ESCAPE Trial - No Benefit From Pulmonary Artery Catheterization In Severe Heart Failure

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ESCAPE Trial - No Benefit From Pulmonary Artery Catheterization In Severe Heart Failure
By JAMA, Oct 6, 2005 - 9:39:38 PM

Hospitalized patients with severe congestive heart failure did not experience a benefit from use of pulmonary artery catheterization, but had more adverse events, according to a study in the October 5 issue of JAMA.

Advances in medical therapy have improved outcomes for many ambulatory patients with heart failure and low ejection fraction (EF; a measure of how much blood the left ventricle of the heart pumps out with each contraction), according to background information in the article. However, each year an estimated 250,000 to 300,000 patients are hospitalized for heart failure with low EF, and the 1-year survival rate after hospitalization may be as low as 50 percent, even with recommended medical therapies. Recent studies have indicated that pulmonary artery catheters (PAC), a device used to monitor hemodynamic status and guide therapy, may increase the risk of death for hospitalized patients.

Lynne W. Stevenson, M.D., of Brigham and Women's Hospital, Boston, and colleagues with the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) trial, tested the hypothesis that for patients with severe heart failure, therapy guided by PAC monitoring and clinical assessment would lead to more days alive and fewer days hospitalized during 6 months compared with therapy guided by clinical assessment alone. The randomized controlled trial included 433 patients at 26 sites and was conducted from January 18, 2000, to November 17, 2003. Patients were assigned to receive clinical assessment and a PAC or clinical assessment alone. The primary goal in both groups was resolution of clinical congestion, with other targets based on levels of pulmonary artery and right atrial pressures.

The researchers found that therapy in both groups led to substantial reduction in symptoms, jugular venous pressure, and edema (swelling from fluid buildup). Use of the PAC did not significantly affect the primary end point of days alive and out of the hospital during the first 6 months (133 days vs. 135 days), death (43 patients [10 percent] vs. 38 patients [9 percent]), or the number of days hospitalized (8.7 vs. 8.3). In-hospital adverse events were more common among patients in the PAC group (47 [21.9 percent] vs. 25 [11.5 percent]). There were no deaths related to PAC use, and no difference for in-hospital plus 30-day mortality (10 [4.7 percent] vs. 11 [5.0 percent]). Exercise and quality of life end points improved in both groups with a trend toward greater improvement with the PAC, which reached significance for the time trade-off at all time points after randomization.

"Based on ESCAPE, there is no indication for routine use of PACs to adjust therapy during hospitalization for decompensation of long-term heart failure. It seems probable that there are some patients and some therapies that yield improved outcome with PAC monitoring and others with counterbalancing deleterious effects," the authors write. "For patients in whom signs and symptoms of congestion do not resolve with initial therapy, consideration of PAC monitoring at experienced sites appears reasonable if the information may guide further choices of therapy.

"The ESCAPE trial defined the most compromised patient population to be studied in an National Heart Lung Blood Institute heart failure trial with medical therapy, with 19 percent (83 patients) mortality at 6 months. No diagnostic test by itself will improve outcomes. New strategies should be developed to test both the interventions and the targets to which they should be tailored. Although most trials in a high-event population have focused on reducing mortality, patients with advanced heart failure express willingness to trade survival time for better health during the time remaining. How patients value their daily lives should help guide both the design and evaluation of new therapies," the authors conclude.

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