Preparing for the Flood: Expanded TAVR Indication Comes with Challenges

“Let the floodgates open.” This is what many in the cardiovascular community said when the FDA expanded the indication for Sapien 3 and Sapien XT transcatheter heart valves to include patients at intermediate risk for surgical aortic valve replacement (SAVR). The news was welcomed, but challenges lie ahead as hospitals inevitably will face surging volumes even as they continue trying to improve efficiency, reduce costs and maintain quality. 

From trickle to tidal wave 

In late 2011, the FDA approved transcatheter aortic valve replacement (TAVR) as a minimally invasive option only for patients at prohibitive risk for SAVR. A year later, TAVR’s indication was expanded to include high-risk patients. Both of the FDA approvals were based on clinical trials using early-generation devices with early operator experience. Since then, outcomes and efficiency have improved as a result of enhanced design of the valves and delivery catheter as well as greater operator experience. 

The highly anticipated next step for TAVR—approval for patients at intermediate risk—came after studies showed TAVR was noninferior to surgery in intermediate-risk patients and superior when operators used the newer-generation Sapien 3 system and when the second-generation Sapien XT (Edwards Lifesciences) was used in the transfemoral cohort (N Engl J Med 2016;374:1609-20; Lancet 2016;387:2218-25). After the results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial results are published, the FDA may follow Europe’s lead and approve the CoreValve Evolut R transcatheter valve system (Medtronic), which is already approved in the United States for prohibitive- and high-risk patients. Other transcatheter valve designs are under investigation and will likely compete for a share of this market.

The pool of potential TAVR patients has been growing since 2011, at about 50 percent year over year. Expanding the indication to intermediate-risk patients will dramatically increase the number of TAVR patients, as it is estimated that at least one-third of those referred for SAVR are at intermediate risk and, therefore, now eligible for the minimally invasive treatment option. This trend can only be expected to grow further if TAVR eventually is approved for low-risk patients. Indeed, this year, the FDA approved two clinical trials, one with the Sapien 3 valve and the other with CoreValve Evolut R system, comparing TAVR to surgery in low-risk patients.

More hands on deck

As patient volume expands, so will the demand for transcatheter valve centers. Whether this demand will be met by expansion into community hospitals or stays focused in established transcatheter valve centers of excellence is to be seen. Regardless, steps will need to be undertaken as the field adapts to the future of TAVR specifically and of structural heart interventions in general. 

First, programs will need to become more efficient by allowing large numbers of cases to be performed routinely without disturbing the rhythm of the catheterization laboratory or hybrid operating room. To streamline TAVR procedures, dedicated and experienced staff and protocols will be required.

Second, excellent outcomes must be maintained if TAVR technology is to remain sustainable in comparison to surgery, particularly as lower-risk groups are treated.

Third, we will need more skilled operators to accommodate the growing demand. Today, only a few U.S. hospitals offer advanced structural heart disease training positions, and those training opportunities are not sponsored by the Accreditation Council for Graduate Medical Education (ACGME). To maintain quality and ensure competency, a concentrated effort by the interventional cardiology community to require standardized specialized training in structural heart disease interventions is necessary. 

Charting a cost-effective course

Finally, the economics of TAVR still need to be optimized to ensure cost-effectiveness. As compared with SAVR, TAVR has been shown to be associated with faster early recovery with shorter duration in the ICU and hospital, less need for rehabilitation services at discharge and better short-term quality of life. All of these factors should give TAVR the clear advantage over surgery with respect to reducing cost and resource utilization; however, current economic data in support of TAVR are inconclusive in the high-risk patient population. This finding has been driven mostly by significant difference between the costs of the valves themselves: approximately $5,000 for SAVR vs. $30,000 for TAVR. As we treat more lower-risk patients, the inherent advantages of the less invasive therapy on postoperative recovery and length of hospital stay are likely to become less apparent from an economic standpoint. Unless the valves become considerably cheaper, programs will have to adopt major cost-saving strategies. For example, standard protocols to predict those at risk for complications and strategies to minimize them will be key to avoiding lengthy hospital stays and extra resource utilization.

Another strategy may be the universal adoption of the “minimalist” approach to TAVR, which has been shown to offer significant cost savings without compromising quality or outcomes (JACC Cardiovasc Interv 2014;7[8]:898-904). The minimalist approach involves same-day admission, conscious sedation instead of general anesthesia, moving patients directly into telemetry units instead of ICUs, and early mobilization and hospital discharge. In fact, many of the lower-risk patients now eligible for TAVR will likely qualify for the minimalist approach, which will undoubtedly improve efficiency and reduce costs.

The Society for Cardiovascular Angiography and Interventions (SCAI) has recognized the importance of advocacy and education as essential for ensuring quality and competency. For example, SCAI offers a robust structural and valvular educational resource for interventional cardiologists. Now more than ever, SCAI will be proactive in shaping the future of structural heart disease interventions by foreseeing and addressing the challenges ahead. 

Ronnie Ramadan, MD, is an advanced structural heart disease fellow at Emory School of Medicine in Atlanta. Clifford J. Kavinsky, MD, PhD, is professor of Medicine and Pediatrics, director of the Rush Center for Adult Structural Heart Disease and director of the Rush Cardiovascular Fellowship Program for the Section of Cardiology at Rush University Medical Center in Chicago.