Transcatheter aortic valve replacement (TAVR - also known as TAVI or transcatheter aortic valve implantation) is a new technology proposed for use in treating aortic stenosis. A bioprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve. Currently two devices have received the CE Mark for use in Europe and one, the Edwards SAPIEN valve, is awaiting FDA action for marketing in the US.
CMS has received a formal national coverage determination (NCD) request from the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC.) Based on clinical trial data, the requestors stress that the most successful patient outcomes occur when the following criteria are met: the procedure is performed in a specialized heart center and managed using a multidisciplinary team in which each member has appropriate training and credentialing (for which requirements are currently under development), the procedure is performed in a modified conventional cardiac laboratory or hybrid operating room that contains the specialized equipment necessary for the procedure, and the multidisciplinary team uses a planned approach to co-management decision making as well as technical insertion of the device. The requestors also identify the importance of long-term outcome analysis and ongoing analysis of data through continuous review of the data and refinement of recommendations. To accomplish this they recommend that CMS require reporting of TAVR procedures in an STS-ACC transcatheter valvular therapy (TVT) registry as one of several conditions of coverage.
The PARTNER trial (Cohort B, inoperable patients) reported stroke and death rates associated with TAVR of 6.7% and 5% respectively at 30-days and 10.6% and 30.7% respectively at 1-year. CMS is concerned that these adverse events may be more frequent when TAVR is furnished in settings where the physician and or the facility have limited experience or procedure volume to establish and maintain adequate expertise.
We will review evidence pertaining to the health outcomes attributable to the use of TAVR, including evidence on the experience and qualifications of physicians and facilities that affect these outcomes. Of particular interest to CMS is the conditions under which TAVR may be reasonable and necessary under Sections 1862(a)(1)(A) and 1862(a)(1)(E). Within the US, TAVR has historically been performed only by physician investigators in centers of excellence within clinical trials, not by other practitioners or in facilities with limited experience with TAVR. This limited experience in the US raises the question of generalizability of the existing evidence base to more "real world" settings.
September 28, 2011
February 2, 2012
May 1, 2012