July 2022 Print issue

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

July 2022 • Volume 49 • Number 7

Surgical Robots, Once ‘On the Horizon,’ Poised to Transform Surgery

Distance From Facility Increases Patients’ Risk For Advanced Colon Cancer, Mortality

By CHRISTINA FRANGOU

DENVER—Over the next five years, robotic surgery in the United States will be transformed, driven by an expansion of commercially available robotic platforms.

At the 2022 annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons, Santiago Horgan, MD, a professor of clinical surgery at the University of California, San Diego, predicted that robotic surgery is about to enter a new chapter. (Firsthand stories presented at SAGES by surgeons on how they implemented robotics into their practice can be found following this article on pages 18 and 19.)

“In the next five years, we will have at least four or five soft tissue robotic platforms and maybe two or three flexible robots for endoscopy, colonoscopy, etc. So, it’s a very promising time,” Dr. Horgan said.

Continued on page 16

Early Adopter: Telemedicine Here to Stay Surgeon Sees Technology y as Natural Evolution of Healthcare thcare

By KATE O’ROURKE

TAMPA, FLA.—The odds of presenting with metastatic or

Intuitive's da Vinci SP system.

T4 colon cancer, having delayed surgical intervention, and having worse mortality increased directly and linearly with distance to treatment facilities, according to new research.

The findings were presented at the 2022 annual meeting of the American Society of Colon and Rectal Surgeons.

According to presenting study author Andrew Russ, MD, an associate professor of surgery at the University of Tennessee Medical Center, in Knoxville, colon cancer outcomes in the United States have improved over the past 30 years due to an emphasis on screening and improved treatments. But specific regions of the United States have worse outcomes; the rural Southeast is one of these regions.

Continued on page 12

Reducing Breast Tulsa Shooting Re-excisions: A Potential Intensifies Concerns Area for Cost Savings About Violence Against Healthcare Workers

By MONICA J. SMITH

By MONICA J. SMITH

LAS VEGAS—Re-excision after breast-conserving

T

By CHRISTINA FRANGOU

he COVID-19 pandemic may have ignited a surge in telemedicine, but onee Pennsylvania surgeon has been en using communications techhnology to perform a significant nt amount of his work remotely for more than 15 years.

It started with one patient making a postoperative visit.

“She gave me a hug and said, ‘I’m sorry I have to see you.

I just drove an hour to ask four questions. The back of my house abuts one of your rural hospitals; why couldn’t I

surgery has a significant impact on patients, who face a second operation with its risk for complications and potentially worse cosmetic outcomes. Reexcision is also a burden on OR time and cost, and represents an area that, with even a modest reduction, could yield big benefits, according to a new study.

“Re-excision rates have been discussed as a measure of quality for breast surgery, but there is not a large amount of data on healthcare costs. So, we looked within our healthcare system to see how much of a cost burden re-excision is, and how improving reexcision rates might help,” said Jeffery Chakedis, MD,

multiple shooting in a medical building in Tulsa, Okla., has shocked and devastated the medical community and intensified concerns about rising rates of violence against healthcare workers.

In June, an orthopedic surgeon, a sports medicine physician, a clinic supervisor and the spouse of a patient were killed, shot by a man who blamed his surgeon for pain following back surgery two weeks earlier.

“We, united as orthopaedic surgeons, find

Continued on page 13

Continued on page 15

Continued on page 6

IN T HE NEWS

4 ACS Welcomes Bipartisan Firearms Law as ‘Good First Step’ F OC U S ON FLUOR ESC EN C E

20 New Column Explores Imaging Technology OP IN ION

26 Publish or Perish: An Aphorism for General Surgery Residents facebook.com/generalsurgerynews

Efficiency and Ergonomic Benefit Using POWERSEAL™ Sealer/ Divider Curved Jaw, Double-Action in Gynecologic Procedures PAGE 10

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DON’T MESH AROUND

IN THE NEWS

New Bipartisan Firearms Law Welcomed

By ACS as ‘Good First Step’ Bill Aligns With Some FAST Recommendations But Falls Short in Other Areas

By CHRISTINA FRANGOU

I

n late June, President Joseph Biden signed a gun violence bill into law—the outcome of a rare bipartisan compromise intended to stop mass shootings and reduce deaths and disability from firearm violence.

The most significant firearms legislation in nearly three decades, the bill increases mental health funding and will make it more difficult for people who are deemed dangerous to access firearms.

The legislation came after a series of mass shootings, including an attack at an elementary school in Uvalde, Texas, that killed 19 children and two of their teachers, and a shooting at a health center in which a surgeon and three others were murdered by a former patient (page 1).

In the week after the Uvalde shooting, the American College of Surgeons (ACS) reiterated its longstanding call for legislation to address firearm violence.

Representatives of the ACS said the organization welcomes the Bipartisan Safer Communities Act, but noted that the law falls short of recommendations set out in 2018 by the American College of Surgeons Committee on Trauma Firearms Strategy Team (FAST).

“We fully support the bill as a good first step to address this public health crisis. We believe that more can be done to make our communities safer, and we will continue to advocate for bipartisan, common-sense solutions rooted in our recommendations,” said ACS Executive

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

Director Patricia L. Turner, MD, MBA, FACS. In 2019, FAST—a group of trauma surgeons that includes both gun owners and non-gun owners— called on federal legislators to adopt “implementable solutions” that could help prevent mass shootings and would reduce the number of deaths and serious injuries from firearm violence in the United States.

FAST recommendations cover 13 areas, including background checks, registration, licensure, firearm education and training, safe storage practices, red flag laws, addressing mental health issues, and more research to better inform an approach going forward to help address the root causes of violence (J Am Coll Surg 2019;228[2]:198-206).

(A request for comment to the National Rifle Association about the ACS response to Uvalde and the FAST recommendations was not returned.)

The recent bill aligns with the FAST recommendations in several areas: enhanced background checks for any prospective gun buyer under 21 years of age; a provision that extends to dating partners a prohibition on domestic abusers having guns; and increased funding for mental health programs. The deal also set out incentives for states to enact red flag laws to seize guns temporarily from people deemed a threat to themselves and others.

The bill does not address calls for enhanced education and training, safe storage practices, more funding for research and a review of the designation of

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.

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Peter K. Kim, MD Bronx, NY

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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.

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Dr. Patricia Turner speaks about the American College of Surgeons’ commitment to crafting solutions that save lives and minimize preventable deaths.

high-capacity magazine-fed, semi-automatic rifles.

“While we think this legislation is a great start, there’s more important work that needs to be done,” said Eileen Bulger, MD, FACS, Medical Director of ACS Trauma Programs, and one of the FAST recommendations authors.

“We encourage congressional leaders to consider the remaining FAST recommendations for future legislation. In addition, we want to be sure that as a nation, we empower the medical community across all healthcare settings to act in the best interests of their patients in a variety of palpable ways. These paths include counseling patients on safe firearm storage; screening patients at risk for firearm injury or death; and engaging the community in addressing the social determinants of violence through hospitals and healthcare systems.”

Dr. Turner said the surgical community “remains unwilling to wait for another tragedy to befall another community when we know there’s a way to save lives today.”

The aim of FAST was to develop an effective strategy to reduce firearm injury, death and disability. continued on page 7

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4

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Activ Surgical: Technologies to Illuminate Critical Structures During Surgery What surgical challenges are you addressing?

Peter Kim, MD, PhD, Activ Surgical Co-founder and Chief Medical Science Officer: The ability to recognize certain critical structures and monitor blood flow is essential for surgeons to ensure their patients have the best possible chances of healing with minimal complications. To guide them, surgeons today depend heavily on what they can see with their eyes or feel with their gloved hands. This helps to explain why preventable medical errors—25% of which stem from preventable surgical errors—are responsible for more than 400,000 U.S. lives affected each year at a $36 billion global cost.

For example, unlike ICG-based imaging, with ActivPerfusion there’s no dye required at all. As a result, ActivSight promises to be highly adaptable and less expensive.

How easy is the technology to integrate and use?

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Surgeons can turn on ActivSight maps anytime—before, during or after key procedural steps.

What’s next for Activ technology?

Dr. Kim: ActivSight video has potential as rich surgical data stores

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IN THE NEWS

GENERAL SURGERY NEWS / JULY 2022

Shooting Ups Concerns About Violence Against Healthcare Workers continued from page 1

ourselves coming to terms with a senseless act of violence and unbearable loss in our family and community,” wrote Felix H. “Buddy” Savoie III, MD, the president of the American Academy of Orthopaedic Surgeons (AAOS), in an open letter to the organization’s members.

“A physician’s office SHOULD BE a safe haven for doctors and patients alike, and we must do all we can to prevent these tragedies now and in the future,” he continued.

Preston Phillips, MD, an orthopedic surgeon, a husband and the father of three children, worked at Saint Francis Hospital for 17 years.

He performed spine surgery on Michael Louis on May 24. Over the next several days, Mr. Louis called Dr. Phillips’ office repeatedly complaining of pain. He purchased a semiautomatic handgun from a local pawnshop on May 29. Two days later, he returned to his surgeon’s office for additional treatment, and called again the following day complaining of back pain. That same

specialist who worked at Saint Francis, also was killed in the attack. She graduated from the Oklahoma State University Center for Health Services medical school, in Tulsa, in 2000, and completed her residency at Greenville Memorial Hospital in South Carolina.

Amanda Glenn, a staff worker at the clinic and a married mother of two teenaged boys, was another victim. Her family described her as someone who “who always put everyone else first.”

William Love was killed while visiting the clinic with Deborah, his wife of 55 years. His family said Mr. Love heard the gunshots and knew his wife would not be able to escape on her own, so he sacrificed his life to save her.

Ryan Parker, MD, the associate chief medical officer at Saint Francis and an emergency room physician, said the hospital’s trauma team waited to take care of patients who did not arrive.

“To think that our caregivers were the victims, it’s just incomprehensible to me. They died while serving others. They died in the line of duty,” she said.

Healthcare and social service workers are five times more likely to experience workplace violence than other workers, and account for three-fourths of all nonfatal workplace injuries and illnesses requiring days away from work.

Mr. Brogan said many hospitals are not transparent about violence against employees because they don’t want to tarnish their image. He said nurses have been told that abuse by violent patients is part of the job.

“We’ve got to stop sweeping (violence) under the carpet. We’re going to lose an awful lot of clinicians” who leave the profession rather than work in violent environments, he noted.

Surgeons, too, have said they are worried about violence in hospitals.

“As a surgeon who works with the underserved population who has easy access to guns, this gives me thoughts as to whether it may be safer to switch careers,” said Peter Kim, MD, a general surgeon who works in the Bronx, a borough of New York City.

‘Tulsa’s terror … should remind us all of both the accelerating incidents of violence in healthcare settings and the urgency of legislative action to safeguard our caregivers, other healthcare staff, and every patient or family member in those facilities.’

—Jean Ross, RN

afternoon, Mr. Louis purchased an AR-15-style rifle from a local gun store. A few hours later, he returned to Dr. Phillips’ office, where he proceeded to kill four individuals and wounded a number of patients before shooting himself. Police said they found a letter he carried stating that he wished to kill the surgeon and anyone who stood in his way.

An unnamed person who was on a virtual visit with a healthcare provider in the clinic made the first call to 911.

Dr. Phillips was a Black surgeon in a specialty in which only 2% of surgeons are Black, according to a snapshot published by the AAOS in 2019 (bit.ly/3OQ7rqm).

At the time of his death, he was preparing for a trip to West Africa to carry out his fifth mission with a nonprofit organization, Light in the World Development Foundation.

A 1990 graduate of Harvard Medical School, Dr. Phillips completed two fellowships at Boston’s Beth Israel Deaconess Medical Center in 1986 and 1996, and had advanced degrees in organic chemistry and pharmacology, as well as theology.

“He was, he is a man that we should all strive to emulate,” said Cliff Robertson, MD, the president and CEO of Saint Francis Heath System during a press briefing.

He said Dr. Phillips’ clinic often ran behind schedule because the surgeon was known for taking extra time with patients.

Stephanie Husen, DO, a sports and internal medicine

For many in the healthcare community, the events in Tulsa are the latest example of their worst fears coming true as they face increasing violence, harassment and threats.

The day after the shooting in Tulsa, a man stabbed a doctor and two nurses inside Encino Hospital Medical Center in the San Fernando Valley, in California. All three victims were transported to a local trauma center in critical condition, according to media reports.

Violence against healthcare workers has been on the rise for more than a decade. But now, people who work in hospitals and clinics are feeling the effects of two ongoing public health crises that have led to increased risks for them: firearm violence and the COVID-19 pandemic.

“We’ve seen exponential growth of violence during COVID,” said Gerard Brogan, RN, the director of nursing practice at National Nurses United. He attributes the increase to patients with higher expectations of the healthcare system and more questions about the value of medical interventions, all while misinformation feeds anger at healthcare workers.

Nurses and aides who spend the most time at patients’ bedsides experience the brunt of violence in hospitals, but physicians also are targeted.

According to data from the U.S. Bureau of Labor Statistics, the incidence of violence-related healthcare worker injuries increased by 67%, from 6.4 per 10,000 full-time workers in 2011 to 10.7 per 10,000 in 2018.

Source: Wikimedia Commons

6

He said he was deeply affected by the shooting in Tulsa, which followed soon after mass shootings in Uvalde, Texas, and Buffalo, N.Y., and a less publicized shooting inside a Taiwanese Presbyterian church in Laguna Woods, Calif., in which a gunman fatally shot a doctor, John Cheng, MD, who tried to stop him.

Dr. Kim said his hospital and others nearby have had active shooter incidents and he has friends who’ve lost colleagues to firearm violence in hospitals. He worries about the safety of colleagues, patients and himself. He considered cutting back his hours, retiring early or giving up trauma coverage to do more elective surgery in an effort to reduce his risk exposure.

Dr. Kim said he’s not alone in his fears about safety in hospitals. “All of us are on the edge, and these things just add up cumulatively to make you think that maybe it’s time to go.” Dr. Kim is a member of the editorial advisory board of General Surgery News.

In the days after the Tulsa shooting, National Nurses United renewed its call for legislation to protect healthcare workers from violence, saying the incident reflects an increasingly dangerous environment. “Tulsa’s terror … should remind us all of both the accelerating incidents of violence in healthcare settings and the urgency of legislative action to safeguard our caregivers, other healthcare staff, and every patient or family member in those facilities,” said Jean Ross, RN, the president of National Nurses United. continued on page 8

IN THE NEWS

JULY 2022 / GENERAL SURGERY NEWS

Firearms continued from page 4

In the year after the FAST recommendations were first released, firearm injuries became the leading cause of death among children and adolescents in the United States. From 2019 to 2020, the relative increase in the rate of firearm-related deaths of all types—suicide, homicide, unintentional and undetermined—among children and adolescents was 29.5%, more than twice as high as the relative increase in the general population (N Engl J Med 2022;386:1955-1956).

Ronald M. Stewart, MD, the chair of the Department of Surgery at University Hospital, in San Antonio, provided care for victims from two of the biggest mass shootings in modern U.S. history: the 2017 massacre at Sutherland Springs First Baptist Church when a gunman opened fire on parishioners and killed 26 people, and the school shooting in Uvalde.

Dr. Stewart and his colleagues at University Health received four patients from the school who are improving, “which really brings us joy in this dark time,” he said.

However, the victims face a long road ahead in recovery and will be affected by the incident for the rest of their lives, he added.

In both attacks, gunmen used highvelocity weapons that are “horribly lethal at close range” and cause destructive tissue injuries, he said.

Dr. Stewart, who previously chaired the ACS Committee on Trauma, credited work by surgeons to develop regional trauma systems of care, saying these systems make lifesaving differences in their communities.

Lives are also saved after gunshot wounds thanks to the ACS’s “Stop the Bleed” program and new recommendations that whole blood be administered quickly to seriously injured shooting patients, he said. But treatment is not enough to solve the problem: “These tragedies are preventable. We can prevent these atrocities.”

Trauma surgeons “are all deeply disturbed by the inordinate amount of firearm injuries and death we must constantly address,” said Jeffrey Kerby, MD, PhD, the current chair of the ACS Committee on Trauma and the Brigham Family Endowed Professor and director of the Division of Trauma and Acute Care Surgery at the University of Alabama at Birmingham.

Dr. Kerby’s trauma center has experienced a 40% increase in firearm-related injuries over the past two years, he said.

“We are in the midst of an epidemic of firearm violence, and we need to act.”

Surgeons who spoke at an ACS briefing stressed that their recommendations are neither partisan nor politically motivated, but driven by a desire to reduce deaths and injuries from firearms.

The FAST recommendations were developed through “a very deliberative

process that included the participation and perspective of other surgeons who, like me, were also gun owners, but who seek to reduce the impact of gun violence on our country,” said Patrick V. Bailey, MD, a pediatric surgeon by training who serves as the medical director in the ACS Division of Advocacy and Health Policy.

Dr. Bailey said he believes the recommendations do not place a heavy burden on the rights of individual gun owners and he hopes they will encourage Congress to “enact substantive legislation directed at mitigating gun violence.”

The FAST recommendations include

the following: • A robust and accurate background check should be conducted for all purchases and transfers of firearms.

• There should be a program for firearm registration and development and implementation of an electronic database for registered firearms.

• A formal reassessment should be made of the firearms designations in the National Firearms Act classifications.

High-capacity, magazine-fed, semiautomatic rifles should be evaluated and consideration given to reclassification as an National Firearms Act class III

firearm or a new class designation.

• Formal gun safety training should be required for new gun owners, along with hunter safety and safe gun handling education. Any training program must include four vital safety rules: Assume the gun is always loaded; finger off the trigger until ready to fire; never point at anything you do not intend to kill or destroy; and always check all chambers before cleaning.

• Direct adult supervision is needed in the use of firearms for children younger than 12 years of age continued on page 27

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OPINION

GENERAL SURGERY NEWS / JULY 2022

Patient Portals: The Good, Bad and the Ugly

By FREDERICK L. GREENE, MD, FACS

A

few days ago, a good friend living out of state contacted me for medical advice for her husband who recently underwent a “coronary scan” ordered by his cardiologist. Her husband was notified by the hospital radiology group that his results were available and ready for review on his hospital portal. Obviously, like reasonable medical consumers, they both immediately signed into the portal even though they had yet to be contacted by the cardiologist. Although they could not interpret all of the radiological jargon in the report, the finding that did stand out to them was “an incidental 8.3 centimeter anterior mediastinal mass consistent with a thymic tumor”! They then unsuccessfully tried to contact their cardiologist.

I got the call at this juncture. They had no idea what to do with this frightening information. After explaining the differential of an anterior mediastinal mass in layman’s terms, I advised them to seek the counsel of a thoracic surgeon at their nearby academic medical center. This has been accomplished successfully.

Unfortunately, this scenario is not unique and has been promoted by the dictates of the 21st Century Cures Act that went into effect in November 2019.

While aimed at the concept of making it easier for patients to have direct access to their electronic health information (EHI), there is a definite downside, which was the central core of my editorial “Mind your P’s and Q’s” (General Surgery News, December 2020). As I wrote, “the law means that inpatient and

outpatient notes will be released without delay and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures, and mammograms. This federal mandate, called ‘open notes’ by many, is potentially perplexing and frightening for patients.”

I opined in that piece that not only should clinicians and all healthcare personnel be mindful of what is written in their EHI notes, but also there is a real concern that patients will frequently have information prior to any discussions with their managing physicians. This fear has certainly come to fruition.

At my own institution, there have been a number of instances when radiographical and pathologic results indicating breast cancer and other malignancies have been reviewed on patient portals before the ordering physician even being contacted.

These unfortunate instances have been discussed in cancer committee meetings and other venues to ensure these calamitous occurrences do not continue. My recommendation to all is to monitor these occurrences carefully at your own institutions and, if occurring, create a system whereby sensitive and frightening information is not released to patients prior to informing managing physicians of the findings. A second important corollary is to counsel our patients that these communications might occur and we are available for discussion whenever interpretations are needed. Although I certainly support the concept of disclosure of EHI to patients and responsible caregivers, the

Violence in Healthcare continued from page 6

Incidents in which healthcare workers were killed with firearms by patients or their family members have been around for a long time, but are accelerating in pace.

A study published in the Journal of the American Medical Association in 2015 reported that an average of nine hospital shootings occurred each year between 2000 and 2005. But over the next five years, the average grew to more than 16 occurrences annually, resulting in 161 deaths (JAMA 2015;313[12]:1209-1210).

In January 2015, the son of a former patient fatally shot Michael J. Davidson, MD, a cardiothoracic surgeon, at Brigham and Women’s Hospital, in Boston—the 14th active shooter incident in a hospital in the United States in 12 months and the 15th fatality.

In July 2016, a man shot and killed an 88-year-old patient and a 36-year-old hospital employee at the Parrish Medical Center, in Titusville, Fla., apparently at random.

In November 2018, in an attack that began as a domestic dispute, a gunman killed a police officer, a

Not only should clinicians and all healthcare personnel be mindful of what is written in their EHI notes, but also there is a real concern that patients will frequently have information prior to any discussions with their managing physicians. This fear has certainly come to fruition. unfortunate disadvantages of these strategies are being seen on a daily basis. These ill-fated occurrences should be considered “sentinel events,“ in the parlance of the Joint Commission, and discussed by all involved parties to ensure the root causes are remedied and appropriate failsafe measures are in place.

These harmful consequences of hospital patient portals are concerning, but an even uglier phenomenon has been reported recently (“Hospitals sent information to Facebook,” Charlotte Observer, June 18, 2022). Several large hospital systems, perhaps unwittingly, used a digital tracker in their patient portals and online appointment systems, which could have sent

doctor and a pharmaceutical assistant at Mercy Hospital, in Chicago.

In July 2020, in New Jersey, a man who was upset about his father’s urology appointment shot and killed a patient services representative who tried to discuss the situation.

Inside hospitals, physicians and other healthcare workers who are based in the emergency room or who care for psychiatric patients face the highest rates of inhospital violence. In some places, they have additional security and training, and have added lights and staff to protect employees.

It may be time for surgeons and other specialists to look to emergency room personnel to learn how to promote safety for physicians, colleagues and patients, said John Mellinger, MD, the president of the Society of American Gastrointestinal and Endoscopic Surgeons.

“The time has sadly come where, as a profession, we need to think about applying those lessons of safety in contexts outside the environments in which we’re used to doing so,” Dr. Mellinger said. “The social tensions and pandemic pressures we’ve been navigating as a society over the last few years have brought the sense that we’re

Facebook information regarding patients’ health conditions, allergies, medications and even sexual orientation. Perhaps this sensitive information is filtered by Facebook before being sent to advertising systems, but no one really seems to know.

Obviously, these practices could constitute a breach of the Health Insurance Portability and Accountability Act. The bottom line is we need to assure that the EHI offered to patients through the 21st Century Cures Act is appropriate, nonthreatening and safely transmitted to pro■ tect our patients and ourselves.

—Dr. Greene is the senior medical advisor for General Surgery News.

no longer in crisis intervention, but rather dealing with a broader and more chronic and entrenched reality.”

The American Medical Association and the American College of Surgeons reiterated the need for action against firearm violence in response to the Tulsa shooting.

In a statement, AMA President Gerald E. Harmon, MD, said gun violence continues to be a public health crisis that is “out of control in the United States.” He said: “The victims are grade-school children and their teachers, people shopping for groceries on a Saturday afternoon, those attending their house of worship, and most recently in Tulsa, those who have dedicated their lives to healing.”

In May, federal legislation was introduced that would mandate the U.S. Occupational Safety and Health Administration to create a federal standard requiring healthcare and social service employers to develop and implement a comprehensive workplace violence prevention plan.

Mr. Brogan said the legislation would force a change of culture in health systems by requiring reporting on incidents of violence. “We’d certainly like surgeons across the country to support nurses in their efforts to get some legislation to bring attention to this,” he said.

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IN THE NEWS

JULY 2022 / GENERAL SURGERY NEWS

Baseball Stat Inspires Novel Surgical Metric for AAA Repair

By CHASE DOYLE

B

aseball and surgery may seem like unexpected teammates, but new research shows advanced statistics taken from our national pastime could actually improve assessment of surgical quality.

The study of patients undergoing abdominal aortic aneurysm (AAA) repair found that weighted Wins Above Average, a risk-adjusted, complicationweighted surgical quality metric, successfully distinguished high- and low-quality centers for both open and endovascular AAA repair (J Vasc Surg 2022;S07415214[22]01371-4). Authors of the study also noted that their methodology could be broadly applicable for measuring surgical quality.

“Despite very high-quality data concerning surgical outcomes, current surgical quality metrics have limited utility,” said lead study author Douglas W. Jones, MD, the director of the Limb Preservation Center and an assistant professor at the University of Massachusetts Medical School, in Worcester. “This study shows that there is an opportunity to use more advanced techniques to comprehensively capture a range of outcomes.”

According to Dr. Jones, there are practical and statistical limitations in existing surgical quality metrics, which often fail to account for differences in nonfatal outcomes. As an example, mortality rate, the most frequently cited metric, has utility for only high-mortality procedures, he said.

To develop a more comprehensive surgical metric, Dr. Jones and his colleagues used the Vascular Quality Initiative database to analyze nonruptured open and endovascular AAA repair between 2016 and 2019. Inspired by Wins Above Replacement, a sabermetric baseball statistic that measures a player’s total contribution to his team and compares his value with a replacement-level player at the same position, the researchers defined a surgical “win” as AAA repair without major complication (in-hospital) or mortality (in-hospital or within 30 days). Next, they divided medical centers into quality quartiles based on performance in win-based metrics.

Overall, 3,683 patients underwent open AAA repair and 21,165 patients underwent endovascular AAA repair.

For open repair, crude rates of win, mortality and failure to rescue were 62.8%, 4.2% and 10.3%, respectively. For endovascular repair, the rates were 94.4%, 1.1% and 12.3%, respectively.

When stratified by weighted Wins Above Average, patients undergoing open repair at “best” quartile centers had a higher win rate (72.0% vs. 52.7%)

and lower mortality (3.1% vs. 6.2%) than at “worst” quartile centers. For endovascular repair, centers in the top quartile also had higher win rates (96.2% vs. 92.1%), lower mortality (0.4% vs 2.2%), and a lower failure-to-rescue rate (5.7% vs. 17.9%) than the lowest quartile centers.

Some Barriers Aren’t Meant to be Broken

“Weighted Wins Above Average is a cumulative metric centered around zero,” Dr. Jones explained. “A positive number indicates a better than expected performance, whereas a negative number indicates below average, and that number

translates directly to the number of patients that are having good or bad outcomes.”

Of note, stratification by volume showed high-volume centers had improved weighted Wins Above Average for open repair but not for endovascular repair compared with low-volume centers. According to Dr. Jones, this finding, which is consistent with previously published data, further validates this novel measure of surgical quality. ■

9

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Efficiency and Ergonomic Benefit Using POWERSEAL™ Sealer/Divider Curved Jaw, Double-Action in Gynecologic Procedures Lena Nguyen, DO The Women’s Health Center Fountain Valley, California

Introduction More than 25 years after becoming commercially available, bipolar electrosurgical devices designed to grasp and dissect tissue as well as seal vessels continue to be requested by surgeons and refined by manufacturers.1 In gynecologic surgery, bipolar energy tools and other medical devices are used frequently in a variety of procedures, including laparoscopic endometrial biopsy and hysterectomy.2 As such, guidelines from organizations like the American College of Obstetricians and Gynecologists recommend that surgeons remain aware of current evidence and use of new technology to improve the patient experience and outcomes.2 One of the latest bipolar energy devices for use in gynecologic surgery is the Olympus POWERSEAL™ 5-mm Curved Jaw Sealer/Divider, Double-Action. The POWERSEAL Sealer/Divider is indicated to ligate and divide vessels, including lymphatics and tissue bundles up to 7 mm for laparoscopic, minimally invasive, and/ or open surgical procedures.3-6 In addition to providing demonstrated, effective sealing with an average seal time of 2.8 seconds on vessels up to 7 mm in diameter,3,7 the POWERSEAL Sealer/Divider was designed with enhanced ergonomics for the surgeon which are reflected in a number of design elements including reduced reach distances to device landmarks, such as the jaw lever, cut trigger, and rotation wheel.8 Ergonomics has long been an important topic of discussion among clinicians operating frequently,9 but now it seems to be at the forefront of surgeons’ minds more than ever. However, ergonomic considerations are only one of the updates that has led Lena Nguyen, DO, a gynecologic surgeon at The Women’s Health Center in Fountain Valley, California, to select the POWERSEAL Sealer/Divider as a preferred tool in her armamentarium. “The main advantage of the POWERSEAL Sealer/Divider is its ergonomics, but there are several features I have come to appreciate over the numerous other power devices I have used,” she said. “One is the latch-on setting, which is useful

10

GENERAL SURGERY NEWS • JULY 2022

for preventing the tissue from slipping during coagulation for a more reliable seal and a lower bleeding risk.”

POWERSEAL Sealer/Divider: Clinical Comparison Dr Nguyen has a basis for making informed comparisons: Her training in surgery involved use of bipolar surgical energy devices, and she reports experience with most of the commonly used and currently available types. At one of the centers where she performs surgery, she is obligated to use a competing device due to existing contracts. As a

result, she has familiarity with a competitive product which she once preferred and now also has familiarity with the POWERSEAL Sealer/Divider.

“I am still using the device on which I may have the most experience, but when I started performing surgery at a different center, I was given a choice of the POWERSEAL Sealer/Divider or another widely used device, and I began using the POWERSEAL Sealer/ Divider,” Dr Nguyen said. “For me, the POWERSEAL Sealer/Divider had a better feel than other devices I had used previously. The grip has the right size and design; I have small hands and this made a difference.”

Figure. POWERSEAL™ Sealer/Divider 5-mm Curved Jaw, Double-Action features a curved, tapered jaw tip and long jaw length for efficient sealing and cutting (left); latch-on option to maintain secure jaw position while grasping or sealing (top right); and an ergonomic handle requiring reduced squeeze force for device activation (bottom right).

Images courtesy of Olympus America Inc.

Supported by

Along with its capability of effectively sealing large vessels, the POWERSEAL Sealer/Divider has been designed to minimize hand fatigue and strain associated with minimally invasive procedures.

A survey of surgeons performing minimally invasive gynecologic cancer surgery showed that a majority reported some physical discomfort due to surgery, with female surgeons among those most affected.11 “When you have to hold the jaws closed repeatedly, it can eventually lead to strain,” Dr Nguyen said. She has observed in her own practice, that the risk for muscle strain is exacerbated by the demands of working in tight laparoscopic spaces.

When she transitioned to the POWERSEAL Sealer/ Divider, “there was no significant learning curve,” Dr Nguyen said. Calling the device “intuitive,” she noted that POWERSEAL Sealer/Divider has a better fit in the hand than other tools she has used, along with thoughtful features. For one, she appreciates the placement of the energy activation button. Situated away from the jaw lever and cut trigger functions of the device, there is little risk for confusion or accidental energy activation. “One of the devices I have used in the past had the dissecting trigger and the coagulation button in the same general area, which made me pause each time to make sure I had my finger on the right button,” Dr Nguyen said. The POWERSEAL Sealer/Divider has the button for the

POWERSEAL Sealer/Divider: Clinical Benefits The POWERSEAL Sealer/Divider was created to make surgical tasks more intuitive, easier, and more efficient than previous-generation devices. Direct comparisons with the LigaSure™ Maryland Jaw in a laboratory setting provide a degree of validation for many of these advantages. As an example, the squeeze force to close the jaw has been reduced by 55%, with similar resulting jaw force and sealing strength.8 The squeeze force to activate the cutting blade has been reduced by 10%.8 The POWERSEAL Sealer/Divider also is equipped with a longer jaw length (22.5 vs 21.0 mm) and a longer cut length (19.3 vs 18.2 mm) than the LigaSure™ Maryland Jaw, both of which improve efficiency by permitting modest, but potentially meaningful, longer dissections and sealing length, while not compromising proven vessel burst pressure reliability of 3 times systolic blood pressure.7 Moreover, the taper and curve of the jaws improve their maneuverability when navigating in the abdominal cavity (Figure).12 Overall, “this is a device that is easy to get into position for dissecting and sealing tissue,” Dr Nguyen said. When the latch-on setting is deployed, it is not necessary for the jaws to be fully closed, a feature that not only prevents injury to thick tissue, but can increase versatility when the objective is to maneuver tissue out of the field of view or perform other tasks not immediately related to dissection and sealing. As with any energy device like POWERSEAL Sealer /Divider, caution should be used during surgical procedures to avoid unintended damage to surrounding tissues when activating energy. During surgical procedures in which patients exhibit certain types of vascular pathology (e.g., atherosclerosis, aneurysmal vessels), apply the seal to unaffected vasculature for best results.

POWERSEAL Sealer/Divider: Clinical Experience Dr Nguyen uses the POWERSEAL Sealer/Divider primarily to mobilize the uterus, fallopian tubes, and ovaries. The POWERSEAL Sealer/Divider should not be used in tubal sterilization or tubal ligation.

“Having experience with many of these devices, I have to say that I do like the POWERSEAL Sealer/ Divider and prefer it to other devices,” said Dr Nguyen, who added that she would move to this device exclusively if given the option at each of the surgical centers where she operates.

The POWERSEAL Sealer/Divider received regulatory approval in the United States in 2021. Before

its commercial release, extensive studies were conducted globally. While many of the relative advantages of the POWERSEAL Sealer/Divider were directed toward improving fundamental capabilities in the dissection and sealing of vessels, there was also attention to the important role played by intraoperative tasks, such as grasping and retracting the tissue, which are independent of the sealing function. Dr Nguyen noted that while she is pleased with the capabilities of the device, it was the ergonomic update that makes POWERSEAL Sealer/Divider a top choice for her. “This device is simply easier to hold, and it has a superior grasp,” she said.

Conclusion The single-use POWERSEAL Sealer/Divider is an advanced bipolar energy tool designed for versatile and effective dissection and sealing in a wide array of procedures. In her practice, Dr Nguyen has found POWERSEAL Sealer/Divider preferable to other devices in its class for gynecologic surgery. For her, the design of the POWERSEAL Sealer/Divider that accommodates smaller hand sizes and is equipped with latch-on/latch-off jaws helps facilitate surgical tasks, while increasing the likelihood of a reliable seal.

References 1. Lyons TL, et al. JSLS. 2005;9(1):39-41.

2. American College of Obstetricians and Gynecologists.

Obstet Gynecol. 2020;135(4):e160-e166.

3. Data on file. Internal test report DN0044249.

Olympus America Inc. 4. Data on file. DN0044289 POWERSEAL 1 (toe-in) design verification ESG-400 benchtop vessel sealing report.

Olympus America Inc. 5. Data on file. Acute study report DN0044705.

Olympus America Inc. 6. Data on file. Chronic study report DN0044706.

Olympus America Inc. 7. Data on file. Internal test report DN0043135.

Olympus America Inc. 8. Data on file. Internal Design Verification electrical & mechanical test reports DN0046457. Olympus America Inc. 9. Stone R, et al. BMJ. 2004;328(7448):1115-1118.

10. Data on file. Internal vessel sealing report DN0044404.

Olympus America Inc. 11. McDonald ME, et al. Gynecol Oncol. 2014;134(2):243-247.

12. Data on file. POWERSEAL Curved Jaw Double Action (PS1) design validation report DN0044403. Olympus America Inc. Disclosure: Dr Nguyen was paid for her testimony featured in this article.

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

GENERAL SURGERY NEWS • JULY 2022

LCR45280V01

Design Features and Ergonomic Improvement

sealing function placed on top of the device and the cutting trigger placed within the handle, designed for both ergonomics and safety.

JULY 2022 BB2223

By maintaining the jaw in gripping position, the POWERSEAL Sealer/Divider eliminated the need to apply constant squeeze pressure.8 With a single button, latching on and off becomes an efficient part of grasping and retracting vessels for sealing (Figure). “Without a good grasp on the tissue, there is a higher risk of not achieving adequate coagulation,” Dr Nguyen said. Relative to the LigaSure™ Maryland Jaw and Blunt Tip, and the Ethicon ENSEAL® G2 Straight & Curved Tissue Sealer, the POWERSEAL Sealer/Divider requires less squeeze force to close the jaws, and the latch-on feature eliminates the need for continuous squeeze force through the seal cycle.8 In her experience thus far with the POWERSEAL Sealer/Divider, Dr Nguyen has not had any bleeding events due to tissue slippage, which can occur with some surgical devices and would prompt a second reseal when it occurs during a procedure. She credits this result to the device design: instead of one jaw opening on a fixed opposition, the double-action POWERSEAL Sealer/Divider jaws both open uniformly, which can make positioning of the jaws easier.10 In addition, the jaws themselves are wider than the LigaSure™ Maryland Jaw.8

11

r

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IN THE NEWS

GENERAL SURGERY NEWS / JULY 2022

Microbiome Differs in Complicated Versus Uncomplicated Diverticulitis

By KATE O’ROURKE

TAMPA, FLA.—The microbiome of complicated diver-

ticulitis is defined by different bacterial species and abundances compared with uncomplicated diverticulitis, according to new research. The findings were presented at the 2022 annual meeting of the American Society of Colon and Rectal Surgeons.

The new study was conducted by researchers at Penn State Health Milton S. Hershey Medical Center, in Hershey, Pa., and Juniata College, in Huntington, Pa. In the study, at the time of elective surgical resection for diverticulitis, diseased and adjacent normal tissues were isolated from 43 patients with complicated (perforated) diverticulitis and 57 patients with recurrent uncomplicated diverticulitis. The patients were matched on age, sex, race and body mass index. Complicated diverticulitis was confirmed by CT evidence of perforation and/or abscess. The researchers extracted DNA from full-thickness specimens for 16S ribosomal RNA gene sequencing, targeting the V4 hypervariable region.

Sequences were analyzed and a quantitative characterization based on taxonomic classification was performed.

There were significantly more active smokers with complicated versus uncomplicated diverticulitis (37%

vs. 6%; P=0.002). When comparing the diseased tissues of complicated with uncomplicated diverticular resections, complicated diverticulitis had a relative decrease in Bacteroides massiliensis and a significant increase in microbes involved in sulfur cycling, including Clostridium the class Synergistia, as well as the Sulcadaveris furovaceae family, Sulfurovum species, Aggregatibacter species and phylum Bacteroidetes. Further species of bacteria enriched in complicated diverticulitis included Campylobacter ureolyticus and Clostridium cadaveris. When compared with the adjacent normal tissue, the diseased tissue of complicated diverticulitis had a higher abundance of sulfur-reducing bacteria. In the gastrointestinal “This study is certainly important. I think the microtract, sulfur is reduced to hydrogen sulfide, which is an inflammatory mediator and deleterious to the host in biome is a real area of really meaningful and imporhigh concentrations. tant focus of research, especially in diverticulitis and According to senior author Nimalan Jeganathan, MD, GI surgery in general,” said Alexander Hawkins, MD, a colorectal surgeon at Penn State Health Milton S. an associate professor of surgery at Vanderbilt UniverHershey Medical Center, it is the first study implicating sity Medical Center, in Nashville, Tenn., who was not sulfate-reducing bacteria in complicated diverticulitis. involved with the study.

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Rural Colon Cancer Risk continued from page 1

The researchers gathered 2013-2017 data from patients with colon cancer from the National Cancer Database. They analyzed outcomes including metastatic disease at diagnosis, T stage at diagnosis and time from diagnosis to chemotherapy initiation. The study cohort included 326,176 patients diagnosed with colon cancer in the South Atlantic (Delaware, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida and the District of Columbia) and East South Central (Alabama, Kentucky, Mississippi and Tennessee) regions of the United States.

The researchers found that increased distance from a treating facility was associated with: • a statistically significant increase in the risk for presenting with advanced TNM stage (Table 1); • a statistically significant increase in time to surgical intervention (Table 2); • an increase in time to beginning adjuvant chemotherapy only in the group 101 to 200 miles away (12.168; P=0.017; standard error, 5.12); and • a statistically significant increased risk for mortality (Table 3).

The median survival was 82.4 months for the closest group (zero to 24 miles), versus 75.1 months for the farthest group (201 or more miles).

“In conclusion, increased distance from a treating facility is an independent risk factor for presentation with later stages of colon cancer,” Dr. Russ

‘Time to surgery and time to adjuvant chemotherapy are increased as distance from treating facility is increased. Patients have a stepwise decrease in overall survival as distance from a treating facility increases. Efforts should be made to provide increased screening efforts and additional screening options to those patients who have limited access to care.’

—Andrew Russ, MD Table 1. TNM Staging Logistic Regression Distance, miles

Adjusted odds ratio

P value

95% CI

25-50

1.25

0.001

1.10-1.35

51-100

1.35

0.001

1.31-1.40

101-200

1.42

0.001

1.35-1.50

201+

1.62

0.001

1.53-1.72

Table 2. Time to Surgery Logistic Regression Distance, miles

Time to surgery, days

P value

Standard error

25-50

5.10

0.001

0.27

51-100

9.96

0.001

0.41

101-200

14.5

0.001

0.66

201+

13.75

0.001

0.73

Table 3. Overall Mortality Logistic Regression Distance, miles

Hazard ratio

P value

95% CI

25-50

1.109

0.001

1.089-1.129

51-100

1.137

0.001

1.106-1.169

101-200

1.186

0.001

1.135-1.239

201+

1.276

0.001

1.216-1.338

said. “Time to surgery and time to adjuvant chemotherapy are increased as distance from a treating facility is increased. Patients have a stepwise decrease in overall survival as distance from treating facility increases. Efforts should be made to provide increased screening efforts and additional screening options to those patients who have limited access to care.”

According to Deborah Keller, MS, MD, a clinical assistant professor of surgery, Division of Colorectal Surgery, at the UC Davis Medical Center, in Sacramento, a large portion of the U.S. population resides in the regions covered in the study, so the authors are to be congratulated on looking for ways to improve the quality of cancer care delivered there.

“This study is interesting in showing evidence to support trends that we see clinically. The association between greater distance and more advanced disease at presentation is an important start,” Dr. Keller said. “However, there are a lot of limitations in the data source that restrict our ability to conclude that distance alone is the reason for later presentations in these regions or that these patients did not have access to care. I look forward to the full manuscript for the covariates considered. Also, evaluating recent data where telemedicine is more widespread and looking at that variable within this relationship will help make valuable insights ■ from this abstract.”

IN THE NEWS

JULY 2022 / GENERAL SURGERY NEWS

Telehealth continued from page 1

have been seen there?’ And I said, ‘good question.’”

That was when Andrew Watson, MD, a colorectal surgeon and the senior medical director at Digital Health, UPMC Health Plan, and a professor of surgery at the University of Pennsylvania, in Pittsburgh, began to question the necessity of face-to-face exams. For one thing, a sizeable percentage of Pennsylvania’s population is rural, and his patients often had to drive long distances for an office visit in Pittsburgh.

“We have bridges, rivers, hills, tunnels, traffic, snow and mountains. You want a 70-year-old postoperative patient with a cancer diagnosis to drive on those roads?

It’s just not fair to them,” Dr. Watson said.

Telemedicine also helps patients avoid such inconveniences as taking time off work, securing child care, braving bad weather or simply leaving the comfort of home. “When people aren’t well, it’s natural not to want to leave their home,” he said.

From a physician’s perspective, he sees telemedicine as a natural evolution of healthcare in the digital world that helps doctors expand their practice and their reach. Of course, the technology has greatly evolved since Dr. Watson first started seeing patients remotely. In 2006, he used video conferencing carts between hospitals, typically in rural locations. Now Dr. Watson uses a variety of devices—cellphone, computer, broadband, Wi-Fi—for a range of purposes: video visits with new patients and postoperative patients, telerounding inside hospitals from remote locations, and even covering his partner’s patients.

“It’s becoming mainstream medicine,” Dr. Watson noted. “I’ve done rounding and clinics overseas—it really doesn’t matter where I am. While some populations don’t have access to modern communication, many people do have an iPad with a signal, and access to broadband is now fairly ubiquitous.”

Although telemedicine may be a byproduct of the modern consumer electronics market, there is an element of it that harks back to an era predating landlines and rotary dials: the house call.

“You learn a tremendous amount about patients when you see them at home on video. You see their surroundings and you meet their pets. Sometimes you can tell when there are problems at home; I’ve had patients smoking on video visits,” Dr. Watson said.

He also has intervened when patients clearly needed emergency services. “We’ve had them stay on the phone while we call the ambulance. Then, when the paramedics came, we were able to

explain the problem.”

There are some nuances to telemedicine that set it apart from traditional office visits, Dr. Watson said. “The examination and the workflow are the two big things to learn. The workflow begins with how you room a patient and examine them with somebody else helping you. How do you describe what you’re thinking, and how do you document your findings?”

But these are skills that can be learned, just as surgeons who do open procedures learn laparoscopy, he said. Like it or not, telemedicine will only expand in the

‘I’ve done rounding and clinics overseas—it really doesn’t matter where I am. While some populationss don’t have access to modern communication, manyy people do have an iPad with a signal, and access to broadband is now fairly ubiquitous.’

—Andrew Watson, MD years to come, so it behooves physicians to adopt it.

“It’s worth pointing out that the companies behind telemedicine are the largest ones in the world—Apple, Microsoft and

Amazon—and they’re not slowing down.

This is going to challenge many norms, and it may be uncomfortable, but it’s going to democratize healthcare and the way it’s distributed,” Dr. Watson said.

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IN THE NEWS

GENERAL SURGERY NEWS / JULY 2022

When Is Diastasis Recti a Surgical Problem?

By CHRISTINA FRANGOU

BELÉN, COSTA RICA—There’s no good

consensus on how and when to operate on patients with diastasis recti, according to Shirin Towfigh, MD, a hernia specialist at the Beverly Hills Hernia Center, in California, who presented at the 2022 meeting of the International Hernia Collaboration.

Dr. Towfigh called for the creation of a registry focused on surgical treatment of diastasis recti. This registry will help identify best practices, she said.

“We need to learn more because everyone is doing their own approach, and we have very little opportunity to learn from others,” she said.

In 2021, the European Hernia Society (EHS) released guidelines on management of rectus diastasis (Br J Surg 2021;108[10]:1189-1191). It’s the largest recent effort in the hernia literature to classify diastasis recti and make treatment recommendations.

However, there is too little evidence to

surgery, depending on their goals make strong treatment recommenand medical conditions, she pointdations, the EHS concluded. The ed out. organization made only one recomDr. Towfigh outlined her algomendation, calling for diastasis recti rithm for surgical repair of diastasis to be defined as a separation of more recti when traditional abdominothan 2 cm between rectus muscles. plasty is not indicated. For patients The EHS also proposed a new who require a hernia repair within a classification system for diastasis recti diastasis, she recommended a laparobased on the width of muscle separascopic or robotic posterior repair with tion, post-pregnancy status and the Related content: Dr. Shirin Towfigh mesh, or minimally invasive anteripresence of a concomitant hernia. discusses groin pain in women with or plication with or without mesh.

Dr. Towfigh, an expert in hernia Dr. Eric Pauli at the 2022 International Hernia For patients who primarily require repair, particularly in women, said Collaboration meeting. To view this short a good diastasis repair, she recommost cases of diastasis recti do not video, visit www.generalsurgerynews.com/ mended minimally invasive anterior require surgical repair, but can be Multimedia plication with or without mesh. conservatively managed with exerFor any patient who undercises to strengthen the transversus abdominal muscles while seated, or per- goes surgery for diastasis recti, surgeons abdominis.

These exercises do not include tra- forming squats against a wall. “I often should use nonabsorbable sutures in at ditional crunches, planks or sit-ups, give patients the analogy that we are least two layers, she said.

Some patients are very concerned or exercises that extend the abdomen, working on their inner binder, the corset about excess skin, which can be a signifrequire lying backward or extending over of the abdomen,” she said. a large exercise ball, she said. Instead, The evidence for abdominal binding icant quality-of-life issue, Dr. Towfigh Dr. Towfigh recommends that patients is poor, but the practice is not associat- said. These patients should be referred to engage their transversus abdominis mus- ed with significant risks, she said. Even a plastic surgeon for an open abdominocles by squeezing and contracting their with exercise, some patients still require plasty, she said.

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What’s in a Name?

Why You Should Brand Yourself an ‘Abdominal Core Surgeon,’ Not a ‘Hernia Surgeon’

By CHRISTINA FRANGOU

BELÉN, COSTA RICA—Surgeons who repair

hernias should brand themselves as “abdominal core surgeons,” said Flavio Malcher, MD, MSc, the director of the Abdominal Core Health Center at NYU Langone Health and an associate professor of surgery at NYU Grossman School of Medicine, in New York City. Dr. Malcher made his remarks at the 2022 International Hernia Collaboration meeting.

In 2019, Benjamin Poulose, MD, a professor of general and gastrointestinal surgery at The Ohio State University College of Medicine, in Columbus, coined the phrase “abdominal core health” to describe a specialty dedicated to preventing and treating hernias.

Now the term is used at institutions throughout the United States, including Ohio State, Cleveland Clinic, Stony Brook, Upstate University Hospital, Harvard University, Mayo Clinic, University of South Florida and NYU Langone Health.

In 2020, the Americas Hernia Society Quality Collaborative Foundation, a hernia-specific foundation that provides resources for surgeons in academic and private practice, renamed itself the Abdominal Core Health Quality Collaborative Foundation.

Here are four reasons surgeons should rebrand as abdominal core surgeons, according to Dr. Malcher.

1. Abdominal core health better reflects what hernia surgeons are trying to achieve.

Hernia surgeons address abdominal wall tumors and diastasis recti, and try to prevent future hernias, in addition to hernia repair.

2. Surgeons who treat hernias are part of a multidisciplinary team necessary to help patients improve their long-term abdominal core health. Multiple factors affect abdominal core health: age, sex, previous pregnancies, prior repairs and physical activity, among others. Dr. Malcher said patients should be counseled about prehabilitation and rehabilitation so they can reduce their risk for complications and improve their abdominal strength.

3. The term “abdominal core health” highlights the need for health-promoting behaviors. Dr. Malcher said patients should be counseled about behaviors that can reduce their complication risk, as these risks are significant. A study published in JAMA in March showed that one in six Medicare beneficiaries who underwent hernia repair surgery between 2007 and 2018 required a reoperation for recurrence within the next 10 years (JAMA 2022;327[9]:872-874).

4. The term is helpful for marketing a hernia practice. Surgeons who brand their practices as centers for abdominal core health stand out in a marketplace that has plenty of hernia centers, Dr. Malcher noted.

But there’s one major reason that the new branding isn’t taking off worldwide: “Abdominal core health” doesn’t translate well into Spanish or Portuguese, he said.

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Pre-op Opioid Use Predicts Post-op Consumption

By GSN STAFF

A

new study found that patients who had taken opioids in the year before undergoing surgery consumed more opioids after surgery than opioid-naive patients, with chronic users taking most of the medications.

Investigators from the University of Michigan Medical School, in Ann Arbor, led by Mark Bicket, MD, PhD, of the Department of Anesthesiology, and Jennifer Waljee, MD, MPH, MS, of the Department of Surgery, examined data from 26,001 adults 18 years of age and older who underwent one of nine elective surgeries over a twoyear period (Reg Anesth Pain Med 2022;47[6]:346-352).

According to the investigators, the findings underscore the personalized nature of pain relief in a postsurgical population and clarify the need for opioid prescribing guidelines that balance effective pain relief with avoiding leftover opioids.

“Individuals who take prescription opioids before surgery may have unique needs to treat pain after surgery, and this study provides data for the first time on how many pills these patients report needing to take after discharge from surgery,” Dr. Bicket said in a press release.

Using data from the Michigan Surgical Quality Collaborative confidentially matched to state prescription drug monitoring programs, the investigators saw that opioid use within 30 days of surgery was linked to a greater number of initial opioid prescriptions and more refilled prescriptions.

Moreover, chronic-operative opioid use (nine months and more) was associated with a trend toward consuming more postoperative opioids.

Patients with preoperative opioid use also had more comorbidities than their opioid-naive counterparts, such as higher body mass index and chronic obstructive pulmonary disease.

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IN THE NEWS

JULY 2022 / GENERAL SURGERY NEWS

Breast Re-excision Cost Savings continued from page 1

a surgical oncologist at the Permanente Medical Group in Walnut Creek, Calif., presenting his research at the 2022 annual meeting of the American Society of Breast Surgeons.

Dr. Chakedis and his colleagues conducted a retrospective review of all patients undergoing breast-conserving surgery (BCS) over a five-year period, defining re-excision as an ipsilateral breast surgery within six months of the incisional surgery, ranging from margin re-excision to completion mastectomy.

The study included 54 surgeons and 8,804 patients, 1,628 of whom required re-excision, for an overall re-excision rate of 18.5%.

After comparing the two cohorts— those having BCS alone and those having BCS plus re-excision—the group found several differences. Patients were more likely to require re-excision if they were younger, had high-density breasts, had a higher T1 stage, had hormone receptor– negative and HER2-positive tumor subtypes, or had ductal carcinoma in situ or lobular cancers. Neoadjuvant chemotherapy was protective against re-excision.

“This data really shows us the patients who have a higher risk for re-excision; methods to decrease or ameliorate that risk might be warranted in these populations,” Dr. Chakedis said.

Comparing OR time between the two cohorts, patients who required re-excision had a slightly shorter initial surgery than those who did not, at 72 and 77 minutes, respectively. Re-excisions averaged 61 minutes.

“Comparing the two, with re-excision you add not only another operation, but you increase OR time by about 82%. This data shows that even though the initial operation is a bit shorter, doing an operation that may decrease your re-excision rate will save time overall,” Dr. Chakedis said.

Re-excision is also costly, about four times the cost of surgery that did not require a second procedure. This cost varied enormously depending on the type of surgery: Costs for margin reexcision were 42% higher; costs were 29-fold higher in patients who underwent re-excision after mastectomy with implant-based reconstruction.

“Then we asked the question: What would be the savings if we were to reduce the need for re-excision in surgeons who had a re-excision rate above 20%?” Dr. Chakedis said.

The re-excision rate for surgeons in this study ranged from 7% to 39%, with 25 surgeons (46%) having re-excision rates above 20%. Using a model to bring the reexcision rate to less than 20% for all surgeons reduced the number of operations by 320 over a five-year period, operative

costs by 14% and OR time by 11%.

“Our model showed if you take the time with the initial operation, with a different device or technique, you’ll save money over time. This may incentivize healthcare systems to reduce re-excision rates,” Dr. Chakedis said.

Sarah Blair, MD, a professor of surgery and the vice chair of the Department of Surgery at the University of California, San Diego, commented in an email to General Surgery News that Dr. Chakedis

has had formal training in residency and during his fellowship on the best methods to reduce positive margin rates for BCS. “His analysis started with defining the issues at his institution and quantifying it in his cost analysis. Next, he said he is implementing the ASBrS’s toolbox as a strategy for Kaiser surgeons to reduce positive margin rates,” Dr. Blair said.

“At UCSD, we examined our positive margin rate a few years ago, and it was below 10% because we routinely perform cavity margins. Surgeons want to do the right thing when shown the data. Educa■ tion is the first step.”

The re-excision rate for surgeons in this study ranged from 7% to 39%, with 25 surgeons (46%) having re-excision rates above 20%. Using a model to bring the re-excision rate to less than 20% for all surgeons reduced the number of operations by 320 over a five-year period, operative costs by 14% and OR time by 11%.

For Complex Ventral Hernia Repairs

MOVE ON FROM THE OLD BIOLOGICDERIVED MESH

TO ONE THAT MOVES WITH THE BODY

1-3†

STRUCTURE. FUNCTION. MOTION.1-3

† Animal model results do not necessarily translate to clinical results.

References: 1. Sasse KC, Lambin J-H, Gevorkian J, et al. Hernia. 2018;22(6):899-907. doi:10.1007/s10029-018-1830-0 2. Young DA, Jackson N, Ronaghan CA, Brathwaite CEM, Gilbert TW. Regenerative Medicine. 2018;13(4). doi:10.2217/rme-2018-0023 3. Young DA, McGilvray KC, Ehrhart N, Gilbert TW. Regenerative Medicine. 2018;13(7). doi:10.2217/rme-2018-0091 Gentrix® Surgical Matrix, Gentrix® Surgical Matrix Hiatal, Gentrix® Surgical Matrix Plus INDICATIONS: Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal, and Gentrix Surgical Matrix Plus are intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic and reconstructive surgery includes, but is not limited to, the following open or laparoscopic procedures: hernia (e.g. hiatal/diaphragmatic) and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair. Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal, and Gentrix Surgical Matrix Plus minimize tissue attachment to the device in case of direct contact with viscera.

CONTRAINDICATION: Patients with known sensitivity or allergy to porcine materials.

WARNINGS AND PRECAUTIONS: 1. Devices are not intended for transvaginal placement or treatment for pelvic organ prolapse or stress urinary incontinence.

2. Devices are not intended for bridging hernia defects. 3. Exposure to contaminated or infected field can lead to weakening or breakdown of device.

4. If active infection is present, treat patient to resolve infection prior to device implantation. 5. Do not use if cracked, broken, or otherwise damaged.

Gentrix® Surgical Matrix Thick INDICATIONS: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic and reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

CONTRAINDICATION: Patients with known sensitivity or allergy to porcine materials.

WARNINGS AND PRECAUTIONS: 1. Devices are not intended for transvaginal placement or treatment for pelvic organ prolapse or stress urinary incontinence.

2. Devices are not intended for bridging hernia defects. 3. Exposure to contaminated or infected field can lead to weakening or breakdown of device.

4. If active infection is present, treat patient to resolve infection prior to device implantation. 5. Do not use if cracked, broken, or otherwise damaged.

Gentrix, Integra, and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/ or other countries. All other trademarks and trade names are the property of their respective owners. ©2022 Integra LifeSciences Corporation.

All rights reserved. Printed in the USA. 2754523-1-EN

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IN THE NEWS

GENERAL SURGERY NEWS / JULY 2022

Robots Poised to Transform Surgery continued from page 1

Dr. Horgan, who has been performing robotic surgery since 2000 and is a pioneer in NOTES (natural orifice transluminal endoscopic surgery) procedures, said he believes that flexible robotic systems will transform the practice of general surgery.

Two surgical device companies now have FDAapproved flexible systems that can navigate into the far reaches of the lungs. Dr. Horgan said he expects this technology will soon be approved for general surgery procedures and revolutionize surgical approaches to the gastrointestinal tract.

“Patients will get the best of the best. If they need an endoluminal approach, it will be done from the inside.

If they need an external approach, it’ll be from the outside,” he said.

Much has changed in the 28 years since the FDA

approved the first robotic general surgery device. Called Automated Endoscopic System for Optimal Positioning, or AESOP (Computer Motion), this first robot in general surgery allowed surgeons to maneuver an endoscope inside a patient’s body during surgery using voice commands. Four years later, Zeus (Computer Motion) arrived on the scene with its three robotic arms and voice-operated camera.

In 2000, the FDA-approved Intuitive Surgical’s da Vinci surgical system for general laparoscopic surgery.

Basic tasks like suturing and knot-tying were faster with the da Vinci compared with Zeus, although still slower than laparoscopy (Surg Endosc 2003;17:574-579). Over the da Vinci’s first decade, surgeons were slow to adopt the technology; the first generation was unwieldy, timeconsuming and expensive compared with laparoscopy.

The second generation, however, brought improvements in the technology. Over the last decade, robotic surgery has taken off: Use of robotic surgery for general surgery procedures surged from 1.8% in 2012 to 15.1% in 2018 (JAMA Netw Open 2020;3[1]:e1918911). The growth in hernia repair over the same period was even more remarkable: from 0.7% to 28.8% for repair of inguinal hernias and from 0.5% to 22.4% for ventral hernias.

Several robots now approved in Europe or elsewhere are expected to move into the United States in the next five years. Also, there are promising new platforms approved outside of general surgery or in later stages of development.

Below is a list of robots that are available in the United States or Europe for general surgery procedures, and robotic platforms in or nearing clinical trials. This list is based largely on Dr. Horgan’s 2022 presentation at SAGES. The details of the surgical platforms have been independently confirmed by the manufacturers, unless otherwise noted.

■

Surgical Robotic Systems da Vinci Surgical Systems X and Xi Now in its fourth generation, Intuitive Surgical’s da Vinci robotic platforms account for the largest share of robotic-assisted surgical (RAS) procedures in the United States and worldwide. In December 2021, Intuitive reported that more than 10 million RAS procedures have been performed worldwide with its surgical systems.

Today, Intuitive has two multi-port robotic systems in use: Xi and X. The two platforms share the same arm architecture, surgeon console and vision cart. The X is marketed as the “value-oriented option” of the two systems and is designed for use in a single quadrant; the Xi can be used in multi-quadrant procedures.

Intuitive received FDA clearance for the Xi system in 2014 and for the X in 2017.

Avatera Made and designed by Germany’s avateramedical GmbH, the Avatera system is designed with single-use instruments and consists of two main components: a four-arm surgical robot and surgeon console. In May 2022, the company announced successful completion of the first 10 operations in humans with the Avatera system, including removal of prostate and kidney tumors.

Avatera has received the CE mark and is approved for minimally invasive surgery in urology and gynecology in the European Economic Area.

Bitrack Bitrack is developed by Rob Surgical, a Spanish startup created by the Polytechnic University of Catalonia and the Institute for Bioengineering of Catalonia. This system was first tested on animal models in 2014 and completed technical validation in 2018. Bitrack enables four-quadrant anatomic access with open-source ports that allow for robotic and laparoscopic instruments to operate simultaneously, and is controlled by a surgeon at an open console.

The company says its intended uses are in general surgery, urology, colon and rectal surgery, gynecologic surgery and thoracic surgery. It has not yet been cleared for use in any country.

(Rob Surgical did not respond to requests for confirmation of this information.)

Senhance Surgical System From Research Triangle Park, N.C.–based Asensus Surgical, the Senhance system received FDA clearance for general surgery in March 2021, after being cleared for laparoscopic colorectal and gynecologic surgery in 2017.

The Senhance surgical system is the first platform to offer 5- and 3-mm instruments, which the surgeon remotely controls through three separate robotic arms while seated at a console unit. Its most notable feature is the Intelligent Surgical Unit, which allows machine vision–driven camera control and recognition of objects and locations in the surgical field. In 2021, more than 2,100 procedures were performed globally with the Senhance system, representing 44% growth over the previous year.

Hugo RAS System In February 2022, Medtronic’s Hugo RAS system was used to perform the first robotic prostatectomy in Europe. The Hugo RAS system is a modular, multi-quadrant platform designed for a broad range of soft tissue procedures, and combines wristed instruments, 3D visualization and Touch Surgery Enterprise, an artificial intelligence–powered surgical video and analytical platform.

Medtronic received a CE mark for urologic and gynecologic procedures for Hugo in October 2021, and has received regulatory approvals in Canada, Australia and Israel. In the United States, the Hugo system is an investigational device not for sale.

Versius Developed by Cambridge, England–based CMR Surgical, Versius consists of modular bedside units with fully wristed instruments, which are controlled by the surgeon at an open console with 3D imaging. The small-scale design allows it to be moved between ORs, and the surgical team can select the number of arms needed for a given procedure.

In March 2022, Versius launched a headset for virtual reality training to help surgeons and teams learn the platform and practice their skills, making it the first soft tissue surgical robotics system to offer VR training, according to the company. Versius’ VR program will be launched in pilot hospitals in July 2022, with a rollout in approved countries later this year.

Versius is approved for use in Europe, Australia, India and Brazil, and was introduced in Hong Kong in April 2022. It is not cleared for sale in the United States.

Dexter Distalmotion, the Swiss company that designed and manufactures this system, says Dexter offers “on-demand robotics,” allowing a surgeon to switch between available techniques and tools—regardless of manufacturer—as needed during one operation. The system consists of three robotic arms, which are controlled from a console. Two arms hold robotic instruments and the third holds the endoscope. Distalmotion does not develop proprietary imaging technology or energy systems, but is an open platform compatible with all laparoscopic instruments, generators and 3D imaging systems—a measure that will help reduce costs associated with robotic surgery, according to the company. Originally designed by three recent doctoral graduates in engineering from the Swiss Federal Institute of Technology, Distalmotion received a CE mark for its Dexter system in December 2020, and is used for procedures in general surgery, gynecology and urology. It is not cleared for sale in the United States.

IN THE NEWS

JULY 2022 / GENERAL SURGERY NEWS

Single-Port Systems da Vinci SP Made by Intuitive, the da Vinci SP (single-port) system consists of three, multi-jointed, wristed instruments and a fully wristed high-definition camera, which emerge through a single cannula. The FDA cleared the SP system for urology procedures in 2018 and for radical tonsillectomy and tongue base resection in 2019.

‘Patients will get the best of the best. If they need an endoluminal approach, it will be done from the inside. If they need an external approach, it’ll be from the outside.’

—Santiago Horgan, MD

Vicarious Surgical Robotic System Waltham, Mass.–based Vicarious Surgical Inc. says its surgical system represents a “paradigm shift” in robotics with its combination of advanced miniaturized robotics and software that uses a single incision of 1.8 cm. Once in the body, the robotic arms move in all directions, giving surgeons better access to the abdomen, and is being developed to provide an experience similar to the surgeon’s own upper body movements.

In 2019, the Vicarious surgical robot received a breakthrough device designation from the FDA, the first surgical robot to receive this designation, according to the company. The system is not available for commercial sale in the United States.

In a press statement, Vicarious Surgical said ventral hernia repair will be the first indication for which the company will seek approval. Vicarious will not make an FDA submission for its surgical robot until 2024.

MIRA Platform Headquartered in Lincoln, Neb., Virtual Incision Corp. bills its MIRA platform as the world’s first miniaturized RAS platform. That’s where the name comes from: Miniaturized In vivo Robotic Assistant. The device weighs 2 pounds and can be used in any OR without needing to drape, dock or move heavy equipment. This will reduce turnover time, according to the company.

In August 2021, the first-in-human surgery using MIRAa robotic-assisted right hemicolectomy—was performed at the Bryan Medical Center. Nine months later, the FDA approved an Investigational Device Exemption (IDE) supplement for Virtual Incision to complete the final stage of a clinical study analyzing MIRA in bowel resections.

Results of the completed study will support MIRA’s upcoming FDA de novo application for market application, according to the company.

Enos Surgical System In 2020, Toronto-based Titan Medical Inc. rebranded its SPORT surgical system as the Enos Surgical System. The Enos platform consists of a surgeon workstation and patient cart with an integrated 2D HD camera with illumination, a steerable 3D HD endoscope with illumination and two multi-articulating arms. The insertion tube is delivered through a 25-mm incision.

The company says one of the advantages of Enos is its small size, allowing for easy maneuvering around facilities.

Enos is in the final stages of product development, and has commenced transfer to a manufacturing partner with the first units expected for delivery in late summer 2022 for safety and verification testing. Titan plans to file an IDE with the FDA in the first quarter of 2023. If approved, Titan will then launch an IDE clinical study in gynecologic surgery.

The company plans to launch the Enos system commercially after receiving marketing authorization from the FDA, anticipated in early 2025.

Titan also has a research and development office in Chapel Hill, N.C.

Hominis Surgical System In March 2021, Memic Innovative Surgery Ltd. received de novo marketing authorization for its Hominis RAS platform for use in single-site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures including hysterectomy. Hominis—which comes from the Latin word for man or human being—is the first and only FDA-authorized surgical robot that features what the company calls “miniature humanoid-shaped arms” with shoulder-, elbow- and wrist-like joints that replicate the motions of a surgeon’s arms.

In June 2022, Memic reported that doctors at HCA Florida Kendall Hospital, in Miami, performed a hysterectomy and bilateral salpingectomy using the Hominis system, the first time this technology was used for a minimally invasive hysterectomy in the United States.

The company says it plans to pursue general surgery and transluminal indications for the Hominis platform, and is developing AI-enabled features to support its surgical indications.

Memic was founded in 2013 and is based in Tel Aviv, Israel, with a wholly owned subsidiary in Fort Lauderdale, Fla.

Flexible Systems Ion Endoluminal System In 2019, Intuitive’s flexible robotic-assisted platform was approved for minimally invasive biopsy in the lung. The system features a maneuverable catheter with a 3.5-mm diameter and 2-mm working channel capable of reaching all 18 segments of the lung to biopsy lesions. Guided by fiberoptic shape-sensing technology, the catheter locks into place for precise placement of biopsy tools when it reaches a target nodule.

The Ion system works in combination with PlanPoint software, which helps a surgical team can plan out a procedure on 3D airway trees generated from patient scans. During bronchoscopy, the surgeon uses Ion’s controller to navigate along the planned path.

MONARCH Platform Manufactured by Auris Health Inc., a subsidiary of Ethicon Inc., MONARCH is a flexible robotic endoscopic system that is controlled remotely by a surgeon and uses computerassisted navigation based on 3D models. Each component of the endoscope can be independently articulated, advanced, retracted and locked, allowing for access into difficult-toreach places where small nodules may be located. One study showed that MONARCH reaches an average 4.2 cm further than a conventional thin bronchoscope (Ann Thorac Surg 2018;106[1]:293-297).

In May 2022, the MONARCH platform received 510(k) clearance from the FDA for endourologic procedures, making it the only flexible robotic platform approved for use in bronchoscopy and urology. The company plans to initiate the first-in-human clinical study later this year for an endourologic application.

The EndoLuminal Surgical System From ColubrisMX ColubrisMX grew out of research initiated at the University of Texas Health Science Center at Houston. The company designed a microsurgical robotic system specifically intended for transanal surgery, allowing for excision of colorectal neoplasia and luminal defect closure. In October 2020, Sam Atallah, MD, a colorectal surgeon at the Endo-Surgical Center of Florida, in Orlando, used the EndoLuminal surgical system to perform the first endoluminal, fully robotic operation in North America, removing a precancerous growth from the lower intestinal tract. The surgery was the first in an FDA-approved feasibility trial carried out at three U.S. sites last year.

(ColubrisMX did not respond to requests for confirmation of this information.)

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18

OPINION

How I Implemented Robotics Into My Practice tice

Articles compiled by CHRISTINA FRANGOU

‘I Was Once the Anti-Robot Guy’ Andrew S. Wright, MD Center for VideoEndoscopic Surgery Endowed Professor University of Washington, Seattle

After finishing my fellowship in 2005, I’d done about 70 cases on the original platform (da Vinci Surgical System, Intuitive Surgical). The cases took longer, cost more and had no benefit to the patient. I did them for about another year or two, but gave up doing robotics in clinical general surgery by about 2007. However, I continued to work on the robot in the research lab.

Until 2018, I was definitely the anti-robot guy. However, I’ve now migrated about 40% of my practice to the robot. I do about 40% laparoscopy, and 20% are my open complex abdominal wall cases.

There’s really no argument: Robotics is more expensive than laparoscopy. In a study from the National Inpatient Sample of over 91,000 operations, robotics— compared with laparoscopy—increases cost by about 20% (Surg Endosc 2019;33[7]:2217-2221). That ranges from a 6% increase in hysterectomy to 25% in colectomy. You can make an argument about your own personal case volume or experience, but these are the national numbers, not including the cost of the robotic platform and amortization.

For basically every procedure across the board—cholecystectomy, hernia, inguinal hernia—costs and operative times are higher on the robot than laparoscopy. You can make an argument that robotics saves money and cost over open surgery, however, mostly due to decreasing length of stay. Where the robot facilitates transition

from open to minimally invasive surgery, there’ss a costeffectiveness argument.

Despite the increased costs, we’ve seen a tremendous rise in robotic surgery. A 2018 study from the University of Michigan showed that over six years, we’ve seen an eightfold increase in robotic surgery nationally within general surgery. A large proportion is driven by hernia: a more than 40-fold increase in inguinal and ventral hernia repairs with the robotic platform (JAMA Netw Open 2020;3[1]:e1918911).

The data suggest that a lot of robotic work is really cannibalizing from laparoscopy. The same study showed that open surgery was declining and laparoscopic surgery increasing in the years before a hospital adopted the robot. But when the robot arrives, both open and laparoscopic surgery show a mild decrease, while robotic surgery increases dramatically.

Because of that, the market for robotics is huge. By some estimates, it will be an annual $10.3 billion market in the United States by 2030. That money has to come from somewhere, and it comes from clinical and hospital system revenue. There is a real cost to robotics from a systems standpoint.

How can you make robotics more cost-effective? If you can decrease your OR time by about 20 to 30 minutes, you can make robotics more cost-effective than laparoscopy (Ann Surg 2020;272[2]:334-341). Or you can decrease your robotic instrument cost by about $1,300 per case; do you really need four instruments when three might do? Or you can decrease the incisional hernia rate to less than 5%. These are all ways to drive the cost down and cost-effectiveness up.

A study from the Providence healthcare system with

The Right Robot for the Right Operation Amit Trivedi, MD Chair, Department of Surgery Pascack Valley Medical Center Hackensack Meridian Health Westwood, N.J.

I

work at Pascack Valley Medical Center in suburban New Jersey. It was a vacant building for about five years before my hospital system bought it. I brought my bariatrics practice there. I knew the next step in the hospital’s growth, if it was going to survive, would be robotic surgery. The easiest thing for me to do would have been to bring the da Vinci surgical system (Intuitive Surgical) there. We have four of them at my main campus, but we simply couldn’t afford the da Vinci system at the newly opened hospital.

So, I looked for the next affordable thing. The only other option at that point was the Senhance surgical system (Asensus Surgical), which was approved by the FDA in 2017. It’s an open console system that has three arms in the United States and four arms outside the United States. You use your own trocars and camera system. The current version has straight-stick instruments, although the company now has approval for articulating instruments.

As with any new robotic platform, an FDA training course is required. When I started in 2018 on this process, I had to go to Germany for training. When I came back, we had to change the credentialing process at the hospital.

I was credentialed for robotic surgery, but that meant specifically for the da Vinci robot. Now we had to change it to allow for newer robotic platforms. Each hospital will have to navigate this as new robotic systems are introduced.

After credentialing, you have to figure out where to place the robot. I had access to a less than 400-square-foot OR. We put the unit in there, and we’ve been there ever since.

You have to establish a robotic team. This newly opened hospital had barely done laparoscopy, and now we’re doing robotics on a platform that nobody had heard of.

We launched the Senhance robotic program in March 2019. I’ve completed 298 robotic cases as of last week. You can’t start off with everything robotically on a new platform. I learned that it’s best to say, “I’m going to try to do as much as I can on this platform for this particular operation.” Give it a time limit. However much we accomplish in that time, that’s what we do robotically and then we move on. Go back to laparoscopy and finish the case.

Try it again next time. As you go through this, you’ll do more and more robotically. Now we’re at the point where we complete pretty much everything that we set out to do robotically. But that’s the safe way to approach it.

There is a natural dip in enthusiasm on the new technology adoption curve called “the trough of disillusionment.” There are software glitches and instruments that you want that they don’t have. But technology evolves.

What encouraged me to continue was the introduction of the Intelligent Surgical Unit (ISU) to the Senhance

multiple hospitals, almost 50 surgeons and 957 cases, showed the importance of volume in building a program (Am J Surg 2018;215[5]:874-878). For high-volume robotic surgeons who do more than 30 cases per year, costs are about $5,000 lower than for low-volume surgeons.

If you’re going to be cost-conscious, you have to be systematic about it and build a program that looks at things like instrumentation, OR efficiency and staff training. In my system, our biggest barrier is the staff room turnover times; wheels in to wheels out, it’s not just console time that matters. That’s where staff training is really critical.

That said, cost is not all that matters. For me, value is what matters. We often think of value to the hospital, but what about the value to the surgeon? I developed tennis elbow from laparoscopic surgery. I’ve had to take a month to six weeks off from operating multiple times because of my elbow. That’s what drove me to adopt the robot. Surgeons are manual laborers. Surgery is physically arduous work. Up to 80% to 90% of surgeons have had pain within the last week, and 40% of surgeons are currently in pain (Surg Endosc 2019;33[3]:933-940).

That has a tremendous impact on productivity, quality and shortened careers.

I found that doing some robot, some lap and some open helps me. It allows me to mix it up. To help study and address ergonomics, we formed a new society, the Society of Surgical Ergonomics (https://www.societyofsurgicalergonomics.org/). All are welcome to join.

■ This presentation was condensed and edited for clarity.

Dr. Wright reported that he is a consultant to DLA Piper.

So, why am I not doing what everybody else is doing? Multiple robotic systems are going to be out there soon. I see newer robotic systems as complementary additions, not necessarily replacements. robotic platform. Otherwise, I would probably have stopped using this system. The ISU is a machine-vision, FDA-approved box that hooks up to the Senhance system. I think of it as giving me the ability to write apps.

One FDA-approved “app” is called Follow Me, and gives [the surgeon] the ability to automatically track the camera based on recognition of the instrument tip. With another app, I’m able to get an accurate real-time measure of things like ventral hernia defects and tumor margins. I can measure anything I want and document into the chart. Another app allows you to place tags on tissues or structures that you want to identify.

So, why am I not doing what everybody else is doing?

Multiple robotic systems are going to be out there soon.

I see newer robotic systems as complementary additions, not necessarily replacements. Over time, I think we’ll find the right robot for the right operation that optimizes cost, functionality, patient safety and surgeon ergonomics. ■ This presentation was edited and condensed for clarity.

Dr. Trivedi reported that he is consultant to Asensus.

OPINION

JULY 2022 / GENERAL SURGERY NEWS

Bringing Robotics to My Hospital for a Bariatric Practice Monique O. Hassan, MD Assistant Professor of Surgery, Texas A&M University College Station, Texas Bariatric Surgeon, Baylor Scott and White Health Dallas

I

didn’t see any robotics when I was in medical school. I went on to serve in the military, with four overseas deployments.

Obviously, I didn’t do any robotics during that time, but I did pick up a MIS (minimally invasive surgery) practice.

During my fellowship in MIS, my program sent me for the SAGES fellowship course in robotic surgery. I was excited about bringing robotics back to my practice. But the job market is pretty hard for bariatric surgery. I was lucky to land where I am now, which is a practice that’s 100% bariatric. The trade-off was that no one at the practice was doing robotic surgery.

I’m not a very tall person. When I operate, I stand on two or three steps, which is frustrating. There are many studies about ergonomics, especially in women. During my first year of working, I found difficulty in terms of holding the stapler. I had trouble with a lot of the devices. Six months into my first year, I developed tennis elbow, and I pretty much panicked. I was like, “I just got this job and now I have to be out.”

I looked around for other things I could try and decided to ask my chair to consider robotics. Texas is a huge state and our obesity rates are rising. Most of our bariatric patients have a body mass index (BMI) over 50 kg/m2. I pointed out how the platform for robotics has improved. The stapler is much better. The cost potentially could still come down. There are wider clinical applications, too.

I got the go-head to start as a trial. As we started building, the program started growing. More patients were coming. I invited the hospital’s vice president of operations to come to the operating room and watch a robotic case. He was fascinated. He saw how we can treat a patient with a BMI of 60 and she can go home the same day. After that, he supported us.

I got involved with the hospital’s robotic steering committee and that’s a powerful way to leverage if you want to increase your robotic practice. The steering committee can also help in terms of training programs and curricula. We set up a new training program for residents and surgeons who wanted to train. Suddenly, we went from two robotic surgeons to seven. We expanded our robotic program and got an additional robot.

The other thing specific to bariatric surgery is omnichannel marketing. Our bariatric patients come well versed and they do a lot of research. So, it’s important to have a good marketing plan, which Intuitive Surgical [maker of the da Vinci robot] or your hospital can help with. You can build that organically and

spread the word. The more patients who know about it, the more they’re likely to start coming.

After about 25 cases, I looked at our cost numbers to make sure this is something we should sustain and presented them to our administration. For a sleeve gastrectomy, it’s a little bit under $1,000 that I’m saving per case compared with my lap cases. Obviously, this is something that we should continue doing.

But surgical outcomes are really the key. I looked at a small sample of my

patients and compared them with laparoscopic data. I found the hospital length of stay was decreased. I had higher-BMI patients but fewer readmissions, and overall, our patient satisfaction scores are going up. That led to increased referrals. Those referrals are important for the ■ hospital.

This presentation was edited and condensed for clarity. Dr. Hassan reported that she is a speaker and proctor for Intuitive Surgical.

The new Sonicision™ 7 curved jaw ultrasonic dissector

The power to coagulate larger vessels.

The freedom to do it without cords.

1,†

2,‡

Power and freedom are the ultimate combination. They come together in a new ultrasonic device that brings next-generation energy to the OR. Meet the Sonicision™ ultrasonic dissector that delivers a 7 mm indication and a cordless design.3 That’s the power of freedom.

†26 out of 27 surgeons surveyed after use agreed. ‡29 out of 33 surgeons surveyed after use agreed.

1. Based on internal test report #RE00329878 rev A, Marketing evaluation of surgeon experience using the Sonicision™ 7 curved jaw cordless ultrasonic dissector. Apr. 14–15 and 20-22, 2021.

2. Based on internal test report #R0042752 rev A, Marketing evaluation of surgeon experience using the Sonicision™ curved jaw cordless ultrasonic dissector. Feb. 13–17, Feb. 28, March 3, May 16, 2017.

3. Sonicision™ 7 Cordless Ultrasonic Dissection System [user’s guide]. Minneapolis, MN: Medtronic, 2021. ©2022 Medtronic. Medtronic, Medtronic logo and Engineering the extraordinary are trademarks of Medtronic. 6/2022 – US-SE-2200130 – [WF#7034485]

19

20

GENERAL SURGERY NEWS / JULY 2022

DR. FERNANDO DIP: Can you explain what fluorescence-

guided surgery (FGS) is?

DR. RAUL ROSENTHAL: FGS is a novel imaging technology used in real-time in the operating room. Using fluorescence, the surgeon can see more, and as a result, better understand the anatomy, analyze tissue or even detect tumors. This breakthrough technology is essential in some surgeries. FGS has different advantages in that it is safe, easy to use, has no learning curve and can be applied to almost all specialties.

DR. DIP: What is the history of the use of fluorescent

Focus on FluorescenceGuided Surgery A New Column Welcome to the inaugural issue of Focus on Fluorescence-Guided Surgery. In this first issue, we have the privilege of interviewing Raul Rosenthal, MD, a co-editor of this column and a pioneering expert in fluorescence-guided surgery (FGS). Dr. Rosenthal is the regional chairman, Digestive Disease Institute; chairman, Department of General Surgery; director, the Bariatric and Metabolic Institute; and director, general surgery residency program at Cleveland Clinic Florida, in Weston. Dr. Rosenthal began using FGS more than 14 years ago and has been one of the pioneers in developing this type of technology in a variety of traditional open and minimally invasive surgical procedures.

We welcome feedback, comments and suggested topics for discussion.

imaging in medicine?

DR. ROSENTHAL: The use of fluorescence in medicine started many years ago. It was first used to analyze different types of microorganisms. Lividity was reported using fluorescent antibodies to recognize Rickettsia prowazekii in cell cultures.1 Afterward, fluorescence allowed physicians to evaluate different types of cells.

The lack of high-quality imaging available on the market did not allow this technology to advance. In the last several years, technological advances that enabled significant improvement in the quality of imaging allowed researchers to fine-tune this technology in the OR safely.

In order to use fluorescence during a surgical procedure, a dye and an optical system with a specific light source and a camera capable of capturing the light images are required. Once the stain is administered, the surgical field is illuminated with a particular wavelength. The fluorescent dye is excited and releases light with a higher wavelength captured by filters and projected on a screen. In this way, the stained structures can be identified by the surgeon, and that is why it has been labeled “real-time surgery.”

DR. DIP: Why do you consider this technology to be

essential?

DR. ROSENTHAL: For many years, only white light

COLUMN EDITORS Fernando Dip, MD

Raul Rosenthal, MD

Figure 1. Indocyanine green (ICG).

was used in the OR to illuminate the surgical field.

White light cannot penetrate blood and tissue more than a few microns, allowing only a superficial view of the tissues and structures.2 Fluorescence, a nearinfrared (NIR) technology, uses invisible light with a wavelength between 700 and 900 nm. In the NIR window absorption of the light, autofluorescence is minimal, allowing surgeons to see deeper structures than with white light.3 When surgeons operate, it is essential to understand the surgical anatomy to know exactly where the structures are located. Unfortunately, anatomic variations often make it difficult to recognize these structures. In addition, it is important to know if the tissues that will be sutured are well perfused. In some cases, tissues that look pink and well vascularized may not be well perfused. If a surgeon misidentifies and dissects a wrong structure or sutures non-vascularized tissue, this may result in an unexpected iatrogenic injury to the patient.

Despite many different technologies being developed to improve surgical outcomes, only a few have prevailed throughout the years and have been adopted as standard of care. A novel technology needs to meet at least three criteria to be accepted: 1. an actual clinical need exists; 2. the new technology solves a problem; and 3. the technology does not impede the workflow.4 In my opinion, FGS meets all three criteria. Unfortunately, the rate of intraoperative complications, such as bile duct injuries, anastomotic leaks and tumor recurrences, has not decreased over the years. Increasingly,

more publications are now measuring surgical outcome improvements using FGS. Moreover, what is interesting about FGS is that it does not interrupt or impede the OR workflow. The entire FGS system is integrated. Light sources and filters can be activated simply by pushing a button without the need to stop or delay the procedure.

This technology is undoubtedly a new paradigm in the evolution of surgery. We have seen incredible advances that have changed the history of medicine and surgery in the past. Using analgesics and anesthetics allowed surgeons to perform more extensive operations. The use of antibiotics decreased the rate of infections and reduced the mortality rate after a variety of procedures. Minimally invasive surgery enabled quicker recovery when compared with open surgery. With the help of fluorescence, for the first time in the history of surgery, a surgeon can now see through the tissue.

DR. DIP: What does a surgeon need to start using this technology?

DR. ROSENTHAL: The technology is straightforward. We create fluorescence light using near-infrared light and a specific dye that will glow when illuminated. The equipment is very similar to what we already have in the OR. The only difference is that we can activate different light modes. We can use standard white light or activate the NIR mode to see the tissues with fluorescence. With this new equipment, we can operate using fluorescence and white light simultaneously.

With this overlay image, the procedure is safer because we have more information while operating.

Before the procedure starts, a fluorescent dye must be administered. One of the most commonly used dyes is indocyanine green (ICG). ICG can be injected intravenously, subcutaneously or intratumorally, depending on the structures that need to be identified.

ICG is used because it is safe and was approved by the FDA in 1959 (Figure 1). Many surgeons have already been using ICG to evaluate liver function tests.

ICG has several advantages. It is selectively filtered and secreted by the liver. Since it is not metabolized in the liver, ICG can be used in other procedures, such as hepatobiliopancreatic surgery.5 The adverse effects are very minimal to none and it remains in the body for at least 24 hours. As soon as it is injected, ICG binds to proteins. Although it is not specific to most organs or tumors, it can identify and differentiate various tissues.

DR. DIP: What are the main surgical arenas in which this technology has a place?

DR. ROSENTHAL: This technology has been adopted in almost all surgical procedures. For example, ENT [ear, nose and throat] surgeons use NIR-guided surgery to evaluate the location and perfusion of the parathyroid glands during thyroidectomies to avoid postoperative hypocalcemia. The use of autofluorescence can help to detect the location of the parathyroid glands.6 Once the thyroid is dissected, ICG can be intravenously administered and the perfusion of the parathyroid glands can be determined. This is crucial in deciding if the parathyroid gland needs to be removed, reimplanted or left in the surgical field.7-9 In gastrointestinal surgery, leaks due to unperfused tissues may occur. With the use of ICG and NIR light, we can evaluate the vitality of the tissue and, in some cases, change the site of anastomoses. This problem can be seen in esophageal, foregut and colorectal surgery. We know that a leak can be caused by issues such as tension of the stumps, a patient’s lack of adequate

FOCUS ON FLUORESCENCE

JULY 2022 / GENERAL SURGERY NEWS

Figure 2. Perfusion assessment in colorectal surgery.

nutrition and lack of perfusion. We are trying to eliminate at least one crucial variable with this technology.

In colorectal surgery, more and more reports support the use of this technology. Years ago, Jafari et al reported a multiinstitutional study evaluating perfusion assessment in laparoscopic left-sided/ anterior resection (PILLAR II) using fluorescence.10 After analyzing 139 patients, they concluded that NIR angiography is a safe and feasible tool for intraoperative assessment of tissue perfusion during colorectal resection (Figure 2).

Lastly, Neddermeyer and his group published similar results when analyzing 132 colorectal resections (70 sigmoid resections and 62 total mesorectal excisions [TMEs]), of which 70 (53%) were performed with ICG near-infrared fluoroangiography (NIFA) and 62 (47%) without it. Following ICG/NIFA, the transection line was changed in nine cases (12.9%). Overall, 10 patients (7.6%) developed an anastomotic leak— one patient (1.4%) in the ICG/NIFA group and nine (14.5%) in the non-ICG/ NIFA group (P=0.006).11 Plastic surgery is another field in which FGS is extensively used. When performing a free flap, surgeons need to evaluate, in real time, the small vessels to avoid tissue necrosis and failure of a flap. In the past, flap dissection was guided only by the surgeon’s experience and universal zonal classification based on the perforator distribution. Now, ICG angiography allows the objectification and visualization of the perfused areas directly after the flap harvest.12 Another important use of this technology is sentinel lymph node identification in some tumors. Cancer staging is crucial to selecting the best treatment for a patient. For many years, the use of Tc99m [radiosotope technetium-99m] was the standard of care for sentinel lymph node identification in different types of tumors. Since NIR-guided surgery was developed, many studies have compared the use of Tc-99m and ICG for sentinel lymph node identification. FGS has been demonstrated to be as accurate as Tc-99m to identify the sentinel lymph nodes. Moreover, FGS does not use radiation; it is a real-time procedure, and the surgeon can follow the lymph vessels through the skin and, most importantly, the node can be dissected, protecting surrounding tissues.12

One of the areas in which FGS is frequently used is hepatobiliary surgery.

Laparoscopic cholecystectomy is one of the most common procedures performed worldwide. Unfortunately, bile duct injuries still occur, ranging between 0.4% and 1% (Figures 3A and 3B). The majority occur because the cystic duct and main bile duct are misidentified.13,14 It has been shown recently that FGS can increase visualization of the extrahepatic bile ducts threefold compared with white light. To perform a fluorescent incisionless cholangiography, ICG is administered intravenously 45 minutes before the

procedure. Then ICG is eliminated by the liver and remains in the extrahepatic bile ducts for at least 24 hours. When the fluorescent system is activated, the cystic ducts and main bile duct glow and can be visualized easily by the surgeon, making the procedure safer. Retrospective studies are demonstrating improvement in outcomes, such as decreased conversion rates. More recently, a cost-effectiveness evaluation came out in favor of the routine use of fluorescent cholangiography during laparoscopic cholecystectomy as a cost-effective surgical strategy.15

DR. DIP: Is there a role for cancer identification with FGS? DR. ROSENTHAL: The use of this technology for cancer tissue detection is still under evaluation. Unfortunately, cancer is an unresolved problem associated with high morbidity and mortality rates.

Early-stage detection and tumor resection seem to be the most powerful tools for treatment. Nevertheless, sometimes complete resection is very difficult. Cancer tissue, on some occasions, may look like normal tissue, thus residual cancer cells might remain in the surgical continued on the following page

21

22

FOCUS ON FLUORESCENCE

GENERAL SURGERY NEWS / JULY 2022

Fluorescence continued from the previous page

field. With fluorescence, the surgeon can detect tumor cells that otherwise cannot be seen with white light.16 Newer wavelengths and dyes are areas under evaluation. Researchers are studying different electromagnetic spectrum ranges to visualize cancer cells. The first part of the electromagnetic spectrum is between 650 and 900 nm and the second area is between 1,000 and 1,700 nm. Longer wavelengths allow more penetration, minimal tissue absorption and low autofluorescence.17 In terms of new dyes, several publications have reported the delineation of tumors using different probes. Steinkamp et al developed a probe (ONM-100) that could assist the surgeon during tumor resection.

These authors studied 13 patients with squamous cell carcinoma of the neck who received the probe before the procedure.18 During the procedure, fluorescence of the tumor and background allowed for better analysis by the surgeon. Fluorescent lesions on the resection margins showed occult carcinomas and severe dysplasia. Some investigators are working with antibody dye conjugates, such as SMG-101, that can identify adenocarcinoma of the colon with predictive positive values ranging from 99.04% to 90.24%.19 Probes required rigorous trials to evaluate efficacy and adverse effects prior to approval for human use and are currently not available.

DR. DIP: Do you recommend the use of this technology

routinely or selectively?

DR. ROSENTHAL: In some cases, it would probably be essential to adopt FGS routinely, especially in centers with residents and in some procedures when the anatomy may frequently vary. This is the case for laparoscopic cholecystectomy, where we may find a variation in the anatomy of the bile ducts in 21% of cases.20 If a bile duct is misidentified, this may create an injury. These complications increase morbidity and mortality rates and have a negative impact on a patient’s quality of life, as well as increasing the cost of health services. We now have the technology to perform a safer procedure using fluorescence.

Our group started using FGS for laparoscopic cholecystectomies. We performed a fluorescent incisionless cholangiography to visualize Calot’s triangle during the procedure. The results were so impressive that we decided to publish the main reasons to support its routine use.

The use of this technology is feasible. The majority of manufacturers have included the capability for FGS in their equipment, making the use of technology more accessible. The contraindications for its implementation are few. Thus, we can administer ICG to almost all patients. The technology is beneficial because it provides additional information to the surgeon that might simplify some procedures. The learning curve is minimal. FGS is safe because the wavelength used is in the NIR spectrum and does not harm any tissue.21 DR. DIP: This technology seems to be very useful.

What are the main barriers to adoption of this technology?

DR. ROSENTHAL: All new technology must overcome the process of adoption. Innovators will accept the technology almost immediately, whereas skeptics might never adopt it no matter how useful it is. Time will determine the real need for this technology in the OR for different applications.

Recently, using the Delphi method, the International

Figure 3A. Calot’s triangle using white light.

Figure 3B. Calot’s triangle under fluorescence view.

Society for Fluorescence Guided Surgery (ISFGS) surveyed to determine the main barriers to adopting the use of FGS. A total of 94 surgeons responded. They reported that, in their institutions, the use of FGS represents 20% of the procedures performed. The majority (69%) work in academic centers. Interestingly, the cost of the equipment was reported by 25% of the surgeons as being the main barrier, followed by training at 30%, and lack of access to the equipment at 44%.

As physicians, our responsibility is to follow the evidence published in peer-reviewed, high-impact journals.

What we do know is there are more and more reports that support the use of FGS in various procedures.22,23 The adoption of FGS varies around the world. The most common adoption seems to be for gastrointestinal and transplant surgery, especially in Asian Pacific countries, whereas in Western countries, FGS is used more commonly for colorectal and plastic surgery procedures.24 DR. DIP: What is the future of fluorescence-guided

surgery?

DR. ROSENTHAL: For the majority of procedures, this

technology will evolve and likely become the standard of care, or at least a readily available tool in the surgeon’s armamentarium. Considerable improvements in the specificity of the technology will occur over time, and a greater number of structures will be seen in real time. This technology is certainly here to stay, and its adoption will increase.

There are some aspects of this technology that are being evaluated: • Quantification of the intensity of the fluorescent signals is essential. Unfortunately, absolute fluorescence intensity depends on patient conditions and may differ when different types of lights or cameras are used. To decrease that variability, normalization of the measurement of time‒intensity curves may be used.25 Some manufacturers are developing software that can analyze the images in real time. To date, the interpretation of images has been subjective. Surgeons can see images that glow or not and make decisions according to their experience. Understanding of the images depends on the interpretation by the surgeon.

• Time‒intensity curves. Some groups recently

analyzed the fluorescence behavior of tissue vascularization in 13 patients in whom 17 flaps were performed. After administration of 7.5 mg of ICG intravenously, the behavior of tissue fluorescence was described for three minutes. Software created a timeintensity curve of the measured intensity in arbitrary units. The researchers showed when tissue is critically poorly perfused, the areas in the perfusion curve are lower than the curves obtained in well-perfused flaps. This fact is significant because objectivity in the interpretation of the images is guaranteed.25 • Dynamics of perfusion.

1. Leak prevention. Fluorescent intensity might be essential to evaluate the quality of the tissue.

What some surgeons are currently evaluating is that the time it takes for ICG to reach the anastomotic site may be an essential factor to consider.26 This is referred to as the “dynamics of perfusion.”

2. Tumor evaluation. Undoubtedly, evaluating the dynamics of ICG in tissues is a hot topic. It is known that benign and malignant lesions have different vasculatures. Cancer cells are characterized by a chaotic and leaky vasculature that might be recognized with fluorescence imaging.

Although understanding the images for some tumors is complex in the OR, unique software that creates algorithms is used to learn different fluorescent patterns.27 • New structures. Some groups are evaluating the use of different wavelengths, filters and dyes to visualize other structures, such as nerves. Some researchers are using the autofluorescence properties of nerves to visualize them. Others are trying to tag nerves with different fluorescent probes to differentiate them from other structures.

• New dyes. It is likely that, in the future, a surgeon will be able to select a dye to visualize a specific tissue or cell. Specifically, patients with colorectal tumors will be given a specific stain marked with an antibody that identifies that tumor and not another tissue. To visualize ureters during colorectal surgery, a specific dye will be administered for ureters and that does not mark any other adjacent structure.

■ For a full list of references, visit generalsurgerynews.com The ISFGS wishes to acknowledge its Corporate Council—Arthex, Diagnostic Green, Karl Storz, Medtronic, Olympus, Optimedic, OnLume and Richard Wolf— for their continued generous support.

VIDE O Introduction to the International Society

for Fluorescence Guided Surgery (ISFGS) youtube.com/watch?v=6jptxzks0dE

The International Society for Fluorescence Guided Surgery (ISFGS) is dedicated to the global advancement of FGS, connecting surgeons, nurses, other allied professionals, and patients, and growing the overall awareness and implementation of FGS worldwide. Visit ISFGS at www.isfgs.org and visit the ISFGS patient portal at ISFGSpatientportal.

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23

HandXTM: A Digital, Fully Articulating, Handheld Laparoscopic Platform What are the benefits of using HandX™ versus robotic systems?

and affordability of handheld solutions.

The HandX™ by Human Xtensions is an electromechanical software-driven computerized system. It is small and provides the surgeon with the wristed action needed in minimally invasive surgery (MIS) in hard-to-reach, tight areas of the anatomy.

Surgeons have commented, “The product does 95% of what a surgical robot does at 5% of the cost.” The HandX™ system is lightweight and compact, has a minimal footprint in the OR, and has a short learning curve and setup time. HandX™ can be used in any hospital OR.

Why use HandX™ over other options?

What surgical scenarios provide value to the surgeon when using HandX™?

In a way, the definition of MIS was the transfer of pain from the patient to the surgeon. Today, Human Xtensions’ mission is to relieve that pain by enabling surgeons ease of use with flexible instruments and do more for the patient during surgery. As a result, the HandX™ can provide value to the surgeon in any laparoscopic surgical scenario, especially in challenging tasks such as suturing and dissection in confined spaces and hard-to-reach anatomies.

What is unique about this technology?

The HandX™ is the only 5-mm electromechanically softwaredriven, fully articulating handheld laparoscopic platform. The HandX™ offers the possibility of improving surgeons’ dexterity, precision and ergonomics more cost-effectively than other platforms. In addition, the HandX™ digital platform can empower the minimally invasive surgical landscape by allowing rapid improvements with personalized digital platforms that combine the power of robotics with the ease of use

The HandX™ acts as an extension of the human hand inside the patient’s anatomy during MIS. With 8 degrees of freedom and a variety of 5-mm flexible instruments, the HandX™ allows

the surgeon to have excellent control and guidance options through an ergonomic and easyto-operate, software-driven platform.

What is the learning curve for HandX™, and do you need a dedicated robotic team?

for other robotic systems. Most surgeons feel comfortable and safe performing surgery after a brief introduction and practice.

In addition, there is no need for a dedicated robotic team to operate with the HandX™. The HandX is easy to use, and the setup involves common OR practice.

The HandX™ system’s learning curve is significantly shorter than

For more informaƟon, visit human-x.com.

24

IN THE NEWS

GENERAL SURGERY NEWS / JULY 2022

Routine DVT Screening in Trauma Likely Overkill With Prophylaxis

By MONICA J. SMITH

NASHVILLE, TENN.—With vast improvements in

pharmacologic prophylaxis against venous thromboembolism in trauma patients, routine ultrasound surveillance of these patients may no longer be necessary, and represents a potential area for substantial cost savings, according to new research.

“Many trauma centers have employed screening lowextremity venous duplex ultrasound surveillance protocols for detection of deep venous thromboembolism [DVT]. However, the utility and cost-effectiveness of this practice has been called into question,” said Victoria Miles, MD, a general surgery resident at the University of Tennessee Health Science Center College of Medicine Chattanooga, presenting her team’s research at the 2022 Southeastern Surgical Congress.

In 2021, the Critical Care Committee of the American Association for the Surgery of Trauma published updated guidelines recommending against routine ultrasound surveillance for DVT in trauma patients who receive adequate prophylaxis.

“Therefore, we hypothesized that our screening lower extremity [ultrasound] protocol would rarely detect DVT in our trauma patients who receive early prophylaxis. We also sought to determine risk factors that may better guide trauma DVT screening practices,” Dr. Miles said.

To do so, she and her team conducted a retrospective review of all nonpregnant, adult trauma patients admitted to their Level I trauma center between December 2019 and November 2020, excluding those whose hospital stay was less than three days.

Following a practice management guideline in use at the institution for more than a decade, patients with a long bone fracture, spinal cord injury, pelvic fracture, immobility, or thoracic or lumbar spine fracture that required surgery underwent ultrasound surveillance for DVT on hospital day 3. All others underwent ultrasound on hospital day 7. Bilateral lower extremity ultrasound surveillance was repeated every seven days for all inpatient trauma admissions.

Regarding prophylaxis, patients were given lowmolecular-weight heparin within 24 hours of admission,

unless there was evidence of active bleeding or traumatic brain injury.

Over the 12-month study period, 1,365 trauma patients underwent 1,369 screening ultrasounds that identified 27 DVTs (2%).

“Fifteen percent of those were symptomatic, 70% had experienced a delay or interruption in their prophylaxis, 74% had an ipsilateral lower extremity injury, and 11% had an ipsilateral femoral central line placement during their hospitalization,” Dr. Miles said.

Basing the cost of bilateral lower extremity screening ultrasound on the Centers for Medicare & Medicaid Services allowable of approximately $200, Dr. Miles and her team estimated a cost savings of more than $240,000 annually at their institution if the routine [ultrasound] screening were eliminated in favor of a targeted screening protocol.

Pulmonary embolism occurred in less than 1% of non-DVT patients and 15% of DVT patients. Only 2% of patients with DVTs suffered fatal injuries, with only one being secondary to the thrombosis.

Patients with DVT were likely to have a higher injury severity score, longer length of stay, higher body mass

index and increased incidence of lower extremity injury. After logistic regression, the statistically significant predictors of developing DVT were lower extremity Abbreviated Injury Scale score of 2 or 3, male sex, and longer length of stay.

Basing the cost of bilateral lower extremity screening ultrasound on the Centers for Medicare & Medicaid Services allowable of approximately $200, Dr. Miles and her team estimated a cost savings of more than $240,000 annually at their institution if the routine ultrasound screening were eliminated in favor of a targeted screening protocol.

“The emphasis placed on early initiation of DVT prophylaxis in the past decade has changed the face of pulmonary thromboembolism (PTE) in trauma altogether. With this drastic improvement in PTE rates, DVT screening programs should focus on high-risk patients. As such, our study found an area for potential significant cost savings in trauma centers with universal lower extremity US [ultrasound] screening practices still in place,” Dr. Miles said.

Amy Hildreth, MD, a trauma surgeon with Atrium Health Wake Forest Baptist in Winston-Salem, N.C., and invited discussant at the meeting, noted that in a 2003 report also from the Chattanooga group, the rate of lower extremity DVT was around 12%. “Today it is approximately 2%. How do you account for this decrease?”

She further asked whether, given the low DVT rate they found in this study, it is time to retire their current screening protocol and move to screening symptomatic patients only. (At the SESC meeting, Dr. Hildreth’s questions were delivered by her colleague Rachel D. Appelbaum, MD, also a trauma surgeon at Wake Forest.)

Dr. Miles said the decreased DVT rate is likely due to their aggressive chemical prophylaxis protocol and improved administration rate of DVT prophylaxis. “We now have an Epic order that requires a physician’s name to approve holding a dose of prophylaxis.”

As a result of the research, the institution is no longer screening universally for DVT. “Even our vascular surgeons, who formally read all screening ultrasounds, are ■ on board,” Dr. Miles said.

Sacral Neurostimulation Improves Symptoms Of Low Anterior Resection Syndrome

By KATE O’ROURKE

TAMPA, FL.—Sacral neurostimulation improves continence and pelvic floor function in patients with low anterior resection syndrome, according to new research. The findings were presented at the 2022 annual meeting of the American Society of Colon and Rectal Surgeons.

Low anterior resection syndrome (LARS) affects up to 70% of patients after rectal resection (Colorectal Dis 2019;21[11]:1240-1248). Symptoms can be mild or permanent and negatively affect quality of life.

The investigators evaluated the impact of sacral neurostimulation (SNS)

on continence and continence-related symptoms in patients seeking treatment for LARS. Using the institutional database at Beth Israel Deaconess Medical Center and the Medtronic database, the researchers identified patients diagnosed with LARS refractory to medical therapy who underwent SNS implantation from 2005 to 2021. The researchers collected data on bowel dysfunction preand post-implantation as well as oncologic and surgical history.

Among 680 proctectomies identified during the period, 13 patients with LARS underwent implantation of the SNS device. The average age was 50 years and 85% were men. All patients

had resections for rectal cancer. Eleven patients (85%) received neoadjuvant chemoradiation, one received radiation after resection and one did not receive radiation. One patient was an active smoker and four were former smokers. The most common LARS symptoms were increased frequency of stools (85%), fecal incontinence (77%) and clustering of bowel movements (64%).

Eleven patients (85%) reported improvement in symptoms. Of the two patients (15%) who did not experience improvement, one proceeded with SNS removal and a colostomy, and the other underwent SNS removal without creation of a colostomy. One complication (8%), a

wound infection, required removal of the SNS device.

According to presenting author Eric Rosenfeld, MD, a fellow in colorectal surgery at Beth Israel Deaconess Medical Center, in Boston, the study demonstrates that sacral neuromodulation is an effective tool to treat LARS symptoms not managed by nonsurgical means, and should be considered in patients with significant LARS not managed by conservative means. “Neuromodulation is an effective option for refractory LARS,” Dr. Rosenfeld said.

The study was limited in that it was retrospective and conducted by one surgeon at a single center.

■

IN THE NEWS

JULY 2022 / GENERAL SURGERY NEWS

Asymptomatic COVID-19 Patients Still Need to Wait for Elective Surgery

By BOB KRONEMYER

D

elaying elective surgery for 10 days after COVID-19 symptoms first appear or after the first positive test for the infection has been working well since December 2021. However, a new study recommends that asymptomatic patients also should still wait to undergo such procedures (Br J Anaesth 2022;128[5]:e311-e314).

“This decision is based on data that suggests that by day 10, the patient is no longer infectious and therefore not in a condition to put healthcare personnel at risk, nor does the patient seem to be at risk for poor outcomes,” said lead investigator Matthias Eikermann, MD, PhD, the chair of anesthesiology at Montefiore Health System (MHS), in New York City.

The idea for the study emerged during the highly infectious fourth surge (December 2021 to present) of the pandemic, “where the staff of many New York City hospitals, including ours, were impacted quite severely,” Dr. Eikermann said. “The question came up at a meeting of our hospital executive command team as to how to define the criteria for safe elective surgery during a period of rising numbers of patients presenting with a SARS-CoV-2–positive test.”

The command team discussed recommendations from the national societies of anesthesiology and surgery, “which appeared not to apply to the patients we were treating,” Dr. Eikermann said. “We had heard about the more benign omicron variant, but it was surprising to us to see that the clinical presentation was so different between surge 1 and 3 and during 4.”

In early 2022, COVID-19 pneumonia was almost eliminated: down to 0.2% of emergency department visits at MHS in New York City and Westchester County, N.Y. However, during previous surges, March 2020 to November 2021, 33.6% of the 7,872 hospitalized patients at MHS with positive polymerase chain reaction tests lost their ability to live independently and 18.4% died in the hospital.

“By contrast, during the fourth surge, which resulted in 538 hospitalizations, 10.4% of patients were admitted to a nursing home and 5.2% died in the hospital,” Dr. Eikermann said.

Data describing poor outcomes of patients with COVID-19 obtained during the first surge, when elective surgery was initially canceled, “cannot be applied to our current scenario,” said Dr. Eikermann, a professor of anesthesiology at Albert Einstein College of Medicine, in New York City.

“There is no evidence to suggest that after positive COVID-19 tests in 2022,

the risk of elective surgery is increased. But thee smisrisks of virus transmission still exist.” h patient for Although each elective surgery at MHS has a comerative evaluation, “a prehensive preoperative shortening of the time could expose vulnerable patients and staff members to the risk of COVID-19 infection,” Dr. Eikermann said.

Also, as new COVID-19 strains emerge, recom recommendations may need to be modified modified, based on transmissibility and viru virulence.

D Dr. Eikermann and his cco-authors are evaluating w whether patients with positiv tive COVID-19 tests have an increa increased risk for subtler adverse signs and symptoms, such as post-op neurocognitive disorders like delirium, anxiety and depression.

Douglas Colquhoun, MB, ChB, an assistant professor of anesthesiology at the University of Michigan, in Ann Arbor, said the study does not “directly assess the impact of COVID-19 infection on surgical patients across the pandemic surges. The changing profile of mortality and severe outcomes in the general population ■ is, however, interesting.”

Dr. Colquhoun reported funding from the National Institutes of Health for research in pulmonary outcomes after surgery.

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26

OPINION

GENERAL SURGERY NEWS / JULY 2022

Publish or Perish: An Aphorism for General Surgery Residents

BY MIGUEL A. LOPEZVIEGO, MD, FACS

I

t has now become a requirement for graduation from many of the five-year general surgery residency programs in this country for residents to complete an additional one or two years of compulsory basic science research. The medical students who hope to enroll in these programs are well aware of this obligation before they rank these programs on their match list, and therefore are obliged to fulfill this academic requirement at some point during their training. The vast majority of these medical students agree to this condition when selecting their desired surgical training programs despite having absolutely no idea what their eventual research project(s) will be. Subsequently, many of these medical students, as junior residents—after dedicating two or three years to their clinical training—come to the realization that they have absolutely no interest in, or passion for, basic science research. They then are forced to either lobby for an exception to this research requirement by filling a void

general surgery residency programs are so committed to the idea of mandatory research.

In deliberations on subjects like mandatory resident research, it is prudent to investigate the question of who benefits from putting a resident in the lab. In America, that usually involves following the money! The term “publish or perish,” coined by Archibald Coolidge in 1932, helps open that discussion.

All academic departments associated with universities are under intense pressure every year to provide evidence of research projects that lead to publications in peer-reviewed journals. It is the hope of every academic department that these research projects, if well received and impactful enough, will lead to lucrative grants.

Nonetheless, even if funds are not generated to support the department, a lengthy bibliography of journal articles, regardless of their significance or quality, creates the impression for those who subsequently review the program, and its faculty, that a robust and inquisitive academic environment exists. These publications help the respective deans, department chairs and section chief to satisfy these academic expectations for “schol-

‘Perhaps it is time to consider the question of what value comes to our individual residents, and more importantly to our profession, when we force them into the laboratory to perform research they do not want to do.’

that has developed in the programs roster or reluctantly submit to this demand of their program director. Perhaps it is time to consider the question of what value comes to our individual residents, and more importantly to our profession, when we force them into the laboratory to perform research they do not want to do.

Mandatory basic science research for general surgery residents is a controversial topic. For decades, many of the nation’s top academic residency programs have included dedicated time “in the lab” as a critical part of their residency training. Many of us may remember a time when Duke University’s surgery program was described as being “a decade with Dave (Sabiston).” However, there is little logic, and even less data, supporting the idea that mandatory research produces a better general surgeon. More importantly, it would be hard to argue that a 30-year-old resident who plans to go into community practice and will never again be involved in any type of research would not serve his patients better by doing two years of additional subspecialty fellowship training (in any subspecialty) instead of participating in some esoteric laboratory investigations that they care nothing about.

As such, it seems we should now be asking why some

arly activities” while simultaneously buffing their own CVs (curriculum vitaes). Logically, so long as no dramatic additional financial costs are incurred, allocating a block of residents each year to mandatory laboratory work is likely to secure a guaranteed and reliable annual source of journal publications. When one recognizes the practical benefits of mandating resident research in the nation’s surgery departments, where the full-time academic faculty members’ careers and promotions are dependent on their quantity of publications, it is logical that we, as the surgeons charged with mentoring and training these residents, ask two very important questions: What benefit is society receiving from this type of research and what benefit is the individual resident obtaining from this significant time commitment? We should explore these questions separately.

There was a time when most scientists, and nearly all educated people, believed that all research was good. This intuitively seems to be a logical point of view since one would hope that any new or incremental advances in knowledge or fine-tuning of past hypotheses and investigations should be beneficial to science, and thus to humanity. Interestingly, however,

any contemporary scholarly review of this issue will be met with hundreds of opinion pieces and research papers convincingly arguing that meaningless, poorly prepared, uninspired, and often fraudulent or misleading research studies are being prepared by poorly trained or incompetent researchers at a furious pace to fill the pages of the exploding number of print and online journals in order to satisfy the academic demands of our institutions of higher learning. Many of these journals will now publish, often for a hefty price, any scientific article you are willing to email to them. These publications confuse and dilute the priceless effect of the precious few high-value, rigorously performed studies, which should be guiding our practice of medicine. Many of these same meritless publications are blended later with the few credible ones to generate grand statistical meta-analyses of the compiled data, which can further confuse the clinicians who look for legitimate scientific guidance.

The cost of these studies to taxpayers is not insignificant: Funding a resident’s salary and benefits for two years in addition to paying for the exceptionally high cost of operating a basic science lab just to “get their name on a few papers” that are then published in obscure journals and never cited again cannot be a clever way to use taxpayer dollars. Our fellow citizens would be shocked to see what a weak bang for the buck they are getting for funding mandatory general surgery resident research. We must at some point, as surgeons involved in resident education, ask questions such as: What was the last resident research project resulting from one or two years of full-time laboratory work by a resident in your institution (or at an away institution) that ended up impressing you or making a meaningful contribution to the science of surgery? Year after year, our residents disappear into the labs of this country and work hard to generate “a few papers” that bear their names as co-authors. Is this having any measurable benefit in the training of our surgeons or is this simply a nefarious route for academic surgery departments to generate more lines on their annual publication list? I would be fascinated to see what percentage of faculty members in our country’s surgery residencies have any idea what their own residents’ research projects and publications were during their mysterious two-year sabbaticals!

The institutions of higher education in surgery have now stepped up the ransom on our residents even further. Many competitive fellowship programs, such as surgical oncology and pediatric surgery, all but demand two years of laboratory work. Why? Is this a high-level filter to lighten the number of residents applying for these highly prized fellowships, by weeding out the ones unwilling to submit to two more years of wasted time before they begin their practices? Is it not possible for a highly motivated and extraordinarily talented, clinically focused general surgery resident to complete an elite pediatric surgery fellowship and have a remarkable career in clinical surgery that benefits thousands of children? Our experiences suggest the answer is yes but that perhaps the machine of academic surgery with its thick bureaucracy, proud new divisions and complete lack of respect for a resident’s time (other than the 80-hour workweek rule) needs a constant captive labor force to help pound out the publications and keep the illusion of “the surgery research lab” alive.

Let me be clear that I enthusiastically support allowing any motivated resident or medical student who

OPINION

JULY 2022 / GENERAL SURGERY NEWS

passionately wants to explore an enigma of basic science the freedom to enter the laboratory for as long they need, not just two years. The young, highly driven investigator with endless enthusiasm and the creative and abstract potential of a 28-year-old mind should be encouraged and supported fully in their dreams to make legitimate scientific progress! It is the only hope for humanity and for progress in our field. I am reminded of a highly-motivated Thomas Fogarty who decided to pursue research on an embolectomy catheter in response to an interesting clinical dilemma he encountered during his hospital vascular surgery experiences as a student and resident. His time in the lab forever changed surgery and impacted the lives of hundreds of thousands of patients around the world. Our residency programs need to stop forcing our future clinical surgeons who have neither talent nor interest in basic science or technological research into the lab. Forcing this type of resident into basic science work for two years is like forcing your 15-year-old daughter who hates playing the piano and has no talent for it to keep taking piano lessons. She is a good kid so she will do it because she loves you, but no good will come of it. You will be wasting both her time and your money, and eventually it will make her resent you. The exact same thing is happening with our residents!

Perhaps it is time for surgery departments to start looking for the next Thomas Fogarty in their midst, the resident(s) with both the attitude and aptitude for basic science research, and then move heaven and earth to help make them successful. These same departments need to simultaneously become better wards of taxpayers’ money and their residents’ precious time. The world needs to spend its research dollars in the laboratories where meaningful research is being done and supporting the investigators who have the dedication, preparation and ability to make significant contributions to science.

Our residency programs need to keep our residents in the ICUs, hospital wards and operating rooms of our nation’s teaching hospitals, where they can master the complex art and science of clinical surgery and never force an uninspired clinician into the lab. This novel approach will save a bunch of rats’ lives and help a lot of ■ very sick patients.

—Dr. Lopez-Viego is a vascular and general surgeon, and a clinical professor of surgery at Charles E. Schmidt College of Medicine, Florida Atlantic University, in Boca Raton.

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

Firearms continued from page 7

and indirect supervision for children between 12 and 18 years where not already regulated by states.

• Firearm owners must provide safe and controlled firearm storage. Owners who fail to do so should be held responsible for adverse events related to discharge of their firearm.

• Individuals who are deemed an imminent threat to themselves or others should have their firearm ownership temporarily or

permanently restricted based on due process. Mandatory reporting to, and by, law enforcement and medical personnel for those who are threatening to themselves or others should become standard practice.

• Mass shooting events should be treated as terrorism. The FAST group supports and encourages domestic law enforcement efforts and strategies within the limits of Fourth Amendment protections to predict, detect and deter future mass firearm violence.

• Firearm technology should be developed in a way that would significantly

Digital Editions Available Online

reduce the risk for self-harm, prevent unintentional discharge and prevent unintended use by a person other than the registered owner of the firearm.

• Research on firearm-related injury and prevention of injuries should be federally funded at a level commensurate with the burden of the condition without restriction.

• The public, professionals in law enforcement and the press should take steps to eliminate notoriety of the shooter and use an editorially muted approach to coverage of ■ these events.

27

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IN THE NEWS

GENERAL SURGERY NEWS / JULY 2022

Race, Neighborhood Deprivation Tied to Mortality After Cancer Surgery

By KATE O’ROURKE

B

lack patients who had elective resection for pancreas, lung, colon and rectal cancers had higher mortality rates than whites, regardless of neighborhood deprivation and dual eligibility status for health insurance, according to new research.

The findings were presented at the Society of Surgical Oncology 2022 International Conference on Surgical Care (abstract 56).

Disparities in mortality following high-risk cancer operations have been well documented, but how social risk factors interact and contribute to disparities remains unknown. In the new study, Sidra Bonner, MD, MPH, a general surgery resident at the University of Michigan, in Ann Arbor, evaluated how mortality is associated with race, neighborhood deprivation and dual eligibility.

The researchers used exclusively Medicare inpatient claims, and identified Medicare beneficiaries undergoing elective resection for pancreas, lung, colon and rectal cancers between January 2016 and December 2018. Beneficiaries were stratified into quartiles based on their neighborhood Area Deprivation Index (ADI) score, a composite measure of

housing, education and employment, at the census tract level.

Dual-eligible Black beneficiaries from neighborhoods with the highest levels of deprivation had the highest probability of mortality, at 3.6% (95% CI, 2.34%4.98%). The difference in mortality between Black and white beneficiaries was largest for non‒dual-eligible individuals living in low levels of deprivation, at 2.3% (95% CI, 1.3%-3.4%) versus 1.7% (95% CI, 1.5%-1.8%). Comparatively, the difference in mortality for dual-eligible beneficiaries at high deprivation levels between Black and white groups was smaller at 3.6% (95% CI, 2.9%-4.3%) versus 3.7% (95% CI, 2.9%-4.3%). The probability of mortality was higher for Black beneficiaries in all combinations of ADI and dual eligibility status.

“The effect of race was more pronounced among those with more resources. These findings highlight the need to address structural racism and community-level factors in quality improvement efforts in cancer surgery,” Dr. Bonner said.

“This is an important study as it suggests that part of the reason for worse cancer surgery outcomes lies in factors related to the community one lives in, their employment status and their

‘Surgeons may need to tailor care differently to individuals in underserved areas so that we are meeting their needs in an attempt to improve their cancer surgery outcomes.’

—Douglas Tyler, MD educational background,” said Douglas Tyler, MD, the John Woods Harris Distinguished Chair in Surgery at The University of Texas Medical Branch, John Sealy School of Medicine, in Galveston.

He was not involved with the research.

“The study pushes cancer [care] providers to think creatively about expanding

access and care out into communities with worse outcomes. It also highlights that healthcare providers, especially surgeons, may need to tailor care differently to individuals in underserved areas so that we are meeting their needs in an attempt to improve their cancer surgery ■ outcomes,” Dr. Tyler added.

Disparities Identified for Medicare Advantage Individuals

By KATE O’ROURKE

C

ompared with traditional Medicare, Medicare Advantage beneficiaries undergoing lung, esophagus, stomach and pancreas resections were significantly less likely to have surgery at a high-volume center.

Medicare Advantage enrollment was also associated with worse overall survival, according to new research presented at the 2022 Society of Surgical Oncology International Conference on Surgical Care (abstract 60).

Over the last two decades, the popularity of Medicare Advantage plans has increased, with more than one-third of older (≥65 years of age) Americans now

enrolled in them. In contrast to traditional Medicare, Medicare Advantage plans control costs by limiting utilization to certain contracted, in-network providers and by requiring prior authorization for specialist referrals.

“Our prior work identified significant gaps in Medicare Advantage plan coverage for high-volume cancer surgery,” said lead study author Kevin M. Sullivan, MD, a fellow in the Complex General Surgical Oncology Fellowship in the Graduate Medical Education Program at the City of Hope, in Duarte, Calif.

In the study, Dr. Sullivan and his team compared the impact of Medicare Advantage enrollment with traditional Medicare on access to high-volume complex cancer surgery and long-term overall survival. The researchers performed a retrospective analysis from 2000 to 2012 using the Office of Statewide Health Planning and Development Inpatient Database linked to the California Cancer Registry. They included patients aged 65 years or older, undergoing elective inpatient curativeintent cancer surgery for stage I to III cancers

‘Insurance plans need to be mindful of the access they are providing for complex cancer care. It does make a difference.’

—Nabeel Zafar, MD

of the lung, esophagus, stomach, pancreas, colon and rectum.

The researchers identified 67,580 Medicare beneficiaries who met inclusion criteria comprising 14,545 lung resections, 1,833 esophagectomies, 3,567 gastrectomies, 2,132 pancreatectomies, 36,336 colectomies and 9,167 proctectomies.

Medicare Advantage beneficiaries had worse overall survival compared with traditional Medicare when undergoing lung (hazard ratio [HR], 1.07; P=0.002), stomach (HR, 1.12; P=0.035) and pancreas (HR, 1.12; P=0.01) resections.

“Based on these findings, access to high-volume complex cancer surgery should be prioritized in Medicare Advantage plans,” Dr. Sullivan reported.

“Multiple studies in the past have shown that getting complex cancer surgery at a high-volume center is better for the patient’s short and long-term outcomes. This is particularly true for pancreas cancer and esophageal cancer,” said Nabeel Zafar, MD, an assistant professor of surgery at the University of Wisconsin–Madison, who was not involved with the research.

“This study is definitely significant, as it highlights an important aspect of the Medicare Advantage plans and the consequences. While it’s never possible to demonstrate causality in retrospective studies like this, this data is still likely one of the best data sources we have to study this phenomenon. Insurance plans need to be mindful of the access they are providing for complex cancer care. It does make a difference.”

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THE SCIENTIFIC GREATS

GENERAL SURGERY NEWS / JULY 2022

Vivien Theodore Thomas (1910-1985) or the intern Cooley, or next to Taussig at the foot of the operating table. Blalock ivien T. Thomas was a Black mediinsisted Thomas stand at his elbow, on a cal technician who developed a procestep stool where he could see what Blalock dure to treat cyanotic heart disease in the was doing. After all, Thomas had done the 1940s. Although he was not a physician, he procedure dozens of times—Blalock only worked under the direction of Dr. Alfred once, as Vivien’s assistant.

Blalock at Johns Hopkins Hospital, in Finally, after the bulldog clamps were Baltimore. Thomas, who was a carpenter’s clamped off the vessels, blood flow was apprentice, took a temporary job as a laborestored. The anastomosis began to funcratory assistant to Blalock when he was 19 tion, shunting the pure blue blood through years old. The partnership lasted 34 years, the pulmonary artery into the lungs to be and together, the two men would practicaloxygenated. Underneath the sterile drapes, ly invent heart surgery. In those days, heart the patient turned pink. surgery was not only considered taboo, but Almost overnight, dozens of blue babies beyond the reach of any regular surgeon. and their parents came to Hopkins from all Thomas was born in New Iberia. In over the United States and abroad. For the his youth, his family moved to Nashville, next year, Blalock and Longmire rebuilt Tenn., where he was educated in the pubhearts virtually around the clock. lic school system. In 1929, after working Visitors had never seen anything like it. as an orderly in a private infirmary to raise Thomas’ presence in the OR mystified the money for college, his desire to become distinguished surgeons who came from all a doctor vanished with the onset of the over the world to witness the operation.

Great Depression. He lost all his savings.

They could see that the man on the stool In 1930, he decided to take a position at behind Blalock was not an MD. He was Vanderbilt University as an assistant in not scrubbed in as an assistant and he never Blalock’s laboratory. touched the patients. Why did the famous Blalock taught Thomas the intrinsic doctor keep turning to him for advice? details of working at the lab with instruOver time, the blue-baby operation not ments and experimental animals, and only helped save the lives of thousands inspired him to learn and use scientific of similarly afflicted children around the methods to accomplish these difficult tasks. world, but also opened the door to nowBlalock subsequently recognized and realfamiliar procedures like the coronary artery ized that Thomas was a unique individual bypass.

Vivien Thomas (1910-1985) who could learn faster and come up with his Thomas was a member of the medical Work was done on a gray-toned paper, 16 x 20, using graphite, own ideas and inventions. Famous cardiac school faculty from 1976 until 1985, and lumograph and general carbon pencils and white chalk pencil. surgeon Denton Cooley once said: “Viviwas presented with the degree of Honor2022.

Artist: Moises Menendez, MD, FACS en wasn’t even a college graduate. He was ary Doctor of Laws by the Johns Hopkins just so smart, and so skilled, and so much University in 1976. his own man, that it didn’t matter.” Together, Thomas and then anastomosing it into the pulmonary artery.

Following his retirement, Thomas began work on his and Blalock conducted groundbreaking research into the The hypertension studies, as such, “were a flop,” Thom- autobiography. (https://en.wikipedia.org/wiki/Vivien_ causes of hemorrhagic and traumatic shock. The work as said.

Thomas - cite_note-54). He died of pancreatic cancer later evolved into research on crush syndrome that saved Alone in the lab, Thomas set about replicating the on Nov. 26, 1985. the lives of thousands of soldiers during World War II. “blue-baby” defect and performing the subclavian-toThis lifesaving procedure came to be known as the Thomas’ abilities as a surgical assistant and research pulmonary anastomosis in about 200 laboratory dogs. “Blalock–Taussig shunt.” Thomas’ name was omitted. associate were of the highest caliber, and when Blalock He then adapted the instruments for the first human However, in the interest of fairness and to honor the moved to Johns Hopkins in 1941, he asked Thomas to surgery from those used on the experimental animals significant contributions of Thomas, this eponym evenaccompany him. In 1941, the only other Black employ- and coached Blalock through the first 100 operations tually became the “Blalock–Thomas–Taussig shunt.” ■ ees at Johns Hopkins Hospital were janitors. People on infants. As he was working out the final details in the Sources stopped and stared at Thomas, flying down the corri- experimental lab, a frail, cyanotic baby named Eileen Ayd MA. Almost a miracle. Vivien Thomas and Alfred dors in his white lab coat. Visitors’ eyes widened at the Saxon lay in an oxygen tent in the infant ward at the Blalock: Their story has made physicians weep and teenagers sight of a Black man running the lab. It is important to hospital. She had a condition called tetralogy of Fallot, cheer, and this month it comes to television. DOME. Johns remember that much of America was under some form one of the primary congenital defects that lead to blue- Hopkins Medicine. 2003;54(1). https://web.archive.org/ web/20120302102051/http://www.hopkinsmedicine.org/ of segregation in the 1940s. Officially sanctioned or not, baby syndrome. Even at rest, the nine-pound girl’s skin dome/0301/close_up.cfm as a rule, Black individuals did not enjoy the same free- was deeply blue, her lips and nail beds purple. Blalock Brogan TV, George AM. Has the time come to rename the doms as their white counterparts. stated he was going to perform an operation to bring Blalock-Taussig shunt? Pediatr Crit Care Med. 2003;4(4):2003.

In 1942, Dr. Helen Taussig, a Hopkins cardiologist, more blood to Eileen’s lungs.

McCabe K. The remarkable story of Vivien Thomas, the Black went to Blalock and Thomas, looking for help with the Overnight, the tetralogy operation moved from the man who helped invent heart surgery. Published June 19, 2020. cyanotic infants she was seeing. At birth, these babies lab to the operating room. Because there were no nee- Washingtonian.com became weak and turned blue, and sooner or later, all of dles small enough to join the infant’s arteries, Thomas Obituary. Vivien Thomas, pioneer in surgical research, dies. them died. Surely there had to be a way to “change the had to devise sutures and instruments as he had used in The Baltimore Sun. Nov. 27, 1985. pipes around” to bring more blood to their lungs, Tauss- the lab—as well as the lab’s clamps, forceps and right- Schneider D. The invention of surgery: a history of modern ig said. Alone in the lab, Thomas set about to answer angled nerve hooks. On Nov. 29, 1944, the surgery was medicine. Pegasus Books; 2020:36-37.

—Dr. Menendez is a general surgeon and self-taught two questions: Would the Vanderbilt procedure relieve set up for the cyanotic baby. cyanosis? Would infants survive it?

Before the procedure, Blalock called for Thomas to portrait artist in Magnolia, Ark. Since 2012, he has The Vanderbilt procedure involved producing pul- be in the OR, not watching from the gallery or stand- completed a series of portraits of historical figures, monary hypertension in dogs by dividing a major artery ing next to the chief resident, Dr. William Longmire, particularly well-known physicians and surgeons.

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