On August 16, 2019, FDA approved transcatheter aortic valve replacement (TAVR) in severe aortic stenosis patients at low-risk for surgery. This was a highly-anticipated move following the compelling results of low-risk TAVR trials presented earlier this year at the American College of Cardiology Scientific Session. Unlike previous indication expansions, FDA approved both the Medtronic and Edwards valves at once.
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After humble beginnings before its initial U.S. approval in 2011 as a last resort for inoperable patients, TAVR is now positioned to become the standard of care for severe aortic stenosis patients.
Amid the excitement that continues to surround advancements in structural heart care, it's important to take a step back and reflect on what these changes truly mean for aortic stenosis patients and the structural heart programs that care for them. Below, I've outlined my thoughts on the top implications for cardiovascular providers in light of this announcement.
1. Structural heart centers will need to scale capacity—and quickly.
Structural heart centers have historically run on very lean infrastructures, in part due to the challenging financials and low margins associated with transcatheter valve procedures. However, as low-risk approval opens the door to at least evaluate all severe aortic stenosis patients requiring valve replacement, TAVR programs will need to scale capacity to accommodate more screening and procedures. This means adding screening and procedure days, as well as physicians, coordinators, and staff.
It will also be critical for programs to increase operational and procedural efficiency to ensure they can manage more patients in a cost-effective manner, all while maintaining a patient-centered and cross-continuum approach.
I'll note that the low-risk TAVR approval also comes on the heels of MitraClip's indication expansion to patients with secondary mitral regurgitation, which may have even greater opportunity to increase structural heart center volumes. As a result, programs offering MitraClip will likely feel the pressure to scale capacity even more acutely.
2. However, programs may not get an immediate influx of patients.
All that being said, we heard from some high-volume TAVR programs that they aren't expecting an immediate influx of referrals for low-risk TAVR. These are not patients who have typically been thought of for TAVR, and some physicians have been hesitant to refer low-risk patients without data on long-term durability of the valves. This will require programs to provide additional education and assurances of true multidisciplinary evaluation in order to change referral patterns.
Regardless, as low-risk TAVR becomes embedded into practice for structural heart programs, volumes will increase. Patient preference will also be a driver, as we see more aortic stenosis patients explicitly requesting transcatheter over open procedures.
3. New TAVR programs may get locked out in competitive markets, and should carefully evaluate market need before investing.
CMS updated the National Coverage Determination (NCD) for TAVR earlier this summer for the first time since the procedure was approved in 2011. The new NCD lowers the volume bar for new programs to begin offering TAVR to 20 aortic valve related procedures in the two years prior to TAVR program initiation and 300 PCI per year (among additional hospital and physician requirements as listed in the NCD). However, established programs will now need to maintain 50 AVR (SAVR or TAVR), at least 20 of which are TAVR, per year.
This means that it may be somewhat easier for programs to start offering TAVR—but if they are not able to quickly carve out a role in their market and develop the referral streams, they may have difficulty maintaining viability. And as low-risk patients begin getting TAVR, there will be fewer surgical AVRs to help meet these ongoing requirements.
We will also likely see stakes continue to rise for recruiting physicians with experience in structural heart to begin and maintain a program.
Beyond volumes, newer programs may face even more difficult financials. Leading TAVR programs have been working diligently since 2011 to improve workflows and efficiency for TAVR procedures. In turn, CMS has aligned reimbursement with the more efficient (i.e., lower-cost) performance of these established programs. New programs will likely not be able to begin with a "minimalist" approach, which could make it even more difficult for them to maintain per-case margins than established programs.
As with any high-end service, CV leaders should carefully evaluate if their market has the demand necessary to support another TAVR program before making this investment.
In this year's Cardiovascular Roundtable national meeting, our team is providing guidance for how programs should evaluate structural heart investments in light of these dynamics. Learn more here.
4. TAVR care must adapt to serve a low-risk patient population.
Low-risk TAVR patients are not the typical TAVR patients whom programs have been used to serving. They are younger and likely have greater expectations for access, long-term care coordination, and streamlined recovery. Programs will be held to a higher standard of cross-continuum care management and reducing complications as younger patients come through their doors.
Further, younger patients are more likely to shop around for their TAVR care or encourage their PCPs to seek out the best provider for them. Some programs are already seeing low-risk patients reach out directly to their structural heart program seeking a second opinion. While not the norm yet, CV programs should make sure they are developing patient-focused material that will help patients sort through the complex and overwhelming process of preparing for screening and a TAVR, while also providing a patient-friendly, coordinated intake and screening experience.
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