High Mortality Without ESCAPE: The Registry of Heart Failure Patients Receiving Pulmonary Artery Catheters Without Randomization

• Published in: Journal of cardiac failure Vol. 14; no. 8; pp. 661 - 669
• Main Authors: Allen, Larry A., MD, Rogers, Joseph G., MD, Warnica, J. Wayne, MD, DiSalvo, Thomas G., MD, Tasissa, Gudaye, PhD, Binanay, Cynthia, RN, BSN, O'Connor, Christopher M., MD, Califf, Robert M., MD, Leier, Carl V., MD, Shah, Monica R., MD, Stevenson, Lynne W., MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2008
• Subjects: Alberta; Cardiac Catheterization - methods; Cardiovascular; Disease Progression; Female; Generalizability; Heart Failure - drug therapy; Heart Failure - mortality; Heart Failure - physiopathology; Hemodynamic measurements; Hemodynamics; Humans; Length of Stay; Male; Middle Aged; Outcomes; Prospective Studies; Pulmonary Artery - physiopathology; Registries; Registry; Tailored therapy; Treatment Outcome; Alberta; Registry; Generalizability; Tailored therapy; Hemodynamic measurements; Outcomes
• ISSN: 1071-9164; 1532-8414; 1532-8414
• DOI: 10.1016/j.cardfail.2008.05.004

Abstract Background In the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE), there was no difference in days alive and out of the hospital for patients with decompensated heart failure randomly assigned to therapy guided by pulmonary artery catheter (PAC) plus clinical assessment versus clinical assessment alone. The external validity of these findings is debated. Methods and Results ESCAPE sites enrolled 439 patients receiving PAC without randomization in a prospective registry. Baseline characteristics, pertinent trial exclusion criteria, reasons for PAC use, hemodynamics, and complications were collected. Survival was determined from the National Death Index and the Alberta Registry. On average, registry patients had lower blood pressure, worse renal function, less neurohormonal antagonist therapy, and higher use of intravenous inotropes compared with trial patients. Although clinical assessment anticipated less volume overload and greater hypoperfusion among the registry population, measured filling pressures were similarly elevated in the registry and trial patients, whereas measured perfusion was slightly higher among registry patients. Registry patients had longer hospitalization (13 vs 6 days, P < .001) and higher 6-month mortality (34% vs 20%, P < .001) than trial patients. Conclusions The decision to use PAC without randomization identified a population with higher disease severity and risk of mortality. This prospective registry highlights the complex context of patient selection for randomized trials.