OR Management Digital Edition - September 2021

Management News The Independent Source of News for Operating Room Managers, Supply Chain Professionals & C Suite Volume 16 • September 2021

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A Bright Future for Surgery Using New Technology to Improve Outcomes

Rafael J. Grossmann, MD, a surgical educator, wearing MagicLeap XR Smart Glass.

Preventing SSIs in General Surgery Benefits, Costs of Robotic Hernia Repair Weighed AI: Current Realities, Future Possibilities Brought to you by the publisher of

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TABLE OF CONTENTS

BULLETIN BOARD

4 Timing of Operations for COVID-19 Patients Associated With Mortality 6 AI: Current Realities, Future Possibilities 8 Updated Skin Antisepsis Guidelines Aim to Reduce Surgical Site Infections 10 OR Greening Call to Action: Climate Change, Health and Surgery

Trending Articles Online Read the most-viewed articles last month on ormanagement.net.

1. Ergonomic Injuries in Surgery: A Quiet but Pervasive Problem 2. Study Highlights 10-Year Trends in Incisional Hernia Repair 3. Top 10 Errors Related to COVID-19 Vaccination 4. Roux-en-Y or One-Anastomosis Gastric Bypass: Which Is the Better Bariatric Treatment?

Web Exclusive: Read at ormanagement.net

14 Using New Technology to Improve Surgical Outcomes

The History of Robotic-Assisted Surgery

18 Preventing SSIs in General Surgery

By Edward L. Felix, MD

20 Tips on Being an Expert Witness 21 Fall 2021 Buyer’s Guide 22 Benefits, Costs of Robotic Diaphragmatic Hernia Repair Weighed

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OR Management News • Volume 16 • September 2021

3

CLIN IC A L NE WS

Timing of Operations for COVID-19 Patients Associated With Mortality

By MICHAEL VLESSIDES

O

ne of the most ambitious international research efforts ever undertaken has concluded that when it comes to the safety of surgery following SARSCoV-2 infection, timing matters.

A prospective cohort study of more than 15,000 collaborators (Anaesthesia 2021 Mar 9. doi.org/ 10.1111/ anae.15458) concluded that patients who underwent surgery within six weeks of their COVID19 diagnosis had a greater risk for death than their counterparts whose surgery was performed at least seven weeks later.

“At the time the pandemic was first starting, we performed a cohort study to examine what happens in patients with perioperative COVID-19,” said Dmitri Nepogodiev, MB ChB, the public health registrar at the University of Birmingham, in England (Lancet 2020;396[10243]:2738). “We found a very high mortality rate in patients who developed COVID around the time of surgery—about 24%.

“I think that that paper probably changed practice around the world, where physicians were less willing to operate on COVID-positive patients,” he added.

“But as the pandemic went on, it became apparent that there would be an increasing number of people who had been positive for COVID, and we can’t put off operating on them forever. So the question became: What is the right timing to wait before operating on these people?”

To find the answer, institutions in 116 countries enrolled consecutive patients into the trial, all of whom were undergoing elective

or emergency surgery for any indication. All surgeries took place in October 2020.

Patients were classified as having preoperative SARS-CoV-2 infection based on several internationally recognized criteria. The investigators also collected data on the presence or absence of SARSCoV-2 symptoms and whether the symptoms had resolved by the time of surgery.

The time from diagnosis of SARS-CoV-2 infection to the day of surgery was categorized as up to two weeks, three to four weeks, five to six weeks, or seven or more weeks. The study’s primary outcome was 30-day postoperative mortality.

“We obviously knew we were going to need a large number of patients, because the rate of perioperative SARS-CoV-2 infection was going to be relatively low,” Mr. Nepogodiev said. “So, we worked really hard to engage as many surgeons and anesthesiologists around the world as possible.”

In total, 140,231 patients were included from 1,674 hospitals. Of these, 3,127 (2.2%) had a preoperative SARS-CoV-2 diagnosis. The time from SARS-CoV-2 diagnosis to surgery was up to two weeks in 1,138 patients (36.4%), three to four weeks in 461 patients (14.7%), five to six weeks in 326 patients (10.4%), and seven weeks or more in 1,202 patients (38.4%).

Most patients were asymptomatic at the time of their surgery.

Proximity to Diagnosis Negatively Affects Mortality The overall 30-day postoperative mor-tality rate was found to be 1.5% (2,151/140,231). Among patients with

SARS-CoV-2, however, those whose surgery was closer to their infection diagnosis fared much worse than those with delayed surgery. The 30-day postoperative mortality rate was 9.1% (104/1,138) in patients whose surgery was within two weeks of their diagnosis, 6.9% (32/461) at three to four weeks, 5.5% (18/326) at five to six weeks, and 2.0% (24/1,202) at seven weeks or more. In contrast, 30-day mortality in patients who did not have a diagnosis of preoperative SARS-CoV-2 infection was 1.4% (1,973/137,104).

Logistic regression models were used to calculate adjusted 30-day mortality rates, which proved largely consistent with unadjusted models.

“Obviously, you would expect some selection bias of patients,” Mr. Nepogodiev said. “The ones that are operated on closer to the time of their COVID diagnosis are probably sicker and can’t be delayed. But even when you adjust the data, it seems to be robust that patients benefit from waiting seven weeks.”

These findings, he added, were consistent across a variety of subgroups, including age, severity of patient’s condition, urgency of surgery and grade of surgery.

When the researchers restricted their analyses to patients who had experienced preoperative SARS-CoV-2 infection, those with ongoing COVID-19 symptoms had a higher adjusted 30-day mortality rate than their counterparts whose symptoms had resolved or those who had been asymptomatic. Moreover, after a delay of at least seven weeks following continued on page 12

‘It became apparent that there would be an increasing number of people who had been positive for COVID, and we can’t put off operating on them forever. So … what is the right timing to wait before operating on [these] people?’

—Dmitri Nepogodiev, MB ChB 4

OR Management News • Volume 16 • September 2021

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TEC HN O LO GY

AI: Current Realities, Future Possibilities

By VICTORIA STERN

I

n 2012, a patient arrived at Stanford University Medical Center with a large wound on his foot. The man had been walking on it for a month before coming in for care.

Elsie Gyang Ross, MD, an assistant professor of surgery and medicine at Stanford University School of Medicine, in California, quickly recognized the patient had a circulatory condition known as peripheral artery disease (PAD), in which vessels narrow and restrict or block blood flow to the limbs. The condition affects an estimated 8 million to 12 million Americans but often goes undiagnosed. If left untreated, PAD can increase the risk for stroke and myocardial infarction or, in this case, lead to a wound that doesn’t heal.

Dr. Ross’ patient had wet gangrene of the foot. Despite an antibiotic regimen, debridement and revascularization, he ultimately required a below-knee amputation.

“But a lot can be done to treat patients before we need to consider surgery, such as amputation or lower extremity angiography,” Dr. Ross told OR Management News.

In particular, Dr. Ross said, what if clinicians could use artificial intelligence to diagnose patients sooner or predict who would develop PAD so patients can begin treatment earlier and avoid surgery?

In 2014, Dr. Ross, along with her colleagues at the Stanford Center for Biomedical Informatics Research, began evaluating machine learning algorithms to identify patients at risk for PAD. Machine learning algorithms—mathematical tools that help make sense of data—learn from experience. In other words, when more data are fed into the algorithm, the diagnosis or prediction becomes more accurate.

A 2016 analysis described the process of constructing machine learning models using data from 1,755 patients who had undergone elective coronary angiography but whose PAD status was unknown. Dr. Ross and her team found that the machine learning algorithms could recognize PAD and predict mortality better than standard

6

AI in the Surgery World The presenters discussed a range of other promising AI tools that support surgical decision making and automation of care.

Here are a few highlights.

Diagnosis Radiology: Aidoc developed a suite of AI-based software that can flag abnormalities on CT scans, including pulmonary embolism, intracranial hemorrhage and large-vessel occlusion.

Pathology: PathAI is developing machine learning models to help pathologists diagnose a range of conditions from liver and breast biopsies, and predict disease progression as well as the best treatment options.

Decision Making Surgical site infection prediction: DASH Analytics developed a machine learning platform to predict a patient’s risk for SSIs. A threeyear study found that the algorithm reduced SSIs by almost 75% in a subset of general and colorectal surgery patients at University of Iowa Hospitals and Clinic.

Automation Robot-assisted surgery: The medical device company Microsure designed MUSA, the first surgical robot for open microsurgery, which received certification for clinical use in Europe in 2019. The robot stabilizes a surgeon’s movements to enable more precision during lymphatic surgery to connect vessels with diameters between 0.3 and 0.8 mm, as well as during hand and free flap surgery (Nature Comm 2020;11[757]).

OR Management News • Volume 16 • September 2021

linear regression models (J Vasc Surg 2016;64[5]:1515-1522.e3). A 2019 study that included 7,686 patients with PAD and incorporated almost 1,000 variables from electronic health records reported that the machine learning models could accurately forecast which PAD patients would develop major cardiac and cerebrovascular events (Circ Cardiovasc Qual Outcomes 2019;12[3]:e004741).

The goal of these models and others, Dr. Ross explained, is not for machine learning or its operationalized counterpart, AI, to take over care or make decisions for surgeons. “AI is there to make us better,” she said. “It should run quietly in the background, catching our blind spots and helping us make more informed decisions about patient care.”

Developing and validating AI and machine learning models take time and an enormous amount of data before they can be integrated into clinical practice.

However, interest in AI technology has ballooned in the past few years, with approvals by the FDA increasing from just two at the end of 2017 to more than 80 by September 2020.

At the 2020 American College of Surgeons Clinical Congress, Dr. Ross, along with Genevieve B. Melton-Meaux, MD, PhD, FACS, and Rachael A. Callcut, MD, FACS, explored the latest advances in surgical AI, highlighting tools that can improve diagnosis, decision making and outcomes in surgery (abstract PS424).

In addition to diagnosing and prioritizing more urgent cases, AI-based tools can help predict outcomes or improve surgeons’ performance in the OR. During her talk, Dr. Ross discussed an imaging platform that guides surgeons during endovascular aneurysm repair. The intraoperative image-based, 3D fusion CT automates conversion of preoperative scans into 3D models and, in the OR, overlays these images onto the patient’s live fluoroscopy to highlight the renal arteries for position of the guidewire. continued on page 8

Adjust Your Perspectice Using the da Vinci Firefly Imaging System The da Vinci Xi® and da Vinci X™ surgical systems with integrated fluorescence imaging capability provide you with real-time endoscopic visible and near-infrared fluorescence imaging.

This fluorescence imaging capability provides you with the opportunity for visual assessment of at least one of the major extra-hepatic bile ducts, as well as the cystic artery during cholecystectomy procedures performed using the da Vinci® system. It can also be used to assess vessels, blood flow, and related tissue perfusion during cases across your da Vinci Total Practice* when indicated.

White Light Imaging Firefly imaging is not visible in white light imaging mode.

Standard Firefly Mode In Standard mode, the image is displayed as a fluorescent green overlay on a black and white background view. The closer the endoscope is to the tissue, the stronger (more intense green) the signal appears.

Sensitive Firefly Mode In Sensitive mode, the system attempts to automatically adjust the signal intensity and brightness to be consistent, whether the endoscope is moved closer or farther away from the tissue.

Note: Sensitive Firefly mode is only available with Endoscope Plus.

Scan to learn more about the evolution of surgery

Images above show porcine pelvic vasculature using the da Vinci Xi Endoscope Plus. * Total da Vinci Practice refers to the transferable value of da Vinci surgery across procedures in surgeon’s minimally invasive surgery (MIS) practice. It is at the surgeon’s discretion to determine when a patient is a candidate for MIS surgery and whether da Vinci surgery is an option.

Firefly Fluorescence Imaging The da Vinci fluorescence imaging vision system (Firefly® fluorescence imaging) is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci fluorescence Imaging vision system enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow, and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.

recommended. Anaphylactic deaths have been reported following ICG injection during cardiac catheterization.

Total ICG dosage should not exceed 2 mg/kg per patient.

Anaphylactic or urticarial reactions have been reported in patients with or without histories of allergy to iodides.

Fluorescence imaging of biliary ducts with the da Vinci fluorescence imaging vision system is intended for adjunctive use only, in conjunction with standard of care white light and when indicated, with intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Da Vinci Xi/X system precaution statement The demonstration of safety and effectiveness for the specific procedure(s) discussed in this material was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.

Intuitive’s ICG packs are available for sale in the U.S. ONLY. Intuitive’s ICG packs are cleared for commercial distribution in the U.S. for use in combination with the fluorescence-capable da Vinci HD vision system and Firefly integrated hardware.

Intuitive-distributed ICG contains necessary directions for use of ICG with Firefly fluorescence imaging. Using generic ICG with Firefly fluorescence imaging is considered off-label and is not

Important safety information For Important Safety Information, indications for use, risks, full cautions and warnings, please refer to www.intuitive.com/safety.

© 2021 Intuitive Surgical, Inc. All rights reserved. Product and brand names/logos are trademarks or registered trademarks of Intuitive Surgical or their respective owner.

See www.intuitive.com/trademarks.

1089596-US RevA 09/2021

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INF ECTIO N CO NTRO L

Updated Skin Antisepsis Guidelines Aim to Reduce Surgical Site Infections

By BOB KRONEMYER

S

ince its introduction in the 19th century, skin antisepsis has helped to reduce the incidence of health care–associated infections.

Updated guidelines from the Association of periOperative Registered Nurses (AORN) now offer new evidence to help interdisciplinary teams make decisions and standardize preoperative skin antisepsis protocols.

“Standardization eliminates variability, resulting in less waste, fewer errors and improved quality outcome,” said lead author Karen deKay, MSN, RN, CNOR, CIC, a perioperative practice specialist at AORN, in Denver. “Skin antisepsis is a broad term that includes several interventions to reduce the microbial load on the patient’s skin and inhibit rapid rebound growth of microorganisms from the skin where the incision will be made.”

Skin antisepsis is important because the removal of soil and transient microorganisms, as well as the reduction of resident microorganisms, minimize the number of bacteria on the skin near the surgical site, according to Ms. deKay. “The intervention most perioperative personnel are familiar with is surgical site preparation. When an incision is made, it compromises our body’s coat of armor and increases the likelihood of introducing microorganisms internally,” she said.

“Hence, reducing the number of microorganisms near the incision site decreases the chance of skin microorganisms entering the surgical site through the incision, thereby decreasing the chance for a surgical site infection [SSI].”

Clinical practice guidethe risk of death, hospitallines for SSI prevenization, prolonged recovtion from various health ery and even long-term agencies and professional complications. By reducing societies recommend decolcomplications, the guideonization, alcohol-based skin line promotes patient safety.” antiseptics and bundles to Dr. Camins said the curdecrease the incidence of SSIs. rent and previous versions “Most clinicians are of the AORN guidelines Skin antisepsis is aware of the benefit of “provide clinicians the important because decolonization in reductools necessary to reduce ing SSIs,” Ms. deKay said. the bioburden found on the the removal of “However, they may not be skin to avoid contaminasoil and transient aware that decolonization is tion of the surgical wound. microorganisms, not indicated for all surgical Skin antisepsis is one of the patients and that commumost important measures as well as the nity, hospital and proceto prevent infections durreduction of resident ing surgery.” dure risk factors need to be microorganisms, evaluated by an interdisciFollowing the recomplinary team to determine minimize the number mendations of the guidewhich surgical population lines and the manufacturer’s of bacteria on the skin instructions for using antiwould benefit the most near the surgical site. septic solution carefully from decolonization.”

Likewise, clinicians are “will result in a lower risk mindful of the need to decolonize for colo- for the development of SSIs,” he said. nization by methicillin-resistant StaphyloHowever, one potential obstacle in coccus aureus (MRSA). “However, they may implementing the guidelines is the time not be cognizant of the need to also decol- and resources required to form an interonize for methicillin-susceptible Staphylo- disciplinary team or using a facility’s curcoccus aureus colonization,” Ms. deKay said. rent SSI prevention task force “to take a “Patients with both methicillin-susceptible closer look at how preoperative patient and methicillin-resistant S. aureus in their skin antisepsis elements can contribnares or on their skin are more likely to ute to a reduction in the facility’s SSIs,” develop Staphylococcus aureus SSIs.” Ms. deKay said. If these elements are Bernard Camins, MD, the medical already part of a facility’s SSI bundle, director of infection prevention for the “you need to provide the resources necMount Sinai Health System, in New York essary to establish a process that will City, and a member of the AORN Guide- closely monitor adherence to these praclines Advisory Board, noted the guidelines tices, as regular observation of processwill decrease the risk for developing infec- es can identify inconsistencies and areas ■ tions after surgery, “therefore decreasing for improvement.”

Artificial Intelligence continued from page 6

“It is clear that health care is digitizing rapidly and that AI will permeate it increasingly and in profound ways,” Dr. MeltonMeaux, a professor of surgery and Core Faculty of the Institute for Health Informatics at the University of Minnesota, in 8

OR Management News • Volume 16 • September 2021

Minneapolis, said during her ACS talk.

Despite these trends, Dr. Callcut cautioned that “we’re still in the hype cycle of AI—a lot of excitement, but the applications have not been scaled yet.”

Dr. Ross agreed, highlighting other limitations and challenges of AI. “AI is also not going to do robotic surgeries for us. That vision of AI is far off, especially given the technology we have now.” ■

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PE RSPEC TI VE

OR Greening: Climate Change, Health and Surgery An Urgent Call to Action

By AMY COLLINS, MD; AMANDA DILGER, MD; NEELU TUMMALA, MD; JULIE MOYLE, MSN, RN; and KAELEIGH SHEEHAN

Asthma, cardiovascular disease

NG URES ISI RAT E

Environmental

Forced migration, Degradation civil conflict, mental health impacts

G SIN S EAEVEL L

TEM R P

Extreme Heat

Water and Food Supply Impacts

Malnutrition, diarrheal disease

MO R WE E

Malaria, dengue, encephalitis, hantavirus, Rift Valley fever, Lyme disease, Changes chikungunya, in Vector West Nile virus Ecology

Increasing Allergens

Respiratory allergies, asthma

Water Quality Impacts

Cholera, cryptosporidiosis, campylobacter, leptospirosis, harmful algal blooms

Climate-Smart Surgery: Financial, Social and Environmental Benefits Relative to their physical footprint, ORs make an outsized contribution to a hospital’s climate footprint. Surgery in the United States is very energy-, resource- and waste-intensive, requiring sterilization processes, lighting, cooling and ventilation. ORs consume three to six times more energy per square foot than anywhere else in the facility and generate 30% of a hospital’s overall waste, including two-thirds of its regulated medical waste.10,11 The surgical supply chain is large and expensive, responsible for 40% to 60% of a hospital’s supply chain costs, with recent studies finding that 71% to 82% of health care emissions are derived from the supply chain.2,3 In addition, volatile anesthetic gases, particularly desflurane and nitrous oxide, are potent greenhouse gases that can be responsible for 51% of an OR’s emissions at an average U.S. hospital.10 While surgery’s immense environmental footprint is often considered necessary to provide high-quality care, studies have shown the impact can be reduced without compromising patient safety continued on page 12

Figure Source: bit.ly/3tqiZqS

Air Pollution

Severe Weather

Heat-related illness and death, cardiovascular failure

2

OR Management News • Volume 16 • September 2021

Injuries, fatalities, mental health impacts

SEA R

10

Impact of Climate Change on Human Health

EME TR EX THER A

Extreme Weather and Surgical Care Extreme weather events, from droughts to severe storms are increasing in frequency and severity. In 2020, the United States experienced a total cost of $22 billion in weather and climate disasters (22 separate billion-dollar events), including the historic wildfires along the West Coast, setting a new annual record.3 Overall, these events resulted in the deaths of 262 people and cost the nation a combined $95 billion in damages, according to the Office for Coastal Management. Such disasters can lead to morbidity and mortality from injuries and illness, and adversely affect the health of surgical patients and the ability to provide safe operative care.

Extreme weather can affect surgical care in other ways. In October 2012, Superstorm Sandy caused a 14-foot storm surge in New York City resulting in power loss, flooding and the forced evacuation of 322 patients at NYU Langone Health.4 Afterward, due to the infrastructure damage, surgery was suspended for two months, and hundreds of providers sought privileges at other hospitals. Temporary closure of other New York City hospitals and relocation of patients caused delays in scheduled surgeries.5 During the extreme cold weather in parts of Texas in February 2021, hospitals canceled urgent and nonurgent surgeries due to heat and water issues related to the unexpected conditions.6 Health care leaders can protect against disruptions to health delivery and improve the organization’s financial viability by preparing their facilities for such weather-related events, and building climate-smart, resilient hospitals.4 Weather events also may disrupt health care supply chains, which can affect surgical care. Puerto Rico is home to major pharmaceutical, medical device and supply manufacturing plants.

After Hurricane Maria devastated the island in 2017, U.S. hospitals faced a shortage of normal saline IV bags, pharmaceuticals and surgical devices including hernia mesh, Medtronic surgical staplers, scalpels, Stryker orthopedic instruments and products used in cataract surgery.7 The pandemic raised awareness of the vulnerabilities8 in the

health care supply chain and the sector’s dependence on singleuse disposable supplies and equipment. Facilities already building resilience into their operations were better positioned to face the challenges of supply shortages experienced during the pandemic.

For example, facilities that were already utilizing washable isolation gowns were able to reuse them 75 to 100 times, rather than endure the 2,000% increase in cost during peak demand for single-use disposable isolation gowns.9 Lessons learned from the pandemic and extreme weather events can help advance supply chain resiliency.

IN CO CR

y now, many hospitals and patients have experienced the impact of a changing climate: temperature and precipitation extremes, wildfires, hurricanes, flooding and changing disease vectors—many of which have disrupted surgery schedules and adversely affect patient and community health. The ironic reality is that health care, the only U.S. economic sector with an ethical mission to do no harm, is contributing to the problem and responsible for 8.5% of all U.S. greenhouse gas emissions and the loss of 388,000 disability-adjusted life-years in 2018.1 Recognizing this, health professionals are increasingly taking action to promote climate solutions, including climate-smart health care, which is essential to protect public health and our future.2

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to protecting the environment. A 2021 Deloitte study among millennial and Gencontinued from page 10 eration Z participants found the pandem$2,593 $121 or quality.12 Recognizing the opportuic had reinforced their desire to drive Hospitals that pursue nity to reduce the climate impact of positive change in their communithese programs could see FLUID MEDICAL annual savings of surgical services and costs, many hosties and the world, and preferred to MANAGEMENT DEVICE SYSTEM REPROCESSING pitals are taking action and “greening stay with their employers longer than $20,060 per $3,389 $6,206 operating room the OR.” Practice Greenhealth reports five years when those companies priin its 2020 Sustainability Benchmark oritized people and environmental susReport that hospitals that implementtainability over profits.22 REUSABLE OR KIT STERILIZATION REFORMULATION ed best practices resulted in a conservative CONTAINERS $1,098 Conclusion REUSABLE median annual savings of $20,060 per OR, $1,742 MEDICAL and a median regulated medical waste stream A successful program for greening the PRODUCTS $2,411 that is 60% of total facility waste.11,13 OR requires action from all members of the Scope 3 emissions from the supply chain are the single surgical team. Because they are among the most trusted largest source of greenhouse gases in health care.14 Clinicians and respected professionals, physicians and nurses have many are concerned about the footprint of the OR, with surveys find- opportunities to leverage their reputation, influence and health ing the majority of surgeons and nurses believe that OR waste is expertise to advance climate solutions in the OR, across their excessive and more supplies should be reused.15,16 Surgeon, anes- organizations, and with their patients and communities.23 Leadthesia and nurse leaders have an opportunity to reduce these ership by example is what is needed to avert the worst climate emissions by making known their preference for and choosing and health impacts on future generations, and health professionenvironmentally preferred products and practices, for example: als in the OR have the opportunity to lead the way.

• selecting reusable or reprocessable rather than single-use In the next article of the climate-smart surgery series, we will disposable products, supplies and equipment9,17; outline the business case for specific environmental best practic• reviewing OR kits and preference cards to eliminate es in the OR, and provide examples of perioperative professionunnecessary items18; als driving change.

■ • considering anesthetic agent selection19; References can be viewed online at ormanagement.net.

• reevaluating surgical approaches, tests, interventions and 20 medications ; and Dr. Collins is an emergency medicine physician and a senior clinical advisor • considering telehealth for pre-op and follow-up visits.

In addition to the increased efficiency, financial savings and for physician engagement at Health Care Without Harm, in Boston. Dr. waste reduction from climate-smart programs, environmental Dilger is a facial plastic and reconstructive surgeon at Massachusetts Eye and Ear Infirmary, in Harwich, and an instructor of otolaryngology-head stewardship offers a competitive advantage with regard to public and neck surgery at Harvard Medical School, in Boston. Dr. Tummala image, as well as patient and employee satisfaction. Health care is an ENT physician and a clinical assistant professor of surgery at the providers understand the serious health threats posed by climate George Washington University School of Medicine and Health Sciences, in change and feel a responsibility to advocate for strategies that Washington, D.C. Ms. Moyle is an OR nurse and a sustainability strategy reduce greenhouse gas emissions.21 Corporate social responsibil- manager at Practice Greenhealth. Ms. Sheehan is the manager of Practice ity is a key recruitment and retention strategy for younger health Greenhealth’s “Greening the OR” initiative and a sustainability strategy professionals who want to work for organizations committed manager.

COVID-19 Timing continued from page 4

SARS-CoV-2 infection, patients with ongoing symptoms were still found to have a higher mortality rate (6.0%) than their counterparts whose symptoms had resolved (2.4%) or who had been asymptomatic (1.3%).

“So the advice is you should probably wait seven weeks if you can, but if you still have symptoms at seven weeks, you might want to wait longer until the symptoms resolve,” Mr. Nepogodiev explained.

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David J. Wlody, MD, noted that the research has been the subject of considerable discussion among him and his colleagues. “The decision to operate will obviously depend upon the clinical setting,” said Dr. Wlody, a professor and the chair of anesthesiology at SUNY Downstate College of Medicine, in Brooklyn, N.Y. “For example, there are certain nominally elective surgical procedures that must be performed in a timely fashion, such as resection of aggressive neoplasms, vascular surgery for ongoing ischemia due to peripheral vascular disease, and worsening angina.”

OR Management News • Volume 16 • September 2021

As Dr. Wlody discussed, one potential area of concern regarding surgery in COVID-19 patients is whether those who are asymptomatic and appear to be recovered may nonetheless have undetected residual pathology that would be revealed under positive pressure ventilation during general anesthesia. “So, we believe an open question is if any tests are indicated in asymptomatic, recovered patients, such as pulmonary function tests or echocardiograms to detect impairment of RV [right ventricular] function due to pulmonary vascular damage,” he said.

“The need for such testing should be considered ■ in the context of the extent of the surgery.”

Figure Source: Practice Greenhealth.

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TECHN O LO GY

Using New Technology to Improve Surgical Outcomes Here we feature Rafael J. Grossmann, MD, a surgeon and educator in Bangor, Maine, who performed the first-ever live surgery using Google Glass, in June 2013. This piece has been adapted from The Surgeons’ Lounge, a regular column in General Surgery News (column editor: Samuel Szomstein, MD, Cleveland Clinic Florida, Weston).

Questions from Isabel Elssner, a senior pre-med student at the University of North Carolina at Chapel Hill How have you been using technology to improve your surgical outcomes?

There is plenty of evidence that surgical outcomes have improved significantly over the past several decades. We have to infer that the smart use of technology played a key role—from the use of anesthesia, analgesia and antisepsis, to minimally invasive, endoscopic and robotic surgery.

Today’s technology is advancing in a somewhat exponential way. I think that today’s challenge is how to use these technologies to improve education and diagnostics, and to achieve equity in global access to ethical, safe and compassionate care. I think that the current socioeconomic, political and environmental landscape is creating a “perfect storm” situation that will exacerbate an already stressed health care ecosystem. If we look at how the demand for health care services is increasing versus the rapidly decreasing availability, and especially access to safe and affordable health care services, we are confronting a grave problem.

• augmented reality (AR), in which the user experiences digital content superimposed on the real world, viewed through a mobile device or a head-mounted display—think of “Pokémon Go” or the NFL’s magic “first down” yellow line; and • mixed reality (MR), in which the digital content interacts with and responds to the physical world as if it were part of the real surroundings.

Figure 1. Google Glass.

How can technology help provide better access to surgical care?

Technology can help. I would argue that the smarter use of technology can paradoxically create a more empathetic and humane health care system. The proper use of these tools can get us closer to our patients, and, in some way, rescue the rapidly fading doctor–patient relationship.

One of the technologies that can enhance education, teaching and learning is immersive media. I’ve been involved in this field for close to a decade, sharing clinical expertise and futuristic insights to help shape its evolution.

Immersive technologies refer to platforms (Figures 1-3), such as: • virtual reality (VR), in which the user is immersed in a digital, computer-generated environment or a 360-degree video, completely isolated from the surrounding real world—think of gaming in an Oculus Quest device; 14

OR Management News • Volume 16 • September 2021

How have you been using technology to improve surgical education?

In the field of surgical education, there are several platforms that use VR as a way to train the next generation of surgeons.

Platforms such as FundamentalSurgery, PrecisionOS, OssoVR and OramaVR are shaping the future of surgery learning.

Simulation in VR to learn and practice the different steps of a surgical procedure is not new. What is exciting and innovative is the use of haptic feedback to make that experience uniquely real. That’s what FundamentalSurgery has developed: the possibility of immersing yourself in the actual surgery and providing a safe, repeatable environment to learn. The offer of repetition and damage-free failures through simulation is a key benefit for continued on page 16

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New Technology continued from page 14

learning and shows huge value in technology for surgical education. It is only with the addition of haptics and sophisticated high-fidelity simulation techniques, however, that you can truly understand the benefits of precise learning.

Precise learning is a combination of tracked data points to test a user’s submillimetric accuracy alongside the user’s interactions with the different tissue textures, all within a surgical environment. When combining the repetition with not just procedural steps but also individual complex steps, muscle memory is built, and skills transfer through “feeling” the virtual body, which is a huge step up from some of the current VR simulation platforms.

With this highly intuitive system, the platform allows surgeons to experience the same sights, sounds and accurate physical sensations of the human anatomy, enabling them to hone and rehearse skills in a safe and measurable environment, dovetailing perfectly with the cadaveric and assisted/observational learning in the OR, without putting patients at risk. The haptic interactions data also create a personal dashboard to highlight weaker and stronger areas within each step of the procedure.

Another example of using technology in education involves the live streaming of a surgical procedure. The design of some of the current headsets allows the audience to have a “preferred seat” in the surgical theater.

In June 2013, I performed the first-ever live operation using Google Glass. All I did was to securely livestream that surgery to facilitate the experience of the medical students—showing them my perspective, my focal point during an operation and enabling them to participate in a “virtual,” synchronous fashion, asking and answering questions as if they were physically present. I decided to use that new technology to enhance their educational experience.

Obviously, this is not a substitute for being in the OR, but just an alternative, a complement to their surgical education, especially in times when the OR might be too crowded, or when, as in the current pandemic, one cannot be physically present.

Another example is the case of telehealth. According to a report, it is estimated that approximately 5 billion people do not have access to safe or affordable surgery (Lancet Glob Health 2015;3[6]:e31-e323). This is an unacceptable reality and a problem that can be mitigated by the use of these tools.

The COVID-19 global crisis has shown us the benefits of remote communications and connectivity in every aspect of human endeavor. Health care was no exception, and despite detractors and obstacles, it has made a tremendous difference. The way I see it, telehealth represents another tool to connect with patients and colleagues, just like email, phones, paper and even fax machines. It is a complement, not a substitution, to the physical interaction.

We are seeing more frequent reports of how head-mounted display (or HMD) like Vuzix, Realwear, Microsoft Hololens and others have been used to breach geographical and educational barriers, to enable remote surgical assistance (https://journals. sagepub.com/doi/full/10.1177/1553350619871787).

In the field of AR, the ability to perform teleconsultations 16

OR Management News • Volume 16 • September 2021

Left: Figure 2. In the OR with MagicLeap XR Smart Glass. Right: Figure 3. Varjo 2, the most advanced virtual reality headset. with a platform like Proximie, which uses “telestration” to bring the “hand,” skill and knowledge of an expert surgeon to guide a remote colleague, represents a clear example of the smart use of technology to augment surgical care and provide more equitable and inclusive access to global health (bit.ly/3yPthly).

In the space of surgical navigation, platforms like MagicLeap and BrainLab have partnered to enable a “mixed reality viewer,” which allows the visualization of holographic, 3D imaging to facilitate and enhance the performance of a surgical procedure. The images are literally “released from the confines of flat screens and taken into your world.” A surgeon in the OR, wearing a MagicLeap headset powered with the BrainLab software, can have access to the patient’s diagnostic imaging in an unlimited number of axes, making the viewing much more intuitive and ergonomic (bit.ly/38KoqY8).

Another interesting field in which technology enhances learning is serious games for health. A platform like Level Ex brings the power and fun of gaming to empower medical learning. It creates video games for doctors that capture the challenges in practicing medicine. It has tapped the convergence of medicine and entertainment, bridging the gaps in the health care industry through state-of-the-art video game technology and design.

Are there any negative aspects to using new technologies in medicine?

There are certainly risks in the use of technology. Its improper use could make interactions impersonal, less empathetic and less emotional, more mechanical. There is a potential risk for violation of patients’ private health information. There are also legal, regulatory and cost barriers that must be addressed. These issues are real, but they should not be deterrents to the exploration of these tools to improve the way we practice and teach medicine.

These issues are solvable as long as the developers, regulators and users take them into account. The problem is not the technology, ■ but the use we make of it.

Read Dr. Grossmann’s blog at www.RafaelGrossmann.Health.

Dr. Grossmann is a medical advisor to FundamentalVR, Level Ex and MagicLeap.

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INF ECTIO N CO NTRO L

Preventing SSIs in General Surgery What the Data Show: An Expert’s Take

By MONICA J. SMITH

D

espite decades upon decades of progress in surgery, surgical site infections are still extremely common, accounting for one-fifth of all nosocomial infections.

The impact on patients ranges from trivial to deadly. The associated costs, such as increased hospital length of stay, readmissions and admission to ICUs, can be staggering—from $1,500 to $5,000 per day per SSI in the United States.

Over generations, guidelines for SSI prevention have evolved as new methods are proposed, put to the test, and ultimately accepted or discarded. For now, these are the interventions known to be most beneficial in general surgery in the preoperative, perioperative and postoperative settings, with comments

by Philip S. Barie, MD, MBA, a professor of surgery and public health in medicine at Weill Cornell Medicine, in New York City, and the executive director of the Surgical Infection Society Foundation for Education and Research.

Preoperative Glycemic control. Glycemic control is not limited to patients with diabetes. Hyperglycemia is associated with an increased risk for an SSI; aim for a preoperative blood glucose level of 110 to 150 mg/dL. “It’s well established that hyperglycemia impairs neutrophil function and wound healing. In patients with diabetes, the risk of infection increases because the neutrophils’ ability to respond to infection is impaired, both in terms of chemotaxis and phagocytosis. Glycemic control is important not just in the preoperative period, but throughout the perioperative and postoperative periods as well.”

Smoking cessation. Current smoking is the highest risk factor for an SSI; counsel patients to refrain from smoking at least four to six weeks before their procedure. Although there is no literature regarding marijuana and e-cigarette use, their discontinuation also is recommended.

“The reason smoking is a risk factor is not just tissue hypoxia, but because nicotine is a vasoconstrictor; it impairs wound healing and also inhibits delivery of antibiotics to the wound. A lot of people won’t be able to stop completely, but if you can get them to cut down even a little bit, it helps.”

Chlorhexidine bath or shower. Antiseptic bathing has been shown to reduce bacterial colonization of the skin for up to 24 hours. Although this has not been proven to reduce SSIs, it may still play a role.

“This is primarily a matter of personal hygiene and accountability; if you’re scheduled for surgery in the morning, you shouldn’t be taking out the garbage before you come to the hospital.”

Perioperative Antibiotic prophylaxis. The role of prophylactic antibiotics 18

OR Management News • Volume 16 • September 2021

is somewhat controversial, and indications vary by procedure. The mostt he recent guidelines of the urAmerican College of Surng geons recommend using nly prophylactic antibiotics only nwhen indicated and disconcitinuing at the time of incision closure. ‘b i ’ the h Surgical S i l Care C “To achieve maximal ‘buy-in,’ Improvement Project guidelines said to administer prophylactic antibiotics immediately prior to the procedure and for no longer than 24 hours afterward (48 hours for cardiac surgery). However, the data show clear that a single dose is effective. It’s far more important to re-dose intraoperatively than postoperatively, especially with short half-life agents such as cefazolin or cefoxitin, if the case is long or if there is a high volume of blood loss.”

Wound protectors. Once controversial, the use of wound protectors is generally supported, particularly in open abdominal surgery and elective biliary tract and colorectal procedures.

“The data aren’t that strong, but surgeons have understood for years that if you minimize contact with wound edges, you’re less likely to inoculate bacteria into the wound.”

Antiseptic sutures. Strong evidence suggests that triclosan-coated antiseptic sutures are superior to standard sutures for decreasing the risk for SSIs, and they are recommended for fascial and subcutaneous closure of clean and clean-contaminated cases.

“The main foil for antiseptic sutures is that they cost 10% more than standard sutures, and some hospitals balk at that. But you can buy an awful lot of triclosan-coated sutures for the cost savings of a single infection, which can run to thousands of dollars.”

Postoperative Negative wound pressure. “This is so new it may not even appear in the guidelines yet. But the use of a wound vacuumassisted closure device [Prevena, 3M Corp.] on closed wounds draws out the fluid that accumulates in wounds and appears to reduce the risk of SSI.” Drain management. Use drains only when necessary and discontinue them as soon as possible. “After 24 hours, drains become a two-way street, just as likely to introduce bacteria as to evacuate them.”

Do not continue prophylactic antibiotics, cover indwelling tubes and drains with antibiotics, or perform antibiotic wound irrigation. “Surgeons learn to do the latter in residency and don’t want to let it go, but it remains unproved.”

■ Sources can be viewed online at ormanagement.net. The online version covers other interventions for SSIs, some promising, some unproven.

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FE ATUR E

Tips on Being An Expert Witness

By MONICA J. SMITH

W

hen medical issues turn into legal ones, attorneys often call on medical professionals—doctors, nurses and operating room managers—to inform the case and help make decisions on how to proceed. Serving as an expert witness has its perks, but there’s a lot to consider before taking on this responsibility.

At the 2020 OR Manager conference, Rosemary Welde, MBA, BCC, RN, drew on her 30 years’ experience as an expert witness to thoroughly explore the role.

“Either you’re already doing expert witness work and building clients, or you’ve taken a course and gotten certified. Somehow or another, an attorney got your number and contacted you. What do you need to do?” Ms. Welde said.

What Does It Take to Be One, And Why Would You Want to?

The function of an expert witness is to draw from their own expertise in order to express an independent opinion relevant to the case. Some states require physicians testifying in a malpractice case to be of the same specialty, and some require the expert to be licensed in the same state.

“The qualifications include specific onthe-job experience, usually an advanced degree in a particular field; excellent communication, organizational and research skills; and flexibility in your schedule,” Ms. Welde said.

The work pays well, averaging $350 per hour for medical expert witnesses and $500 per hour for medical expert testimony, but this varies by degree and with experience.

“As I’ve gained experience and expertise in multiple areas, I’ve raised my rates,” said Bruce Ramshaw, MD, a managing partner at CQInsights, a health care data analytics firm in Knoxville, Tenn. “Consulting as a 20

medical expert is one of the few areas for physicians in health care where you can be reimbursed what your expertise is worth, whereas most of what we do clinically is negotiate with insurers for rates based on negotiating power rather than expertise or outcomes.”

When You Should Take a Case And When You Shouldn’t There are a number of elements to consider when you’re asked to serve as an expert witness. First and foremost, does your experience apply?

“Usually when I decline a case, it’s because I don’t feel it’s an area of my expertise, and that expertise has changed over time,” said Dr. Ramshaw, whose clinical work has shifted from a broader general surgery practice to primarily focusing on hernia repair in the past 15 years.

‘Consulting as a medical expert is one of the few areas for physicians in health care where you can be reimbursed what your expertise is worth, whereas most of what we do clinically is negotiate with insurers for rates based on negotiating power rather than expertise or outcomes.’

—Bruce Ramshaw, MD Also, be certain you don’t know anyone involved in the case. “If you know any of the involved parties—the surgeon, nurses or anesthesiologist—legally you cannot serve as an expert,” Ms. Welde said.

Finally, determine whether you will be available for meetings, deposition and, if

OR Management News • Volume 16 • September 2021

the case goes to court, trial. Depositions usually last about two hours depending on the complexity of a case. “But if the case goes to trial, you’ll need to be available for at least two weeks,” Ms. Welde said.

Moving Forward and Preparing Once you’ve decided to take a case, you’ll have to deal with the nuts and bolts of compensation. “The insurance carrier of the attorney’s client will need to approve your CV and fee schedule for you to be an expert in the case,” Ms. Welde said. “Then you’ll need to agree on a billing process.”

Dr. Ramshaw’s approach to reviewing a case starts with a general but thorough overview. “I go through the information available with an open mind, putting myself in the treating physician’s shoes at the time of the treatment. Once I understand that information, I go back and focus on areas I think are really important, to develop a whole story.”

Ms. Welde keeps an eye out for red flags while reviewing preoperative records, anesthesia notes, intraoperative records and postoperative notes. “Some things you’ll want to consider are the length of the procedure, blood loss, number of staff involved and complications.”

Most important, ask yourself if the standard of care was met. “This is absolutely critical and is one thing you’ll be asked at the deposition: What is the standard of care and was it met?” Ms. Welde said.

Often, the case is resolved after the depositions are taken. “In my experience, cases go to trial less than 10% of the time,” Dr. Ramshaw said. “It’s a grueling process for everyone involved, with a lot of potential for secondary victims. Nobody wins emotionally, so both sides are under some ■ incentive not to take it to court.”

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OR Management News • Volume 6 • September 2021 21

CLIN IC A L NE WS

Benefits, Costs of Robotic Diaphragmatic Hernia Repair Weighed

By ETHAN COVEY

A

recently published study has found that the costs associated with robotic diaphragmatic hernia repair may outweigh any potential clinical benefits compared with laparoscopic surgery.

The findings add interesting context to ongoing discussions about the increased role of technology in surgical procedures (J Am Coll Surg 2021;233[1]:9-19.e2).

“We set out to study robotic and laparoscopic approaches to diaphragmatic hernia repair [DHR] with the hypothesis that there would be a benefit within the first year postoperatively, related to the improved visualization and dexterity the robot provides,” said lead author Sujay Kulshrestha, MD, a surgeon at Loyola University Medical Center, in Maywood, Ill. The retrospective analysis included information from 2011 to 2018 on patients who underwent transabdominal DHR, and associated inpatient and outpatient encounters within 12 months after the operation. Data were gathered from the Healthcare Cost and Utilization Project State Inpatient and State Ambulatory Surgery and Services Databases for Florida.

Of 8,858 identified patients who underwent DHR surgery, 67.3% were treated by laparoscopic DHR, 17.2% by open DHR, and 15.5% by robotic-assisted DHR. The overall rate of robotic DHR increased from 5% in 2011 to 26.4% in 2018.

Generally, patients who underwent open procedures were older, more likely to be male, had higher comorbidity scores, and were more likely to have Medicare or Medicaid insurance than those who underwent laparoscopic or robotic DHR. The researchers found that of the three surgical approaches, open procedures were associated with the worst outcomes.

Recipients of open DHR had a longer index hospital length of stay and were less likely to be discharged home than those undergoing laparoscopic or robotic DHR. However, when compared with laparoscopic surgery, robotic DHR did not fare well.

The median length of stay for patients treated by robotic DHR was longer than for those undergoing laparoscopic DHR, and robotic DHR was associated with the highest overall index hospitalization costs. Upon matched analysis, there were no differences in the overall rate of post-index hospital-based encounters between surgical approaches.

“Our results did not identify a tangible clinical or financial benefit that outweighed robotic DHR’s up-front costs,” Dr. Kulshrestha said. “This points to the possible need to expand the follow-up period for research to better understand global effects of these operations—a lot of the complications we identified were beyond the first 90 days after the index operation.”

Shanu N. Kothari, MD, the vice chair of medical staff affairs 22

OR Management News • Volume 16 • September 2021

‘With a variety of robotic platforms in various iterations of development, I would presume that the charges related to robotic platforms will continue to go down with time.’

—Shanu N. Kothari, MD at the USC School of Medicine in Greenville, S.C., also pointed to the need for longer-term data. “The follow-up was one year, so truly long-term follow-up data remains to be determined.”

Dr. Kulshrestha concurred. “In terms of future directions, similar studies with extended follow-up could help identify late postoperative complications, or provide an understanding of what operations are clinically beneficial and cost-effective for prioritizing limited time at a robotic console.”

Dr. Kothari also noted that the currently high costs of robotic DHR will likely decrease, potentially making the approach more affordable and leveling existing differences in pricing between institutions. “With a variety of robotic platforms in various iterations of development, I would presume that the charges related to robotic platforms will continue to go down with time,” he said.

Most concerning, according to Dr. Kothari, was the higher rate—17.2%—of patients who still underwent open DHR, and the fact that frequently they were the sickest individuals. “These are exactly the risk factors of patients who would benefit the most from a minimally invasive approach, whether it be laparoscopic or robotic,” he said. “The tendency, even in an urgent setting, to do open surgery ‘because it is faster and better for the patient’ is unfounded by studies including this one. These patients spend an extended time in the hospital, are more likely to go to an extended care facility, and in this analysis, the charges were equivalent to the use of a robotic platform.”

Dr. Kothari added that the true impact of these various approaches over time is unknown, especially as reoperation rates in the study were very low. “The real question that remains unanswered is the following: What is the financial burden of symptomatic diaphragmatic hernias on health care expenditures and, what, if anything, can we as surgeons do to minimize recurrence ■ rates?” he said.

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*

(units†

of Kcentra 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

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

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

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