Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE)

BACKGROUND:

Congestive heart failure constitutes one of the major categories of morbidity, particularly in the elderly, and is responsible for the utilization of significant resources, including a large number of hospitalizations (estimated at 800,000 to 2.3 million per year) and related health care costs. In 1993, 4.7 million Americans carried the diagnosis of CHF, and about 400,000 new cases are diagnosed every year. It is estimated that there are 800,000 to 1.2 million CHF patients with NYHA class III-IV symptoms. The diagnosis and treatment of CHF and its episodes of decompensation can be facilitated by pulmonary artery catheter use, but its efficacy is highly dependent on the physician's experience in the treatment of such patients. Recently, concern has been raised about the benefits of PAC, also known as Swan-Ganz catheterization.

In response to concerns about the benefits and safety of PAC, the NHLBI and the Food and Drug Administration (FDA) co-sponsored a workshop in August 1997 entitiled "Pulmonary Artery Catheterization and Clinical Outcomes (PACCO)". The purpose of the workshop was to provide an objective assessment of the state-of-the-science of PAC and its various uses. Experts in critical care, pulmonary medicine, cardiovascular medicine, surgery, pediatric cardiology, nursing, biostatistics, ethics, and medical economics identified several important clinical areas as priorities for clinical trials; persistent/refractory congestive heart failure (NYHA class IV) received top priority to test whether a PAC-directed treatment strategy achieves a better and less costly long-term outcome compared to a non-invasive treatment strategy. In addition to providing data on outcome, hospital utilization, and costs, the study would have additional benefits. For example, it would provide a clear benchmark for testing other technologies, now in developmental stages, that could supplant PAC in the future. Finally, the study would provide the basis for developing competency requirements for physicians, nurses, and others who insert and use pulmonary artery catheters, which was a strong recommendation of the PACCO Workshop.

DESIGN NARRATIVE:

Patients were randomized into two treatment arms: A total of 218 patients were assigned into a treatment strategy without PAC hemodynamic monitoring (Usual Group) and 215 patients into a treatment strategy guided by PAC (Hemodynamic Group). The primary endpoint was the combined endpoint of rehospitalization and death.