TAVR-Related Complications, High Resource Use Decreasing at a Surgeon-Led Program

SAN DIEGO, CA—Complications after TAVR are associated with longer hospital stays, higher costs, and increased resource utilization, but one center’s experience with surgeons at the helm shows that each of these metrics are coming down, according to new data.

At this surgeon-led TAVR program, the most recent data from 2018 suggested 90% of TAVR cases occurred without any complications.

While most TAVR centers are led by interventional cardiologists, Alexis Okoh, MD (Newark Beth Israel Medical Center, NJ), who presented study results here at the annual meeting of the Society of Thoracic Surgeons (STS), explained to TCTMD that the TAVR team at his institution is unique in that it is captained by a surgeon.

Hence, the main implication of these findings is that it is “pretty clear that when you have a cardiac surgeon involved actively, you really have really good outcomes with TAVR,” he said. “I want them to actively get involved with TAVR because when you have a cardiac surgeon driving the boat, the outcomes are phenomenal.”

[W]hen you have a cardiac surgeon driving the boat, the outcomes are phenomenal. Alexis Okoh

The Centers for Medicare & Medicaid Services (CMS) still requires both a surgeon and a cardiologist to sign off on TAVR cases, but the extent to which surgeons across the country do more than give their okay is variable. Stefano Schena, MD, PhD (Johns Hopkins Hospital, Baltimore, MD), who co-moderated the session in which the study was presented, told TCTMD that as of now “the game is mostly controlled by cardiologists when it comes to TAVR, but a lot of institutions are keeping an effort to make it a multidisciplinary decision, so there is not just one leader; there [are] at least two leaders or one on each specialty.”

Costs of Complications

For the study, Okoh and colleagues analyzed clinical and billing data from 1,163 TAVR patients at their center between 2012 and 2018. While 83% of the population had no complications, 12% had one complication and 5% had two or more. The need for a new permanent pacemaker occurred in 5% of TAVR cases, with acute kidney injury and vascular complications each seen in 3%. Rates of in-hospital mortality and significant paravalvular leak were 2% and 1%, respectively.  

Not surprisingly, having any complication was associated with an incremental procedure cost of $10,649 and an additional 3 days in the hospital. Notably, in-hospital death, pacemaker implantation, and acute kidney injury were linked with additional costs of $15,789, $8,608, and $6,587, respectively.

Over the study period, the proportion of uncomplicated cases rose from 71% to 90% and high resource utilization—defined as when patients stayed more than 7 days in the hospital or were discharged to a rehab facility—decreased from 75% to 12% (P for trend < 0.001 for both).

On multivariate analysis, TAVR year (2018 vs 2012) was the only predictor of non-high resource utilization cases (OR 0.24; 95% CI 0.15-0.36).

Complication Rate? The Goal is Zero

Okoh acknowledged that three main factors played a role in the reduction of complications and resource use over the study period: patient risk has gone down, device and delivery technology have improved, and the heart team approach has been embraced. This study highlights how the TAVR process has improved and allayed the initial concerns about the cost with the procedure.

“As long as you are decreasing complication rates, your costs are definitely significantly reducing,” he said.

With the potential for TAVR to move toward low-risk patients, Schena said it is likely that the procedure will be done with even more of a minimalist approach. “[This will be] done with the purpose not only to offset the extreme costs that each TAVR has, but also for the goal so that each hospital can benefit from less resource utilization,” he said. “Unfortunately, there [are] less and less funds to support this type of technology, and we're also moving toward other structural procedures that would be very costly, so if we don't make TAVR less expensive, there will be no room for all the centers to accommodate that technology.”

Looking forward, Okoh said his team plans to maintain their database and continue following TAVR patients. “Our goal is to have a complication rate of 0%,” he said. “At least in the next year, we really want to hit the single digits.”