General Surgery News - March 2021

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GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

March 2021 • Volume 48 • Number 3

Learning Resilience

Harassment of Docs On Social Media A Growing Problem

Cognitive Skills Can Help Surgeons Manage Stress, Improve Performance and Avoid Burnout

By VICTORIA STERN

By ETHAN COVEY

P

hysician burnout costs the U.S. health care system about $4.6 billion annually. Almost 40% of that amount—$1.7 billion—can be attributed to surgeon burnout, according to a widely cited analysis (Ann Intern Med 2019;170[11]:784-790).

Estimates of burnout among surgeons vary depending on the definitions and measures used, but one point is clear: The telltale symptoms of emotional exhaustion, cynicism and diminished sense of purpose are common and growing more prevalent during the COVID-19 pandemic (JAMA Surg 2020;155[11]:1043-1049; JAMA Netw Open 2020;3[3]:e203976).

At its core, Carter Lebares, MD, said, “burnout is really a surrogate marker of profound stress and distress.”

The good news is that not all stress is bad, Dr. Lebares said during a presentation on Resilience Training for Surgeons at the virtual 2020 American College of Surgeons (ACS) Clinical Congress

O

ne-fourth of physicians report being personally attacked on social media, with many experiencing death threats, verbal abuse and sharing of personally identifying information, according to a new study.

Additionally, one in six female physicians reported online sexual harassment.

“It is important that in an era when physicians are engaging in advocacy and education on public health on social media that they risk being attacked,” said Vineet M. Arora, MD, a Herbert T. Abelson professor of medicine at the University of Chicago Pritzker School of Medicine.

Dr. Arora and her colleagues conducted the study as a way to test a hypothesis that harassment and

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MONEY MATTERS

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OPINION

OPINION

Negotiating Your COVID-19’s Silver Lining Employment Agreement We Are the New Influencers

Robotic Surgery: ‘Déjà Vu All Over Again’

What to Know About RVU-Based Contracts

By LINDA WONG, MD

By EDWARD L. FELIX, MD B

By VICTORIA STERN

T

B

’d like you to take a leap of faith back in time to eighth-grade algebra because, believe it or not, your compensation formula is that simple,” said Ann Bittinger, Esq, referring to formulas based on relative value units (RVUs).

Ms. Bittinger, a health care attorney who heads the Bittinger Law Firm based in Jacksonville, Fla., has been negotiating physician employment agreements for more than

he COVID-19 pandemic has affected millions of people, and taken the lives of hundreds of thousands of Americans and millions globally. Many deaths have been long, drawn-out and complicated. Even those who recover can have lingering symptoms and chronic consequences.

COVID-19 has put people out of work, displaced people from their homes, interrupted schooling, and is responsible for depression, despair, anxiety and suicide. Nearly every aspect of our normal life has been completely turned upside down. Life as we know it has become unrecognizable. What good could possibly have come from this?

eing locked down in California for the past 10 months because of COVID-19 risk, I have been restricted to Zoom lecturing and being lectured, reading my journals, and participating in the multiple medical social media platforms. This sounds onerous, but it has given me plenty of time to reflect on what I have learned over the past 40-plus years since I finished my formal training as a general surgeon.

Many of you know me as the moderator of “The Great Debates” column in General Surgery News, in which I’ve always remained neutral and let the

Continued on page 12

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“I

F IR ST LOOK

EXTENDED WOUND CARE COVERAGE

4 Highlights from the 2021 EAST Scientific Assembly OP IN ION

6 Stop Making Surgeons Undertreat Pain IN THE NEWS

14 Causes of Interprofessional Conflicts Page 15 facebook.com/generalsurgerynews

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FEBRUARY 2021

OPINION

MARCH 2021 / GENERAL SURGERY NEWS

Public Perceptions

By FREDERICK L. GREENE, MD

A

fter you have just comfortably eased into your seat on the Boeing 777 for your five-hour flight to the West Coast and have arranged all of your appropriate technology and reading material, the pilot comes on the intercom: “Ladies and gentlemen, this is Capt. Tim Roberts and it is my pleasure to welcome you on board today for our flight to Los Angeles. I am also delighted to let you know that Jack Marshall will be in the pilot’s seat. Jack has had many hours in our flight simulator and has had terrific supervision by one of our outstanding line check pilots. I, of course, will be right here as his co-pilot and will be ready to assist him in any way that I can. So sit back, relax and enjoy today’s flight.”

So, what is your visceral response to this announcement? As a public consumer, are you happy to be part of this learning exercise, although you might not have an understanding of the training involved? Would you relish an opportunity to transfer to another flight? Would you rather not have known what plans have been made in the cockpit for today’s trip? In fact, the flying public knows very little as to what went into the training of a “new” pilot, but for most of us, we feel safe that graduated experience is working in the commercial airline world. Similarly, the public has little knowledge of the training of a newly minted surgeon and the participation of a surgical trainee in operative care that ultimately leads to the development of one who is capable of independent skill and decision making.

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

A recent article in the Journal of the American College of Surgeons (2021;232:8-15) addressed this issue through an electronic survey of the nonmedical public that captured attitudes and perceptions regarding surgical resident autonomy in training. The response rate to this survey was an amazing 93% (2,005 of 2,148)!

The study evaluated demographic characteristics of the respondents (age, sex, race, ethnicity, insurance coverage and educational level) and compared them with a willingness of those surveyed to have surgical residents participate in their operative procedures, if required.

After multivariable logistic regression analysis, the factors most likely associated with respondents who would decline allowing a resident to participate in their operation were female sex, lack of health insurance, Black race and Hispanic ethnicity. Further analysis showed that younger participants (<50 years), males, Blacks, Hispanic respondents, those working in health care or insured tend to believe that resident involvement increased operative complications!

What are we to make of this study? For me, it is clear that the surgical community needs to undertake a very vigorous and concerted effort to educate the public on the importance of resident participation in the clinical management of patients who seek care, especially in our academic surgical training centers. This educational responsibility must include individual attending and supervising surgeons, as well as our professional surgical organizations dedicated to the education and certification of surgeons. The public needs to know that graduated experience and participation of young surgeons in MISSION STATEMENT OF GSN It is the mission of General Surgery News to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for discussion and opinions, from all viewpoints, on the issues most important to surgeons.

Peter K. Kim, MD Bronx, NY

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Lauren A. Kosinski, MD Chestertown, MD

Gina Adrales, MD, MPH Baltimore, MD

Marina Kurian, MD New York, NY

Maurice Arregui, MD Indianapolis, IN

Raymond J. Lanzafame, MD, MBA Rochester, NY

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

Timothy Lepore, MD Nantucket, MA

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

Robert Lim, MD Tulsa, OK

James Forrest Calland, MD Charlottesville, VA

John Maa, MD San Francisco, CA

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The surgical community needs to undertake a very vigorous and concerted effort to educate the public on the importance of resident participation in the clinical management of patients who seek care, especially in our academic surgical training centers. clinical operative management, despite the modern use of simulators and skill laboratories, is the ultimate way that the next generation of surgeons will gain autonomy and independence. Importantly, only one-fifth of the survey respondents noted above believed that PGY-5 surgical residents should be allowed to perform an operation at the “supervision only” level!

Just like the airline captain who announces a strategy to his or her attentive passengers, those of us who have the privilege of including surgical trainees in our operative management have an important role in educating each patient regarding the need and benefits of having continued on page 14

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IN THE NEWS

GENERAL SURGERY NEWS / MARCH 2021

First Look: Reports From the EAST Scientific Assembly 2021

By JENNA BASSETT, PhD

The first-ever virtual EAST Scientific Assembly convened on Jan. 13-14, 2021.

Rh-Positive Blood a Viable Alternative to Rh-Negative for Transfusion in Trauma Patients There are no significant differences in hemolysis, transfusion complications or survival when using Rh-negative versus Rh-positive low-titer whole blood (LTO-WB) for transfusions, according to researchers from the Red Duke Trauma Institute at Memorial Hermann-Texas Medical Center, in Houston.

In a prospective, single-center observational study performed from November 2017 to October 2019, researchers examined the safety of replacing Rh-negative with Rh-positive LTOWB in trauma patients, regardless of recipient Rh status. A total of 637 severely injured patients were enrolled in the study. Of the group, 448 were treated with Rh-positive whole blood and 189 received Rh-negative whole blood.

Researchers monitored markers of hemolysis at three, 24 and 48 hours following admission. The only difference between the groups was total bilirubin level, which was elevated in the Rh-positive group at the 24- and 48-hour time points.

For transfusion-related complications, the incidence of transfusion-related circulatory overload was significantly higher in the Rh-negative group, while the Rh-positive patients had fewer ICUfree days and ventilator-free days. Of note, the Rh-positive group was potentially more severely injured than the Rh-negative group.

In subgroup analyses, no differences were observed in hemolysis markers when patients receiving Rh-negative LTO-WB were stratified by recipient Rh type. In patients receiving Rh-positive LTO-WB, the only significant difference was 48-hour serum potassium level. In similar analyses, no differences were seen in transfusion complications or outcomes across subgroups of patients receiving Rh-negative or Rh-positive LTO-WB. Study limitations included lack of randomization and the observational design of the study. In addition, exclusion criteria were expanded to satisfy patient safety concerns when switching from Rh-negative to Rh-positive whole blood, which may be confounding.

“Clinicians considering a whole blood program or already providing this therapy should feel confident utilizing type O-positive whole blood instead of more limited type O-negative product. This will dramatically improve the availability of this product for hemorrhage resuscitation,” said presenting author Cameron McCoy, MD, an assistant professor of surgery at the University of Kansas Medical Center, in Kansas City.

“Next, centers must evaluate how to safely expand the use of type O-positive whole blood for all severely injured trauma patients,” Dr. McCoy said. “As we study this therapy more, I think restrictions based upon age and sex will be eliminated.”

Readmission Adds to Necrotizing Soft Tiissue Infection Disease Burden Patients with necrotizing soft tissue infections (NSTIs) experience greater disease burden with hospital readmissions, according to the results of a new analysis.

Patients with NSTIs have a high risk for unplanned hospital readmission, but the factors that influence readmission are poorly understood. Researchers from Tulane University School of Medicine, in New Orleans, retrospectively investigated the incidence and factors associated with unscheduled readmission among patients with NSTIs. Of the 82,738 patients diagnosed with necrotizing fasciitis, gas gangrene or Fournier’s syndrome, 30.3% were readmitted within 90 days. Of the readmitted patients, 79.8% had unscheduled readmission. The most common causes of readmission were septicemia, cellulitis, abscess and postoperative infection.

Patients with unplanned readmission were generally older, female, more likely to be diabetic, had higher Charlson Comorbidity Index score and were less likely to be obese.

In a multivariate analysis, factors associated with readmission were prolonged versus short length of stay, Medicaid versus Medicare as the primary payor, and leaving against medical advice. No demographic variables, clinical characteristics or interventions were associated with readmission.

Of the readmitted patients, 3.8% died during their hospitalization. Age older than 65 years and fragmentation

of care caused by readmission to a different hospital were independently associated with mortality, while being obese favored survival.

Presenting author Eman Toraih, MD, an associate professor of medical genetics at Tulane University School of Medicine, said clinicians need to ensure that discharged patients have the resources they need so they will not require readmission. “This may mean ensuring that they do not only have a prescription for antibiotics, but also the means and resources to obtain antibiotics and take them as directed. In addition, these patients often have complicated wound care needs, and we must ensure that those needs are met after discharge.”

In the future, Dr. Toraih envisions the implementation of formalized protocols for patients being discharged after NSTIs. “These protocols may need to be directed toward patients that are at high risk of readmission, such as those that had a prolonged hospital stay. These protocols may help with access to antibiotics and wound care needs. In addition, these protocols should provide clear lines of communication to the discharging care team in case the patient has questions or problems after discharge. This may help prevent fragmentation of care in another hospital.”

Dr. Toraih added: “Our vision is to apply artificial intelligence to design mobile application or online risk assessment tools to predict the probability of readmission and complications for each patient.”

AI Risk Calculator Predicts Trauma Patient Mortality An artificial intelligence‒based calculator, the Trauma Outcomes Predictor (TOP), accurately predicts outcomes for trauma patients, researchers have reported.

“TOP is a novel, accurate, smartphone-accessible and user-friendly calculator for risk and outcome prediction in trauma patients,” said presenting author Lydia Maurer, MD, a general surgery resident at Massachusetts General Hospital, in Boston.

The calculator was developed using American College of Surgeons Trauma Quality Improvement Program (ACS TQIP) data from 2010 to 2016, and included clinical information from 747,249 patients (derivation cohort) describing patient characteristics, mechanism of injury, injury severity, injury score by body region, and clinical characteristics on presentation. Patients who died in the emergency department were excluded from model development.

Once developed, the TOP calculator was tested in a validation cohort consisting of 186,804 patients. The c-statistic for blunt mortality was 0.88, and for penetrating mortality it was 0.94.

The study authors also tested the performance of the TOP calculator across different types of complications.

C-statistics for individual complications ranged from 0.69 to 0.84.

The calculator performed well across penetrating trauma patients; the c-statistics for cardiac arrest requiring CPR, severe sepsis and deep surgical site infection were

0.83, 0.82 and 0.81, respectively. In blunt trauma patients, the c-statistic was 0.84 for cardiac arrest requiring CPR and was 0.79 for acute respiratory distress syndrome.

Limitations of the study included potential biases in the source data and lack of information on clinician intervention.

“While TOP offers excellent predictive ability for mortality and several individual complications, it is not clear whether there is a point at which clinicians could intervene to favorably alter outcome,” Dr. Maurer explained.

“A novel sister methodology, called Optimal Prescriptive Trees, is a machine learning‒based method that promises to identify ‘intervention points,’ where clinicians can intervene to alter the patient outcome and decrease the risks of mortality and morbidity.”

In addition to identifying intervention points, the study authors are working toward integration with electronic medical record systems, Dr. Maurer said, explaining that “integration into the EMR is an important milestone, as it will allow the machine learning algorithms to learn directly from patient data through a ‘feedback loop’ and thus continue to improve.”

“TOP can be a useful adjunct to clinical judgment for counseling critically injured trauma patients and their families at the bedside,” Dr. Maurer said. “This type of AI-based technology can also be leveraged for nuanced, risk-adjusted quality benchmarking of trauma programs.”

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OPINION

GENERAL SURGERY NEWS / MARCH 2021

A Heart-Touching Moment

By MIKE M. MALLAH, MD

L

ast night, I had to emergently open a man’s chest in an attempt to save his life. It had to be done in under 60 seconds. This was my first one.

It’s called a resuscitative thoracotomy (previously an emergency department thoracotomy). It’s an extreme, seemingly violent measure. A last-ditch Hail Mary pass into the end zone when your team is down, and the clock already ran out. Four out of five patients don’t survive (Updates Surg 2019;71[1]:121-127).

In the trauma bay, a thoracotomy is the last play of our game. This guy had been shot. He lost about half his blood volume before we even saw him.

My attending saw the clock running out before I did.

The basic steps of a thoracotomy are simple enough to state: With a blade, you slice from the sternum around the left chest to the back. You get into the chest

between two ribs and pull them apart.

Hard. You move the lung out of the way.

Grab the heart. If there is no injury to the heart itself, you cup it between your hands and manually squeeze like hell, over and over. Over and over, to pump blood to the brain. It happens when your heart is giving up on you, but your trauma surgeon is not.

Trauma surgeons hate giving up. Surgery itself is like a sport. You have to practice. After all, it is the “practice of medicine,” no? I’ve read about this particular procedure dozens of times. I actually did one on a cadaver once. But when the patient rolls into the trauma bay with a medic on top of him doing CPR, when all the alarms are going off, when you are the trauma chief in charge and your attending looks at you and says, “We need to get into the chest, now!”, you could have read the steps a thousand times, but you will not be fully prepared for the line you are about to cross.

Luckily, I had run the scenario a

thousand times in my mind and it was automatic. That is why we train for so many years and don’t sleep. This is why we practice. Because when the time comes for you to step up, it must be automatic. I was on autopilot.

I didn’t snap out of it until I looked down and saw the man’s heart in my hands. I could feel my hands cramping, but did that matter really? What the heck am I doing? Then I looked at his face. A complete story—I knew

That is why we train for so many years and don’t sleep. This is why we practice. Because when the time comes for you to step up, it must be automatic.

I was on autopilot.

nothing about him. Does he have a family? Was this shooting accidental? Did he deserve it? If we saved him and he met me, what would he say?

The trajectory of this whole story, his life, continues or ends here—in this stillness holding us, surrounded by chaos, with my hands massaging his heart. ■ —Dr. Mallah is a general surgery chief resident at Carolinas Medical Center, Charlotte, N.C., and an aspiring global trauma/ war surgeon. He will begin a trauma/surgical critical care fellowship at Virginia Commonwealth University later this year.

Stop Making Surgeons Undertreat Postoperative Pain

By JEFFREY A. SINGER, MD, and JOSH BLOOM, PhD

I

ndisputable evidence shows the absence of a correlation between the number of opioid prescriptions and opioid abuse or addiction. This has not, however, dissuaded practicing physicians from buying in to the false narrative that prescribing opioids for pain is fueling the overdose crisis.

According to statistics from the CDC, the number of all opioid prescriptions dropped roughly 42% from 2012 to 2019, a year when overdose deaths hit a new peak of 71,327.

The top four implicated drugs—illicit fentanyl and its analog, heroin, cocaine and methamphetamine—were involved in far more deaths than any prescription opioid. Yet surgeons are repeatedly encouraged to use IV acetaminophen—which is simply Tylenol—to treat postoperative pain in order to spare their patients the risk for addiction.

The literature is jam-packed with studies about the effect, or lack thereof, of IV Tylenol in controlling pain from a variety of surgical procedures. But virtually all of these are retrospective studies, which are inferior to controlled prospective studies with predetermined end points and a control group (usually placebo). Now there’s a randomized, double-blind, placebo-controlled trial—the gold standard of clinical trials—and if this doesn’t disabuse doctors from prescribing acetaminophen for postoperative pain, nothing will. Lead author Alparslan Turan, MD, and colleagues published the results in JAMA last July (2020;324[4]:350-358) and it was recently summarized in General Surgery News.

The Cleveland Clinic group enrolled 580 participants, all of whom were scheduled for abdominal surgery. Half of the participants received 1 gram of IV Tylenol; the rest

got a saline placebo. Doses of each were given every six hours for up to 48 hours (the dosing arm was less than 48 hours when the patient was discharged before that time).

The primary outcome was the amount of time that the patients had a blood oxygen saturation level less than 90% (hypoxemia). This strikes us as strange. The reason that someone might get hypoxemia is opioid consumption. In other words, the primary outcome seems to be a surrogate marker for the real primary outcome— the amount of opioids consumed. It is the opioids that cause the hypoxemia, not the Tylenol or saline. But the secondary outcomes included post-op opioid consumption as well as pain, nausea and vomiting, sedation and respiratory function. Nevertheless, the results were striking: The placebo group was hypoxemic for 0.7 minutes per hour. For the Tylenol, that number was 1.1 minutes per hour, which is clinically and statistically insignificant. The groups had the same oxygen levels because they consumed the same amount of an opioid. Why? Because the Tylenol did nothing to reduce their pain.

During the 48 hours after surgery, the numerical pain scores were virtually identical: 4.2 for the Tylenol group and 4.4 for the placebo group. Other secondary end points—postoperative nausea and vomiting, sedation and respiratory function—were identical between the two groups.

This trial was clean in the way it was designed, carried out, and the results measured and analyzed. At least for abdominal surgery, it is safe to say that IV Tylenol is useless. It performed identically to placebo. Although it is possible that IV Tylenol would be of any use in other types of operations, it is very unlikely.

Studies show the overdose potential of opioids,

when used as directed in the medical setting, ranges from 0.022% to 0.04%. Multiple Cochrane systematic reviews point to extremely low addiction rates in chronic noncancer pain patients receiving long-term opioid therapy, and a recent report found a total “misuse” rate of 0.6% among more than 568,000 patients receiving opioids for acute postsurgical pain during an eight-year period (BMJ 2018;360:j5790).

Yet pain patients, acute or chronic, have been getting a drug that has no utility for pain from abdominal surgery and probably for any surgery. In the mad dash to get away from opioids, patients have become human guinea pigs for untested, unproven drugs. And it’s not just Tylenol. Other drugs, possibly just as useless, such as antidepressants (selective serotonin reuptake inhibitors and tricyclics) and gabapentin, all with limited evidence of efficacy, are being force-fed to pain patients in need of a real medicine simply to decrease opioid use just for the sake of doing so.

We don’t favor overprescribing pain medications.

We favor rationally prescribing pain medications. Surgeons and other health care practitioners should resist the recrudescent opiophobia, a throwback to the disinformation campaigns of the 1970s, that causes them to undermedicate and mismanage their patients’ pain and subject them to other possible harms.

■ —Dr. Singer practices general surgery in Phoenix and is a senior fellow at the Cato Institute. Dr. Bloom is the director of chemical and pharmaceutical science at the American Council on Science and Health.

Drs. Singer and Bloom reported no relevant financial disclosures.

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

IN THE NEWS

MARCH 2021 / GENERAL SURGERY NEWS

Social Media Harassment continued from page 1

personal attacks were prevalent among physicians engaging with social media (JAMA Intern Med doi: 10.1001/ jamainternmed.2020.7235).

“I have been an active social media user for years with the primary focus of disseminating evidence-based information so patients can make informed decisions,” said co-author Shikha Jain, MD, an assistant professor of medicine in the Division of Hematology and Oncology, University of Illinois Chicago. “With more health care workers and physicians utilizing social media in this manner over the years, we conceptualized this study to get a better understanding of how other physicians across the country used social media, and what their experiences were in the digital space.”

The team developed a survey that was distributed via Twitter from Feb. 6 to March 20, 2019. Respondents were asked to answer yes or no to two questions: Have you ever been personally targeted or attacked on social media? Have you ever been sexually harassed on social media? A comment box was included for respondents to detail such incidents.

A total of 464 participants who self-reported as U.S.-based physicians completed the questionnaire. Of the respondents, 57.8% were women or nonbinary, and 42.2% were men. The median age was 39 years.

Reports of attacks on social media were widespread, with 23.3% acknowledging abuse. Common themes for harassment included anti-vaccination, anti-gun control and anti-abortion comments, as well as personal attacks based on physicians’ race or religion. Sexual harassment frequently included receipt of inappropriate and sexually explicit messages or comments.

“The thing that was most surprising for me was the intensity of the attacks and sexual harassment incidents described that included things like death threats and threats of rape,” Dr. Arora said. “I also think it’s important to note that women physicians, in particular, face a double hit: They could be attacked and also face the risk of being sexually harassed.”

The authors noted that their research was completed before the outbreak of COVID-19, but the pandemic makes the findings even more relevant.

“Over the last year, we have truly seen the importance of disseminating evidence-based factual information founded in science,” Dr. Jain said. “Physicians and other health care workers have been using social media effectively to disseminate facts and science, but unfortunately there has also been a parallel ‘infodemic’ where we have seen misinformation and false information spread. We have

seen our scientific leaders attacked and bullied for advocating for public health measures that would save lives. Now more than ever, we need to trust our scientists and public health officials, and this is one of the first studies to show conclusively that those individuals who use their platforms to disseminate information are targeted, bullied and harassed.”

In an effort to increase social media

MORE THAN

7 MILLION PATIENTS

advocacy, Drs. Arora and Jain founded an organization called IMPACT4HC (Illinois Medical Professionals Action Collaborative Team), a group of health care workers with social media presence who are actively advocating and educating as part of a team.

They have also created a tool kit to help health care professionals navigate how to properly and safely use social media.

“We have found that having others to support you and your messaging can be

7

very helpful in the social media space,” Dr. Jain said. “When engaging on social media, I remind people that the amount of energy you expend is up to you. While having a spirited discussion with someone who thinks differently than you can result in a productive exchange of ideas, if the person is simply attacking you or trying to get a rise out of you, there is no ■ need to continue to engage.”

Dr. Arora reported funding from the Journal of Hospital Medicine as a social media editor, the American Board of Internal Medicine and the Joint Commission, and is a founding member of TIME’S UP Healthcare.

HAVE RECEIVED

EXPAREL SINCE 20121

BUILT TO WEATHER POSTSURGICAL PAIN Non-opioid EXPAREL, powered by DepoFoam® technology, delivers precise pain control for the critical first few days after surgery to enable enhanced recovery.

In laparoscopic colorectal surgery, ERAS and multimodal protocols with EXPAREL improved clinical and economic outcomes2: FEWER OPIOIDS % over 3 days*†

65

(overall opioid consumption)

Significantly better PAIN CONTROL

1 DAY SHORTER LOS

In the PACU‡ (P=0.001)

2.96 days vs 3.93 days (P=0.003)

Learn more at: www.EXPAREL.com ERAS=enhanced recovery after surgery; PACU=post-anesthesia care unit; LOS=length of stay. *The clinical benefit of the decrease in opioid consumption was not demonstrated in pivotal trials. † A retrospective observational study of 140 patients who underwent laparoscopic colon surgery, comparing local infiltration with EXPAREL 266 mg/20 mL expanded with 20 mL normal saline and 20 mL of 0.25% bupivacaine HCl to a historical matched control group for postsurgical pain, opioid use, and length of stay. Opioid utilization was measured using the World Health Organization’s defined daily dose (DDD), converting each opioid used into the respective DDD (intravenous fentanyl [1 DDD = 100 mcg], intravenous dilaudid [1 DDD = 2 mg], oral dilaudid [1 DDD = 4 mg], oral oxycodone [1 DDD = 20 mg], and hydrocodone [1 DDD = 10 mg]). ‡ Pain was measured using a visual analog scale (0 to 10).

Indication 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.

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.

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

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

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

References: 1. Data on File. 6306. Parsippany, NJ: Pacira BioSciences, Inc.; July 2020. 2. Keller DS, Pedraza R, Tahilramani RN, Flores-Gonzalez JR, Ibarra S. Impact of long-acting local anesthesia on clinical and financial outcomes in laparoscopic colorectal surgery. Am J Surg. 2017;214(1):53-58.

Scan the QR code to see how EXPAREL improves postsurgical outcomes

Warnings and Precautions for Bupivacaine-Containing Products Central Nervous System (CNS) Reactions: There have been reports of adverse ©2020 Pacira BioSciences, Inc. Parsippany, NJ 07054 PP-EX-US-6100 10/20

B I O S C I E N C E S ,

I N C .

8

response

COVID-19’s Silver Lining continued from page 1

A Much-Needed Reset?

The pandemic forced us to stop, reset and decide what is really important. Before this started, the world was wrapped up in social media, civil unrest, the next new technical gadget, artificial intelligence and big business.

Everything was big. Athletes made big salaries, played in new big stadiums, broadcast on a million sports stations.

In entertainment, there were big-budget movies, with big stars getting

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.

whopping salaries, pop stars doing big concerts, and online sites streaming all this entertainment for big bucks. In business, Wall Street was golden, with everyone making big money on everything. On the other hand, the health care industry was mired in decreased reimbursement, regulations and unhappy physicians afraid to speak the truth.

The science of medicine plodded along at a snail’s pace, limited by funding and lack of attention.

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

When the pandemic hit, everyone had this overriding epiphany: Without good health, we are nothing. Physicians, nurses and health care workers were suddenly on the forefront fighting the battle. Overnight, we became “heroes,” and people thanked us for our work. This was all a new experience; previously we were accused of overcharging, ordering too many tests, not curing everyone and simply not doing enough.

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

This is our chance to shine and show everyone we are far more important than sports, entertainment, politics, business or really anything else. Nothing will happen in a sick, ailing society.

Am I A Hero? I Don’t Feel Like One Not sure about the rest of you, but I didn’t feel like a hero. I just went to work, same as before the pandemic except with a mask on all day. We said we needed telehealth, and the prior five to 10 years of struggling to make this work and get reimbursed all went away with a snap of insurance companies’ fingers. We needed more personal protective equipment (PPE) and resources, and suddenly everyone wanted to help. Gowns, gloves, toilet paper and paper PPE production increased. Car companies tried to make ventilators. Everyone sewed masks. The military loaned us ships for temporary hospitals. Beer companies made hand sanitizers. The world pitched in and recreated their businesses, all in the name of health care.

There was talk about how to treat COVID-19. Doctors and researchers communicated with less competitive spirit and more collaborative efforts to get answers. This was a race to the cure, so everyone who was writing anything about COVID-19 got published in record time.

Forget the two months of articles being reviewed by editors and waiting four more months to publication. It didn’t matter if it was n=1 patient or if you tried a repurposed old drug searching for an indication on your patient—it would be published.

Granted, this made things particularly confusing for doctors who had to sort out the many versions of the COVID-19 tests and possible treatments.

The more I read, the more confused I got. Hydroxychloroquine? Steroids?

Remdesivir? Convalescent serum? Furthermore, lay publications and online sites made the readers pretty sure that they would be protected if they took vitamin D, zinc, potassium and selenium.

Those trying to puff up their CVs had a field day—anything you wrote about “COVID” would be published. Forget peer review. The more that got out there, the more there was to prove or debunk with the next paper—it was a logarithmic growth of literature.

response because it is gratifying, but also because their work will be lifesaving—literally.

Reality stars, musicians and athletes may have glamorous careers, but they have low odds of actually making a difference in a sick and crippled society.

Who are you going to call in a pandemic? One of the Kardashians? Drew Brees or Tom Brady? A social media influencer? Bitcoin may be worth a lot now, but a bitcoin cannot intubate a patient. Bitcoin cannot become a nurse. An influencer cannot influence COVID-19. Health care workers make a difference every day by just showing up for work—work that

We Can Do Whatever We Have the Will to Do! The pandemic taught us, though, that researchers are truly capable of finding a virus and making a vaccine against it quickly. Science is awesome. Discovery is only limited by governmental regulations to get them approved and produced. When the FDA gatekeepers get their butts in gear, a vaccine can get to the public in nine months. The pharmaceutical companies can also ramp up production and make millions upon millions of vaccines and have them ready on the approval date. It really boggles the mind how hospitals experience constant shortages of common medications and backlog of orders, and yet when everyone makes an effort, millions of doses of vaccines can be made in a week. The bureaucracy of new therapies can by minimized in a pandemic. This should happen more often, and the pandemic showed us that it’s possible.

The “silver lining”? Science and health care have everyone’s attention. This is our chance to shine and show everyone we are far more important than sports, entertainment, politics, business or really anything else. Nothing will happen in a sick, ailing society. There will be no entertainment, no sports. Business will limp along. In short, society will slow down and possibly stop unless we step in.

On a financial level, more funding should be devoted to all things related to health care and promoting science. We also need to put more dollars to work to improve health care infrastructure. Insurance companies, while performing a service, are often at odds with the health care system. Rather than using onerous restrictions and control to pull money out of and actually weaken the medical system, insurers should be putting dollars, our premium dollars, back into the system—into education, into physicians’ hands and into patients’ pockets. Graduating students should be encouraged to pursue careers in health care, not only

they love to do.

The pandemic has demonstrated the power of human resilience to learn, adapt and move forward despite any obstacles put before us. Nurses, doctors, technicians, environmental assistants and even hospital administrators are now valued more highly than bitcoin, social media influencers, TV reality stars and sports heroes combined. So, now that we have stopped and reset, let’s use this opportunity to reinvent a world where health care is truly the backbone of our society, and scientists and health care workers are ■ the new influencers.

REPROCESSED VESSEL SEALING DEVICES HAVE VISIBLE CONTAMINATION ON THEM.1,† A study published in Surgical Endoscopy raises questions about the sterility of reprocessed vessel-sealing devices

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

96% OF REPROCESSED DEVICES

FAILED ACROSS A MIX OF 4 DIFFERENT TESTS THAT CHECKED FOR ORGANIC MATERIAL1,‡

1 OUT OF 165 REPROCESSED DEVICES

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Learn more about OEM LigaSure™ technology and our risk-sharing and LQGHPQLƬFDWLRQ SURJUDPV RQOLQH at medtronic.com/vesselsealing

© 2020 Medtronic. All rights reserved.

10/2020 – US-SE-2000158 – [WF# 4604546]

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

IN THE SAME STUDY, OEM LIGASURE™ DEVICES

Read the full study here.

Medtronic does not manufacture, distribute, warrant, or indemnify reprocessed LigaSure™ vessel sealing devices. To quickly determine if a LigaSure™ device from Medtronic is inauthentic, check the packaging, the product, and the plug. If there’s a logo other than Covidien™ or Valleylab™, it’s not an authentic device from Medtronic.

—Dr. Wong is a professor of surgery at the University of Hawaii Cancer Center, in Honolulu. She is a member of the General Surgery News editorial advisory board.

OF THE TIME.1 †Contamination was found following disassembly of the devices and jaws. The study found that 52% of reprocessed devices studied had visible contamination. The remaining 48% did not have contamination that was visible to the naked eye. ‡The combination of failed tests included visual inspection, optical and scanning electron microscopy, hemoglobin detection, and sterility testing. §Sterility assurance level of 10-6 accepted by the FDA as laid out in the Association for the Advancement of Medical Instrumentation (AAMI) standards ST67 and TIR 12 for devices contacting normally sterile tissue.

1. Chivukula, S.R., Lammers, S. & Wagner, J. Assessing organic material on single-use vessel sealing devices: a comparative study of reprocessed and new LigaSure™ devices. Surg Endosc (2020). https://doi.org/10.1007/s00464020-07969-8.

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OPINION

GENERAL SURGERY NEWS / MARCH 2021

Robotic Surgery: ‘Déjà Vu All Over Again’ continued from page 1

debaters fight it out. Those who know me on a personal level know that at meetings, in the literature, and on social media, I’ve never hesitated to give my opinion, which I hope has been data driven. In this brief editorial, I would like to voice my personal opinion on a subject that is near and dear to my heart and which I have not hesitated to be vocal about in the past.

I would like to begin by quoting a famous baseball philosopher, Yogi Berra: “It’s like déjà vu all over again.” Having had the privilege of being involved in the development of minimally invasive surgery (MIS) since 1990, I have seen surgical history repeat itself over and over again. As Arthur Schopenhauer, the well-known 19th-century German philosopher, said, “All truth passes through three stages. First, it is ridiculed. Second, it is violently opposed. Third, it is accepted as being self-evident.” This is exactly what I have seen happen over the past 30-plus years during the growth of MIS. Of course, it is not bad to doubt innovation. We must be very careful how we judge it and accept it, but this can be a slippery slope. By looking back at what I have observed as MIS procedures were introduced, I hope to share with you how Schopenhauer’s principles apply to surgery today and how we might alter this process in the future.

Since the introduction of MIS in 1985

by Dr. Erich Muhe in Germany, laparoscopic cholecystectomy and many of the procedures that followed have repeated the stages of Schopenhauer’s truth.

Muhe was not only ostracized by the German surgical society, but accused of a crime. Finally, in 1999, he was recognized as a hero and pioneer by the Society of American Gastrointestinal and Endoscopic Surgeons, completing Schopenhauer’s final stage.

Laparoscopic appendectomy, laparoscopic antireflux approaches, laparoscopic colon resection for malignancy, and laparoscopic inguinal hernia repair have all been the target of similar attacks.

Surgeons who demonstrated excellent results with these procedures have been criticized and personally ridiculed, but eventually had their procedures accepted or even considered the standard of care.

They had been told that what they were proposing was not practical or possible when those who disagreed with them were not able to duplicate their results. I believe that in all of these cases, there has been one reason for such dramatic differences in surgeons’ outcomes—the surgeon’s expertise or level of experience.

Laparoscopic appendectomy is an excellent example of a procedure that our group and others were performing with

excellent results in the The growth of MIS early 1990s, but it wasn’t inguinal hernia repairs being supported by the peer-reviewed literature. has increased rapidly Many authors were reportsince the introduction ing an increased incidence of complications when this of the robotic platform approach was compared in part because of with open appendectomy. The reason for their mentoring, simulators poor results, however, soon and formalized became evident. Surgeons performing the emergent instruction. I predict procedures lacked the lapit is only a matter of aroscopic experience and supervision that the procetime until the final dures required. Only after stage of acceptance the teachers and their resident students gained expeis achieved. My hope rience and the laparoscopic is that it won’t take expertise for complicated procedures did laparoscopnearly the 25 years it ic appendectomy become did with laparoscopic the new gold standard that it is today. inguinal hernia repair.

A minimally invasive approach to antireflux surgery is another example of a proce- denied, but many of us who supported dure that was initially ridiculed by many the approach were personally attacked experts in the field because of their own at meetings. A series of papers appeared early poor results. Later, these same sur- in the literature supporting the deniers’ geons championed the approach after claims that a laparoscopic approach was they gained laparoscopic expertise and too expensive, took too long to perduplicated the results of those they pre- form, had too many complications and viously opposed. was inferior to an open approach. HowLaparoscopic colon resection for can- ever, after 25 years, when surgeons had cer was an even more obvious example achieved experience in the laparoscopic of a procedure that went through the approach, the claims justifying such ridithree stages: ridicule, opposition and, cule and opposition proved false. The key, finally, acceptance. I remember vividly a once again, was the acquisition of expeconversation I had with Morris Frank- rience. Published guidelines now support lin, a friend and pioneer in the field. the laparoscopic approach as self-evident, We questioned why others were report- instead of opposing or ridiculing it. ing such dismal results with laparoscopYou may wonder what prompted my ic colectomy for malignancy while we “déjà vu” experience and made me review were not seeing any of the complications some of the less remembered history of or problems. Port site metastases were MIS described here. It was the battles reported, and many esteemed colorectal that I recently witnessed on social media surgeons were opposing the laparoscop- surgical platforms and in the recent suric approach for colorectal malignancies. gical literature. This time, the battle is They wanted to prevent the use of lap- over the use of a robotic platform for aroscopy for malignancy outside of ran- inguinal hernia repair. This conflict is domized studies. Only when their study reminiscent of the battles over the lapwas completed did they agree that the aroscopic approach in which I was an laparoscopic approach for colonic malig- active participant. This time, however, nancy was equal to or better than an I began as one of the ridiculers. Early open approach for patients. Once again, adopters of the robotic approach made the ridicule and opposition were due to certain claims that I just couldn’t accept, inexperience. but as they modified those initial claims, A final example of an MIS procedure I decided to reevaluate the approach and that went through Schopenhauer’s stag- to not be a ridiculer of those performing es to eventually gain worldwide accep- the procedure but rather tried to evaluate tance is laparoscopic inguinal hernia their assertions with a view to the past. repair. Although this approach was based I asked myself if the robotic approach on an accepted open technique, it was to inguinal hernia repair had value, and almost universally attacked vocally and whether its proponents or deniers were in the literature. Not only was its validity correct this time.

“All truth passes through three stages. First, it is ridiculed.

Second, it is violently opposed.

Third, it is accepted as being self-evident.”

—Arthur Schopenhauer

There have been many peer-reviewed studies of robotic inguinal hernia repair—some pro and some con—but a recent well-written randomized study would, at first glance, suggest that the robotic approach does not have any advantages over a conventional laparoscopic approach and, in fact, may be inferior in some respects (JAMA Surg 2020;155[5]:380-387). The study’s conclusion: “Results of this study showed no clinical benefit to the robotic approach to straightforward inguinal hernia repair compared with the laparoscopic approach. The robotic approach incurred higher cost and more operative time compared with laparoscopic approach, with added surgeon frustration and no ergonomic benefit to surgeons.” This seemed contrary to what many robotic surgeons were saying online and in the literature. Because these results reminded me so much of the early published results of laparoscopic inguinal hernia repair as well as the other MIS approaches just discussed, I wondered if experience of the surgeons was an underlying factor.

If we look at each of their conclusions, could experience of the surgeons have been the underlying cause of the differences they found? They state in their paper that the surgeons were fellowship-trained and had experience with at least 25 cases using each approach. What they didn’t state is whether there was a vast difference in experience with each approach or between surgeons.

In a similar paper comparing open and laparoscopic inguinal hernia repair (N Engl J Med 2004;350:1819-1827),

OPINION

MARCH 2021 / GENERAL SURGERY NEWS

surgeon experience beyond the 25-case criteria markedly influenced results (personal communication). Since laparoscopic inguinal repair has been employed for many more years than the robotic approach, I would suspect that the surgeons in this study had much more experience with the laparoscopic approach, and this confounder may have significantly biased the outcome of their study. This would have influenced all of their conclusions including operative time, cost and frustration. Although they quote several studies to show their operative times were in line with previous studies, in contrast it has been demonstrated by Muysoms et al that once a surgeon is past the learning curve, operative times for the robotic transabdominal preperitoneal (TAPP) and laparoscopic TAPP inguinal hernia repair are equal (Surg Endosc 2018;32[12]:4850-4859).

From my own personal experience, when I am early in the learning curve for a new approach, my level of frustration with the new procedure is higher because of the comfort I have with my established approach. Although the surgeons had completed at least 25 robotic cases, it is likely that their degree of comfort was worse for the robotic cases because of their greater expertise with the longestablished laparoscopic approach. As for cost differences, this again is influenced

by OR time and experience. OR time decreases with experience, and more experienced robotic surgeons have been able to decrease the number of instruments used, thus decreasing costs. This level of expertise may not have been attained by all surgeons participating in their study, and therefore may have negatively influenced the robotic arm of the study.

As someone who was initially a vocal skeptic of the robotic approach for inguinal hernia repair, I must now confess that I see this approach in a new light.

As more surgeons master the robotic platform, and as they demonstrate results that are equal to the laparoscopic approach and maintain equivalent costs as the supporters of the approach have done, the robotic approach to inguinal hernia repair should have a long and healthy life. As an advocate of the MIS approach to inguinal hernia repair, I see the robotic approach as just another tool in the tool box. Expertise can only come from experience, and, as it has with other MIS approaches, it will make all the difference in future outcomes. The growth of MIS inguinal hernia repairs has increased rapidly since the introduction of the robotic platform in part because of mentoring, simulators and formalized instruction. I predict it is only a matter of time until the final stage of acceptance is achieved. My hope is that it won’t take nearly the 25 years it did for laparoscopic inguinal hernia repair.

In the future, we must be very careful how we judge data that are published, and view studies that include cases performed during the learning curve with a critical eye. This can be very difficult because the number of cases required to graduate into the expert category varies widely between surgeons. When we evaluate negative studies and those that are contrary to accepted opinion, we need to determine whether study design may have affected the outcomes. Were there confounders that could have positively or negatively influenced the results? Once we have answered these questions, only

then should we decide to accept, reject or continue to investigate the conclusions.

If others have already presented positive results of a newer surgical technique or approach, we don’t need to be deniers, but rather we should seek to understand why they were successful.

Barry McKernan, a surgeon and laparoscopic pioneer, once said to me: “The man who says it can’t be done shouldn’t stand in the way of one already doing it.”

Ridicule and violent opposition should be replaced by careful evaluation of data and educated debate. If we accept dogma, we will cease to innovate. My hope is

11

that we can judge this new robotic platform, as well as others to come, without repeating Schopenhauer’s stages of truth or Yogi Berra’s astute observation: “It’s ■ like déjà vu all over again.”

—Dr. Felix is a surgeon from Pismo Beach, Calif. He is a member of the editorial advisory board of General Surgery News.

Dr. Felix reported no relevant financial disclosures.

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

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GENERAL SURGERY NEWS / MARCH 2021

Negotiating Your Employment Agreement: RVU-Based Contracts continued from page 1

two decades. At the 2020 Clinical Congress of the American College of Surgeons, held virtually, she delineated what surgeons need to know before signing RVUbased employment contracts (session PS481).

The formula tying a physician’s pay to this productivity metric looks fairly straightforward, according to Ms. Bittinger: $/wRVUs x wRVUs = $ Paycheck The total RVUs a physician has worked (wRVUs) multiplied by a conversion factor ($/wRVUs), typically ranging from $25 to $80, equals a physician’s salary.

But, Ms. Bittinger said, a host of features embedded in compensation agreements may complicate a surgeon’s take-home pay.

Contractual Minefields

Aside from negotiating the initial salary offer, physicians may face more subtle contractual language that affects their bottom line.

For surgeons starting their careers or moving to a new location, employers typically offer a guarantee period spanning two years, wherein doctors earn a set amount regardless of the RVUs they generate.

“But there are a lot of pitfalls in the contractual language that you need to be aware of,” Ms. Bittinger said.

The salary that employers settle on during the guarantee period estimates the RVUs that a physician will generate each month, based on the hospital’s internal data or the physician’s previous work experience. That means a physician contract should also spell out whethSalary Wiggle Room er the guaranteed base salary represents a floor or a cap.

The top question that Ms. Bittinger hears from her In other words, can a surgeon earn more by working physician clients is “How can I negotiate a higher salary?” more RVUs? “Increasing the conversion factor is the best way to Also, what happens after the guarantee period ends? increase your overall compensation,” said Ms. Bittinger, The guarantee period may only secure a surgeon’s comwho noted that increasing the RVU expectaxpecta pensation for that time frame. But if an employer based pen tions means surgeons will simply be expectecta surgeon’s su salary on 7,000 expected RVUs per year during ed to do more procedures. “But to be in the guarantee time but the surgeon only tallied 6,000, will his or her compensation decrease after the successful, you need to have data to sup-6 guarantee period expires? port your position.”

Depending on the contract, it’s possible. “Once The conversion factor typically the guarantee goes away, surgeons may switch to comes from Medical Group Managea salary determined by their raw RVU data each ment Association compensation data or month,” Ms. Bittinger said. other industry numbers. That means In the best-case scenario, an employer has a syssurgeons need to arrive at the negotiating table armed with an undertem in place that can immediately report RVUs standing of the typical or average Ann Bittinger, Esq. generated over the previous month. But more conversion factor in their specialty, often, these RVU calculations lag a month or area and hospital. two behind. That is why most employers instiIf, for instance, every GI surgeon employed at a hos- tute a draw—an estimate or advance against the RVUs pital receives $50 per RVU, that conversion factor will that a surgeon actually generates. If a surgeon accumube difficult to negotiate unless a surgeon has specific lates a consistent average RVU in the first two years of subspecialty training or other notable skills that justi- the guarantee salary period, estimating a monthly salary fy being treated differently from the group, Ms. Bit- after this period may be fairly straightforward. tinger explained.

An issue arises when that average RVU estimate

Key Questions to Ask Employers • Base salary: Is there flexibility in my salary?

Can I increase the conversion factor? What salary survey data are employers relying on?

fluctuates substantially. Generating 1,000 RVUs in one month and 800 in another, for instance, would mean an $8,000 drop in monthly earnings. If surgeons receive an advance on their salary assuming 1,000 RVUs, but are below that threshold, “they may owe their employer money,” Ms. Bittinger said. “Depending on the employment contract, you could potentially have to write your employer a check to repay the draw that was too high.

No one wants to get into that situation.”

That’s why employers typically have a soft reconciling period every quarter to assess and monitor the RVU situation and to give surgeons time to make up for any lows in their practice.

“To avoid big dips in monthly earnings or earning less after the guarantee period, I recommend including language that ensures a floor salary or a monthly income that can never dip below a certain percentage of the guarantee,” Ms. Bittinger told General Surgery News.

Inserting protective contract language is one option.

Another is removing potentially harmful language.

“Some contracts include clauses that say an employer can lower your draw at any time without getting your consent first,” she said.

Transparency Issues “If I asked you today how many RVUs you have— what’s your count so far for this month, quarter or year—can you tell me that number? And how do you know?” Ms. Bittinger asked. “It’s really important that there’s some kind of transparent communication about where you’re at.”

Bigger health systems may have a system that surgeons can access easily that tallies their RVUs on any given day.

But surgeons need to be aware of a few factors: Who’s entering the codes? Who’s billing? What’s the lag time between seeing a patient and seeing the RVU count logged in the system?

These are good questions to ask in your interview, continued on page 14

Other Contract Minefields to Consider Paid time off/maternity leave: With RVU-based salaries, when you don’t show up for work, you are not generating RVUs and thus may not get paid, even if your contract allows for paid time off.

“Sometimes promises of big paid time off and maternity leave can be empty if you’re on a pure RVU-based compensation formula,” Ms. Bittinger said.

Quitting: If you quit a job during the first few days of a quarter, you may not receive a bonus for generating RVUs above a certain threshold or may be on the hook for expected RVUs that you didn’t deliver on. Look out for contracts that include language negating a bonus if you quit before the quarter ends.

• Guarantee period: Is this guaranteed base salary a floor or a cap? How long will this period last?

“If you quit on March 28 and the quarter ends on March 31, your bonus payment would be gone, so make sure you are leaving a job at the right time,” Ms. Bittinger said.

• After the guarantee: How will my salary be calculated going forward?

Will I owe my employer money if I don’t reach the expected RVU threshold?

Be aware of the following provisions: • Can an employer unilaterally relocate you to a new office without your permission?

• How much time will it take to rebuild relationships and get referrals in a new practice?

• Will new providers be added to your team and potentially take some expected work off your plate?

• RVU transparency: How can I check on my daily and monthly RVUs?

Practice dynamics: After working overtime in a fellowship, you may get a job offer in a sleepy suburban area.

You’re ready to enjoy the slower pace of life, but once your guarantee goes away, it may be hard to generate RVUs. • Will a senior team member take the bulk of advanced procedures, which are worth more RVUs? • Will you have support from a nurse practitioner or a physician assistant?

• Will you have easy access to an OR?

“You may not be able to incorporate safeguards into your employment agreement, but it’s worth asking about those kinds of dynamics,” Ms. Bittinger said.

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14

IN THE NEWS

GENERAL SURGERY NEWS / MARCH 2021

2 Studies Highlight Causes Of Interprofessional Conflicts

By CHRISTINA FRANGOU

F

emale surgeons feel unfairly judged when they act in ways that conform to the behavioral norms of their profession rather than traditional gender norms—a double standard that they believe contributes to conflicts with other health care workers, according to new research.

These interprofessional conflicts can harm female physicians’ well-being and professional reputations, contribute to burnout, and affect patient care, according to the authors. “These conflicts made people physically sick and made them dread coming to work,” said co-author Dana Telem, MD, MPH, the director of the Michigan Comprehensive Hernia Program and a professor of surgery at the University of Michigan, in Ann Arbor. “You can easily see how that translates into diminished success, satisfaction or wellness.”

Investigators conducted semi-structured interviews

‘If you get upset or react to a situation, you’re considered emotional or reactionary, whereas if a man does it, they’re being assertive or advocating for their patients.’ with 30 female surgeons across the United States who experienced a conflict that led to action by a nonphysician. Many participants reported that conflicts arose with other professionals in the hospital when female surgeons felt their actions mirrored those of male surgeon mentors or peers but were unwelcome because they are women.

One participant said: “If you get upset or react to a situation, you’re considered emotional or reactionary, whereas if a man does it, they’re being assertive or advocating for their patients.”

Another participant said: “I think there is an inherent tension between women physicians and women nurses.”

And another: ‘‘It can affect patient care because it makes you not want to go back to the scene of the crime, if you will. I was probably less interactive in trying to engage the team in conversations about patient care.’’

Two reports from the interviews were published in JAMA Network Open (2020;3[10]:e2019843) and Annals of Surgery (2020 Jul 7. [Epub ahead of print]).

Study co-author Lesly Dossett, MD, an assistant professor of surgery at the University of Michigan, said the idea for the project came from conversations and private social media channels in which female surgeons said they were stressed about interprofessional conflicts.

The women said they had been written up or reported for issues that were sometimes presented as safety concerns, but the surgeons believed the conflicts arose from sex bias. On Twitter, as the study was being conducted, women from various professions started the hashtag #whyiwaswrittenup, intended to demonstrate inequities in standards for professional conduct.

Although sex equity in surgery has been well studied, most interventions are directed at surgeons or hospital leadership rather than the broader community of health care providers. “But there is an equity experience for women surgeons that doesn’t come from surgeons or health-system leaders,” Dr. Dossett said.

The reports found: • Interprofessional conflict experienced by female surgeons was primarily due to breakdowns in communication, breaches of protocol or the surgeons’ response to perceived performance-related issues.

• The reporting of events often surprised female surgeons, as they had not perceived a significant conflict with staff. Participants said they did not believe the reports reflected malicious intent but felt these conflicts reflected a bias and gender scripts of society at large.

• Female surgeons said these conflicts had substantial personal and professional implications, describing feelings of self-doubt, depression, frustration, devastation, humiliation and anxiety, as well as physical symptoms (e.g., gastrointestinal distress, loss of appetite, insomnia, burnout and exhaustion).

• Participants believed patient safety mechanisms are frequently misused for addressing personal complaints.

These reports should undergo an internal informal complaint process separate from the adjudication system addressing events that affect patient safety.

Stephanie Bonne, MD, an associate professor of surgery at Rutgers New Jersey Medical School in Newark, was one of the first surgeons to use the hashtag #whyiwaswrittenup on social media, encouraging women to share their stories.

Dr. Bonne said these studies put “science behind things that women surgeons have been talking about for years, which is that the experience of being a woman in surgery is very different than being a man.” She hopes these reports will encourage everyone to speak out when they see discrimination against colleagues.

The authors acknowledge that this work has significant limitations. The design is decidedly one-sided: Investigators relied on female surgeons to self-identify workplace conflicts, and they did not interview other staff regarding their experience of conflict with female surgeons. This study also did not look at questions of race/ethnicity, experience level or other factors. Similar studies of male surgeons have not been conducted.

The authors plan to conduct future studies with nonphysician staff and male surgeons for additional perspectives.

But these reports help the surgical community address inequities, said Thomas K. Varghese Jr., MD, the executive medical director of the Huntsman Cancer Institute and a professor of surgery at the University of Utah, in Salt Lake City. “Overwhelming evidence of gender discrimination, disparities, injustice, and of women and minorities being treated unfairly” exists and has for a long time, he said. Qualitative studies take the surgical community one step closer to meaningful change, he added. “That’s really the bigger question: What are you going to do about it? This is a brave first step to deep dive, explore and disentangle these issues,” he said.

He added that speaking up remains a key component of promoting a safe workplace culture. He and the study authors said patient safety reporting procedures should ■ not be used to respond to personal conflicts.

Public Perceptions continued from page 3

these young men and women involved in real-world operations. My own approach has always been to introduce participating residents to my patients and to indicate that we are a team who will provide their care and that, although my resident assistant may perform portions of their operation, I will be supervising and involved in every facet of their procedure. Did I ever experience negativity and pushback? Of course. Just as the study cited above indicated, there are patients who eschew ever having trainees involved in their operative care. Indeed, I have had a few patients seek an alternative surgical venue after I explained that I was dedicated to my academic responsibility to train young surgeons in the operating room.

The mission for us as a surgical community is to counter misinformation regarding the strategies used to train young surgeons and to assure that they have the skill and judgment for independent surgical practice. Unfortunately, the past decade has indicated that residents who complete their training have concerns about their achievement of autonomy and certain operative skill sets. Our surgical organizations must develop educational programs and effective messaging for the public, just as the airline industry has done, to allow all potential patients to understand that graduated, hands-on surgical training is a strategy that no one should fear or disparage.

■ —Dr. Greene is a surgeon in Charlotte, N.C.

Negotiating Contracts continued from page 12

Ms. Bittinger said. The answers will highlight how transparent the RVU data really are and whether it’s actionable. Facing a two-month lag between seeing a patient and their RVUs updated in the system means surgeons will not be able to track their productivity and compensation easily.

Finally, how do surgeons know if these RVU counts in the system are good numbers? Can employees audit the report?

Ms. Bittinger recommends that surgeons keep track of the procedures they do every day and know what they’re billing so they can retrospectively audit those reports.

“A good system will allow you to log on and see that when you saw patient Ann on August 1 that you did ABC procedure and that was worth 456 RVUs. That’s fantastic,” she said. “But other tallies are running totals, which makes it difficult for a surgeon to audit the tally against what she actually did that day.”

During the pandemic, Ms. Bittinger saw new contractual pitfalls arise after some employers breached their employment contracts by cutting pay or furloughing physicians.

“Given these breaches, I’ve seen employers adding an ‘act of God’ provision, which says if there is a hurricane or pandemic, we can lower your salary or let you go without breaching the employment contract,” Ms. Bittinger told General Surgery News. “I’ve never seen this in employment agreements before, but surgeons need to be wary of these clauses.”

■

GENERAL SURGERY NEWS EXTENDED WOUND CARE COVERAGE March 2021

Column Editors Jarrod P. Kaufman, MD, FACS, and Peter Kim, MD

Experts Highlight Emerging Biophysical Approaches to Advanced Wound Care

By JENNA BASSETT, PhD

T

Data Grow for Negative Pressure Wound Therapy With Instillation, Dwell Time

By VICTORIA STERN

I

n early 2020, a 54-year-old man arrived at the Arizona Burn Center, in Phoenix, with a thirddegree burn stretching from his knee to the midthigh. The patient had spilled scalding-hot food down his right leg while cooking dinner.

Marc Matthews, MD, got to work immediately.

After surgically debriding the wound to the muscle and fascia, he began a process known as negative pressure wound therapy (NPWT) with instillation and dwell time to continuously clean and promote wound healing (V.A.C. VERAFLO Therapy, KCI).

A standard of care for treating wounds, NPWT acts as a vacuum, suctioning excess fluids and debris continued on page 18

he field of wound care is evolving rapidly as novel technologies are steadily being developed.

In a session at the virtual 2020 Symposium on Advanced Wound Care fall meeting, Hollie Mangrum, PT, DPT, CWS, and Renee Cordrey, PT, PhD(c), MSPT, MPH, CWS, reviewed six new and emerging biophysical approaches.

Wounds that heal improperly, incompletely or too slowly may lead to chronic wounds and morbidity that can impose a significant burden on the patient and provider. It comes as no surprise, then, that clinicians and researchers have developed advanced wound care technologies to support safe and optimized healing.

Extracorporeal shock wave therapy is an emerging technology that uses sound waves to promote wound healing and decrease pain.

MONEY MATTERS

Looking for Rewarding Work That Pays?

Consider Wound Care

By MONICA J. SMITH

Images: Adobe Stock

G

eneral surgeons looking for ways to offset pandemic-related revenue loss might consider exploring wound care management. They may already have some of the skills, the need is high, and the reimbursement is there.

“If you’re doing wound care, you’re going to be very busy and you’re going to be compensated,” said Harold Brem, MD, the chief of the Division of Wound Healing & Regenerative Medicine at Newark Beth Israel Medical Center, in New Jersey. “You’ll probably see more hospital patients and be capitated at a higher rate than if you were doing gallbladder operations, and you’ll be providing an equally if not greater service by meeting an unmet patient need.”

This demand is especially high now because many patients delayed care last year out of fear of exposure to COVID-19 in medical settings. “They got precipitously worse,” Dr. Brem said. “These patients

usually don’t have the advantages of being treated by a skilled surgeon, but when you apply the best surgical skills, the healing rates are terrific. And it’s extremely rewarding. For many surgeons, this work may turn out to be the most satisfying surgery they do.”

Who Owns Wound Care Management?

Currently, more than 7 million people in the United States live with chronic wounds. Despite this number, no doctors are formally trained in wound care. Once predominantly the domain of nurses, wound care management doesn’t belong to any specific specialty, although some may be a more natural fit than others. The four specialties that include wound care as part of their primary board certification are plastic surgery, general surgery, vascular surgery and dermatology.

“In the last 20 years, we’ve seen a rise in wound care centers driven by reimbursement for hyperbaric continued on page 22

“Physical therapists started using energy modalities, such as electrical stimulation and ultraviolet light, several decades ago,” explained Dr. Cordrey. These technologies support recovery by stimulating a patient’s natural woundhealing processes. Electrical stimulation sends electrical pulses through electrodes attached to the wound site, which increases capillary density and perfusion to support oxygenation. Because cells have an electrical charge, the polarity of the electrode can draw oppositely charged cells, through which electrical stimulation also promotes continued on page 24

Wound Care: The ‘Wild Wild West’? Part 2 Page 16

15

16

GENERAL SURGERY NEWS / MARCH 2021

Wound Care: The Wild, Wild West?

(Part 2) n this issue, we feature Part 2 of Wound Care: The Wild, Wild West. (Part 1 was published in the October 2020 issue, page 13). This is a relatively new topic for our On the Spot column but a relevant one to most practices, since there is some element of wound care in every surgical specialty. Some of the questions we tackle are the following: • Is the bar too low for bringing wound products to the marketplace based on classification as devices and not drugs?

I

• Is it fair to say that often physicians do not know how to stage pressure injuries correctly

by National Pressure Injury Advisory Panel guidelines?

• Do topical antibiotics have a role in wound care?

• Do Dakin’s solution, vinegar and saline still have a vital role in wound care?

Read on to see what these experts think!

I would like to thank all of the contributors for their efforts and candor. Their hard work and time make this a compelling and informative second installment for all readers. Feel free to email me at colleen@cmhadvisors.com with any ideas for debate. Thanks for reading! nson —Colleen Hutchinson Colleen Hutchinson is a medical ical communications consultant at CMH Media, a, based in Philadelphia. She can be reached at colleen@cmhadvisors.com.

➊

Topical antibiotics have a role in wound care.

DR. PARK: ON THE FENCE. A wound is a culture dish on which you want tissue to grow and infectious microbes to die.

Topical antibiotics are not suitable for infection, but can potentially aid in decontamination without the systemic toxicity of antibiotic therapies, but are ineffective as substitutes for surgical debridement and therapies for infection—which is different from contamination.

Topical antibiotics play no significant role in wound care. Studies have failed to show a benefit of topical antibiotics in preventing infections.

A comparison of bacitracin ointment and white petrolatum revealed no significant difference in the rate of infection [JAMA 1996;276(12):972-977]. Furthermore, on rare occasions, antibiotic ointment use is associated with contact reactions or dermatitis that can hinder wound healing. It is most likely the moist wound environment provided by ointments, i.e., Vaseline or petrolatum, that promotes wound healing. What does render a big impact on wound healing is irrigation, which removes particulate matter and decreases the bacterial count. In addition, comorbidities and conditions such as diabetes, renal insufficiency, obesity, vascular disease, immunodeficiencies, malnutrition and smoking may play a bigger role in wound complications, and their presence needs to be prioritized and optimized.

DR. CORDOVA: DISAGREE.

This is because I am concerned that the routine use of topical antibiotics in chronic wound care might be setting the stage unnecessarily for antibiotic resistance. There are many effective topical non-antibiotic antimicrobials available to use instead.

Since a chronic wound’s bioburden [bacterial load] is usually protected in a biofilm environment, the use of a topical antibiotic might have an overall decrease in its effectiveness while at the same time increasing its risk for the development of resistance.

DR. CAVALIERE: AGREE. Physicians and other health care pro-

viders receive limited wound care education and training. Pressure injury staging is not difficult; however, if not used on a regular basis, the stages are easy to forget.

Correct documentation of pressure injury presence and stage upon admission are necessary to allow hospitals to report and track patient safety and quality. A pressure injury that is not documented within 24 hours of admission may be considered hospital-acquired and the hospital will not be reimbursed for the cost of caring for the pressure injury.

In many hospitals, evaluation and treatment of pressure injuries is considered a nursing responsibility with limited physician involvement. Pressure injuries typically develop in patients suffering from severe illness and patients with multiple comorbidities. Physician involvement in wound evaluation and management is essential to ensure the extent of the wound is considered in the context of the patient’s overall health. Discussion with patients and family members regarding overall condition and prognosis should include a review of the status of the wound.

DR. WOLLHEIM: DISAGREE, since I would not characterize the frequency of incorrectly staging a pressure injury as “often.” There are many health care clinicians who stage correctly. However, I do agree with the concept that if a pressure injury is incorrectly staged, this could have negative regulatory and/or legal implications.

DR. WOLLHEIM: DISAGREE.

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

Alfredo C. Cordova, MD, FACS The Ohio State University Wexner Medical Center, Department of Surgery, Division of Critical Care, Trauma, and Burn Cleveland

Woosup Michael Park, MD Chief, Vascular Surgery Cleveland Clinic Abu Dhabi Al Maryah Island, Abu Dhabi

Don Wollheim, MD, FACS General Surgeon and Managing Partner at Implexus Wound Care Service Certified in wound care and diabetic wound care by the National Alliance of Wound Care and Ostomy Watertown, Wis. Disclosure: All panelists reported they have no relevant financial disclosures.

➋

It is fair to say that often physicians (and other disciplines of health care) do not know how to stage pressure injuries correctly by National Pressure Injury Advisory Panel guidelines, creating regulatory, legal and reimbursement vulnerabilities.

DR. PARK: ON THE FENCE. There

are severe biases involved in staging that are driven by reimbursement and penalties.

These are useful tools to guide therapies, but are most often used for quality metrics and billing.

Physician involvement in wound evaluation and management is essential to ensure the extent of the wound is considered in the context of the patient’s overall health.

—Christi Cavaliere, MD I believe that most physicians and other health care providers are familiar with and understand the pressure injury staging system as described by the National Pressure Injury Advisory Panel. However, the staging does lend itself to a level of subjectivity among providers, and this fact may lead to regulatory, legal and reimbursement vulnerabilities. In addition, although the ulcer management may be addressed, some details in the documentation may be overlooked. Considering these patients often have numerous comorbidities and active medical and social issues requiring attention, the provider may be distracted in a detailed description of findings while addressing the continued abundance of documentation, charting and reporting.

DR. CORDOVA: DISAGREE.

MARCH 2021 / GENERAL SURGERY NEWS

➌

EXTENDED WOUND CARE COVERAGE

Dakin’s solution, vinegar and saline still have a vital role in wound care.

Despite the plethora of wound care products on the market, these continue to perhaps be the most costeffective and have proven the test of time.

“Wound” is an incredibly broad diagnosis and therefore wound treatment must be tailored to the specific wound. Over the past several years, moist gauze dressings or “wet to dry” dressings have been denounced in favor of “advanced wound dressings.” Many of these “advanced” dressings are absorptive—meant to be changed less frequently—and may be relatively expensive. A large, infected wound with necrotic tissue needs to be washed/ irrigated, the necrotic tissue needs to be removed, and more frequent dressing changes may be needed.

These solutions can be used for irrigation and/or packing and can help debride necrotic tissue, making them a valuable tool. Even with use of advanced wound dressings, these products can be used to irrigate and clean a wound. More concentrated solutions may irritate the tissue or slow healing; however, dilute solutions are well tolerated. The solutions are relatively inexpensive and can be prepared in the kitchen, making them accessible to patients who have limited resources or lack insurance coverage for dressing supplies.

➍

DR. CAVALIERE: AGREE.

[I have] seen tiny tubes of unguents sold for thousands of dollars, only to be discredited, with many patients having paid out of pocket. Simple, cheap and effective therapies always lose out to the ‘latest, greatest’ thing.

—Woo Sup Michael Park, MD DR. PARK: AGREE. Changing the chemical environment of a wound, irrigation, decontamination—all of these agents have a role and have over a century-long track record. That they are cheap and not reimbursed may be one of the reasons why they have been discarded.

Saline definitely still has a role in modern wound care except in the neonate. The pendulum is shifting away from utilizing Dakin’s and dilute acetic acid (vinegar) as antimicrobial agents and replacing them with newer, other commercial products.

However, Dakin’s and acetic acid are still being used. If so, they should be used correctly. Dakin’s is only effective against gram-positive organisms and needs to be applied twice a day. Acetic acid is effective against both gram-positive and gram-negative organisms, especially Pseudomonas, and needs to be applied three times a day.

DR. WOLLHEIM: ON THE FENCE.

Dakin’s, vinegar and saline play a vital role in wound care. Dakin’s and vinegar have proven bactericidal and fungicidal properties. However, their use should be for a limited period of time as it may cause fibroblast cytotoxicity and paradoxically impair wound healing. It is important to know that these products are available in different concentrations, and those that are more dilute still remain effective and have a safer profile while promoting antisepsis with a lesser degree of cytotoxicity. Saline is a simple, more physiologic, and efficacious solution that provides a moist environment conducive for adequate wound healing. These solutions are all highly accessible, cost-effective and successful in debridement.

The bar is too low for bringing wound products to the marketplace based on classification as devices and not drugs.

DR. PARK: AGREE,

having seen tiny tubes of unguents sold for thousands of dollars, only to be discredited, with many patients having paid out of pocket. Simple, cheap and effective therapies always lose out to the “latest, greatest” thing.

DR. CAVALIERE: ON THE FENCE. There

are numerous woundrelated products with grand efficacy claims and limited data. This scenario makes choosing products challenging and puts frustrated physicians and suffering patients in a vulnerable position. Products that are low risk and relatively inexpensive may be appropriate to try even with limited data. Unfortunately, many patients assume economic hardship with the hope that a fancy new product will help them heal. A more rigorous and uniform process to evaluate wound products and to assess comparative efficacy would promote more cost-conscious wound care and improve outcomes.

If a new product is not a medication and does not need to undergo the scrutiny of a drug, then I think the nondrug product should be made available for the clinician’s use. All wounds are different, and maybe a newer product might have a unique quality to heal the wound in comparison with other established products in the same category.

The clinician should follow the trajectory of healing regardless of if the product is new or old to the marketplace. In general, the clinician should see a positive response within two weeks, such as a 10% per week decrease in the wound’s cross-sectional area, a decrease in the amount of nonviable tissue compared with viable tissue in the wound bed, and/or maybe less pain, among other parameters. If there is no improvement, then the clinician should consider moving on to a different therapy, be it from an old or new product/therapy.

Early Antibiotics for Sepsis Don’t Result In Overall Higher Use

By ETHAN COVEY

D

ecreasing the time it takes to deliver antibiotic therapy to patients with sepsis does not necessarily correspond to an overuse or misuse of antibiotics, according to data presented at the SCCM’s 50th Critical Care Congress (abstract 38).

“A variety of programs have incentivized rapid antibiotic treatment for severe sepsis, but at the same time, there has been growing concern that earlier antibiotic timing for sepsis may result in increased antibiotic treatment for more patients overall, including those without infection,” said Sarah M. Seelye, PhD, a data scientist with the VA Center for Clinical Management Research, in Ann Arbor, Mich.

To date, however, there has been little evidence to support this claim.

DR. WOLLHEIM: DISAGREE.

➎

Access to hyperbaric therapy for acutely sick patients is a problem with no real solution in sight.

There is not enough data to understand if a wound would have healed with optimal vascularity, surgical management and excellent wound care, with or without afternoons spent in a tank.

DR. PARK: ON THE FENCE.

DR. CORDOVA: AGREE.

AGREE. Hyperbaric oxygen therapy [HBOT] clinics are very expensive to establish, and the administration of the therapy requires its own unique expertise. Although it would be great for all patients to readily have access to HBOT, not all geographic areas can support its use. For the acutely ill patient who does not live in a region where HBOT is readily available, this might require them to be transferred to a hospital, long-term acute care hospital or long-term care facility, with an admission lasting several weeks. This could create a hardship for family members, too. “No real solution in sight” might be an understatement.

■ DR. WOLLHEIM:

Dr. Seelye and her colleagues investigated whether hospital-level acceleration in antibiotic timing for sepsis is associated with increased antibiotic use among all patients hospitalized with potential infection.

They identified 1,101,239 hospitalizations for potential sepsis infection, which took place in 132 Veterans Health Administration hospitals during 2013-2018.

More than half (55.2%) of these patients received antibiotics within 48 hours of emergency department (ED) admission, and 10.7% met the criteria for sepsis.

During the study period, a marked acceleration in time to antibiotics was seen, with the median time to antibiotics among sepsis hospitalizations declining from 5.8 hours in 2013 to 4.8 hours in 2018. This acceleration was seen in 84% of the surveyed hospitals, she said.

However, no association was found between changes in the timing of antibiotic delivery and total antibiotic use among patients with potential infection. In 2013, approximately 57% of patients with potential infection were treated with antibiotics within the first 48 hours following ED arrival. By 2018, the percentage had declined to 55%.

“Despite this acceleration in antibiotic timing for sepsis, we found no evidence that changes in time to antibiotics for sepsis were associated with rising antibiotic use among all hospitalizations for potential sepsis,” ■ Dr. Seelye said.

17

18

IN THE NEWS

NPWT continued from page 15

from the wound bed (Plast Reconstr Surg 2006;118[2]:390-397; J Trauma 2011;71[1 suppl]:S147-S150). However, research indicates the technique may not eliminate bacteria effectively enough in complex wounds (J Wound Care 2016;25[8]:475-478).

That’s where instillation and dwell time come in.

“With NPWT plus instillation and dwell time, you’re constantly washing out the wound,” Dr. Matthews, a program director of the burn surgery fellowship at the Arizona Burn Center and an associate professor of surgery at Creighton University, in Omaha, Neb., and the University of Arizona, told General Surgery News. “Over a few days, this process does your debridement for you and leads to a better, more granulated wound bed for an eventual skin graft.”

A growing body of evidence suggests that adding instillation and dwell time to standard NPWT leads to faster healing, fewer operative visits, shorter length of stay and higher rates of closure before discharge in complex wounds (Wounds 2020;32:279-282; Plast Reconstr Surg 2014;133[3]:709-716).

Despite these findings, the adjunctive therapy has not been widely adopted. A main barrier, according to Dr. Matthews, is that case series dominate the literature. “Those who use the technique feel there’s a decided difference in patient outcomes, but there has been no definitive proof,” he said. In other words, “we didn’t have randomized controlled trials.”

At the 2020 Symposium on Advanced Wound Care (SAWC) annual meeting, Dr. Matthews discussed the latest research, which included the first randomized controlled trial of NPWT, and barriers to implementation.

In June 2020, surgeons published a randomized controlled trial that compared 69 patients receiving NPWT with instillation and dwell time and 63 on NPWT (Int Wound J 2020;17:11941208). The instillation group exhibited a significant decrease in bacterial counts after the initial surgical debridement and a lower risk for rehospitalization (three vs. nine patients), although there were no significant differences in the number of debridements, time to wound closure or wound complications.

Paul J. Kim, DPM, who led the effort, noted that the lack of significant difference in the number of debridements was “somewhat unexpected,” given previous study findings and his own experience.

But he pointed to several drawbacks— including the use of polyhexamethylene antiseptic to irrigate the wounds, which may have slowed granulation tissue formation, and protocol variations across

GENERAL SURGERY NEWS / MARCH 2021

institutions—that may have affected the results.

Two other studies published in 2020 aligned more closely with the case series literature. A meta-analysis of 13 studies, which Dr. Kim presented at the SAWC meeting, showed patients receiving NPWT with instillation had significantly fewer surgical debridements, reduced bacterial burden and shorter duration of therapy (1.5 vs. 3.5 days) than those receiving NPWT alone or conventional dressings. Additionally, a 2020 retrospective analysis found that 42 patients undergoing instillation with saline had

A growing body of evidence suggests that adding instillation and dwell time to standard NPWT leads to faster healing, fewer operative visits, shorter length of stay and higher rates of closure before discharge in complex wounds.

significantly fewer operations, shorter length of stay and higher percentage of closed wounds than the 74 patients receiving NPWT (Cureus 2020. doi: 10.7759/cureus.9047).

Dr. Matthews called the retrospective analysis “groundbreaking,” noting it “should be a game changer for wound care.”

After reviewing the 2020 research, Dr. Matthews detailed his own experience.

For his third-degree burn patient, he described covering the wound bed with a reticulated open-cell foam dressing with through holes to aid the removal of

IN COMPLEX HERNIA REPAIR, PATIENT RISK FACTORS AND POSTOPERATIVE WOUND COMPLICATIONS CAN CONTRIBUTE TO THE PERIL OF HERNIA RECURRENCE

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

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

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

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

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

MARCH 2021 / GENERAL SURGERY NEWS

EXTENDED WOUND CARE COVERAGE

exudate and then irrigating the wound with a solution of hypochlorous acid for 20 minutes, followed by negative pressure for 160 minutes. This three-hour cycle was repeated for several days, at which point Dr. Matthews applied a fresh dressing. Ultimately, the patient required five operations interspersed with NPWT with instillation until granulation tissue began to form and an autograft could be placed.

Consensus guidelines, published last year, provide a framework for when to use this technique, which includes fullthickness burns after excision as well as

traumatic, infected and diabetic wounds (Int Wound J 2020;17[1]:174-186). Still, wound care experts have been slow to adopt NPWT with instillation. According to Dr. Kim, the medical director of the Wound Program at The University of Texas Southwestern Medical Center, in Dallas, the perception that standard NPWT “is good enough” and instillation “adds greater complexity” represents a major hurdle.

Luis G. Fernández, MD, a trauma surgeon, believes the mentality of “we’ve always done it this way” is often a barrier to the development of innovative

approaches that may benefit patients.

“It’s human nature to fear change, and it takes time and effort to learn and adapt to a new paradigm,” said Dr. Fernández, the medical director of trauma wound care and a professor of surgery at The University of Texas Health Science Center, in Tyler.

Alex Wong, MD, who was not involved in the research, noted that NPWT alone may be the instinctive first choice for surgeons based on accessibility and familiarity, but he sees the advantages of adding instillation. “The data on NPWT with instillation looks solid

and consistent, and intuitively it makes sense to clean the wound more,” said Dr. Wong, an associate professor of surgery in the Division of Plastic and Reconstructive Surgery at the University of Southern California’s Keck School of Medicine, in Los Angeles. “After reviewing the evidence and updated consensus guidelines, I may increase my use of NPWT plus instillation.”

■ The SAWC talk was supported by an educational grant from 3M+KCI. Drs. Fernández, Kim and Matthews reported relationships with the company.

Update on Surgical Smoke

STRATTICE™ RTM, a 100% biologic mesh, is a durable solution for abdominal wall reconstruction based on the long-term outcomes of low hernia recurrence rates across multiple published clinical studies1-5 In a recent retrospective evaluation, biologic meshes were shown to have a

CUMULATIVE HERNIA RECURRENCE RATE OF

8.3

% AT

7 YEARS POST-OP1,*

*Includes po porc rcin inee annd bo bovi v ne ace cellul ular dermall matrices (ADMs) (n = 157).

Bridged re repa p ir andd human ADM wer e e excluded from the study grou o p.

TO LEARN MORE ABOUT STRATTICE™ RTM, SPEAK TO YOUR ALLERGAN REPRESENTATIVE

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

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

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

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

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

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

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

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

References: 1. Garvey PB, Giordano SA, Baumann DP, Liu J, Butler CE. Long-term outcomes after abdominal wall reconstruction with acellular dermal matrix. J Am Coll Surg. 2017;224(3):341-350.

2. Golla D, Russo CC. Outcomes following placement of non-cross-linked porcine-derived acellular dermal matrix in complex ventral hernia repair. Int Surg. 2014;99(3):235-240. 3. Liang MK, Berger RL, Nguyen MT, Hicks SC, Li LT, Leong M. Outcomes with porcine acellular dermal matrix versus synthetic mesh and suture in complicated open ventral hernia repair. Surg Infect (Larchmt). 2014;15(5):506512. 4. Booth JH, Garvey PB, Baumann DP, et al. Primary fascial closure with mesh reinforcement is superior to bridged mesh repair for abdominal wall reconstruction. J Am Coll Surg. 2013;217(6):9991009. 5. Richmond B, Ubert A, Judhan R, et al. Component separation with porcine acellular dermal reinforcement is superior to traditional bridged mesh repairs in the open repair of significant midline ventral hernia defects. Am Surg. 2014;80(8):725-731.

Allergan® and its design are trademarks of Allergan, Inc. STRATTICE™ and its design are trademarks of LifeCell Corporation, an Allergan affiliate. © 2019 Allergan. All rights reserved. STM122131 03/19

An increasing amount of research confirms that surgical smoke can contain toxic gases and vapors such as benzene, hydrogen cyanide, formaldehyde and bioaerosols, as well as live cellular material and viruses (http://bit.ly/3qfQCc8).

“While exposure of surgical smoke to patients is short term and relatively low risk, surgeons, perioperative nurses and other operating room staff are exposed to surgical smoke daily,” Ana Pujols McKee, MD, the executive vice president, chief medical officer, and chief diversity and inclusion officer at the Joint Commission, said in a press release. “At high concentrations, surgical smoke may cause ocular and upper respiratory tract irritation and potentially create visual problems for the surgeon. This is why it is so important for hospitals and ambulatory surgery centers to be aware of the risks of surgical smoke and how they can best mitigate those risks.”

The literature reveals that nanoparticles comprise 80% of surgical smoke and are the real danger in inhaled smoke (Biointerphases 2007;2[4]:MR17MR71). These particles are less than 100 nanometers in size (i.e., 0.1 micron), and when inhaled, enter a person’s blood and lymphatic circulatory systems and travel to distant organs (Circulation 2002;105[4]:411-414).

In an effort to keep health care workers up-to-date, the Joint Commission recently published a new advisory, “Alleviating the dangers of surgical smoke,” which reviews current regulations, recommendations and standards from several governmental and professional organizations.

To view the guidelines, and several safety actions, go to http://bit.ly/3oGSPgd. ■

19

20

OPINION

SSIs: What Surgeons Should Know About Their Hospital’s Cleaning Program

By DAVID TAYLOR, MSN, RN, CNOR

M

any patients experience pain postoperatively related to their surgery.

Unfortunately, far too many operations result in a surgical site infection (SSI).

Doctors and hospitals may say infections following surgeries are a potential risk, but for many, postsurgical infections can be the result of contaminated treating

environments and/or negligence. In the United States, approximately 27 million surgical procedures are performed each year, with as many as 5% of those resulting in an SSI.1 Contamination within an OR can be introduced through a variety of sources: surgical instruments and equipment, personnel and the patient, inanimate objects and surfaces, the air and even insects,

potentially causing harm. To provide a safe environment for both the patient and health care worker, an environmental control program should be established for the OR to keep microorganisms to a minimum.

In 2017, the American College of Surgeons and Surgical Infection Society published SSI guidelines found that they are the most common and costly type of

Successfully Treat Non-healing Wounds Safely at Home Multimodality Topical Wound Oxygen (TWO2) therapy explained: • Delivering the highest level of topical oxygen supplementation to non-healing wounds = greater & more durable healing1 • Cyclical-pressure noncontact compression delivery = addresses edema & underlying peripheral vascular disease2 • OƭŞĿēĿǶ ČîƥĿūŠ ʏ ŞîĿŠƥîĿŠƙ ŞūĿƙƥ DžūƭŠē environment & facilitates healing3

1 R.G. Frykberg. et. al., “Multinational, Multicenter, Prospective, Randomized, Double-Blinded, ¡ŕîČĚċūɠ ūŠƥƑūŕŕĚē ¹ƑĿîŕ ƥū /DŽîŕƭîƥĚ ƥĺĚ /IJǶ ČîČNj ūIJ NjČŕĿČîŕ ¹ūƎĿČîŕ ØūƭŠē ~NJNjijĚŠ ¹ĺĚƑîƎNj ɚ¹Ø~2) in the Treatment of Chronic Diabetic Foot Ulcers,” Diabetes Care, vol. 43, no. 3, p. 616–624, 2020.

2 Øɍ ¹îDžǶ ČŒɈ ¬ɍ ¬ƭŕƥîŠɈ ɨ¹ĚČĺŠĿČîŕ îŠē ČŕĿŠĿČîŕ ūƭƥČūŞĚ ūIJ ƥūƎĿČîŕ DžūƭŠē ūNJNjijĚŠ ĿŠ ČūŞƎîƑĿƙūŠ ƥū conventional compression dressings in the management of refractory nonhealing venous ulcers,” Vasc Endovascular Surg, vol. 43, p. 30–37, 2013.

3 cɍ¡ɍ cƭŠŒĚƑɍ Ěƥɍ îŕɈ ɨ ŕĿŠĿČîŕ TŞƎîČƥ ÀƎūŠ ØūƭŠē OĚîŕĿŠij îŠē TŠǷ îƥĿūŠ ĿŠ qūĿƙƥɈ ØĚƥɈ îŠē 'ƑNj Environments,” Advances in Wound Care, vol. 2, no. 7, pp. 348-356, 2013.

www.aotinc.net Learn more about TWO2, the next generation of multi-modality topical oxygen wound therapy

health care‒associated infection (HAI) and accounted for 20% of all HAIs. The annual incidence of SSI in the United States is between 160,000 and 300,000, or 2% to 5% of patients undergoing inpatient surgery, and the attributable health care cost ranges from $3.5 billion to $10 billion annually. On average, an SSI increases a hospital length of stay by 9.7 days.2 The recommendations put forth by the Association for peri-Operative Registered Nurses, and the Association for the Healthcare Environment’s Practice Guidance for Healthcare Environmental Cleaning, are the standards used by most health care facilities in setting up their infection prevention procedures regarding the OR and other procedural spaces.

However, as a consultant, I have provided hundreds of OR assessments across the country, and have often found cleanliness and infection prevention practices to be lacking. Preoperative leaders are not maintaining their ORs to industry standards, and after interviewing surgeons they had no clue of the problems.

Cleaning measures are needed before, during and after surgical procedures (in between procedures), and at the end of each day. Such cleaning must be considered an environmental essential, and infection prevention considerations should include the following: Air handling or ventilation systems of the surgical suite should be designed to minimize contaminants. Air entering the room through the HVAC system should originate from the ceiling and exit through the return near or at the floor. Air exchanges should be a minimum of 15 per hour with at least four of those air exchanges originating from a fresh air source, and be HEPA filtered.

Many hospitals have increased their air exchange rates to as high as 25 per hour with 100% of those being fresh air.

Proper attire (scrubs) should be freshly laundered and donned at the hospital to reduce the number of contaminants carried in from outside of the OR. Because scrubs are considered a form of personal protective equipment, they should be

EXTENDED WOUND CARE COVERAGE

Ultraviolet disinfection.

taken off prior to health care workers leaving for the day.

Traffic during the operation should be confined to the members assigned to that procedure. The microbial levels in the air are directly proportional to the number of people moving about and talking within the OR. Minimizing the number of people in the room, or how many times members of the team enter or exit throughout the procedure can help reduce infection rates.

Bloodborne pathogens have the potential to be infectious, as well as other body fluids including saliva; cerebrospinal, synovial, pleural, pericardial, peritoneal and amniotic fluids; semen; and vaginal secretions. Caution should be taken when handling specimens, organs (other than intact skin), and cell or tissue cultures.

to as UV germicidal irradiation. Many companies are now offering this technology for use in hospitals and other industries. In the wake of the COVID19 pandemic, UV technology has been used more extensively, but unfortunately there are limitations for its use. Because UV radiation exposure is hazardous to humans, it is typically used in one of four configurations: in unoccupied room disinfection, upper room disinfection, air handler unit surface disinfection and air handler surface airstream disinfection.4 Whether or not an infection rises to the level of medical malpractice

will depend on the circumstances surrounding how and when the infection occurred. Medical malpractice cases can be difficult to prove; nevertheless, surgeons should be aware of preventive measures and call on their hospital leadership to do everything in their power to ensure patients remain safe and free of infection.

■

References 1. Hospital infection control: surgical site infections. http://bit.ly/3qYmYbX 2. Ban KA, Minei JP, Laronga C, et al.

American College of Surgeons/Surgical

21

Infection Society surgical site infection guidelines‒2016 update. Surg Infect (Larchmt). 2017;18(4):379-382.

3. Indoor air quality: what are the trends in indoor air quality and their effects on human health? http://bit.ly/2O1UNKX 4. UVGI vs. BPI: which air-cleaning technology is best for your building? http://bit.ly/3bHUfBZ

—David L. Taylor III, MSN, RN, CNOR, is the principal of Resolute Advisory Group, LLC, a health care consulting firm in San Antonio.

He can be reached at DavidTaylor@ ResoluteAdvisoryGroup.com.

NOBODY LIKES DOING IT OVER.

Employing New Technologies New technologies are designed to help keep ORs cleaner and can include products with ultraviolet light and advances in heating, ventilation and HVAC systems, such as needlepoint bipolar air ionization (NPBI) technology. What are the pros and cons of using these technologies?

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GENERAL SURGERY NEWS / MARCH 2021

Wound Care: Rewarding Work continued from page 15

oxygen care,” said John Lantis, MD, a professor of surgery at Mount Sinai Hospital, in New York City. “In most cases, these centers are run by a for-profit company that forms a partnership with a local hospital system. The for-profit company and the hospital determine who pays which employees and who pays for the development of the space.

In addition, the hospital system benefits from the ancillary spinoffs.”

According to Dr. Lantis, “in that model,

podiatrists have thrived; there are also providers in infectious disease, emergency medicine, physical medicine and rehabilitation, and general medicine.” However, even though there are certifications for wound care from organizations such as the American College of Wound Specialists, they don’t meet the level of rigor demanded by institutions like the American Board of Medical Specialties, he said.

“The organizations that give certificates may differentiate in which

‘There is a core knowledge you need to know: what you’re doing and why you’re doing it. The concept of just starting to do wound care is a bit like deciding to do laparoscopy without any training in it.’

—John Lantis, MD certification they give to different levels of training, but they will certify a medical assistant, a nurse, a physical therapist, a doctor—therefore, ownership is diverse,” Dr. Lantis noted.

So, apparently, is the quality of care.

Wound care technology has advanced significantly, but overall outcomes are often subpar, sometimes as low as a 50%

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to 60% healing rate at six months. “That may be due to people not following algorithms and really not knowing what they’re doing,” Dr. Lantis said.

Since a large part of wound care is pain control and wound debridement, general surgeons may be better equipped than nonsurgical specialists to treat these wounds, he said. Especially in the outpatient setting, this can be well reimbursed.

“But there is a core knowledge you need to know: what you’re doing and why you’re doing it. The concept of just starting to do wound care is a bit like deciding to do laparoscopy without any training in it,” Dr. Lantis said.

The application and use of cellular tissue-based products (i.e., skin substitutes), which many surgeons know from the operating room, also can be remunerative. “But again, you need to be familiar with their use, handling, indications and expected outcomes,” Dr. Lantis added.

Basics of Starting Out Any general surgeon getting into wound care will face some up-front costs: acquiring the appropriate products for debridement and postprocedural advanced dressings, and possibly reinforcing the front office staff, Dr. Lantis said.

“You may want to partner with someone more familiar with those dressings, such as a wound and ostomy care nurse.

Also, home care provides a large amount of wound care, so you’ll need be able to handle the demands of communication coordination with home care and home care nurses,” he added.

An easy way to get your feet wet is to look up nearby wound care centers.

Many are staffed five or six days per week, in half-day shifts, allowing for 10 to 12 blocks per week. Tell them you’re a boardcertified general surgeon interested in doing two or three days weekly and ask if they have any openings. These wound care programs usually offer structured training and provide algorithms for care.

“That’s like buying a mutual fund.

It minimizes your risk while maximizing your productivity, and enhances the general surgeon’s ability to provide good care,” Dr. Lantis said.

Another relatively easy entrance is to develop an on-call schedule for wound care at your local hospital. “Most hospitals would love to have a general surgeon rounding, where they could, say, call the general surgery service for any skin issues,” Dr. Brem said. “This could be separate from their regular general surgeon or wound care nurse on call or in ■ collaboration with those services.”

MARCH 2021 / GENERAL SURGERY NEWS

EXTENDED WOUND CARE COVERAGE

Understanding Reimbursement for Wound Care

By Monica J. Smith Several times per week, Kathleen D. Schaum, MS, a wound care reimbursement strategy consultant, fields phone calls from health care providers asking, “How can I get paid by Medicare for that?”

At the 2020 fall Symposium on Advanced Wound Care, Ms. Schaum, the founder and president of Kathleen D. Schaum & Associates, Inc., said the answer to this question requires understanding the three components of reimbursement: coding, coverage and payment that pertains to each specific scenario.

To determine clients’ potential for reimbursement, she asks them to focus on a few details. As an example, a client seeks Medicare reimbursement for negative wound pressure therapy. In this case, the questions are: “Are they using durable medical equipment or disposable negative pressure?

Who is applying the negative pressure? What is the site of care?

If another procedure will take place concurrently, what is that other procedure?”

In addition, there are other considerations, Ms. Schaum said. Medicare may reimburse: • if the procedure is covered for that patient. Since not every technology can be applied to every patient, Ms. Schaum advised checking National Coverage Determinations, Local Coverage Determinations and Local Coding Articles on the Centers for Medicare & Medicaid Services’ website (see links below).

“Physicians and qualified health care professionals often say, ‘Isn’t this the coder’s job? I don’t have time to read these.’ But I’ll tell you, these things are not that long and they are the playbook for physicians and qualified health care professionals,” Ms. Schaum said.

• if the physician performed the procedure. For example, if the physician provides wound/ulcer management in a hospital– owned, outpatient provider-based department, that physician “can bill for it if he/she performed the procedure. But if they write an order for a department staff member to perform it, only the facility can bill for it.”

• if the service/procedure is not part of a National Correct Coding Initiative procedure-to-procedure (NCCI PTP) edit. When two services/procedures are performed during the same encounter, verify whether an NCCI PTP edit exists that would cause payment denial for one of the services/procedures.

• if the procedure is not included in the consolidated bill payment system of a skilled nursing facility.

Many wound and ulcer patients are in skilled nursing facilities, which submit consolidated bills to Medicare and get paid a lump sum for their patients’ care.

“So, you’ll need to know which procedures are in the consolidated billing system and which are not,” Ms. Schaum said. For the latter, you can bill Medicare; for the former, you’ll have to contract with the facility to bill them for that work.

Resources From the CMS Website • PTP Coding Edits http://go.cms.gov/3uCkcvi • How to Use the Medicare National Correct Coding Initiative https://go.cms.gov/2O7ONju • Overview on Skilled Nursing Facility Consolidated Billing http://go.cms.gov/3e2bBwn • 2021 Part B MAC Update http://go.cms.gov/3kz5ZLe

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24

IN THE NEWS

The Scientific Greats: A Series of Drawings

By MOISES MENENDEZ, MD, FACS

GENERAL SURGERY NEWS / MARCH 2021

Biophysical Therapy continued from page 15

autolytic debridement and collagen deposition (Nursing 2002;32[12]:17).

“In fact, electrical stimulation earned a strength of evidence of A in the AHCPR [Agency for Health Care Policy and Research] pressure ulcer treatment guidelines in the early 1990s,” Dr. Cordrey said. “Since then, further research has improved our use of the older modalities, but a greater understanding of chronic wound physiology led to the development of new tools to promote wound healing via different pathways.”

Topical Oxygen Therapy

Joseph Lister (1827-1912) 2013. Work was done in a toned paper, 19 x 25, using charcoal pencils without blending. Paper was treated with coffee and Betadine solution.

Artist: Moises Menendez, MD, FACS

Joseph Lister, 1st Baron Lister (1827-1912) Sir Joseph Lister was a British surgeon and pioneer of antiseptic surgery. In the early to middle 19th century, surgery was a gruesome, traumatic experience, one that even the bravest of people avoided like the plague. The infection rate and mortality were extremely high for patients who underwent surgery. To start, there were no anesthetics—they simply hadn’t been invented yet—which meant that patients were fully conscious when undergoing their operations. With the discovery of general anesthesia in the mid-1800s, the number of surgical procedures increased, leading to a rise in the number of infected wounds.

Lister believed in the ideas of Louis Pasteur, based on the etiology of fermentation, and envisioned that this process was the same as the one causing infection and gangrene in limbs. Having observed the marked difference in morbidity and mortality between simple and compound fractures, he postulated that infection came from exposure to the air in compound fractures without the protection from the skin. He began his antiseptic method with compound fracture wounds because the standard treatment of amputation was always available should this method fail. Lister changed the treatment of compound fractures from amputation to limb preservation, and opened the way for abdominal and other intracavity surgery.

Lister found a way to prevent infection in wounds during and after surgery. He was the first to apply the science of germ theory to surgery. By applying Pasteur’s advances in microbiology, he promoted the idea of sterile portable ports while working at the Glasgow Royal Infirmary, in Scotland. Lister successfully introduced the use of carbolic acid (now known as phenol) to sterilize surgical instruments and to clean wounds, which led to a reduction in postoperative infections and made surgery safer for patients, thus distinguishing himself as the “father of modern surgery.”

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

Topical oxygen therapy (TOT) is the topical application of pure, humidified oxygen to a wound to hinder the growth of bacteria, enhance growth factor signaling, and promote angiogenesis and collagen synthesis. TOT is delivered via sealed chambers or topical diffusers. Patients using topical oxygen chambers undergo TOT at home for 90-minute intervals several times weekly, whereas topical diffusers are worn continuously under a dressing.

Two randomized controlled trials showed significant improvements with TOT in healing rates among patients with diabetic foot ulcers, including patients with large wounds (J Wound Care 2018;27:S30-S45 and Diabetes Care 2020;43[3]:616-624). Importantly, the speakers noted precautions to take with TOT to ensure optimal oxygen penetration, for example, removing eschar and avoiding petroleum-based dressings.

Cold Atmospheric Plasma Cold atmospheric plasma (CAP) is the application of partially ionized gases to disinfect, promote tissue growth, and treat itch around a healing wound. Daily CAP treatment is indicated for chronic wounds, decreasing bacterial load, preparing donor sites for a skin graft, skin conditions such as itch and eczema, scar treatment, and pain relief. Anticancer applications of CAP are also being investigated.

Several studies have reported safe and effective reductions in bacterial load and accelerated wound healing with the use of CAP in different clinical settings (Br J Dermatol 2010;163[1]:78-82; Br J Dermatol 2012;167[2];404-410; Clin Plasma Med 2013;1[2];25-30; J Eur Acad Dermatol Venereol 2015;29[1];148-155; Wound Repair Regen 2013;21[6]:800-807). CAP users should be cautious of the generation of reactive oxygen species and potential risks for skin damage.

Photobiomodulation Photobiomodulation is a means of altering cell behavior using light to promote healing. The mechanisms of action are complex, but in general, light absorption by tissues causes broad changes in cell signaling, which triggers the release of growth factors and reactive oxygen species and modulates pain response and inflammation. Depending on the wavelength of light used (red vs. blue light), different types of cells will respond. Macrophages, lymphocytes, fibroblasts and epithelial cells all respond in ways that relieve pain and promote more rapid healing.

Clinical studies of the use of red light showed

reduced pain and wound improvement. Preclinical studies using blue light found decreased bacteria levels, improved perfusion and altered keratin synthesis (Lasers Med Sci 2018;33[4]:729-735; Int J Low Extrem Wounds 2017;16[1]:29-35; Evid Based Complement Alternat Med 2013;960240; Lasers Med Sci 2017;32[2]:275-282; J Vis Exp 2017;(122):54997; Injury 2011;42[9]:917-921). Precautions with this treatment include monitoring for inflammatory responses and potential tissue damage.

Ultraviolet-C UV-C light is invisible light that is used to stimulate vasodilation, histamine and growth factor release, and wound contraction. At therapeutic doses, UV-C causes DNA damage that destroys pathogens without causing irreparable damage to human cells. UV-C is effective against antibioticresistant organisms, and UV-C resistance has not been reported. There are no standard protocols for the use of UV-C, but it can be applied in short, up to 120-second treatments. Notably, UV-C is contraindicated in patients with a history of skin cancer.

“I really think ultraviolet-C, which is covered under Medicare, is underused. It is a simple, safe and inexpensive means to treat superficial infections and critical colonization, even with organisms resistant to our antibiotics,” Dr. Cordrey said.

Extracorporeal Shock Wave Therapy Extracorporeal shock wave therapy (ESWT) is an emerging technology that uses sound waves to promote wound healing and decrease pain by stimulating inflammation, growth factor release, and production of collagen and nitric oxide synthase; disrupting biofilms; and promoting angiogenesis, fibroblast proliferation, cell migration and keratinocyte activity. Meta-analyses show improved healing of diabetic foot ulcers with ESWT compared with standard-of-care treatment (Wound Repair Regen 2017;25[4]:697-706; Can J Diabetes 2020;44[2]:196-204.e193). Studies are ongoing to understand the role of ESWT in other etiologies, and there remain unanswered questions about its use, for example, around malignancies, near the head and in pediatric patients.

Vibration Therapy Vibration therapy is a low-intensity treatment that may help prevent muscle breakdown and necrosis. Studies in patients with healthy feet suggest that vibration increases perfusion and decreases hyperemia (Wound Manag Prev 2020;66[8]:7-14).

Although the responses were less pronounced in patients with diabetes, these small changes may still be clinically relevant (Front Bioeng Biotechnol 2019;7:310). More research is needed to understand the future roles of this therapy.

Each of the emerging technologies discussed in this session offers promising new opportunities for wound healing support. Further development and adoption of new strategies will optimize healing and help patients recover from injury and surgery more quickly, comfortably and safely.

“I have no idea about what is next in wound care technology. That’s why it’s so interesting,” Dr. Cordrey said. “It’s a rapidly evolving field of practice, and as we learn more about how chronic wounds function, we find new ways to target them.”

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IN THE NEWS

GENERAL SURGERY NEWS / MARCH 2021

Cognitive Skills Can Help Surgeons Manage Stress, Improve Performance continued from page 1

(abstract PS431). Research shows that experiencing small bursts of stress-fueled adrenaline can actually enhance a person’s energy level and motivation.

“Surgeons are already familiar with this experience, and many of us were drawn to surgery because of it,” Dr. Lebares, an assistant professor of surgery and the director of the Center for Mindfulness in Surgery at the University of California, San Francisco, told General Surgery News. “But what if surgeons could be taught a set of cognitive skills that would make stress less painful and could increase performance under stress more reliably?”

In her ACS talk, Dr. Lebares detailed her efforts to answer this question, focusing on one approach: enhanced stress resilience training (ESRT). Over the past five years, she has adapted and studied this tailored version of mindfulness-based cognitive training to determine whether surgeons benefit from these skills.

Building the Evidence Base A long-standing body of research shows that training in mindfulness curbs stress and enhances performance and mood. Learning these cognitive skills, for instance, can help students score higher on exams and professional athletes get in the “zone” during clutch moments of a game (Front Psychol 2019;10:1875; Dev Psychol 2015;51:[1]:44-51).

Dr. Lebares recognized how this training could benefit surgeons but, in 2016, no studies existed in this population.

That year, she launched UCSF’s Center for Mindfulness in Surgery to begin studying how training in these cognitive skills may improve surgeons’ mental health and performance.

Her first clue that ESRT could work for surgeons came from a national survey exploring why some general surgery residents are more resilient to burnout (J Am Coll Surg 2018;226[1]:80-90). After

analyzing the data, she found that certain surgeons naturally exhibited mindfulness tendencies—greater self-awareness and an ability to regulate their emotions—and these traits lowered their risk for burnout, suicidal thoughts and depression.

“These results suggested that purposefully building mindfulness skills in surgeons could have a similar effect and help a broader set of people,” she said.

Dr. Lebares began testing this theory in surgery residents. First, she needed to see whether integrating formal mindfulness-based training in surgical education would be feasible and whether residents would be on board with it.

“One concern is that surgeons may get caught up in the misconceptions and jargon surrounding mindfulness and miss the core idea,” Dr. Lebares noted. “That’s why, during training sessions, I start by explaining the goal of ESRT. We’re not trying to create Buddhas or yoga teachers; we’re just teaching a set of cognitive skills that help surgeons recognize when a stressor arises, and teaches us to turn our reactions into responses. This simple shift in perspective can totally change how we handle stress and how we feel in general.”

In Dr. Lebares’ Mindful Surgeon pilot study, 21 surgical interns volunteered to be randomized to an early iteration of ESRT training, which involved twohour sessions of breathing, counting and meditation exercises over eight weeks, and a logistically similar control scenario (JAMA Surg 2018;153[10]:e182734).

Initial interviews confirmed that integrating ESRT into surgical training was indeed feasible, and the training improved surgeons’ ability to handle stressful situations at work and at home.

A follow-up analysis showed that participants continued to practice these skills a year later. ESRT participants had higher mindfulness scores, better scores on tests of executive function, and fewer

‘We’re not trying to create Buddhas or yoga teachers; we’re just teaching a set of cognitive skills that help surgeons recognize when a stressor arises, and teaches us to turn our reactions into responses. This simple shift in perspective can totally change how we handle stress and how we feel in general.’

—Carter Lebares, MD

stress and depressive symptoms than the control group (JAMA Netw Open 2019;2[5]:e194108).

“In our interviews, we also found that residents liked the training, found tons of ways to apply it and, perhaps most importantly, changed how they internalized stressful experiences,” Dr. Lebares said.

Despite the positive findings, she knew convincing practicing surgeons to make time for this training would be a bigger challenge. To appeal to a wider range of surgeons, she streamlined the time commitment—initially to six weeks of 90-minute sessions and later to five weeks of one-hour sessions. A newly published analysis showed that the shorter training program still led to improvements in burnout symptoms and reduced the proinflammatory gene response (Ann Surg 2021;273[3]:424-432).

Outside of formal training, finding time to practice these skills is key. Dr. Lebares recommended carving out spare moments in the day while waiting for the elevator, washing hands or driving home.

“One surgeon described paying attention to her feet touching the pavement as she walks from the hospital to her car,” she said. “This mental routine allows her to leave work and transition to home.

Another surgeon said he uses time waiting for lab results or the elevator to meditate, saying it ‘reclaims the moment,’ which I think means just letting go of the stress and frustration of waiting or rushing. We are seeing that doing this kind of informal, anytime micropractice is quite powerful and shows us that surgeons don’t have to become monks to benefit from meditation.”

Beyond ESRT Last year, ESRT became part of the mandatory curriculum for surgical interns at UCSF. Outside of UCSF, surgeons have been slow to adopt ESRT, but the pandemic has spurred greater interest from programs across the United States, Canada and Europe.

“Over the past six months, I’ve been getting calls and emails from more and more surgery programs who want to make this training part of their academic work and want to teach it,” said Dr. Lebares, who has adapted ESRT training to a remote form, which she now offers across four time zones to ER physicians and surgeons. “We’ve demonstrated that ESRT reduces burnout, and have created a road map to help other institutions implement this training.”

But ESRT training is just one strategy to reframe the culture of surgery at the individual and program levels.

In a complementary ACS session,

Lilah F. Morris-Wiseman, MD, FACS, highlighted another approach to improve surgeon well-being (abstract PS324). In July 2016, the University of Arizona in Tucson launched a well-being and resiliency program for general surgery residents, which paired residents and faculty, as a way to facilitate confidential discussions about challenging experiences on the job.

An initial study that assessed the program one year after implementation found perceived stress and emotional exhaustion among 49 surgery residents decreased while their satisfaction with work relationships, communication skills, productivity and work‒life balance increased (J Am Coll Surg 2018;226[4]:369-379). A 2020 follow-up analysis found that residents continued to report improvements in team communication and sense of community (J Surg Educ 2020;77[3]:508-519).

“While we may not have the power to change health care systems, we can change our departmental cultures and give our faculty and trainees the tools to succeed in [the] complex environment,” Dr. Morris-Wiseman, a clinical assistant professor of surgery at the University of Arizona in Tucson, said during her presentation.

In the session on surgeon well-being, Yue-Yung Hu, MD, MPH, an assistant professor of pediatric surgery at Northwestern University Feinberg School of Medicine, in Chicago, discussed her team’s efforts to better understand national-level system and cultural issues that affect surgeon experience and burnout.

Part of the problem, Dr. Hu said, is that “most programs have no data about their performance on these issues and lack access to readily available strategies to make improvements.”

These gaps in understanding prompted Dr. Hu and her colleagues to launch the SECOND trial—Surgical Education Culture Optimization through targeted interventions based on National comparative Data—to improve the well-being of residents nationwide and ultimately establish wellness tool kits tailored to different programs.

To measure how resident well-being differs on the local level, Dr. Lebares’ group also recently began a project exploring how the culture of programs influences the types of interventions that are accepted and effective (JAMA Netw Open 2021;4[1]:e2032676).

“Ultimately, we want to provide guidance as to where and how to use our precious resources to engage and prioritize surgeon wellness in different environ■ ments,” Dr. Lebares said.

Important Safety Information (continued) Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra is also contraindicated in patients with disseminated intravascular coagulation. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT).

Hypersensitivity reactions to Kcentra may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment.

In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

Kcentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

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

Pre-treatment INR

BRIEF SUMMARY OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Kcentra safely and effectively. See full prescribing information for Kcentra.

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding.

• Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Kcentra in clinical trials and post marketing surveillance. Monitor patients receiving Kcentra for signs and symptoms of thromboembolic events.

• Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra may not be suitable in patients with thromboembolic events in the prior 3 months.

------------------------------------INDICATIONS AND USAGE---------------------------------Kcentra, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with: • acute major bleeding or • need for an urgent surgery/invasive procedure.

-----------------------------DOSAGE AND ADMINISTRATION--------------------------------For intravenous use after reconstitution only.

• Kcentra dosing should be individualized based on the patient’s baseline International Normalized Ratio (INR) value, and body weight.

• Administer Vitamin K concurrently to patients receiving Kcentra to maintain factor levels once the effects of Kcentra have diminished.

• The safety and effectiveness of repeat dosing have not been established and it is not recommended.

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

† ‡

2–< 4

4–6

>6

25

35

50

Not to exceed 2500

Not to exceed 3500

Not to exceed 5000

Dosing is based on body weight. Dose based on actual potency is stated on the vial, which will vary from 2031 Factor IX units/mL after reconstitution. The actual potency for 500 vial ranges from 400-620 units/vial. The actual potency for 1000 unit vial ranges from 800-1240 units/vial.

Units refer to International Units.

Dose is based on body weight up to but not exceeding 100 kg. For patients weighing more than 100 kg, maximum dose should not be exceeded.

---------------------------------DOSAGE FORMS AND STRENGTHS-------------------------• Kcentra is available as a white or slightly colored lyophilized concentrate in a single-use vial containing coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S. --------------------------------------CONTRAINDICATIONS -----------------------------------Kcentra is contraindicated in patients with: • Known anaphylactic or severe systemic reactions to Kcentra or any components in Kcentra including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin.

• Disseminated intravascular coagulation.

• Known heparin-induced thrombocytopenia. Kcentra contains heparin.

----------------------------------WARNINGS AND PRECAUTIONS---------------------------• Hypersensitivity reactions may occur. If necessary, discontinue administration and institute appropriate treatment.

• Arterial and venous thromboembolic complications have been reported in patients receiving Kcentra. Monitor patients receiving Kcentra for signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thrombotic or thromboembolic (TE) event within the prior 3 months. Kcentra may not be suitable in patients with thromboembolic events in the prior 3 months.

• Kcentra is made from human blood and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

-----------------------------------ADVERSE REACTIONS---------------------------------------• The most common adverse reactions (ARs) (frequency * 2.8%) observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. (6) • The most serious ARs were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis.

To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring at 1-866-9156958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Revised: October 2018

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When time is essential, it’s time for Kcentra

Learn more at www.Kcentra.com

*Effective hemostasis measured up to 24 hours for the Acute Major Bleeding trial and until the end of procedure (up to 24 hours) for the Urgent Surgery/Invasive Procedures trial. Rapid INR reduction to ≤1.3 at 0.5 hours after end of infusion. †In 2 head-to-head trials, Kcentra demonstrated superiority to plasma in 3 of 4 efficacy endpoints. Superior hemostatic efficacy in the Urgent Surgery/Invasive Procedures trial and equally effective hemostasis in the Acute Major Bleeding trial. Faster INR reduction (to ≤1.3 at 30 minutes after end of infusion) in both head-to-head trials. ‡8 hours for Urgent Surgery/Invasive Procedures trial and 12 hours for Acute Major Bleeding trial. Administer vitamin K concurrently to patients receiving Kcentra. Vitamin K is administered to maintain vitamin K-dependent clotting factor levels once the effects of Kcentra have diminished.

Important Safety Information Kcentra is a blood coagulation factor replacement indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Kcentra is for intravenous use only.

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events.

Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events.

Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months.

Please see additional Important Safety Information and the brief summary of full prescribing information on adjacent page.

Kcentra is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC. Kcentra® is a registered trademark of CSL Behring GmbH. Biotherapies for Life® is a registered trademark of CSL Behring LLC. ©2020 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA www.CSLBehring.com www.Kcentra.com KCT-0320-AUG20