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New Heart Procedure Promising, But More Evidence Needed

Fri, 12/14/2012 - 12:45pm

(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 (www.ecri.org), a non-profit 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 SELECTplusT 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.

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