General Surgery News ( October 2020) by McMahon Group

OP INION

My Worst Surgical Error

Page 25

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

October 2020 • Volume 47 • Number 10

Awareness Key to Preventing OR Fires, Other Mishaps

Study Finds Wide Variation in Outcomes Among High-Volume Cancer Surgeons

By KAREN BLUM

he combination of oxygen, heat sources and alcohol-based skin preparations has the potential to cause fires that could harm patients and OR staff, a speaker said during the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons, held as a virtual meeting this year. Many people think of fires as a campfire with yellow flames reaching toward the sky, Edward Jones, MD, said in a session on serious mishaps in the OR. By contrast, most OR fires are fueled by an alcohol-based skin prep and appear as a blue flame, said Dr. Jones, an associate professor of surgery at the University of Colorado School of Medicine and the director of surgical endoscopy at Rocky Mountain

By CHASE DOYLE

igh-volume surgeons have been synonymous with high-quality care for decades, but new research is raising questions about the volume–outcome relationship. According to data presented at the SSO 2020 Annual Cancer Symposium, held virtually, not all high-volume surgeons at high-volume hospitals have optimal outcomes. Although findings from the retrospective analysis showed a significant association between high-volume surgeons at high-volume hospitals and improved postoperative outcomes, there also was wide variation in complication rates for each of the four high-risk cancer operations. In addition, wide variation in 90-day mortality rates was found for esophageal and pancreatic cancer resection, investigators of the study reported.

Continued on page 28

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OPINION

The Surgeon Of the Future

Research Reveals Disparities in Incisional Hernia Outcomes

By IOANA BAIU, MD, MPH

By MONICA J. SMITH

1953. Pump on. ... Increase flow. w. ... Cross-clamp on. When John Gibbon Jr. and d Frank F. Allbritten Jr. daringly performed the first open-heart surgery using a rudimentary cardiopulmonary bypass machine created in a lab, they did not hesitate. They were not afraid that the machine would ever take over the operation. Technology

New Orleans—New research on incisional hernia shows patients who fall into disadvantaged groups are more likely to present with surgical emergencies, and to experience the higher rates of complications and longer hospital stay associated with them. “Incisional hernia is largely preventable, and there are unique opportunities for intervention to avoid a much more difficult operation,” said Clarissa Mulloy, MD, a surgical resident. “Addressing this issue will lead to better outcomes and lower cost burden on the patient and the health care system.”

OPINION

The Virtual ACS Congress 2020 And Beyond By HENRY BUCHWALD, MD, PhD

Continued on page 30

Continued on page 4

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he American College of Surgeons has chosen as its theme for the 2020 Clinical Congress: The Joys of Learning, Collaborating and Givingg Back. In this cataclysmic year of COVID-19 with its fatalities, casualties and severe economic consequences, the Continued on page 27

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OCTOBER 2020 / GENERAL SURGERY NEWS

COMING NEXT ISSUE

Wound Care During COVID-19: How the Pandemic Reshaped Vascular Care in New York City

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Read the five most-viewed articles last month on generalsurgerynews.com.

‘There are an estimated 200 to 300 reported OR fire incidents, resulting in two to three deaths, annually. ... It only takes one bad case to not only result in patient harm but also in likely harm to the hospital and health system.’ From “Awareness Key to Preventing OR Fires, Other Mishaps,” Pages 1, 28

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Achieving the ‘Holy Grail’ in Laparoscopic Cholecystectomy

The Role of Robotics In Hernia Repair

The Era of Specialization Is Upon Us

Are We Shielding Residents From the Demands of Surgery?

Surprise Medical Bills: An Overview e ▼

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OPINION

GENERAL SURGERY NEWS / OCTOBER 2020

Surgitourism By FREDERICK L. GREENE, MD

ow that you have been intrigued enough by the title to continue reading, I am hopeful that you will take time over the next few minutes to escape from the really important issues that we are facing to contemplate a topic that perhaps might have alluded you over the last six months. Yes, I am referring to travel. In view of all the canceled professional meetings and restrictions that we face regarding both domestic and international excursions, I am sure that many yearn to escape from our Zoom-centered existence and actually look forward to attending an in-person meeting or educational course, or to take a vacation that still seems like a distant fantasy. As I opined in a recent editorial (“More Than CME,” January 2020), most of us, including myself, have missed opportunities to include memorable travel moments during jaunts for our professional educational needs. Now is the time to reflect on experiences lost and, more importantly, to develop a plan to create more memorable and noteworthy travel opportunities—hence, my neologistic creation, “surgitourism.” I am offering this new travel term to encourage all of us to enhance our appreciation of our surgical culture and heritage as we plan for those much-needed travel opportunities in the post–COVID-19 world. The melding of important sites relating to our surgical history with magnificent locations for travel is virtually unlimited. Think about those occasions to appreciate the beauty of our own United States. For me, travel to the mountains of North Carolina has afforded

Keats’ experience as a student of Sir Astley Cooper is annotated and reflected in many of his poems. instances for respite over these last Moving on to the European few months. While driving to continent, surgical traditions and Cashiers, N.C., I have reflected on culture can be appreciated in every the beautiful landscape and uticountry that we visit. Stopovers in lized the time to relive the region’s both Zurich and Vienna allow us rich history surrounding the High to pursue the rich heritage left to Hampton estate. Originally owned us by Theodor Billroth. Although by Wade Hampton II and his heirs, Billroth’s house in Vienna was the property was sold in 1890 to demolished in 1906, a memorial a niece, Caroline Hampton and plaque at Alser Straße 20 placed her new husband, Dr. William in 1981, the centennial of the first Halsted. This obviously is a mustsuccessful gastrectomy by Billroth, see on your surgitourism itinerary. indicates the former site. One of If Boston fits into your travel plans, my favorite cities, Bern, Switzera visit to the Ether Dome at Masland, holds a treasure trove for us sachusetts General Hospital is also The Ether Dome at Massachusetts since Emil Theodor Kocher was a must. If you get to the Twin Cit- General Hospital. born and spent his career here. ies, seek out Harriet Island Region- Credit: Ravi Poorun/Wikimedia Commons This treatise is certainly not al Park in St. Paul, Minn. While meant to be an exhaustive travelreally no longer an island, this property was once owned ogue, but serves only as a potential stimulus and incenby Dr. Justus Ohage who performed the first cholecys- tive as we plan our post-pandemic lives. It is safe to say tectomy in the United States. that all of us will look at the world and our future a litEventually, we will have prospects of traveling inter- tle differently as we attempt to return to normalcy. We nationally. These are truly exceptional occasions to will undoubtedly have a heightened appreciation of our practice surgitourism. When traveling to the United ability to travel and observe our world through a much Kingdom, spending time at the Gordon Museum of different lens. As we hopefully resume our traditions Pathology at Guy’s Hospital and King’s College Lon- in 2021 and beyond of attending in-person meetings, don can really unite us with our surgical roots. One of educational courses and opportunities to experience my favorite haunts in London is the home of John Keats our beautiful country and the world, we must never, in the idyllic area of Hampstead, located in the Lon- ever again take these opportunities and what they don Borough of Camden. Here, at the Keats House, offer us for granted. Bon voyage on your surgitourism you can see the notebook that John Keats kept dur- experience! ■ ing his study as a surgical dresser at both Guy’s and St. Thomas’ Hospitals. Although not technically a surgeon, —Dr. Greene is a surgeon in Charlotte, N.C.

Research Reveals Disparities in Incisional Hernia Outcomes continued from page 1

Based on reports in the ventral hernia literature, Dr. Mulloy and her colleagues at Louisiana State University in New Orleans hypothesized that patients in minority groups—such as older patients, female patients, those at lower socioeconomic levels (using insurance status as a surrogate), and nonwhite race—will present more frequently with emergent/ urgent incisional hernia cases compared with majority group members. For the study, the researchers obtained data on admissions related to incisional hernia from the Healthcare Cost and Utilization Project National Inpatient Sample from 2012 to 2014. Their biostatistician performed analyses in two tiers; a database characterized admission type as elective, emergent admissions (people who came through the emergency department), and urgent (everyone not in the first two groups). The study included a total of 39,296 cases, most of which were elective (61%). There was a significant difference in the rate of urgent admissions between age groups, with the greatest proportion seen in patients over 65 years of age.

Similarly, women accounted for 40% of urgent admissions, while men accounted for 35%. In terms of socioeconomics, self-paying patients had the highest proportion of urgent admissions followed by patients with Medicaid coverage.

White patients made up the lowest proportion of urgent cases, while Black patients had the highest rate of urgent admissions. When controlling for age, insurance status and sex, race disparities remained significant. “The lowest proportion of urgent admission was among patients with private insurance,” Dr. Mulloy said, who is now a surgical resident at Temple University, in Philadelphia. White patients made up the lowest proportion of urgent cases, while Black patients had the highest rate of urgent admissions. When controlling for age, insurance status and sex, race disparities

remained significant. “Compared with white patients, the odds of admission being urgent were significantly higher for racial minorities; it was highest amongst Black patients,” Dr. Mulloy said. In the future, she and her colleagues plan to compare local outcomes with national findings and use that information to develop and fund clinical trials aimed at addressing the disparities in incisional hernia presentations. Dr. Mulloy presented her research, which she described as the first nationallevel health disparities study of incisional hernia, at the 2020 Southeastern Surgical Congress. “As we continue to work to improve health disparities in America, we first need to identify them and understand their underlying causes,” said Jessica Burgess, MD, an assistant professor of surgery at Eastern Virginia Medical School, in Norfolk, who had a couple of questions for Dr. Mulloy. “Patients who present for emergent/urgent hernia repairs have a higher rate of complication and increased

cost associated with their hospitalization. Do you advocate for more elective repair instead of watchful waiting in these atrisk populations? Also, what do you think is a possible solution to this problem?” Dr. Mulloy said she and her colleagues support early repair for patients at the highest risk for urgent care, particularly self-paying patients. “We think it’s better to intervene early, when cases are still elective.” As for possible solutions, she and her team have come up with two complementary strategies, the first of which is surgeon and physician education, “as we are the ones who have to educate our patients on the risks of taking a watchand-wait approach to incisional hernia,” Dr. Mulloy said. “The second component is prevention of incisional hernia to avoid the problem entirely.” Recent work from her group has found a 60% to 80% reduction in incisional hernia formation using amniotic tissues. “Prophylactic mesh reinforcement of laparotomy closures has also been shown to be effective at preventing incisional hernia,” she said. ■

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IN THE NEWS

GENERAL SURGERY NEWS / OCTOBER 2020

Choice of Prophylactic Mastectomy Driven Strongly by Emotion Randomized Controlled Trial Shows Fear and Anxiety Increase Perceived Risk of Recurrence By MONICA J. SMITH

ome retrospective studies have suggested that negative emotions, such as anxiety and fear, have profound influence over patients with breast cancer who choose contralateral prophylactic mastectomy when less invasive procedures are an appropriate option. Now, a randomized controlled trial supports these findings. “As we are all aware, rates of CPM for early-stage breast cancer continue to rise even though no study has shown a survival benefit. There are many proposed reasons for this, including emotion, though the mechanisms for this influence on decision making remain unclear, and no study has shown causality between emotion and choice of surgery,” said Andrea Merrill, MD, a surgical oncology fellow at the Ohio State University, in Columbus. Based on the principles of decision psychology, Dr. Merrill and her colleagues hypothesized that negative emotions toward breast cancer sway patients in favor of CPM in two ways: by increasing their perceived risk for future breast cancer, and by rendering CPM a more attractive option. They tested their hypothesis by randomizing 1,030 women aged 30 to 59

High Volume continued from page 1

“Overall, Leapfrog [Hospital Safety Grade] annual volume standards for surgeons and hospitals are associated with significantly better postoperative outcomes, but there’s wide variation in outcomes across high-volume surgeons at highvolume hospitals,” said lead study author Christopher Aquina, MD, MPH, a complex general surgical oncology fellow at the Ohio State University Wexner Medical Center, in Columbus. “Therefore, volume alone should not be used in assessing quality of care or for credentialing purposes.” As Dr. Aquina reported, the relationship between higher procedure volumes and better outcomes in cancer surgery has been observed since the late 1970s. Based on this association, the Leapfrog group identified minimum surgeon and hospital procedure volume standards for high-risk surgical oncology procedures, including esophagectomy, lung resection, pancreatectomy and proctectomy. According to Dr. Aquina, however, recent studies have had conflicting results regarding the association between Leapfrog volume

years, with no personal or family history of breast cancer and no known BRCA1/2 mutation, to one of three narratives about being diagnosed with breast cancer and making decisions about surgery. “The narratives were designed to invoke very negative, negative or less negative emotion about breast cancer and were based on real-life online patient stories,” Dr. Merrill said. Here are two contrasting excerpts of what participants read: • “I felt terror. I felt the camera lens of my life, the aperture closing for good. I thought this is it; I’m going to die. Despair sucked each step, each breath. Grief smothered us.” • “I knew then and there that I had to be ready to fight, and I was not going to back down no matter how bad it was.” After reading their assigned narrative, participants were given information about breast cancer treatments and the risk for future breast cancer. The researchers assessed participants’ emotions by applying the holistic, unipolar, discrete emotion (HUE) measure and the Self-Assessment Manikin scale. Patients assigned to the less negative narratives had lower HUE scores than those assigned to the negative and very negative narratives. “More negative emotion resulted in greater perceived risk of breast

outcomes and thresholds. Furthermore, variation in outcomes among high-volume surgeons at high-volume hospitals that meet this standard is unknown. For this study, Dr. Aquina and his colleagues searched the Medicare 100% Standard Analytic File for esophagectomy, lung resection, pancreatectomy and proctectomy for cancer between 2013 and 2017. The researchers then assessed the association between Leapfrog annual volume standards for surgeons and hospitals and postoperative outcomes. Variation in outcomes across high-volume surgeons of high-volume hospitals also was assessed. For secondary analyses, Dr. Aquina and his colleagues used the Statewide Planning and Research Cooperative System (SPARCS), an all-payor hospital discharge database in New York state. As Dr. Aquina reported, approximately 120,000 patients and 55,000 patients were included in the Medicare and SPARCS cohorts, respectively. In the Medicare cohort, high-volume surgeons at high-volume hospitals were independently associated with lower riskadjusted odds of postoperative complications for each of the four operations, Dr. Aquina said. High-volume surgeons at

cancer recurrence. As negative emotions increased, so did the perceived risk of future breast cancer in all of these scenarios,” Dr. Merrill said. “Those who read the less negative narrative were less likely to choose CPM than those in the negative or very negative group.” To Julie Margenthaler, MD, a professor of surgery at Washington University School of Medicine in St. Louis, the study’s data clarify an issue breast surgeons recognize but is difficult to quantify.

‘More negative emotion resulted in greater perceived risk of breast cancer recurrence. As negative emotions increased, so did the perceived risk of future breast cancer in all of these scenarios.’ —Andrea Merrill, MD “We’re all very concerned about the increasing trend of CPM in women who are not at increased risk, but no one has figured out how to tackle this issue other than education and talking through patient concerns.” Noting that she personally does not have any training in counseling patients from a psychological

high-volume hospitals also were independently associated with lower odds of 90-day mortality across each of the four operations. Aside from a lack of an association between high-volume surgeons at high-volume hospitals and complications for esophagectomy, the results in the SPARCS cohort were nearly identical to those of the Medicare cohort, Dr. Aquina reported. Despite this association, researchers also identified wide variation across high-volume surgeons at high-volume hospitals in both cohorts. For the average patient at the average high-volume hospital, said Dr. Aquina, there was a twofold difference in the adjusted complication rate between the best- and worst-performing high-volume surgeons for all four operations. Furthermore, there was fourfold variation in the adjusted 90-day mortality rate among patients undergoing esophagectomy by high-volume surgeons at high-volume hospitals. The researchers acknowledged limitations of the study. Because Medicare and SPARCS consist of administrative data, said Dr. Aquina, they are susceptible to coding errors and have limited clinical

standpoint, Dr. Margenthaler added, “This is something that we, as breast surgeons, may need some assistance with.” When patients initially receive a diagnosis of breast cancer, psychological counseling tends to take a back seat to what doctors and other members of the care team may perceive as more pressing matters, such as decisions around surgery, radiation and chemotherapy, Dr. Margenthaler said. At her institution, the general practice had been to screen new patients with breast cancer for distress and refer them to counseling services. But just recently, counseling services have become part of the initial meeting among patients and their care team. The change has been well received by patients. “This study really drives home the point that we need to have our psychology colleagues involved early in the process, rather than down the road,” Dr. Margenthaler said. But what the study did not investigate are other factors that would influence decision making in patients who have been exposed to the very negative narrative. “It’s hard to know what their social support system was like, what their socioeconomic status is, other stresses going on in their life. All of that is going to play a big part in shaping their decision, I would expect,” Dr. Margenthaler said. ■

and operative information. Notwithstanding these limitations, the study had a large cohort size that included 175,000 patients of all age ranges, he added. “This is the first study to evaluate variation outcomes across high-volume surgeons at high-volume hospitals,” Dr. Aquina concluded. “Our findings support tracking of individual surgeon outcomes, either at the institutional level or through the National Registry.” Moderator of the session, Adam Yopp, MD, an associate professor of surgical oncology at UT Southwestern Medical Center, in Dallas, noted that high-volume surgeons at high-volume centers might be performing more complex cases compared with lower volume surgeons, and that this could account for the discrepancy in outcomes. According to Dr. Yopp, it’s also possible that the Leapfrog annual volume standards for surgeons are wrong. “There may be an inflection point where patients are doing better on a continuous scale by [number of ] surgeries,” he said. “By using the Leapfrog data, there’s an a priori conclusion that this is the golden standard, but maybe it’s not.” ■

IN THE NEWS

OCTOBER 2020 / GENERAL SURGERY NEWS

Fit and Efficacy Deteriorate With Reuse of N95 Masks By BRIAN DUNLEAVY

early half of all N95 masks worn by anesthesiologists during the COVID-19 pandemic fail fit tests after four days of reuse, according to an analysis published on June 26 by the British Journal of Anaesthesia (doi. org/10.1016/j.bja.2020.06.023). The results, based on assessments performed on 74 anesthesia providers at Washington University School of Medicine in St. Louis (WUSTL) in April and May, suggest that many of the masks being worn by health care professionals during the height of the SARS-CoV-2 outbreak in the United States did not provide an adequate “seal to the face … to ensure small aerosolised droplets are filtered,” the researchers said. “In most cases, simply wearing a disposable [N95] respirator eventually damages it to the point it can no longer form a seal to the face,” said study co-author Ryan Guffey, MD, an assistant professor of anesthesiology at Barnes-Jewish Hospital/WUSTL. In general, “risk of seal or fit failure increases with the amount of time the respirator has been worn,” he added. Shortages of N95 masks and other personal protective equipment (PPE) at hospitals across the country have been well documented. Lack of available masks has forced many hospitals to encourage staff to reuse them—following cleaning and decontamination. For their research, Dr. Guffey and his colleagues performed repeat N95 fit testing on 74 anesthesia providers, 46 of whom were women and 28 of whom were men. Overall, they found that female anesthesiologists were more likely to fail fit testing (63%) than their male colleagues (29%). Failure rates were 46% after four days of wear, 50% after 10 days, and 55% after 15 days. N95 respirators that failed fit testing were worn a median of eight days and used a median of 18 times, the researchers reported. However, 73% of users with N95 masks that failed testing believed their respirators fit well, while testers believed that 89% of N95 masks with failed fit tests “were of good or like new quality,” the researchers said. “Despite being trained on user seal testing, participants could not reliably detect poorly fitted respirators without formal fit testing,” Dr. Guffey said. Based on their findings, he and his colleagues recommend that, if local supplies allow, use of disposable N95 respirators be based on CDC guidelines, which limit reuse to five times (cdc.gov/ niosh/topics/hcwcontrols/recommend-

edguidanceextuse.html). “This corresponds to one to two shifts for health care workers with exposure to patients with COVID-19 in our study population,” Dr. Guffey said. Use of reusable elastomeric respirators can help decrease disposable N95 demand, he added, as can universal COVID-19 testing before hospital admission. In addition, universal

masking of patients also can decrease risk for virus transmission and, thus, N95 demand, according to Dr. Guffey. “As testing becomes more accessible, we should advocate for single use with N95 masks in patients that are confirmed positive,” said Bryant Tran, MD, FASA, an assistant professor of anesthesiology and the director of the Regional Anesthesia and Acute Pain Medicine Fellowship at Virginia Commonwealth University Medical Center, in Richmond,

who was not involved in the WUSTL study but has published research on similar topics (Geriatr Orthop Surg Rehabil 2020;11:2151459320930554). “This is especially important for [clinicians] who are performing high-risk aerosolizing procedures such as intubations,” he continued. “With a PPE shortage, reuse of N95 masks may be most appropriate in patients who are undergoing an aerosolizing procedure and have ■ tested negative for the coronavirus.”

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EXPAREL is indicated for single-dose inﬁltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efﬁcacy have not been established in other nerve blocks.

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.

Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. Adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via inﬁltration were nausea, constipation, and vomiting; adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via interscalene brachial plexus nerve block were nausea, pyrexia, and constipation. 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 population: patients <18 years old 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.

For more information, please visit www.EXPAREL.com or call 1-855-793-9727. Please refer to brief summary of Prescribing Information on adjacent page. References: 1. Lambert WJ, Los K. DepoFoam® multivesicular liposomes for the sustained release of macromolecules. In: Rathbone MJ, Hadgraft J, Roberts MS, Lane ME, eds. Modiﬁed-Release Drug Delivery Technology. Vol 2. 2nd ed. New York, NY: Informa Healthcare USA, Inc; 2008:207-214. 2. Gorﬁne SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011;54(12):1552-1559. 3. Data on File. 6306. Parsippany, NJ: Pacira BioSciences, Inc.; July 2020.

GENERAL SURGERY NEWS / OCTOBER 2020

Lessons in Insignificance By BARRET HALGAS, MD

‘Undoubtedly, philosophers are in the right when they tell us that hat nothing is great or little otherwise than by comparison.’ —From “Gulliver’s Travels” by Jonathan Swift

he residents’ mail was delivered halfway through morning clinic, and

Brief Summary (For full prescribing information refer to package insert) INDICATIONS AND USAGE EXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and 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 amide-containing 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 18 years old • 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 Nerve Block Clinical Studies The safety of EXPAREL was evaluated in four randomized, double-blind, placebocontrolled 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. 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 co-administration 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.

I opened o a letter from a regional referral center in my area. I had ha referred a patient months ago ag for consideration for organ transplant, and this letter was informing me that he/ she was not currently eligible but could be at some point in the future. This was a monumental decision after months of studies and appointments. The patient I saw just before opening

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 embryo-fetal 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) 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 Safety and effectiveness in pediatric patients have not been established. 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

the letter was a routine post-op after removing some residual shrapnel debris that was causing chronic pain. The surgery had lasted all of 15 minutes, but appeared to significantly improve his symptoms. There was an irony between these two unrelated events. The letter, written on cardstock with a glossy letterhead in the left-hand corner, presented an obvious importance. Then there was the almost insignificance of removing a sub-centimeter fragment of metal

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 for injection 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. • 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 in Adults Local Analgesia via Infiltration 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. Regional Analgesia via Interscalene Brachial Plexus Nerve Block 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 November 2018

I want surgical interns to understand that significance is defined by the patient, and not the operation.

from my patient. And I realized in that moment that the reason I love general surgery is because it glorifies the minutia and the hundreds of small ailments that introduce fear and pain into our patients. Before anything that resembled surgery today, barber-surgeons in London attempted any procedure that required a steady hand and a sharp knife. The company of men represented everything that the Royal College of Physicians looked down upon. With no formal education other than a crude apprenticeship, they were available to trim beards, bathe wounds, lance boils, pull teeth, suture and amputate. These menial public services were well beneath the physicians of the day, either thought of as too trivial or too demeaning. Now we offer complex operations, aided by technology, some that require collaboration with other services, using multiple platforms for approach. But these big moments are only possible because surgeons found significance where others found none. Without exception, surgery residents are drawn to the big operations. To come out on the other side of a Whipple or retroperitoneal sarcoma resection feels important, and it should. I’m sure that in every training program, an inguinal hernia repair has, at some point, been labeled an “intern case;” or an upcoming adrenalectomy, a “chief case.” This kind of vocabulary is perpetuated in residency, by residents. I understand the intent behind these labels. It implies that the intern, at their current level of training, will maximally benefit from performing an inguinal hernia repair. They are, or should be, familiar with the

IN THE NEWS

OCTOBER 2020 / GENERAL SURGERY NEWS

Retiring Surgeon Follows Passion, Transitions To Coaching Position By MONICA J. SMITH

anatomy and are technically capable of performing a lasting repair. To the latter point, the chief will benefit from reviewing the workup of an adrenal mass, should have a better grasp of the anatomy and approach, and has performed enough complex laparoscopic cases to be proficient—and not spend half the time trying to find their nondominant hand. But these categories, I think, unintentionally embed a bias that hernias are somehow less important, or less significant, then an adrenalectomy. I want surgical interns to understand that significance is defined by the patient, and not the operation. One of my mentors told me that he receives more gifts after a lateral internal sphincterotomy than any other operation. There will never be a day when surgical interns don’t try to “out-operate” each other. But I hope the reason is because they want more complexity, more knowledge and more opportunity, and not because they are blind to the importance even a small operation can have on a patient. Interns, go see the splinter or blister down in the emergency department when they call you. Inspect the IV the nurse just placed on your patient. Close the incision perfectly after standing for six hours with the suction. Do the small things other people don’t care to do. Find purpose in the insignificant. Because at the end of the day, there is literally noth■ ing beneath a general surgeon. —Dr. Halgas is a chief surgical resident in El Paso, Texas. His columns on surgical residency appear every other month.

hile surgeons’ attitudes toward retirement vary widely, many try to find a way to continue contributing to the profession, applying the wisdom they’ve gained over the course of their surgical career. As Carlos Pellegrini, MD, approached retirement from his position as the chief medical officer (CMO) at the University of Washington‒Seattle, he embarked on training to be a coach for medical professionals and leaders. “It was a great way for me to continue to do the same kind of work that, in a way, I had been doing before, though coaching is different from teaching and mentoring and does use additional tools,” Dr. Pellegrini said. As part of the executive coaching team for Marquis Leadership, Dr. Pellegrini focuses primarily on two aspects of professional development: coaching individuals interested in broadening their leadership potential and working with institutions to foster a culture of professionalism. “That can include developing codes of professional conduct, cultivating diversity and inclusion, working on programs to promote health care equity, and developing an appropriate work force—essentially, understanding how human beings fulfill the needs they have,” Dr. Pellegrini said. Coaching builds on the teamwork aspect of surgery that Dr. Pellegrini found deeply satisfying, and that he credits for staving off the burnout that plagues many surgeons today. “When I got called in the middle of the night to the emergency department, I had the privilege of being needed by a patient—we all want to be needed—and of interacting with my colleagues, my friends. To me, this was far greater than the problems related to electronic health records, bureaucratic regulations and loss of autonomy,” he said. “Leading a team means to establish a norm of conduct and compassion for one another as well as for the patient; the satisfaction of the patient is the triumph of the team,” he noted. Coaching would seem a natural extension of Dr. Pellegrini’s

work at the University of Washington. When he was first appointed the chair of the Department of Surgery, one of his tasks was to recruit new hires. “I had the obligation of looking after these people, helping them develop their skills and assets to the full extent of their capability.” On the verge of retiring from that position, Dr. Pellegrini was asked to take on the position of CMO and vice president of medical affairs, overseeing the entire clinical workforce. He did this for three years. “In both positions, my focus was on developing people and on helping people develop themselves,” he said. As Dr. Pellegrini approached retirement, it was clear he wanted to find a way to continue helping people achieve professional fulfillment, but he would need additional training to do so. He found the tools he needed in a one-year course with SeattleCoach, a coaching consulting firm. “It’s a modular program,” Dr. Pellegrini explained. “You can expand on the number of tools you have, from coaching individuals to coaching groups and so forth. I took the modules, fulfilled my requirements, got certified and started coaching.” Dr. Pellegrini joined Marquis Leadership about four months after he retired from the University of Washington and has now been there nearly a year. He also continues to volunteer with the American College of Surgeons and is a member of the Joint Commission. He intends to continue coaching as long as it makes sense. “As long as I feel I bring value to what I’m doing, and so long as there is interest on behalf of others to hire me, I will continue doing it. This is something I feel very happy doing right now,” Dr. Pellegrini said. “At some point I’ll have to stop, but I don’t see that happening for at least three to five years.” He encourages other surgeons to pursue their interests after retirement. “If there are areas or issues where you have passion, there’s no reason not to explore them. Surgeons can contribute substantially after their retirement that may help them to continue to feel relevant while also helping human■ ity at large.”

‘If there are areas or issues where you have passion, there’s no reason not to explore them. Surgeons can contribute substantially after their retirement that may help them to continue to feel relevant while also helping humanity at large.’ —Carlos Pellegrini, MD

IN THE NEWS

GENERAL SURGERY NEWS / OCTOBER 2020

When a Cough Can Kill: How Hospital HVACs Fight COVID-19 By ALISON McCOOK

t a hospital in Wuhan, China, a group of investigators swiped swabs over high-touch areas such as computer mice, bed handrails and trash cans, all of which tested positive for the virus that causes COVID-19. Perhaps most concerning, traces of the SARS-CoV-2 virus were present in the air. Like influenza, COVID-19 is transmitted by respiratory droplets, which can linger in an enclosed space for more than 10 minutes. A patient who asks for a glass of water in a crowded hospital hallway can generate thousands of droplets per second. What happens to the person without a mask who steps into that air space? Fortunately, hospitals have spent centuries improving infrastructure to prevent airborne transmission of other potentially deadly pathogens, such as the virus that causes measles, which can float in the air for up to two hours after an infected person coughs or sneezes. That infrastructure includes an intricate web of air filters and strict practices when treating patients who have (or may have) a contagious disease, with special attention paid to where procedures can generate droplet-rich aerosols. Preventing airborne transmission of deadly diseases in hospitals “is a huge concern,” Michael J. McDavid, a technical sales representative for Professional Abatement and Remediation Technologies (PART) LLC, said. Although some hospitals are taking extra precautions because of COVID-19, he said he is “cautiously optimistic” that the same techniques that reduce the risk for measles, tuberculosis and other contagious diseases will work for COVID-19. For companies like his, which have worked for years on air quality in health care settings, the new coronavirus is “just another pathogen we’re dealing with now. Nothing else has changed.” For a symbol of the fight against airborne transmission in hospitals, look no farther than Florence Nightingale, who advocated in the 1800s that facilities should take steps to improve ventilation. Over the years, hospitals have gradually developed more sophisticated building designs, always finding ways to improve air quality. “It’s a science that is continually evolving,” Mr. McDavid said. Most facilities are now airtight, he said, bringing in 100% of their air from the outside, and exhausting any contaminants to the outside. Before COVID19, their primary concern was mold. “You bring in a lunchbox or other materials from the outside, and that introduces mold,” Mr. McDavid said. “It’s

everywhere all the time, even in the most sophisticated system in the world.” Hospitals have elaborate filtration systems in place, including several banks of filters in various locations. When air is taken in from the outside, it typically passes through a prefilter, which cleans the air before it hits any equipment in the hospital’s heating, ventilation and air conditioning (HVAC) system. The air then travels through a return fan, then the heating and cooling components,

another set of pre-filters, and the final filters—which, in the OR, are often high-efficiency particulate air (HEPA) filters. These are not the one- or twoinch HEPA filters the average person can buy, Mr. McDavid said. “These things are three feet deep.” Air ducts are cleaned regularly, according to Mr. McDavid, an instructor for the National Air Duct Cleaners Association’s Certified Ventilation Inspector certification training course. The NADCA’s

Assessment, Cleaning and Restoration standard recommends annual inspections of air-handling units, supply and return/ exhaust ducts in health care facilities. “Proper assessment, maintenance and cleaning of the HVAC system is important to ensure the system is operating properly and appropriate air exchange and filtration is maintained,” Mr. McDavid, whose employer, PART LLC, is also a member of the NADCA, added. If a contagious patient must undergo

L I

IN THE NEWS

A bad HVAC system is bad for COVID-19. Earlier this year, researchers showed how one asymptomatic person likely infected nine others after all of them ate at the same restaurant, perhaps via strong airflow from the air conditioner, which spread virus-laden air between three tables.

a surgical procedure, it takes place in an airborne infection isolation room, which uses negative pressure to exhaust all air to the outside, passing through HEPA filters along the way, Amber Wood, MSN, RN, the senior perioperative practice specialist with the Association of periOperative Registered Nurses, said. Negative pressure can increase the risk for surgical site infection, so facilities often operate in a positive pressure OR and adopt additional protective measures, such as limiting staff (all of whom must wear higher level respirators, or N95 masks), using a portable HEPA filter or ultraviolet germicidal irradiation to clean the OR air and waiting for a 99% exchange of new air before using the space for other patients, Ms. Wood said. But even these extra precautions aren’t foolproof. Last year, the CEO of Seattle Children’s Hospital revealed that, since 2001, several children had died from Aspergillus mold, spread into ORs via contaminated air (www.seattletimes. com/seattle-news/times-watchdog/ mold-infections-at-seattle-childrenshospital-tied-to-14-illnesses-six-deathssince-2001/). A bad HVAC system is bad for COVID-19. Earlier this year, researchers showed how one asymptomatic person likely infected nine others after all of them ate at the same restaurant, perhaps via strong airflow from the air conditioner, which spread virus-laden air between three tables (Emerg Infect Dis 2020 Jul. doi: 10.3201/eid2607.200764). The virus is present in stool, so any traces in toilets can become aerosolized from a flush, Lidia Morawska, PhD, the director of the International Laboratory for Air Quality and Health at the Queensland University of Technology, in Brisbane, Australia, said. Indeed, a study of two hospitals in Wuhan, China, found elevated levels of SARS-CoV-2 RNA in aerosols taken from patients’ toilet areas (Nature 2020. doi: 10.1038/ s41586-020- 2271-3). Because much about the airborne spread of the new virus remains unknown, some experts are looking to another virus for clues: SARS-CoV-1, which caused outbreaks of severe acute respiratory syndrome in the early 2000s. Researchers have documented numerous cases when the virus may have spread through the air, including in hospitals (Indoor Air 2004;15:83-95). One outbreak occurred after a patient with diarrhea visited a Hong Kong housing complex and used the toilet; soon after, more than 300 residents were infected (J Epidemiol Community Health 2003;57:652-654). Given the concerns about potentially high airborne levels in bathrooms, Dr. Morawska recommended that hospitals continued on page 26

IN THE NEWS

GENERAL SURGERY NEWS / OCTOBER 2020

Steroids Found to Improve Survival of Critically Ill COVID-19 Patients By MARIE ROSENTHAL

teroids appear to improve the survival of the sickest COVID-19 patients, by dampening the cytokine storm, according to three recent reports in JAMA—one of them a meta-analysis. As a result, the World Health Organization issued a new guideline recommending systemic corticosteroids for the treatment of patients with severe and critical COVID-19. However, the guideline suggested that corticosteroids not be used for those with mild disease. The WHO said treatment in mild COVID-19 cases brought no benefits, and could even prove harmful. Steroids appear to work by calming the inflammatory response, which occurs when the body’s immune system overreacts, damaging the lungs and surrounding tissue in seriously ill COVID-19 patients. “There is now strong evidence to suggest that the blockade of inflammation in COVID-19 is effective in severely ill patients,” said C. Michael White, PharmD, FCP, FCCP, the department head and a professor of pharmacy practice at the University of Connecticut School of Pharmacy, in Storrs. Dr. White was not part of the studies but has conducted systematic reviews into other treatment options for COVID-19 and was asked to comment. The meta-analysis reviewed seven randomized clinical trials from 12 countries with a total of 1,703 critically ill patients with COVID-19 comparing corticosteroids with the standard of care. The trials studied three different corticosteroids—dexamethasone, hydrocortisone and methylprednisolone—and the authors analyzed the results of the RECOVERY, REMAPCAP, CoDEX, CAPE COVID and three additional trials. The primary end point was risk for death after 28 days. Fewer people receiving any type of systemic steroid died (222/678; 33%) than those who did not receive steroids (425/1,025; 41%) (JAMA 2020 Sep 2. [Epub ahead of print]). Dexamethasone had the largest populations studied and was the only steroid with significant survival benefits in a subgroup analysis (36% reduction in odds), but hydrocortisone had almost the same reductions in odds (31%) and just missed significant findings. Methylprednisolone was only assessed in a single small trial and the odds reduction was a nonsignificant 9%, but with a very large confidence interval. The meta-analysis helped to clarify whether the benefit from steroids seen in the earlier RECOVERY trial was due to dexamethasone or was a class effect, but this pooling of data seems to point to a class effect, according to Steven J. Martin, PharmD, BCPS, FCCP, FCCM, the dean and a professor of Ohio Northern University Rudolph H. Raabe College of Pharmacy, in Ada. Dr. Martin did not participate in the studies. “I believe the RECOVERY trial’s use of dexamethasone led to the early speculation that that drug may be preferred, but the other two trials with hydrocortisone and methylprednisolone also demonstrated positive benefits. Thus, at this point, one would conclude that this is a class effect,” Dr. Martin explained. The CoDEX trial supporting the use of dexamethasone was performed in Brazil. This open-label, multicenter, randomized clinical trial of 299 patients with COVID-19 and moderate or severe acute respiratory distress syndrome compared IV dexamethasone plus standard of care with standard of care alone. They saw a statistically significant increase in the number of days patients were alive and free from mechanical ventilation.

‘I believe the RECOVERY trial’s use of dexamethasone led to the early speculation that that drug may be preferred, but the other two trials with hydrocortisone and methylprednisolone also demonstrated positive benefits. Thus, at this point, one would conclude that this is a class effect.’ —Steven J. Martin, PharmD, BCPS, FCCP, FCCM The dexamethasone group had a mean of 6.6 days off the ventilator (95% CI, 5.0-8.2) versus four days in the standard of care group (95% CI, 0.2-4.38; P=0.04), but there was no mortality difference between both groups (JAMA 2020 Sep 2. [Epub ahead of print]). An international group in the REMAP-CAP trial looked at whether hydrocortisone also had promising effects on critically ill patients with COVID-19 (JAMA 2020 Sep 2. [Epub ahead of print]). In the randomized hydrocortisone study, 403 patients with suspected or confirmed COVID-19 who required respiratory or cardiovascular organ support, such as mechanical ventilation or drugs to support their blood pressure, were enrolled between March and June 2020. The cohort included patients of mixed ethnicities in the United Kingdom, Ireland, Australia, the United States, the Netherlands, New Zealand, Canada and France. One group was treated with a fixed dose of 50 mg of hydrocortisone four times per day for seven days; another group was treated with hydrocortisone only if their blood pressure dropped; and a third group received no hydrocortisone. The results showed that using the fixed dose of hydrocortisone led to a 93% chance of a better outcome—greater chance of survival and less need for organ support—than not using hydrocortisone. If the hydrocortisone was given only when the blood pressure was low, the chance of a better outcome was 80%. (This study stopped recruiting patients early after the RECOVERY trial published data in early June, suggesting dexamethasone boosted recovery (N Engl J Med 2020 Jul 17. [Epub ahead of print]. doi: 10.1056/NEJMoa2021436). “The data seemed clearest for dexamethasone, but in totality they all worked,” said Shmuel Shoham, MD, an associate professor of medicine at the Johns Hopkins University School of Medicine, in Baltimore. Dr. Shoham was not part of the studies but has been involved other treatment studies for COVID-19 and sits on the COVID-19 treatment guideline panel of the Infectious Diseases Society of America. “That does not mean it is better than the other ones,” he said. “If available, it might still make sense to use dexamethasone as a first option, but it looks like it is the class effect rather than individual corticosteroids that is important.” Hydrocortisone has mineralocorticoid effects that produce a positive sodium balance and higher serum

sodium concentrations, increased extracellular fluid volume, hypokalemia and alkalosis, Dr. Martin explained. “Expanded extracellular fluid is generally a good thing in shock, but alkalosis can worsen oxygenation if the pH becomes too high. Hypokalemia can cause heart rhythm disturbances if too low. Dexamethasone doesn't have mineralocorticoid activities, and I can't tell whether that was a good thing or bad thing in these studies. “There are potency differences, but the dosing of the drugs was adjusted to account for those differences,” he said. “At this point, one would conclude this is a class effect.” Dr. White agreed: “While dexamethasone has the strongest data set showing benefit, hydrocortisone is a very reasonable alternative. Methylprednisolone had too small a trial to make a meaningful determination of its efficacy; the 95% confidence interval was very wide. But in equipotent doses, there is reason to believe from other inflammatory diseases that methylprednisolone could also be an alternative if dexamethasone and hydrocortisone were unavailable.” This is an important consideration because “dexamethasone was one of the drugs on back order and shortage since the initial RECOVERY trial results came out, so being able to diversify to other corticosteroids would help meet demand,” Dr. White explained. Dosing seems to be an important consideration, according to Drs. White and Martin, and lower doses appear to be as effective as higher ones. “I have to believe dose is important,” Dr. Martin said. “The dosing for the trials in the meta-analysis was varied. In trials that administered low doses of corticosteroids, the overall fixed-effect OR [odds ratio] was 0.61, and the corresponding absolute risk was 29% for low-dose corticosteroids versus an assumed risk of 40% for usual care or placebo. In trials that administered high doses of corticosteroids, the fixed-effect OR was 0.83, and the corresponding absolute risk was 36% for high-dose corticosteroids versus an assumed risk of 40% for usual care or placebo.” Even the authors of the meta-analysis concluded that higher doses were not more beneficial than lower ones. Using lower doses could also help reserve the medication for more patients, according to Dr. White. It’s important to advise patients that all of the patients in these studies were critically ill and required some type of oxygenation, typically ventilator support, all three experts said. There is little to support widespread use by mildly ill patients. “We have learned in other disease states that steroids have a clearly demarcated role in managing systemic inflammation without worsening the underlying condition,” Dr. Martin said. “Too much steroid can cause problems of its own.” The WHO recommended against the use of steroids outside of critical patients in its COVID-19 treatment recommendations. “At the beginning of the year, at times, it felt almost hopeless, knowing that we had no specific treatments. It was a very worrying time. Yet less than six months later, we’ve found clear, reliable evidence in high-quality clinical trials of how we can tackle this devastating disease,” said Anthony Gordon, MD, FFICM, FRCA, the chair of anesthesia and critical care at the Imperial College Lon■ don, who participated in the REMAP-CAP study. Dr. Gordon reported receiving grants from the NIHR and the NIHR Research Professorship.

GENERAL SURGERY NEWS EXTENDED WOUND CARE COVERAGE Column Editors Jarrod P. Kaufman, MD, FACS, and Peter Kim, MD

Can Silver Heal Wounds?

Pressure Injuries: What to Do When Surgery Fails By CHASE DOYLE

Separating Fact From Fiction By ALISON McCOOK

he patient’s wound was large, complicated and painful. The 68-year-old man came to see wound care expert George J. Koullias, MD, a vascular surgeon at Stony Brook Surgical Associates, in New York, with a large mixed ulcer that had been plaguing him for two years. The bone was exposed, and part of the wound was necrotic. His doctor had referred him to Dr. Koullias for amputation. But Dr. Koullias wanted to try something else. After extensive debridement of the wound, the patient had a series of biofilm control–based dressing applications and placental allografts. Then for the last year, after the wound was in a healing trajectory, he applied—and reapplied—Aquacel Ag (ConvaTec), a hydrofiber dressing that contains silver. For almost one year, the patient reapplied the product every 48 hours. “Gradually, it led to a complete healing of two major wounds,” Dr. Koullias said during a presentation at the

Symposium on Advanced Wound Care 2020 virtual meeting. No amputation was necessary: “We’ve seen him a few weeks ago, and he is doing great.” Clinicians have been using silver, which has strong antimicrobial activity, in wound care for more than 2,000 years. However, it also can impair healing by damaging some cell types, and research about its benefits has produced mixed results (Plast Reconstr Surg Glob Open 2019;7[8]:e2390). So what is fact, and what is fiction?

dvanced-stage pressure injuries, or pressure ulcers, are a difficult and increasingly common problem whose challenges persist long after the completion of surgery. Meticulous postoperative care and timely management of complications are critical to a successful outcome.

Fact or Fiction: Silver Can Delay Healing Unpublished data from a ConvaTec study that compared Aquacel Ag (both its original and updated versions, Extra and Advantage, respectively) with a wound dressing without silver (Tegaderm, 3M) in an acute porcine wound model found equal rates of healing. Based on these results, David Parsons, PhD, FRSC, the director of science and technology at ConvaTec, in Deeside, Wales, concluded that Aquacel Ag continued on page 14

The Importance of Adequate Debridement By JARROD P. KAUFMAN, MD, FACS Column Editor, Wound Care Premier Surgical & Premier Vein Center, Brick, N.J. Clinical Assistant Professor, Department of Surgery, Temple University School of Medicine, Philadelphia Clinical Affiliated Faculty at the McGowan Institute for Regenerative Medicine, University of Pittsburgh

elcome to our new section on wound care and tissue management. As section editor, we look forward to presenting you with relevant topics, guidance and information on new products to assist you in caring for this challenging group of patients. We also look forward to your feedback and collaboration on topics that would be of interest to our readers.

the wound and wound bed. Irrigation is defined as using fluids to clean and treat the wound, usually distinguished as low pressure (bulb syringe); intermediate pressure, using a syringe with a gel catheter or blunt needle; or even high pressure, as seen with motorized or pulsed lavage systems. Either of these two aforementioned methods can use varying types of fluids based on the desired response and need of the particular wound bed. Disinfection comes into consideration when wounds are known or presumed to contain significant biofilm and bioburden, which necessitates using antiseptic agents and antimicrobial agents along with removal of devitalized tissue where the microorganisms live and thrive on the necrotic material.

Terminology To begin, it is important to differentiate between cleansing, irrigation and disinfection in distinction to debridement. All of these are important components in the care of acute and chronic wounds. Cleansing is usually taken to mean simply using fluid(s) to remove adherent materials and nonviable tissue from

Types of Debridement Debridement is defined generally and medically as “surgical removal of foreign matter and dead tissue from a wound; [the] removal of dead or contaminated tissue and foreign matter from a wound, especially continued on page 20

Treatment of a pressure ulcer.

During the Symposium on Advanced Wound Care (SAWC) 2020 virtual meeting, John C. Lantis II, MD, the vice chairman and a professor of surgery at Mount Sinai West and St. Luke’s Hospitals/Icahn School of Medicine, in New York City, discussed risk factors associated with recurrence after surgery and presented several nonsurgical options for managing pressure injuries. As Dr. Lantis explained, the standard nonsurgical treatment for a clean, full-thickness pressure ulcer continued on page 15

Wound Care: The ‘Wild Wild West’? Page 16

IN THE NEWS

GENERAL SURGERY NEWS / OCTOBER 2020

Silver continued from page 13

products “do not hinder the wound healing process.” That may not apply to all wounds and silver products, said Jeffrey E. Janis, MD, a professor of plastic surgery at the Ohio State University Wexner Medical Center, in Columbus. In a 2019 review of nearly 60 studies that examined silver’s benefits in wound care, Dr. Janis found that dosing matters (Plast Reconstr Surg Glob Open 2019;7[8]:e2390). “Not enough ionic silver doesn’t have any benefit, and

too much may be too much of a good thing.” That “sweet spot” seems to be a sustained dose between 30 and 60 ppm, he said; anything above that seems to slow healing, he said, likely by damaging keratinocytes and fibroblasts. “We don’t want major bucket dumps of silver ions.” Answer: fiction (when used properly)

Fact or Fiction: Silver Increases Antimicrobial Resistance Resistance is always a concern with any anti-infective agent, Dr. Parsons said, but there hasn’t been any clinical evidence of

A diabetic foot ulcer at presentation (left). After treatment with Aquacel Ag Advantage (ConvaTec), day 10 (middle) and day 37 (right).

a concern with silver. “When challenged with silver, 100% of tested organisms are eliminated.” ConvaTec has found that the Aquacel Ag Advantage product is effective in vitro against all forms of bacteria,

The next generation in sharp debridement.

including superbugs. “We have yet to find a wound pathogen that can’t be cleared with our silver dressings,” he said. Dr. Janis, also the chief of plastic surgery at Wexner Medical Center, agreed, noting that despite the fact that silver has been around for thousands of years, “I haven’t seen any data that resistance is built up to it.” Answer: fiction

Tips for Using Silver in Wound Healing • Stick to dosages of 30 and 60 ppm, in sustained release. • Use silver in infected wounds, as an adjunct to surgical debridement. • Avoid silver for clean, noninfected wounds and closed surgical incisions. • With burns, sick to dressings that contain nanocrystalline silver. Source: Plast Reconstr Surg Glob Open. 2019;7(8):e2390.

Fact or Fiction: Silver Helps With Wound Care

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In a 2015 paper, more than 100 patients received Aquacel Ag for various types of hard-to-heal wounds; over an average treatment period of four weeks, the majority of wounds (95%) healed or improved, and 17% healed completely (J Wound Care 2015;24[1]:11-22). “That’s quite remarkable,” said Dr. Parsons, who co-authored the study. But some formulations of silver work better than others, he cautioned. “It’s impossible to generalize about silver dressings,” he told meeting attendees. “Silver can definitely be effective,” Dr. Janis said. “And that’s what the literature would say.” He agreed with Dr. Parsons that the metal needs to be in a usable form—ionic—and the data would only support its limited use in specific indications (see “tips”). He said he regularly uses Aquacel Ag and other silvercontaining products to facilitate wound healing in his patients in the appropriate circumstances, specifically around infected wounds for a short period of time. “We see silver is effective when being used correctly.” Answer: fact ■ Disclosures: ConvaTec sells Aquacel Ag, a wound care product that contains silver. Dr. Janis reported no relevant financial conflicts of interest.

OCTOBER 2020 / GENERAL SURGERY NEWS

is wound cleansing followed by topical dressing, pressure redistribution, elimination of drainage, and supportive care. With this approach, six-month healing rates are 40% to 45% for stage III ulcers and 31% to 34% for stage IV ulcers (J Am Geriatr Soc 2004;52[3]:359-367). For patients who undergo flap reconstruction surgery, however, a large retrospective study showed a complication rate of 58.7% (Plast Reconstr Surg Glob Open. 2017;5[1]:e1187). “In patients with low body mass index, ischial pressure ulcers, diabetes and active smoking habits, surgical interventions may have more limited success,” said Dr. Lantis, who noted various perioperative protocols. “It’s important to maximize nutrition, control blood pressure, and utilize off-loading techniques. “For ischial tuberosity pressure injuries, patients should wait at least six weeks before sittings and start with just 10 minutes of sitting at a time,” he added. According to Dr. Lantis, recurrence and nonoperative management of pressure injuries are often identical, and patients who recur after flap reconstruction surgery rarely return to the OR. Dr. Lantis summarized the evidence for several nonsurgical treatment approaches:

4. Transdermal topical oxygen: A single-blind, multicenter, randomized controlled trial found greater wound healing in the experimental group after 12 days of wound oxygen therapy, which suggests this approach may promote wound healing in patients with pressure ulcers (Iran Red Crescent Med J 2015;17[11]:e20211). 5. Stem cell therapy: Preliminary data indicate that cell therapy using

autologous bone marrow mononuclear cells could be a treatment option for stage IV pressure ulcers in patients with spinal cord injury and could help avoid major surgical intervention (J Spinal Cord Med 2011;34[3]:301-307). In 19 patients (86.36%), the pressure ulcers treated with this approach had fully healed after a mean time of 21 days. 6. Anabolic steroids: A trial ended early after interim results demonstrated an unlikely benefit from treatment with oxandrolone (Cochrane Database Syst Rev 2017;6[6]:CD011375). There is

no high-quality evidence to support the use of anabolic steroids in treating pressure ulcers. “Based on a review of the literature, postsurgical dehiscence can be well managed with ongoing sharp debridement, and topical oxygen therapy may help facilitate these closures,” Dr. Lantis ■ concluded. Disclosures: Dr. Lantis has been a consultant to, or a principal investigator for, 3M, Coloplast, Integra, Kerecis, MediWound, Pluristem, Smith & Nephew and TissueTech.

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reduction in wound size versus standard of care alone (J Tissue Viability 2019;28[1)]21-26).

Pressure Injuries

EXTENDED WOUND CARE COVERAGE

1. Debridement: A retrospective chart review of sacrum, sacrococcyx, coccyx, ischium and trochanter region pressure injuries showed that bedside surgical debridement using a sharp excisional technique was performed on 190 of 319 (59.5%) of wounds (Wounds 2017;29[7]:215221). Of those 190 wound sites, 138 (73%) had a reduction in square surface area, and there were a total of 43 (23%) wounds that had a square surface area of 0 (reepithelialized), which has a healing rate of 23%. 2. Negative pressure wound therapy: Overall, there is low-quality and inconclusive evidence regarding the clinical effectiveness of negative pressure wound therapy as a treatment for pressure ulcers, who cautioned against routinely offering this treatment unless it is necessary to reduce the number of dressing changes (e.g., in a wound with a large amount of exudate). 3. Cellular and tissue-based therapy: Results of a small randomized study suggest that weekly treatment of chronic pressure ulcers with small intestinal submucosa wound matrix increases the incidence of 90%

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Wound Care: The ‘Wild Wild West’? his issue I am tackling a new topic for On the Spot: wound care. This topic, which transcends all surgical specialties, is new territory for me. I’d like to thank Christi Cavaliere, MD, for helping me understand some of the current practices and debates in this field. So is wound care practice, as one panelist phrased it, “more style than science”? Is hyperbaric oxygen therapy all it’s cracked up to be? And is wound care really the “Wild Wild West” of patient care? Read on to see what some of the experts think! I would like to thank all of the experts for their contributions to this column. Their hard work and time

make this a compelling and informative installment for all general surgeons. Don’t forget to check out the Gut Reaction on page 18 as well for some quick candid thoughts from these contributors. Feel free to email me at colleen@cmhadvisors.com with any ideas eas for debate, and look for “Wound Care Part rt 2” in an upcoming issue. Thanks for reading!! —Colleen Hutchinson n Colleen Hutchinson is a medical communications consultant at CMH Media, based in Philadelphia. She can be reached at colleen@cmhadvisors.com.

EXPERT PANELISTS Christi Cavaliere, MD Department of Plastic Surgery, Cleveland Clinic, Cleveland

Venita Chandra, MD, FACS Clinical Associate Professor of Surgery at Stanford University; Co-Medical Director, Stanford Advanced Wound Center; Founder, Stanford Extremity Preservation Program, California Disclosure: Training/Teaching for Smith & Nephew.

Daniel Eiferman, MD, MBA, FACS Associate Professor of Surgery, Division of Critical Care, Trauma and Burn at the Ohio State University Wexner Medical Center, Columbus

Jeffrey E. Janis, MD, FACS Director of Emergency Surgery and Trauma Unit, Department of Surgery, Humanitas Clinical and Research Hospital, IRCCS, Milan; Professor of Plastic Surgery, Neurosurgery, Neurology and Surgery and Chief of Plastic Surgery, the Ohio State University Wexner Medical Center, Columbus

iWn

A specialised news source in the wounds arena A trusted provider of latest news, review of cutting-edge research, congress coverage and opinion from thought leaders

Disclosure: Consultant to Allergan/LifeCell; royalties from Springer Publishing and Thieme.

Jarrod P. Kaufman MD, FACS Surgeon and Founding Member, Premier Surgical & Premier Vein Center, Brick, N.J.; Clinical Assistant Professor, Department of Surgery, Temple University School of Medicine, Philadelphia; Clinical Affiliated Faculty, McGowan Institute for Regenerative Medicine at the University of Pittsburgh Disclosure: Consultant to Geistlich, MBOT-MTF and MTF.

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For complimentary print subscription*and e-newsletter subscription** visit www.iwoundsnews.com and click Subscriptions *Available for US and EU readers only **Available worldwide

Hayato Kurihara, MD, FACS, FEBS Director of Emergency Surgery and Trauma Unit, Department of Surgery, Humanitas Clinical and Research Hospital, IRCCS, Milan Disclosure: Smith & Nephew (invited speaker on surgical site infection prevention and negative pressure wound therapy in open abdomen management in 2019 and 2020).

Martin I. Newman, MD, FACS Interim Chair and Residency Program Director, Department of Plastic Surgery, Cleveland Clinic Florida, Weston

OCTOBER 2020 / GENERAL SURGERY NEWS

Negative pressure wound therapy using Prevena (3M/ KCI) can prevent wound complications in certain wound categories. DR. CAVALIERE: AGREE The Prevena nega-

tive pressure wound therapy device can be a very useful tool for incision management. I generally consider use with high-risk wounds associated with tension and edema. I have found the device helpful for some patients undergoing complex closure of spine, sternal, knee and breast wounds. It is important to review patient- and wound-related factors when considering use. The device adds moderate cost and can be beneficial in high-risk patients; however, broad application in low-risk patients would not be cost-effective.

EXTENDED WOUND CARE COVERAGE

to vacuum-assisted closure (VAC) 15 or 20 years ago, front-line surgeons and physicians seem to recognize certain benefits of using this branded negative pressure wound dressing without possessing a complete understanding of why. And, like the VAC, I am anxious to see what peer-reviewed literature reports in the decades ahead. A recent PubMed search using the keyword “Prevena” yielded only 50 results. In contrast, a search of the same database returns close to 7,000 hits for the keyword “VAC” and over 4,000 hits for “negative pressure wound therapy.”

DR. EIFERMAN/DR. JANIS: AGREE There have

been substantial data to support its use (and cost-effectiveness) in certain patient subpopulations. It’s not an appropriate treatment for all, but for those at higher risk for incisional complications. DR. KAUFMAN: AGREE These types of

NPWT devices have greatly assisted us in managing incisional wound complications and do help in their prevention. I have seen this particularly after complex abdominal wall procedures.

DR. NEWMAN: DISAGREE I cannot support a

statement that includes the phrase “can prevent wound complications.” Having said that, the Prevena may help to reduce the incidence of some of the more common undesirable outcomes following surgery. This appears to be much examined in wounds of the lower anterior abdomen following gynecologic or contaminated colorectal procedures. Similar

many devices for prevention of SSI and the use of pNPWT already confirmed positive results, but it’s important to underline that the ideal use of NPWT should be considered if integrated in a specific bundle for SSI. Post-incisional infection after surgery is multifactorial and, according to international guidelines, surgeons, anesthesiologists and nurses should focus on preoperative, intraoperative and postoperative stages where specific strategies must be implemented (e.g., no hair removal strategy, perioperative oxygenation, glucose level

DR. KURIHARA: AGREE Nowadays there are

continued on the following page

FOR COMPLEX HERNIA REPAIRS

DR. CHANDRA: ON THE FENCE Prevena is used

in the closed wound operative setting as a prophylaxis with the goal of decreasing seromas, wound infections and dehiscences. The use of negative pressure is clearly well established for use in open wounds; the concept of use in closed wounds is an interesting one. There is a mixture of data in terms of which patients may benefit most from prophylactic negative pressure wound therapy (pNPWT). The issue, of course, is the balance of cost over benefit. In my practice, I use pNPWT in high-risk patients for surgical site infections (obese, diabetic, groin wounds, etc.) but not as a standard for all of my procedures. The World Health Organization published guidelines on recommendations relating to SSIs (Lancet Infect Dis 2016;16[12]:e288-e303). They reviewed the publications on the topic and overall recognized that there was only lowquality evidence available. They found abdominal and cardiac surgery demonstrated benefit with the use of pNPWT, while it was not statistically significant in orthopedic or trauma surgery. Ultimately, they suggested the use of pNPWT on closed surgical incisions in highrisk conditions. They defined high-risk conditions to include patients with significant surrounding soft tissue or skin damage suggesting poor tissue perfusion, decreased blood flow, dead spaces or intraoperative contamination.

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Wound Care continued from page 17

control). Due to economic costs, accurate patient selection for correct use of the NPWT device should be mandatory; this might be challenging since a dedicated protocol to identify those patients who might benefit from NPWT for a specific surgical intervention ideally needs a scoring system. For this reason, periodic audit meetings in the different surgical areas should be set in place.

The discipline of wound care, compared with most other disciplines and specialties, is basically the “Wild Wild West” of patient care. DR. CAVALIERE: AGREE Wound care as a dis-

cipline is unique in that there is no distinct training program recognized by the Accreditation Council for Graduate Medical Education (ACGME), and there are a variety of certification options, although distinct wound care certification is not required. Dressings, woundrelated devices, and cell and tissue-based products have multiplied severalfold over the past decade; however, largescale outcome studies are often lacking, making wound care practice more style than science. Wounds are typically associated with other medical issues, such as diabetes, immunosuppression, rheumatologic diseases and neurologic diseases. Controlling for these comorbidities also complicates evaluation of

best practices and outcomes. Standardizing training requirements would help to build a more systematic approach to patient care. Development of an acceptable wound healing model against which new dressings and devices could be tested would also promote evidence-based care. Efforts are underway through various wound organizations to develop a curriculum and best practices, but there is more work to be done.

includes optimization of many factors, including local wound care and debridement, infection control, edema control, off-loading, perfusion management, nutrition management, revascularization or reconstruction, and management of patients’ underlying medical issues. All of these factors need to be considered and factored in at every evaluation; thus, systematic and organized multidisciplinary approaches to these patients work best.

DR. KURIHARA: ON THE FENCE Historically, surgeons’ awareness of wound healing, especially in terms of infection prevention, has been quite low; this is probably due to the fact that wound healing, although an important part of patient recovery, is not perceived as an important and desirable end point, since it is timeconsuming and distracting from focusing on new surgical cases and more attractive techniques. Nevertheless, the number of publications on wound management and prevention of SSIs has been remarkably increasing in recent years, showing a new interest in this topic. Many hospitals all over the world are creating specific pathways on SSI and dedicated multidisciplinary wound management teams, and we are already on our way to assist with a more structured approach to wound care.

DR. EIFERMAN/DR. JANIS: DISAGREE Wound

DR. CHANDRA: DISAGREE The discipline of

wound care is absolutely not the “Wild Wild West” of patient care. The challenge with wound care is the complexity of patients, and the importance of taking a multidisciplinary and wholistic approach to patients. Good wound care

healing underpins all surgical specialties. While much is known, there are still gaps that require more research. As long as we use the best available evidence and continue to investigate what we don’t know, I would not consider that the Wild West. However, it is our collective obligation to stay on top of the latest relevant literature. Otherwise, one’s practice never matures since training, despite advances in the field. DR. NEWMAN: ON THE FENCE Although I am not a fan of the term “Wild Wild West,” I certainly understand the frustration of the person who applies it to the discipline of wound care. “Wound care” taken as a whole, represents a multi-billion-dollar industry. As such, it attracts not only well-motivated health care teams, but it also draws those with purely financial goals. The aggressive nature of industry, as well, may play a role in promoting the use of less than well-proven adjuncts to the discipline of wound care. In addition, the willingness of certain health care providers to try something new before it is Treatment tool, device or therapy that you can’t live without

supported by well-designed studies may reflect a growing impatience on part of the patient and provider. Thus, the combination of a chronic disease, a potentially large financial benefit, aggressive industry promotion, and impatient patients and providers may result in less vigilant respect for the scientific method. Ultimately, it is up to the individual or team providing care to determine whether a particular adjunct is effective in healing wounds and supported by independent, nonsponsored literature. DR. KAUFMAN: ON THE FENCE The field has gotten better over the years that I have been in practice. But due to the variety of specialties and varied training of those who participate in wound care treatment, it is true that some would agree with this statement. For the most part, there is a paucity of prospective randomized controlled trials to support clinical decision making. The critiques are that most of the evidence that exists consists of small case series and is largely anecdotal.

Hyperbaric oxygen therapy (HBOT), generally speaking, is not worth the time and cost. DR. CHANDRA: DISAGREE I am cautious

about singing the praises of HBOT, as this is a costly and cumbersome treatment; however, there definitely are scenarios and patients who really serve to benefit. In fact, my gut feeling is that we don’t typically do HBOT on some patients who could serve to benefit from it, as I describe below.

GUT REACTION

Best wound care meeting

Christi Cavaliere, MD

American College of Wound Healing and Tissue Repair

Increasing number of wounds due to abnormal soft tissue calcification

Any plastic surgery textbook; it’s important to understand surgical options for reconstruction

Debridement in the OR

Bill Kuzon

Compression stockings that patients can’t put on

Daniel Eiferman, MD

Symposium on Advanced Wound Care

Missed bladder perforation

“Talent Is Overrated,” by Geoffrey Colvin

LigaSure (Medtronic)

R. Anthony Perez-Tamayo

Inappropriate use of technologies and products

Martin I. Newman, MD

Symposium on Advanced Wound Care

Necrotizing fasciitis

“Textbook of Chronic Wound Care: An EvidenceBased Approach for Diagnosis and Treatment”

Vacuum-assisted closure

Dr. Smith

Nonproven adjuncts

Venita Chandra, MD

Because wound care is so multidisciplinary, I usually go to my specialty conferences (vascular surgery) and participate in the wound care/limb salvage section

Mixed arterial venous wound; patient was compressed without addressing her underlying arterial insufficiency first

Anything they like; it is important to take a break and relax a bit from this intense work we do

A 15 blade

I have many, from different walks of my life

Any of the expensive “skin substitutes” if used in a patient who is not medically optimized and whose wound is not properly prepared

Jeffrey E. Janis, MD

Symposium on Advanced Wound Care

Any of Dr. Eiferman’s surgeries

“Wound Care Practice”

Either the VAC or VersaJet (Smith & Nephew)

Chris Attinger

Inappropriate use of technologies and products

Hayato Kurihara, MD

European Wound Management Association

Enteroatmospheric fistula in open abdomen

“Wound Care Essentials: Practice Principles” (Lippincott, Williams and Wilkins; 2011 [3rd ed.])

Negative pressure wound therapy systems

The nurses of my hospital!

Long-term hospitalization

European Wound Management Association is the best by far

Accidental radiofrequency ablation of superficial femoral artery

“QBQ! The Question Behind the Question,” by John G. Miller, and “Good to Great,” by James C. Collins

Advanced wound care grafts (CTP)

All who taught me how to adequately debride, and especially Dr. Alex Uribe

Allografts or xenografts that require wasting material (that don’t come in a variety of sizes)

Jarrod P. Kaufman, MD

Worst complication I’ve seen recently

Good book for residents and fellows to read

My mentor

Biggest waste of money in wound care

OCTOBER 2020 / GENERAL SURGERY NEWS

It is important to recognize that HBOT is not a magic wand, and all the other factors in terms of wound care, including management of patients underlying medical issues, infection control, off-loading, etc., need to be optimized before proceeding with HBOT. I believe HBOT is most helpful in patients with relative wound bed ischemia, such as the Wagner 3 diabetic foot ulcers and radiation wounds. My theory—and this has not been validated—is that in patients with extreme chronic wounds of nearly all types, such as a 10-year-old venous stasis ulcer, the significant peri–wound scar results in relative wound bed ischemia and HBOT could potentially be beneficial in these patients as well. This is an area in which I hope we will see more data/research in the future. DR. NEWMAN: DISAGREE The benefits of

HBOT are well documented for certain applications. Other applications may not have as much support. The statement “not worth the time and cost,” however, appears to leave the patient out of the equation. Instead, it appears to focus on the dollars and cents of wound care as a business. From a purely economic point of view—for example, how much money will it cost to heal a particular wound—it is generally recognized that HBOT consumes significant resources. However, it is impossible to quantify the human benefits of successful HBOT, for example, reduction in the incidence and severity of decompression sickness, preservation of a limb or an appendage in a diabetic or previously irradiated patient, and the treatment of some burn patients.

EXTENDED WOUND CARE COVERAGE

associated with relative ischemia, such as radiation-related wounds, small vessel disease in diabetic foot ulcers, and compromised flaps. Evidence to support use is limited for some wound types such as pressure ulcers. HBOT requires approximately two-hour sessions five days per week for six weeks. This is a significant time commitment, and many patients face issues arranging transportation. HBOT has applications in the acute care setting, such as acute ischemia and necrotizing soft tissue infections; however, due to reimbursement structure and location of chambers in outpatient

wound centers, HBOT is less likely to be used for these acute diagnoses. Further research is needed to better define the role of HBOT in treating various wound types and to determine the optimal treatment duration. DR. EIFERMAN/DR. JANIS: DISAGREE HBOT has specific indications for which it is effective (gas gangrene, osteoradionecrosis, decompression sickness, etc.). When used outside of evidence-based indications, then the value equation may be more questionable.

DR. KAUFMAN: DISAGREE For the correct

and indicated applications, this is a very safe and effective treatment. Some of the indications that are generally accepted include gas gangrene, central retinal artery occlusion, crush injuries, compartment syndrome after decompression, acute peripheral arterial ischemia, decompression sickness, exceptional blood loss anemia, necrotizing soft tissue infections, chronic osteomyelitis, delayed radiation injury (bowel and bladder and bone necrosis), air or gas embolism, compromised skin grafts and flaps, severe anemia, and carbon monoxide poisoning. ■

EVIDENCEBASED MEDICINE

Trends in Hemostasis

A Data-Driven, Evidence-Based Methodology for Achieving Best Practices in Blood Management and Hemostatic Resource Utilization in Surgery

DR. KURIHARA: AGREE The role of HBOT

is also still very controversial in case of life-threatening necrotizing soft tissue infections. So far, evidence of the therapeutic concept of HBOT is still limited to positive experiences only in case studies and animal studies. Moreover, it’s not yet available in most hospitals, and at the moment, it might be considered as an adjunctive treatment only in selected cases and not as a standard of treatment. It also should be underlined that under no circumstances should HBOT delay surgical debridement, if indicated, especially in case of necrotizing soft tissue infection. Furthermore, the additional costs for any HBOT are very high ranging in Europe, from 8,000 to 25,000 euros; therefore, the combination of lack of evidence and economic impact, at the moment, does not seem to justify extended use of this approach.

Download a PDF or request free hard copy reprints

DR. CAVALIERE: DISAGREE HBOT is one of

ormanagement.net/VitalEdge

many tools in the wound care toolbox. Broad application in all wound categories is not appropriate. Increasing oxygen delivery makes sense for wounds

ormanagement.net/download/BB1914_WM.pdf

Supported by

20 CLINICAL REVIEW

GENERAL SURGERY NEWS / OCTOBER 2020

Debridement continued from page 13

by excision.”1 There are multiple types of debridement that can be used, and these are critical in transitioning the chronic wound which is stalled in the inflammatory phase through all of the phases of wound healing to a fully epithelialized healed wound. The most commonly used types of debridement in clinical practice include: • mechanical, also known as “sharp” or surgical; • hydrodebridement; • thermal/laser debridement; • ultrasonic debridement; • enzymatic debridement; • maggot debridement therapy; • autolytic debridement; and • whirlpool therapy.

Figure. Phases of wound healing.

Some therapies are combined or blended modalities from the above list and others combine them independently to achieve optimal clinical results. The time-tested and most efficient method is debridement with surgical instruments (scalpel, scissors, dermatomes, sharp curettes, bone rongeurs, forceps). This is not always practical based on the wound site and the location for the debridement (office, wound care clinic, nursing home or OR).2 Hydrosurgical debridement can be accomplished with a variety of commercially available devices (Table). These devices allow for use of pressurized fluid that actually can cut and remove tissue at various depths based on the settings used.

Wound Debridement in the Literature Multiple studies in the literature demonstrate that the frequency and extent of adequate debridement leads to more rapid wound healing. Clinical judgment and experience lead to the knowledge of “how much to debride” so that vital tissue is not removed. General principles of this practice include removal of all grossly necrotic tissue as well as removal of tissue down to healthy-appearing tissue with visible signs of bleeding signifying adequate blood supply. This process was studied in chronic venous leg ulcers and diabetic foot ulcer wounds by Cardinal et al, in 2009. and their results suggested that frequent debridement of these types of wounds may increase wound healing and closure rates.3 Wilcox et al, in 2013, retrospectively studied the frequency of debridement and time to healing in 312,744 wounds. This four-year study in 525 wound care centers showed

that only 70.8% of wounds healed with debridement alone. Further, they concluded that the more frequently wounds were debrided, the better was the healing outcome. Gordon et al espoused a contrary view in 2012, noting that the rationale is valid for the debridement of diabetic foot ulcers, but finding insufficient data supporting debridement for venous ulcers and pressure ulcers.4 A similar conclusion was reached by the Cochrane review performed by Gethin et al, in 2015.5 These investigators concluded that there is limited evidence to indicate that repetitive debridement of venous leg ulcers has a clinically significant impact on wound healing. Further critiques included the small number of participants, low number of studies, and lack of meta-analysis which precluded any strong conclusions for the benefit of debridement in these types of wounds.

Conclusion Table. Commonly Used Hydrosurgical and Ultrasonic Devices for Debridementa Device

Versajet 2

Debritom

Manufacturer

Smith & Nephew

Medaxis

Selected Benefits

Indication(s)

• Preserves viable tissue and reduces debridement procedures • Creates a smooth wound bed • Removes bacteria • Reduces time to closure

• Wound debridement (acute and chronic wounds, burns) • Soft tissue debridement • Cleansing of the surgical site for sharp debridement and/or pulsed lavage irrigation

• Different debridement options • Tissue-preserving option that creates bleeding but avoids excessive debridement

• • • •

• Tissue-selective ultrasonic debridement • Removes bioburden • Reduces blood loss

• Debridement of wounds (burns, diabetic ulcers, pressure injuries, soft tissue injury) • Using an ultrasonic aspirator for sharp debridement, fragmentation and aspiration of tissue

• No-touch selective debridement • Portable, battery-operated, closed debridement system

• • • • • •

Venous and arterial leg ulcers Diabetic foot ulcers Pressure wounds Acute wounds and burns

Debridement is a time-honored method that still has immense value for patients with acute and chronic wounds. When performed correctly and with appropriate frequency, debridement clearly leads to increased healing rates and closure in most types of wounds. Care needs to be taken, however, to clearly define the type of wound being cared for to ensure that the appropriate adjunctive methods are used in special wounds like venous ulcers or pyoderma gangrenosum. ■

References 1. Dictionary.com

SonicOne

Pulsar II

UltraMIST

Misonix

Sanara

Cellularity

• Non-contact, low-frequency ultrasound • Pain-free delivery through a fluid mist that acts as the medium to deliver energy to the wound

Partial- and full-thickness wounds Pressure ulcers Surgical wounds Diabetic ulcers Arterial and venous insufficiency wounds Traumatic wounds

• To promote wound healing through wound cleansing and maintenance debridement (removal of fibrin, yellow slough, tissue exudates and bacteria)

Not an exhaustive list. The devices included in this table are those most commonly used in practice in the author’s experience.

2. Wilcox JR, Carter MJ, Covington S. Frequency of debridements and time to heal: a retrospective cohort study of 312,744 wounds. JAMA Dermatol. 2013;149(9):1050-1058. 3. Cardinal M, Eisenbud DE, Armstrong DG, et al. Serial surgical debridement: a retrospective study on clinical outcomes in chronic lower extremity wounds. Wound Repair Regen. 2009;17(3):306-311. 4. Gordon KA, Lebrun E, Tomic-Canic M, et al. The role of surgical debridement in healing of diabetic foot ulcers. Skinmed. 2012;10(1):24-26. 5. Gethin G, Cowman S, Kolbach DN. Debridement for venous leg ulcers. Cochrane Database Syst Rev. 2015;2015(9):CD008599.

elcome to the October issue of The Surgeons’ Lounge. We dedicate this issue to breast reconstruction after surgery for breast cancer. In this issue, Lisandro Montorfano, MD, a general surgery resident at Cleveland Clinic Florida, in Weston, asks Andres Mascaro Pankova, MD, from the Department of Plastic and Reconstructive Surgery at Cleveland Clinic Florida the most common questions about

breast reconstruction after surgery for breast cancer. We also present a short history of breast reconstruction. We look forward to our readers’ questions, comments and interesting cases to present. Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons‘ Lounge Szomsts@ccf.org

Breast Reconstruction After Surgery for Cancer LISANDRO MONTORFANO, MD:

What are the current options for breast reconstruction after surgery for breast cancer? ANDREAS MASCARO PANKOVA, MD:

I personally like to classify breast reconstruction into three pathways, and this is exactly how I explain it to my patients. Although this is a very simplistic approach, it is an easy way to explain it to patients. I also tell my patients that the main pathways may have smaller inroads that interconnect.

as the deep inferior epigastric perforator flap (DIEP), the superior gluteal artery perforator (SGAP)/inferior gluteal artery perforator (IGAP), or the profounda artery perforator flap (PAP). The main advantage of this reconstructive modality is the fact that the patient’s own tissue is used and none of the potential complications related to implants will occur, such as capsular contracture, implant infection or breast implant‒associated anaplastic large cell lymphoma (BIA-ALCL). DR. MONTORFANO: What is the best timing for breast

reconstruction? DR. MASCARO PANKOVA: There are usually three settings

Option 1: External Prothesis The first option is to use an external prosthesis and not perform a formal surgical reconstruction. In this case, the breast surgeon performs the mastectomy and closes the incision. After surgery, the patient is referred to a professional prosthesis fitter who creates an external prosthesis that anatomically fits the specific patient. I think this option should always be discussed with the patient because it has distinct advantages, the main one being the fact that the plastic surgeon does not get involved and none of the potential complications that are related to a surgical procedure will occur. Option 2: Breast Implant The second pathway is to perform a reconstruction using a breast implant as the final result. The implant has a shell that is made of silicone; the inside filling can be of silicone gel or normal saline solution. There are several options to achieve this goal. The patient can have a tissue expander placed first to slowly create a breast mound, and, in a second stage (surgery), the final implant is placed. In selected cases, the implant can be placed immediately—a modality known as direct-to-implant breast reconstruction. In some cases, the patient’s native tissue is required to provide further coverage and a latissimus dorsi flap can be used in association with a tissue expander or an implant. This is an example of connection between the three pathways described. Option 3: Autologous Breast Reconstruction The third pathway is based on using the patient’s native tissue to perform the breast reconstruction. This is called autologous breast reconstruction. There are several options and locations used to perform this modality of reconstruction. The basics of this type of reconstruction involve the use of flaps. The flaps can be pedicled, such as the TRAM [transverse rectus abdominis myocutaneous] flap or the latissimus dorsi flap; or they can be free flaps that require microsurgical expertise, such

or timings in which breast reconstruction can be done. They all have their distinct advantages and possible disadvantages. Immediate Reconstruction Immediate breast reconstruction is done in the same surgical setting as the mastectomy. It has advantages such as providing the best cosmetic result because of preservation of the anatomic landmarks and skin. It also has a potential psychological benefit and immediate return of body image. It is a single-stage procedure with lower overall socioeconomic cost. At the same time, there are some disadvantages associated with immediate breast reconstruction, such as the difficulty to assess mastectomy flap viability. With that being said, there are emerging technologies becoming available that may have a role in assisting with this disadvantage, such as the SPY Intraoperative Perfusion Assessment System (LifeCell). There is also a risk for postoperative radiotherapy requirements that must be carefully evaluated to minimize the risk for future deformity. The increased risk for postoperative complications should be taken into account because they can delay postoperative adjuvant chemotherapy or radiotherapy, when required. Delayed Reconstruction Delayed breast reconstruction is performed in a different setting/stage than the mastectomy. It has some advantages such as no delay in postoperative chemotherapy/radiotherapy as a result of reconstructive complications. It also allows careful monitoring of patients with advanced carcinomas (stages III and IV) over time, before performing definitive reconstruction, and it is associated with a decreased risk for complications. The skin damage of mastectomy/radiation can be replaced at the time of reconstruction. At the same time, there are some disadvantages associated with delayed breast reconstruction, such as the loss of breast skin envelope and natural landmarks (eg, the inframammary fold). If an autologous breast reconstruction is planned,

the recipient vessel dissection is more tedious because of scarred/irradiated axilla or chest wall. The flap size requirement is usually greater than with immediate reconstruction. The psychological morbidity of living with a mastectomy defect has an effect on patients. Delayed–Immediate Reconstruction Delayed–immediate breast reconstruction is an alternative option in which the reconstruction is partially started in the immediate setting/surgery but the final decision as to what kind of final surgery to perform is deferred. This type of reconstruction was devised in response to the inability to accurately predict nodal status and the need for radiation. Reconstruction is started with placement of a tissue expander. The final reconstruction is performed when the final pathology is available: • If pathology is negative, proceed with reconstruction. • If positive, consider deflation/removal of the expander and delay reconstruction until after radiotherapy. DR. MONTORFANO: What factors can affect the choice of

breast reconstruction method? DR. MASCARO PANKOVA: There are several factors that are

associated with the decision of what type of reconstruction to perform. Among them is the overall health of the patient. If a patient has several comorbidities and an overall very high medical risk, the decision not to perform a formal surgical reconstruction should be entertained and the use of an external prosthesis should be considered. The aforementioned clinical situation is rather unusual, and most women are candidates for a surgical reconstruction, regardless of their age. At the same time, patients who have a higher surgical risk are better candidates for a shorter and potentially simpler surgery such as an implant-based reconstruction, as opposed to an autologous-based reconstruction. With that being said, I have to admit that being a microsurgeon, I am biased toward autologous-based reconstruction, and, in my opinion, most women (not all) who can undergo an implant-based reconstruction can also undergo an autologous breast reconstruction. One of the most effective breast cancer treatment adjuncts is radiation therapy. This is a tool that provides the capability to reduce local recurrence. At the same time, radiation therapy increases the rate of local complications, especially related to implant-based breast reconstruction. This is a critical factor in the decisionmaking process. In the setting of known external beam radiotherapy, the patient is counseled that the use of autologous-based reconstruction has a lower rate of local complications such as infection, capsular contracture, implant extrusion and overall failure of the continued on the following page

SURGEONS’ LOUNGE

GENERAL SURGERY NEWS / OCTOBER 2020

Breast Reconstruction continued from previous page

reconstruction. Each patient is unique, and the final decision of what type of reconstruction to perform is determined on a case-by-case basis. DR. MONTORFANO: What type of follow-up care is

required after breast reconstruction? DR. MASCARO PANKOVA: Most of the patients who undergo

an implant-based reconstruction will be admitted overnight and will be discharged on postoperative day 1. Most patients will also have drains after surgery, independent of the type of reconstruction performed. Strict drain care is usually required after surgery. If a patient undergoes a breast reconstruction with tissue expanders, she will usually start her expansion process two to three weeks after surgery and will require serial expansions every seven to 10 days until the proposed volume is achieved.

If a patient undergoes autologous breast reconstruction with a free flap, the patient will be monitored on a very strict in-patient protocol. Most patients will be in the ICU for the first 24 hours, requiring free flap monitoring every hour using a Doppler, or one of several other methods, to assess flap perfusion. After the first 24 hours, the free flap monitoring decreases to every two hours, and then to every four hours, until discharge. This requires the patient to stay in the hospital for four to five days. Postoperative length of stay is a point that, as microsurgeons, we are challenging. The idea of discharging the patient earlier is a goal in the near future. DR. MONTORFANO: Does breast reconstruction affect

breast cancer recurrence screening? DR. MASCARO PANKOVA: If a patient had a breast completely removed (mastectomy) and reconstructed, future screening mammograms on the reconstructed breast(s) are not needed. Currently, there are no data to support

the value of routine screening mammography after mastectomy and reconstruction, regardless of whether the patient had an implant or flap reconstruction. The only exception is the use of MRI screening to detect possible rupture of a silicone implant. DR. MONTORFANO: What are some new advances in

breast reconstruction after mastectomy? DR. MASCARO PANKOVA: I would like to take the opportunity to answer this question with a slightly different approach. I believe that BIA-ALCL is a very hot and new topic in breast reconstruction and I would like to address it briefly. BIA-ALCL is a rare type of T-cell lymphoma (cancer of the immune system) that can develop in the scar tissue capsule and fluid surrounding a breast implant. In some cases, it can spread throughout the body. BIAALCL is not breast cancer. It can occur around salinefilled or silicone gel‒filled implants that have been continued on page 24

The History of Breast Reconstruction Techniques By Lisandro Montorfano, MD, Eric Emberton, MD, and Carlos Rivera, MD, Cleveland Clinic Florida, Weston The first documented cases of breast cancer are in the papyrus writings of the ancient Egyptians. Hippocrates was the first one to describe stages of breast cancer in the early 400s B.C.E. Fast-forward to 1889, Dr. William Halsted was the first to perform a radical mastectomy to control the disease. However, in the 1800s, breast reconstruction was not emphasized or researched, as preservation of tissue was thought to be a risk factor for local recurrence. Breast reconstruction was first described by German physician Vincenz Czerny in 1895, by harvesting and using a lipoma from a patient’s flank to construct a breast mound. A decade later, Dr. Iginio Tansini (Italy) and Dr. Louis Ombredanne (France) first described the use of musculocutaneous flaps for breast reconstruction, using the latissimus dorsi and pectoralis muscle, respectively. Sir Harold Gilles from New Zealand then later performed his first breast reconstruction with a tubed abdominal flap method in 1942. However, these techniques were overlooked for decades and considered operations with limited indications. As science and medicine continued to evolve with new evidence and guidelines emerging, the surgical treatment of breast disease shifted toward less aggressive approaches. This change revitalized interest in breast reconstruction. In 1977, due to improvement in the mastectomy technique, Schneider, Hill and Brown, and separately, Muhlbauer and Olbrisch reintroduced the latissimus dorsi musculocutaneous flap for breast reconstruction. Two years later, Robbins reported the use of a vertically oriented skin muscle flap

Vincenz Czerny of the rectus abdominis muscle. This technique allowed larger volumes of tissue to be transferred to recreate a breast mound. Hartrampf, Schlefan, and later, Black, described a transversely oriented abdominal musculocutaneous (TRAM) flap for breast reconstruction in 1982, allowing the use of the lower abdominal skin and subcutaneous tissue for reconstruction while also providing a more aesthetic donor site closure. The pedicle TRAM flap underwent several modifications over time to improve its blood supply and became one of the preferred techniques for autologous breast reconstruction. Holmstrom was the first surgeon to describe the use of discarded tissue from an abdominoplasty for breast reconstruction in the 1970s. This was the first description of a free TRAM flap. Over the years, this flap has become the standard for microvascular autogenous breast reconstruction. Regarding implant-based reconstruction, Cronin and Gerow were

two remarkable surgeons who introduced the silicone gel breast implants in 1963. Radovan introduced the use of tissue expanders for breast reconstruction later in 1982. This development enabled patients with more extensive skin defects to become candidates for reconstruction of their breast. Reconstruction of the nipple-areola complex is the last step in the process of a post-mastectomy breast reconstruction. In the past, reconstruction of the areola involved skin grafts and contralateral areola contributions. Becker was the first to suggest tattooing the nipple-areola complex on a reconstructed breast in 1986. This technique provides a high image quality and offers extensive pigment tones to match the contralateral areola. Several additional techniques for nipple reconstruction have also been described, including Little’s skate flap, Anton and Hartrampf’s star flap, Cronin’s S flap, Bostwick’s C-V flap, and Smith and Nelson’s mushroom flap. Although all of these methods are acceptable to reconstruct the nipple-areola complex, supporting literature is controversial as to which flap is best. In summary, breast reconstruction is an important tool for patients to accept and overcome their physical and psychiatric ailments associated with the diagnosis and treatment of breast cancer. Several options are available and should be personalized to each patient’s individual needs and desires. The idea that a patient has to live without breasts is now an archaic concept with breast reconstruction becoming a routine choice for women undergoing breast cancer surgery.

Suggested Reading • Bland KI, Klimberg VS, Copeland EM III. Halsted radical mastectomy. In: The Breast: Comprehensive Management of Benign and Malignant Diseases. 5th ed. Elsevier; 2018:422442.e2. • Brent B, Bostwick J. Nipple-areola reconstruction with auricular tissues. Plast Reconstr Surg. 1977;60(3):353-361. • Cronin TD, Gerow FJ. Augmentation mammaplasty: a new “natural feel” prosthesis. In: Transactions of the Third International Congress of Plastic and Reconstructive Surgery. Excerpta Medica; 1963. • Czerny V. Plastic replacement of the breast with a lipoma [in German]. Chir Kong Verhandl. 1895;2:216. • Gilles HD, Millard DR. Principles and Art of Plastic Surgery. Little Brown & Company; 1957. • Hartrampf CR, Scheflan M, Black PW. Breast reconstruction with a transverse abdominal island flap. Plast Reconstr Surg. 1982;69(2):216-225. • Holmstrom H. The free abdominoplasty flap and its use in breast reconstruction. Scand J Plast Reconstr Surg. 1979;13(3):423-427. • Little JW. Nipple areola reconstruction. Clin Plast Surg. 1984;11(2):351-364. • Moon HK, Taylor GI. The vascular anatomy of rectus abdominis musculotaneous flaps based on the deep superior epigastric system. Plast Reconstr Surg. 1988;82(5):815-832. • Muhlbauer W, Olbrisch R. The latissimus dorsi myocutaneous flap for breast reconstruction. Chir Plast (Berlin). 1977;4:27. • Radovan C. Breast reconstruction after mastectomy using the temporary expander. Plast Reconstr Surg. 1982;69(2):195-208. • Robbins TH. Rectus abdominis myocutaneous flap for breast reconstruction. Aust N Z J Surg. 1979;49(5):527-530. • Schneider WJ, Hill HL, Brown RG. Latissimus dorsi myocutaneous flap for breast reconstruction. Br J Plast Surg. 1977;30(4):277-281. • Silva OE, Zurrida S. Breast Cancer: A Practical Guide. Elsevier Science; 2002. • Tanzini I. Spora il mio nuova processo di amputazione della mammella. Riforma Medica. 1906;22:757. • Teimourian B, Adham MN. Louis Ombredanne and the origin of muscle flap use for immediate breast mound reconstruction. Plast Reconstr Surg. 1983;72(6):907-910.

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IN THE NEWS

GENERAL SURGERY NEWS / OCTOBER 2020

Colorectal Cancer Risk Calculators Don’t Compute By CAROLINE HELWICK

our patient’s estimated risk for colorectal cancer could depend on which assessment tool you choose. A new study of risk calculators found that the assessments consistently included information about age, sex, body mass index, tobacco use and family history of CRC. They were less consistent about race, education, personal medical history, diet, exercise, and use of alcohol and medications, such as nonsteroidal antiinflammatory drugs, aspirin, oral contraceptives, estrogen, vitamin D and calcium. “Given the variation in risk calculators, it is important to understand which ones are best built in terms of study population, methods used for model development, model metrics, and perhaps most importantly, the extent of testing and validation,” Thomas Imperiale, MD, the Lawrence Lumeng Professor of Gastroenterology and Hepatology at the University of Indiana, in Indianapolis, and the senior author of the study, said. “It’s about knowing which one is best for your patient, your setting and so forth.” In the study, which Dr. Imperiale and his colleagues submitted to the 2020 Digestive Disease Week, the researchers examined five online risk assessment tools for CRC to see how they compared, and whether the 3% risk threshold that has been recently recommended could apply to other models. The researchers used scenarios for low-, average- and high-risk patients to look for variation, and they found it, according to Jennifer Maratt, MD, an assistant professor of medicine at Indiana University School of Medicine, who helped conduct the study (abstract Tu1802). A 15-year CRC risk greater than 3% was the screening threshold recommended by an expert panel using the QCancer risk model (Br Med J 2019;367:15515).

Models for CRC lacked consistency in the risk factors they included and the time frames across which they estimated risk. Some models predicted lifetime risk, and in these models the lifetime risk also varied, regardless of sex and race. Variation increased for older adults and for longer time frames of estimated risk. “It’s hard to say which calculator to use, but by taking multiple risk factors into consideration, we can start to personalize CRC screening decisions. However, if we apply a risk threshold to decide who to offer screening to, there needs to be more consistency in predicted risk and more data to show which models are the most robust so that we can use these tools in clinical practice,” Dr. Maratt said. The researchers examined the National Cancer Institute’s Colorectal Cancer Risk Assessment Tool, Cleveland Clinic’s Colon Cancer Risk Assessment (CC), Colorectal Cancer Predicted Risk Online (CRC-PRO), QCancer and My CancerIQ. They looked at the factors that each tool included and assessed each’s output for three hypothetical screening scenarios, varying them by age (50 vs. 75 years), sex and race. “Not all models provide lifetime risk estimates, but of those that do, we found more inconsistencies in lifetime estimates in comparison to shorter time frames,” Dr. Maratt said. As an example, inconsistencies were found in 0% of five-year and 17% of 10-year time frames, but jumped to 71% of lifetime CRC risk estimate comparisons (P<0.001), according to the researchers (Table). By age, risk estimates were inconsistent for 17% of theoretical 50-year-olds, rising to 42% for 75-yearolds (P=0.02). Only QCancer provided 15-year risk estimates. The highest screening thresholds achieved in 50-year-olds were 3.3% for white men and 2.5% for Black men.

Surgeons’ Lounge continued from page 22

placed for breast reconstruction after mastectomy or cosmetic breast enlargement. BIA-ALCL seems to only develop in women who have implants with a textured surface (shell) or who have had them in the past. To date, there are no confirmed reports of BIA-ALCL in women who have only had smooth implants. The most common symptoms of BIA-ALCL are swelling (due to fluid buildup) or pain in the area of a textured breast implant. These symptoms tend to develop years after the implant is placed (on average, seven to 10 years), but they may develop earlier. Some patients have had a lump adjacent to the implant surface or a lump in the lymph node in the armpit.

Table. CRC Risk Estimates: Average-Risk White Man Time Frame

5 years, %

10 years, %

Lifetime, %

Risk Calculator

50-Year-Old

75-Year-Old

NCI

0.4

1.1

QCancer

0.3

1.7

CRC-PRO

1.0

4.0

QCancer

0.6

4.0

NCI

4.4

2.6

5.0

My CancerIQ

>7.0

CC, Cleveland Clinic Colon Cancer Risk Assessment; CRC-PRO, Colorectal Cancer Predicted Risk Online; NCI, National Cancer Institute Colorectal Cancer Risk Assessment Tool

On the other hand, all sexes and races in the 75-year-old group exceeded 3%, the highest being a 17.1% risk for white men followed by 13.1% risk for Black men.

None Ready for Routine Use Dr. Maratt said more studies are needed to determine the internal validity of the CRC risk calculators to identify the most robust models with reliable risk estimates, “so that they can be reliably used to guide decision making.” Dr. Imperiale said he does not use any of these models “routinely” or “quantitatively,” but based on their particular variables he may recommend one or another to a given patient. He and several colleagues developed and published a scoring index themselves for average-risk patients (Ann Intern Med 2015;163:339356). He tends to use this “short model” or the National Cancer Institute tool, he said.

If BIA-ALCL is suspected, doctors should order imaging with ultrasound or MRI. If the imaging results show more than minimal fluid collection around the implant or a mass near the implant, then a sample of the fluid should be collected using fine needle aspiration. The fluid should be tested for CD30, a protein that is found in higher than normal amounts on lymphoma cells, particularly in BIAALCL. If the fluid tests positive for CD30, the fluid should also be tested for anaplastic lymphoma kinase, a protein that helps control cell growth. If the pathology results indicate BIA-ALCL, the National Comprehensive Cancer Network guidelines recommend surgery to remove the implants and the entire surrounding scar tissue capsules. The surgeon should perform an en bloc capsulectomy, that is, removing the breast implant and the capsule of scar tissue surrounding it in one piece. ■

Aasma Shaukat, MD, MPH, the GI section chief at the Minneapolis VA Health Care System, and a professor of medicine at the University of Minnesota, in Minneapolis, said she would welcome an accurate CRC risk calculator, but to date, there is none. Although risk calculators are widely used in many areas of medicine, they are challenging to develop, requiring “multiple layers of external validation in diverse populations and regular updates,” Dr. Shaukat said. “For CRC risk, while there are several models developed, none are ready for clinical use. This is because, other than age and sex, there are not very many strong risk factors known, and their level of magnitude for risk of CRC varies,” Dr. Shaukat said. “However, the need for a risk calculator continues to grow, particularly in the COVID era, as we try to understand how to prioritize screening.” ■

Suggested Reading • Agarwal T, Hultman CS. Impact of radiotherapy and chemotherapy on planning and outcome of breast reconstruction. Breast Dis. 2002;16:37-42. • Cordeiro PG. Breast reconstruction after surgery for breast cancer. N Engl J Med. 2008;359(15):1590-1601. • De La Cruz L, Blankenship SA, Chatterjee A, et al. Outcomes after oncoplastic breast-conserving surgery in breast cancer patients: a systematic literature review. Ann Surg Oncol. 2016;23(10):3247-3258. • D’Souza N, Darmanin G, Fedorowicz Z. Immediate versus delayed reconstruction following surgery for breast cancer. Cochrane Database Syst Rev. 2011;(7):CD008674. • McAnaw MB, Harris KW. The role of physical therapy in the rehabilitation of patients with mastectomy and breast reconstruction. Breast Dis. 2002;16:163-174. • Roostaeian J, Pavone L, Da Lio A, et al. Immediate placement of implants in breast reconstruction: patient selection and outcomes. Plast Reconstr Surg. 2011;127(4):1407-1416. • Schmauss D, Machens HG, Harder Y. Breast reconstruction after mastectomy. Front Surg. 2016;2:71-80.

OPINION

OCTOBER 2020 / GENERAL SURGERY NEWS

My Worst Surgical Error The Unintended Harm That Comes From a Volume Model By BRUCE RAMSHAW, MD

s surgeons, we love to be busy in the OR. We tend to compete on our volume of cases and boast about the number of operations weâ&#x20AC;&#x2122;ve performedâ&#x20AC;&#x201D;often overestimating. Iâ&#x20AC;&#x2122;ve even heard physician practice administrators laugh about how easy it is to increase surgeon productivity just by letting them know another surgeon has a higher volume. I remember responding in that competitive way of thinking early in my career, too. At the height of the volume model in my surgical practice, I was performing surgery in two and sometimes three ORs at the same time. I would go back and forth between rooms with a fellow in one, a resident in another, and sometimes a consultant OB-GYN or neurosurgeon in another that I was helping on a part of their case. The rule is that I had to be scrubbed in for the â&#x20AC;&#x153;criticalâ&#x20AC;? portions of a procedure. This meant that sometimes a fellow or resident had to wait for me to get to a point in another OR case and couldnâ&#x20AC;&#x2122;t proceed with the procedure until I was able to scrub in again. I was always overbooked in clinic. It seemed like â&#x20AC;&#x153;Iâ&#x20AC;&#x2122;m sorry Iâ&#x20AC;&#x2122;m lateâ&#x20AC;? was added to my last nameâ&#x20AC;&#x201D;as in, â&#x20AC;&#x153;Hi, Iâ&#x20AC;&#x2122;m Dr. Ramshaw; Iâ&#x20AC;&#x2122;m sorry Iâ&#x20AC;&#x2122;m lateâ&#x20AC;?â&#x20AC;&#x201D; whenever I walked into an exam room to meet a patient. I would try to spend as much time as needed with each patient, and that is partly why I would run late. And it got worse over time as patient problems seemed to get more and more complicated. This led to more and more stress on operating days because the eight to 12 cases I needed to book to hit my productivity targets were being filled with patients who had increasingly challenging problems. We saw more obesity, more patients with prior abdominal operations, more extreme conditions, all leading to more difficult operations that took longer to perform. This meant that my OR days gradually increased from ending at about 6 or 7 p.m. to finishing in the OR regularly at 8, 9, or even after 10 p.m. About once a month or so, I would be operating on elective cases after midnight. This was not only potentially harmful to patients but not healthy for me. Like many of us, I had cognitive dissonance about my volume. At the time, I truly believed it was a good thing to do as many cases as possible on a surgery day. The dissonance went like this: Iâ&#x20AC;&#x2122;m an expert in my field, so the more operations I can do a day, the more people

Iâ&#x20AC;&#x2122;m helping; therefore, I should continue to figure out ways to maximize my surgical volume. Itâ&#x20AC;&#x2122;s good for the patients Iâ&#x20AC;&#x2122;m helping; itâ&#x20AC;&#x2122;s good for the hospital, which receives most of the revenue I generate; and itâ&#x20AC;&#x2122;s good for meâ&#x20AC;&#x201D; good for my reputation, my contribution to clinical research, and, of course, for my salary. But objectively, I was not healthy, and eventually something was bound

to happen under the stress of this volume. It eventually didâ&#x20AC;&#x201D;the worst complication Iâ&#x20AC;&#x2122;ve ever had that was directly related to my surgical performance. I was doing a very large complex ventral hernia repair that was located on the lower abdomen of a patient who had more than 10 prior attempts at repairing the hernia. After that many failed hernia repairs, the hernia was huge. It was late in the afternoon when I began the hernia repair

laparoscopically. It was a challenging case that was very frustrating due to the size and location of the hernia as well as extremely dense scar tissue. At one point there was bleeding from a vessel up in the hernia sac, which I thought was the inferior epigastric artery. I applied a 5-mm clip that easily stopped the bleeding. Because it was such a difficult operation and because I had concerns about continued on the following page

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OPINION

Surgical Error continued from page 25

the possibility of a missed or delayed bowel injury—and possibly because I was due to be in another OR, I don’t remember—I decided to stop the operation and keep the patient in the hospital for observation, returning to the OR to place the mesh a few days later. I never did get the chance to return to the OR to fix the hernia. Immediately after the surgery, I went to the family waiting room to explain what had happened, how difficult the surgery had been, and why I wanted to wait a few days before completing the hernia repair. I typically just called the family on the phone after an operation because I was usually late and needed to scrub into another OR as soon as possible, but my gut told me I needed to talk to the family in person. Complications in a complex environment like health care are known to not have a single root cause. Despite all the root cause analyses that have been attempted in health care, the reality is that when a major complication or death occurs, many factors have contributed to that bad outcome that have all lined up in just the wrong way. This is called the “Swiss cheese model” from safety science, meaning that when all of the holes in slices of cheese line up in just the wrong way, a bad outcome can occur. There is not one cause. In the case of my patient’s complication, the factors that could be contributory included patient factors, like the size and location of the hernia; the severity of the scar tissue; the possibility that the patient was obese or smoked (again, I don’t remember); my health and my busy schedule, which added to my stress; an OR environment that may not have supported others to speak up; the anesthesiologist’s decision to keep the patient intubated overnight because they were

GENERAL SURGERY NEWS / OCTOBER 2020

so busy with other cases (the volume model doesn’t just affect surgeons); the ICU nurse and resident surgeon doing the post-op check not doing a complete physical exam—they both had documented throughout the night that the patient had full and equal pulses in both feet and both legs were warm and felt normal. I learned of one other factor in retrospect. There was an anatomic anomaly due to all of the prior operations and scar tissue. That anomaly, combined with

I became nauseous as I watched the vascular team identify the blockage. It was the surgical clip I had placed more than 12 hours earlier. … It is a terrible trauma for anyone to tell a family about the loss of life or a limb after a tragic accident. But it’s even more traumatic when that accident is actually the mistake a surgeon made during a procedure.

HVACs continued from page 11

increase ventilation in infected patients’ bathrooms, and maintain regular cleaning of bathroom surfaces. Some hospitals are taking extra precautions to prevent airborne transmission of SARS-CoV-2, Ms. Wood said. For instance, when patients need to be intubated— a procedure that can generate droplets—facilities may perform the intubation in airborne infection isolation rooms before transporting patients to the OR, or use a plexiglass box or plastic sheeting if intubating in the OR. If a facility is short on N95 respirators, team members may remain outside the room during intubation

the fact I was viewing a 2D screen, led to my misperceiving that the bleeding vessel was the inferior epigastric artery when it was actually the femoral artery. With all of those factors lined up in just the wrong way, we didn’t know what had happened until the next morning when the patient was extubated and immediately screamed, “My leg hurts!” I don’t blame the people who were caring for the patient that night. I’ve learned how important it is in health care to move away from a culture of blame and create a just culture for an optimal safety environment. I was called immediately, and I scrubbed out of the operation I was in to go see the patient. I was confused, because my brain still couldn’t comprehend that the artery I clipped could be the femoral artery. I thought there must be a blockage from a blood clot or some other reason for the lack of blood flow to the lower extremity. I consulted vascular surgery, spoke with the family about the need to return to the OR, finished the case I was doing, and then delayed additional cases so I could observe the vascular surgeons as they attempted to help my patient. I became nauseous as I watched the vascular team identify the blockage. It was the surgical clip I had placed more than 12 hours earlier. An amputation of a portion of the patient’s leg was eventually required. It is a terrible trauma for anyone to tell a family about the loss of life or a limb after a tragic accident. But it’s even more traumatic when that accident is actually the mistake a surgeon made during a procedure. Devastated, I left the OR to immediately talk with the family. I was fortunate that the patient and family were kind and understanding people. I had learned by then how important it is to apologize and transparently explain all of the details about what happened

and extubation, she said, and wait to enter until the air exchange has removed 99% of airborne particles. But it’s not just intubation that can be dangerous, Ms. Wood said. “There are unknown risks in surgery for aerosolization of COVID-19‒infected blood and body fluids, and some procedures may be higher risk, such as endoscopy.” Modifying existing HVAC systems, which hospitals have been optimizing for decades to prevent airborne transmission of other pathogens, doesn’t make sense to Mr. McDavid. If anything, some facilities, such as the Johns Hopkins Hospital, in Baltimore, are adding more of what works, such as HEPA filters and negative pressure rooms to create more space to isolate COVID-19

when there is a bad outcome, especially a medical or surgical error. I tried to see the patient every day during their recovery on the vascular service, even after the patient was transferred to a rehabilitation unit. I know I contributed to a much worse quality of life for that patient and their family because of my surgical error. I’ve learned since then that the volume model that I was functioning in was also a contributing factor to this patient’s outcome. During the time in my career when I maxed out volume, I gained weight due to poor eating habits and not making time to exercise. Today, I weigh about 60 pounds less than I did then. My day usually started with a stop for a fast-food breakfast near my home, eating in the car on the drive to work, then stopping at another fast-food restaurant after work around 10 p.m. or later for dinner to eat on my drive home. In between I would wolf down something for lunch somewhere in the middle of the day. I remember the hospital cafeteria egg salad sandwiches were pretty good. During the past few years, the awareness of the potential harm to patients and physicians in a volume model has been raised. There has been a growing concern about the practice of concurrent operations and the systemic nature of physician burnout and suicide. But we need to do much more. If a system is unjust, we shouldn’t teach conformity—we should ■ change the system. A personal note to this patient and family: If you somehow read this article, please know I am again deeply sorry about the suffering you experienced from my surgical error. Please also know that your suffering is one of my many motivations to work toward the transformation of health care from a system based on volume to one based on value for patients. —Dr. Ramshaw is a general surgeon and data scientist from Knoxville, Tenn., and a managing partner at CQInsights. He is a member of the editorial advisory board of General Surgery News.

patients (www.hopkinsmedicine.org/coronavirus/articles/all-hands-on-deck.html). The SARS-CoV-2 virus is not measles, Mr. McDavid said; most of the respiratory droplets that contain the new virus are likely large enough that they fall to the ground or other surfaces relatively quickly. In that scenario, protecting staff and patients in hospitals is mostly a matter of adequate protective gear and housekeeping, he said, using proper chemicals to wipe down surfaces. “Yes, the new coronavirus is something different, and we’re learning a lot about it,” Mr. McDavid said. “But, really, the same mitigation efforts are in place as for mold, asbestos and other types of mitigation [that have] ■ taken place over the years.”

OPINION

OCTOBER 2020 / GENERAL SURGERY NEWS

COVID-19 and ACS continued from page 1

ideas and subjects chosen for presentation involve the telling of scientific truths about COVID-19—about what is known, what is unknown, and what needs to be discovered. We have been and continue to be subjected daily to a bombardment of emails, other electronic communications and media messages advertising the availability of videos and commentaries by “experts”—real and otherwise—as well as by webinars, Zooms and town meetings to be joined, free, all of them eager to inform us of a particular perspective on the COVID-19 pandemic. This endless stream of material contains kernels of real data within a morass of misinformation, disinformation and texts from those seeking notoriety for adding their perspectives. In addition, the delayed, misleading or erroneous statements, made by some of the world’s most prominent health care and pandemic professionals, possibly fearful of losing their appointments, have also contributed to the harm caused within this vaudeville atmosphere. Further, we have received and continue to receive misguided and ambiguous statements from our national and regional leadership, motivated by personal interests and politics rather than by rationality and science. This babel has contributed to our unfortunate national achievement of ranking first among nations for the incidence and mortality of COVID-19. We now have over 25% of the entire world’s cases (about 6/23 million) and growing, and about 25% of the world’s known COVID-19 deaths (about 200,000/800,000), and

A chemical does not favor the policies of a political party or politicians. A chemical is entirely unaware of complex beliefs of religion, laws, national constitutions. Yet, every day, this chemical promotes misery, kills and destroys the structure of society. This virus is the vector of a disease pandemic, but it is still only a chemical without a creed. growing. If we examine these numbers with respect to population, the United States, in September, had about 17,000 cases per 1 million people compared with about 3,000 per 1 million for the rest of the world (about a sixfold increase), and about 525 deaths per 1 million compared with about 100 for the rest of the world (about fivefold). With the prevailing infection and mortality rates in the United States, annual COVID-19 death will be 10-fold the annual seasonal flu mortality. COVID-19 is the third leading cause of death in the United States, surpassed only by heart disease and cancer. Although recovery from the seasonal flu is usually total, current data of residual COVID-19 pathology do not support this expectation. The 2020 virtual ACS Congress is dedicated to the dissemination of COVID-19 scientific truths. The program committee set aside seven special and panel sessions, comprising six hours and 45 minutes of lectures, symposia and discussions, over three meeting days, committed to the COVID-19 crisis. The presentations cover the tripartite 2020 congress themes of learning,

collaborating and giving back. This knowledge has the potential to initiate an intelligent containment response. Special Session 341 of the ACS meeting, titled Transformation of Residency Training in Surgery: COVID-19 Pandemic and Beyond (Monday, Oct. 5, 12 p.m.), was founded on its function of educating the next generation. In many institutions around the country, the COVID-19 first responders have been surgeons, including surgical residents. Until now, very few surgeons were trained in viral isolation procedures, in and out of the OR, critical care for fluid-filled lungs, and ECMO (extracorporeal membrane oxygenation) management under these conditions. This knowledge for the present should be considered necessary for the future curriculum of residency training. Special Session 441 is a presentation called Leadership, Workforce, Communication During COVID19 Pandemic: Lessons Learned (Tuesday, Oct. 6, at 12 p.m.). I presented examples of exemplary leadership in my August column, wherein I outlined the responses of three hospitals across the country—EvergreenHealth, continued on the following page

IN THE NEWS

GENERAL SURGERY NEWS / OCTOBER 2020

OR Fires and Mishaps

surgical drapes. Additional oxygen can be used, however, when using surgical scalpels or other tools that do not conduct energy.

continued from page 1

Regional VA Medical Center, in Aurora. Because these fires are often surrounded by blue surgical towels, they can be hard to detect and rapidly get out of control. Smoldering conditions without flames in the OR also are considered fires and can be reported per Joint Commission requirements. “This comes into play with laparoscopy, when the fiber-optic light cord, when left in place for a short period of time, can result in burns through surgical drapes or towels,” Dr. Jones said. “This can be classified as a fire even if it doesn’t extend beyond this or cause harm to the patient.” There are an estimated 200 to 300 reported OR fire incidents, resulting in two to three deaths, annually, according to the nonprofit ECRI Institute in Plymouth Meeting, Pa. This may sound small, but there has been an increasing number of voluntarily reported surgical device-related fires in the FDA’s Manufacturer and User Device Experience database, Dr. Jones said (J Am Coll Surg 2015;221[1]:197-205.e1). “It only takes one bad case to not only result in patient harm but also in likely harm to the

hospital and health system,” he noted. To prevent fires, Dr. Jones said, focus on three things: fuel, heat and an oxidizer. The most common oxidizers are oxygen or nitrous oxide, while heat sources include electrosurgical units, lasers or fiber-optic lights. Fuel sources can include alcohol preps as well as drapes, gowns, gauze, and even patient hair or tissue. He offered the following tips. Be careful with supplemental oxygen. Turning up the flow on “open” oxygen systems like masks can increase the oxygen up to 50% more; draping the patient also can increase the oxygen content. Once the oxygen content increases to higher than 30%, things that are not usually flammable suddenly become so, Dr. Jones said. Use a closed oxygen system in high-risk situations. When operating on the face, near the mouth or nose, consider using an endotracheal tube. “This isn’t 100% protective, but it’s a lot more protective than having a mask with additional oxygen right next to where you’re working,” Dr. Jones said. Avoid oxygen content greater than 30% or creating pockets of oxygen with

COVID-19 and ACS continued from page 27

in Kirkland, Wash.; NewYork-Presbyterian/Weill Cornell Medical Center, in New York City; and M Health Fairview Bethesda Hospital, in St. Paul, Minn.—as well as the ACS. Although they learned on the job, the hospitals performed admirably. They organized responsible workforces and established communication networks. Above all, they provided rational and calm leadership, an attribute lacking in our national and so many state governments. The ACS promulgated clinical guidance, ethical considerations, a surgical triage protocol, and a call for Operation Giving Back volunteers, as well as the establishment of a registry of data for future reference in the event of another infectious pandemic. This was true leadership by taking action, by being in the forefront, and by taking responsibility. The remaining five congress sessions are all special COVID-19 panels. Their subject titles include Impact of the COVID-19 Pandemic on Intimate Partner Violence; COVID-19 Related Respiratory Failure; Well-Being Challenges During COVID-19 Pandemic: Preparing for the Next Crisis; COVID-19 Related Critical Care Management Issues; and COVID-19 and Surgery: The International Perspective. These are not surgical specialty sessions but timely universal discussions for all of us as general surgeons. Beyond the 2020 virtual congress and into the future of COVID-19, scientific truths will be our guides for dealing not only with the disease as surgeons, but as we conduct our daily lives, and in our family and community lives. We will move forward to discover the infection rate; mortality rate and distribution; prevalence and validity of testing for infection and immunity; modes of disease spread; and relative effectiveness of isolation,

Select the appropriate risk device for the procedure. When creating a tracheostomy in the airway, Dr. Jones said, don’t cut into the trachea with an energy device while the oxygen is elevated. If there is significant bleeding, skip the energy device and instead use a good surgical technique to suture leaky blood vessels.

‘We still call it electrocautery. That’s old-fashioned and implies it’s a nonthreatening device. We’re all comfortable with it, but very few surgeons can explain the function of these devices and fewer the potential threat they represent for surgeons and patients.’ —Paschal Fuchshuber, MD, PhD

masking, social distancing and other methods of containment. Also important to our lives will be understanding the risks of travel; the status of antiviral drugs; and the availability, safety and effectiveness of vaccines. How will we obtain these scientific truths? We will accumulate data, perform statistical analyses, start registries, and use computer simulations and animal testing. We will perform randomized controlled trials. In other words, we will do what we have done as the cornerstone of modern medicine: We will follow the scientific method, and we will listen to those who do so. I quote David B. Hoyt, MD, the executive director of the ACS: “In responding to this event, we just build upon the infrastructure that we have, which again is designed to try and serve all—not just all patients—but serve everyone involved with surgery.” We will learn from experience—the experience of others and ourselves. Some nations have been exemplary in their response to COVID-19, countries able to prevent or control this pandemic: New Zealand, South Korea, Norway, Germany and others, although they will have setbacks. They were able to do so without drugs, without a vaccine, using containment, by combinations of universal testing, rapid isolation of the infected, quarantining of contacts, masking, social distancing, and a closure of public facilities. These countries accepted a short-term sacrifice to their economy in order to preserve it for the long term. They made the lives and health of their people the primary concern of government. As practicing physicians and surgeons, we base our therapeutic decisions and the recommendations we make to our patients on experience as well as on scientific evidence. There is an old adage: Good judgment is gained by experience; experience is the result of bad judgment. If that is true, we as a nation have made enough bad decisions for the nation to have gained the

Use caution with alcohol-based preps. Non–alcohol-based preps such as chlorhexidine or iodine are not flammable, Dr. Jones said. However, one in five cases using alcohol can be flammable (J Am Coll Surg 2017;225[1]:160-165). Even after waiting the recommended three minutes of drying time, the area is still potentially flammable, especially if the alcohol has pooled, he said. Fires can also start from alcohol that has seeped into the drapes or towels near the patient. Do not drape the patient until the prep is dry and there are no pools present. If a fire does start, it needs to be identified immediately, Dr. Jones said. Stop the flow of airway gases if the patient is intubated and remove the endotracheal tube,

requisite experience to now make good decisions. The SARS-CoV-2 virus that causes COVID-19 consists of single-stranded RNA, its genetic blueprint consisting of the nitrogen bases of adenine, cytosine, uracil and guanine, linked to the sugar ribose. Bound to the string of RNA are nucleoproteins that give the virus its spatial structure. Encapsulating the viral core is the viral envelope of lipids and the spike proteins that allow the virus to penetrate cells. The virus cannot replicate itself; it requires a host cell for survival. We are, therefore, dealing with a complex biochemical. It is, in essence, a chemical, not a being. A chemical does not favor the policies of a political party or politicians. A chemical is entirely unaware of complex beliefs of religion, laws, national constitutions. Yet, every day, this chemical promotes misery, kills and destroys the structure of society. This virus is the vector of a disease pandemic, but it is still only a chemical without a creed. A hallmark of civilization has been specialization. A nation maintains armed forces to counter outside threats, police to control crime, firefighters to fight fires, and health care professionals to combat and prevent disease. As health care providers, COVID-19 is our responsibility, and it is our duty to vanquish it. To overcome COVID-19, the ACS, other professional societies, scientists, physicians, nurses and medical industries must work together to defeat this virulent chemical by adherence to scientific truths and by commitment to our oaths as healers. We must continue to be the voices ■ of hope in this ongoing time of crisis. —Dr. Buchwald is a professor of surgery and biomedical engineering, and the Owen H. and Sarah Davidson Wangensteen Chair in Experimental Surgery (emeritus), at the University of Minnesota, in Minneapolis. His articles appear every other month.

IN THE NEWS

OCTOBER 2020 / GENERAL SURGERY NEWS

especially if extra oxygen is flowing in. If there is an airway fire, pour saline in the airway and disconnect the breathing circuit. Extinguish fire on any burning material and on the patient if present, and restore breathing and care for the patient. In addition, electrosurgical devices need to be used with caution to prevent serious OR mishaps, said Paschal Fuchshuber, MD, PhD, FACS, a clinical associate professor of surgery with UCSF East Bay, in San Francisco, and a surgeon with the Sutter East Bay group practice. “We still call it electrocautery,” Dr. Fuchshuber said. “That’s old-fashioned and implies it’s a nonthreatening device. We’re all comfortable with it, but very few surgeons can explain the function of these devices and fewer the potential threat they represent for surgeons and patients.” Electrosurgery still causes sparks, he said, and the electric current produces an electromagnetic field that can transfer energy from one instrument to another without the surgeon being aware. Because surgeons cannot see injuries happening with the naked eye, they have to understand the devices to prevent burns. “Modern laparoscopic electrosurgical devices produce electromagnetic fields like antennas,” Dr. Fuchshuber said. “These can emit or

receive energy even if they’re not active.” Furthermore, if an electrical cord is wrapped around an instrument, the instrument can become electrically charged and cause burns to both the surgeon and patient. Breaks in insulation occur on 13% to 39% of laparoscopic instruments even out of the wrapper (e.g., Surg Endosc 2016;30[11]:4995-5001), Dr. Fuchshuber noted, and gloves are not perfect insulators to protect the hands. Particular caution must be used when operating in the vicinity of implantable devices like a pacemaker, he said. Electromagnetic energy can transfer from the surgical instrument to the tip of the device’s lead, potentially heating it and causing burns. If an adverse event does occur and needs to be disclosed, don’t go it alone, said Kinga Powers, MD, PhD, FACS, an associate professor of surgery at Stony Brook Medicine in New York. Get help from a risk manager immediately. Avoid altering the medical record, and don’t blame or shame yourself. Stress needs to be managed, Dr. Powers said: “It’s normal to be emotionally affected and feel guilty when a patient suffers a complication.” Take care of yourself, avoid hindsight bias and analyze the event objectively. Focus on what you can learn, and seek professional help if needed. ■