Sapien transcatheter aortic valve Image source: Edwards Lifesciences

The Centers for Medicare & Medicaid Services (CMS) is reviewing the possibility of covering transcatheter aortic valve implantation (TAVI) after it received a formal national coverage determination request from two associations, the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC).

Currently the procedure is not approved in the U.S.; however, results of the Cohort B of the PARTNER trial presented at TCT.10 showed promise. The researchers reported that TAVI may improve one-year survival in high-risk patients not eligible for surgery and may be a good alternative to standard aortic valve replacement techniques. However, despite the procedural promise of TAVI, there are also concerns with possible vascular and technical complications associated with the device.

In July, the FDA’s Circulatory System Device Panel favored TAVI approval in the U.S. The panel voted on three items, including: safety, effectiveness and whether the benefits outweighed the risks. If the FDA accepts panel recommendations, TAVI procedures would be available to U.S. patients.

However, CMS noted that it is aware of the high stroke and death rates associated with TAVI, and said that it remains concerned about adverse events that may occur, particularly when the procedure is performed by less experienced operators. Rates of stroke and death at 30 days were 6.7 percent and 5 percent, respectively, for those who received TAVI. At one year, these rates were 10.6 percent and 30.7 percent, CMS reported.

STS and ACC said that the procedure is most successful when it is performed in a specialized heart center under a multidisciplinary team. ACC and STS said that future trials and long-term outcome analyses will be imperative to refine recommendations for the procedure. The associations recommended that the CMS require that operators report transcatheter aortic valve replacement (TAVR) procedures to a STS-ACC transcatheter valvular therapy registry as one of the conditions of coverage.

“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,” CMS said in a statement.

Irvine, Calif.-based Edwards Lifesciences, developer of the investigational Sapien transcatheter heart valve, released the following statement: “The company believes a well-written national coverage determination (NCD) that ensures adequate patient access to this important and rapidly evolving therapy would be a positive for patients and physicians. The NCD draft is just entering the public comment period, and we expect it to evolve as the societies, regulators and other stakeholders provide their input on the important details.”

TAVI has already been approved for use in Europe.