February 24, 2021

Researchers say procedures can be performed safely in an outpatient setting.

With increasing numbers of orthopedic procedures being performed and reimbursed at ASCs, postoperative patient safety issues move to the forefront. For the ortho ASC, a primary goal is reduce postoperative complications that lead to costly, unplanned hospital admissions and ER visits as much as possible.

In a study published in The American Journal of Sports Medicine, a team of researchers at The Ohio State University's Wexler Medical Center examined the frequency, reasons and factors that influenced hospitalizations, returns to the clinic, and ER events within 24 hours of surgery at a new sports medicine ASC.

The retrospective review examined 4,650 procedures — total joint replacements were not included — performed at the center from its opening in November 2016 to October 2018, along with associated patient demographic and clinical data including age, sex, CPT code, procedure type, ASA classification, BMI, tobacco use and medical history. It then categorized the reasons patients sought unplanned postoperative care within the first 24 hours after surgery into three groups: medical complication, postoperative pain and other postoperative complication.

The team found that just 35 patients, or less than 1%, sought additional care within 24 hours of surgery. Medical complications were the reason for 16 of the 35 patients seeking care, making it the most common of the three categories. The researchers found those who required unplanned care were older with more medical comorbidities and higher ASA scores, and were more likely to have undergone upper extremity procedures.

The researchers characterized the percentage of patients seeking unplanned post-op care as "relatively low" and consistent with other reports in the literature. They also noted that upper extremity procedures, particularly those of the shoulder, may carry an increased risk of requiring medical treatment within 24 hours of surgery.

ASCs must balance OR efficiency with clinical precision.

Richard Berger, MD, an assistant professor at Rush University Medical Center in Chicago, replaces about a thousand knees every year, but treats each as a unique case. His goal is to restore every joint's original, normal range of motion and stability.

"Based upon how the knee moves with all the muscles, ligaments and tendons intact, I determine how the native knee was aligned, and adjust placement of the implant to match it," he explains. "After I place the implant and put the knee through an entire range of motion, the joint's surface areas remain in perfect contact throughout, which leads to a more stable joint, less pain for the patient and better post-op function."

Dr. Berger is relentlessly focused on placing the right implant the right way. That's because the cost of a slight error can be disastrous for the patient and the facility. "The key is getting it right the first time, because fixing a poorly done knee never works out," he says. To achieve optimum results, he suggests focusing on these factors:

• Fixation method. Dr. Berger is concerned about the revival of cementless fixation for knee implants in the quest for quicker, easier and more efficient patient care. He says the method works well for hips because bone almost always grows into the implant and remains stable for a long time, but it's problematic for knees because limited local blood supply inhibits ingrowth. Meanwhile, wear from implant pieces can infiltrate bone and cause destructive osteolysis; cement blocks those particles. Diagnosing postoperative problems is also difficult.
• Infection prevention. Surgical site infections, while rare, are devastating to total knee patients. Dr. Berger says harmful bacteria can be introduced intraoperatively if the incision isn't closed quickly enough. "Once bacteria get into a knee replacement, the body has a hard time fighting it," he explains. "Best case, you reopen the knee, thoroughly wash it out, and administer IV antibiotics for four to six weeks. Sometimes, though, you must remove the prosthesis, so the patient has no knee function until the infection goes away, and before reinsertion of a new implant a few months later."
• Fit, form and function. Implant technology continues to develop in the direction of complete patient customization, but more progress needs to be made. A decade ago, Dr. Berger helped design the first female knee implant, which had narrower contours to better match the female anatomy. He remains skeptical about fully customized implants. "In my experience, they're associated with some challenges because they're customized based upon a scan of the arthritic, deformed knee — and not the original healthy knee," he says. Additionally, surgeons can't complete cases if custom implants don't fit. "I find it much better to have hundreds of combinations of implants to fit each patient in the OR," he says.
• Robotic assistance. Although Dr. Berger could use a robotic navigation platform with a cutting system to perform knee replacements, he chooses not to. "It simply puts the knee right back where it was with arthritis," he says. "Maybe one day we'll have enough algorithms and data for a robot to match pre-arthritic knees, but we're not even close." However, Dr. Berger believes robotic assistance's ability to help surgeons perform to the average could prove helpful to low-volume and inexperienced knee replacement specialists. "If their skills are below average, the technology will help make them better," he says.

Dr. Berger says 98% of his patients are happy with their knees and would have the operation again. "With unsatisfied patients, the problem is often mismatched expectations," he advises. "It's important to lay it all out for them in clear language by describing exactly how their new knee will function after surgery and the life activities in which they can expect to participate."

A growing trend to watch as ASCs adopt orthopedic procedures in the COVID-19 era and address challenges and partnerships to adjust and evolve.

Total joint replacement (TJR) has two main goals: to relieve pain and to restore deteriorated function most commonly associated with arthritis. While the ability of joint replacement to relieve pain and restore function has remained largely unchanged since the 1970s, implants are now markedly better than they used to be, and the technology aiding in the procedure has starkly improved as well. In addition to better implants and technology, one of the most significant recent changes is the ability of TJR to be performed in outpatient settings.

In a comprehensive analysis of this major trend, Michael P. Ast, MD, reviews key aspects of successfully performing total joint replacement in the outpatient setting.¹ The topics he addresses include hurdles to adoption, the impact of COVID-19 as well as the value of the proper partner in this endeavor. TJR surgeries have been migrating out of the hospital setting gradually as outpatient joint replacement has shown to have a higher rate of patient satisfaction², equivalent or lower rate of complications,³ and a high level of surgeon satisfaction.

"It is also incredibly beneficial to the healthcare system in general because of its lower cost, both for the initial procedure and the potentially reduced incidence of complications," says Dr. Ast.

Given the current trend towards outpatient joint replacement, what barriers have prevented outpatient joint replacement in the past, and what is driving the change in the current landscape? Even with a growing population of vocal surgeons pushing to move more surgery to the outpatient setting or ASC, this transition has been gradual.

Barriers to TJR Adoption

According to Dr. Ast, the industry as a whole has been slow to adopt TJR in an outpatient setting for two primary reasons.

"First, in the early 2000s, patients were still largely being treated with opioids after surgery, and since opioid medications have tremendous amounts of side effects, patients were often unable to undergo rehabilitation during the first few days following a procedure. Patients typically experienced a significant amount of pain during the early perioperative period, which made it difficult to perform tasks necessary to be discharged in a timely fashion. This resulted in longer stays at the hospital for recovery purposes," says Dr. Ast.

"Second, two decades ago the blood transfusion rate after primary elective joint replacement was almost 25%. Transfusions are not typically possible at an ambulatory surgery center, since many centers have strict policies stating that blood and blood products will not be administered, and that patients will be transferred to a more appropriate facility in the event that an emergency transfusion is required," he explains.

Since there had not yet been advances in pain management and blood management, the past was not as outpatient friendly as it is today. Fast forward to the present: almost all joint replacement surgeons in the United States utilize some type of multimodal analgesia with local anesthetics, anti-inflammatories and other opioid alternatives. Most have eliminated the use of IV opioids, which carry the highest risk of perioperative side effects. With less significant pain levels following surgery, patients are able to walk and begin rehabilitation more quickly.

Additionally, the widespread adoption of blood management protocols, including preoperative screening and treatment of anemia and liberal use of tranexamic acid (TXA), has reduced the risk of requiring blood transfusion for an appropriately selected patient to less than a half a percent.⁴

Driving the Migration

While the capacity to conduct total joint replacement surgeries has improved gradually, Dr. Ast postulates that the COVID-19 pandemic could force a more rapid migration of high acuity surgeries to the ASC as hospitals need to source innovative ways to adapt rapidly in response to the post-COVID-19 landscape.

"Since the pandemic was declared earlier last year, patients have become acutely aware of the risk that visiting a larger general hospital may pose to their health, and in turn, have postponed elective procedures in an effort to prevent exposure to individuals who have been infected with the COVID-19. ASCs and specialty hospitals stand to benefit significantly from this climate and provide a respite for hospitals and healthcare providers who are facing a backlog of postponed procedures," says Dr. Ast.

However, making such a transition may be perceived as complicated and costly, according to Dr. Ast.

"Vendor partners, such as Stryker, are poised to help make the TJR migration more efficient. Partnering with these vendors can provide access to a broad level of support such as evidence-based peri-operative protocols, necessary equipment and supply chain solutions that make ASCs and specialty hospitals run more efficiently," says Dr. Ast.

One of the toughest obstacles ASCs face is that they often lack the basic equipment necessary to do higher acuity cases, like joint replacement and spine surgery, because they were never built, designed or equipped with that intent. The emergence of Stryker's ASC business and similar vendors gives ASCs convenient options to expand their capacity for higher acuity surgeries with opportunities to assist in financing, capital upgrade requirements, and solutions for supply chain issues.

The same problem – that many centers were not designed with TJR surgeries in mind – informs a different issue at play: sterilization. ASCs, especially older ones originally designed for lower acuity cases, typically do not have the sterilization resources needed for the equipment necessary for cases like joint replacement. This is another area that new ASC-focused solutions can address by using technology and resources to limit the equipment necessary to do these surgeries as well as provide solutions for sterilization.

Additionally, especially in surgeon owned ASCs, the upfront capital cost to outfit an ASC to perform total joint replacement surgery is significant. Many ASCs simply don't have the capital on hand to make those investments immediately. Creative financing ideas from vendor partners, like Stryker, can be extremely beneficial to help eliminate barriers to new programs and growth.

There is no question that ASCs are going to become popular as a setting for TJRs over time. The traditional model of general hospitals providing large levels of inpatient orthopedic care is on the decline. Dr. Ast notes, "All trends indicate that we should expect outpatient facilities and orthopedic specialty hospitals to provide the majority of orthopedics in the future."

An intriguing pilot program puts a counterintuitive notion to the test for outpatient total joints.

OrthoIllinois Surgery Center performs several total joint replacements each week. That its staff must constantly manage complex instrument trays packed with the necessary tools to perform these intense procedures shouldn't be surprising. That they do it without a sterile processing department (SPD) might be.

Last month, the Rockford, Ill.-based surgery center teamed with Vested Medical of Elmhurst, Ill., to test the concept of whether an off-site sterilization processing program for the center's total joint replacement instrument trays could work. The theory was that the program could increase surgical capacity, reduce reprocessing backlogs and minimize contamination risk — all while maintaining high standards of patient care.

Here's how the process works: The ASC provides its case schedule to Vested Medical, which then customizes sterile instrument trays at its facility based on the specifications of OrthoIllinois surgeon John Bottros, MD, FAAOS. Vested Medical's sterile processing professionals deliver the trays to the surgery center and pick up dirty instruments for reprocessing. Dr. Bottros claims the process is seamless and that he can now serve more patients on a given day.

OrthoIllinois business manager Leanne Brennan says the idea hatched because the ASC's existing SPD had reached capacity. "We needed to get creative if we were going to accommodate a few more cases each day," she explains.

The nature of the offsite reprocessing program goes far beyond simply outsourcing SPD to a third party. Vested Medical stresses the importance of building the program to meet or exceed all current and potential future regulatory standards, as well as collaborating closely to suit OrthoIllinois' specific requirements. "We had to fully understand their needs and fit into their existing system," says the company's Vice President of Operations Paul Borland. "We try to understand the flow, touchpoints and accessibility, so we are a real extension of their process."

Researchers conclude direct anterior and posterior approaches equally safe and effective.

Surgeons who perform total hip replacements disagree on whether it's best to approach the joint from the front or back. A recent study that examined the relative safety in outpatient settings of the two competing approaches suggests both have a point.

Researchers at the University of Tennessee in Memphis compared 90-day complications between 346 direct anterior approach (DAA) and 86 posterior approach (PA) for total hip arthroplasties performed at a single ASC. They examined data regarding demographics, comorbidities, preoperative and discharge pain scores, overall time spent in the ASC, overnight stays, ER visits, readmission, reoperation and complications within a 90-day period.

Encouragingly, they found no significant variations or red flags in any of those metrics between the two approaches. "There were no differences in the safety outcomes, and overall there were few complications in the 90-day period, regardless of the surgeon's preferred approach," the researchers write in the study published in The Journal of Arthroplasty. "This study indicates both DAA and PA are equally safe for THA in the outpatient setting, and the choice of surgical approach should be based on patient and surgeon preference."

These results can help to reassure administrators from undue concern about patient safety when recruiting surgeons who might prefer one approach over the other.