Innovative Heart Procedure Shows Promise, but More Evidence is Needed, says ECRI Institute

Dec 13, 2012, 09:42 ET from ECRI Institute

New report assesses the evidence, infrastructure requirements for transcatheter aortic valve implantation

PLYMOUTH MEETING, Pa., Dec. 13, 2012 /PRNewswire-USNewswire/ -- A new heart valve procedure intended to treat patients with severe aortic stenosis and individuals who are at high risk for surgical complications or death is gaining traction in the U.S.


ECRI Institute (, a nonprofit organization that researches the best approaches to improving patient care, recently evaluated the evidence behind the use of the only transcatheter heart valve approved for marketing in the United States 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, ECRI Institute 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.

ECRI Institute focused its report on findings from published studies that involved 3,798 patients who received the valve. All-cause death was equivalent when comparing TAVI to aortic valve replacement, and vascular complications were more frequent in TAVI patients.

The report addresses the infrastructure and staffing requirements for the procedure, including criteria laid out by the Centers for Medicare & Medicaid Services (CMS). Requirements include an existing heart valve surgery program, a hybrid catheterization lab or hybrid operating room with appropriate imaging capabilities, and space for post-procedural intensive care.

According to ECRI Institute's SELECTplus™ pricing database, the total cost for the equipment and infrastructure required for a TAVI program, including construction and renovation, averages around $3.8 million.

The U.S. Food and Drug Administration (FDA) approved the first TAVI valve for marketing in the U.S. 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.

"We are cautiously optimistic about the procedure, but healthcare professionals should continue to educate themselves and their patients about the risks and benefits of TAVI, especially as interest in the procedure gains momentum," says Diane Robertson, director of health technology assessment information services.

To learn more about ECRI Institute's Emerging Technology Evidence Report on the heart valve, or its Health Technology Assessment Information Service, call (610) 825-6000, ext. 5891, or e-mail

About ECRI Institute
ECRI Institute (, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research to healthcare to discover which medical procedures, devices, drugs, and processes are best to enable improved patient care. As pioneers in this science for 45 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. Strict conflict-of-interest guidelines ensure objectivity. ECRI Institute is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI Institute PSO is listed as a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services. Find ECRI Institute on Facebook ( and on Twitter (