Slow Uptake of Transcatheter Aortic Valves: Learning from History?

Transcatheter aortic valve replacement (TAVR) has been one of the most exciting new developments in cardiovascular medicine in recent years. The growing enthusiasm over TAVR led to concern and even alarm in some quarters that the introduction of TAVR would ignite a stampede of uptake, mirroring the early over-enthusiasm for similarly disruptive devices like stents and ICDs, leading to repeated cycles of criticism, investigations, and pullbacks.

Early signs now indicate that history may not be repeating itself and that the careful and deliberate introduction of TAVR may result in an entirely different pattern. Remember that ACC and STS requested a National Coverage Decision (NCD)from CMS and, following the initial approval of TAVI, released a critical consensus document offering a roadmap to responsible introduction of the new procedure.

Wells Fargo medical device analyst Larry Biegelsen (email), attending the STS/ACCF Transcatheter Heart Valve (THV) Symposium in Chicago last week, reports that uptake of the Edwards Sapien device has been slow, suggesting that the measured approach advocated by the ACC and STS and others has had an impact.

He cites three reasons for the slow uptake:

  1. Reimbursement for TAVR has been “spotty” because local Medicare contractors are waiting until May for the final National Coverage Decision (NCD).
  2. Many surgeons and cardiologists believe that TAVR will not be profitable even when reimbursement is finally settled.
  3. The high cost of establishing a TAVR center is dampening the enthusiasm of some hospitals.

Biegelsen also reports that cardiologists and surgeons have not yet settled on how to split the approximately $4,000 professional fee for each procedure. Finally, Biegelsen notes that TAVR may not be profitable even after the NCD is announced, and that its value may be as a “loss leader” to help hospitals capture more valuable traditional valve procedures:

…there is a perception that many TAVR procedures are not profitable even when reimbursed. One speaker presented data showing that TAVR procedures are only profitable when they fall under two of the five surgical valve DRGs (219 and 216) and that only about 56% of his institution’s TAVR procedures fall under these two profitable DRGs. However, according to this presenter, a TAVR program may be profitable for a hospital when one takes into account the increase in the number of referrals for surgical valve procedures which are very profitable.

Edwards believes that the NCD process has introduced a temporary degree of uncertainty over reimbursement that may hold back usage right now but that the clarity achieved when the NCD is finalized will provide a big boost to Sapien sales.

Sanjay Kaul told CardioBrief that the TAVR consensus document “emphasized rational dispersion” of TAVR and that Edwards appears to be “taking a responsible course up till now.”

Rita Redberg commented about the underlying reasons for this slow uptake::

It is an interesting comment on our health care system that the reason for the projected slow uptake of TAVR is related to the lower than expected profit margin for the procedure and not due to caution that current data is not adequate to establish that longer-term benefits (mortality and quality of life compared to no procedure) will outweigh known risks (stroke, vascular complications, AI, and need for pacemaker).

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