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Clinical Trials Challenge Balloon Pumping

Fri, 08/27/2010 - 7:30am

Patients with coronary artery disease undergoing angioplasty do not benefit from having their circulation artificially supported with a balloon pump as a preventative measure during angioplasty, according to the first randomized trial studying the practice and published in the Journal of the American Medical Association (JAMA).

Patients with poor heart function and extensively narrowed heart arteries are at higher risk of complications following angioplasty and there has been much interest in the balloon pump as a means of reducing such adverse events. When a balloon pump is used, it is placed inside the patient's aorta to provide circulatory support to their failing hearts.

Over the last 20 years, cardiologists across the world have adopted use of the balloon pump as a preventative measure during high-risk angioplasty, but this common practice has been based on anecdotal accounts and small observational studies, which are limited by selection bias.

The Balloon pump assisted Coronary Intervention Study involved 301 patients with severe left ventricular dysfunction and extensive coronary artery disease. They were randomly assigned to either have the balloon pump inserted before angioplasty or to have angioplasty without planned balloon pump support.

There was no difference in the proportion of patients who suffered major cardiovascular complications (comprising death, acute myocardial infarction, cerebrovascular events or further re-vascularisation) at hospital discharge capped at 28 days in the group who received a balloon pump beforehand compared to those who did not However, approximately one in eight of the latter group required an emergency balloon pump insertion during the procedure, emphasizing the importance of having a balloon pump on standby when undertaking such cases.

Dr Simon Redwood, Reader in Interventional Cardiology at King's College London and Honorary Consultant Cardiologist at Guy's and St Thomas' said: “For many years we have strongly advocated the use of the balloon pump to support patients' circulatory system during high-risk coronary angioplasty and wanted to build up definitive evidence to support its use. We believed this multi-center study would establish once and for all the clinical and safety benefits of using the pump as a preventative measure.

“However, rather than demonstrating the benefits, we found that inserting a balloon pump into the aorta as a preventative measure has little or no impact on the incidence of major complications and death in high-risk cardiac patients, although there is still an important role for using a pump in an emergency.

“Angioplasty is now the most common interventional treatment for treating coronary artery disease. The study findings raise important questions about current clinical practice and whether it is necessary to use a balloon pump routinely during the procedure. The findings may reflect the fact that angioplasty has become a less risky procedure over time as cardiologists have increased their skills.”

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