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

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Distractions in the OR How to Identify and Manage Them

Using Machine Learning to Predict SSIs Optimizing the Patient for Surgery Advantages of Robotic Liver Surgery Brought to you by the publisher of

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TABLE OF CONTENTS

BULLETIN BOARD

4 Using Machine Learning to Predict Surgical Site Infections 6 Distractions in the OR: How to Identify and Manage Them 8 Optimizing the Patient for Surgery: The Pre-op Psychological Survey 10 Robot Facilitates Less Invasive Approach To More Liver Resections, Study Suggests

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

1. Study Examines Factors in Early Readmissions After Bariatric Surgery 2. Colorectal Cancer Surgery Outcomes Unaffected by General Anesthetic X 3. Better Surveillance for Serious Hospital-Associated Infections 4. Keynote Talk Targets Physician, Patient Wellness 18 Months Into Pandemic

12 Antibiotic Use Highly Tied to C. diff In Hospitals 14 Handovers During Cardiac Surgery Can Increase Mortality 16 Can Infection Prevention Go Green?

Heard Here First “Robotic liver surgery overcomes several limitations of conventional laparoscopy, as it offers 3D visualization, improved articulation, precise vascular dissection, the ability to suture with both hands and better ergonomics.”

18 Effect of Pot Smoking on Major Surgical Outcomes Insignificant 19 Transgastric Debridement for Necrotizing Pancreatitis Needs a Team Approach 20 Clinical Pearls in Hernia Repair: Avoiding Errors 21 Buyers Guide 22 Anatomy of a Lawsuit: Advice for Wound Care Providers EDITORIAL STAFF Paul Bufano Managing Editor pbufano@mcmahonmed.com Kevin Horty Group Publication Editor khorty@mcmahonmed.com

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OR Management News • Volume 16 • December 2021

3

IN FECTIO N CO NTRO L

Using Machine Learning to Predict Surgical Site Infections Results of Two Studies Conflict on Generalizability of Algorithms

By MONICA J. SMITH

(GLM) in predicting colorectal deep organ-space SSIs (C-OSIs, hile most health systems are at the beginning of the jour- e.g., postoperative intraabdominal abscess). ney in using artificial intelligence and machine learning Among the 2,376 elective colorectal resections performed at to predict surgical complications, surgeons at the forefront of this Mayo Clinic between 2006 and 2014, the C-OSI rate was 4.6% science are expanding our knowledge by investigating ways to (108). The BPMI model identified 57 of these patients: a senovercome the obstacles to AI, as described in two recently pub- sitivity of 56%, compared with the GLM’s sensitivity of 47%. lished studies.

The BPMI model lost its advantage when the model was built to “These articles pose different questions, but what they have use extra-institutional data (i.e., based on the American College in common is that they’re both examining the challenges of of Surgeons National Surgical Quality Improvement Program), bringing AI to bear on the problem of surgical site infection,” which reduced its sensitivity to 47%. commented Philip S. Barie, MD, MBA, a professor emeritus They concluded that for optimal performance, the BPMI model of surgery at Weill Cornell Medicine, in New York City, and should be built using “data specific to the individual institution” the executive director of the Surgi(Surg Infect 2021;22[5]:523-541). cal Infection Society Foundation for ‘My concern is that somebody will “We’re going to be seeing more Education and Research. and more of these models, and peodevelop a big model based on a very “Studies of SSI prevalence are ple need to understand the limitachallenging to perform and inter- heterogeneous data set that may not tions of them, and how to use them pret if not done prospectively, using in their institution,” Dr. Cima said. reflect the risk profile or the patient trained observers inspecting each “My concern is that somebody incision,” Dr. Barie told OR Man- profile of an individual hospital. I’d hate will develop a big model based on agement News. “Retrospective studies a very heterogeneous data set that to see them penalized or made to look always leave doubt as to what exactmay not reflect the risk profile or the ly was observed, whether patients like they’re not performing well when patient profile of an individual hoswere omitted inadvertently because pital. I’d hate to see them penalized the model was never designed to be of sporadic reporting from the outor made to look like they’re not perpatient setting, or if data reporting is used in their environment.’ forming well when the model was incomplete. Moreover, thousands of never designed to be used in their —Robert Cima, MD patients are required to achieve adeenvironment,” Dr. Cima said. quate statistical power to study clean Because retrospective chart review operations owing to the low prevalence of infection.” is cumbersome, other investigators have sought to automate the One study, conducted by researchers at Mayo Clinic in Roch- process using machine learning and natural-language processing. ester, Minn., addressed the problem of missing data, which can The other study, which specifically investigated the generalizskew retrospective analyses and subsequent prospective predic- ability of SSI-detection machine learning–generated algorithms, tions of SSIs. found that machine learning models designed at one center “The nice thing about machine learning is that it allows the worked just as well at another. system to refine a model as it evolves, as long as you can get data “We’re at the beginning of an acceleration of having machine for the system to look at; we wanted to know what the impact learning and AI used more widely in health care, but the work of missing data is on the ability to model infections,” said Rob- to validate models isn’t always done optimally. In many instancert Cima, MD, a professor of surgery at Mayo Clinic College of es, we expect it to be like a ‘plug-and-play’ technology, where you Medicine and Science, in Rochester, Minn. install the solution in and it works. But the truth is, in some cases “What we found is that unless you do certain corrections, your there is a degradation in performance or the need for more optimodel is going to suffer from it.” mization,” said Genevieve Melton-Meaux, MD, PhD, a profesTo evaluate a method for handling missing data, Dr. Cima and sor of surgery and Institute for Health Informatics core faculty his colleagues compared a Bayesian-Probit regression model with at the University of Minnesota Medical School, in Minneapolis. continued on page 13 multiple imputation (BPMI) with a generalized linear model

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OR Management News • Volume 16 • December 2021

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FE ATURE

Distractions in the OR How to Identify and Manage Them

By ALISON McCOOK

6

OR Management News • Volume 16 • December 2021

FEAT URE

T

he operating room is a surprisingly busy place. her colleagues presented the following advice to reduce OR Not long ago, a group of researchers at St. Michael’s distractions: Hospital and the University of Toronto reviewed surgical “black • Ensure proper communication. ORs need to always make box” recordings, taken during 25 total laparoscopic hysterectosure people can communicate with one another, despite mies (General Surgery News, July 2015, page 1; bit.ly/3FcRLcG). distractions. As an example, if music is played too loudly, These recordings included various data points from around the turn it down during key moments. Enforce strict rules about OR, such as noises, team activity and physiologic details from the phones in the OR. “Sometimes, we’re not aware of how patient. During each procedure, the team experienced a median distracting being on your cell phone is.” of 89 door openings, 158 machine alarms and 10 incoming calls • Respect critical periods. Distractions can be particularly to the OR. More than 60% of the cases included a conversanversa disrupt disruptive during critical periods in a procedure, which tion that was unrelated to it (Cureus 2021;13[7]:e16218).

18). differ according to your specialty, Ms. Schulthess noted.

The number of distractions during the procedures sururan For anesthesia, that critical time may be intubation prised study author Pansy Schulthess, RN, the manager er e and extubation; for surgeons, it may be creating an of quality, patient safety and education, Perioperativee an anastomosis.

If distractions arise during a critical Services at St. Michael’s, who spoke about the study period, you can politely inform your colleagues that at the Association of periOperative Registered Nursyou can’t shift your focus at the moment. “We need es (AORN) 2021 virtual Global Surgical Conferto recognize each other’s critical phases.” ence & Expo (session 1010).

“Prior to reviewing the black box data and videos, Pansy Schulthess, RN • Stay focused on the procedure. Surgical staff I didn’t have a good understanding of how often are always multitasking, and it’s important to distractions were occurring and what their implications might anticipate inevitable distractions. For instance, some surgical be,” Ms. Schulthess told attendees. The equivalent, she said, staff may have to teach while performing a procedure. “It’s would be if during her presentation—which lasted roughly half important to always pay attention to the procedure, even if you’re the time of a typical hysterectomy—there were approximately 45 trying to communicate something important to someone else.” door openings and 80 alarms. “It would be very hard for me to convey information to you in an effective way with the constant Lisa Spruce, DNP, RN, agreed that distractions are an issue in distractions.” the perioperative setting, which is “one of the most complex work Many studies have shown that distractions are a way of life environments in health care.” in the OR and can affect surgical performance (Surg Endosc Dr. Spruce reiterated the idea that ORs need to minimize dis2016;30[5]:1713-1724). By studying the nature and timing of tractions that don’t serve a clinical function and respect critical OR distractions captured by the black box recordings, clinicians periods during surgery, and suggested the creation of a “no-intercan develop ideas for how to mitigate them and minimize their ruption zone” during which nonessential talk and work are proimpact, Ms. Schulthess said. “The black box videos and data have hibited. However, facilities can’t take a top-down approach to helped me in my own practice highlight and pay more attention designing interventions to reduce distractions and noise, cautioned to the times in a procedure when it might be easier to communi- Dr. Spruce, the director of evidence-based perioperative practice at AORN. “Making changes to minimize noise and distractions cate and when it would be distracting.”

During her session, Ms. Schulthess played several videos that should be done by a multidisciplinary team approach to create a reenacted actual black box recordings, showing how common dis- safer environment for patients and perioperative team members.”

This work should apply not just to traditional ORs, she noted, tractions can disrupt procedures in numerous ways. They ranged from loud music, to a surgical staff member needing to scrub out but anywhere invasive procedures are performed, such as ambubecause of a phone call, to circulating people watching a video latory surgery centers. “Operative and invasive procedures are on a phone and not noticing a new scrub person was waiting for high-risk activities that require vigilance, concentration and situational awareness,” Dr. Spruce said. “Distractions and noise can their gown to be tied, thus delaying the transition.

Each facility should analyze its own distractions, but based cause disruptions in communication and teamwork, which may ■ on the recordings captured at St. Michael’s, Ms. Schulthess and contribute to errors that can compromise patient safety.”

Common OR distractions include:

Door openings

Incoming calls

Loud music

Unrelated conversations

Machine alarms

OR Management News • Volume 16 • December 2021

7

P E RSP ECTIVE

Optimizing the Patient for Surgery: The Pre-op Psychological Survey

By MICHAEL J. ASKEN, PhD, and DANIELLE E. LADIE, MD, MPH, FACS B

I

t is obvious that optimizing the patient prior to surgery is essential for maximizing desirable outcomes. While these efforts typically focus on managing comorbidities and assessing physiologic parameters, “comprehensive” optimization is achieved by including attention to the psychological status of the surgical patient.

With evolving specialization in surgery and increasing sophistication of procedures, psychological evaluations have become integral in the evaluation of patients for certain operations, such as bariatric, transplant and pain-related orthopedic surgeries.1,2 The benefits of psychological “preparation” of surgical patients has been proposed as an important consideration.3,4 Less developed, in contrast to specialized psychological evaluations, is a simple and broad approach to assessing every patient’s psychological state in a manner appropriate for use by the surgeon involved in the case. Psychological preparation of the patient requires a first step of evaluation through a preoperative psychological survey (POPS).

While not an in-depth, diagnostic or psychopathology-oriented evaluation (hence the term “survey”), the qualitative POPS addresses a variety of areas of patient functioning that can bear directly on the quality and satisfaction of the surgical experience for both the patient and surgical team. A more specific and comprehensive evaluation may become indicated as a result of information elicited from such a general psychological inquiry.

There are two reasons why an assessment like the POPS is indicated: Surgery is a psychological, as well as physical, experience and psychological factors affect the surgical course, outcome and recovery.5-10 Although the POPS could be delegated to another member of the surgeon’s team, we strongly suggest the surgeon engage the patient. We describe the POPS as a “discussion” with the patient that provides direct and useful information to the surgeon, illuminating issues that the surgeon will want to ensure are addressed.

Perhaps, as importantly, this interaction can convey the sincerity of the surgeon’s concern for the patient’s overall well-being, enhance the perception of a positive bedside manner and bolster the quality of the surgeon-patient relationship.

When engaging the patient, the following items should be considered: 1. Discuss the patient’s perceptions of past surgical experiences.

The goal here is to illuminate psychological and emotional residuals (both positive and negative) that might still linger from those experiences. Did all go smoothly and as expected? Were there aspects that were uncomfortable, frustrating, angering or

anxiety-arousing? What views of surgery—trust or fear—did past experiences create for the patient?

2. Discuss the patient’s view of others’ experiences with the same or similar procedures.

What has the patient heard from friends or relatives about the pending surgery? Are these stories exaggerated, especially in a negative way? The plethora of television medical dramas, social media commentary and internet (mis)information can influence a patient’s perception of their situation.

3. Discuss the patient’s understanding of their condition and need for the procedure.

The patient should have a substantial understanding of their condition, how the surgery will affect their condition and, consequently, a positive acceptance (if not enthusiasm) of the surgery.

The reality is that patients do not always fully comprehend, or may be confused about, aspects of their condition and care.

4. Discuss the patient’s understanding of the procedure itself.

This is where you want the patient to tell you what they understand about their situation. What you told them is crucial, but what they heard, retained and understand is essential.

5. Discuss the patient’s short-term expectations.

Explore what the patient understands will happen going into the procedure, immediately after and in the ensuing 24 to 48 hours. Is there a realistic expectation of hospital length of stay, pain levels and fatigue? Discussion of postoperative sensations, such as stitches pulling, itching, numbness or oozing can be valuable. When these events occur unexpectedly, there is a tendency to interpret them in a negative manner (“my wound is tearing open!”).

6. Discuss the patient’s long-term expectations.

Ultimately, you want to hear that the patient has an accurate and reasonable expectation of time and any postoperative rehabilitation that is required. You want to listen for their understanding of what the procedure will accomplish and perhaps what it will not. Unrealistic expectations lead to a difficult postoperative course, strained interactions, disappointment and anger.6 7. Discuss current life stresses.

Stress is common, but a burned-out, dejected, pessimistic patient is not in an optimal state for surgery. While the acute need for surgery may preclude immediate intervention for stresses, their acknowledgment, especially with a commitment to help with follow-up postoperatively, can provide a sense of relief and a more optimistic outlook for the patient. continued on page 13

8

OR Management News • Volume 16 • December 2021

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C LIN IC A L NE WS

Robot Facilitates Less Invasive Approach to More Liver Resections, Study Suggests

By MONICA J. SMITH

ATLANTA— Use of the robotic platform for minor and major liver resections appears to be safe and feasible, and may open minimally invasive hepatectomy to more patients, according to the findings of a recent study.

Despite the significant development of minimally invasive surgery over the last few decades, three-fourths of liver resections are still open procedures, mainly due to the complexity of the intrahepatic anatomy, the need for rapid bleeding control and the minimally invasive skills required to perform laparoscopic procedures, said Harel Jacoby, MD, an advanced gastrointestinal and hepatobiliary surgical fellow under Iswanto Sucandy, MD, the director of robotic surgery at Advent Health Tampa, in Florida.

“Robotic liver surgery overcomes several limitations of conventional laparoscopy, as it offers 3D visualization, improved articulation, precise vascular dissection, the abilityy to suture with both hands and better ergonomics,” mics,” he said, presenting the research at the 2021 Southeastern Surgical Congress.

Furthermore, in 2019, the interternational consensus statement ment on robotic hepatectomy reportported equivalent peri- and postoperstoperative outcomes compared with laparoscopy.

To investigate the safety and d feasibility of robotic liver resec-tion, surgeons at Advent Health h Tampa prospectively followed wed consecutive patients undergoingg robotic minor or major hepatec-tomy for any indication between n 2016 and 2020. They defined ned minor hepatectomy as a liver resection with ith ttwoo or fewer contiguous Couinaud segments, and major hepatectomy as the resection of three or more.

Ultimately, the study included 220 patients, 82 of whom (37%) had minor hepatectomy and 138 (63%) who underwent major hepatectomy.

“Demographically, there were no statistically significant differences between major and minor hepatectomy patients; however, it’s worth noting that more than 50% patients had previous abdominal operation, but this didn’t affect our ability to complete the procedure using the robotic platform,” Dr. Jacoby said.

The most common indications for hepatectomy were colorectal metastasis and hepatocellular carcinoma. Patients with hepatocellular carcinoma were more likely to undergo a major hepatectomy, while patients with benign lesions were more likely to undergo a minor hepatectomy.

10

OR Management News • Volume 16 • December 2021

The operative duration for minor hepatectomy was about four hours, and five hours for major hepatectomy. Estimated blood loss for minor and major hepatectomy was 100 and 200 mL, respectively. There was one interoperative complication requiring conversion to open in a patient who had a previous right hepatectomy.

“However, the postoperative course for this patient went well, and he was able to be discharged home on post-op day 4,” Dr. Jacoby said. The average length of stay was three days for minor hepatectomy patients and four days for major hepatectomy patients.

Nine patients had postoperative complications, most of which were seen, somewhat surprisingly, in the minor hepatectomy group; and two patients died related to cardiopulmonary events.

“We were able to maintain excellent oncologic outcomes, as p 97% of our patients had an R0 resection; no patients had an R2 resection,” Dr. Jacoby sa said.

“We found minor and major robotic hepatectomy to be safe and feasible, associated with excellent short-term outcomes, and w we believe that the robotic app approach will play a wider role in he hepato-pancreato-biliary [HPB] ssurgery,” he said. The Advent H Health group expects to make fu further data on robotic major hep hepatectomy available to the scient entific public.

Laura Enomoto, MD, MSc, a su surgical oncologist and an assista tant professor of surgery at the U University of Tennessee Medical Ce Center, in Knoxville, applauded the res researchers for contributing to the growing body of literature reporting the safety and efficacy of robotic hepatectomy.

“Your rate of conversion to open is low, and your complication rate is low as well,” she said. But she questioned why they didn’t compare robotic hepatectomy with laparoscopic or open hepatectomy, which is a more standard study design for investigating new technologies or techniques.

Dr. Jacoby was unsure as his institution switched fully to robotic programs for all but the most minor procedures in recent years.

Dr. Sucandy told OR Management News that in their program, comparisons of robotic, laparoscopic and open procedures are now being performed using a propensity score matching method.

“A prospective randomization is near impossible to achieve, since most patients come specifically for the robotic minimally ■ invasive liver surgery,” he said.

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IN FECTIO N PRE VE NTIO N

Antibiotic Use Highly Tied to C. diff in Hospitals

BY ETHAN COVEY

A

ntibiotic use is significantly associated with hospital-onset Clostridioides difficile infection (HO-CDI), according to data taken from a large cohort of U.S.-based acute care hospitals (ACHs).

The findings build upon previous research that reported on antibiotic usage and HO-CDI rates from 2006 to 2012 (Infect Control Hosp Epidemiol 2021 May 7. doi:10.1017/ ice.2021.151; bit.ly/3ojGVfc-IDSE).

“This study is important because it confirms and extends previous research on the association of broad-spectrum antibiotics and CDI,” said Sophia Kazakova, MD, PhD, a health scientist with the CDC’s Division of Healthcare Quality Promotion. “These findings should encourage clinicians, infection control and antibiotic stewardship programs to strengthen antibiotic use monitoring and continue to focus on reducing use across all classes of antibiotics to reduce CDI.” The researchers reviewed data on adult discharge and inpatient charge records for antibiotic use, CDI testing and CDI treatment for 921 ACHs from Jan. 1, 2012, to Dec. 31, 2018, HO-CDI rates were calculated and compared with days of therapy (DOT) for seven antibiotic classes.

The results showed a clear association between higher levels of antibiotic use and rates of HO-CDI. For every 50 DOT per 1,000 patient days increase in antibiotic use, HO-CDI rates increased by 2.8%. When looking at specific classes of antibiotics, 10 DOT per 1,000 patient days increases in the use of carbapenems, cephalosporins and piperacillin-tazobactam were associated with 1.3%, 0.6%, and 1.1% increases in the rate of HO-CDI, respectively.

New to this batch of data was information regarding the use of 12

OR Management News • Volume 16 • December 2021

nucleic acid amplification testing (NAAT) for diagnosis. Upon examining temporal trends in hospital use of NAAT testing, the authors found that hospitals using only NAAT diagnostic tests for CDI had a 16% higher HO-CDI rate.

“Even when controlling for NAAT use and other known patient and hospital confounders, we found strong positive cross-sectional and temporal associations between CDI and total and class-specific antibiotic use,” Dr. Kazakova noted. “This indicates that future studies should include this factor in CDI models.”

Among the four hospitals that decreased total antibiotic use during the study period by 30% or more, HO-CDI rates decreased by 40%. Decreases in fluoroquinolone and carbapenem use corresponded with annual decreases in HO-CDI rates of 4% to 7% and 4% to 8%, and decreases in cephalosporins, fluoroquinolones, and carbapenems corresponded with annual decreases in the HO-CDI rate of 4% to 16%.

Mohamed H Yassin, MD, PhD, an associate professor of medicine, University of Pittsburgh School of Medicine, told OR Management News that the paper showed that hospitals need to focus efforts on traditional infection prevention efforts as well as antibiotic stewardship programs to reduce unnecessary antibiotic use. “This paper sends a clear message to hospitals to increase their efforts further to reduce antibiotic use,” he said.

Dr. Kazakova added that additional study may help clarify appropriate antibiotic usage. “Since higher antibiotic use is associated with higher rates of CDI, more research into defining and quantifying inappropriate and unnecessary use would be ■ valuable,” she said.

Machine Learning and SSIs

Pre-op Psychological Survey

continued from page 4

continued from page 8

To do so, Dr. Melton and her colleagues tested automated SSI-detection algorithms developed and validated using electronic health record (EHR) data from 8,883 patients at their institution, and then applied those algorithms to 1,473 patients at the University of California, San Francisco.

Looking at the detection of superficial, incisional, organ-space and total SSI complications, the researchers found no difference in area under the curve for any outcome. They concluded that the algorithms developed at one site are generalizable to another (J Am Coll Surg 2021;232[6]:P963-P971).

“Currently there is no standard way SSIs are documented in the EHR that would make it easier for a person to extract the data—if they are documented at all. Here, they’re using machine learning and AI to go through records looking for certain terms that correlate with the presence of an SSI, saying that the process of screening might be automated, with a particular advantage that the need to manually review low-risk cases might be eliminated,” Dr. Barie commented.

8. Discuss the patient’s usual way of coping with challenges.

A gentle, but effective way to approach this is by discussing how the patient usually deals with challenges and stressors. You might hope to hear approaches such as “I read up on things,” “I lean on my friends” and “My faith sustains me.” While usual perioperative support is still important here, such statements are a good foundation for the response to surgery. Responses like “I don’t know” and “I get pretty down” suggest a psychological infrastructure that would probably benefit from greater professional support.

‘We’re at the beginning of an acceleration of having machine learning and AI used more widely in health care, but the work to validate models isn’t always done optimally.

In many instances, we expect it to be like a ‘plug-and-play’ technology, where you install the solution in and it works.’

—Genevieve Melton-Meaux, MD, PhD “Basically, they’ve developed a tool that makes it easier for the surveillance people to find these SSI cases accurately.”

So, what explains the discrepancy in generalizability between the two papers? Both Drs. Cima and Melton suspect it has to do with characteristics of the institutions, the types of patients they see and the way their surgeons practice, and the questions that each of the algorithms are designed to answer.

“In our case, it appears that what we used to build the model is robust and good, but it’s unclear if that would scale across the country. These were both academic health systems; it might be different at a smaller center, or with different patient populations or over time as surgical practices change,” Dr. Melton said.

“These are important questions that we’re going to ■ need to be able to answer more and more.”

9. Discuss current care and relationships with medical/nursing staff.

Despite best efforts, and for many reasons, patients don’t always perceive that they received the kind of care they expected. While never acceptable, frustration, anger, anxiety or fear of returning to a floor or team’s care is especially concerning going into surgery. A deteriorating relationship with staff is a risk for psychological morbidity.11 10. Discuss current/past counseling history and assess mental status.

Discussion of these last areas often is the most difficult and sensitive for both the surgeon and patient. Generalizing problems with the term “stress” (everyone has it!) can reduce intrusiveness. Asking “how are you doing” is an effective way to start and listen for current, acute or ongoing anxiety or depressive thinking. Surgeon discomfort here should not be a rationale for avoiding this assessment. It is often extremely valuable as a baseline in the face of postoperative concerns like delirium and other cognitive changes.

The preoperative psychological assessment has the potential to provide important information to the surgeon for optimizing patient readiness for surgery. Obviously when concerns are revealed, addressing them in some manner from reassurance to psychiatric/psychological consultation is indicated.

The ability, interest and comfort of surgeons to engage productively in such discussions will vary greatly. We are not suggesting a prescription for how to evaluate a patient psychologically, but rather the value of generally increasing awareness of the patient’s psychological state and needs. Again, we differentiate POPS from in-depth psychological, neuropsychological or psychiatric evaluations that are essential in certain surgical scenarios and clinical situations.

What is suggested is a thoughtful discussion with the patient. The content and extent are to be determined by each individual surgeon and situation. Some patients (with an avoidant coping style) will be reluctant to engage fully and they should not be pressed.3 However, completing a POPS through discussion allows an opportunity for unique concerns to emerge while cultivating the relationship.

■ —Dr. Asken is the director at Provider Well-Being, UPMC Central PA Region, Harrisburg, Pa. Dr. Ladie is a transplant surgeon and the vice chair, Department of Surgery, UPMC Central PA Region, Harrisburg, Pa. References can be found online at ormanagement.net.

OR Management News • Volume 16 • December 2021

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CLIN IC A L NE WS

Handovers During Cardiac Surgery Can Increase Mortality ‘Handover tools specific to cardiac diac

By MICHAEL VLESSIDES

I

s there a link between anesthesia handovers during cardiac surgery and increased postoperative mortality? A study has found evidence for this association.

The multicenter team of Canadian researchers concluded that such handovers were not only significantly associated with increased 30-day and one-year mortality, but also ICU length of stay.

“We know from the literature that anesthesiology handover is common and is actually becoming more common year on year,” said John O’Connor, MD, a cardiac anesthesia fellow at the University of Ottawa Heart Institute, in Ontario. “In addition, anesthesiology handover is more common in cardiac surgery than noncardiac surgery.

“Although anesthesiology handover has been associated with increased morbidity and mortality, the precise impact of anesthesiology handover after cardiac surgery is not fully understood,” he added. “To our knowledge, this has not been investigated at a population level, nor has it been investigated up to one year after surgery.”

To shed light on this possible relationship, Dr. O’Connor and his colleagues examined patients presenting for a series of cardiac surgical procedures in Ontario between October 2008 and September 2019. Patients were included in the retrospective cohort study if they underwent coronary artery bypass surgery, single or multiple valve surgery, thoracic aortic procedures, or a combination thereof. Heart transplantation and ventricular assist device implantation surgeries were excluded. The trial’s primary end point was one-year mortality, and secondary end points included 30-day mortality and ICU length of stay.

Propensity score analysis was used to control for potential confounding variables, including patient characteristics, procedure type, surgeon characteristics and anesthesiologist characteristics. Multivariable Cox proportional hazard models assessed the relative hazard of 30-day and one-year mortality, and Poisson regression estimated the effect of intraoperative handover on ICU length of stay.

The final study cohort consisted of 102,209 cases. Anesthesia handover occurred in 1,926 of the group (1.9%). Interestingly, intraoperative anesthesiology handovers were found to occur more commonly in male patients, emergent procedures, academic hospitals, with female primary anesthesiologists, and among surgeons with lower case volumes.

A Question of Handover Method In a presentation at the 2021 virtual annual meeting of the Society of Cardiovascular Anesthesiologists, Dr. O’Connor reported that intraoperative anesthesiology handover was associated with a 52% increased risk for mortality at one year (hazard ratio [HR], 1.52; 95% CI, 1.1-2.0). Similarly, patients who

14

OR Management News • Volume 16 • December 2021

anesthesiology possibly need to be developed and put in place to enhance patient safety.’

—John O’Connor, MD experienced such handovers also had a 61% increased risk for 30-day mortality (HR, 1.61; 95% CI, 1.1-2.3).

In addition, the study found a rate ratio for increased ICU length of stay of 1.45 (95% CI, 1.2-1.3).

These results were corroborated by Kaplan-Meier analysis, which found lower estimated one-year survival for patients whose procedures were subject to anesthesiology handovers.

“The difference in patient survival is evident early in the postoperative course and continues over quite a long period of time,” Dr. O’Connor said.

As Dr. O’Connor explained, the study demonstrates the risk presented by intraoperative anesthesia handover among cardiac surgery patients. “That’s even after controlling for patient factors, procedure factors and staffing factors,” he said. Nevertheless, the authors recognized the need for more research to clarify the relationship and the potential effect of external factors.

“How is handover being performed?” Dr. O’Connor asked.

“What tools are being used? And is adequate training occurring for this? Finally,” he added, “we think that handover tools specific to cardiac anesthesiology possibly need to be developed and put in place to enhance patient safety. Perhaps we need to do something a little different to change these results.”

Look to the Aviation Industry For Alparslan Turan, MD, whose group conducted similar research covering all surgical cases (Anesthesiology 2014;121[4]:695-706), the benefits of a streamlined handover process are clear. “The most structured handover processes in the world come from the aviation industry,” said Dr. Turan, a professor and the vice-chair of the Department of Outcomes Research at Cleveland Clinic, in Cleveland. “I think these types of processes need to be implemented in anesthesiology.

“There are multiple studies in every aspect of anesthesia care to show what a critical time it is in the perioperative process,” he said. “Handovers are a time when critical information can be lost, which ultimately affects outcomes for the patient—all the studies show that.”

Yet the way Dr. Turan sees it, the standardization of handovers needs to be the product of institutional or even societal efforts.

“The motivation should come from higher up and be implemented in every case. The American Society of Anesthesiologists has rules for things like monitoring, and the same should go for handovers, which should be a part of the quality evaluation of ■ anesthesia programs and departments.”

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INF ECTIO N PRE VE NTIO N

Can Infection Prevention Go Green?

By ALISON McCOOK

E

ndoscopes are dirty—and not just from the standpoint of infection. They’re dirty because of how much their use and reprocessing contribute to hospitals’ waste and carbon footprints.

Each endoscopy bed generates nearly 7 pounds (3.09 kg) of waste every day, putting it in the top three of all hospital departments (Lancet Gastroenterol Hepatol 2020;5[7]:636-638). It’s easy to see where the waste comes from: disposable tools and protective gear, high-throughput caseloads, and use of large amounts of water and disinfectants during reprocessing.

Garbage generated in the reprocessing of one scope.

Image courtesy of Ofstead & Associates Inc.

Some experts fear the waste problem in endoscopy could worsen, as the field moves more toward disposable products to reduce the risk for infection. The trend toward disposables is creating some tension between infection control and environmental protection, where emphasizing one may put the other at risk, said Nitin K. Ahuja, MD, an assistant professor of clinical medicine and the co-director of the program in neurogastroenterology and motility at the Perelman School of Medicine, University of Pennsylvania, in Philadelphia.

“I’m sympathetic to the thinking of people concerned with infection control, but it’s hard for those of us who are concerned about waste,” Dr. Ahuja said. “Is the disposable duodenoscope just another thing that’s going to end up in the ocean?”

Flying Blind When he first heard about the disposable duodenoscope, Bu’Hussain Hayee, MBBS, PhD, a consultant gastroenterologist 16

OR Management News • Volume 16 • December 2021

at King’s College Hospital London, was very concerned. “A hospital like King’s, where I work, performs 1,000 procedures using duodenoscopes per year. This is a huge demand for disposable equipment, which I just cannot see being realistic,” he said. “I have also yet to hear a convincing argument that this is sustainable at all.”

However, there’s no way of knowing whether the alternative—reusable scopes that need reprocessing—has any less environmental impact because of the lack of data comparing the footprint of reusable and disposable tools, Dr. Hayee said.

Cleaning one endoscope uses between 90 and 100 L (22 gallons) of water, filtered using reverse osmosis to ensure purity, which consumes a lot of energy, he said. “Obviously, single-use scopes do not need water to reprocess them, so there is that. But we can only incinerate used scopes; they can’t be recycled, so the impact is high.”

The bottom line, Dr. Ahuja said, is there needs to be more research about the environmental impact of the waste associated with endoscopy: disposable materials such as packaging, single-use instruments and personal protective equipment versus the water, detergents and decontamination used during reprocessing of reusable instruments. “Certainly, more could be done to understand what percentage of resources in any given endoscopy is contributing to the global carbon footprint.”

Ideas for Reducing Waste Dr. Ahuja recommends that providers think deliberately about their use of accessories during procedures, such as using only one for a small and large polyp in the same colon, so there are fewer things to throw away or reprocess. Dr. Hayee’s practice has installed energy-efficient light bulbs and infrared faucets to control water flow in sinks and started emailing reports and digitizing information, instead of using paper. They also are recycling all noncontaminated waste, and using thermal compaction machines to deal with personal protective equipment and aprons that otherwise would be incinerated, creating an inert plastic “flock” that can be sold to plastic manufacturers for reuse.

The biggest step providers can take is to simply cut back on unnecessary procedures, Dr. Ahuja said—a particular problem for practices in which doctors are paid according to the number of procedures they perform. “Substantive change with regard to the carbon footprint of medicine at large would probably entail moving away from productivity as a primary incentive and toward outcomes instead. We would need to include environmental outcomes as part of the shared set of things we all care about as a ■ professional community.”

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CLIN ICA L NE WS

Effect of Pot Smoking on Major Surgical Outcomes Insignificant

By MICHAEL VLESSIDES

A

s more North Americans are partaking of legal cannabis, exposure to the substance does not seem to affect major surgical outcomes, according to the results of a large cohort study.

Canadian researchers have concluded that routine cannabis use does not affect a composite outcome of respiratory/cardiac arrest, ICU admission, stroke, myocardial infarction and mortality during hospital stays.

“Cannabis contains cannabinoids, which can interact with neurotransmitters, thereby creating potential drug interactions in the perioperative period,” said Betty Huiyu Zhang, MD, a resident at the University of Ottawa, in Ontario. “Preclinical studies indicate the potential for such cardiovascular complications as arrhythmias and blood pressure changes.

“Smoking cannabis can also cause airway hypersensitivity, and smaller retrospective studies have suggested that cannabis may be associated with increased propofol requirements for induction and sedation,” Dr. Zhang added.

Other research has found a potential link between cannabis use and perioperative analgesic difficulties, and mixed results with respect to postoperative pain control.

Therefore, Dr. Zhang and her colleagues evaluated the effect of routine cannabis use on perioperative outcomes in a large 18

OR Management News • Volume 16 • December 2021

patient cohort. The researchers captured data from 1,818 surgical patients presenting to the institution between January 2018 and March 2019. Cannabis users were identified by self-disclosure at their preoperative visit.

Multiple logistic regression with propensity score matching was used to adjust for a number of potentially confounding baseline variables, including age, sex, body mass index, smoking status, other recreational drug use, surgical setting (inpatient vs. ambulatory), type of surgery and type of anesthesia.

‘Our results do not demonstrate a convincing ng association between self-reported cannabis use and either major surgical al outcomes or pain management.’

—Betty Huiyu Zhang, MD

C LINICA L NEWS

No Difference Across Several End Points In a presentation during the 2021 Annual Regional Anesthesiology and Acute Pain Medicine Meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract 1875), Dr. Zhang noted that 606 patients preoperatively reported cannabis use, while the remaining 1,212 served as controls. The total prevalence of reported cannabis use was 4% (606/15,048).

For the propensity score–matched analyses, there was a final cohort of 524 cannabis users with complete information and 1,152 controls. No difference was found between groups with respect to the study’s primary end point: Seven cannabis users (1.2%) experienced the composite outcome of respiratory/cardiac arrest, ICU admission, stroke, myocardial infarction or mortality during their hospital stay, compared with 11 controls (0.9%), yielding an odds ratio of 1.06 (95% CI, 0.23-3.98).

Although cannabis users experienced a greater incidence of arrhythmias than controls (2.7% vs. 1.6%; P=0.15), along with a decreased incidence of postoperative nausea and vomiting requiring treatment (9.6% vs.

12.6%; P=0.08), these differences were not statistically significant. The incidence of severe pain during recovery was also comparable between groups, affecting 30.9% of cannabis users and 33.5% of their counterparts who did not use cannabis (P=0.31).

Cannabis Use Hard to Pinpoint “More rigorous study should be designed to examine these outcomes,” Dr. Zhang said.

As the researchers discussed, the study represents the largest single-center effort examining regular cannabis use in average doses. Nevertheless, the analysis was not without its shortcomings, which included self-reporting of cannabis use (which may create underreporting); the researchers’ inability to quantify the amount, duration or type of cannabis use; and a lack of categorization of other recreational drug use.

Marco Echeverria-Villalobos, MD, an assistant professor of anesthesiology at The Ohio State University Wexner Medical Center, in Columbus, said the primary challenge in studies such as this is accurately estimating the percentage of cannabis users in a population of surgical patients.

“Despite the wide use that cannabis or cannabinoids have as recreational or medical drugs, the percentage of patients that can be identified preoperatively as recreational or medical cannabis users by self-disclosure is still very low (4.0%-4.2%), as we can observe in other studies that have included larger sample sizes [Int Orthop 2019;43:283-292]. This continues to be an important limiting factor of studies that seek to accurately estimate the real impact of cannabis use on perioperative out■ comes.

Transgastric Debridement For Necrotizing Pancreatitis Needs a Team Approach

By CHRISTINA FRANGOU

P

atients required fewer interventions, spent less time in the hospital and had fewer readmissions after undergoing operative rather than endoscopic transgastric debridement for necrotizing pancreatitis, according to one of the largest case series of patients treated for this condition.

But the authors say their results demonstrate that both approaches have a place in management of necrotizing pancreatitis.

Instead of advocating one approach over the other, investigators called for multidisciplinary collaboration in caring for these patients, including clinicians who have experience in surgical and endoscopic treatment, as well as percutaneous treatment and medical therapy.

“This is a team effort. It takes experienced judgment and multidisciplinary teamwork with GI and surgery to determine the optimal approach to treating necrotizing pancreatitis, whether it’s surgical or endoscopic,” said lead author Nicholas J. Zyromski, MD, a professor of surgery at Indiana University School of Medicine in Indianapolis.

Some patients treated operatively later received endoscopic and percutaneous treatment, while some treated by endoscopy required subsequent operations, he noted.

The study included 643 patients with pancreatic necrosis who were treated at Indiana University Hospital between 2008 and 2019. In this group, 160 patients underwent transgastric debridement: 59 were treated endoscopically (37%) and 101 operatively (63%).

A multidisciplinary team made the decision on whether to use endoscopy or surgery after considering the patient’s history, the disease etiology and clinical characteristics.

Patients treated endoscopically required 3.0±2.0 debridements per patient, compared with 1.1±0.5 in the surgical group. Overall, 81% of patients who had endoscopic transgastric debridement required repeat interventions, up from 7% in the surgical group.

The endoscopic approach was associated with longer postoperative lengths of stay in the hospital (13.8±20.8 vs. 9.4±6.1 days; P=0.047).

Patients treated endoscopically also had higher rates of readmission (67% vs. 20%; P<0.001).

Surgical transgastric debridement should be the first choice for patients with biliary necrotizing pancreatitis and suitable anatomy, while patients with alcoholic pancreatitis or hypertriglyceridemic pancreatitis may be better suited for an endoscopic approach, Dr. Zyromski said.

More patients died in the endoscopic group (7% vs. 1%), and newonset organ failure was similar in the two groups at 13%.

Investigators said mechanical intervention for necrotizing pancreatitis should be delayed at least four to six weeks after onset.

■ OR Management News • Volume 16 • December 2021

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Clinical Pearls in Hernia Repair: Avoiding Errors

By CHASE DOYLE

H

us Abdomi inis Releas se Transversus Abdominis Release There are several places to start, including mid-rectus, over the transversus abdominis, below the arcuate line and the falciform ligament. Choosing the right place depends on the patient’s history and the part of the peritoneum or posterior sheath that is most preserved.

“Medial tension is key,” Dr. Blatnik said. “I do this with three clamps, evenly spaced, with cautery along the way.”

Dr. Blatnik encouraged surgeons to gain experience differentiating the peritoneum from the transversalis fascia, a thin aponeurotic membrane that lies between the inner surface of the transverse abdominis and the parietal peritoneum. This is an important distinction, especially in the subcostal region where the peritoneum can be very thin, he said.

When doing a release, Dr. Blatnik underscored going laterally around thin or challenging areas before working back. If a difficult closure is anticipated, use the ‘Mesh is not always a nice flat piece hernia sac as part of posterior closure, he said.

ernia repairs can be a challenging surgical problem, even for experienced surgeons. During MedStar Georgetown University Hospital’s Abdominal Wall Reconstruction 2021 Conference, Jeffrey A. Blatnik, MD, noted several tips and tricks for avoiding errors when performing these complex procedures.

According to Dr. Blatnik, an associate professor of surgery at Washington University in St. Louis, the most important step is to understand the limits of the hernia, the patient and the hospital, respectively, before the procedure. This means considering the patient’s age, medical conditions, the size of the hernia, complications from prior operations and several other factors.

“Having these limitations in the back of your mind when you start to evaluate complex hernia patients can help you avoid making the first error of operating on somebody that you or your facility lack the resources to take care of,” Dr. Blatnik said.

Dr. Blatnik shared the following clinical pearls:

Getting Access Surgeons should develop a plan to get that can easily peel away. I will into the abdomen by studying the CT Closing the Posterior Sheath scan and abdomen. Previous repairs and not compromise the abdominal the presence of old mesh are complicatFor patients with a straightforward wall to remove every centimeter, ing factors for hernia repair. midline hernia without a hernia repair “I try to get into the abdomen away especially if I’m not there for history, closing the posterior sheath from previous surgery,” said Dr. Blatnik, can be a straightforward process. For infection. Take care of unnecessary who noted that this is primarily done many patients, however, this part of via sharp dissection. “I use a scalpel to damage to the abdominal wall.’ the surgery may require creativity. feel the fibers of the old mesh as I divide For a posterior sheath that won’t —Jeffrey A. Blatnik, MD them, and I like to open the entire midclose, Dr. Blatnik advised getting latline before dissecting out laterally.” eral and saving the part with the greatWith respect to lysis of adhesions, Dr. Blatnik recommended est tension for last. By removing the safety towel at that point, “finding a plane out lateral and circling back.” He also advised some of the tension can be relieved. “It’s also important not to “staying on the bowel side of things” to avoid inadvertently mobi- rely on suture to pull the edges together, and if it still won’t close, lizing the colon or injuring the peritoneum. then patch,” he said.

Dr. Blatnik also recommended using omentum for small holes Dealing With Old Mesh and absorbable mesh for larger holes. Lateral holes in the posteOld hernia mesh is not only incredibly painful for patients but rior sheath should be closed transversely to avoid additional midis the greatest predictive factor of challenges. Dr. Blatnik recom- line tension. mended dividing the mesh down the middle while opening the Closing the Fascia abdomen and then freeing underlying adhesions first.

“When removing old mesh, the lateral edge of old mesh is key,” Run primarily with long-term absorbable suture. As the tenhe said. “If the mesh ends medial to linea semilunaris, you can sion increases, however, surgeons should transition to figure 8 usually salvage the posterior sheath. If it ends lateral to the linea sutures, and if there is a big lateral defect from a transverse incisemilunaris, however, you’re going to lose some peritoneum.” sion, a barbed suture is recommended. Dr. Blatnik also advised Dr. Blatnik advised leaving old mesh in position while doing a keeping an eye on airway pressures as the fascia is closed. release and removing it at the end. He also suggested using land“Ultimately, do everything you can to preserve the peritonemarks, such as tacks or sutures, when working around old mesh um,” Dr. Blatnik concluded. “And when the going gets tough, get ■ to mark borders. lateral and work your way back to the midline.”

20

OR Management News • Volume 16 • December 2021

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OR Management News • Volume 16 • December 2021 21

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Anatomy of a Lawsuit: Advice for Wound Care Providers

By CHASE DOYLE

W

ith more than 17,000 lawsuits for pressure injuries alone each year, legal action can be a very real consequence of practicing clinical medicine, especially for wound care providers.

During the Symposium on Advanced Wound Care Spring 2021 meeting, Lee C. Ruotsi, MD, ABWMS, CWS-P, UHM, and Joyce Black, PhD, RN, discussed treatment and documentation strategies to reduce the risk for litigation, and to defend the treatment provided in a legal setting, should that become necessary.

Dr. Black, a professor at the University of Nebraska Medical Center, in Omaha, noted that to win a lawsuit, a patient’s lawyer must prove the following elements: • a professional duty owed to the patient; • breach of such duty; • injury caused by the breach; and • resulting damages, including wound, pain, disability and medical costs.

An attorney may not file a lawsuit if they do not see proof of all four elements on initial review.

According to Dr. Black, proper documentation is a critical piece in avoiding litigation. Typical consultation notes include history of the present illness, review of systems and the physical exam, followed by a diagnostic impression and treatment plan. If the patient’s condition is believed to be misclassified, the provider should document the etiology per the assessment and include supporting data.

Failure to accurately identify the etiology of the wound can sometimes come at the demand of the administration. Because treatment of pressure injuries is not reimbursed, Dr. Black said, there may be pressure to diagnose the condition as a diabetic foot wound instead, for example. However, the treatment that follows is not the same, which could present serious problems during litigation.

The question that arises frequently in legal discussions is whether the condition was present on admission or unavoidable. Present-on-admission documentation allows for deep tissue pressure injuries that are identified as evolving at the time of admission.

For deep tissue pressure injuries to be classified as “unavoidable,” said Dr. Black, the skin condition needs to be examined at the time of admission, but this is not limited to a 24-hour period, as these types of pressure injuries are not visible for 48 hours. Accurate assessment of risk, an appropriate plan of care and documentation of care are also required by the Centers for Medicare & Medicaid Services to establish a condition as unavoidable.

Costly Mistakes According to Dr. Black, the ability to speak to patients openly and honestly is an essential skill for a wound care provider 22

OR Management News • Volume 16 • December 2021

and may even protect a provider from medical malpractice. When healing cannot occur, for example, it is imperative that the patient or family be “kept in the loop,” she said.

“A family is going to be pretty upset if they thought a wound was minor or small and the patient ends up in the emergency room,” Dr. Black said. “If a family is taking pictures of the wound, then you should be taking pictures of the wound because those photographs will come into play.”

Although mistakes in the electronic health record (EHR) rarely lead to patient harm, she added, those errors frequently result in lawsuits. Red flags in the EHR include changes in the record, gaps in time and information, improper wound measurements, and incorrect wound terminology.

Under Pressure According to Dr. Ruotsi, the medical director at Saratoga Hospital Center for Wound Healing and Hyperbaric Medicine, in Saratoga Springs, N.Y., pressure injury is the single leading source of medicolegal litigation, and long-term care facilities and hospitals are the main targets. Common pitfalls of pressure injury include the following: • failure to perform and document the initial skin exam; • failure to establish accurate staging (staging drives dressing and surface choices); • failure to implement proper wound care; • failure to evaluate and implement plan for nutrition; • failure to implement proper pressure redistribution surface(s); • failure to implement and document turning and repositioning schedule; and • delay in recognition and intervention for worsening wound.

“It is useful and instructive to base your care and documentation on a hypothetical review of your own chart,” Dr. Ruotsi said. “If you reviewed your chart, would you be satisfied with your care?”

With this approach, providers should consider the things that they would not want to see in a chart, such as missing or incomplete initial skin exam, inappropriate or missing wound care orders, and failure to address skin issues in a timely fashion.

“At the end of the day, what we’re looking for is simply goodquality, well-documented patient care,” Dr. Ruotsi said. “Do the right thing; document that you did it; and be sure that your ■ charting reflects your policies and procedures.”

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