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No increase in deaths for heart failure patients with pulmonary artery catheter

individualize medications for each patient.

The ESCAPE trial was led by Dr. Lynne Stevenson of the Brigham and Women's Hospital in Boston and coordinated by the Duke Clinical Research Institute (DCRI). Dr. Robert Califf, director of the DCRI, noted that this study demonstrates a critical principle of technology assessment at a time when many new technologies are being introduced in the hopes of improving health. "A diagnostic technology, even if it provides accurate information, can be beneficial, neutral, or detrimental, and the PAC is neutral," said Califf.

Pulmonary artery catheterization, also called Swan Ganz catheterization, was introduced for use in 1970 to provide bedside assessment and management of circulation and blood flow at a higher level of precision than has been available from other tests. The device was quickly embraced by the medical community and its use expanded beyond acutely ill cardiac patients, before its benefits were actually proven. There was no consensus regarding the risks and benefits of a PAC-based strategy. In fact, by 1996 the controversy over excessive risks was so high that several professional societies held a consensus conference to review the literature and available data on clinical benefit and safety. The consensus report, endorsed by several organizations including the Society of Critical Care Medicine, called for a clinical trial on the use of the PAC. In response to continued concerns, the NHLBI and FDA convened a workshop on the PAC in 1997 and the resulting report recommended a randomized clinical trial to test its safety and effectiveness.

ESCAPE provided important information about the effect of the PAC on patients' quality of life, although it was not the primary outcome tested.

"It was encouraging that patients in both groups had major improvement in their symptoms and their ability to exercise. Patients whose therapy was guided by the PAC reported a greate
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Contact: NHLBI Communications Office
nhlbi_news@nhlbi.nih.gov
301-496-4236
NIH/National Heart, Lung, and Blood Institute
9-Nov-2004


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