Heart Pump Device Didn't Help People Getting High-Risk Surgery, Study Says

High-risk cardiac patients undergoing a procedure to clear blocked arteries didn’t benefit from a medical device commonly used to help hearts pump during the operation, British researchers said.

A study of 301 patients with weakened hearts found no significant differences in death rates, heart attacks, strokes or the need for retreatment, regardless of whether they had an intra-aortic balloon pump inserted to augment blood flow. The devices, whose sellers include Teleflex Inc., Getinge AB’s Maquet unit and Abiomed Inc., did reduce surgical complications.

The results show the balloon pumps shouldn’t be used routinely in high-risk heart patients, as they currently are about 5 percent of the time, said Simon Redwood, the study’s senior author and a director of the cardiac catheterization lab at St. Thomas’ Hospital in London. About one in eight patients who didn’t get the devices at the start of the procedure needed later rescue therapy, mainly because of dangerously low blood pressure, according to the report in the Aug. 25 Journal of the American Medical Association.

“One of the commonest indications is to support high-risk angioplasty” patients, Redwood said in an e-mailed response to questions. “This study will result in a drop in their use in angioplasty, but they should always be available as rescue.”

Angioplasty is performed to restore blood flow to the heart. The study examined the use of the balloon pumps during the artery-clearing procedure.

Rescue Therapy

The need for a balloon pump as a rescue therapy and the decreased number of complications among patients receiving it at the start of the trial show it is a useful tool, said Christian Keller, chief executive officer of Maquet Cardiovascular in Wayne, New Jersey, in an e-mailed statement.

The research was funded by the British Cardiovascular Intervention Society, based in London, with a grant from Maquet Cardiovascular of Wayne, New Jersey, and Johnson & Johnson of New Brunswick, New Jersey. Eli Lilly & Co., based in Indianapolis, supplied medication used during the study.

Spokesmen for Limerick, Pennsylvania-based Teleflex and Danvers, Massachusetts-based Abiomed didn’t return phone calls seeking comment.

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

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