New assessment of evidence for the effectiveness of TAVI rates the technique's benefits as 'moderate'

The ECRI Institute, a nonprofit organization that researches the best approaches to improving patient care, has evaluated the evidence behind the use of the only transcatheter heart valve approved for marketing in the US and Europe in transcatheter aortic valve implantation (TAVI). Based on the results of its systematic search of the literature for clinical studies that compared the device to standard medical therapy or to aortic valve replacement, it assessed the quantity, quality, and consistency of the best available evidence on the technology as "moderate."

"TAVI seems to provide benefit over the non-surgical option for inoperable patients. However, using TAVI for high-risk or immediate-risk patients still needs to be monitored, as there is a lack of consistent evidence that suggests a clear benefit over standard open aortic valve replacement," says Vivian Coates, vice president of information services and health technology assessment, ECRI Institute.

The FDA approved the first TAVI valve for marketing in November 2011. In October 2012, the agency extended the indication to patients who are eligible for surgery but at high risk for serious surgical complications or death. Previously, the valve had only been approved to treat severe aortic stenosis in individuals who are not candidates for open valve replacement surgery. Additional TAVI valves are in ongoing clinical trials for the U.S. market.