Controversy Settled: Catheter Procedure Does Not Increase Mortality in Advanced Heart Failure Patients
But lack of benefit on major outcomes suggests limiting use to experienced centers and patients with severe symptoms that persist despite previous therapies
BOSTON - Pulmonary artery catheterization (PAC), an invasive diagnostic procedure used to guide treatment for patients with critical illness, has remained one of the most controversial topics in critical care medicine, following publication of a major observational study that suggested it may unintentionally increase risk of death in severely ill patients. Some physicians urged the procedure be banned all together. Now, researchers from Brigham and Women’s Hospital (BWH) and Duke University put an end to many aspects of an ongoing debate over its use specifically for heart failure patients. Hospitalized patients whose therapy was guided by PAC experienced the same survival and re-hospitalization outcomes as patients whose therapy was evaluated with expert physical assessment. The findings are published in the October 5, 2005 issue of the Journal of the American Medical Association.
This landmark, NIH-funded ESCAPE trial (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) compared the invasive PAC procedure with physical examination at the bedside, in a randomized controlled trial of 433 heart failure patients at 26 sites conducted from January 2000 to November 2003. The Boston sites participating in the ESCAPE study were Brigham and Women’s Hospital and Massachusetts General Hospital.
According to Lynne Warner Stevenson, MD, co-director of the cardiomyopathy/heart failure program at BWH and the lead investigator for ESCAPE “Cardiologists have been at odds about using catheterization to treat heart failure patients. The goal of this national trial was to first determine if this procedure was safe and if so, to provide heart failure specialists with the information they need to decide when it might be useful. In terms of death and re-hospitalization, we found that there is no benefit but also no harm from using the catheter during heart failure therapy at those sites with extensive experience in this strategy. The marked improvement in symptoms for both groups of patients after heart failure hospitalization at these selected centers was very gratifying. The neutral result for the primary outcomes contrasts with a strong trend shown for improved quality of life outcomes in the PAC group.”
ESCAPE clinical recommendations
Taking into consideration both the primary outcomes and the secondary quality of life measurements, the ESCAPE authors provide the following two recommendations:
· Medical centers with significant experience in both the use of PAC and in expert clinical assessment of the heart failure patient have two comparable options available to guide therapy for their patients. According to Stevenson, cardiologists will need to weigh the neutral outcome data against a trend showing that patients whose therapy was monitored by PAC improved their exercise capacity and perceived more enhanced value of their everyday life.
· Medical centers that are not experienced with PAC use in heart failure should not begin using it for this complex population.
Additional study findings
· There was a strong trend toward more benefit from PAC in centers with the most experience.
· PAC was associated with better preservation of kidney function.
· Patients who had the PAC procedure tended to walk farther and have fewer heart failure symptoms.
· When comparing individual adverse events, the PAC group was more likely to have complications during their hospital stay, but none that led to death or re-hospitalization.
· ESCAPE was the first major trial in heart failure to directly assess how the patients valued their lives, by asking them how many months out of two years of expected life they would be willing to trade away in order to feel better (the time trade-off utility assessment). PAC patients experienced double the improvement in this quality of life indicator.
“This study reminds us to take a step back and realize that what we most need are better therapies to improve survival and then find non-invasive, risk-free ways to guide those therapies to enhance the value of life with heart failure, so that patients want to live each day,” concluded Stevenson who is also a professor of Medicine at Harvard Medical School.
The study was funded by National Heart, Lung and Blood Institute.
Please contact BWH Media Relations for more information at (617) 534-1600 or BWHMediaRelations@partners.org.
BWH is a 747-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare System, an integrated health care delivery network. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832 and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives, dedication to educating and training health care professionals, and strength in biomedical research. With $370M in funding and more than 500 research scientists, BWH is an acclaimed leader in clinical, basic and epidemiological investigation - including the landmark Nurses Health Study, Physicians Health Studies, and the Women's Health Initiative. For more information visit www.brighamandwomens.org
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