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Evidence lacking for 'inflatable-pants' heart failure therapy

A new review of studies supports the government's opinion that too little evidence exists to support a device that uses balloon-like pants as a treatment for heart failure.

External counterpulsation (ECP), a noninvasive therapy to improve blood flow to the heart, is most commonly used to relieve hard-to-treat chest pain for heart patients who are not candidates for surgery.

Last year, the equipment manufacturer asked the federal government to expand its coverage of ECP and begin reimbursing cardiologists who use the device for other heart conditions, including heart failure.

The Centers for Medicare and Medicaid Services -- which sets reimbursement guidelines for the two federal benefit programs -- declined to expand its policy on external counterpulsation to cover heart failure or other cardiac conditions. Now, the Technology Evaluation Center of the Blue Cross and Blue Shield Association, whose member companies represent the largest health benefits provider in the United States, has reviewed the science behind ECP for heart failure.

"The evidence supporting the role of ECP as an effective treatment for heart failure is lacking in both quantity and quality," the review found.

The one controlled trial of external counterpulsation for heart failure is unpublished. It showed some modest improvements in the time patients were able to exercise and some gains in patients' ranking on a scale that classifies the extent of heart failure, the review said.

"To me it's not convincing evidence," said senior scientist David Mark, M.D., of Blue Cross and Blue Shield Association's Technology Evaluation Center.

The systematic review was conducted by the Technology Evaluation Center (TEC), which analyzes clinical and scientific evidence to evaluate whether a technology improves health outcomes. This is the first time TEC evaluated the device as therapy for heart failure, and ECP did not measure up.

TEC Assessments provi
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Contact: Maxine Gere
Maxine.GERE@bcbsa.com
Center for the Advancement of Health
21-Feb-2006


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