Study questions benefits, risks of standard hospital procedure Catheter inserted into heart collects data on sickest patients

September 18, 1996|By NEW YORK TIMES NEWS SERVICE

A standard procedure used more than a million times a year on seriously ill patients in this country offers no benefit and may kill some people, according to a new study that is causing consternation among many doctors.

For 25 years, doctors working in the high-technology world of intensive care units have relied on the procedure to diagnose, monitor and treat very sick patients, like those experiencing heart, lung or multi-organ failure.

The procedure involves inserting a thin tube into the heart through a neck vein to collect data to guide minute-to-minute therapeutic decisions. The information concerns actions of the heart and lungs, the amount of fluids in the body and other bodily functions.

But the authors of the study, led by Dr. Alfred F. Connors Jr. of Case Western Reserve University in Cleveland, said doctors had never tested the procedure in a large randomized controlled trial, the most scientifically rigorous type of study.

This study was not that type of trial, and some experts immediately challenged the study's findings. Nevertheless, the authors said it offered compelling evidence but not proof of the procedure's dangers. They also said they could not determine precisely why the procedure might be dangerous.

The procedure is known as pulmonary artery catheterization, or right-heart catheterization, and the controversy over the technique results from a study and an editorial in today's issue of the Journal of the American Medical Association.

The study found that patients who underwent the procedure in the first 24 hours of their stay in an intensive care unit had a higher death rate, longer hospital stays and larger medical bills than those who did not receive it.

The study involved more than 5,700 patients at five teaching hospitals and is believed to be the largest, most detailed study ever done on the procedure. But some experts in critical care medicine criticized the method used in the study as being less precise than that used in a randomized controlled trial.

In the editorial, Dr. James E. Dalen of the University of Arizona and Dr. Roger C. Bone, the journal's consulting editor, demanded that either the National Heart, Lung and Blood Institute should immediately subject the procedure to a randomized controlled trial or the Food and Drug Administration should declare a moratorium on its use.

Dr. Peter F. Pasternack, a cardiologist at New York University, said that many experts believed that the devices were used too often and left in place too long, risking infection and the formation of dangerous blood clots.

Pub Date: 9/18/96

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