLION ADULT PATIENTS HAVE RECEIVED EXPAREL SINCE 20121

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

74%

fewer opioids

31%

were used over 3 days in laparoscopic colorectal surgery2*†

faster return to bowel function

in open ventral hernia repair (P <0.001)3

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

Connect with us to learn more about how EXPAREL can support your practice ERAS=Enhanced Recovery After Surgery; LOS=length of stay; TAP=transversus abdominis plane. *The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials. † Opioid use was measured by the defined daily dose, with 1 unit equaling 100 mcg of intravenous (IV) fentanyl, 2 mg of IV hydromorphone HCl, 4 mg of oral hydromorphone HCl, 20 mg of oral oxycodone, or 10 mg of oral hydrocodone.

For laparoscopic colorectal surgery trial: Retrospective trial comparing patients receiving local infiltration of EXPAREL (n=70) as part of an ERP (enhanced recovery protocol) with those being placed in an ERP (n=70).

For open ventral hernia repair trial: Retrospective, observational study comparing patients who received an ERAS protocol with EXPAREL (n=100) with a historical group prior to the introduction of the protocol (n=100).

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

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

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

Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia. If EXPAREL and other non-bupivacaine local anesthetics, including lidocaine, are administered at the same site, there may be an immediate release of bupivacaine from EXPAREL. Therefore, EXPAREL may be administered to the same site 20 minutes after injecting lidocaine. EXPAREL is not recommended to be used in the following patient populations: patients <6 years old for infiltration, patients younger than 18 years old for interscalene brachial plexus nerve block, and/or pregnant patients. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease.

Warnings and Precautions Specific to EXPAREL Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, or intravascular or intra-articular use. The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials.

Warnings and Precautions for Bupivacaine-Containing Products Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression. Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to dysrhythmias, sometimes leading to death. Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients. Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use. Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use.

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

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

References: 1. Data on file. 6450. Parsippany, NJ: Pacira BioSciences, Inc.; January 2021. 2. Keller DS, Pedraza R, Tahilramani RN, Flores-Gonzalez JR, Ibarra S, Haas EM. Impact of long-acting local anesthesia on clinical and financial outcomes in laparoscopic colorectal surgery. Am J Surg. 2017;214(1):53-58. 3. Majumder A, Fayezizadeh M, Neupane R, Elliott HL, Novitsky YW. Benefits of multimodal enhanced recovery pathway in patients undergoing open ventral hernia repair. J Am Coll Surg. 2016;222(6):1106-1115.

©2021 Pacira BioSciences, Inc. Parsippany, NJ 07054 PP-EX-US-6769

06/21

7

8

IN THE NEWS

GENERAL SURGERY NEWS / JUNE 2022

SAGES President continued from page 3

would allow evaluation of a surgeon’s performance on an operation based on a submitted video.

The fundoplication VBA tool was developed by SAGES, led by Matthew Ritter, MD, after interviewing 42 international experts and reviewing surveys from 180 surgeons about the critical procedures, steps, skills and potential errors involved in fundoplication. The committee has established a scoring rubric for fundoplication.

In addition, SAGES has partnered with the Academy for Surgical Coaching to develop a video-based, peer coaching program in robotic and laparoscopic fundoplication.

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.

The fundoplication VBA is the first of many expected from SAGES. The society is currently accepting videos from surgeons of laparoscopic cholecystectomy and inguinal hernia repair, which will help develop scoring systems for these procedures. Videos can be submitted at www.sages.org.

SAGES is also partnering with the American Society for Metabolic and Bariatric Surgery to create a bariatric-specific VBA.

Surgeon-Specific Website For Safe Pain Management Earlier this year, SAGES launched OpiVoid, which is a website designed to help surgeons reduce opioid prescriptions while ensuring pain management for patients.

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)

Available at www.Opivoid.org, the site offers handouts for patient education, as well as videos and other resources on intraoperative interventions and postoperative pain management.

All-in-One Educational Portal Beginning this March, all SAGES educational offerings are available on a single portal called OWLS, short for Organization Wide Learning System.

Through OWLS, users can access online learning, including SAGES TV and the SAGES image library, from any device. Users can enroll in courses and exams; schedule, reschedule or cancel FLS, FES (Fundamentals of Endoscopic Surgery) and FUSE (Fundamental Use of

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.

continued on page 23

• 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

JUNE 2022 / GENERAL SURGERY NEWS

Point-of-Care Ultrasound: A Vital Tool in the Emergency Department

By MICHAEL VLESSIDES

‘So, am I saying that ultrasound saves lives? No. But humans with a brain and tools can. And that’s the business we’re in: saving lives and giving patients a second chance. I think POCUS is teachable, repeatable and gives you immediate information.’

H

ow valuable a tool can point-of-care ultrasound be in the emergency department? According to a pair of presentations at the 2022 Eastern Association for the Surgery of Trauma Annual Scientific Assembly, the possibilities for the technology are virtually limitless, for both surgeons and emergency medicine physicians alike.

For Paula Ferrada, MD, point-of-care ultrasound (POCUS) for surgeons has many potential uses in trauma/emergency medicine scenarios, although none may be more effective than limited transthoracic echocardiography (LTTE). “If we all become experts in full-service echocardiogram, we can have every measurement we need regarding patients’ perfusion status,” said Dr. Ferrada, a professor of medical education at the University of Virginia, and the chief of the Division of Trauma and Acute Care Surgery at Inova Healthcare in Charl Charlottesville. “But we don’t have to.

“W “With an ultrasound probe in our hand, we can perform limited transthoracic echocardiogram, which is a two-dimensional test wh that tha gives us real-time physiological information about what’s happening with the patient and allows us to change therapies, if need be.”

As Dr. Ferrada discussed, Paula Ferrada, MD LTTE is an attractive alternative to formal transthoracic echocardiography, primarily because it does not require an echocardiogram machine and represents an agile alternative, particularly in emergency settings. What’s more, she and her colleagues believe the technology is so approachable that almost any trauma attending can master its use, with minimal training.

To test this hypothesis, Dr. Ferrada and her colleagues conducted a study of seven attending physicians at a Level I trauma center. The participants, who had between one and 29 years of experience, first received 70 minutes of didactic and 25 minutes of hands-on training in LTTE. They then performed the test on hypotensive patients in an attempt to evaluate for contractility, fluid status and pericardial effusion.

The attending physicians then used the LTTE findings to improve patient perfusion. As part of the trial, patient perfusion status was determined by serum lactate level both before LTTE and six hours thereafter.

Findings were compared with cardiology-performed transthoracic echocardiography.

The participants performed a total of 52 LTTEs; two patients were excluded due to blunt trauma arrest. The average time to perform the test was four minutes, 38 seconds. In the end, the correlation between LTTE and cardiology-performed transthoracic echocardiography was 100%. Finally, attendings scored a mean of 88% in a post-training written test.

After these findings were corroborated in several subsequent trials, Dr. Ferrada decided to conduct a randomized controlled trial on the subject. She and her colleagues enrolled 240 individuals into the resulting investigation, all of whom were the highest-level-alert patients with at least one measurement of systolic blood pressure less than 100 mm Hg, mean arterial pressure less than 60 mm Hg and/or a heart rate over 120

—Paula Ferrada, MD

beats per minute. Patients were randomized to undergo LTTE or not as part of their initial evaluation.

Of the 215 evaluable patients, 92 underwent LTTE. Patients received significantly less IV fluids (1.5 vs. 2.5 L; P<0.0001), spent less time from the trauma bay to the OR (35.6 vs. 79.1 minutes; P=0.0006), had a higher rate of ICU admission (80.4% vs. 67.2%; P=0.04) and had a lower mortality rate (11% vs. 19.5%; P=0.09). Of note, the mortality differences observed in the trial were particularly evident in patients with traumatic brain injuries (14.7% vs. 39.5%; P=0.03).

“So, am I saying that ultrasound saves lives?” Dr. Ferrada asked. “No. But humans with a brain and tools can, and that’s the business we’re in: saving lives and giving patients a second chance. I think POCUS is teachable, repeatable and gives you immediate information,” she concluded. “And if I can do it, you can do it, and every everybody can do it.” nd Amar Vira, MD, the ultrasound cy education director for emergency ol medicine at Dell Medical School sat The University of Texas at Ausw tin, offered his perspective on how emergency medicine physicians can collaborate with surgeons with respect to the use and interpretation of POCUS- Amar Vira, MD derived images.

As Dr. Vira explained, ultrasound is a core part of emergency medicine training. Every emergency medicine resident is required to complete an ultrasound rotation.

“Residents have to each perform a minimum of 150 scans,” Dr. Vira said. “Each institution has to have a quality assurance program in place to review those images, and there’s an ultrasound director at every ACGME [Accreditation Council for Graduate Medical Education]–accredited program.”

The specialty is also guided by a set of guidelines produced by the American College of Emergency Physicians (ACEP), which lays out a detailed framework for use of the technology. In addition, POCUS fellowships were initiated by the American Board of Emergency Medicine in 2008, and now boast more than

100 participating programs across the country. Program accreditation is also the preserve of ACEP, whose efforts help to standardize the quality of practice across its members.

“So, we take this pretty seriously,” Dr. Vira said. “We want to make sure the programs themselves meet our standards, and that our residents are performing these scans properly.”

As Dr. Vira concluded, one of the goals of such efforts is for emergency medicine physicians to aid surgeons who practice in the emergency setting.

“Ultimately, this is something where I would hope that our surgeon colleagues can review the scans we’ve made and make a clinical decision based on what they see,” he added. hat Peter K. Kim, MD, explained that ole the session illustrates the vital role ncy that POCUS plays in the emergency eld department. “This is where the field sive is going, which is using less invasive tools that are readily available, quick, easy, powerful and don’t use radiation,” said Dr. Kim, an associate professor of surgery Peter K. Kim, MD at the Albert Einstein College of Medicine, in New York City.

“The ultrasound machine is so powerful that it should essentially replace the stethoscope, and in the intensive care unit and emergency room it may replace other things as well.”

Dr. Kim said the ability for surgeons and emergency department physicians to successfully collaborate was demonstrated in a 2021 case series of three patients (J Emerg Med 2021;61[3]:e40-e45) who sustained blunt trauma. The cardiac component of the focused assessment with sonography in trauma, or FAST, examination in the emergency department determined that the patients developed pericardial tamponade from overlying rib or sternal fractures.

“That article was a collaboration between surgeons and the emergency room physicians where we were advocating for the use of ultrasound to look at the heart in the setting of blunt trauma,” Dr. Kim explained. “We’ve saved ■ many people’s lives by using ultrasound that way.”

9

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

POWERSEAL™ Sealer/Divider Curved Jaw, Double-Action: Utility in Bariatric Surgery Nikhilesh R. Sekhar, MD, FACS, FASMBS Senior Faculty of Surgery Icahn School of Medicine at Mount Sinai New York, New York New York Bariatric Group Fairfield, Connecticut

Introduction Ensuring effective vessel sealing in bariatric surgery is crucial to reducing the risk for intra- and postoperative bleeding and leakage, as well as the need for revisional surgery.1,2 In addition to understanding patient-related and clinician-dependent risk factors for complications, it is key for surgeons to choose tools and technology that have been proven to provide quality vessel sealing for this patient population.2 Since their introduction, bipolar surgical energy devices have been selected by surgeons to provide hemostasis and tissue dissection with limited thermal spread,3,4 particularly when used in laparoscopic sleeve gastrectomy.3 Obese patients approved for bariatric surgery may present with comorbidities or unexpected anatomic findings that make the procedure more challenging, such as presence of nodules or tumors that may complicate dividing the greater omentum.5,6 By using effective vessel sealing devices, surgeons are better equipped to manage the potentially thicker vessels of obese patients1 and focus on successfully completing complex procedures.

Recently introduced in the US market, the Olympus POWERSEAL™ Sealer/Divider 5-mm Curved Jaw, Double-Action is a bipolar electrosurgical device indicated to complete ligation and division of vessels, including pulmonary vessels, tissue bundles, and lymphatics, up to 7 mm for laparoscopic, minimally invasive, and/or open surgical procedures, including bariatric surgeries (Figure). Along with proven sealing capability, POWERSEAL Sealer/Divider also has been designed to offer improved ergonomics over other bipolar energy devices, as well as consistent average sealing time of less than 3 seconds (Table).7-11

POWERSEAL Sealer/Divider Value In Laparoscopic Sleeve Gastrectomy Ligating the blood supply of the stomach so it can be removed can be one of the most time-consuming portions of laparoscopic sleeve gastrectomy,

10

GENERAL SURGERY NEWS • JUNE 2022

POWERSEAL™ Sealer/Divider Features according to Nikhilesh R. Sekhar, MD, FACS, FASMBS, And Clinical Value senior faculty of surgery at the Icahn School of MedCompared with the most recent iterations of comicine at Mount Sinai in New York, New York, and a peting devices, POWERSEAL Sealer/Divider has a bariatric surgeon at New York Bariatric Group, in Fairlonger jaw length (22.5 vs 21.0 mm) than the Ligafield, Connecticut. This process includes mobilization Sure™ Maryland Jaw advanced bipolar energy device, of the fundus, which is the source of satiety-regulatenabling it to seal more tissue with each activation of ing ghrelin.12 Resection of the fundus provides an immediate reduction in cravings following the prothe device.13 POWERSEAL Sealer/Divider also features a longer cut length than the LigaSure™ Maryland Jaw cedure, according to Dr Sekhar. He noted that reliadvanced bipolar energy device (19.3 vs 18.2 mm), able hemostasis is critical to the overall safety of this meaning it can transect more tissue with each actuaportion of the procedure, and that surgical energy tion. POWERSEAL Sealer/Divider’s wider jaw aperture devices are a standard tool to achieve this. facilitates positioning of tissue between the jaws.13 The “Every sleeve gastrectomy now is performed differences are meaningful, according to Dr Sekhar. with a surgical energy device because it would be “When you are talking about a millimeter or 2 in jaw too difficult to remove the stomach without one. size, it does not seem like much of a difference,” he But you want the most reliable tool to move effisaid. “However, if you think about this over 20 or so ciently,” Dr Sekhar said. “Efficient surgery has plenty activations per case, this is going to make a difference. of advantages for the patient, including less tissue The average seal time is less than 3 seconds, but if you handling, less time under anesthesia, and the potenavoid several activations, this difference adds up.” tial for faster recovery.”

The POWERSEAL Sealer/Divider is designed for About a year ago, Dr Sekhar performed his first vessel sealing up to and including a diameter of bariatric surgery case using the POWERSEAL Sealer/ Divider, which seals vessels up to 7 mm with advanced bipolar energy. The following information reflects his experience with the device. He noticed a difference using the POWERSEAL Sealer/ Divider within his initial several cases. “I found that it was faster than other options,” Dr Sekhar said. With consistent energy delivery, POWERSEAL Sealer/ Divider provided “a quick bloodless seal of the vessels,” he added.

After multiple cases performed since then, Dr Sekhar concluded that POWERSEAL Sealer/Divider offers more rapid hemostasis relative to existing devices, including the one that he considered satisfactory previously. He also considers the device easy to use, particularly for those with prior surgical energy device experience. “There was not a signifiFigure. POWERSEAL™ Sealer/Divider 5-mm Curved Jaw, cant learning curve for using this Double-Action (top) with close-up of ergonomic handle device relative to others with (bottom). which I have had experience,” he Images courtesy of Olympus America Inc. said. “Within just 1 or 2 cases, I felt comfortable.”

Supported by

• Vessel sealing ≤7 mm, including pulmonary vessels, tissue bundles, and lymphaticsa • Significantly better seal integrity performance in side-by-side GLP animal lab testinga • Fast sealing, with average seal time <2.8 seconds on vessels ≤7 mm in diameterb • Efficient and consistent sealing performance through longer sealing length and higher jaw pressurec • Equivalent tissue sticking resistance compared with nano-coated LigaSure™ Maryland Jaw (Medtronic) due to the POWERSEAL Sealer/Divider’s proprietary waveform and jaw constructiond a

Based on GLP Acute & Chronic animal studies reports DN0044705 and DN0044706.

b

Based on internal test reports DN0043135 and DN0044249.

c

Based on internal Design Verification electrical & mechanical test reports DN0046457.

d

Based on internal vessel sealing report DN0044404.

Based on references 7-11.

7 mm. This is a size that is likely to be more meaningful for surgeries involving pulmonary vessels, tissue bundles, and lymphatics, but Dr Sekhar noted that this capability sets this device apart from competitors and is meaningful to him in bariatric surgery.

“We do not commonly run into vessels of this size when dissecting the stomach, but I consider this one of the strong points of this device,” he said. “It is good to know that we have a margin of error, and it certainly provides reassurance of efficacy in smaller vessels with a single activation of the device.” As with any energy device like POWERSEAL Sealer/Divider, caution should be used during surgical procedures in which patients have certain types of vascular pathology (eg, atherosclerosis, aneurysmal vessels).

For best results, the seal should be applied to unaffected vasculature.

Evolution in Surgery Energy Devices The POWERSEAL Sealer/Divider, unlike other bipolar energy devices, allows the device jaws to be locked in a closed position in 1 simple step. Importantly, the latch-on feature does not require the jaws to be fully closed in order to activate energy.

This prevents injury to thick tissue and provides the device with more versatility. “If you need to grasp tissue, other devices typically require continuous pressure, which is not necessarily comfortable or effective when trying to perform another task at the same time,” Dr Sekhar explained.

The POWERSEAL Sealer/Divider jaw features a curved and tapered design to facilitate navigation of the jaws into position. This jaw design allows for effective blunt dissection as well as precise tissue dissection,14 with consistent cutting performance even after multiple blade activations during a procedure.10,14-16 Double-action jaws mean that neither is fixed; both hinge open, maximizing functionality.

The division of functions on the device is also clear and straightforward, Dr Sekhar noted. “There is no way to confuse the sealing function, which is controlled by the button on the top of the device, and the cutting function, which is controlled with the trigger,” he said. “It would be very difficult to cut the vessel before it is sealed, so the risk of unintended injury is low.”

When the POWERSEAL Sealer/Divider is in its offlatch setting, tactile feedback and an audible signal help reinforce to the clinician that sufficient pressure is being supplied.15,16 This feedback is relevant to safety and delivery of 7-mm vessel sealing regardless of the latch setting selected by the surgeon. “For me, the most important feature is the increase in the jaw length, but there is no trade-off in terms of safe completion of the dissection. The device has been reliable in my hands,” said Dr Sekhar, who has yet to encounter a significant bleeding event in his experience with the device. Additionally, several features distinguish this device from others, particularly a comfortable grip regardless of hand size. The smaller distance between controls makes the functions easier to perform,10 and the device requires reduced squeeze force compared with the LigaSure™ Maryland Jaw advanced bipolar energy device when closing the jaws or actuating the cut blade.10

Visualization Systems When the POWERSEAL Sealer/Divider is used with the Olympus® VISERA™ 4K UHD imaging system, a native 4K end-to-end visualization system, Dr Sekhar notes an additional advantage. “With the 4K system, the surgical field is seen so much more clearly. It allows you to work more confidently,” he said. “I definitely see a synergy between these effective sealing devices and good visualization. It maximizes safety.”

For often complex and multiple-step bariatric procedures, the use of advanced bipolar surgical energy devices for dissecting and sealing vessels has enabled surgeons to provide effective hemostasis and potentially reduce the risk for bleeding and/or leakage.3,4 As the newest and most advanced product in this class, the POWERSEAL Sealer/Divider has introduced several incremental advances, including longer jaw length,13 fast sealing,8,9 and features relevant to versatile application in surgical procedures.

“I have had experience with perhaps every iteration of surgical energy device over the past 20 years. I have seen how they progressed from tools that were associated with risks, particularly bleeding, to the more reliable devices that we now have available,” Dr Sekhar said. “In my experience, the POWERSEAL Sealer/Divider is safe, and it is faster than others on the market. I would certainly advocate for this device.”

References 1. Boeker C, et al. Int Surg. 2021;105(1-3):637-642.

2. Makal GB. Medical Journal of Mugla Sitki Kocman University.

2020;7(2):99-102.

3. Velotti N, et al. J Obes. 2019;2019:3402137.

4. Santini M, et al. Eur J Cardiothorac Surg. 2006;29(2):226-230.

5. Al Samaraee A, et al. Qatar Med J. 2020;(2):23.

6. Seeras K, et al. Sleeve gastrectomy. [Updated 2022 Feb 1]. In: StatPearls [Internet]. StatPearls Publishing; 2022.

Accessed May 5, 2022. https://www.ncbi.nlm.nih.gov/ books/NBK519035 7. Data on file. GLP Acute & Chronic animal studies reports DN0044705, DN0044706. Olympus America Inc. 8. Data on file. Internal test report DN0043135.

Olympus America Inc. 9. Data on file. Internal test report DN0044249.

Olympus America Inc. 10. Data on file. Internal Design Verification electrical & mechanical test reports DN0046457. Olympus America Inc. 11. Data on file. Internal vessel sealing report DN0044404.

Olympus America Inc. 12. Lin E, et al. Arch Surg. 2004;139(7):780-784.

13. Data on file. Internal side-by-side testing measuring time and number of seal/cut cycles to seal/transect 20 cm of porcine mesentery – report DN0044405. Olympus America Inc. 14. Data on file. POWERSEAL Curved Jaw Double Action (POWERSEAL CJDA) marketing claims report DN0044691.

15. Data on file. POWERSEAL Curved Jaw Double Action (PS1) design validation report DN0044403. Olympus America Inc. 16. Data on file. POWERSEAL 1 design verification electrical and mechanical report DN0042457. Olympus America Inc. Disclosure: Dr Sekhar reported a paid consultantship to Olympus Corporation of the Americas.

For more information about the POWERSEAL™ Sealer/ Divider, please visit https:// medical.olympusamerica.com/ products/powerseal.

GENERAL SURGERY NEWS • JUNE 2022

LCR44961V01

• A true curved, tapered, and double-action Maryland dissector/grasper design

Conclusion

BB222

Table. Features of POWERSEAL™ Sealer/Divider 5-mm Curved Jaw, Double-Action

11

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IN THE NEWS

GENERAL SURGERY NEWS / JUNE 2022

Keeping Surgical Patients Safe From Unintended Harm

By ETHAN COVEY

A

s part of the 2021 virtual American College of Surgeons Clinical Congress, experts gathered to review several hot topics in surgical patient safety. These subjects—some newer developments and other challenges that continue to present complications for surgeons and their staff—were reviewed during a series of presentations and an accompanying panel discussion.

The sessions, highlights of which are included below, focused on how practices and technologies are evolving in order to address peri- and postoperative challenges, and allow for more successful risk management strategies. The goal, said the moderator of the session, Juan A. Sanchez, MD, the regional vice president at HCA Healthcare Physician Services Group, in Brentwood, Tenn., is “to keep surgical patients safe from unintended harm.”

Venous Thromboembolism, Healthcare-Associated Infections Pose Continuing Threat Venous thromboembolism (VTE) and healthcareassociated infections (HAIs) are “two highly relevant topics that really apply to the daily practice of surgery,” said Peter A. Najjar, MD, an assistant professor of surgery at Johns Hopkins Medicine, in Baltimore.

Dr. Najjar added that inpatient VTEs remain very common. “In fact, there is good evidence to suggest that they are the most common preventable cause of in-hospital death.”

Although pharmacologic prophylaxis against VTEs has been shown to be safe, effective and cost-effective (and is advocated by existing guidelines), these methods remain underused (Agency for Healthcare Research and Quality; October 2015. AHRQ Publication No. 16-0001-EF).

Effectively preventing VTEs requires a multistep process incorporating standardized risk assessment, ordering prophylaxis and delivery of prophylaxis. When possible, risk assessments should be integrated into a patient’s electronic health record. Ordering of appropriate prophylaxis, Dr. Najjar said, should be based on patient and procedural risk factors, and ensuring prophylaxis is administered to the patient is of the utmost importance. Missed opportunities for prophylaxis can be common, and they highlight the need for additional educational efforts.

“With this comprehensive strategy, the goal is to reduce the incidence of VTE to only those that are not preventable using best practice in modern surgical settings,” Dr. Najjar said.

Another problem that continues to present a significant source of preventable morbidity and mortality is HAIs. The most common type of HAIs, accounting for more than 30% of infections, is surgical site infections (SSIs). It is estimated that SSIs cause 8,000 deaths annually in the United States, and 40% to 60% are preventable (Surg Clin North Am 2015;95[2]:269-283).

For both HAIs and SSIs, further decreasing rates likely requires the bundling of multiple techniques.

“Over time, we’ve gotten so good at reducing SSIs through antiseptic technique and meticulous

cal hemostasis, technical nd skill improvement, and ng procedural planning ve that infection rates have dropped substantially,”” n Dr. Najjar said. “So, in order to demonstratee ea meaningful improvement, there are veryy few ‘silver bullets’ thatt n will take an infection rate down substantial-ly from those levels..

That’s where I thinkk othe power of good prome cess and bundles come into play.”

Avoiding Unintended Retained Surgical Items and Patient Identification Errors Improvements can also be made in preventing retained surgical items (RSIs) and hospital-based patient misidentification.

“RSIs are a ubiquitous problem that crosses body cavities, small and large cases, in addition to crossing surgical specialties,” said Lauren T. Steward, MD, an assistant professor of GI, trauma and endocrine surgery at the University of Colorado Department of Surgery, in Denver.

Dr. Steward said basic counting procedures are not enough to eliminate these occurrences.

“Communication should be enhanced,” Dr. Steward said, including verbal communication and acknowledgment when placing small objects into, and removing them from, the patient’s body. Additionally, backup strategies should be used, such as a white board on which placement and removal of items are actively recorded. Surgical debriefs should verify that items placed in the body have been removed, and x-rays can be used to rule out the presence of RSIs. Dr. Steward noted that it is especially important for hospital leadership to continuously demonstrate that patient safety is a priority, ranking even higher than productivity and efficiency.

“In order to avoid RSIs, we have to recognize that there is a problem that affects all disciplines of surgery and all types of cases,” Dr. Steward said. “It is going to take a multidisciplinary effort in order to prevent RSIs, and all team members should be empowered to speak up.”

Patient identification errors are defined as the failure to correctly identify patients, resulting in mistakes in medication, transfusion and testing. These errors also include wrong-person procedures and the discharge of infants to the incorrect family.

There are many causes of patient misidentification and they can occur at multiple points during a hospital stay. During registration, incorrect information may be given or recorded; inadequate staff training and time pressures may result in errors; and there may be duplicate medical records or communication issues across departments.

To prevent these mishaps, reliance on at least two patient identifiers at all times is key. Protocols and standardized procedures are of the utmost importance,

and technological advances—wristbands that include patient photographs, or biometric methods such as fingerprint, retina or palm scans—may be implemented.

“We must recognize that there is a problem and that patient misidentification can happen at any point during a patient’s hospitalization,” Dr. Steward said.

Evaluating Frailty, Perioperative Nutrition And Prehabilitation for Surgery Ensuring patients are well enough to have positive outcomes is of core importance to the surgical process.

“Frailty is a syndrome of decreased physiologic reserve and resistance to stressors which leaves patients vulnerable to worse outcomes,” said Steven C. Cunningham, MD, the director of pancreatic and hepatobiliary surgery and director of research at Ascension Saint Agnes Hospital, in Baltimore. “Frailty is strongly, and unsurprisingly, correlated with poor outcomes after surgery.”

Criteria for determining a patient’s level of frailty include weight loss, weakness, exhaustion, low physical activity and slowness of movement, and can be assessed via self-report and in-office testing.

Dr. Cunningham stated that patients who are determined to be in the intermediate category of frailty are at elevated risk for complications, as well as being twice as likely to become frail within three years, thus putting them at much increased risk for adverse health outcomes.

As such, Dr. Cunningham noted the importance of assessing for the five criteria of frailty with any patients determined to be at risk, and then performing appropriate interventions.

Malnutrition also is associated with an increased risk for postoperative adverse events, and rates increase as patients are older and sicker. For malnourished patients, it may be worth considering preoperative nutrition consultation and therapy. For well-nourished patients, dietary restriction, such as fasting, may provide benefits. However, Dr. Cunningham noted, this approach has not yet received mainstream acceptance.

Rehabilitation programs, aimed at improving a patient’s health before surgery, show some promise, but the data remain inconclusive.

“There is conflicting evidence regarding length of stay and morbidity and mortality, but there is good evidence for improved functional and exercise capacity,” ■ Dr. Cunningham said.

IN THE NEWS

JUNE 2022 / GENERAL SURGERY NEWS

13

Study: Skip Ultrasound in Pregnant Patients With Abdominal Pain

By MONICA J. SMITH

NASHVILLE, TENN.—When the find-

ings of a physical examination in a pregnant woman presenting with acute abdominal pain are suggestive of surgical pathology, the patient should proceed to MRI, according to a new study that found ultrasound imaging to be of little value in this patient population.

“Though abdominal pain in pregnancy is common, surgical reasons for this pain are not,” said Alexa Marquez, DO, an obstetrics and gynecology resident at Ascension Genesys Hospital in Grand Blanc Township, Mich. She presented the research at the 2022 Southeastern Surgical Congress.

Certain physiologic changes that occur in pregnancy—increased baseline heart rate, hyperemesis, leukocytosis—can obscure these clinical scenarios, so clinicians rely on imaging in addition to patient history and physical exam to diagnose pathology such as acute appendicitis that would warrant surgery.

To evaluate the efficacy of ultrasound and MRI in this patient population, Dr. Marquez and her colleagues conducted a retrospective review of pregnant patients reporting to the emergency department or labor and delivery triage with acute abdominal pain, at their institution between 2015 and 2020.

Of the 136 patients deemed to have acute abdominal pain, 57 had a positive or concerning physical exam, 55 had a benign exam, and 24 had an undetermined exam. Of these 136 patients, 81 (with positive or inconclusive findings) had ultrasound, with 16 abnormal and 56 benign or negative results.

“Of note, in pregnancy, the uterus displaces a lot of vital organs, including the appendix. A lot of these exams state that the appendix was not visualized, and these patients were classified as having a negative ultrasound, so that’s something to keep in mind,” Dr. Marquez said.

Of the 81 patients who had ultrasound, 61 went on to MRI and 36 were negative. Three patients underwent surgery for acute appendicitis, a diagnosis that was confirmed by pathology.

“All of these patients had negative ultrasounds but MRIs concerning for acute appendicitis,” Dr. Marquez said.

Compared with MRI, ultrasound had a sensitivity of 32%, specificity of 79%, positive predictive value of 50% and negative predictive value of 62%. “With that, the diagnostic accuracy of ultrasound in these patients was 59%—essentially indeterminate to low, and unable to reliably rule in or rule out a condition,” Dr. Marquez said.

She found the research very interesting to work through, and very clinically

applicable and relevant to pregnant patients.

“If you have a pregnant patient whose appendix is on the verge of rupturing, time is of the essence. At our institution, when you order an ultrasound, it can take up to an hour for someone to scan that patient, another hour for the ultrasound to be ready, and then maybe another hour for a physician to make a plan for moving forward. If you cut out the ultrasound for a patient presenting with something acute, that might help

you expedite the care,” Dr. Marquez said.

Based on the findings of their study, Dr. Marquez and her colleagues suggest that pregnant patients with acute abdominal pain whose physical exam findings suggest surgical pathology should proceed directly to MRI rather than having an ultrasound, “as ultrasound here had little diagnostic value.”

However, David V. Feliciano, MD, a professor of surgery at the University of Maryland School of Medicine, in

Baltimore, who moderated the plenary session at which Dr. Marquez presented her research, noted that these findings were based on only three patients who had acute appendicitis. Ultrasound did identify pathologies (e.g., ectopic pregnancy) in other patients in this study who underwent surgery.

“I would caution against discounting [ultrasound] based on this. In experienced hands, it can be quite useful,” Dr. Feliciano said.

■

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14

IN THE NEWS

GENERAL SURGERY NEWS / JUNE 2022

Fluorescence-Guided Lumpectomy Merits Further Study, Researchers Say

By KATE O’ROURKE

T

he use of pegulicianine fluorescenceguided surgery (pFGS) for identifying residual cancer in the tumor bed of patients undergoing breast-conserving surgery has an excellent safety profile and merits additional study, according to new research.

The findings were presented at the Society of Surgical Oncology 2022 International Conference on Surgical Cancer Care (abstract 20). The study showed fluorescence-guided surgery can be used to define tumor location and margins during the procedure.

Led by Shelley Hwang, MD, MPH, the vice chair of research and chief of breast surgical oncology at Duke University, in Durham, N.C., researchers set up a prospective, single-arm, open-label feasibility study at 16 sites in the United States. The study enrolled 234 female patients 18 years of age and older with newly diagnosed invasive or intraductal cancer undergoing breast-conserving surgery. The patients were injected

intravenously with pegulicianine prior to surgery at a dose of 1.0 mg/kg. After tumor excision per standard of care, researchers used pFGS for identification and removal of residual cancer.

All patients received pegulicianine and 230 completed pFGS. One patient experienced anaphylaxis during the administration of pegulicianine and pFGS prompted additional margin excisions in 138 patients, while residual tumor was found in 26 patients (19%). Negative margins after breast-conserving surgery were achieved in 83.5% patients.

Dr. Hwang found pFGS-guided excision of residual tumor in 7.3% of patients with negative margins via standard of care. In these 14 patients, pFGS guided the removal of residual tumor that would have remained behind. Among the 38 patients with positive margins after breast-conserving surgery, 23 had pFGS shaves; six of these patients (15.8%) were converted to negative margins on final pathology. In three additional patients with positive margins, pFGS suggested further excision, but this was not

A study presented at the Society of Surgical Oncology 2022 International Conference on Surgical Cancer Care showed fluorescence-guided surgery can be used to define tumor location and margins during breast-conserving surgery.

performed based on surgeon judgment.

Overall, the final positive margin rate after pFGS was 15%. The overall sensitivity, specificity and negative predictive value of pFGS were 69.4%, 70.4% and 98.3%, respectively.

Residual tumor was removed after breast-conserving surgery in 19% of patients who underwent an additional margin excision for a positive pFGS signal. The safety profile of pegulicianine was excellent and consistent with other imaging agents used in breast conserving surgery, according to Dr. Hwang.

“These findings, including a notably high negative predictive value, support further clinical assessment of pFGS, which is currently being conducted in the prospective randomized trial INSITE,” Dr. Hwang said.

“In this study, the positive margin rate as determined by standard techniques was 16.5% without the fluorescing agent and was 15% with the fluorescing agent.

The patients had to be in the hospital four hours prior to surgery for the injection and 0.5% had an anaphylactic reaction to the agent. Based on those

Cut It Out? Questionable Indications for Surgery Explored continued from page 1

RVU Expectations Dr. Applewhite, an endocrine surgeon and ethicist at Albany Medical College, in New York, explained that surgeons may be unduly influenced by productivity expectations from their hospitals and under pressure to operate in borderline or unindicated cases.

“The payment structures and the RVU expectations in the hospital drive certain surgeons, hospitalists and other proceduralists to bend standards of care to fulfill the expectation of their RVUs at the benchmark,” said Dr. Applewhite, who noted a lack of transparency around payment methods, insurance coverage and reimbursement. “Hospitals that emphasize stable case volume to keep the doors open may pressure surgeons to bring revenue through the door, regardless of how it gets there.”

However, attempts to rationalize the practice of operating solely for RVUs are disabused by the principle of informed consent. In other words, would the patient agree to surgery if he or she underwent a thorough and honest informed consent discussion? According to Dr. Applewhite, few patients would agree to an operation for a condition that can be managed medically without surgery—just to boost hospital revenues.

“Operating just so that the hospital can make money or that a surgeon can meet her RVU expectation and keep her salary is not a sufficient reason,” she said.

“It’s hard to argue that strict financial or productivity considerations should influence the decision of whether to operate, but there may be an unconscious bias towards operating if patients are medically on the fence,” Dr. Nabozny added.

OR: Use It or Lose It Dr. Nabozny, an acute care surgeon at the University of Rochester, in New York, noted that OR time

“This is the ethical issue with OR utilization,” Dr. Applewhite explained. “To maintain block time, surgeons who need to be able to schedule cases with relatively short lead time may be pressured to book smaller cases that could be done in the clinic.”

Referring Physician Expectations

utilization can be another major unconscious factor in deciding whether to operate. If a surgeon cannot fill their preassigned OR block time, it can be given to other surgeons, which makes it harder to operate subsequently. Conversely, said Dr. Nabozny, when the available ORs are full, as has been the case during the last 18 months of the COVID-19 pandemic, patients with the same medical indications may not undergo surgery or the operation may be delayed.

Dr. Applewhite gave the example of a surgical oncologist who typically removes lumps and bumps in the clinic where she has good support staff. Although these procedures are more convenient for the patient and reduce costs to the practice, hospitals may threaten the loss of the surgeon’s OR blocks if they are not consistently filled. To preserve her OR time, the surgical oncologist thus considers moving small cases to the OR, even though they could be performed successfully with fewer resources.

The expectations of referring physicians are another common factor in the decision to operate, said Dr. Nabozny, who noted that referring physicians have been known to request procedures rather than opinions from surgeons.

Dr. Applewhite gave the example of a high-volume endocrinologist who is very good at his job, but views surgeons as pure technicians and dictates what operations should be performed in his referring notes.

Although the endocrinologist is usually right, said Dr. Applewhite, one time he recommends a total thyroidectomy with bilateral modified radical neck dissections for large thyroid cancer, even though no abnormal lymph nodes are detected with imaging. The surgeon feels uncomfortable taking out radiographically normal tissue that has not been biopsied to show cancer, but the endocrinologist is convinced that the abnormal lymph nodes are there and claims the surgeon will prevent harm in the long run by operating now.

“While this can be grating, these physicians are the source of referrals,” Dr. Nabozny said. “Some balancing between satisfying referring physicians and providing appropriate operative care must be undertaken to ensure patient referrals going forward.”

Patient Preferences Finally, patient preferences also play a significant role in the decisions to operate—but not without limits.

15

JUNE 2022 / GENERAL SURGERY NEWS

numbers, it is questionable if the agent adds enough to justify the time and cost,” said Lisa Jacobs, MD, an associate professor of surgery and the chief of the Division of Breast Cancer Surgery, Johns Hopkins University Department of Surgery, in Baltimore.

“However, of patients that would have been read as negative margins without the agent, 7.5% were identified as having tumor only because the fluorescing agent prompted additional margin excision,” Dr. Jacobs added. “Those patients would have proceeded on with their other therapies not knowing that they actually had positive margins that were undiagnosed. This highlights that lack of precision of margin assessment. What we do not know is what the outcome for those patients would have been and if this matters at all. The patients would have likely received some version of systemic therapy, either chemotherapy or hormone therapy, and radiation therapy. It is possible that the undiagnosed positive margin would have been effectively treated by those other therapies and not resulted in a local recurrence. It is also possible that the local recurrence rate would be reduced by identifying those patients. It is encouraging that a prospective randomized trial is being conducted to answer some of these questions.” ■

Dr. Nabozny noted, for example, that undergoing elective surgery for sigmoid diverticulitis is a preference-sensitive decision with many factors that need to be weighed. Such a decision becomes “more questionable,” however, when a patient with only an episode of diverticulitis requests the operation because a family member died of perforated diverticulitis, he said.

“Each time we make a decision for surgery, patient preference must be weighed to determine how much it should influence one’s decision to offer surgery,” Dr. Nabozny said.

Dr. Applewhite gave the example of a 54-year-old woman who had a lumpectomy for atypical ductal hyperplasia and has a family history of premenopausal breast cancer. Although a genetic panel revealed no mutations that would increase the risk for breast cancer, the panel detected a genetic mutation of undetermined significance that might increase the risk for other types of cancer. The patient, who was suffering from crippling anxiety and resulting depression given her family history, ultimately decided that she wanted a bilateral mastectomy after months of deliberation.

“Although the patient does not have an indication for bilateral mastectomy and has no genetic predisposition that puts her in excess risk above the general population, her quality of life is compromised, and she has immediate psychological problems,” Dr. Applewhite said.

“Sometimes, respecting patient autonomy and operating may be within the bounds of standard of care, even if surgery is not clearly medically ■ indicated.”

Retirement Is 20 Years Away: Why Should I Worry Now?

By KAREN BLUM

P

lanning for successful retirement should begin early, a panel of surgeons said at the 2021 virtual American College of Surgeons Clinical Congress. This includes getting your finances in order, taking measures in the operating room to prevent injuries, and thinking about how best to use your time.

Devise a budget that creates a plan for both savings and spending, advised William Cioffi Jr., MD, FACS, the J. Murray Beardsley Professor and Chairman of surgery at the Warren Alpert Medical School of Brown University, in Providence, R.I. Use outside experts for help—make sure to have an independent financial advisor, a tax/estate lawyer and an accountant.

Have a sequential plan in mind. The first 10 years of practice can be considered defense protection, Dr. Cioffi said. Protect yourself and your family with a strong insurance plan that includes health, life, disability and longterm care options. Start your savings strategy, setting aside 10% of gross income as a good start.

Five to 15 years into practice, as earning potential starts to increase, surgeons can move to offense planning, he said. Boost savings and investments, save for college education for the children, accelerate mortgage payments and plan for emergencies, saving 15% of gross income if possible. Then, 15 to 30 years into practice is a good time to be more aggressive, Dr. Cioffi noted. Diversify your investment portfolio, concentrating on growth. Rethink your budget and spending.

More than 30 years into practice, he said, have a wellconstructed distribution plan working with your financial team. Decide when to start collecting Social Security payments, and plan for your family and social legaWhat can cy before actually retiring. The I afford? final year before retirement is a good time to have elective medical or dental work done while you’re fully insured, Dr. Cioffi advised. Assess What do I want? if your budget is realistic. Rebalance your portfolio and consider Medicare options.

Common mistakes include procrastinating in taking care of finances, not using bona fide professionals, borrowing from savings, cashing out retirement plans when switching careers, and not altering your risk strategy as you age, he said. Some 48% of surgeons retire sooner than expected, he noted.

Taking Care of Yourself It’s also imperative to take care of yourself physically and professionally, and appreciate time with family so you have no regrets, said Margo Shoup, MD, MBA, FACS, the president of the Orlando Health Cancer Institute, in Florida.

Pay attention to the ergonomics of surgery to prevent neck and back problems, Dr. Shoup advised. Make sure the lighting is exactly how you like it, so you don’t have to turn your head awkwardly to see something. If you wear

loupes, ensure they are adjusted appropriately. Keep the bed height where it should be and maintain good posture.

Professionally, periodically ask yourself if you’re doing exactly what you want to, she added. “Be insightful about this and really dig down deep inside to understand if the goals you set for yourself prior, and the road you are on currently, align with where you want to be in the next 10 years.”

If you find you’re unhappy, there are lots of other opportunities to change your career or situation. “As surgeons, we get outside our comfort zone every day when we’re operating,” Dr. Shoup said, “but we don’t do that with our career, which may leave us stagnant.”

Finally, take care of your personal life, she said. Having it all is a misnomer, but surgeons can prioritize. Enjoy your family so you can make great memories now to look back on later.

What Do You Want to Do in Retirement?

There are plenty of things to do in retirement “beyond the rocking chair,” said John Hanks, MD, FACS, a professor emeritus of surgery at the University of Virginia, in Charlottesville.

It’s never too early to start thinking about why and when you want to retire, Dr. Hanks said. There are many benefits to having a well-planned life after practice. People are living longer, which presents an opportunity to take advantage of years of good health and explore a variety of paths.

First, ask yourself what you want to do with this time, he said. Do you want to reduce or restructure your clinical practice? Take advantage of your technical skills in a less stressful environment? Add in research or advocacy work? Are you interested in political activism, community or charity work?

What skills Second, ask what you do I have? can afford to do, Dr. Hanks said. Sound financial planning is essential.

Third, what do you have the skills to do? Would you like to pursue practice in What is a resource-limited environment here or abroad? required?

Are you interested in student or resident mentoring, simulation teaching or coaching, or administrative work?

Fourth, think about what is required for you to consider these options, Dr. Hanks noted. Look into maintaining state licensure or other credentials and CME requirements.

Apply for a passport and/or visas if necessary.

Options for post-medical life are wide open, he said, including service, education, relaxation, travel, and spending time with family, including grandchildren.

“The earlier a concrete plan is put into place, the better position you will be in to explore options,” Dr. Hanks said. “Yes, the rocking chair awaits all of us, but also opportunities for personal satisfaction, and a continued path to help others exists in new and ■ rewarding ways.”

IN THE NEWS

16

GENERAL SURGERY NEWS / JUNE 2022

The Dawn of the 23-Hour Colectomy

By MONICA J. SMITH

NEW YORK—In recent years, surgeons in

Europe and Canada slashed the hospital length of stay for laparoscopic colectomy, in some cases keeping patients for only a couple of hours including procedural time. American teams, too, are advancing toward the outpatient colectomy.

At Montefiore Medical Center in New York City, colorectal surgeon Abier A. Abdelnaby, MD, and her colleagues have

performed same-day (23-hour) colectomies in a growing number of patients by adhering to several perioperative protocols, judicious patient selection and patient preparation—an approach a few centers are taking.

“If their pain is under control, if they got up and walked after surgery, I tell my residents to round and discharge them.

The patients love it; the residents love it; and it’s overall very successful,” said Dr. Abdelnaby, the director of Colon and

Rectal Surgical Services and the program director of the general surgeryy residency program m at Montefiore Medical Center and Albert ert Einstein College of Medicine,, also in New York City.

At the 2021 Controversies, Problems and Techniques niques in Surgery meeting, Dr. r. Abdelnaby

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‘P ‘Patients have qquicker return to bowel b function and the likelihood of them developing a p postoperative ileus ve low.’ is very —Abier A. Abdelnaby, MD —Ab

described what it takes to dramatically reduce length of stay (LOS) for what was once a very costly and often morbid procedure, and reflected on how far colon and rectal surgery has come over the decades.

“Looking at the tremendous progress and advances we’ve made, it does raise the question of what the future holds for patient care and our ability to give the highest quality of care for our patients,” Dr. Abdelnaby said.

A Stroll Down Memory Lane When Dr. Abdelnaby was a surgery resident, most operations were performed in an open fashion, which gave tremendous opportunities to the surgeons. “We got to learn the anatomy up close and to teach the anatomy to our successors. But it was terrible for patients. They were in a lot of pain and stayed in the hospital for eight, nine, 10 days, with [nasogastric] tubes and Foley catheters for several days.”

This approach was costly in terms of LOS, and the heavy reliance on opioids for pain management resulted in a lot of ileus.

“Dealing with the most contaminated part of the body, our risk of wound infection was significant, especially with a long, open incision. As obesity became more prevalent in the population, everything became more of a concern,” Dr. Abdelnaby noted.

The advent of laparoscopy brought new challenges, such as the loss of tactile sensation. However, as the instrumentation evolved and surgeons gained laparoscopic skills, they began to investigate how this new modality could benefit patients.

“One of the first questions we asked was whether we should be doing anastomoses intracorporeally [IC] or extracorporally [EC],” Dr. Abdelnaby said.

Early in laparoscopic colectomy, surgeons were comfortable with EC, which minimized the risk for contamination within the abdomen. For IC, ease with laparoscopic suturing was necessary, again while adapting to the loss of tactile sensation.

“But IC reduced LOS, which saves a lot of money for hospital systems. Patients have quicker return to bowel function and the likelihood of them developing a postoperative ileus is very low. You can also get a greater number of harvested lymph nodes, fewer wound infections, less pain

IN THE NEWS

JUNE 2022 / GENERAL SURGERY NEWS

and less bleeding,” Dr. Abdelnaby said.

As the debate over EC and IC continued, with IC generally winning, the surgical robot made its debut and was adopted quickly by surgeons in urology and gynecology. The single-quadrant robot that made robotic prostatectomy a gold standard wasn’t necessarily an ideal fit for colorectal surgery, but it did facilitate IC. “This revolutionized a lot of our practices. It has completely changed mine— I’ve abandoned laparoscopy altogether,” Dr. Abdelnaby said.

Robotic Surgery and ERAS As surgeons were getting familiar with the robot, medical centers began to incorporate enhanced recovery after surgery (ERAS) protocols. These care pathways involve a multimodal approach aimed at getting patients on their feet and out of the hospital as quickly as responsibly possible.

“To me, the most important element of implementation of the ERAS protocol is the preoperative counseling. A lot of patients believe that if they have this operation, they’ll be in the hospital for at least a week and that they need to prepare for that. When you sit down and say, ‘we can get you out of the hospital in three days’ and explain why, they welcome the idea,” Dr. Abdelnaby said.

Other ERAS components she finds particularly useful are judicious monitoring of fluid administration in the operating room, adequate pain control, minimization of postoperative opioid use, early feeding, mobilization soon after surgery, and getting rid of the orogastric/ nasogastric tube and the Foley catheter before patients leave the OR. “ERAS protocols are another thing that revolutionized care while we were adopting robotic surgery,” Dr. Abdelnaby said.

Keeping in mind the cost of a hospital stay, which averages about $1,600 per day across U.S. surgical wards and much more for an ICU stay, patients who require transfusions and patients with surgical site infections, Dr. Abdelnaby was disheartened to learn that her own robotic colectomy patients’ average LOS was 3.3 days.

“We’re using the robot, we’re providing the highest technology and we’re implementing ERAS. Why are these patients here for so long?”

Thinking about technique, Dr. Abdelnaby decided to adopt natural orifice specimen extraction (or NOSE) surgery. “This is very specific to colorectal surgery, and it makes a huge difference.”

In addition, she no longer waits for patient bowel function to return. “Most of our colon resections are done on the left side; we perform endoscopy on the table, ensure that the anastomosis is circumferentially patent and hemostatic—that there is no mechanical reason to prevent a patient from passing gas. Then they can do that in the comfort of their own home.”

As of early December 2021, Dr. Abdelnaby and her colleagues had performed 17 such 23-hour colectomies, discharging patients in less than one full day. She first learned of outpatient colectomy at the 2019 meeting of the Society for Gastrointestinal and Endoscopic Surgeons, when an anesthesiologist presented data from her group in France.

“The most important thing for them was pain control: reducing intraoperative pain, preventive analgesia, multimodal analgesia and opioid-free discharge, which is also what we’re doing,” she noted.

Dr. Abdelnaby’s goal for her team

now is to increase the number of patients undergoing 23-hour colectomy and eventually being able to discharge patients within four to six hours after surgery.

She stressed the importance of patient selection for this short-duration LOS. For example, older patients with numerous comorbidities, taking multiple medications, would not be good candidates for the 23-hour colectomy.

“But patients who are healthy with minimal comorbidities and medications, good functional status—these are the patients you want to target. I talk to them extensively preoperatively about the

It takes trust to advance together

ERAS protocols; make sure their pain is managed; and most importantly, ensure someone is following up. Your nurse practitioner, your physician assistant or you yourself, get on the phone and call those patients to see how they’re doing.”

According to Canadian research presented at the 2021 Society of Gastrointestinal and Endoscopic Surgeons, some carefully selected patients can be safely discharged home the same day if they are followed closely by a health care team remotely, although some experts questioned whether the approach was feasible in the United States (bit.ly/3x36Bay). ■

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18

GENERAL SURGERY NEWS / JUNE 2022

QUESTION for Stephanie M. Pannell, MD From Karan Chawla, MS4, University of Toledo, Ohio

A Patient With Recurrent Diverticulitis Welcome to the June issue of The Surgeons’ Lounge. In this issue, Dr. Stephanie M. Pannell, the associate chief medical officer and director of the surgery clerkship program at Toledo University, in Ohio, discusses a patient with recurrent diverticulitis. Also in this issue, we feature the “History of the Foley Catheter.”

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

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

A 44-year-old man presented to the hospital approximately eight months before with severe left lower quadrant pain. A CT scan and labs showed inflammation around the sigmoid and mild leukocytosis of 12 x 109/L (Figure).1 The patient stated that during this first episode, he was diagnosed with diverticulitis and was treated as an outpatient with oral antibiotics. The patient followed up with his primary care provider 10 days after discharge and his labs were normal. Since the initial diagnosis, the patient stated that his lower left quadrant pain never resolved completely although it had improved with antibiotics. On further questioning, he said he had been on antibiotics three separate times since his initial diagnosis. The patient also said the physician he first saw told him he would need a colonoscopy once the pain subsided.

On physical exam, the patient had some lower left quadrant tenderness to palpation. His white blood cell count was 9,500/mcL and other labs were within normal limits. The patient presented to the office complaining that the pain was starting to affect his quality of life and he was ready to do whatever was necessary to get

Figure. CT scan showing sigmoid wall thickening and fat stranding around an indistinct diverticulum.

better.

• What is your initial diagnostic impression?

• Should this patient have a colonoscopy or repeat imaging?

• Is there a nonoperative treatment for the patient’s symptoms?

• What surgery would you perform?

Dr. Pannell’s REPLY Diverticulosis of the colon is a common condition, affecting about 50% of the population in the United States.2 Acute diverticulitis is an inflammatory condition that may develop in involved segments of the colon with diverticulosis, and may progress to perforated diverticulitis and pericolic abscess.

Acute diverticulitis usually lasts for two days to two weeks. The most notable symptoms of acute diverticulitis are lower left quadrant pain, fever and leukocytosis.

Chronic diverticulitis develops when symptoms persist for more than six months. Symptoms may mimic varying degrees of obstruction, such as constipation, decrease in caliber of stool, nausea, vomiting and bloating. Chronic inflammation may result in fibrosis and scarring, often leading to luminal narrowing of the involved segment of the colon and resulting in development of the obstructive symptoms.3 Normally, after an episode of acute diverticulitis, the patient will be scheduled for a colonoscopy in about six weeks after the resolution of symptoms to decrease the likelihood of procedure-related complications.4 The patient described here is still exhibiting left lower quadrant pain. As such, I would not feel safe to proceed with a colonoscopy while patient is still having pain after the bout of acute diverticulitis.

The colonoscopy is performed to rule out malignancy. However, finding an occult malignancy would not change my management of this patient. I would not obtain further imaging since the patient had a CT scan eight months ago, unless the patient has new symptoms or worsening of existing symptoms.

I would have recommended certain lifestyle changes, such as tobacco cessation, reduction of meat intake, increased physical activity and weight loss, to reduce the risk for recurrent diverticulitis.5,6 However, after eight months of dealing with smoldering diverticulitis and

failure of medical management to resolve it completely, this patient is a candidate for resection of the involved segment of colon. Without surgical intervention, this patient’s symptoms will not resolve because there are no other nonoperative treatment options.

This patient is an ideal candidate for minimally invasive sigmoidectomy with primary anastomosis.6 If there appears to be severe inflammation around the area of contamination intraoperatively, I would do a proximal loop ileostomy before closing the abdomen.6 Often in medical schools, we talk about acute episodes of diverticulitis that either resolve or require acute intervention. We must recognize that there is a subset of patients who present with chronic lower left quadrant pain and fall into the category of chronic diverticulitis.

These patients should be recognized early after minimal treatment to prevent delay in care.

■

References 1. Destigter KK, Keating DP. Imaging update: acute colonic diverticulitis. Clin Colon Rectal Surg. 2009;22(3):147-155.

2. Hughes LE. Postmortem survey of diverticular disease of the colon. I. Diverticulosis and diverticulitis.

Gut. 1969;10(5):336-344.

3. Sheiman L, Levine MS, Levin AA, et al. Chronic diverticulitis: clinical, radiographic, and pathologic findings.

AJR Am J Roentgenol. 2008;191(2):522-528.

4. Stollman N, Smalley W, Hirano I; AGA Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on the Management of Acute Diverticulitis. Gastroenterology.

2015;149(7):1944-1949.

5. Liu PH, Cao Y, Keeley BR, et al. Adherence to a healthy lifestyle is associated with a lower risk of diverticulitis among men. Am J Gastroenterol. 2017;112(12):1868-1876.

6. Hall J, Hardiman K, Lee S, et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Treatment of Left-Sided Colonic Diverticulitis.

Dis Colon Rectum. 2020;63(6):728-747.

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JUNE 2022 / GENERAL SURGERY NEWS

THE INSTRUMENT, THE NAME

A Brief History of the Foley Catheter

By Ronit Patnaik, MD, UT Health, San Antonio, and Lisandro Montorfano, MD, chief resident in general surgery, Cleveland Clinic Florida, Weston It is unclear when urinary catheterization was invented. Urinary retention was described in the early papyrus manuscripts of the ancient Egyptians.1,2 By 1500 BC, Egyptian priest–physicians also reported using simple bronze, tin or reed catheters to relieve the painful symptoms of retention.3 Not infrequently, direct puncture or open surgical drainage of the bladder was required.2 Availability of appropriate material had a considerable influence on the development of different types of catheters. In 400 BC, lead-based catheters were described due to their malleability, which allowed them to follow the natural course of the urethra.4 By 300 BC, catheters were made of rigid material and curves to facilitate their passage into the bladder.5 Around this time, the word “catheter” was first used by the Greeks, derived from the word “kathienai,” which means “to thrust into” or “to send down.”6 Catheters have evolved significantly since ancient times. Fabricius of Acquapendente is credited with developing the earliest indwelling catheter, which was made of cloth impregnated with wax and molded on a silver sound.5,7 They were adequately rigid to allow the sound to be withdrawn once it was in place. However, their use was limited by rapid softening of the wax, which led to collapse of the molded wall.7 In 1839, American inventor Charles Goodyear discovered the process of converting elastin gum into rubber by vulcanization.8 This development improved the firmness and durability of rubber, expanding its use as a material for catheters. The manufacture of catheters from natural rubber heralded one of the most significant advances in the device’s development.

In 1929, Dr. Frederick E. B. Foley, an American urologist, first described the use of a soft rubber, self-retaining balloon-tip catheter to achieve hemostasis after transurethral (cystoscopic) resection of the prostate and simultaneously provide bladder drainage.9 This longitudinally grooved, rubber catheter had an attached inflating tube and a rubber balloon, allowing it to be a reliable selfretaining catheter (Figure 1).

This design was further refined for use as an indwelling catheter to provide continuous drainage of the bladder.

Dr. Foley collaborated with American Anode Inc., and Dr. Ward Beebe of Beebe Laboratories to develop this design by dipping coagulating latex on a metal form, which enabled the balloon and catheter to be a smooth, one-piece

device.10 It soon became apparent that this design was a solution to the general problems of urinary retention and incontinence (Figure 2).

In 1935, Dr. Foley presented his newly designed catheter at the meeting of the American Urological Association in San Francisco.11 The medical manufacturing company, C.R. Bard, in New Jersey, soon began to distribute the device under the name “Foley catheters.” Dr. Foley eventually published his design in 1937.11 This model improved patient comfort and avoided adhesive fixation of the catheter to the skin (Figure 3).

due to the cytotoxicity of the material.12 Latex catheters are now coated with silicone elastomers to reduce this risk and to provide a slippery surface for reduced friction.13 Some work has focused on developing antimicrobial coatings to the catheter surface with the aim of reducing urinary tract infections. This work has been met with mixed success.14 Despite its clear benefits, the Foley catheter remains one of the primary sources of hospital-acquired infections, which increases morbidity, mortality and the financial burden on the healthcare system.15

References 1.

Breasted JH. The Edwin Smith Surgical Papyrus: Hieroglyphic Transliteration With Translation and Commentary.

Vol. 1 and 2. University of Chicago Press; 1930.

2.

Leake CD. The Old Egyptian Medical Papyri. University of Kansas Press; 1952.

3.

Hanafy HM, Saad SM, Al-Ghorab MM. Ancient Egyptian medicine contribution to urology. Urology.

1974:4(1):114-120.

4.

Milne JS. Surgical Instruments in Greek and Roman Times. Clarendon Press; 1907.

5.

Nacey J, Delahijnt B. The evolution and development of the urinary catheter. Aust N Z J Surg.

1993;63(10):815-819.

6.

Feneley RC, Hopley IB, Wells PN. Urinary catheters: history, current status, adverse events and research agenda. J Med Eng Technol.

2015;39(8):459-470.

7.

Murphy LJ, Desnos E. The History of Urology. Charles C Thomas Pub Limited; 1972.

8.

Goodyear C. Gum-Elastic and its Varieties: With a Detailed Account of its Applications and Uses, and of the Discovery of Vulcanization (Vol. 2).

New Haven, Conn; 1853.

9.

Foley FE. Cystoscopic prostatectomy: a new procedure and instrument; preliminary report. J Urol.

1929;21(3):289-306.

Figure 1. Photos and illustrations from Dr. Foley’s 1927 publication of a hemostatic bag catheter.9

Although the materials used to make Foley catheters have changed since the 1930s, the basic design has not. The catheter typically has two channels: the drainage channel for the passage of urine and the inflation chan- Figure 2. Dr. Foley’s 1937 publication describing nel to allow the cathe- the “Foley hemostatic bag catheter” or the “Foley ter to be inflated with catheter.”11 water, enabling the catheter to be retained in the bladder.

The smooth, rounded tip of the catheter extends beyond the balloon, and one or more eyeholes are cut in the tube adjacent to the tip to allow urine to drain.6 The indwelling Foley catheter made short- and long-term catheterization feasible for both male and female patients.

This advancement started a new era in the management of urinary retention and urinary incontinence, and allowed physicians to accurately track urine output in sick patients.6 The basic design of the Foley cathe- Figure 3. Illustration from Dr. Foley’s ter has remained unchanged, but it has 1937 publication describing the undergone subtle improvements. At Foley catheter.11 first, open flasks or buckets were used Yet, decades after its invention, for urine collection from the Foley. In the 1960s, a drainage bag was strapped the Foley catheter continues to be to the patient’s bed as a more hygienic an indispensable tool in modern cliniand aesthetically appealing option. The cal practice. However, its use and the catheters were originally made of latex, catheter itself will continue to evolve but an increased incidence of urethral to address the associated morbidity strictures was reported in the 1980s and mortality.

10. Carr HA. A short history of the Foley catheter: from handmade instrument to infection-prevention device.

J Endourol. 2000;14(1):5-8.

11. Foley FE. A self-retaining bag catheter: for use as an indwelling catheter for constant drainage of the bladder.

J Urol. 1937;38(1):140-144.

12. Ruutu M, Alfthan O, Talja M, et al.

Cytotoxicity of latex urinary catheters.

Br J Urol. 1985;57(1):82-87.

13. Stensballe J, Looms D, Nielsen PN, et al. Hydrophilic-coated catheters for intermittent catheterisation reduce urethral micro trauma: a prospective, randomised, participant-blinded, crossover study of three different types of catheters. Eur Urol.

2005;48(6):978-983.

14. Johnson JR, Kuskowski MA, Wilt TJ. Systematic review: antimicrobial urinary catheters to prevent catheterassociated urinary tract infection in hospitalized patients. Ann Intern Med. 2006;144(2):116-126.

15. Kunin CM. Can we build a better urinary catheter? N Engl J Med. 1988;319(6):365-366.

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IN THE NEWS

GENERAL SURGERY NEWS / JUNE 2022

‘I‘ think thin we’re going to enter a new era of government regulation that says if you’re going gove to put pu a new mesh on the market, you ccan’t simply tell us that it is the same as some other product.’

What’s in That Mesh? continued from page 1

“Many surgeons choose a mesh based on habit or based on marketing that they’ve received from a mesh company,” Dr. Pauli told General Surgery News. “Not that marketing is specifically bad, I think it just paints a very good picture of the good parts of the mesh without a clear understanding of the bad parts.”

There are many unknowns about what happens in the human body after a mesh is implanted, including how or

why people respond differently to the same mesh, Dr. Pauli said. The surgical field has “broad brushstrokes of what a mesh might do” but not enough understanding of what a mesh is likely to do to a specific individual, he said.

He called for surgeons, surgical societies and course directors to put more effort into education about specific characteristics of mesh. “A higher level of knowledge about mesh is where we need to go,” he noted.

—Eric Pauli, MD How Bodies Respond to Mesh In his presentation, Dr. Pauli explained that human bodies react to mesh implantation with a foreign body reaction, triggering inflammation and fibrosis.

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Over time, fibrosis occurs around and throughout the mesh, causing the mesh to contract.

“If you understand that that response happens to every mesh that you put into somebody, you’ll have a better understanding of how the mesh you’ve chosen will react when you put it into a person,” Dr. Pauli said.

This process varies based on the characteristics of a particular mesh product, according to Dr. Pauli. He advised surgeons to ask themselves questions about every mesh: • What is the base material or materials?

• What is the origin of those materials?

• Is it synthetic? Biologic?

• Is the mesh designed to remain in the body permanently, or designed to absorb or resorb over time?

• How much does the mesh weigh?

• What is the density and quantity of mesh?

Synthetic Mesh Options: The Basics The most commonly used synthetic meshes fall into three categories: expanded polytetrafluoroethylene (ePTFE), polyester and polypropylene, Dr. Pauli said.

Although often considered inert, ePTFE mesh does induce a foreign body response, through fibrosis and encapsulation rather than ingrowth. Of the three synthetic meshes, polyester mesh triggers the greatest inflammatory response, leading to significant fibrosis, a longer inflammatory response and more mesh contracture over time. Polypropylene mesh has the lowest foreign body response, with the least amount of fibrosis and contracture.

The body’s response also is affected by weight, density and porosity of the mesh, Dr. Pauli pointed out. Bridging fibrosis is a phenomenon that occurs when the inflammatory response to a single mesh fiber overlaps with a nearby fiber, which overlaps with another, and so on. This process causes a mesh to contract, and is more likely with heavy, microporous meshes, according to a 2012 study that compared histopathologic effects of mesh in mice (J Surg Res 2012;176[2]:423-429).

On the other end of the spectrum, ultralight, macroporous meshes are associated with an increased likelihood of central mesh fracture, Dr. Pauli noted.

In a 2015 study, surgeons reported a 22% recurrence rate among 26 patients who

IN THE NEWS

JUNE 2022 / GENERAL SURGERY NEWS

underwent open incision hernia repair with retrorectus placement of a lightweight monofilament polyester mesh, up from an expected recurrence rate of 3% to 5% for open transversus abdominis muscle release (TAR) (Hernia 2015;19[1]:155159). Of the eight patients with a recurrence in this study, seven were identified as having a central mesh fracture.

The mechanism causing these fractures is unknown, according to Dr. Pauli.

“Maybe the mesh is just too lightweight.

Maybe this is fatigue fracture around the fibers. Maybe you get some plasticizing of polyester material,” he said.

More recently, surgeons reported a retrospective review of 541 contaminated ventral hernia repairs completed between 2007 and 2019, including 245 clean-contaminated, 214 contaminated and 82 dirty cases (J Am Coll Surg 2020;230[4]:405-413). Surgical site infections occurred in 17.4% of patients who underwent suture repair, 36.8% with biologic mesh, 32.7% with absorbable synthetic mesh and 14.2% with permanent synthetic mesh. The rate of hernia recurrences fell in patients with a permanent synthetic mesh, down to 10.4% compared with 30.9% in those with

absorbable synthetic mesh and 26.3% with biologic mesh. The differences were statistically significant.

Looking Ahead Dr. Pauli predicted that government regulation of hernia mesh products will change. Currently, most meshes reach the U.S. market through the 510(k) clearance process, which requires only demonstration that the new product is substantially equivalent to a previously approved device.

As such, mesh products may enter the market with a minimal amount of clinical data on their safety and long-term effectiveness.

“I think we’re going to enter a new era of government regulation that says if you’re going to put a new mesh on the market, you can’t simply tell us that it is the same as some other product,” Dr. Pauli said. “You’ll have to present us with the data that shows it is safe and provides effective outcomes.”

■ Dr. Pauli reported speaking/teaching honoraria from Becton Dickinson, Boston Scientific, Medtronic and Ovesco, and a consultantship to Actuated Biomedical, Allergan, Baxter, Boehringer Laboratories, Boston Scientific, CMR Surgical, Cook Biotech, Neptune Medical, Noah Medical, Surgimatix and Wells Fargo.

Biologic and Bioabsorbable Meshes There are several types of biologic mesh available in the United States, including products derived from human cadaveric dermis, acellular porcine dermal matrix, sheep rumen, bovine pericardium and porcine small intestine submucosa. Little is known about how the body responds to each of these meshes, Dr. Pauli pointed out, and their cost may outweigh clinical benefits. A study that looked at porcine-based biologic meshes showed chemically cross-linked meshes induced the greatest inflammatory response (Hernia 2010;14[4]:401-407).

Bioabsorbable meshes can be synthetic or biologically derived, and are absorbed by the body through a process of hydrolysis. Three are commonly available on the U.S. market. They are: • Vicryl (Ethicon), a synthetic resorbable polyglactin 910 mesh that reabsorbs in six weeks through hydrolysis; • Phasix (BD), a biosynthetic resorbable poly-4-hydroxybutyrate mesh that reabsorbs in 12 to 18 months. Dr. Pauli noted that he has found small amounts of mesh during reoperations on patients who have had Phasix longer than 18 months; and • TIGR (Novus Scientific), a synthetic resorbable mesh made from two types of fibers: a fast-degrading fiber of glycolide, lactose and trimethylene carbonate, and a slow-degrading fiber of lactose and trimethylene carbonate. The fibers reabsorb in four and 36 months, respectively.

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This activity is jointly provided by Global Education Group and Applied Clinical Education.

CHAIR

What to Do in Challenging Cases In contaminated cases (CDC classes II and III), emerging evidence suggests that synthetic mesh outperforms biologic mesh, when used in sublay hernia operations, according to Dr. Pauli. A 2016 study showed a 46% relative reduction in surgical site occurrences, 61% relative reduction in surgical site infections, 75% reduction in deep surgical site infections and 66% relative reduction in hernia recurrence with synthetic mesh compared with biologic (Surgery 2016;160[4]:828-838).

Charles E. Argoff, MD

FACULTY These activities are supported by an independent educational grant from the Opioid Analgesic REMS Program Companies.

Please see https://opioidanalgesicrems.com/Resources/Docs/List_of_RPC_Companies.pdf for a listing of REMS Program Companies.

This activity is intended to be fully compliant with the Opioid Analgesic REMS education requirements issued by the U.S. Food and Drug Administration (FDA).

Yvonne M. D’Arcy, CRNP, CNS Marc R. Gerber, MD Courtney M. Kominek, PharmD, BCPS, CPE Bill H. McCarberg, MD, FABM

INDEPENDENT REVIEWER Michael Clark

Distributed by CMEZone.com

Access today at www.cmezone.com/SY212

21

22

response

Feedback Overdose continued from page 1

communication and ensure transparency. This all sounds well and good, until everyone wants feedback on everything they do. Then it becomes more like the second definition that is a “screeching or humming sound.”

Quite frankly, I think I have feedback overdose.

In the surgical training programs, attendings evaluate residents and students on their performance, residents evaluate students and attendings, and

students evaluate attendings and residents as their instructors. We also evaluate the program, chair, department, medical school and dean. With residents and students changing every month, we spend as much time evaluating performance as actually performing operations.

They want 360 degrees of feedback.

In the medical centers, we evaluate our staff, the departments, our systems, our nurses and programs. Administration is trying to make everyone feel as if they

are part of the improvement process and that every person in the organization has a voice. Even patients are sent home with satisfaction surveys so they can give feedback on whether the staff was helpful, pleasant, and whether they washed their hands, and whether the medical center was clean and had pleasant facilities. Everyone is sitting down with a survey.

Medical organizations distribute surveys about their processes, their staff

The mission of the Americas Hernia Society is to advance the science and treatment of hernia. The vision of the Americas Hernia Society is to be the worldwide authority on hernia surgery.

AHS fulfills its mission and vision by, among other things: • Hosting periodic meetings for open presentation and discussion of scientific material concerning subjects of common interest.

• Cooperating in educational endeavors with groups of similar interest throughout the world.

• Initiating and cooperating in the publication of a journal and/or newsletter on the subject or hernia/abdominal wall abnormalities.

• Undertaking projects of scientific interest to seek information and otherwise serve the mission of the organization.

Americas Hernia Society www.americasherniasociety.com (847) 228-3302 | info@americasherniasociety.org

The Americas Hernia society offers a number of benefits to our members.

We encourage any surgeon interested in abdominal wall abnormalities to join.

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

and their newsletters. Medical journals send out surveys about how much of their journals we actually read and whether we like their new format. Conference hosts want us to evaluate their meetings and rate each speaker. Did it meet expectations? Was there any conflict of interest that was not disclosed? Or there’s my personal favorite: List one or two things that you will change in your practice because of this conference. My answers: 1) I will turn down the AC setting in my waiting room so people sitting more than 30 minutes will not freeze, and 2) I will not take away from my practice to come to this meeting again.

In addition, there are emails offering to pay money to fill out more surveys. Get paid $50 to fill out this survey on practices for renal cell cancer. Win an Amazon gift card for filling out this survey on various tumor types. In fact, I get surveys from the drugstore each time I purchase something. How was your experience? Did you find everything that you needed? Was the customer service representative helpful?

Everyone wants to know how they are doing, and everyone wants positive feedback. No one wants a suggestion box because people will just complain with those suggestions. We all crave positive reinforcement that we did a good job. However, if they send out enough of these surveys, the people filling them out will have survey fatigue. The sunny, happy people will check “10” for everything, the curmudgeons will check “2” for everything, and if you are just so exhausted with all these questions, you will just check “5” for “neutral” or “NA.” However, if the happy people don’t feel compelled to answer, will the scores be skewed to the ones who are really dissatisfied?

Do any of these surveys truly mean anything anymore? Or do they just reflect the random musings of people who are trying to get CME credit, their $25 for the survey, or just get administration off their backs? People filling out these surveys are probably just not that interested in giving constructive feedback, unless

23

JUNE 2022 / GENERAL SURGERY NEWS

they are truly irritated at the organization and want to give a scathing review of their bad experience to vent, or perhaps they just want the carrot ($25 for fulfilling the requirement).

What’s even more amusing is how organizations then publish their survey results online: “90% of the respondents were happy with our department.” Yay! Does it mean anything? Probably not, but the administrators and VPs like to hand out positive reinforcement to their staff and pat themselves on the back for a job well done. But was it really a job well done when only 10% to 20% of the surveys were filled out? No one knows, but they only want to hear the positive side. Some organizations work hard to improve their scores and make changes in their processes to get a higher rating with the next survey. But was there really an improvement, or did they just randomly sample a group of less dissatisfied people?

The survey is the basis for continuing to stay in business, and may be the tool for research studies or providing employment for the minions that tabulate all this mostly meaningless information. It’s more data, and we are drowning in data that have questionable meaning.

What happened to just speaking up if we have an issue that needs corrective action, or saying “thank you for a job well done” to someone you appreciate? What happened to just being comfortable enough with your skills and performance that you can be satisfied when people say “thank you”? Instead, we all burrow into our computer screen and passive-aggressively fill out a survey of our thoughts.

In the end, our individual feedback is then diluted by other sometimes random responses to arrive at conclusions with dubious meanings.

But if we must continue being inundated with these surveys, I propose that every survey have this question to start: I am filling out this survey because: • I am paid to do it.

• I am forced to do it.

• It is a requirement by the organization.

• I can’t get my CME credit unless I do it.

• I truly care about this.

Thank you for taking the time to ■ answer this survey.

SAGES Address continued from page 8

Surgical Energy) exams; get certificates and transcripts; and claim CME credits.

Institutional users can also assign courses and exams to residents through the portal.

Initiatives in Access to Care And Diversity in the Surgical Workforce The pandemic shone a spotlight on global inequities, systemic racism and its effect on health outcomes, Dr.

Feldman said. People around the world experience unequal access to minimally invasive surgery and endoscopy, including for cancer screening.

SAGES is committed to improving the diversity of the surgical workforce as a critical step in improving patient care, she said. The society is launching a speakers’ catalog that will feature a diverse group of speakers to facilitate better representation at meetings.

Dr. Feldman said she was inspired to become a surgeon on the last day of her clerkship rotation when she was handed a scalpel and asked to open for an

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Evaluating the Correlation Between Neuromuscular Blockade Reversal and Pulmonary Outcomes After Surgery: Implications for Clinical Practice RELEASE DATE: OCTOBER 1, 2020 EXPIRATION DATE: OCTOBER 1, 2022

Faculty Timur Dubovoy, MD (Program Chair)

Jointly provided by Postgraduate Institute for Medicine and Miller Medical Communications, LLC

—Dr. Wong is a professor of surgery at the University of Hawaii, in Honolulu.

Inflammatory Response Column editor: Gary H. Hoffman, MD, is the surgical director at Los Angeles Colon and Rectal Surgical Associates (www.lacolon. com), an attending surgeon at CedarsSinai Medical Center, and an instructor in the Cedars-Sinai colon and rectal surgical fellowship, in Los Angeles.

appendectomy. “An important message from being handed that knife was that others saw me as a surgeon,” she said.

“We all need to be looking out for people who may have potential, and explicitly encouraging and mentoring them.”

At the end of her talk, Dr. Feldman told the audience that technology does not take care of patients, many of whom are supportive as surgeons learn new techniques, she noted. “How we repay that debt to our patients, to our mentors and teachers who paved the way for us … is to continue the work to make things better.”

■

This activity is supported by an independent educational grant from Merck & Co., Inc. Distributed by CMEZone.com

Assistant Professor Department of Anesthesiology University of Michigan Medical School Ann Arbor, Michigan

Glenn S. Murphy, MD Clinical Professor The University of Chicago Pritzker School of Medicine Chicago, Illinois Director, Clinical Research NorthShore University HealthSystem Evanston, Illinois

Brad J. Phillips, DNP, RN, CRNA, NE-BC Adjunct Clinical Instructor University of Michigan School of Nursing Assistant Chief Nurse Anesthetist Michigan Medicine Ann Arbor, Michigan

Access today at www.cmezone.com/CU207

24

OPINION

GENERAL SURGERY NEWS / JUNE 2022

Curing Diabetes Mellitus continued from page 1

17th century, Thomas Willis, like Sushruta, was fascinated by the sweetness of the urine and added “mellitus” to the name of the disease. Not until the 19th century did Claude Bernard discover the glycogenic actions of the liver and Oskar Minkowski link diabetes mellitus to an endocrine function of the pancreas. And, only in the 20th century, did Banting and Best isolate insulin from the pancreas. In January 1922, insulin was first injected into a human patient.

Etiology Even after 3,500 years of descriptive information, knowledge of the underlying metabolic mechanism of diabetes mellitus is, at best, sketchy, incomplete and possibly erroneous. The disease has been divided into two manifestations: juvenile, occurring primarily in childhood or early life (type 1), and adult onset (type 2), with different postulated origins, leaving room for a possible type 3 or more.

Type 1 is commonly believed to be due to an autoimmune destruction of the beta cells of the pancreatic Islets of Langerhans. There is a strong genetic predilection for type 1 diabetes mellitus, from both maternal and paternal genes, certainly when both parents are afflicted. The triggering agent appears to be a common viral infection.

The end result is burnout of the islet cells with the diminution and eventual cessation of insulin production, leading to impaired glucose utilization and hyperglycemia.

Type 2 is commonly believed to be due to the development of peripheral cellular insulin resistance, resulting in an increased demand for pancreatic insulin production until the islet cells are exhausted and the patient is first low in and, finally, devoid of insulin and hyperglycemic. There is no clearly demonstrated explanation for why peripheral insulin resistance occurs in the first place. Again, there is a predisposing heredity component; an excess of high-carbohydrate foods may also be a contributory factor. Obesity is the most precipitating and prevalent disease in type 2 diabetes. A contrary etiologic theory is the gut initiation of a metabolically induced primary abnormality of the pancreatic islet cells, resulting first in insulin overproduction and hyperinsulinemia, which, in turn, as a bodily defense strategy, elicits peripheral insulin resistance with resultant hyperglycemia.

Over those 3,500 years, at least three theories of causation of a common disease or diseases have been postulated, with no scientifically proven, definitive explanation(s) of causation. We have given the disease(s) a Greco-Roman name, clearly defined its

Cartoon by Walter Pories, MD

symptoms, course and outcomes, without a clear insight into mechanism(s) of causation. Remarkably, despite our absence of this knowledge, we have still been able to palliate and probably cure diabetes mellitus.

Palliative Therapy Medical therapy for diabetes mellitus consists of diet, lifestyle suggestions and drugs, particularly insulin. Diet and lifestyle recommendations are concurrent and complementary, namely, maintaining normal weight, reducing or eliminating sugars, and restricting fats in the diet, as well as exercising and refraining from smoking and alcohol. Strict adherence to these principles has offered moderate blood sugar control for some patients and can be of benefit to all.

It has been clearly demonstrated that curative therapy for diabetes mellitus exists. It is now a matter for research and public health initiatives to make curing this disease available to most, if not all.

Drug therapy for diabetes mellitus usually starts with metformin, which decreases glucose absorption, lowers hepatic glucose production and improves insulin sensitivity. Metformin, a biguanide, is taken orally. Several other oral medications are employed in diabetes mellitus therapy, including glucagon-like peptide-1 (GLP-1) analogs and sodium-glucose cotransporter-2 inhibitors.

Essentially, most patients, type 1 and type 2, are eventually placed on insulin, often a combination of fast and slow-acting preparations.

It is estimated that there are 34 million individuals, 10% of the population of the United States, who have received a diagnosis of diabetes mellitus. Because of the dedication of diabetologists, endocrinologists, internists and general practitioners, these individuals have been able to live fairly normal lives and often achieve a normal life expectancy. This is outstanding palliative medicine, but it is not curative medicine. Further, current palliative drug therapy’s influence on diabetes mellitus blood parameters is about half as effective as bariatric surgery, and often, even in one year, more expensive.

Curative Therapy Curative or preventive therapy is available for only a few individuals out of the massive number afflicted with this disease. Why? Because today’s proven curative therapy involves surgery, specifically metabolic surgery. Over 50 years, metabolic/bariatric surgery has been demonstrated to cure (defined as a disease-free interval of ≥10 years) type 2 diabetes in over 60% of obese individuals, and, probably, in the overweight as well. There is a growing cascade of literature on this phenomenon and its metabolic causation, initiated by a 1995 publication by Dr. Walter Pories, with the iconic title: “Who Would’ve Thought It? An Operation Proves to Be the Most Effective Therapy for Adult-Onset Diabetes Mellitus” (Ann Surg 1985;222[3]:339-352).

Pancreatic transplantation may achieve a “cure” at the cost of a lifetime of immunosuppressive therapy. Autologous islet cell transplantation holds some promise and provides evidence of the role of faulty gut metabolism in the etiology of the disease. In a 2017 review of the POSCH (Program on the Surgical Control of the Hyperlipidemias) trial, we showed that at 34 years of follow-up, the incidence of de novo type 2 diabetes was significantly reduced over 2.5-fold in the partial ileal bypass surgery group compared with the control group (Surg Obes Relat Dis 2017;13[1]:45-51). This may have been the result of an average 8-pound weight loss in the surgery group or a metabolic neurohormonal intestinal mechanism.

In a 2011 publication, Mahfoud and colleagues serendipitously discovered that bilateral femoral artery catheter-mediated perirenal sympathetic neuroablation for hypertension normalized type 2 diabetes blood parameters, a finding still present at follow-up in three months’ time (Circulation 2011;123[18]:1940-1946). This discovery of a neuromodulating metabolic surgical diabetes mellitus mechanism outside of the gut is most intriguing.

Thus, it has been clearly demonstrated that curative therapy for diabetes mellitus exists. It is now a matter for research and public health initiatives to make curing this disease available to most, if not all.

What If? What if a percutaneous catheter procedure could cure diabetes? What if a minimally invasive (robotic) partial ileal bypass operation could simultaneously cure hyperlipidemia and prevent type 2 diabetes without the lifelong necessity of drug therapy? These are the “what ifs” of today.

What about the what ifs of tomorrow? What if injectable xenograft (e.g., porcine) islet cells can be rendered nonimmunogenic? What if autologous germ cells can be induced in vitro to become islet cells for catheter implantation? What if foreign islet cells can be encapsulated to allow passage of nutrients, including glucose, and hormones, including insulin, and be a barrier to eliciting an antigen-induced rejection response? Most fascinating of all, what if we elucidate from a retro analysis of the ever-increasing knowledge of the mechanism(s) of metabolic surgery for diabetes mellitus, the metabolic etiology of the disease itself? Understanding the disease will open metabolic intervention avenues for cure and prevention. These metabolic therapies can be minimally invasive surgical procedures suitable for mass utilization or, perhaps, even nonsurgical—a therapeutic or prophylactic pill, or a vaccination.

The Future To realize the future—the eradication of diabetes mellitus—we must believe in the attainability of that future. We should be grateful for palliative therapy but not content with it as an end result of good medicine.

Today we can take the steps toward cure and prevention. Future laboratory and clinical research can achieve these goals. Centuries of medical history offer testimony that physicians and scientists have always believed in and worked toward not the containment but the eradication of a terrible disease.

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

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26

IN THE NEWS

GENERAL SURGERY NEWS / JUNE 2022

William T. Bovie (1882-1958)

By MOISES MENENDEZ, MD, FACS

N

o instrument has been more important to the field of surgery than the Bovie electrocautery device.

When it comes to hemostasis, it is the most frequently used tool in surgery.

William T. Bovie was an American scientist and inventor. He is credited with conceptualizing the field of biophysics and inventing a modern medical device known as the Bovie cautery. In the 1920s, Bovie learned that high-frequency alternating current in the range of 250,000 to 2 million Hz could be used to cut tissue and obtain hemostasis, and he developed the first commercial electrosurgical device at Harvard University. Bovie also taught and/or conducted research at Harvard University, Northwestern University, Jackson Laboratory and Colby College.

The use of cauterization dates to prehistoric times when heated stones were used to control bleeding. In medieval times, blood loss was contained by hot cautery. No major improvement or new technology followed for hundreds of years. At the end of the 19th century, improved use of anesthesia, use of antiseptic agents and a better understanding of anatomy enabled William Halsted and others to achieve further progress with precise clamp-and-tie hemostasis. However, at the turn of the 20th century, the invention of a more practical device to coagulate bleeding vessels became a reality. During that time, it was known, for example, that electric current above certain frequencies could cut tissue without inducing muscular contraction. There were several pioneers in the field of electrocoagulation, but no one came close to William Bovie as the true pioneer of the electrocautery that we use today.

William Bovie was born in 1882, in Augusta, Mich.

His father was a successful physician in rural Michigan. During his upbringing, Bovie demonstrated a fascination for electrical devices. He went on to attend the University of Michigan at Ann Arbor, where he received his bachelor’s degree in 1905. He then moved to Missouri, where he obtained his master’s degree in 1910. After his marriage to Martha Adams, the couple moved to Boston. He completed a PhD in plant physiology at Harvard University.

IBD Biologics continued from page 1

complications following IBD surgery by analyzing all adult IBD patients included in the American College of Surgeons National Quality Improvement Program IBD Collaborative,, led by Sam Eisenstein, MD, at the University of California, San Diego, from rom 18 institutions for 2017-2020.

20. The primary outcome was anyy infectious complications (all infectious complications, surgical site infection [SSI] or anastomoticc leak), and the primary preedictor was exposure to biologics ologics within 60 days prior to surgery.

Univariate analyses assessed factors associated with infectious complications.

William T. Bovie (1882-1958) 2018. Work was done on toned paper, 19x13, with charcoal pencils and white chalk.

Artist: Moises Menendez, MD, FACS

In the 1920s, Bovie was able to develop an apparatus with high-frequency circuits to aid in removing malignant tumors by cutting and coagulating tissue without bleeding. Bleeding had been the significant obstacle in neurosurgery until Bovie and Harvey Cushing began to use the device in 1926. In the summer of 1926, Cushing consulted with Bovie, experimented with the currents and developed the tips that would come into contact with brain tissue. The first surgical trial took place on Oct. 1, 1926. In his surgical note, Cushing reported, among other things: “This operation is a perfect circus—many ringed.” Cushing was able to remove the malignant tumor [with minimal bleeding], a feat that

Propensity scores, which estimated the probability of biologic exposure, were developed with generalized boosted modeling and applied with inverse probability weighting to adjust for differences between the groups. Propensity score‒weighted conditional logistic regression models were used to test associations associa between biologic exposure and outcomes. Multivariable regression models, tivariab informed by backward inform stepwise model selection, step were we used to identify risk factors for outcomes.

The study cohort included 4,578 patients: 50.2% were not pati exposed to biologics before surgery and 49.8% were exposed before surgery. The biologics patients were

could not have been accomplished before. The device helped to greatly reduce bleeding complications during intracranial operations and reduced mortality rates during brain surgery. Cushing was so encouraged by the success of the device that he contacted all of his previous patients with inoperable meningiomas to return for treatment. After that, surgeons from a variety of disciplines all over the world were able to follow his example.

Although it has been refined to improve its safety, the “Bovie,” as we surgeons call the electrocoagulation device, has not changed much in almost a century. After several design changes, the Bovie became a fixture in operating rooms throughout the world.

Known as the founder of the field of biophysics, Bovie chaired the new biophysics department at Northwestern University, in Evanston, Ill., after his relatively brief association with Cushing. He received the John Scott Medal in 1928, for his development of the electrosurgical device. He was made a fellow of the American Academy of Arts and Sciences.

Despite his accomplishments, Bovie was relatively poor in his later life. He had not been motivated by financial gain, so he had sold the patent rights to his electrosurgical device to a manufacturer for $1. He had diabetes, arthritis and long-standing obesity, and his early work with radium led to chronic pain in his hands.

■ He died on Jan. 1, 1958.

Sources Bliss M. Harvey Cushing: A Life in Surgery. Oxford University Press; 2005:407-408, 454-455.

Carter PL. The life and legacy of William T. Bovie. North Pacific Surgical Association: Historian’s Lecture. J Am Surg.

2013;205(5):488-491.

Fulton J. Harvey Cushing: A Biography. The Story of a Great Medical Pioneer. Charles C. Thomas; 1946:537-538.

Massarweh NN, Cosgriff N, Slackey DP. Electrosurgery: history, principles, and current and future uses. J Am Coll Surg.

2006;202(3):520-530.

Van de Laar A. Under the Knife: A History of Surgery in 28 Remarkable Operations. St. Martin’s Press; 2018:293-295.

—Dr. Menendez is a general surgeon and self-taught portrait artist in Magnolia, Ark. Since 2012, he has completed a series of portraits of historical figures, particularly well-known physicians and surgeons.

younger, were more likely to have nonelective surgery, had more steroid/immunomodulator exposure preoperatively, were more likely to require preoperative transfusion and were more likely to have any comorbidity (P<0.001 for all).

Overall, 14.6% of patients developed any infection, 11.4% developed any SSI and 2.2% had an anastomotic leak. Any infectious complication was more common in patients who were older; had a higher body mass index, an open wound at the time of surgery, diabetes, hypertension or other comorbidities; were undergoing emergency surgery; or were American Society of Anesthesiologists physical status class III to IV (P<0.001 for each by univariate analysis). On univariate logistic regression, propensity score‒weighted conditional logistic regression and multivariable logistic

regression, biologic exposure was not associated with any infectious complications, any SSI or anastomotic leak.

The authors, and many others, thought that in the earlier studies, biologic use served as a surrogate for disease severity and extent. “Although the results suggest that biologics need not be held preoperatively for fear of infectious complications, there is a pragmatic reason to hold them given their associated expense.

It simply does not make sense to infuse an expensive medicine and then remove the target organ shortly thereafter,” Dr. Holubar said.

■ Dr. Holubar reported consulting fees from Guidepoint, Shionogi and Takeda, and research funding from the Crohn’s & Colitis Foundation and American Society of Colon and Rectal Surgeons.

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