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Volume 7 • March 202 2022 02 22
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PPredictive redictive AAnalytics nalytics Can Reduce Reduce OR OR Costs Costs Can PProject roject IImproves mproves IInfection nfection Control PProcedures rocedures Control SSame-Day ame-Day Discharge Discharge ffor or Lap Colectomy Colectomy PPossible ossible Lap Brought B Br ough ou g t to y gh you ou ub by y th the e pu publ publisher bllis b i he her o off
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TABLE OF CONTENTS
BULLETIN BOARD
4 Using Predictive Analytics to Optimize Surgical Care, Reduce OR Costs 6 Tips to Improve Patient Safety in the OR 8 Project Tracks, Improves Hospital-wide Infection Control Procedures 10 Same-Day Discharge for Lap Colectomy Possible For Selected Patients 12 Hernia Mesh and Litigation: Where Things Stand 13 Mesh Removal: How Much Does Surgical Approach Matter? 14 Colorectal Cancer Surgery Outcomes Unaffected By General Anesthetic 16 Maybe It’s Cheaper to Pay Your Doctor 18 Surgical Planning in a Crisis: Leaders Share Lessons Learned
Trending Articles Online Read the most-viewed online-only articles on ormanagement.net. 1. Will CODA Trial Results Change Surgeons’ Approach to Appendicitis? X 2. Study Finds Main Drivers of Readmission After Hernia Repair 3. How Best to Manage the Crura During Sleeve Gastrectomy? 4. Nanopore Sequencing Promising for Quick, Accurate Intra-op Cultures
In the Next Issue AI in Surgery: Promise Mixed With Uncertainty “Regardless of all the burdens thrust upon us by our imperfect system, AI is poised to reduce administrative strains, improve patient outcomes and augment surgical training.” —Elsie G. Ross, MD
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20 Study Shows No Link Between NSAIDs and CDI 21 Buyers Guide 22 Cutting Hospital Stay May Increase Complications 22 Receipts Help Surgical Staff Cut Costs
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The Independent Source of News for Operating Room Managers, Supply Chain Professionals & C-Suite
OR Management News • Volume 7 • March 2022
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BUSIN E SS M A NAG E M E N T
Using Predictive Analytics to Optimize Surgical Care, Reduce OR Costs is scheduled. Physicians love it because they are able to save time and use their blocks more efficiently.” One hospital was able to save about $4 million per year by SAN DIEGO—A potential strategy to reduce the astronomical block time reduction alone. “The biggest challenge is trusting costs of the OR, where one minute can fetch up to $133, is to the data,” Ms. Bhatnagar said. “With the models running behind integrate predictive analytics, according to a presentation at the the scenes, you are able to go back to the surgeons and adminis2021 OR Business Management Conference. trators to give them an early warning of how likely a particular “The goal of surgical operations is to improve outcomes while block will be used next month, based on the previous data and also improving efficiency and reducing cost,” said Shikha Bhatthe observed trend.” nagar, the CEO of Healthinsights.ai, an artificial intelligence The surgeon can then take a deliberate action, such as releas(AI) company that provides prepackaged analytics products for ing his block, so another surgeon can use it instead. “We provide the healthcare industry and associated services.. an actionable insight to our surgeons,” she said. To help offset the cost of an inpatient stay, ay, “We do not believe that a machine can fix things,” Ms. Bhatwhich is 2.5 times higher for surgical casess nagar said. “We believe in humans interacting with the data to than nonsurgical cases, advanced analytics can n remedy a problem. But data can only take you up to a certain “enable desired surgeon workflows and deci-point. A lot of cultural change is required as well.” sioning at the time of need, in real time,” A common mistake in healthcare is to centralize the data she said. from multiple local clinical processes, according to Bruce RamAmong the most important areas to evalshaw, MD, the founder and managing partner of, and a shareuate are first-case delays, turnaround times, Shikha Bhatnagar holder in, CQInsights PBC, a healthcare data analytics and inefficient scheduling practices, underuse consulting company headquartered in Knoxville, Tenn. of blocked time, and supply cost comparisons of procedure and surgeon. “Centralized data generates averages but lacks insight,” he said. According to Ms. Bhatnagar, the five levels of analytics are: “The data should be decentralized into context for each whole defin• Level 1: manual input and manipulation of data able process in each local clinical environment. Many subpopulations, like minorities, are not well represented by averages and may • Level 2: manual data extracts from electronic health records suffer harm from algorithms produced using centralized data sets.” and running metrics in Excel Dr. Ramshaw said the small clinical team that actually pro• Level 3: integrated data sourcing and building of basic vides the surgical care should determine what data points and reports/dashboards outcome measures are collected in each local clinical environ• Level 4: mastering retrospective reports with data ment. “The same team should also apply insights gained from integration, plus moving to predictive analytics each analysis to improve outcomes that are measured,” he said. • Level 5: all of the above, plus building and deploying However, because real-world data “is messy, the data requires predictive surgery models to forecast block usage, surgical regular cleansing and feedback loops working with the front-line volume and more, and then delivering those insights to clinical team in each local environment to assess and improve the administrators, surgeons and decision makers quality of the data,” Dr. Ramshaw said. ■ “You need to have driven-data conversations,” Ms. Bhatnagar said. “For example, if a particular service line is not using its Dr. Ramshaw is a member of the editorial advisory board of block, talk to them. Perhaps Fridays can be eliminated if nothing OR Management News. By BOB KRONEMYER
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OR Management News • Volume 7 • March 2022
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CLIN IC A L NE WS
Tips to Improve Patient Safety in the OR By ALISON McCOOK
E
ven the most routine procedure can quickly become unconventional. A hysteroscopy can result in a uterine–sigmoid colon perforation; a sponge can be left in a patient after surgery; or a patient can develop an infection from a device that wasn’t properly reprocessed. The list of things that could go wrong— putting the patient’s safety at risk—is endless. Adverse events cannot be prevented completeletely, but lessons can be drawn from them. That hat was the goal of a recent study by the nonproffit ECRI, which reviewed nearly 2,000 adverse se surgical events that were voluntarily reported ed by OR staff at hospitals around the United States between 2018 and 2019. During the Association of periOperative Registered Nurses (AORN) 2021 virtual Global SurGail Horvath, MSN gical Conference & Expo (session 8837), Gail Horvath, MSN, RN, the senior patient safety analyst and consultant at ECRI, grouped the results into types of surgical mistakes, and presented tips to avoid them. Complications Approximately half of the adverse events reviewed by ECRI were classified as complications, often related to either anesthesia or the surgery itself, such as bleeding or perforation. Complications are unavoidable, but there are ways to reduce the chances they will happen, Ms. Horvath said. For instance, facilities should follow evidence-based recommendations, such as tips to avoid pressure injuries, from the Joint Commission. They can conduct root cause analyses of past adverse events, she said, and analyze current processes to determine ways they can fail. In addition, staff should undergo skill retraining and refresher courses on a regular basis, which “are vital to reducing the risk of surgical complications.” Room and Patient Readiness In three out of 10 incidents reviewed, either the patient or the room wasn’t ready at the time of surgery. It’s more than just an inconvenience, Ms. Horvath said. “Ensuring rooms are properly set up is really essential to getting your patient safely through the procedure.” A robust preadmission process will help develop a good perioperative plan of care, and identify information gaps and other issues that could lead to delays. Make sure your informed consent process is airtight, she noted, as it’s “much
6
OR Management News • Volume 7 • March 2022
more than getting a signature on a piece of paper.” It’s also giving the patient or their representative all the information they need to evaluate the risks and benefits of the procedure. One way to avoid readiness issues is to conduct a preoperative briefing before bringing the patient into the OR, suggested Lisa Spruce, DNP, RN, the director of evidence-based perioperative practice at AORN. During the briefing, staff can review the planned procedure, pertinent lab results or radiographs, patient position planned, pressure injury risk, equipment or instruments needed, the plan for patient skin antisepsis, “and any other questions or safety concerns,” she said. Retained Surgical Items Roughly one-fourth of the reported adverse events involved a surgical item mistakenly left inside the patient, such as needles, sponges or device fragments like catheter tips. These small items “can go unnoticed, but can result in devastating consequences for the patients,” Ms. Horvath said. Staff within each facility may follow different count practices (AORN J 2012;95[2]:228-238), which can put patients at risk. A key step, said Ms. Horvath, is to standardize count policies and procedures, including the timing of counts, and which items should be counted. Facilities could consider adopting a “sterile cockpit” approach to counting, based on an aviation policy that prevents nonessential activities during critical flight periods. “The sterile cockpit approach during surgery will help patients by reducing distractions during key moments in the operation,” she said. Contamination Infection control is a major issue at every hospital. To minimize the impact of contamination on your facility, Ms. Horvath recommended continuously reviewing and updating reprocessing protocols and workflows, to make sure they are both effective and realistic. Reprocessing staff must be properly trained (and retrained) and shouldn’t get overloaded, which can force them to skip steps. Good communication between the OR and sterile reprocessing is crucial, she added, so that neither blames the other for any failures. “It’s critical that you foster collaboration and teamwork between these two essential departments.” Equipment Failures Although equipment failures made up only 5% of the reported incidents analyzed, they can have major consequences for continued on page 20
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INF ECTIO N CO NTRO L
Project Tracks, Improves Hospital-wide Infection Control Procedures By MARCUS A. BANKS
O
perating room staff are likely to get prompt feedback from aware of which infection control supplies they had on hand or sterile processing colleagues if they do not properly preclean which supplies could be disposed of and which needed to go to or spray a medical instrument before sterilization, but such feed- sterile processing. back is less likely to occur for employees in units farther from the In a joint effort involving nursing, infection prevention and OR, such as the women’s health or endoscopy units, according to sterile processing leaders encompassing every unit of the hospiinfection preventionist Jill Holdsworth, CIC, CRCST, of Emory tal, Ms. Holdsworth said, “we figured out what was there, what Hospital Midtown, in Atlanta. needed to be there and what maybe didn’t need to be stocked anyAt the 2021 virtual meeting of the Association for Profes- more.” After taking this inventory, Ms. Holdsworth and her colsionals in Infection Control and Epidemiology, Ms. Holdsworth leagues proactively listed exactly which infection control supplies described Emory’s ongoing strategy for standardizing infection a given unit needed, so there would be no waste when ordering. control procedures throughout her facility. “We didn’t want them to buy a bunch of biohazard bins that “We had so many inconsistencies throughout the hospital with didn’t fit their instruments,” Ms. Holdsworth said, noting that transportation of soiled instruments,” Ms. Holdsworth said, not- this inventory support effort was one major achievement of the ing that sometimes these instruments are carried in Tupperware- initiative. type storage containers. “I see that in a lot of facilities right now, In addition to the inventory support, in April 2018, so we set out just to standardize everything.” Ms. Holdsworth’s team launched an intensive education camWhen Ms. Holdsworth began this paign about infection prevention best effort in 2018, she and her colleagues ‘We had so many inconsistencies practices throughout the hospital. One noticed that OR employees had a consisaspect of this effort was simple, engaging throughout the hospital tent process for managing soiled instruflyers, including one that highlighted the ments that involved spraying them with with transportation of soiled “three easy steps” involved in precleaning surfactant gel and transporting them in medical instruments (box). instruments. I see that in a lot of closed carts that reduce the risk for conAs of February 2019, audits of the tamination. OR employees also received facilities right now, so we set out units outside the OR showed an increase regular training on how to avoid contamin compliance from 20% to 91%. In June just to standardize everything.’ inating surgical equipment. 2019, compliance reached 100%. —Jill Holdsworth, CIC, CRCST In contrast, within procedural or clinCommenting on the Emory project, ical areas outside of the OR, practices Casey Czarnowski, CIC, CRCST, the were much more inconsistent. Infection control training by sterile sterile processing educator at Stanford Health Care, in the San processing staff occurred less frequently or not at all in these areas, Francisco Bay Area, said the initiative points to the fact that infecand proper equipment was not always on hand. Unlike within the tion control will always be crucial. “There’s no time constraint OR, which used an electronic system to audit compliance with when it comes to patient safety,” Mr. Czarnowski said. infection control procedures, there was no consistent way to docHe said he promotes the idea that any member of a hospiument whether staff in other units followed proper protocols. tal staff, regardless of their role or the unit they work in, should Ms. Holdsworth’s first step was to develop a documentation feel empowered to speak up if they think any medical instrument form to track other units’ compliance with best practices for might be contaminated. Mr. Czarnowski likens this to the “stop infection control, using a biohazard container for transport of the line” philosophy of automobile manufacturing, in which any soiled instruments to the sterile processing unit and precleaning employee can request a production halt if they think something and spraying instruments before taking them away. dangerous happened somewhere along the line. With the available data, Ms. Holdsworth determined that For her part, Ms. Holdsworth is not resting on the laurels of units outside the OR were compliant with best infection con- hitting 100% compliance in managing soiled instruments, saying trol practices less than 20% of the time when the project began. that the work of optimizing infection control at Emory Midtown ■ This intake stage also revealed that staff in many units were not will always be ongoing.
8
OR Management News • Volume 7 • March 2022
DO YOUR PATIENTS HAVE MESH HESITANCY? With all the recent publicity surrounding synthetic mesh, is it any wonder that more and more hernia patients are in search of alternatives? OviTex® Reinforced Tissue Matrix can help address these concerns by providing your patients a More Natural Hernia Repair™. To learn more about OviTex’s proven clinical performance and how it can help address mesh hesitancy, visit our website at v.TELABIO.com/GoNatural, or scan the QR code below.
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w w w.telabio.com OviTex Reinforced Tissue Matrices are intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome. Do not use OviTex in patients known to be sensitive to materials of ovine (sheep) origin. For additional important safety information, please see the OviTex Reinforced Tissue Matrix Instructions for Use. Caution: Federal (US) law restricts this device to sale by or on order of a physician. TELA Bio, Inc. owns or has applied for the following trademarks or service marks: TELA Bio, OviTex. A surgeon must use his or her own clinical judgment when deciding which products are appropriate for treatment of a particular patient. Always refer to the package insert, product label, and/or instructions for use before using any TELA Bio product.
C LIN IC A L NE WS
Same-Day Discharge for Lap Colectomy Possible for Selected Patients Study Uses Remote Follow-up and Gives Patients Choice of Discharge or Admission By CHRISTINA FRANGOU
S
ome patients can be safely discharged home on the same day as their laparoscopic colectomy if they are followed remotely by a healthcare team, according to a study presented at the 2021 annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. Some surgeons and patients, however, say they worry about patients being rushed home before they feel ready. In a study carried out at two university-affiliated colorectal referral institutions, 79 out of 105 patients, or 75%, were successfully discharged on the day of their surgery. They were eligible for same-day discharge, or SDD, if they had no significant comorbidities, lived within 30 minutes of the hospital and did not require creation of a new ileostomy. Patients were asked if they preferred to go home or be admitted. All patients underwent remote follow-up with a mobile health app or daily telephone call from their surgeon. Two patients returned to the emergency department within 72 hours of discharge—one for urinary retention and the other with an anastomotic leak, which was managed conservatively. “Same-day discharge can be done safely with either an mHealth phone app or telephone calls for remote follow-ups, which significantly reduces the resource burden but with the same results,” said lead author Lawrence Lee, MD, PhD, an assistant professor of surgery, McGill University Health Centre, in Montreal, in an email to OR Management News. Co-investigator Jules Eustache, MD, a general surgery resident at McGill University, presented the study at SAGES. Overall, 10 patients, or 12.7%, returned to hospital within one month of surgery, consistent with previously published studies of colorectal surgery, said the investigators. The study started before the pandemic but picked up new urgency as COVID-19 put pressure on hospital systems. In the first wave, many patients were afraid to stay in the hospital, and Quebec’s ministry of health asked hospital staff to reserve capacity for patients with illnesses related to the virus, said Dr. Lee. As a result, SDD enabled more patients to have surgery that they otherwise would have waited for, said Dr. Lee. “It is not an exaggeration to say that a good proportion of our SDD patients would not have had their surgery done in a timely manner if the SDD hadn’t existed,” he said. The investigators set out to study SDD because McGill’s experience with an enhanced recovery after surgery protocol, or ERAS, showed that most of the patients remained in hospital after a laparoscopic colectomy only to pass gas. But research from other institutions demonstrated that patients could be safely discharged before their GI function returned.
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OR Management News • Volume 7 • March 2022
‘It just takes one patient having a major complication at home where they cannot get through to their provider or get fast-tracked through the emergency department, and that morbidity becomes a preventable mortality for this concept to go up in flames, so it is critical that implementation is appropriate.’ —Deborah S. Keller, MD The development of mHealth apps around the same time made remote post-discharge monitoring possible, said Dr. Lee. The investigators felt the combination of these principles suggested that SDD in these patients could be safe, he added. Patients underwent laparoscopic colectomy, using a Pfannenstiel incision when extraction was necessary. After surgery, patients spent four to six hours in the recovery room. To be discharged, they had to be able to tolerate a liquid diet, have their pain controlled with oral analgesia, and could ambulate and void independently after removal of any catheters. Patients were only discharged on the same day if they preferred to go home. The main reason for admission was patient preference, followed by intraoperative complications that required monitoring, nausea, poorly controlled pain and urinary retention. Patient Perspectives Should Be Considered By video at SAGES, Sue Blackwell, a patient working with the patient relations group of the Association of Coloproctology of Great Britain and Ireland, said patients want to stay in hospital until they felt ready to go home—“not when clinicians felt they were ready. If that was day 3, then great, but if it was day 10, then also great.” Deborah S. Keller, MD, an assistant professor of surgery at the University of California Davis Medical Center, said patients need to be asked if they are comfortable going home on the same day as their surgery. They often feel rushed by ERAS and SDD policies, she said. Dr. Keller said patients being discharged on the same day need in-depth communication with their surgeon and wearables that continued on page 22
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FE ATURE
Hernia Mesh and Litigation: Where Things Stand By MONICA J. SMITH
trying one case, the bellwether case,” Mr. Bartos said. “Generally, as goes the bellwether case, so goes the entire group of cases.”
P
What Are All These Lawsuits About?
rogress invites criticism, and in surgery, innovation often begets litigation, as most every surgeon whose practice involves mesh-reinforced hernia repair can attest. “The ads for hernia mesh lawsuits are everywhere, and if you Google ‘hernia mesh lawsuit,’ you’ll see ad after ad after ad for lawyers. We face it every day in our offices; it’s ubiquitous,” said Guy Voeller, MD, at the 2021 virtual Abdominal Wall Reconstruction Conference. Dr. Voeller is a professor of surgery at the University of Tennessee Health Science Center, in Memphis. “But the problem with mesh in hernia repair is that we have to have it; trying to repair many hernias with suture alone is doomed to failure.” Mesh is now the standard of care in hernia repair for its ability to dramatically reduce the rate of recurrence. But it’s also become a target for lawsuits. What started with a smattering of cases in the 2000s has ramped up considerably in the last five years, so much so that many of them are being tried as multi-district litigation (MDL). “MDL is a creature of the federal court system. Typically, you’ll bring a number of cases that have been filed in a variety of districts around the country under one umbrella,” said Todd R. Bartos, Esq., an attorney with The Bartos Group LLC, in Lancaster, Pa. “The MDL is basically an efficient way to consolidate common portions of cases and reduce the risk of inconsistent results. MDLs also encourage the quick resolution of these cases by
The complaints against inguinal and incisional hernia repair with mesh have some similarities, but not entirely. Legal issues in inguinal hernia repair revolve mainly around chronic groin pain. In 2013, a commentary by Josef Fischer in “Fischer’s Mastery of Surgery” argued that mesh is responsible for inguinodynia and that surgeons should stop using it; this provoked a counterargument by Arthur Gilbert that autologous repair, along with its higher recurrence rate, also causes chronic groin pain, Dr. Voeller said. “Dr. Gilbert’s position was that the pain is due to the absence of technique, not the technique itself.” Thus, paper after paper examined recurrence rates and pain with or without mesh; in sum, the clinical data find mesh-based laparoscopic inguinal repairs to be less associated with chronic groin pain than any other type of repair, Dr. Voeller said. “Mesh in and of itself is not a major cause of chronic groin pain.” This is not to imply that mesh is benign. Take the case of mesh in transvaginal pelvic organ prolapse (TV-POP), which was FDA approved for this indication in 2001 as a 510(k) clearance. “But we had no short- or long-term safety data regarding this use due to the 510(k) approval process not requiring clinical trials. As more surgeons started using mesh, we saw more complications at a rate up to 50% for erosion, pain, infection, dyspareunia and GU [genitourinary] issues,” Dr. Voeller said.
Tips for Surgeons Using Mesh Have detailed, documented conversations with patients. “Explain why mesh is necessary, the pros and cons of different types of mesh, and whether there’s an alternative,” said Todd R. Bartos, Esq., an attorney with The Bartos Group LLC, in Lancaster, Pa. “Also, explain post-op instructions. Tell them why it’s important not to lift that 40-pound bag of dog food for the next six weeks.”
12
Take clear operative notes. “The op note is the critical piece to keep surgeons out of the hot seat. It’s one thing for mesh manufacturers to bear the risk of litigation of a failed product, but you want to make sure that you’re minimizing your chances that a failed product will be argued to have also been improperly applied,” Mr. Bartos said.
OR Management News • Volume 7 • March 2022
Maximize patients’ preoperative condition and manage expectations. “We have to let patients know that abdominal wall reconstruction is a very complex surgery with complex issues and the potential for significant complications,” said Guy Voeller, MD, a professor of surgery at the University of Tennessee Health Science Center, in Memphis, at the 2021 virtual Abdominal Wall Reconstruction Conference.
C LINICA L NEWS
Ultimately, the FDA required all companies to withdraw mesh for TV-POP in 2018. Soon, lawsuits around mesh use in that procedure were big news and big money. “In 2019, The New York Times reported that seven manufacturers paid nearly $8 billion to resolve more than 100,000 claims. The law firms got a lot of money; having profited from these claims, they decided to look at mesh in inguinal and incisional hernia,” Dr. Voeller said. Complaints against mesh use in incisional repair are similar to those in TV-POP: pain, erosion, recurrence, bowel obstruction, seroma, infection and death—“all the complications we see with complex reconstruction of the abdominal wall,” Dr. Voeller said. “In these lawsuits, the material is accused of tearing or breaking, the coatings don’t prevent adhesions, the pore size isn’t right—the complaints go on and on.” Plaintiffs’ counsels are not just motivated by money, Mr. Bartos said. “Many are truly in it to protect patients and prevent avoidable harm. Where we get into disputes is whether something is ‘avoidable’ or simply a known risk of using a foreign material to repair a fascial defect. Many times, there are issues of what a manufacturer knew and when it knew it regarding risk profiles. But there is no arguing that it is a lucrative business, and there are some who invest heavily in ads to generate a larger group of plaintiffs.” Where We Stand Now At this point, many of the manufacturers of mesh used in hernia repair are involved in MDLs. Although many cases were suspended in 2020 due to the coronavirus pandemic, these cases are now working their way through the MDL system. The case against Bard and its Ventralight ST mesh rebooted in August 2021. “The use of MDL and bellwether cases gives a sense of where a jury would go in each of the other tens of thousands of potential cases. That allows a reasoned risk calculation for both sides,” Mr. Bartos said. If there is a loss at trial, that is not the end of it. “If Bard loses and there is a damages award, typically the MDL parties would get together to discuss a global settlement, but Bard could appeal a bellweth■ er case defeat,” Mr. Bartos said.
Mesh Removal: How Much Does Surgical Approach Matter? By KATE O’ROURKE
D
oes surgical approach have a role in inguinal hernia mesh removal? At the 2021 annual meeting of the Americas Hernia Society (abstract 50176), researchers of a new study sought to answer this question. The study led by Desmond Huynh, MD, a PGY-4 general surgery resident at Cedars-Sinai Medical Center, in Los Angeles, included 113 patients, 39 of whom had open, 23 of whom had laparoscopic and 51 of whom had robotic mesh removal. The approach was based on initial mesh placement. Mesh that was placed anteriorly in an open fashion was removed via the open technique, and preperitoneal mesh was removed either laparoscopically or robotically. Patients were evaluated two weeks after removal, and long-term follow-up occurred at a mean of 2.5 years. The patients in the three cohorts were well balanced in terms of comorbidities and indications for mesh removal, which included foreign-body sensation, meshoma, reaction, neuralgia and infection. The operative time was longest with the robotic approach (226 minutes), followed by open (181 minutes) and laparoscopic procedures (169 minutes). There was a significantly different rate of intraoperative injury and major vascular injury among the three approaches, with the laparoscopic group having the highest rate of injury (Table). The mean blood loss was 77 mL in open, 96 mL in laparoscopic and 52 mL in robotic procedures, with significant variance. There was no difference in postoperative complications among approaches. There was no difference in pain scores among groups at two-week and long-term follow-up with a mean of 2.5 years. There was a significant improvement in pain scores in all patients after mesh removal. There was no difference in pain score improvement among the approaches. The authors concluded that all mesh removal approaches were effective in treating chronic postoperative inguinal pain after inguinal hernia repair. The three groups were equally affected by treating postoperative chronic inguinal pain, yielding durable improvement. There was significant variance among the groups with regard to operative time, rate of injury and blood loss, with post hoc analysis suggesting that a robotic approach may confer some advantage, Dr. Huynh said. However, these observed differences were small. continued on page 20
Table. Operative Complications Open
Laparoscopic
Robotic
P Value
Intraoperative injury
4 (10%)
8 (39%)
8 (16%)
0.044
Minor vascular (inferior epigastric, gonadal)
4 (10%)
4 (17%)
7 (14%)
NS
Major vascular (external iliac)
0 (0%)
3 (13%)
1 (2%)
0.019
Nerve
0
1 (4.3%)
0
NS
Organ
0
0
0
NS
NS, nonsignificant
OR Management News • Volume 7 • March 2022
13
CLIN IC A L NE WS
Colorectal Cancer Surgery Outcomes Unaffected by General Anesthetic By MICHAEL VLESSIDES
T
he choice of general anesthetic regimen—either total intravenous anesthesia (TIVA) or volatile anesthesia—does not appear to affect cancer outcomes after colorectal surgery. The authors of this systematic review and meta-analysis noted that these findings contrast with previous studies, which showed a protective effect of TIVA in other types of cancer surgery. “There is both clinical and preclinical evidence which suggests that even though exposure to anesthesia is brief, it can potentially have significant clinical impact on outcome after cancer surgery,” said Zhaosheng Jin, MD, a resident at Stony Brook Medicine, in New York. “This project looks at the clinical evidence for whether there’s any significant outcome change between different choices of anesthesia for colorectal cancer surgery, which is one of the most common cancer types in the U.S.” As part of the investigation, Dr. Jin and his colleagues conducted a literature search of the PubMed, Central, EMBASE, CINAHL, Google Scholar and Web of Science databases for clinical studies that compared adult patients who underwent potentially curative colorectal cancer surgery under general anesthesia with total intravenous propofol or with volatile anesthetic agents. The researchers extracted a variety of data from each investigation, including cancer recurrence, recurrence-free survival rate and mortality. “One thing we wanted to exclude to minimize confounding was the concurrent use 14
of regional anesthesia,” Dr. Jin said. “That is another intervention that is thought to affect the outcome of cancer surgeries.” A Surprising Lack of Difference In a presentation at the 2021 virtual annual meeting of the International Anesthesia Research Society (abstract 849), Dr. Jin said that the literature search was conducted through early January 2021. By that point, the investigators had identified a total of four fairly large studies comparing TIVA and volatile anesthesia in colon cancer surgery, each of which was assessed for quality using the Quality of Prognostic Studies (QUIPs) tool: • Enlund et al. Ups J Med Sci. 2014;119(3):251-261; • Hasselager et al. Br J Anaesth. 2020;126(5):921-930; • Makito et al. Anesthesiology. 2020;133(4):764-773; and • Wu et al. Anesthesiology. 2018;129(5):932-941. All of the investigations reported mortality rates after follow-up periods ranging from two to five years. The meta-analysis did not find any significant difference between TIVA and volatile anesthesia for all-cause mortality (hazard ratio [HR], 0.76 for TIVA; 95% CI, 0.54-1.08). The rate of cancer recurrence was reported by two studies. The researchers found no significant difference between TIVA and volatile anesthesia, yielding an HR of 0.80 for TIVA (95% CI, 0.58-1.09). Finally, two studies examined
OR Management News • Volume 7 • March 2022
recurrence-free survival, which again showed no significant difference between the two anesthetic approaches (HR, 1.02 for volatile anesthesia; 95% CI, 0.91-1.15). As Dr. Jin discussed, the findings proved surprising to the researchers, given preclinical data suggesting that propofol and volatile anesthesia have different effects on cancer cells. “On the other hand, cancer is a very broad and arguably nebulous term,” he noted. “Different kinds of cancer cell lines have very different phenotypes, and different types of surgeries will have different physiological impacts on the possible recovery period. So, it may just be that colorectal cancer is not something that is affected by the use of TIVA versus volatile anesthesia.” These findings, Dr. Jin added, contrast with previous research conducted by him and his colleagues. “We did a similar study looking at breast cancer a couple of years ago and found that the choice between volatile anesthesia and TIVA does have some impact in terms of outcomes.” While the current study did not yield similar results, the researchers believe the relatively small pool of studies may play a part, and more studies are needed for reliable evidence. A Robust Randomized Trial Needed “The limitations of retrospective analyses are well known, with nonrandom treatment allocation and unobserved confounding being the most important,” commented Daniel I. Sessler, MD, the Michael Cudahy Professor and chair of the Department of Outcomes Research at Cleveland Clinic. “Combining four registry studies in a meta-analysis does not lessen the major limitations of retrospective analyses, which rarely include sample size. What we need now is a robust randomized trial. Fortunately, VAPOR-C recently started and should provide clear evidence supporting or denying the theory that intravenous anesthesia improves cancer-free survival.” VAPOR-C is the Volatile Anaesthesia and Perioperative Outcomes Related to Cancer trial (ClinicalTrials.gov Identifier: NCT04316013), based in Australia and New Zealand, and has a target sample size of 5,736. ■
STAY CONNECTED!
P E RSP ECTIVE
Maybe It’s Cheaper to Pay Your Doctor By PAULA MUTO, MD, FACS B
O
ur healthcare system is a disaster and getting worse by the day. No one seems to be satisfied, patients complain about the cost, doctors complain about paperwork, employers are tapped out and politicians try to avoid the subject. The only folks who are benefiting from the broken system are the ones in the middle who have created multiple layers of complexity that have siphoned off the majority of the healthcare dollars into a giant black hole. The problem is individuals and employers seeking health care plans feel they have little choice and, therefore, humbly agree every year to another price increase, to pay for the “rising costs” of pharmaceutical, hospital and specialty care. Clearly, there needs to be better options. While technology has moved the practice of medicine from the hospital to the office, to the patient’s home, the established healthcare system has not modernized to meet the new requirements. Hospital workflows have become increasingly burdened with a bureaucracy designed for corporate compliance rather than patient wellness. Doctors have had to constantly adjust and conform to protocols that impede, redirect and distract from properly implementing treatment in a timely manner. That is why the job burnout rate is so high and patient satisfaction so low. It took a pandemic to push us into the future, allowing us to reprioritize care, adopting new technologies while streamlining others. Outpatient joint replacements, for example, are now becoming the new standard, and with improved outcomes, and telemedicine has emerged as an important addition to nearly every practice. In short, doctors have found new ways to work around the system and they are taking their patients with them. There is no price transparency in healthcare. No one ever claims to know the exact price of services, although the balance sheet clearly shows what insurers haven’t paid. Fee schedules are exaggerated to give insurers a chance to bargain. However, spoiler alert: It’s actually much cheaper just to pay a transparent fee for a specific service. It’s expensive to bill, collect and obtain authorizations, and nowadays many patients have such high plan deductibles that they are paying out of pocket anyway. More and more often, paying with insurance can cost more, especially when it comes to medications. Patients should demand to know the price, and many doctors now oblige, and it would behoove hospitals to do the same. The consumers drive demand and healthcare is no different. Buying insurance no longer guarantees a doctor’s time; on the contrary, it limits it. But going to a doctor doesn’t cost as much as a premium. With the advent of telemedicine, good doctors can see their patients more efficiently, 16
OR Management News • Volume 7 • March 2022
lowering the cost for both the office and the patient. Hospitals can also change the equation by offering better access through price-transparent models. There are a number of places where patients can find affordable options for pharmaceuticals, imaging and specialty care, including surgery. Primary care physicians have been the first to see the value in direct pay models, but now every specialty is joining the movement. Employers are discovering medical cost-sharing plans that save companies—big and small—millions of dollars, and as more physicians participate, the market will shift back to the patients. Even the government sees the benefit in direct pay models. The innovations in medicine in the past decade have been remarkable, but physicians and their patients can’t take advantage of all of them because of an archaic system built on principles that no longer apply. The best care is always found nearby, but when an employee works in another state, then what happens? The costs have not and will not be controlled by restrictive insurance networks. Coverage will always be necessary, but in a direct-pay world, the majority of encounters can be paid for out of pocket. In this case, less is more, and keeping people out of the doctor–patient equation saves both time and money. ■ —Dr. Muto is a general surgeon; the founder and CEO of UBERDOC, a digital health platform connecting patients and doctors; and the director of the Vein Center at Muto Surgical, in North Andover, Mass.
‘While technology has moved the practice of medicine from the hospital to the office, to the patient’s home, the established healthcare system has not modernized to meet the new requirements. Hospital workflows have become increasingly burdened with a bureaucracy designed for corporate compliance rather than patient wellness.’
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F E ATURE
Surgical Planning in a Crisis: Leaders Share Lessons Learned By KAREN BLUM
A
ssessing patients’ priority for surgical care, taking more precise inventory of predicted bed use after surgery, and moving some cases to same-day operations or ambulatory surgery centers are some ways surgical teams can still manage their caseloads during times of disruption, a panel of clinicians said during a recent webinar hosted by Becker’s Healthcare. One of the biggest recent and ongoing disruptors has been the COVID-19 pandemic. Spectrum Health, an integrated health system in western Michigan, has introduced seven critical interventions to continue to deliver surgical care during an overwhelming period, said Adam Post, MSN, MBA, the system’s senior director of business operations for radiology and surgery. In March 2020, the health system opened a command center in response to COVID-19 to offer a systemwide approach to coordinate clinical activities and any incident-related communications. A few days later, the surgical services division launched a “surgery camp” to support all COVID-19 operations, consisting of surgeons, project specialists and business intelligence analysts. Mr. Post and his colleagues first realized they needed a way to prioritize surgical cases. While they had never leveled patients by need before, the team introduced and built into the electronic health record a prompt for surgeons to assign patients a priority level of 1 to 4 based on surgeons’ professional assessments, patients’ acuity and projected length of stay; LACE+ index scores and American Society of Anesthesiologists physical status; and preoperative diagnoses. Level 1 cases were considered urgent/ emergent and level 4 were those that could be deferred. They began deferring surgeries for level 4 patients, then for level 3 patients, but as time progressed and more safety protocols were put in place, the system was able to bring in many of those patients for surgery. “We took the performing providers’ assessment and level assignment very seriously in our process, and had surgeon leaders reviewing assigned leveling and assuring adherence to our criteria,” Mr. Post said. As the pandemic wore on, by August 2020, the team wanted to better understand patients’ postoperative destination. Some surgeons who previously were uncomfortable with the idea of safe, same-day discharges for procedures soon became followers, to continue to deliver much-needed care to their patients. “Everything we did was, of course, rooted in what was best and most safe for each patient,” he said. “As of today, we haven’t seen any uptick in clinical outcomes such as emergency department visits or readmissions.” Along with the transition to outpatient care and same-day discharges, the team wanted to better predict their volume of available surgical beds. Some providers were scheduling patients as admissions when they planned to discharge the same day, while 18
OR Management News • Volume 7 • March 2022
others were scheduling patients as outpatient if they required a bed. The team added a post-procedure destination field in the electronic health record to coordinate planned surgical admission volume. It was so helpful—a “game changer for predictive analytics,” Mr. Post said—that the team plans to keep the procedure in place even after the pandemic recedes. Next, by the end of 2020, the team created a deferral dashboard to track all deferred cases. “We treated every deferral like the precious surgical patients that they were, and wanted to assure that when we were able, that their care would be delivered,” he said. The team worked hard to understand where each patient was in the surgical process, either waiting to be scheduled or rescheduled, and whether their procedure was completed or no longer needed.
‘From flooding, to heating, ventilation and air conditioning failures, to full-blown hurricanes, I think we’re going to have better plans and better response strategies, and quicker response times. I think our patient outcomes and our operational effectiveness will be enhanced as a result.’
—Lee Ausmus
Finally, in April 2021, the team introduced daily deferral calls with representatives from incident command, as well as the physician on call, inpatient nursing director, staffing office, bed planning and surgery operations to understand what deferrals, if any, need to be made each day based on the current situation. All together, these methods allowed the team to predict their census for a 1,000-bed-plus hospital system within 0.5%. Some Fortune 500 companies like IBM use the “what if ” philosophy to plan for crises, said Lee Ausmus, the administrator of St. Michael’s Ambulatory Surgery Center in Clearwater, Fla. “I think that’s really key to our ability for quick responses to disruptions or unexpected components,” he said. Organizations like the Federal Emergency Management Agency, as well as first responders, are tuned in to vulnerability assessments, Mr. Ausmus said. “As healthcare leaders, if we can have ongoing readiness, that potentially allows us to conduct the ‘what if ’ with tremendous frequency,” he said. “From flooding, to heating, ventilation and air conditioning failures, to fullblown hurricanes, I think we’re going to have better plans and better response strategies, and quicker response times. I think our patient outcomes and our operational effectiveness will be ■ enhanced as a result.”
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IN FECTIO N CO NTRO L
Study Shows No Link Between NSAIDs and CDI By DAVID WILD
N
on-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) do not increase the risk for Clostridioides difficile infection (CDI), according to a retrospective review of nearly 1,500 people. The results stand in contrast to prior findings that have suggested an association between NSAID use and CDI. “To our knowledge, this is the first study of NSAID use as a risk factor for CDI to account for treatment assignment bias utilizing propensity score matching,” noted lead investigator Adam Ressler, MD, from the Department of Internal Medicine, Division of Infectious Disease, at the University of Michigan, in Ann Arbor (Anaerobe 2021 Sep 8. doi:10.1016/j.anaerobe.2021.102444). “This is significant, as it increases our confidence that our modeled risk of CDI is causally related to NSAID use itself, rather than the underlying indication for the NSAID use.” The authors said prior research on the topic that found an association between NSAID use and CDI “had two major limitations, [including] inadequate assessment of over-the-counter NSAID use and failure to account for treatment assignment bias.” In this study, Dr. Ressler and his team identified 628 CDI cases from a previously published cohort treated at Michigan Medicine and 628 controls who had diarrhea suspicious for CDI but who tested negative for CDI. They analyzed data for prescribed and over-the-counter non-aspirin NSAID use within 30 days of CDI, as well as comorbidities and baseline laboratory findings. To overcome the weaknesses of prior research, patients with CDI and NSAID use were closely matched with nonCDI NSAID users according to sex, presence of back pain and arthritis, baseline serum creatinine, serum albumin, and use of anticoagulants for antiplatelet medications. The investigators found that 22% to 26% of those with or without CDI had used non-aspirin NSAIDs during the previous month, with analyses confirming there was no elevated CDI risk among those receiving NSAIDs (odds ratio [OR], 0.97; 95% CI, 0.72-1.29; P=0.816). The only significant risk factors for CDI they found were older age (OR, 1.09; CI, 1.01-1.17; P=0.02), scores on the weighted Elixhauser Comorbidity Index, a measure of comorbidity burden (OR, 0.98; 95% CI, 0.97-0.99) and prior CDI (OR, 2.64; 95% CI, 1.96-3.56). Dr. Ressler and his colleagues concluded that their “findings do not support an association between NSAID use and an ■ increased risk for CDI.”
20
OR Management News • Volume 7 • March 2022
Patient Safety Tips continued from page 6
patients, Ms. Horvath said. It’s important for institutions to review and optimize their protocols to inspect and maintain equipment, regularly train staff on the use of equipment, and establish a process for responding to and reporting equipmentrelated events, both within and outside the facility, she said. Wrong Site, Wrong Patient Less than 4% of reported incidents involved surgeries performed on the wrong patient or on the wrong surgical site, but that’s no reason to become complacent, Ms. Horvath said. “Just because something didn’t happen to you before doesn’t mean it’s not going to happen today,” she said. “Things that never happened before happen every single day.” Institutions must develop rigorous policies and procedures to prevent such a grave mistake, she noted, and ensure staff remain vigilant, and aren’t just checking safety steps off a checklist. When it comes to surgical patient safety, the key factors are communication and commitment to an accountable culture, said Dr. Spruce. This way, surgical staff can communicate safety concerns and learn from their mistakes. “The pillars of a patient safety culture are ‘trust, report and improve,’ and these provide a foundation for healthcare organizations to achieve high levels of patient safety.” ■
Mesh Removal continued from page 13
“Based on [what the authors say], open repair is always going to be the procedure of choice for meshes that were placed anteriorly. In these cases, open removal was as good as robotic,” said Kamal Itani, MD, the chief of surgery at VA Boston Health Care System, a professor of surgery at Boston University and a faculty member at Harvard Medical School, who was not involved with the study. “It then becomes a comparison between the laparoscopic and robotic approach for posteriorly placed meshes. Although the surgery was longer with the robot, there were less complications with the robotic approach compared to laparoscopic. The numbers are too small, and possible confounders too many to reach solid conclusions. However, [this study] could be hypothesis-generating for a larger prospective multicenter study looking at laparoscopic versus robotic explantation of meshes in patients that had posteriorly placed mesh.” Dr. Huynh noted that mesh removal is safe and effective for treating chronic postoperative inguinal pain in the right patients, regardless of the approach taken. “Due to the reoperative setting and distorted anatomy, these cases should be approached judiciously by surgeons who are practiced in it,” Dr. Huynh said. “Based on our group’s own experience and trends in this data set, we prefer a robotic approach when appropriate. However, we continue to regularly employ the open and laparoscopic techniques when necessary.” ■
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OR Management News • Volume 7 • March 2022 21
CLIN IC A L NE WS
Cutting Hospital Stay May Increase Complications
Receipts Help Surgical Staff Cut Costs
By ETHAN COVEY
By ETHAN COVEY
F
P
ocusing on shortening patients’ length of stay (LOS) following surgery may result in increased rates of post-discharge complications, according to a study presented at the 2021 virtual American College of Surgeons Clinical Congress. “LOS has been used as a meaningful outcomes measure and as a potential target for quality improvement,” said Roujia D. Li, MD, of Northwestern University Surgical Outcomes and Quality Improvement Center, in Evanston, Ill. “One way is by introducing accelerated pathways to decrease LOS, such as an enhanced recovery protocol.” However, Dr. Li questioned whether a push toward shorter LOS has resulted in shifting complications to the post-discharge setting. To answer this question, Dr. Li and her colleagues set out to characterize changes in LOS and post-discharge complications over time, and to evaluate risk factors associated with post-discharge complications. Using data from the ACS National Surgical Quality Improvement Program (or NSQIP) Procedure-Targeted database, patients were identified who underwent colorectal, esophageal, hepato-pancreatico-biliary, gynecologic and urologic surgery from 2014 to 2019. Among a total of 538,712 patients, median LOS decreased from three days in 2014 to two days in 2019. Additionally, overall postoperative complications, readmission rates, median LOS and mortality rates all decreased with time. In contrast, while rates of postoperative complications often fell, those for post-discharge complications did not. The proportion of post-discharge complications—including surgical site infection/ wound dehiscence, infections such as pneumonia, urinary tract infection, sepsis, cardiovascular complications and venous thromboembolism—increased from 44.6% in 2014 to 56.5% during 2019. Patient characteristics associated with post-discharge complications included age, race/ethnicity, American Society of Anesthesiologists physical status class, functional status, body mass index and other comorbidities. “It is crucial to develop a patient monitoring program to focus on the early identification and management of post-discharge complications,” Dr. Li said.
Discharge continued from page 10
are actively monitored and addressed in timely fashion, and they must be given well-defined pathways to contact healthcare providers with questions. “There are few places where all these are currently feasible, but they are necessary for SDD to be safe,” Dr. Keller said. “It just takes one patient having a major complication at home where they 22
roviding surgical staff with case cost receipts, which detail expenditures for procedures, can lead to sustainable costsaving procedures, according to a study presented at the 2021 virtual American College of Surgeons Clinical Congress. “Healthcare costs in the U.S. continue to escalate at a rate outpacing general inflation, and OR costs comprise nearly 25% of all inpatient healthcare costs,” said Bradley S. Kushner, MD, of the Department of Surgery at Washington University in St. Louis, citing data from a Peterson-KFF analysis of Organisation for Economic Co-operation and Development and National Health Expenditure data. “By directly controlling OR supplies utilized, surgeons play a key role in reducing healthcare expenditure,” Dr. Kushner added. Starting in the spring of 2020, Washington University in St. Louis began providing surgical faculty with case supply receipts, delivered immediately through the electronic health record following each surgical case. The receipts detailed total procedure costs, itemized breakdowns of supplies used during the surgery, and provided a comparison of overall costs with institutional peers. Dr. Kushner and his colleagues conducted a survey to evaluate perceptions of the cost receipts and their effectiveness in enacting individual practice and/or cultural change. A total of 119 individuals completed the survey. Response to the case receipts was very strong, with 62% very/extremely interested in the practice, and 74.5% commenting that they reviewed the receipts daily. In addition, 87% noted a feeling of responsibility for lowering costs. Over half reported that viewing the receipts resulted in altering their surgical technique due to cost feedback, 60% changed surgical supplies used, and 80% of the general surgery faculty reported now being aware of how to lower OR costs. “Next steps include evaluating whether this perceived cultural change has led to actual decreases in OR costs,” Dr. Kushner said. ■
cannot get through to their provider or get fast-tracked through the emergency department, and that morbidity becomes a preventable mortality for this concept to go up in flames, so it is critical that implementation is appropriate,” she said. Findings Similar to French Experience
The McGill results are similar to those published by French surgeons in 2019 (Ann Surg 2019; 270[2]:317-321). The French team used a more resource-intensive
OR Management News • Volume 7 • March 2022
follow-up after patients were discharged. Trained nurses spoke with patients daily for the first five days and visited them at home throughout the first week. Patients also underwent regular blood tests. This approach is probably not feasible in North America, said Dr. Lee. The McGill team did not measure the burden of the interventions on the healthcare team and did not assess whether patients preferred the mobile app or telephone. ■
KCENTRA® (Prothrombin Complex Concentrate [Human]) For Intravenous Use, Lyophilized Powder for Reconstitution Initial U.S. Approval: 2013 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. (5.2) ------------------------------------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. (1) -----------------------------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. (2.1) • 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. (2.1)
• 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). (2.3) Pre-treatment INR 2–< 4 4–6 >6 Dose* of KCENTRA (units† of 25 35 50 Factor IX) / kg body weight Maximum dose‡ (units of Not to exceed Not to exceed Not to exceed Factor IX) 2500 3500 5000 Dosing is based on body weight. Dose based on actual potency is stated on the vial, which will vary from 20 31 Factor IX units/mL after reconstitution. The actual potency for 500 unit 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-dose vial containing coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S. (3) --------------------------------------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. (4) • Disseminated intravascular coagulation. (4) • Known heparin-induced thrombocytopenia. KCENTRA contains heparin. (4) ----------------------------------WARNINGS AND PRECAUTIONS---------------------------• Hypersensitivity reactions may occur. If necessary, discontinue administration and institute appropriate treatment. (5.1) • 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. (5.2) • 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. (5.3) -----------------------------------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. (6) To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Revised: July 2020
For hemodynamically unstable patients on warfarin
SEVERE GI BLEEDS CALL FOR IMMEDIATE INTERVENTION Act fast in the face of these unstable vitals* PT-INR >2 Moderate-to-severe bleeding Heart rate >100 bpm Blood pressure <90/60 mmHg
Choose Kcentra for urgent warfarin reversal Learn more about Kcentra and GI bleeds at kcentra.com/case-studies FASTER ACTING†
Superior INR reduction at 30 minutes after end of infusion vs plasma
FASTER ADMINISTRATION, LOWER VOLUME
SUSTAINED INR REDUCTION‡
Statistically significant INR reduction sustained ≤1.3 for up to 8 hours vs plasma
Mean infusion time is under 25 minutes ~85% less volume vs plasma
SCAN TO LEARN MORE
*Not inclusive of all symptoms of hemodynamic instability. †In 2 head-to-head trials, Kcentra demonstrated superiority to plasma in 3 of 4 efficacy endpoints. Superior hemostatic efficacy in the Urgent Surgery/Invasive Procedures trial and equally effective hemostasis efficacy in the Acute Major Bleeding trial. Faster INR reduction (to ≤1.3 at 30 minutes after end of infusion) in both head-to-head trials. ‡8 hours for Urgent Surgery/Invasive Procedures trial and 12 hours for Acute Major Bleeding trial. Administer vitamin K concurrently to patients receiving Kcentra. Vitamin K is administered to maintain vitamin K-dependent clotting factor levels once the effects of Kcentra have diminished.
Important Safety Information WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS
Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months.
Indications
Kcentra is a blood coagulation factor replacement indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K
antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Kcentra is for intravenous use only.
Important Safety Information
Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra is also contraindicated in patients with disseminated intravascular coagulation. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT). Hypersensitivity reactions to Kcentra may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment. In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis. Kcentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.
Please see full Important Safety Information on the following page. Please see enclosed full prescribing information, including boxed warning.
Kcentra is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC. Kcentra® is a registered trademark of CSL Behring GmbH. Biotherapies for Life® is a registered trademark of CSL Behring LLC. ©2021 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA www.CSLBehring.com www.Kcentra.com KCT-0122-DEC21
