Hospitalized patients with severe congestive heart failure do not benefit from use of pulmonary artery catheterization, but they do have more adverse events, according to an article in the October 5 issue of the Journal of the American Medical Association.

Lynne W. Stevenson, MD, 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 pulmonary arterial catheterization 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 US sites and was conducted from January 18, 2000, to November 17, 2003. Patients were assigned to receive clinical assessment and a pulmonary artery catheter 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. Use of pulmonary catheters 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 number of days hospitalized (8.7 vs. 8.3).

In-hospital adverse events were more common among patients in the catheterization group (47 [21.9 percent] vs. 25 [11.5 percent]). There were no deaths related to catheter 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 pulmonary catheterization, 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 pulmonary arterial catheters 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 pulmonary arterial catheter monitoring and others with counterbalancing deleterious effects," the authors wrote. "For patients in whom signs and symptoms of congestion do not resolve with initial therapy, consideration of pulmonary arterial catheter 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 a 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 concluded.
A meta-analysis of previous studies indicated that use of a pulmonary artery catheter in critically ill patients neither increases risk of death or hospital stay or adds benefit, according to another article in the same issue.

Monica R. Shah, MD, MHS, of Columbia University Medical Center, New York, and colleagues performed a meta-analysis of recently published clinical trials testing the safety and efficacy of pulmonary artery catheters. The researchers located randomized controlled trials in which patients were randomly assigned to catheter or no catheter from several databases.

Eligible studies included patients who were undergoing surgery, in the intensive care unit, admitted with advanced heart failure, or diagnosed with acute respiratory distress syndrome and/or sepsis; and studies that reported death and the number of days hospitalized or the number of days in the intensive care unit as outcome measures. The researchers found 13 randomized controlled trials that included 5,051 patients.

"Our meta-analysis of 13 trials evaluating the safety and efficacy of pulmonary arterial catheterization demonstrates that use of the catheter neither improves outcomes in critically ill patients nor increases mortality or days in hospital. This provides a broader confirmation of the recent results of the ESCAPE trial, which showed that the routine use of pulmonary catheterization in patients with advanced heart failure did not reduce or increase death or days in hospital," the authors wrote.

"Our meta-analysis shows that despite the widespread acceptance of the pulmonary artery catheter, use of this device across a variety of clinical circumstances in critically ill patients does not improve survival or decrease the number of days hospitalized. These results suggest that the pulmonary artery catheter should not be used for the routine treatment of patients in the intensive care unit, patients with decompensated heart failure, or patients undergoing surgery until or unless effective therapies can be found that improve outcomes when coupled with this diagnostic tool," the authors concluded.

In an accompanying editorial, Jesse B. Hall, MD, of the University of Chicago, commented, "What is the evidence for the broader issue of pulmonary artery catheter use in the intensive care unit and perioperative setting? The data collected to date certainly do not support routine use of the catheter in any patient group, and the currently available information could be viewed as justifying 'pulling the pulmonary artery catheter' from routine use, a suggestion made almost 10 years ago. One important additional trial is nearing completion and evaluates the use of pulmonary artery catheterization in patients with adult respiratory distress syndrome."

"Should there be a positive result attributable to pulmonary arterial catheterization in this trial, a specific niche for this technology may remain in critical care. If the results of this soon-to-be-completed trial show no benefit of pulmonary arterial catheterization monitoring, it is likely that the available data will indicate that it is time to remove the catheter from widespread use, or at the very least relegate this former common monitoring tool to salvage therapy of an extremely small and select number of patients. The need to question the routine use of this monitoring modality was quite real and the results of the last 5 years of study most valuable. Once again the community of critical care physicians has been edified by the approach of 'Don't just do something, stand there! And then think about it.'"