January 2022 Print issue by McMahon Group

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

January 2022 • Volume 49 • Number 1

Military Surgery: Saving Life, Limb, And Livelihood

The ‘Difficult’ Gallbladder: Approaches to Different Clinical Scenarios

Army Officer Tells Story of How a Forward Surgical Team Saved His Life and Leg

By MONICA J. SMITH

By CHRISTINA FRANGOU

ne minute, he was walking toward the governor’s compound in Asadabad, Afghanistan; the next, Col. Daniel Walrath was sprawled on the ground, engulfed in a cloud of dust. He felt a searing pain in his left leg. That morning of Aug. 8, 2012, as Col. Walrath and his colleagues headed to a security meeting with the provincial governor, a Taliban insurgent wearing an explosive vest stepped into their path and detonated his device—killing himself, another member of the Taliban and four Americans. Col. Walrath, who was leading the 2nd Brigade Combat Team of the 101st Airborne Division of the U.S. Army, was knocked to the ground by the blast. Unsure of what might come next, he crawled into a Continued on page 14

Col. Daniel Walrath, seven weeks after being injured by an IED, uses a walker at Walter Reed National Military Medical Center.

aparoscopic cholecystectomy, one of the most commonly performed and straightforward operations for the general surgeon, usually comes off without a hitch. But difficult cases of acute cholecystitis can quickly turn morbid, and management varies dramatically from patient to patient. “Cholecystitis is thought to be a disease process that all general surgeons can take care of—there’s an expectation that it should go well every time,” said Michael Martyak, MD, an assistant professor of surgery at Eastern Virginia Medical School, in Norfolk. “But with the increasing number of patients with comorbidities such as obesity and diabetes, and patients who struggle with access to care who present for evaluation in a delayed fashion, sometimes surgical management can be difficult.” At the 2021 virtual American College of Surgeons Clinical Congress, Dr. Martyak and other experts in the treatment of acute cholecystitis discussed alternative approaches to difficult gallbladders, considerations for the sickest patients, and how to manage the most dreaded complication: common bile duct injury (CBDI). Continued on page 22

Opioid Prescribing for Safe, Mesh Removal: How Effective Postsurgical Pain Much Does Surgical Management Approach Matter?

OPINION

Maybe It’s Cheaper To Pay Your Doctor By P PAULA MU TO, MD, FACS

By KAREN BLUM

By KATE O’ROURKE

marter prescribing of opioids following surgery can help prevent dependence and overuse of these drugs, panelists said at the 2021 virtual American College of Surgeons Clinical Congress. “As surgeons, it’s important that we understand what our role is in the opioid epidemic,” said Bridget Fahy, MD, FACS, a professor of surgery and the chief of surgical oncology at the

ur health care system is a disaster and getting worse by the day. No one seems to be satisfied, patients complain about the cost, doctors complain about paperwork, employers are tapped out and politicians try to avoid the subject. The only folks who are benefiting from the broken system are the ones in the middle who

Continued on page 15

Continued on page 24

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IN THE NEWS

6 Top Surgical Papers of Last Year Reviewed

REPORT

10 Black Women and Breast Cancer L E T TERS TO THE ED I TO R

20 Responses to “The Most Harm” Opinion Article From Last Month

The Landmark Signia™ Stapling System See Insert After Page 15

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oes surgical approach matter for inguinal hernia mesh removal? At the 2021 annual meeting of the Americas Hernia Society (abstract 50176), researchers of a new study sought to answer this question. The study led by Desmond Huynh, MD, a PGY-4 general surgery resident at Cedars Sinai, in Los Angeles, included 113 patients, 39 of whom had open, 23 of whom had laparoscopic and 51 of whom had robotic mesh removal. Approach was based on

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JANUARY 2022 / GENERAL SURGERY NEWS

GSN’s

Best-Read Stories of 2021

The following is a list of the 10 most-read articles on our website in 2021. You can access these and other top-read stories by visiting generalsurgerynews.com. Registration is easy and free for both the website and our weekly e-newsletters. Go to generalsurgerynews.com/manage-account.

1 Surgery Is a Contact Sport Published in September bit.ly/3Fif30C Opinion by Talar Tejerian, MD I was just another surgeon suffering the same spine problems that so many before me had suffered. If I am not the first, then I surely will not be the last. We must stop ignoring surgeons’ physical health and actively promote prevention.

2 The History of RoboticAssisted Surgery Published in September bit.ly/3smj14z Opinion by Edward L. Felix, MD The pathway by which robots became surgical assistants in today’s operating theater was sometimes tortuous and arduous. It is worth reviewing to understand how we as surgeons may continue to develop and change the future.

3 Robotic Surgery: ‘Déjà Vu All Over Again’ Published in March bit.ly/3zutv3u Opinion by Edward L. Felix, MD You may wonder what prompted my

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

“déjà vu” experience and made me review some of the less remembered history of MIS described here. It was the battles that I recently witnessed on social media surgical platforms and in the recent surgical literature..

4 The Most Harm Published in November bit.ly/3GXoq61 Opinion by Miguel Lopez-Viego, MD It is now common in our academic programs for senior-level general surgery residents and postgraduate fellows to find themselves standing in our nation’s operating rooms, functioning as observers, while the teaching attending does all the critical parts of even the most routine operations, often delegating only administrative and assistant tasks to the trainee.

5 Court Ruling Alters Informed Consent Process Published in April bit.ly/3mkmxZz A four-year-old ruling by the Pennsylvania Supreme Court is making doctors and researchers across the country

change the way they obtain patients’ informed consent. Many are concerned that the landmark decision, Shinal v. Toms, leaves them vulnerable to legal action if a physician delegates informed consent to another member of the patient’s care team.

Published in June bit.ly/3e8nDTo Many general surgeons have only six weeks or so of training in bariatric surgery during residency, but they are likely to encounter post–bariatric surgery patients who will need their help.

6 The History of Inguinal Hernia Surgery

9 Will CODA Trial Results Change Surgeons’ Approach to Appendicitis?

Published in August bit.ly/3eb37li Opinion by Edward L. Felix, MD The purpose of this review is to aid the modern hernia surgeon in the quest to perform a better inguinal hernia repair, no matter the choice of approach.

7 New Device Takes Robotics in Smaller, Simpler Direction Published in January bit.ly/3yNdeX4 We’ve glimpsed a possible future of robotic surgery, and it’s just slightly larger than a bread box.

8 The Post-Bariatric Patient With Complications

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

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Marina Kurian, MD New York, NY

Maurice Arregui, MD Indianapolis, IN

Raymond J. Lanzafame, MD, MBA Rochester, NY

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

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James Forrest Calland, MD Charlottesville, VA

John Maa, MD San Francisco, CA

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Published in December bit.ly/3FecDjf In the largest study of surgery versus antibiotics for appendicitis, almost half of patients who received a single course of antibiotics did not require an appendectomy by four years.

10 Eliminating 24-Hour Call: Does It Work? Published in June bit.ly/3mkCn6c Physicians have long debated the impact of work-hour duration on patient safety and provider well-being, but few institutions have made the leap and deviated from the traditional 24-hour trauma call model. ■

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IN THE NEWS

GENERAL SURGERY NEWS / JANUARY 2022

Rates of Cholecystectomy for Gallbladder Pancreatitis Low

Hernia Recurrence Remains High, Requiring Frequent Surgery

By ETHAN COVEY

dherence to best practices for cholecystectomy in patients with gallstone pancreatitis is low and has not changed significantly since the late 1990s, despite strong clinical evidence and multiple practice guidelines. Additionally, gaps in care exist across the United States, highlighting the need for improved implementation efforts. “Numerous national and international guidelines recommend cholecystectomy during the index admission,” said James C. Etheridge, MD, a general surgery resident at Brigham and Women’s Hospital, in Boston. “A growing body of evidence shows the operation can be safely performed within 48 hours of admission, regardless of symptomatic or biochemical improvement. This reduces length of stay with no discernible effect on mortality, perioperative complications or technical difficulty.” The study used data from the National Inpatient Sample to identify patients admitted to hospital for gallstone pancreatitis from 2015 to 2018. From a total of 163,390 annual admissions for gallstone pancreatitis, 56% underwent same-admission cholecystectomy. This group of patients was generally younger, female, had fewer comorbidities and less severe disease, and the procedure was more common in urban hospitals, teaching centers and the southern part of the country. Only 27% of patients underwent cholecystectomy within 48 hours of admission. “This finding is unsurprising,” Dr. Etheridge said. “Nonetheless, it does indicate that there is room to improve the timelines, efficiency and cost-effectiveness of surgical care for gallstone pancreatitis. “To maximize the public health value of evidence-based practices for gallstone pancreatitis, active implementation efforts are necessary,” Dr. Etheridge added. “In addition, the fact that patients in small and rural hospitals were less likely to receive same-admission cholecystectomy may indicate that limited surgical capacity is a barrier. Future efforts should identify specific approaches to overcome barriers and leverage facilitators for timely surgery.”

ong-term outcomes of ventral and incisional hernia repair (VHR) remain poor, with nearly one in six patients requiring reoperation for hernia recurrence over a 10-year period. Additionally, multiple followup operations are common, with nearly 20% of patients requiring two or three reoperations. “VHR is a very common elective operation, with over 350,000 cases performed each year in the U.S.,” said Ryan Howard, MD, a surgery resident at the University of Michigan Medical Center, in Ann Arbor. “Unfortunately, a proportion of patients who undergo VHR ultimately develop a recurrence of their hernia.” Hernia recurrence can be a devastating outcome, and it has been associated with poor quality of life, functional disability, chronic pain and increased risk for life-threatening complications. Previous studies have shown that rates of recurrence are high, but contemporary recurrence rates are less clear. “Surgical technique and patient selection have changed dramatically over the past decades,” Dr. Howard said. “However, longterm population studies have been lacking.” In an effort to clarify current rates of recurrence, Dr. Howard and his colleagues conducted a retrospective review of Medicare claims to identify patients who underwent VHR from 2007 to 2018. A total of 175,735 patients were identified, 76% of whom had open VHR surgery, 20% laparoscopic and 4% robotic. Mesh was used

in 49% of cases, and myofascial flap creation was used in 10% of cases. The surgical approach changed over time, with minimally invasive (laparoscopic or robotic) techniques being used in 32% of cases in 2018, compared with 2% in 2007. Repair technique also changed, with mesh use increasing from 63% in 2007 to 76% of cases in 2018, and myofascial release increasing from 2% of cases in 2007 to 20% in 2018. Overall, 14.3% of patients underwent hernia reoperation within 10 years. Of this group, 79.4% required just the single reoperation. However, 19.1% of patients needed two or three additional operations, and 1.6% of patients underwent four or more reoperations. Using a Cox proportional hazards model, the adjusted cumulative incidence of hernia reoperation at 10 years was 16.2%. Interestingly, the cumulative incidence of reoperation at one, three and five years after the original operation was highest for patients who underwent VHR from 2007 to 2009, and lowest among those who had the surgery most recently, potentially showing that the increasing use of minimally invasive techniques and myofascial release may improve outcomes. Despite this trend, currently far too many patients are requiring follow-up operations after the first VHR. “Long-term outcomes after this common operation still remain poor,” Dr. Howard said. “Additional efforts, likely targeting patient selection and surgical decision making, are also needed to improve the care of patients with ■ VHR.”

OPINION

My y Vanishing Bookshelves By F FREDERICK L. GREENE, MD

hroughout my surgical career, I have loved collecting books and holding onto them. Books are meaningful and serve as opportunities to remember and reflect on the various facets of my educational, private practice and academic surgical careers. Journals, too, found a way onto my bookshelves and served as reference material and educational updates way before Google and other internet search engines appeared. How many of you remember poring through Index Medicus searching for that important reference? I was always ecstatic when I found it in that journal on my bookshelf. Fortunately, that method of searching for references is in our rearview mirror! My problem has been an inability to dispose of a journal once I had perused it. For many journals, every printed copy was precious and, in my mind, would serve as a helpful reference if I ever needed it. I had begun receiving The New England Journal of Medicine as a second-year medical student, and for the next several decades, I kept every weekly edition and dutifully had each volume bound and imprinted with my initials.

Eventually, I realized this was not healthy and would lead to my being a selectee on the television show dealing with hoarders! Once I stepped away from my clinical practice, I realized that the monographs and journals that I had amassed over years might need a different home. My wife felt the same way! Fortunately, my hospital library was willing to accept my bound journal collections. I found several websites that would serve as repositories for scientific books in order to supply medical libraries in economically challenged countries. One of my other giving opportunities came in the form of our surgical residents who appreciated having a surgical textbook, even though their primary reference sources were online monographs and UpToDate. Giving books to surgical residents is such a joy for me and hopefully has been as meaningful to them. I am also fairly certain that future generations of surgeons will not have the same angst over their books and journals as I have had; there will be no printed medical books and journals! Many of our medical and surgical journals have already gravitated entirely away from the print model in favor of online publications. The latest example, the Journal of the American College of Surgeons, using a new publisher, will be circulated entirely electronically beginning

this month. I suspect many more journals will follow suit. Regarding monographs, our surgical residents and clinical surgeons will most likely only subscribe to e-books capable of downloading to their favorite technology platform. There will be very little incentive for the expense of printing and mailing traditional texts. So, as I continue to downsize my printed volumes, it is with a sense of nostalgia, but also a realization that the publishing world has changed. Perhaps even bookshelves will become anachronistic! Just as we all have experienced over the last two years, we can exist in a virtual world! Even General Surgery News is available in a virtual format, but I do look forward to receiving my print edition of GSN and enjoy cradling it in my hands each month. I hope the opportunity for that experience never goes away! Happy 2022 to you and your families. ■ —Dr. Greene is a surgeon in Charlotte, NC.

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IN THE NEWS

GENERAL SURGERY NEWS / JANUARY 2022

Top Surgery Papers Reviewed at Regional Society Meeting Topics Include Surgical Oncology, Trauma and Colorectal Cancer By MONICA J. SMITH

ATLANTA—Presenters at the Southeastern Surgical Surgical Congress’s Top Papers session are asked to perform form no small feat: Identify the past year’s most outtstanding papers in their disciplines and describe them in 10 minutes or less. What they found for 2020-2021 clarified treatments for some of the deadliest cancers, challenged long-held standard practices, and presented a new way to stay on the cutting edge of research.

Surgical Oncology Breast Cancer Sherry Wren, MD, a surgeon who specializes in gastrointestinal operations, not breast cancer, selected a paper that confirmed the superiority of lumpectomy with radiation over mastectomy for most patients. “This paper really capped off the debate that’s been going on for 20-plus years,” said Dr. Wren, a professor of general surgery at Stanford University School of Medicine, in California. The study, which included 48,986 patients over a sixyear follow-up, confirmed the superiority of breast conservation surgery with radiation over mastectomy with both an overall and a breast cancer–specific relative survival gain of 56% to 70% in node-negative patients. This association remained true in women with low-burden node–positive, but not high-burden node-positive, disease (JAMA Surg 2021;156[7]:628-637). “Because there was no inferior survival from breastconserving surgery and radiation, this shows that there’s no reason to advocate for mastectomy unless a patient has some other significant risk factor, like a strong family history or gene mutations. This also adds doubt to the routine practice of offering mastectomy,” Dr. Wren said. Pancreatic Cancer Researchers at Mayo Clinic aimed to clarify the optimal timing for total neoadjuvant therapy (TNT) and chemoradiation in patients with borderline resectable or locally advanced pancreatic ductal adenocarcinoma by identifying factors associated with morbidity, death and survival in these patients (Ann Surg 2021;273[2]:341-349). “TNT has been most talked about in rectal cancer, and now is expanding to pancreatic tumors with no consensus on the protocol to use,” Dr. Wren said. The final analysis included 231 borderline resectable patients (using Alliance criteria); 85% were treated with folfirinox, 34% got gemcitabine/nab-paclitaxel (GA) and 19% switched regimens. The median number of cycles was six, with 37% having eight or more. Ultimately, the investigators found three factors associated with longer survival: extended chemotherapy (at least six cycles), optimal post-chemotherapy CA19-9 response and a strong pathologic response. “Overall, the radiolographic downstaging rate was 28%, and there was no association with any chemotherapy regimen,” Dr. Wren said. “When you look at survivorships, the three-year recurrence-free survival was 62%, which is really respectable for pancreatic ductal adenocarcinoma, again showing how neoadjuvant has really changed our field.”

Surgical Oncology Resources for Surgical Trainees Lastly, Dr. Wren shared resources she has found particularly helpful for surgical trainees: NCCN.org, “which will walk you through how to work up, stage, treat and surveil almost every cancer,” and the Toronto Video Video Atlas of Surgery, “a free resource that help helps you plan and learn through videob based modules the operative approach to many procedures.” Also, a novel approach to look up any research currently being conducted that may have an impact on pancreatic cancer outcomes: the living Evidence Map of Pancreatic Surge gery (www.evidencemap.surgery). “T “This is something you can download as an app (EVIglance) and it’s an unbelievable resource— it’s really a way of democratizing all of the data going on out there and putting it on your phone,” Dr. Wren said. The researchers intend to expand into other disease states. For now, Evidence Map covers only pancreatic cancer.

Trauma Hard Signs of Extremity Vascular Injury Trauma surgeons have long relied on hard signs (absent distal pulse, distal ischemia, active hemorrhage and others) to decide whether to operate on extremity vascular trauma, said S. Rob Todd, MD, in introducing the research titled “Hard signs gone soft: a critical evaluation of presenting signs of extremity vascular injury” (J Trauma Acute Care Surg 2020;90[1]:1-10). “The study objective was to determine if the hard signs we currently use in deciding the need for surgery are still appropriate today,” said Dr. Todd, the chief of acute care surgery at Grady Memorial Hospital, in Atlanta. Analyzing data from 1,910 patients in the American Association from the Surgery of Trauma registry identified as having vascular injury, they found patients without hard signs were more likely to be diagnosed by computed tomography angiography (CTA), whereas those with hard signs were more likely to be diagnosed via operative exploration. There was no difference between the CTA and exploration groups in terms of amputation, reintervention, hospital length of stay or mortality. “In conclusion, the authors state that the hard signs of vascular injury have significant limitations, and that hemorrhagic and ischemic signs provide far greater clinical utility,” Dr. Todd said. Traumatic Intracranial Hemorrhage Dr. Todd’s second top paper, an investigation of platelet transfusions in patients with traumatic intracranial hemorrhage, also challenged a long-held practice backed by little data (J Trauma Acute Care Surg 2020;88[6]:847-854). “The researchers asked three questions: In patients with traumatic intracranial hemorrhage on pre-hospital antiplatelet therapy, did platelet transfusion improve mortality, reduce the progression of hemorrhage or reduce the need for neurosurgical intervention?” They found no decrease in all-cause mortality in patients who received platelet transfusion. In fact, there was an increased odds ratio for death, 1.29. There was also no difference in hemorrhage progression or decrease in neurosurgical intervention when patients received platelet transfusion.

“The authors did provide the caveat that a small subset of the population might benefit from platelet transfusion; however, the data were insufficient to ascertain that,” Dr. Todd said.

Colorectal Cancer Total Neoadjuvant Therapy and Rectal Cancer Paul Rider, MD, the chief of the Division of Colorectal Surgery at the University of South Alabama, in Mobile, chose only one trial to discuss, but it is an important one: the RAPIDO trial (Rectal cancer And Perioperative Induction therapy followed by Dedicated Operation), which investigated TNT in patients with rectal cancer (Lancet Oncol 2021;22[1]:29-42). “In my practice, I’ve had to delay surgery because of the risks of doing major operational interventions during the COVID-19 pandemic. This paper helped me make better decisions and have a stronger platform to stand on in regards to taking care of patients with rectal cancer,” Dr. Rider said. The trial included patients with newly diagnosed, high-risk adenocarcinoma of the rectum, cancers classified as cT4a/b—a particularly challenging population. “Vascular invasion, nodal positivity, involved mesorectal fascia, enlarged lateral lymph node—patients had to have at least one of those, and there were a few that had two, less that had three or four,” Dr. Rider said. The 462 patients in the experimental arm received short-course radiotherapy (five fractions ✕ 5 Gy, 25 Gy), followed by chemotherapy in six or nine cycles depending on the agent, and then surgery two to four weeks after completion. The 455 patients in the control arm received standard of care.

‘In my practice, I’ve had to delay surgery because of the risks of doing major operational interventions during the COVID-19 pandemic. This paper helped me make better decisions and have a stronger platform to stand on in regards to taking care of patients with rectal cancer.’ —Paul Rider, MD In the experimental arm, 128 patients (23.7%) achieved the primary end point of disease-related treatment failure at three years, compared with 30.4% in the control arm. “That doesn’t sound like much. But in essence you’re getting around 6% or 7% in a population that does poorly one-third of the time. So, it’s a pretty good finding,” Dr. Rider said. Many of the secondary end points did not reach statistical difference, but the difference in pathologic complete response, which was 14% in the control arm and 28% in the experimental arm, was highly significant (P=0.0001). Dr. Rider acknowledged a major criticism of the paper, which is that the investigators changed their primary end point, which was originally disease-free survival. “But they realized that in a neoadjuvant study, some people are never disease-free. So they changed it to disease-related treatment failure, and I think that’s OK when you consider the value of the study and that ■ they recognize they made an error,” he said.

IN THE NEWS

JANUARY 2022 / GENERAL SURGERY NEWS

Dedicated Emergency General Surgery Service Can Reduce Complications, Study Shows By MONICA J. SMITH

ATLANTA—Establishing a dedicated emergency general surgery service line may reduce complication rates, particularly among the common emergency general surgery procedures most prone to issues, according to new research. More than 3 million people are admitted to U.S. hospitals every year with EGS diagnoses, nearly 30% of which require surgery. Although EGS patients comprise only 11% of all surgical admissions, they account for nearly 50% of surgical mortality, with up to an eightfold increase in the risk for postoperative death compared with patients undergoing comparable elective procedures. “In fact, one study found EGS to be a risk factor for death independent of patients’ preoperative comorbid conditions and physiologic status,” said Morgan Roberts, MD, a general surgery resident at the University of South Alabama (USA) Medical Center, in Mobile, speaking at the 2021 Southeastern Surgical Congress. According to a study by Scott et al, seven procedures make up the greatest burden of EGS cases: partial colectomy, cholecystectomy, appendectomy, small bowel resection, laparotomy, lysis of peritoneal adhesion and operative management of peptic ulcer disease (JAMA Surg 2016;151[6]:e160480). “Together, these procedures account for not only 80% of EGS procedures but also 80% of postoperative complications, patient cost and death,” Dr. Roberts said, noting that this distinction allowed for a more quantifiable way to assess the functionality of EGS service. Around the same time the Scott et al study was published, USA Medical Center established a comprehensive in-house EGS service led by a dedicated division director. They assigned call in five-day blocks with attending surgeons available in 12- to 24-hour stretches; this call included only acute care surgeons who were exempt from outpatient responsibilities. To test their hypothesis that implementation of a dedicated EGS service would reduce morbidity and improve outcomes, Dr. Roberts and her colleagues used the subset of seven operations identified by Scott et al to compare their institution’s outcomes before and after establishing the EGS service. In all, 718 patients who underwent one of the seven procedures between January 2013 and May 2019 met the inclusion criteria of being nontraumatic, nonelective cases performed primarily by a general surgeon within 48 hours of presentation. The patients were divided into

More than 3 million

people are admitted to U.S. hospitals every year with EGS diagnoses, nearly 30% of which require surgery. Although EGS patients comprise only 11% of all surgical admissions, they account for nearly 50% of surgical mortality, with up to an eightfold increase in the risk for postoperative death compared with patients undergoing comparable elective procedures.

two cohorts: 409 in the pre-EGS service group and 309 in the established EGS service group. The primary outcome was the overall complication rate following each of the seven types of procedures. “We found that 19% of patients in the pre-EGS group experienced postoperative complications, while only 13% of patients in the post-EGS group experienced a postoperative complication, continued on the following page

MORE THAN 8 MILLION ADULT PATIENTS HAVE RECEIVED EXPAREL SINCE 20121

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

74%

fewer opioids

31%

were used over 3 days in laparoscopic colorectal surgery2*†

faster return to bowel function

in open ventral hernia repair (P <0.001)3

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

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

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

06/21

IN THE NEWS

Dedicated EGS continued from the previous page

representing a statistically significant decrease,” Dr. Roberts said. The primary driver of this decrease was the 10% to 3% reduction in complications after cholecystectomy, which made up about 54% of EGS procedures both before and after implementation of the EGS service; the remainder of operations demonstrated nonsignificant decreases in complications. The researchers also evaluated a number of secondary end points, mainly postoperative mortality, time to operation

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

GENERAL SURGERY NEWS / JANUARY 2022

from initial presentation, frequency of overnight operations and length of stay. “We found a significant increase in overnight operations performed, from 7% in the pre-EGS group going to the OR between 6 p.m. and 6 a.m., to 16% in the post-EGS group undergoing overnight surgeries,” Dr. Roberts said. Changes in other secondary end points achieved statistical significance. Katherine Kelley, MD, of Kelley Acute Care Surgery in Pocono Lake, Pa., noted that Dr. Roberts’ research is consistent with prior studies showing benefits from an acute care surgery model. “As an acute care surgeon, I appreciate the support,”

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

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

Dr. Kelley said. But she questioned why patients who went into surgery more than 48 hours after presentation were excluded from the study. “I would expect that if you included these patients, you might see a more significant improvement in your time [in the] OR. Also, how many of each type of complication were seen? To me, there is a large clinical difference between my patients developing deep vein thrombosis as opposed to a cardiac arrest, sepsis or surgical site infection, and I would be interested to see this breakdown,” Dr. Kelley said.

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

Regarding the 48-hour cutoff, Dr. Roberts explained that their study was based on the Scott et al study, which used that same cutoff. “This was done largely to exclude nonoperative admissions and to look specifically at the quality of surgical intervention these patients were receiving.” She acknowledged Dr. Kelley’s point about the difference between complications such as wound infection and respiratory failure. “But there was actually no difference in any of the individual complications, only in the overall complication rate; I suspect this has to do with power in that there were not a large number of individual complications,” Dr. Roberts said. ■

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

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

5,766,627

8,182,835

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

March 2021

IN THE NEWS

JANUARY 2022 / GENERAL SURGERY NEWS

Elacestrant Impresses in EMERALD Trial of Breast Cancer By KATE O’ROURKE

ew research from the EMERALD trial shows that elacestrant (Radius Health) is the first oral selective estrogen receptor degrader to demonstrate a statistically significant and clinically meaningful improvement in progression-free survival versus standard-of-care endocrine therapy, in breast cancer. The findings come from a phase 3, randomized trial in men and postmenopausal women with estrogen receptor (ER)-positive/HER2-negative metastatic breast cancer in the second- and third-line postCDK4/6 inhibitor setting. The data were reported at the 2021 San Antonio Breast Cancer Symposium (abstract GS2-02). Compared with patients who received standard of care (n=229), patients who were given elacestrant (n=237) had a 30% reduction in the risk for progression or death (P=0.0018). In patients with mutations in ESR1, there was a 45% reduction in the risk for progression or death with elacestrant (n=115) compared with standard of care (n=113) (P=0.0005). In the total population, those who received elacestrant had a higher PFS at six months (34.3% vs. 20.4%) and 12 months (22.3% vs. 9.4%). In patients with mutations in ESR1, those who received elacestrant also had a higher PFS at six months (40.8% vs. 19.1%) and 12 months (26.8% vs. 8.2%). All subgroups of patients benefited from elacestrant. Overall survival data were not mature for analysis, but researchers identified a trend favoring the patients who were treated with elacestrant. Elacestrant was well tolerated with a predictable and manageable safety profile consistent with other endocrine therapies. The most common side effect with elacestrant was all-grade nausea at 35% compared with 18.8% for standard of care. There were no other major differences in adverse events between patients who received elacestrant or standard-ofcare endocrine therapy. “Oral [selective estrogen receptor degraders] have the potential to become a new treatment option in metastatic breast cancer,” said Aditya Bardia, MD, MPH, the director of breast cancer research and the attending physician at Mass General Cancer Center, and an assistant professor at Harvard Medical School, both in Boston. “Further elacestrant combinations in early lines with other targeted therapies including CDK4/6 inhibitors and mTOR inhibitors are ongoing and planned for patients with ER-positive, HER2-negative breast cancer.” Dr. Bardia, who presented the results at a press conference, said although endocrine therapy plus a CDK4/6 inhibitor is the mainstay for the management of

ER-positive/HER2-negative metastatic breast cancer as first-line therapy, most patients eventually experience disease progression often involving mutations in ESR1. In the post-CDK4/6 inhibitor setting, standard of care is single-agent endocrine therapy: fulvestrant (Faslodex, AstraZeneca) or an aromatase inhibitor. Commenting on the presentation, Carlos Arteaga, MD, the director of the Simmons Comprehensive Cancer Center at UT Southwestern Medical Center, in

Dallas, said: “The results clearly suggest that this new [selective estrogen receptor degrader] may become a new treatment option for patients with breast cancer, not only as a single therapy, but also in combination with other targeted therapies.” ■ Dr. Bardia reported consultancy/advisory board relationships with AstraZeneca/ Daiichi Sankyo, Eli Lilly, Foundation Medicine, Genentech/Roche, Immunomedics, Merck, Novartis, Pfizer, Radius Health

and Sanofi, and research grants from AstraZeneca, Daiichi Sankyo, Eli Lilly, Genentech/Roche, Immunomedics, Merck, Natera, Pfizer, Radius Health and Sanofi. Dr. Arteaga reported grant support from Eli Lilly, Pfizer and Takeda; service as a scientific advisor to Arvinas, AstraZeneca, Athenex, Daiichi Sankyo, Eli Lilly, Immunomedics, Merck, Novartis, Susan G. Komen Foundation and Taiho Oncology, and ownership of minor stock options in Provista.

IN THE NEWS

GENERAL SURGERY NEWS / JANUARY 2022

Black Women and Breast Cancer: Experts Discuss Shortcomings in Care By CHRISTINA FRANGOU

lack women have more aggressive breast cancer at a young age than other women, and they’re more likely to die at a young age from these cancers. But they don’t have the same opportunities for screening, genetic testing, treatment and clinical trial participation, experts in oncology reported during a panel session at the 2021 Clinical Congress of the American College of Surgeons. The speakers called on all health care providers involved in women’s cancer to improve care for Black women and their families. “African American women are being deprived of maximum utilization of technologies [that can improve breast cancer outcomes],” said Lisa Newman, MD, MPH, the director of the breast program for the Weill Cornell Medicine/NewYork-Presbyterian Hospital Network, in New York City, during a press briefing at the Clinical Congress. “That’s on us—this is the responsibility of oncology providers,” she said.

Risk Assessment at Age 30 Black women face barriers at every stage of breast cancer diagnosis and treatment, and the effects ripple through their families and communities, panelists said. Debra Monticciolo, MD, a past president of the American College of Radiology and the section chief of breast imaging at Baylor Scott & White Medical Center – Temple, in Texas, said all Black women should undergo a risk assessment for breast cancer by 30 years of age. If the assessment suggests they’re at high risk for cancer, they should undergo supplemental screening, she said. “Waiting until 45 or 50 is not good for any woman, but it’s a disaster for women of color and especially for Black women,” Dr. Monticciolo said. Black women are at higher risk for aggressive cancers at younger ages, research shows. A study from Dr. Monticciolo and her colleagues found that nonHispanic Black women have a 45% higher risk for invasive cancers before age 50 than non-Hispanic white women (Cancer 2021;127[3]:4384-4392). Asian American/Pacific Islander, Native American and Hispanic women also have higher rates of early invasive cancers than white women, the study showed. Minority women are 127% more likely to die from breast cancer before they are 50 years old compared with white women, according to the study. Another study showed that Black women have a nearly threefold increased risk for triple-negative breast cancer (Cancer Med 2021;10[18]:6456-6467). As a result of the growing evidence, the American College of Radiology and Society of Breast Imaging have updated their breast cancer screening recommendations to highlight the heightened risk for Black women and other women of color (J Am Coll Radiol 2021;18[9]:1280-1288). The organizations want annual mammography screening beginning at 40 years of age for all women, but noted that delayed screening will disproportionately harm women of color.

Black Women Rarely Referred for Genetic Testing Black women do not receive enough referrals for genetic counseling and testing, said Tuya Pal, MD, a

geneticist and the Ingram Professor of Cancer Research at Vanderbilt-Ingram Cancer Center, in Nashville, Tenn. Only 36% of Black women underwent BRCA testing compared with 69% of white women in a populationbased sample of women in Florida diagnosed with invasive breast cancer at 50 years of age or younger, in a study by Dr. Pal and her colleagues (Cancer 2017;123[13]:2497-2505). Health care providers often fail to suggest genetic testing to Black women, who were 16 times less likely to receive a referral for genetic testing, the analysis showed. This gap was consistent for women treated across the state, regardless of the size and location of the clinic, according to the study. “There is something systemic going on here where these women are not being told or referred for genetic testing,” Dr. Pal said. If genetic testing confirms that a Black woman has a BRCA mutation, she’s also less likely to receive care that will reduce her cancer risk. Black women with a BRCA mutation were less likely to undergo risk-reducing salpingo-oophorectomy compared with Hispanic and non-Hispanic white women after controlling for clinical and demographic variables, the study showed. Dr. Pal said the consequences of low genetic testing rates extend beyond the immediate patient. Women’s families will not know about their risk. In addition, a lack of genetic information from Black communities affects the quality of risk assessment tools used to guide patient care, Dr. Pal said. Black, Asian and South Asian women are underrepresented in genome-wide association studies, which find associations between genetic variations and particular diseases, and they are used for polygenic risk scores that estimate a person’s risk for cancer. “If we don’t have data on Black women, these risk prediction models do not work well in these women,” Dr. Pal said.

Underrepresented in Phase 3 Trials Black women are disproportionately left out of research that guides cancer treatment decisions, said Oluwadamilola Fayanju, MD, MPHS, the chief of breast surgery and surgical director of Rena Rowan Breast Center, in Philadelphia. Black and Hispanic patients are 20% to 50% less likely to participate in clinical trials, she said. But the situation is more complicated than simple underrepresentation, she added. Black and Latinx individuals tend to be overrepresented in phase 1 trials, which have the highest risk but lowest likelihood of personal benefit for participants. Conversely, they are underrepresented on the other end of the clinical trial continuum, the phase 3 trials with the greatest likelihood of personal benefit. As a result, Black women are being treated with therapies and strategies that have rarely been tested on them, even for cancers that are disproportionately more common in women of color, such as triple-negative breast cancer, Dr. Fayanju said. “We are in danger of potentially not treating breast cancer in those who have some of the most aggressive

‘We are in danger of potentially not treating breast cancer in those who have some of the most aggressive forms of disease, but also endangering our ability to better understand these diseases and better treat them across all kinds of people.’ —Oluwadamilola Fayanju, MD, MPHS

forms of disease, but also endangering our ability to better understand these diseases and better treat them across all kinds of people,” she said. If more women of color were involved in breast cancer trials, researchers and clinicians would better understand the pathophysiology of the disease, she said. She pointed out that multiple complex factors contribute to under-participation in trials. For instance, high-income Black patients were 50% less likely to participate in trials than low-income Black patients, she said. She urged researchers to employ multipronged strategies to improve trial participation. Surgeons and researchers who are involved in clinical trials must proactively reach out to diverse populations, she said. “The truth of the matter is many people who are involved in clinical investigation have never thought about disparities in research other than simply reporting racial and ethnic differences,” she said. She said the Henrietta Lacks Enhancing Cancer Research Act, which was signed into law on Jan. 5, 2021, may improve representation in trials. The legislation requires the federal government to conduct a review of government-funded cancer research trials, including participation by underrepresented populations and the barriers to participation.

Professional Organizations and Insurance Companies Have Role Several panelists said they hope the American Medical Association will take a lead position in raising awareness about the heightened risk and poor outcomes among Black women with breast cancer. Anita T. Johnson, MD, the chief of surgery and director of breast oncology at Cancer Treatment Centers of America, in Atlanta, said insurance companies need to cover screening, testing, counseling and care related to breast cancer risk for Black women. She said these changes will improve cancer outcomes across the population. “Once we fix this issue for Black women, we fix it for all women,” she said. “We fix the late-stage disease presentations, the incidence of triple-negative breast cancer as well as the lack of screening for genetic mutations in people of color.” ■

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Safe Opioid Prescribing for Post-op Pain continued from page 1

University of New Mexico Health Sciences Center, in Albuquerque. Opioids are prescribed in 80% of surgical procedures, Dr. Fahy said. Approximately 6% of opioid-naive patients are prescribed opioids after minor procedures, and will continue using them three to six months later. Of long-term opioid users, 27% received their original prescription after surgery and have a substantially increased risk for opioid dependence and use disorder. Surgeons should use different opioid prescribing strategies related to patient characteristics, said Melissa Red Hoffman, MD, ND, FACS, an acute care surgeon at Mission Hospital and an inpatient hospice physician at the John C. Keever Solace Center, both in Asheville, N.C. Care providers should be mindful about opioid prescribing in patients who are naive to treatment and undergoing uncomplicated elective operations, she said. “The risk of transitioning from shortto long-term use begins to increase after the fifth day of exposure,” Dr. Hoffman said. “Patients who receive a five-day supply of opioids have a 7% chance of continued opioid use at one year.” Preoperative management for these patients should include setting expectations about postoperative pain; discussing usual opioid consumption; and providing instructions on use of nonopioid pain medication and safe opioid use and disposal, she said. Perioperative care can incorporate acetaminophen (1 g preoperatively), infiltration of port sites with lidocaine, 30 mg of IV ketorolac given at the end of the procedure, and just telling post-acute care nurses to give opioids sparingly. At discharge, Dr. Hoffman said, set expectations regarding postoperative pain and ensure patients have options to contact the team with questions. Instruct patients to take acetaminophen and ibuprofen on a scheduled basis for at least 72 hours. If prescribing opioids, use recommendations established by the Michigan OPEN (Opioid Prescribing Engagement Network). Patients should take opioids only for breakthrough pain during the first 24 to 48 hours after surgery. For patients on long-term opioid therapy, verify the home opioid dose using your state’s prescription drug monitoring program (PDMP), Dr. Hoffman said. It is appropriate to continue established opioid medications throughout the hospital stay. However, that dose likely will not be enough to control any additional acute surgical pain. Multimodal analgesia should be used. If a patient cannot tolerate oral medications, consider converting

to IV dosing of the home opioid or its equivalent. At discharge, if opioids are needed for acute pain, inquire whether the patient has a pain contract, she advised. If so, contact the patient’s pain physician to discuss the need for additional opioids. For patients taking more than 50 morphine milligram equivalents (MMEs) per day, consider coprescribing naloxone. When using the PDMP database, Dr.

Hoffman said, it is important to know if patients are receiving either methadone or buprenorphine from an opioid treatment program; that prescription likely will not show up in the database. In addition, consider prescribing or coprescribing naloxone for patients who have an opioid use disorder, those who take more than 50 MMEs per day, and those who take an opioid and a benzodiazepine concomitantly.

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

IN THE NEWS

Patients with opioid use disorder who endorse pain are showing drug-seeking behaviors. In truth, patients with known opioid use disorder may have developed an opioid tolerance, as well as opioid-induced hyperalgesia.

Pain management for patients with opioid use disorder who are on medication-assisted treatment (MAT) has its own considerations, Dr. Hoffman said. There are four main misconceptions regarding the treatment of acute pain in patients on MAT: • The maintenance dose of methadone and buprenorphine will provide adequate analgesia for acute pain. Actually, patients are likely to require higher doses of opioids. • Providing opioids to these patients will result in relapse. In fact, stopping MAT and not adequately treating

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acute pain is more likely to result in relapse than treating acute pain with additional opioids. • Buprenorphine causes respiratory depression and therefore needs to be stopped before starting an opioid for acute pain. In fact, stopping buprenorphine will cause patients to have a significant opioid debt that will necessitate even higher doses of opioids. • Patients with opioid use disorder who endorse pain are showing drug-seeking behaviors. In truth, patients with known opioid use disorder may have developed opioid tolerance, as well as opioid-induced hyperalgesia. For patients on methadone, verify the maintenance dose with the opioid treatment program, Dr. Hoffman said. Methadone should be continued throughout hospitalization. Remember that the maintenance dose, even if it’s high, will not be enough to provide relief of acute pain. Use multimodal analgesia, and because of the alpha-elimination of methadone that is associated with analgesia, consider splitting the maintenance dose into twice-daily dosing to assist with pain control. For patients who cannot take drugs by mouth, conversion to IV dosing should be done with the help of the pharmacy or a palliative care provider, she said. If the regular dose of methadone is interrupted for five or more days, reintroduction should only be done by a knowledgeable provider. Consider peripheral and regional anesthesia as well as opioids. Note that methadone will lengthen the QTc interval, so try to avoid other QTcprolonging drugs. At discharge, contact the opioid treatment program and inform them of the patient’s discharge plan, including the timing of the last dose of methadone, and whether any other opioids have been prescribed, Dr. Hoffman said. For patients on buprenorphine, verify the dose from the PDMP or opioid treatment program. During the perioperative period, continue buprenorphine and use multimodal analgesia, she said. The buprenorphine dose will not provide acute pain relief. Again, because of the alpha-elimination of the drug, splitting the dose into twice-daily dosing can assist with pain control. Consider opioids like fentanyl or hydromorphone, which will be more effective given buprenorphine’s mechanism of action. At discharge, Dr. Hoffman said, contact the opioid treatment program or provider and inform them of the patient’s discharge plan, including whether the person is being discharged with any additional opioids. Ensure patients have a prescription for or a supply of buprenor■ phine at home.

IN THE NEWS

GENERAL SURGERY NEWS / JANUARY 2022

Military Surgery: Saving Life, Limb and Livelihood continued from page 1

stairwell that descended into a nearby canal. A civilian from the U.S. State Department tumbled in after him. Together, they wrapped a tourniquet around the colonel’s upper thigh. Minutes later, an army medic and battalion commander found them. They scooped Col. Walrath into a litter and carried him to a vehicle that raced to the nearest forward surgical team (FST), located about a mile away at a small camp at Forward Operating Base Wright. He remembers physicians hovering over him with questions, needles and lights. That was his last memory for several days. Now retired, Mr. Walrath put the rest of his story together using medical reports, photos and his colleagues’ memories. This fall at the 2021 annual meeting of SAGES, Mr. Walrath described the remarkable series of events that saved his life and leg, and allowed him to serve another nine years in the armed services, eventually returning to Afghanistan. As part of an FST, surgeons work in a tent with very limited supplies. These forward operating bases are often described as similar to the television show ”MASH” But that characterization overplays their size, manpower and resources. Forward surgical teams are mobile; they may have to change their location and set up somewhere else within a few hours. As a result, they can’t carry much equipment and supplies, said Robert Lim, MD, the vice chair of education in the Department of Surgery, University of Oklahoma School of Medicine at Tulsa. Dr. Lim worked as a military surgeon for 23 years before retiring in the summer of 2019. An FST’s interaction with a severely injured patient is usually just long enough to stabilize a patient for transport to a larger facility, Dr. Lim said. It’s a quick, highstakes interaction with a patient and leaves a surgeon with little information about a patient’s outcome— which “can be frustrating and depressing because you’d like to know if you did well,” he noted. At FOB Wright, a surgical team stabilized the bleeding in Mr. Walrath’s leg and loaded him onto a Medivac helicopter headed for Bagram Air Base, then the largest U.S. military base in Afghanistan. In a photo taken mid-flight, Mr. Walrath holds up seven fingers to illustrate his level of pain to the flight medic. Immediately after the picture was taken, the flight medic, Staff Sgt. Troy Halfhill, recognized that his patient was in trouble—his blood pressure was dropping dangerously as bleeding from his leg worsened and the patient would not survive the 60-minute flight to Bagram. Sgt. Halfhill called on the pilot to make an emergency landing at the nearest surgical team at FOB Fenty, in Jalalabad. Dr. Lim and William (BJ) Rice, MD, were working that day at FOB Fenty. Dr. Rice, now the medical director of bariatrics at Presbyterian Rust Medical Center in Rio Rancho, N.M., remembers the call about an incoming patient with severe injuries. When the helicopter landed, Dr. Rice saw a patient who “was obviously bleeding to death.” Dr. Rice, who was the primary surgeon that day, and his team took him “straight into our little operating room,” where they resuscitated the colonel and prepped him for surgery. In these places, surgeons must think about resource management differently than in the United States, especially the blood supply, Dr. Lim said. Blood supply is sometimes the deciding factor in how surgeons make the decision between amputation or limb salvage. “You

Clockwise from top left: Col. Daniel Walrath holds up seven fingers to indicate his pain level after sustaining an IED injury in Afghanistan. Minutes later, the flight medic directs the pilots to make an emergency landing at a nearby forward surgical team site. In July 2013, almost one year after his injury, Col. Walrath relinquished command of his brigade by carrying out a traditional inspection of troops. In January 2021, he deadlifts 340 pounds as part of the Army’s new Combat Fitness Test.

‘What you do as medical professionals is a true calling. It matters to the lives of your patients and their families, more than you know. I can only imagine how difficult it is to rarely see and understand the long-term impacts of your work beyond the operating room.’ —Daniel Walrath, retired Major General can’t do anything that would take up too much time and too much blood,” he said. “Part of my thinking is ‘Can we save him? If yes, then can we save the leg?’” But there was a good supply of blood that day. The surgeons first stopped the bleeding and shunted the patient’s distal popliteal artery. When bleeding continued, they performed a distal embolectomy and shunted the distal tibioperoneal trunk. Dr. Rice said the team spent several hours in the operating room working to resuscitate the patient, stop the bleeding and shunt the vessels to restore blood flow to the leg in order to stabilize their patient for the flight to Bagram Air Base. Once Mr. Walrath arrived at Bagram, vascular surgeon Michael Hogan, MD, now in private practice in Mobile, Ala., carried out a nine-hour surgery to cut a vein out of the officer’s right thigh and graft it onto his left calf to restore blood flow, according to Mr. Walrath. Dr. Hogan, then in his second deployment to Afghanistan, doesn’t recall the case. At the time, Bagram was non-stop with injuries like Mr. Walrath’s. It was hard to keep track of the many patients coming in from bases throughout Afghanistan with major lower-limb trauma. “The likelihood of a limb salvage, even at that time, was very low,” Dr. Hogan said. “The idea was if there’s tissue there that we think we can salvage, you try to revascularize it, optimize the condition as best you can, debride as much grossly infected material as you can and leave some of the marginal stuff behind in hopes that the appearance would improve once you’ve reperfused the area.” Months later, when a vascular surgeon in the United

States checked the integrity of the graft, Mr. Walrath said the surgeon was “utterly amazed when I told him that the graft had been performed in a combat hospital in the middle of Afghanistan.” Mr. Walrath was still intubated when he was evacuated to Landstuhl Regional Medical Center, in Germany. There, he was extubated and flown to the United States, arriving four days after the blast. By then, he had undergone six procedures at four military bases over four days in two countries. Mr. Walrath spent three months recovering at Walter Reed Hospital, in Bethesda, Md. He had an additional 24 operations, mostly fasciotomies and wound washouts to remove infected flesh, he said. Two months after the ambush, doctors told him that the infection had finally cleared and his leg would not have to be amputated. However, he lost all nerve and muscle function below his left knee. That injury—a high-energy, lower-extremity trauma—is common among service members deployed to Afghanistan and Iraq. Approximately 15,000 cases of extremity injury were associated with these conflicts, with close to 1,600 amputations as a result. In 2012, at the time of his injury, the published literature on amputation versus limb salvage among service members was unclear. The following January, a retrospective study of 324 service members deployed to Afghanistan and Iraq who sustained a lower-limb injury showed amputation was associated with better functional outcomes than limb salvage (J Bone Joint Surg Am

IN THE NEWS

JANUARY 2022 / GENERAL SURGERY NEWS

2013;95[2]:138-145). However. staff at military hospitals had already begun to adopt new methods to help injured service members avoid amputation. In 2009, prosthetist Ryan Blanck at the Center for the Intrepid at Brooke Army Medical Center, in San Antonio, had designed a new orthotic device to help limb salvage patients. The Intrepid Dynamic Exoskeletal Orthosis, or IDEO, is a customized, carbon fiber device that runs along the bottom of the foot and up the back of a person’s calf. It operates almost like a spring— transferring energy forward as a person steps down. In this way, the IDEO can help limb salvage patients return to activities like running and high levels of physical activity. At the time of Mr. Walrath’s injury, major military centers had initiated formal rehabilitation programs for limb salvage patients, combining lengthy rehab with the IDEO. The program helped some injured service members return to duty and reintegrate into active lifestyles. In 2013, Mr. Walrath received an IDEO device and started on an intensive rehabilitation program. At first, he learned to take a few steps, then walked, and eventually relearned to run and even jump. He dedicated himself to strength training, studying with experts and amateurs through videos on YouTube. He called his rehabilitation “lifesaving,” saying it allowed him to continue military service, the only work he’d known since he was 17 years old. In July 2013, almost one year after his injury, he relinquished command of his brigade by carrying out a traditional inspection of troops—walking approximately a

quarter-mile in front of his brigade before passing leadership to a new commander. “This final inspection of my brigade was, for me, my testament that the two attackers who blew themselves up 320 days prior had done so in vain,” Mr. Walrath told the SAGES audience. He was promoted to brigadier general in 2015 and major general in 2018. He completed the army’s full fitness test in 2016 and 2021 as part of his service, including a two-mile run accomplished in 19 minutes and 23 seconds. “I was not interested in being a senior leader in the army who could not meet the baseline physical standards that every other soldier had to meet,” he said. Mr. Walrath was deployed to Jordan in 2015-2016 and Afghanistan in 2018-2019, before retiring from service in 2021. In his second deployment to Afghanistan, he returned to FOB Fenty and met with the surgical team working there at the time. He brought with him his medical records from his emergency surgery at the base. By chance, Dr. Lim’s colleague, surgeon Maj. Julia Greene, MD, was working at the base and she recognized her colleague’s name on the operative note. She helped connect Dr. Lim and Mr. Walrath by phone. Until then, Dr. Lim knew that Mr. Walrath had survived the flight to Germany, but that was all. “I thought he would live but that he would require an amputation,” Dr. Lim said. “I doubted he would be able to stay on active duty, let alone be as functionally independent.” In speaking to SAGES, Mr. Walrath said he wanted surgeons to know their actions across operating suites in

Afghanistan, Germany and the United States saved his life and allowed him to continue his career. “What you do as medical professionals is a true calling. It matters to the lives of your patients and their families, more than you know,” he said. “I can only imagine how difficult it is to rarely see and understand the long-term impacts of your work beyond the operating room.” For Dr. Rice, who was seated in the audience during the talk, Mr. Walrath’s story came as a surprise. Early on, Dr. Rice tried to follow up on his former patient— he’d heard that the injured man had arrived in the United States but suffered ongoing infections. Somewhere along the line, however, he’d heard that Mr. Walrath needed his leg amputated. “I was so happy,” said Dr. Rice, after learning about his patient’s outcome, “because that’s why we do what we do. You know what I mean? It was like snatching a victory from the jaws of defeat—that kind of thing.” Dr. Lim said Mr. Walrath’s story illustrates the unique skill set of military surgeons. “Very few surgeons outside of the military are expected to do emergent, lifesaving procedures with low resources in a tent and operate on very technically challenging laparoscopic procedures a few months later,” he said. “It made me pretty proud of what the military can provide to soldiers and servicemen as well as the general public.” SAGES started a military committee in 2009, to provide surgical combat education and advanced laparoscopic education for its military members. Since then, the organization hosts an annual military symposium to highlight research and military-unique skill acquisition ■ that is free for active-duty surgeons.

Mesh Removal: How Much Does Surgical Approach Matter? continued from page 1

initial mesh placement. Mesh that was placed anteriorly in an open fashion was removed via the open technique, and preperitoneal mesh was removed either laparoscopically or robotically. Patients were evaluated two weeks after removal, and long-term followup occurred at a mean of 2.5 years. The patients in the three cohorts were well balanced in terms of comorbidities and indications for mesh removal, which included foreign-body sensation, meshoma, reaction, neuralgia and infection. The operative time was longest with the robotic approach (226 minutes), followed by open (181 minutes) and laparoscopic procedures (169 minutes). There was a significantly different rate of intraoperative injury and major vascular injury among the three approaches, with the laparoscopic group having the highest rate of injury (Table). The mean blood loss was 77 mL in open, 96 mL in laparoscopic and 52 mL in robotic procedures with significant variance. There was no difference in postoperative complications among approaches. There was no difference in pain scores between groups at two-week and long-term follow-up with a mean of 2.5 years. There was a significant improvement in pain scores in all patients after mesh removal. There was

no difference in pain score improvement among the approaches. The authors concluded that all mesh removal approaches were effective in treating chronic postoperative inguinal pain after inguinal hernia repair. The three groups were equally effective in treating postoperative chronic inguinal pain, yielding durable improvement. There was significant variance among the groups with regard to operative time,

rate of injury and blood loss, with post hoc analysis suggesting that a robotic approach may confer some advantage, Dr. Huynh said. However, these observed differences were small. “Based on [what the authors say], open repair is always going to be the procedure of choice for meshes that were placed anteriorly. In these cases, open removal was as good as robotic,” said Kamal Itani, MD, the chief of surgery at VA Boston

Table. Operative Complications Open

Laparoscopic

Robotic

P Value

Intraoperative injury

4 (10%)

8 (39%)

8 (16%)

0.044

Minor vascular (inferior epigastric, gonadal)

4 (10%)

4 (17%)

7 (14%)

Major vascular (external iliac)

0 (0%)

3 (13%)

1 (2%)

0.019

Nerve

1 (4.3%)

Organ

NS, nonsignificant

Health Care System, a professor of surgery at Boston University and a faculty member at Harvard Medical School, who was not involved with the study. “It then becomes a comparison between the laparoscopic and robotic approach for posteriorly placed meshes. Although the surgery was longer with the robot, there were less complications with the robotic approach compared to laparoscopic. The numbers are too small, and possible confounders too many to reach solid conclusions. However, [this study] could be hypothesis-generating for a larger prospective multicenter study looking at laparoscopic versus robotic explantation of meshes in patients that had posteriorly placed mesh.” Dr. Huynh noted that mesh removal is safe and effective for treating chronic postoperative inguinal pain in the right patients, regardless of the approach taken. “Due to the reoperative setting and distorted anatomy, these cases should be approached judiciously by surgeons who are practiced in it,” Dr. Huynh said. “Based on our group’s own experience and trends in this data set, we prefer a robotic approach when appropriate. However, we continue to regularly employ the open and laparoscopic techniques when necessary.” ■

IN THE NEWS

GENERAL SURGERY NEWS / JANUARY 2022

A Surgical Society’s Push to Increase Diversity, Equity and Inclusion By KATE O’ROURKE

n the past year, the Central Surgical Association has focused on diversity, equity and inclusion. Some of these efforts were discussed at the 2021 joint annual meeting of the CSA and Midwest Surgical Association. In the summer of 2020, the CSA established its Diversity, Equity and Inclusion (DEI) Task Force. According to L. Michael Brunt, MD, the 2020-2021 president of the CSA and Pruett Professor of Surgery and section chief of Minimally Invasive Surgery, Washington University School of Medicine in St. Louis, task force L. Michael Brunt, MD members took on this initiative with incredible enthusiasm and energy. Since then, the task force has been turned into a 15-member committee. “We have done several proactive things when it comes to DEI,” Dr. Brunt said. “We appointed the most diverse group of committee chairs and committee members in the history of the Central Surgical Association for the coming year. The DEI Task Force will become a full-fledged committee in the coming year. We have decided to support a scholarship for a junior faculty member from an underrepresented minority to attend our annual meeting. And we have added a statement to our pathway to leadership that diversity in all its forms will be considered.” For a regional surgical society, said Dr. Brunt, diversity doesn’t only mean race, gender or sexual orientation; it also means geographic diversity and includes surgical specialty diversity. “We don’t want to have everybody in leadership be overly concentrated in certain specialties either,” Dr. Brunt said. Dr. Brunt said diverse representation at the periodic council meetings is now a priority. The DEI efforts are prominently announced on the CSA website. “The bottom line is we have made a conscious move to become intentional about DEI issues, and I think the end result will be that the organization will be more robust and broadly inclusive, which will be better for patient care and surgical education,” Dr. Brunt said. He said the CSA is exploring partnerships with other societies to leverage collective strengths to advocate for social justice, reduce health care disparities and counter racism in the United States. As part of the DEI push, the CSA held its first special panel session on DEI issues and disparities in surgery at the joint annual meeting. The panel was co-chaired by Anthony Stallion, MD, of Beaumont Children’s Hospital in Royal Oak, Mich., and Leena Khaitan, MD, MPH, of University Hospitals in Cleveland.

Unconscious Bias: Defining the Issue Panelist Callisia Clarke, MD, an assistant professor and a surgical oncologist, Department of Surgery, Division of Surgical Oncology, Medical College of Wisconsin, in Milwaukee, discussed diversity, equity and inclusion in

surgical societies with a focus on unconscious bias. She said the impact of unconscious bias in academic surgical societies manifests in a few different ways. “We know there are fewer women in leadership and that women surgeons have lower pay for equal work. We know that there is poorer retention in our field for women. There is low recruitment and low retention of underrepresented minorities in surgery and medicine in general. This is pervasive in private practice and academia,” Dr. Clarke said. “We know that even though there is very good representation of Asian Americans in the field of surgery that they are underrepresented in leadership. There is very little acknowledgment of LGBTQ issues in academic surgery, and it’s almost never talked about, and so has not been appropriately studied. You can’t really define the impact of the problem if we truly don’t even know what that is.”

‘[Diversity, equity and inclusion] work is not a fad. It takes time, effort and money to make a difference.’ —Callisia Clarke, MD Dr. Clarke said all of these factors lead to poor work satisfaction, poor attendance at meetings, poor involvement in organizations and ultimately health disparities. Dr. Clarke said several steps can help move organizations in the right direction. First, organizations should take their pulse and learn where they stand on DEI. Second, they should make their intentions regarding DEI known. “I strongly encourage organizations to go back and look at their mission and incorporate DEI into part of their mission, so it is part of the structure, the backbone of the organization, and it’s not a separate or time-related event,” Dr. Clarke said. Third, organizations should implement effective programs for DEI using data to guide them, and they should have both short- and long-term goals. “DEI work is not a fad. It takes time, effort and money to make a difference,” Dr. Clarke said.

Underrepresented Minorities: Recruitment and Retention Panelist Steven Stain, MD, the chair of the Department of Surgery at Lahey Hospital and Medical Center in Burlington, Mass., discussed using sponsors and allies to advance DEI initiatives. He said he has been an ally for the Society of Asian Academic Surgeons and advanced their role with the American College of Surgeons by helping them achieve a governor position with the ACS. Dr. Stain was spurred to help the Steven Stain, MD Society of Asian Academic Surgeons after helping the Society of Black Academic Surgeons achieve an ACS governorship.

Dr. Stain is one of several authors of a manuscript that offers a review of best practices to improve both the recruitment and retention of underrepresented minorities in training programs and beyond (J Surg Educ 2021;78[4]:1058-1065). According to Dr. Stain, diversifying the medical workforce is critical to reducing health care disparity and improving patient outcomes.

The University of Michigan Initiatives Panelist Justin B. Dimick, MD, MPH, the Frederick A. Coller Distinguished Professor of Surgery and the chair of the Department of Surgery at the University of Michigan, in Ann Arbor, discussed work to improve the diversity and culture of equity and inclusion at the university. He said initiatives include working to improve the process by which surgeons are recruited, especially working to ensure a diverse applicant pool, objective questions and implicit bias training; improving the work environment so that all can succeed; and making sure everyone has equal access to mentorship, sponsorship and leadership development opportunities. Launch teams are offered to help all new surgical faculty gain access to mentorship and sponsorship and boost teams to help those in mid-career.

‘Our wall space has been redesigned and now represents the diversity of our faculty, staff and trainees... Walls do talk, and we want them to say to everyone, ‘You belong here and you can excel here.’ —Justin B. Dimick, MD Two-year outcomes of these initiatives, said Dr. Dimick, show that the University of Michigan’s Department of Surgery increased the diversity of new faculty hires. A large group of staff, faculty and residents comprise a “culture crew” that is responsible for improving workplace culture and environment. The University of Michigan also created a cultural complications curriculum to help create a forum to discuss and share perspectives around cultural issues (culturalcomplications.com). Designed to be presented during the standard hospital morbidity and mortality conferences, the curriculum covers 12 core themes in DEI. Each data-driven module introduces the audience to key terminology, provides scientific evidence for the concept and offers sample cases to spur discussion. “There are more than 130 institutions that are implementing this curriculum as part of a collaborative program across the country,” Dr. Dimick said. Another initiative undertaken at the university was to change the walls. Like most walls, they contained almost exclusively white male portraits. “Our wall space has been redesigned and now represents the diversity of our faculty, staff and trainees,” Dr. Dimick said. “Walls do talk, and we want them to say to everyone, ‘You belong here and you can excel here.’” During the question-and-answer session of the DEI special panel, numerous attendees applauded the DEI ■ efforts.

The Overwhelming Benefits of Fluorescence Guided Surgery (FGS) Fluorescence Guided Surgery (FGS) is a medical imaging technique that uses fluorescent dye to identify anatomic structures during surgical procedures. Over the past decade, the benefits of incorporating FGS in surgical practice has resulted in rapid adoption by many leading surgeons and their institutions. The exponential growth in the field of FGS is demonstrated by the number of peer reviewed published articles, which has grown from under 50 in 1995, to over 5,000 being published in 2020. Despite many advances in preoperative medical imaging such as CT and MRI scans, surgeons still almost exclusively operate under white (visible) light during their procedures and must rely on their ability to see and feel target tissues. With the increasing use of laparoscopic surgeries, this ability to ‘feel’ target tissues is taken away. FGS essentially gives the surgeon the ability to ‘see’ in a different wavelength of light that would otherwise be invisible. By combining this visual ability with the special dyes that glow in those wavelengths, surgeons can much more precisely target or avoid certain organs or tissues. In addition, the near-infrared light used in FGS can more easily penetrate human tissues, allowing surgeons to see ‘through’ layers of tissue and organs. As well as allowing a surgeon to see what otherwise would be invisible, FGS has the added advantage of being a real-time imaging process. Whereas traditional imaging like X-Rays, CT Scans, and MRI scans can provide excellent images, they are all limited to providing static images. Fluorescence-guided surgery today is used in multiple surgical situations perfusion assessment, sentinel lymph node (SLN) mapping, identification of solid tumors, and anatomical imaging during surgery. Importantly, FGS can be used seamlessly during the procedure without interrupting the surgeon’s workflow. Currently, ICG is one of the most frequently employed fluorophore used for FGS. ICG was first produced in 1955 by the

Kodak Research Laboratories, and in 1959 it was approved by the U.S. Food and Drug Administration (FDA). Intraoperative fluorescence imaging offers the benefits of high contrast and sensitivity, low cost, absence of ionizing radiation, ease of use, safety, and high specificity. Studies undertaken over the past decade support the overwhelming evidence on the benefits of

FGS including the reduction in percentage of procedures with major complications, reduction in the rate of anastomotic leaks, significant reduction in conversion to open procedures as well as improvement in hospital profit margins and referrals. The International Society of Fluorescence Guided Surgery (ISFGS) is a non-profit organization created for the global advancement of FGS

through clinical practice, education, and the promotion of basic and clinical research. Membership in the ISFGS is essential for those who wish to be involved in FGS, to stay current with up-to-date scientific data as well as surgical techniques and thinking that will improve the practice of surgery. For more information on ISFGS visit www.isfgs.org.

IN THE NEWS

GENERAL SURGERY NEWS / JANUARY 2022

Surgeons Propose New Risk Model for 30-Day Mortality After Major Liver Resection By MARCUS A. BANKS

cluster of eight factors appears to help surgeons predict which patients scheduled for major liver resection are most likely to die within 30 days of the procedure. The risk model, presented at the 2021 virtual Digestive Disease Week, found that patients who receive preoperative steroids, have an albumin–bilirubin score of 2 or more, experience weight loss greater than 10%, are male and at least 65 years of age are much more likely than other patients to die within 30 days of a trisegmentectomy or right hepatectomy (poster Sa671). Although multiple models exist to assess the risk for mortality soon after major liver resection, comprehensive preoperative models including clinical and laboratory values are scarce. The model presented at DDW aims to close this gap. “Almost all of this information would be in a patient’s medical record after their very first visit,” said Andreas Karachristos, MD, a professor of surgery at the University of South Florida, in Tampa, and the senior author of the study. “We encourage surgeons to consider these various factors as they consult with patients on treatment plans.” To build their model, Dr. Karachristos and colleagues queried the records of 4,469 major hepatectomies in the American College of Surgeons National Surgical Quality Improvement Program database. These surgeries occurred from 2014 to 2016; the researchers excluded any surgery without a complete preoperative record. Approximately half of the procedures were in men (51.6%). Eight factors were associated with increased risk for death within 30 days after surgery: albumin–bilirubin grade of 2 or more, a history of congestive heart failure, being male, being 65 years of age or older, low patient functional status, diabetes mellitus, hypertension requiring treatment, and preoperative use of steroids. The researchers weighted all factors equally to make the model as easy to use in daily clinical practice without requiring clinicians to use statistical software to weigh the effects of the different components. A patient with one of these risk factors appeared to be more likely to die within 30 days of surgery than someone with none of them (odds ratio [OR], 1.71), although the confidence interval crossed 0; thus, one risk factor alone may not matter, the researchers reported. The risk for death rose with two risk factors (OR, 5.09; 95% CI, 1.53-16.91),

and death was much more likely for anyone with three or more risk factors (OR, 12.46; 95% CI, 3.93-39.61; P<0.001). Of 119 total recorded deaths, 107 were linked to two or more risk factors. “Risk scores like this can be incredibly helpful in terms of setting expectations for patients and families and helping improve our shared decision making,” said Katherine T. Morris, MD, a surgical

oncologist and the vice chair of Academic and Research Advancement at the University of Oklahoma College of Medicine, in Oklahoma City. Dr. Morris noted that eyeball assessments or even formal assessments of patient frailty can sometimes be misleading. Someone who seems likely to struggle following a major liver resection does well, while someone who expected

to have no issues fares poorly. For this reason, more objective criteria for risk assessment would be useful. Dr. Morris added that risk models rarely weight every criterion equally, and that the risk score as presented at DDW did not incorporate indication for resection, such as primary or secondary tumor. Such information would likely affect ■ 30-day mortality as well, she said.

For complex hernia repair

INDICATIONS STRATTICE™ Reconstructive Tissue Matrix (RTM), STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are intended for use as soft tissue patches to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use of these products include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. STRATTICE™ RTM Laparoscopic is indicated for such uses in open or laparoscopic procedures. These products are supplied sterile and are intended for single patient one-time use only. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS These products should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20. WARNINGS Do not resterilize. Discard all open and unused portions of these devices. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. Do not reuse once the surgical mesh has been removed from the packaging and/or is in contact with a patient. This increases risk of patient-topatient contamination and subsequent infection. For STRATTICE™ RTM Extra Thick, do not use if the temperature monitoring device does not display “OK.” PRECAUTIONS Discard these products if mishandling has caused possible damage or contamination, or the products are past their expiration date. Ensure these products are placed in a sterile basin and covered with room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place these products in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. These products should be hydrated and moist when the package is opened. If the surgical mesh is dry, do not use.

JANUARY 2022 / GENERAL SURGERY NEWS

Effect of Pot Smoking on Major Surgical Outcomes Insignificant By MICHAEL VLESSIDES

s more North Americans are partaking of legal cannabis, exposure to the substance does not seem to affect major surgical outcomes, according to the results of a large cohort study. Canadian researchers have concluded that routine cannabis use does not affect a composite outcome of respiratory/cardiac arrest,

ICU admission, stroke, myocardial infarction and mortality during hospital stays. “Cannabis contains cannabinoids, which can interact with neurotransmitters, thereby creating potential drug interactions in the perioperative period,” said Betty Huiyu Zhang, MD, a resident at the University of Ottawa, in Ontario. “Preclinical studies indicate the potential for such cardiovascular complications as

arrhythmias and blood pressure changes. “Smoking cannabis can also cause airway hypersensitivity, and smaller retrospective studies have suggested that cannabis may be associated with increased propofol requirements for induction and sedation,” Dr. Zhang added. Other research has found a potential link between cannabis use and perioperative analgesic difficulties, and mixed results

WITH THE

with respect to postoperative pain control. Therefore, Dr. Zhang and her colleagues evaluated the effect of routine cannabis use on perioperative outcomes in a large patient cohort. The researchers captured data from 1,818 surgical patients presenting to the institution between January 2018 and March 2019. Cannabis users were identified by selfdisclosure at their preoperative visit. Multiple logistic regression with propensity score matching was used to adjust for a number of potentially confounding baseline variables, including age, sex, body mass index, smoking status, other recreational drug use, surgical setting (inpatient vs. ambulatory), type of surgery and type of anesthesia.

No Difference Across Several End Points

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

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

91.7 7 YEARS %

†

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

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

For more information, contact your Allergan Aesthetics representative or visit hcp.StratticeTissueMatrix.com PRECAUTIONS (continued) Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation. Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh. In large abdominal wall defect cases where midline fascial closure cannot be obtained, with or without separation of components techniques, utilization of the surgical mesh in a bridged fashion is associated with a higher risk of hernia recurrence than when used to reinforce fascial closure. For STRATTICE™ RTM Perforated, if a tissue punch-out piece is visible, remove using aseptic technique before implantation. For STRATTICE™ RTM Laparoscopic, refrain from using excessive force if inserting the mesh through the trocar. STRATTICE™ RTM, STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are available by prescription only. For more information, please see the Instructions for Use (IFU) for all STRATTICE™ RTM products available at www.allergan.com/StratticeIFU or call 1.800.678.1605. To report an adverse reaction, please call Allergan at 1.800.367.5737. For more information, please call Allergan Customer Service at 1.800.367.5737, or visit hcp.StratticeTissueMatrix.com. References: 1. Connor J, McQuillan D, Sandor M, et al. Retention of structural and biochemical integrity in a biological mesh supports tissue remodeling in a primate abdominal wall model. Regen Med. 2009;4(2):185-195. 2. Sun WQ, Xu H, Sandor M, Lombardi J. Process-induced extracellular matrix alterations affect the mechanisms of soft tissue repair and integration. J Tissue Eng. 2013;4:2041731413505305. doi: 10.1177/2041731413505305. 3. Garvey PB, Giordano SA, Baumann DP, Liu J, Butler CE. Long-term outcomes after abdominal wall reconstruction with acellular dermal matrix. J Am Coll Surg. 2017;224(3):341-350. STRATTICE™ and its design are trademarks of LifeCell Corporation Corporation, an AbbVie company company. © 2021 AbbVie. All rights reserved. STM147027 05/21

DON’T MESH AROUND

In a presentation during the 2021 Annual Regional Anesthesiology and Acute Pain Medicine Meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract 1875), Dr. Zhang noted that 606 patients preoperatively reported cannabis use, while the remaining 1,212 served as controls. The total prevalence of reported cannabis use was 4% (606/15,048). For the propensity score–matched analyses, there was a final cohort of 524 cannabis users with complete information and 1,152 controls. No difference was found between groups with respect to the study’s primary end point: Seven cannabis users (1.2%) experienced the composite outcome of respiratory/cardiac arrest, ICU admission, stroke, myocardial infarction or mortality during their hospital stay, compared with 11 controls (0.9%), yielding an odds ratio of 1.06 (95% CI, 0.23-3.98). Although cannabis users experienced a greater incidence of arrhythmias than controls (2.7% vs. 1.6%; P=0.15), along with a decreased incidence of postoperative nausea and vomiting requiring treatment (9.6% vs. 12.6%; P=0.08), these differences were not statistically significant. The incidence of severe pain during recovery was also comparable between groups, affecting 30.9% of cannabis users and 33.5% of their counterparts who did not use cannabis (P=0.31).

Cannabis Use Hard to Pinpoint “More rigorous study should be designed to examine these outcomes,”Dr. Zhang said. As the researchers discussed, the study represents the largest single-center effort examining regular cannabis use in average doses. Nevertheless, the analysis was not without its shortcomings, continued on the page 22

LETTER TO THE EDITOR

GENERAL SURGERY NEWS / JANUARY 2022

Allowing Surgical Trainees to Struggle in the OR

[Re: “The Most Harm,” by Miguel Lopez-Viego, MD, November 2021, page 1] To the Editor: Kudos to Dr. Lopez-Viego for speaking up on this pandemic-like issue among the graduating residents and fellows. He has hit the nail on the head, summarizing what is currently going on in U.S. training programs, an issue which is only getting worse with senior residents/fellows being mere observers now in robotic surgery cases. I am currently a second-year attending, and I can’t emphasize how important it is to “struggle” in the OR. There is simply no amount of observing, reading or watching videos that can prepare you for the real world. Dr. Lopez-Viego has rightly pointed out that senior residents/fellows are exploited for administrative tasks while the attending “gets through” the case for myriad reasons. Surgery is all about “see one, do one, teach one.” Unfortunately, this field is moving away from the “do one” aspect rather quickly. It is incumbent upon our leadership to act on this very important issue and ensure the graduating residents/fellows are up to the task that will be handed to them once they are practicing. This article highlights what happens to the unfortunate folks who are not prepared to face the music. As Dr. Lopez-Viego recounts, “All these surgeons eventually had to leave the community discouraged, disgraced, embarrassed and lacking any confidence.” Reiterating the point, the ACS leadership needs to intervene to avoid—despite multiple years of post-residency training—a pandemic of untrained surgeons. Adeel A. Shamim, MD, DABS Minimally Invasive and Bariatric Surgery Mercy Health, Fort Smith, Ark. To the Editor: I am a third-year general surgery resident and would like to share my sincerest compliments regarding the article “The Most Harm,” by Dr. Lopez-Viego. I strongly agree with his message and feel comforted knowing there are surgeon educators who recognize this issue and are speaking out about it with passion. Dylan Johnson, MD, PGY-3 General Surgery Residency Program HCA Brandon Regional Hospital, West Florida Division To the Editor: I thought this was one of the best articles in the history of General Surgery News. Dr. Lopez-Viego calls it like it is. I am not confident, even with the truth, that the problem will be fixed. I think any patient entering an academic institution should have to sign a waiver acknowledging that they may be operated on by a resident under supervision. Only by making this a standard protocol for all academic institutions will the problem be fixed. Patients who want the benefit of these prestigious and well-equipped training institutions will have to make a trade-off, and, if they don’t want that, they can go to a nonacademic center. The legal and administrative departments will be very hesitant, unfortunately, to fix this problem on their own. Matt Pompeo, MD Dallas

To the Editor: I’m a new general/bariatric surgeon, four months out from fellowship, and I just wanted to say how much I appreciated this article. I couldn’t agree more with Dr. Lopez-Viego. I just wish more academic surgeons took their responsibilities as educators as seriously as he does. Thank you, Dr. Lopez-Viego, for taking the time to write this article and for the countless hours you spend in the OR letting your trainees struggle. That really is the most important part of training. Eric Rachlin, MD Houston To the Editor: Dr. Lopez-Viego’s vitriolic editorial, “The Most Harm,” is long on complaints and criticisms of current surgical education but short on solutions. He describes the ongoing devaluation of classic surgical education in general and intraoperative teaching specifically, yet offers no practical recommendations to remedy the situation. The good doctor must realize that surgical education in academic centers is a historical accident. Its perpetuation into modern times is not necessarily the best way to teach residents how to operate. Academic departments of surgery are not fonts of education. These centers are multimillion-dollar businesses focused on financial stability. The dedicated, patient and selfless surgical educator described by Dr. Lopez-Viego does not exist because there is no RVU [relative value unit] for educational effort. That surgeon is an economic nonentity. The literature on the fate of physicians who have won teaching awards reveals just how valuable the premier medical educator is in today’s environment (Medical Education Online. 2000;5:3. www.tandfonline.com/ doi/abs/10.3402/meo.v5i.4313; Perspect Biol Med 1999;42[2]:280-287. doi:10.1353/pbm.1999.0029). The goals of the academic medical center are too diffuse to provide the type of surgical education sought by Dr. Lopez-Viego. The irrefutable fact is that academic surgeons chose their career path not to perfect their craft and pass it on to others, but to do what is required to become a professor. The goal is to write papers, increase a national profile, attend national meetings, obtain research grants, serve the American College of Surgeons and the American Board of Surgery, spend endless hours on committees and at retreats, and, if there is time—perhaps as an aside—instruct residents on the basic mechanics of clinical surgery. To put it bluntly (and to some degree to keep up with Dr. Lopez-Viego), due to a lack of practice and volume of cases, academic surgeons with few exceptions rarely rise above the competency of the fellow. They remain largely unaware of their lack of operative skills. They exist in a world of arrested surgical development. It’s as if you are climbing the White Mountains of New Hampshire all of your life, never realizing that there is a Mont Blanc. A step forward to remedy the problems outlined in Dr.

Lopez-Viego’s caustic essay—did he really equate delaying challenging cases to senior residents as a criminal act?—is to increase the number of rotations outside of the mother ship for surgical residents. I would guess that 95% of graduating residents who have had outside rotations would say that that is where they “learned to operate.” Place a resident into a busy community surgical group performing 10 to 15 cases per week and that resident will learn how to operate safely and efficiently. That was always the appeal and value of a Veterans Administration [hospital] rotation. The community hospital and the VA have only one mission, not four competing missions. The surgical skills of private-practice surgeons greatly exceed those of academic surgeons. The latter never understand this and, in fact, for mysterious reasons, endlessly debase and ridicule community-based surgeons. In addition to spending more time at community hospitals and Veterans Administration facilities, graduating surgical residents should be required to spend six months in a medically underserved part of the world. Many international opportunities are available. I am familiar with a recently graduated chief surgical resident who did this. He returned with a refined set of surgical skills. Those six months put him years ahead of his colleagues in surgical judgment and the ability to recognize and to manage complications. His personal initiative made up for the deficiencies Dr. Lopez-Viego describes. When a graduating resident takes a job, that resident must be certain that a mentor will be part of the employment contract. I am not talking about a half-hour latté schmooze-fest on a Tuesday morning. I am talking about an experienced, broadly trained mentor 10 or 15 years into practice who has a contractually vested interest in the new hire—an interest in the financial viability of that individual and a greater interest in correcting the failures of that individual. I am talking about a colleague who will appear at 0200 hours to help dig out the left ureter! I am talking about someone who recognizes the issues raised in Dr. LopezViego’s editorial and is going to do something about it—a true surgical leader who can correct current educational deficiencies. The academic surgical construct is simply not designed to produce “cutting surgeons.” If the days of the cutting surgeon are gone, there is no reason to fret over this. Laparoscopy, robotics, interventional radiology and advanced endoscopic skills may make up for the demise of the cutting surgeon. But if they are not gone, primary responsibility for surgical education needs to find a way to escape from the historical confines of academic centers. Current graduates are not finished products. If they were, the resident farewell dinner would not be called a “commencement.” Leo A. Gordon, MD Los Angeles Dr. Gordon is a member of the editorial advisory board of General Surgery News.

We would like your opinion. Please send letters about articles in General Surgery News to the editor at

khorty@mcmahonmed.com.

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IN THE NEWS

GENERAL SURGERY NEWS / JANUARY 2022

The ‘Difficult’ Gallbladder: Approaches to Different Clinical Scenarios continued from page 1

To Drain or Not to Drain Percutaneous cholecystostomy has historically been used as either a bridge to surgery or a definitive treatment in patients who are too frail to undergo surgery. Mortality related to the procedure is less than 0.5%, and percutaneous cholecystostomy is successful from a clinical point of view, relieving fever, pain and inflammatory markers in 85% to 90% of patients. “When you look at our population of high-risk surgical patients, [percutaneous cholecystostomy] is superior to conservative management followed by delayed laparoscopic cholecystectomy,” said Raul Coimbra, MD, PhD, a professor of surgery at Loma Linda School of Medicine, in California. There are a couple of algorithms that can help guide what to do with patients after drain placement (Front Surg 2021;8:616320; Abdom Radiol 2020;45[4]:1193-1197). The second and simpler one advises following up on all patients at two weeks with cholangiography (Figure). “If the patient is a surgical candidate, they should undergo cholecystectomy; if they are not a surgical candidate, one option is percutaneous cholecystolithotomy, though that’s performed in the minority of patients,” Dr. Coimbra said. A novel alternative to percutaneous cholecystostomy worth watching is endosonography-guided gallbladder drainage. “You locate the gallbladder through the stomach or duodenum, perform a cholecystogastric or cholecystoduodenal fistula through a stent, and remove the stones,” Dr. Coimbra said. A recent multicenter, randomized controlled trial found this technique resulted in lower rates of recurrence, and fewer 30-day reinterventions, unplanned admissions, and 30-day and one-year adverse events than percutaneous cholecystostomy (Gut 2020;69[6]:1085-1091). “Both are technically and clinically successful procedures, so both work. But it seems that the performance of the novel technique is much superior,” Dr. Coimbra noted.

Subtotal Cholecystectomy: A Safer Bailout When a CBDI appears imminent during a difficult cholecystectomy, the default has been converting from laparoscopic to open surgery. But it might be counterintuitive for the most recent generation of surgeons, well trained in laparoscopy, to turn to a less familiar option when surgery becomes challenging. “The truth of the matter is that inflammation doesn’t vanish when it’s exposed to air; a difficult gallbladder laparoscopically is a difficult gallbladder open,” said Sharmila Dissanaike, MD, the Peter C. Canizaro Chair of the Department of Surgery at Texas Tech University, in Lubbock. Enter subtotal cholecystectomy, a relatively new approach that is gaining traction. “It’s probably accepted these days as the safest option to prevent severe bile duct injury,” Dr. Dissanaike said. The two types, reconstituting and fenestrating, are both easy to perform laparoscopically and open, Dr. Dissanaike said. “The key is staying high, away from

Cannabis continued from page 19

which included self-reporting of cannabis use (which may create underreporting); the researchers’ inability to quantify the amount, duration or type of cannabis

the danger zone; opening into the gallbladder anterolaterally; leaving only about 1 cm of infundibulum; taking as much of the posterior wall as you safely can; and clearing all the stones.” How do you choose between the two? It’s a bit of a toss-up, weighing potential complications. “Fenestrating will usually give you a bile leak and it has slightly more reinterventions, but reconstituting seems to have more recurrent biliary symptoms,” Dr. Dissanaike said. Finally, she recommended reserving subtotal cholecystectomy for the most difficult cases, when dissection is truly dangerous. “If we drop the threshold to perform subtotal cholecystectomy too low, we might have unacceptably high rates of patients needing reoperation,” Dr. Dissanaike said.

Cholecystitis and Cirrhosis: Managing the Sickest Patients Patients with cirrhosis and cholecystitis are at increased risk for a number of complications and difficult surgery. The decision to proceed with surgery begins with an assessment of the patient’s capacity to tolerate it. “Clearly there is a large spectrum of cirrhosis, and stratifying the perioperative mortality is important,” said Kristin Ellen Raven, MD, a transplant surgeon at Beth Israel Deaconess Medical Center and faculty member at Harvard Medical School, both in Boston. For example, patients classified as Childs A are likely to survive surgery; similarly, those with a Model for End-stage Liver Disease (MELD) score less than 15 who have not been decompensated also have a relatively low mortality risk of 10% to 15%. To further determine surgical risk in cirrhotic patients, Dr. Raven uses a calculator available on Mayo Clinic’s website that takes into account age and American Society

use; and a lack of categorization of other recreational drug use. Marco Echeverria-Villalobos, MD, an assistant professor of anesthesiology at The Ohio State University Wexner Medical Center, in Columbus, said the primary challenge in studies such as this is accurately

of Anesthesiologists physical status in addition to MELD score (https://mayocl.in/32ICYIo). “I find this calculator extremely valuable to discuss risk with patients and family, and to provide solid data to nonsurgical colleagues who may be pushing for an operation.” When surgery is deemed feasible, Dr. Raven advocates for the least invasive operation possible, noting that risk rises with procedure length. “The cumulative risk for perioperative complications is four times higher past two hours than it is for a 30- to 60-minute laparoscopic cholecystectomy. I have a low threshold to open.” For decompensated patients, she recommends starting initial nonoperative management with NPO order and IV antibiotics. “I require that decompensated cirrhotics really force me to operate, meaning they’ve failed several days of conservative management,” Dr. Raven said. But surgery is only part of the challenge in managing patients with cirrhosis. Postoperative care requires hemodynamic monitoring, possible ICU admission, optimal coagulopathy, management of ascites and other considerations. “The ability of your institution to care for these patients postoperatively should weigh heavily in your decision to operate,” Dr. Raven said.

Managing Common Bile Duct Injury Despite such precautionary measures as achieving a critical view of safety and bailing out to subtotal cholecystectomy, common bile duct injuries still occur in up to 0.4% of all laparoscopic cholecystectomies. Katherine Morgan, MD, suggested steps for managing this daunting complication. “The first step, to quote my hilarious partner, is to take your own pulse; it’s terrifying to see an unexpected bile leak, which can compromise your judgment, so take pause,” she said. Second, call a senior partner or phone an accessible hepato-pancreatico-biliary (HPB) surgeon for help, said Dr. Morgan, a professor of surgery and the head of the Division of Hepato-Pancreatico-Biliary Surgery, Medical University of South Carolina, in Charleston. Although she was trained to convert to open when laparoscopic cholecystectomy becomes difficult, like Dr. Dissanaike, Dr. Morgan thinks this approach may no longer be the safest option for surgeons trained more in minimally invasive surgery than open procedures. “Opening does not make this operation any easier,” she said. Third, and most important, obtain drainage. “Controlling the bile leak will prevent sepsis and allow for the inflammatory physiology to resolve to allow the patient to be prepared for a more definitive repair later on,” Dr. Morgan said. Finally, consider an early referral to an HPB center. “Management of CBDI really is a multidisciplinary effort. It involves the therapeutic endoscopist, interventional radiology and HPB surgery,” she said, noting that attempting CBDI repair at the primary hospital has been identified as an independent risk factor for poor outcomes. ■

estimating the percentage of cannabis users in a population of surgical patients. “Despite the wide use that cannabis or cannabinoids have as recreational or medical drugs, the percentage of patients that can be identified preoperatively as recreational or medical cannabis users by self-disclosure is

still very low (4.0%-4.2%), as we can observe in other studies that have included larger sample sizes [Int Orthop 2019;43:283-292]. This continues to be an important limiting factor of studies that seek to accurately estimate the real impact of cannabis use on peri■ operative outcomes.”

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OPINION

GENERAL SURGERY NEWS / JANUARY 2022

Cheaper to Pay Your Doctor continued from page 1

have created multiple layers of complexity that have siphoned off the majority of the health care dollars into a giant black hole. The problem is individuals and employers seeking health care plans feel they have little choice and, therefore, humbly agree every year to another price increase, to pay for the “rising costs” of pharmaceutical, hospital and specialty care. Clearly, there needs to be better options. While technology has moved the practice of medicine from the hospital to the

office, to the patient’s home, the established health care system has not modernized to meet the new requirements. Hospital workflows have become increasingly burdened with a bureaucracy designed for corporate compliance rather than patient wellness. Doctors have had to constantly adjust and conform to protocols that impede, redirect and distract from properly implementing treatment in a timely manner. That is why the job burnout rate is so high and patient satisfaction so low.

It took a pandemic to push us into the future, allowing us to reprioritize care, adopting new technologies while streamlining others. Outpatient joint replacements, for example, are now becoming the new standard, and with improved outcomes, and telemedicine has emerged as an important addition to nearly every practice. In short, doctors have found new ways to work around the system and they are taking their patients with them. There is no price transparency in health care. No one ever claims to know the exact price of services, although the balance sheet clearly shows what insurers

haven’t paid. Fee schedules are exaggerated to give insurers a chance to bargain. However, spoiler alert: It’s actually much cheaper just to pay a transparent fee for a specific service. It’s expensive to bill, collect and obtain authorizations, and nowadays many patients have such high plan deductibles that they are paying out of pocket anyway. More and more often, paying with insurance can cost more, especially when it comes to medications. Patients should demand to know the price, and many doctors now oblige, and it would behoove hospitals to do the same.

Spoiler alert: It’s actually much cheaper just to pay a transparent fee for a specific service.

Denver, CO

SAVE THE DATE March 16-19, 2022

Program Chairs: Jacob Greenberg, MD, EdM and Archana Ramaswamy, MD, MBA

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The consumers drive demand and health care is no different. Buying insurance no longer guarantees a doctor’s time; on the contrary, it limits it. But going to a doctor doesn’t cost as much as a premium. With the advent of telemedicine, good doctors can see their patients more efficiently, lowering the cost for both the office and the patient. Hospitals can also change the equation by offering better access through pricetransparent models. There are a number of places where patients can find affordable options for pharmaceuticals, imaging and specialty care, including surgery. Primary care physicians have been the first to see the value in direct pay models, but now every specialty is joining the movement. Employers are discovering medical cost-sharing plans that save companies—big and small—millions of dollars, and as more physicians participate, the market will shift back to the patients. Even the government sees the benefit in direct pay models. The innovations in medicine in the past decade have been remarkable, but physicians and their patients can’t take advantage of all of them because of an archaic system built on principles that no longer apply. The best care is always found nearby, but when an employee works in another state, then what happens? The costs have not and will not be controlled by restrictive insurance networks. Coverage will always be necessary, but in a direct-pay world, the majority of encounters can be paid for out of pocket. In this case, less is more, and keeping people out of the doctor–patient equa■ tion saves both time and money. —Dr. Muto is a general surgeon; the founder and CEO of UBERDOC, a digital health platform connecting patients and doctors; and the director of the Vein Center at Muto Surgical, in North Andover, Mass. Dr. Muto’s Twitter handle is twitter.com/paulamutomd.

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IN THE NEWS

GENERAL SURGERY NEWS / JANUARY 2022

The Scientific Greats: A Series of Drawings By MOISES MENENDEZ, MD, FACS

Sven Ivar Seldinger (1921-1988) Central venous catheterization was first performed in 1929. Since then, central venous access has become a mainstay of modern clinical practice. It is likely that this procedure is being done in medical centers and clinics by the thousands around the world. From its infancy, central venous access was fraught with significant complications, and, at the time, difficult to master or even perform. Surgeons are also familiar with the classic venous cut-down for vascular access, which also carried the risk for complications and was difficult to perform. Arterial access was done in a similar way. Prior to using this technique, a common practice was to puncture the vein with a large needle, such as a 14 G, aspirate blood, and then immediately cannulate the vessel with a smaller-caliber catheter through the needle. This technique, like the others, was fraught with complications and later abandoned after the Seldinger technique became part of practice. At the end of the 20th century, no surgical procedure had more impact for its simplicity and ease of use than percutaneous vascular access. The most acclaimed pioneer of this technique was Sven Seldinger. Dr. Seldinger was a radiologist from Sweden who developed a technique for visualization of the human blood vessels. In 1953, he introduced the Seldinger technique as a method

CLASSIFIEDS

of obtaining safe access to blood vessels and other hollow organs. This technique remains the backbone of all modern-day interventional and endovascular procedures. The major advantage of the Seldinger technique is that it allows for the insertion of a catheter that is larger in diameter than the needle used. The Seldinger technique’s addition of a flexible, round-ended, metal leader (guide wire) was unique. The sequence included: • needle puncture of the vessel; • a guide wire threaded through the needle; • removal of the needle; • a flexible catheter threaded over a guide wire; and • removal of the guide wire. This process enabled a catheter of the same bore as the needle to be inserted percutaneously, rather than requiring surgical exposure or a large-bore needle. Today, it is used not only in radiology, but also in the emergency room, gastroenterology, thoracic surgery, cardiac surgery and other surgical specialties. Sven Seldinger was born in the small town of Mora, Sweden, where his parents ran the Mora Technical Sven Ivar Seldinger (1921-1988) Institute. He trained in medicine at the famed Karo2019 linska Institute, in Stockholm, from 1940 to 1948, and This work was done on an Arches white paper, went on to train in radiology at the Karolinska Hospi11 x 16, using only charcoal pencils. tal. He remained there for his entire career. Artist: Moises Menendez, MD, FACS Dr. Seldinger first published this technique for obtaining percutaneous access to blood vessels in 1953, in the journal Acta Radiologica. He described the method of using a catheter with the same size as the needle, and which was used at Karolinska Sjukhuset since April 1952. The main principle of the technique consisted of the catheter being introduced on a flexible leader through the puncture hole after withdrawal of the puncture needle. Dr. Seldinger also presented cases of arterial catherizations using his technique. Procedures were done using local anesthesia, and the complications were few and minimal. However, Dr. Seldinger’s chief at the Department of Radiology at the Karolinska did not think his invention and the obvious potential benefits—all the arteries in the human body could be reached by this simple procedure—were enough to form the basis for a thesis. So, Dr. Seldinger had to start on a second project—the development of percutaneous cholangiography. The Seldinger process of intravenous cannulation was a major advance in safety, reliability, reduction of complications, and the ability to place multilumen and specialty devices. One major difference from previous techniques was that the Seldinger technique used a much smaller needle to access the vessel, making it less prone to injure adjacent structures. In 1975, the New York Academy of Medicine gave Seldinger the Ferdinand C. Valentine Award. The Swedish Society of Medical Radiology and the German Roentgen Society awarded him an honorary membership to their organizations. In 1984, Dr. Seldinger received an honorary doctorate from the Faculty of Medicine at Uppsala University, in Sweden. He died at home in Dalarna, Sweden, on Feb. 21, 1998. He is survived by his wife and three daughters. ■

Sources Adas J, et al. Dr. Seldinger and his wire. Michigan College of Emergency Physicians. November/December 2016 Newsletter. Greitza T. Sven-Ivar Seldinger. Am J Neuroradiol. 1999;20(6):1180-1181. Seldinger SI. Catheter replacement of the needle in percutaneous arteriography: a new technique. Acta Radiologica. 2008;434:47-52. Smith RN, Nolan JP. Central venous catheters. BMJ. 2013;347:f6570. Sternbach G. Sven Ivar Seldinger: catheter introduction on a flexible leader. J Emerg Med. 1990;8(5):635-637. Van de Laar A. Under the Knife. A History of Surgery in 28 Remarkable Operations. St. Martin’s Press; 2018:87.

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KCENTRA® (Prothrombin Complex Concentrate [Human]) For Intravenous Use, Lyophilized Powder for Reconstitution Initial U.S. Approval: 2013

• Administer reconstituted Kcentra at a rate of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min (~210 units/min). Pre-treatment INR

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

Dose* of Kcentra (units† of Factor IX) / kg body weight Maximum dose‡ (units of Factor IX) *

† ‡

2–< 4

4–6

Not to exceed 2500

Not to exceed 3500

Not to exceed 5000

Dosing is based on body weight. Dose based on actual potency is stated on the vial, which will vary from 2031 Factor IX units/mL after reconstitution. The actual potency for 500 vial ranges from 400-620 units/vial. The actual potency for 1000 unit vial ranges from 800-1240 units/vial. Units refer to International Units. Dose is based on body weight up to but not exceeding 100 kg. For patients weighing more than 100 kg, maximum dose should not be exceeded.

---------------------------------DOSAGE FORMS AND STRENGTHS-------------------------• Kcentra is available as a white or slightly colored lyophilized concentrate in a single-use vial containing coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S. --------------------------------------CONTRAINDICATIONS -----------------------------------Kcentra is contraindicated in patients with: • Known anaphylactic or severe systemic reactions to Kcentra or any components in Kcentra including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin. • Disseminated intravascular coagulation. • Known heparin-induced thrombocytopenia. Kcentra contains heparin. ----------------------------------WARNINGS AND PRECAUTIONS---------------------------• Hypersensitivity reactions may occur. If necessary, discontinue administration and institute appropriate treatment. • Arterial and venous thromboembolic complications have been reported in patients receiving Kcentra. Monitor patients receiving Kcentra for signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thrombotic or thromboembolic (TE) event within the prior 3 months. Kcentra may not be suitable in patients with thromboembolic events in the prior 3 months. • Kcentra is made from human blood and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. -----------------------------------ADVERSE REACTIONS---------------------------------------• The most common adverse reactions (ARs) (frequency * 2.8%) observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. (6) • The most serious ARs were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis. To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring at 1-866-9156958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Revised: October 2018

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

FASTER ADMINISTRATION, LOWER VOLUME • Mean infusion time is under 25 minutes • ~85% less volume vs plasma

SUSTAINED INR REDUCTION‡ Statistically significant INR reduction sustained ≤1.3 for up to 8 or 12 hours vs plasma

January 2022 Print issue

Articles inside

Top Surgical Papers of Last Year Reviewed

Black Women and Breast Cancer

Responses to “The Most Harm” Opinion Article From Last Month