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Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial.

Publication ,  Journal Article
Binanay, C; Califf, RM; Hasselblad, V; O'Connor, CM; Shah, MR; Sopko, G; Stevenson, LW; Francis, GS; Leier, CV; Miller, LW ...
Published in: JAMA
October 5, 2005

CONTEXT: Pulmonary artery catheters (PACs) have been used to guide therapy in multiple settings, but recent studies have raised concerns that PACs may lead to increased mortality in hospitalized patients. OBJECTIVE: To determine whether PAC use is safe and improves clinical outcomes in patients hospitalized with severe symptomatic and recurrent heart failure. DESIGN, SETTING, AND PARTICIPANTS: The Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) was a randomized controlled trial of 433 patients at 26 sites conducted from January 18, 2000, to November 17, 2003. Patients were assigned to receive therapy guided by clinical assessment and a PAC or clinical assessment alone. The target in both groups was resolution of clinical congestion, with additional PAC targets of a pulmonary capillary wedge pressure of 15 mm Hg and a right atrial pressure of 8 mm Hg. Medications were not specified, but inotrope use was explicitly discouraged. MAIN OUTCOME MEASURES: The primary end point was days alive out of the hospital during the first 6 months, with secondary end points of exercise, quality of life, biochemical, and echocardiographic changes. RESULTS: Severity of illness was reflected by the following values: average left ventricular ejection fraction, 19%; systolic blood pressure, 106 mm Hg; sodium level, 137 mEq/L; urea nitrogen, 35 mg/dL (12.40 mmol/L); and creatinine, 1.5 mg/dL (132.6 micromol/L). Therapy in both groups led to substantial reduction in symptoms, jugular venous pressure, and edema. 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; hazard ratio [HR], 1.00 [95% confidence interval {CI}, 0.82-1.21]; P = .99), mortality (43 patients [10%] vs 38 patients [9%]; odds ratio [OR], 1.26 [95% CI, 0.78-2.03]; P = .35), or the number of days hospitalized (8.7 vs 8.3; HR, 1.04 [95% CI, 0.86-1.27]; P = .67). In-hospital adverse events were more common among patients in the PAC group (47 [21.9%] vs 25 [11.5%]; P = .04). There were no deaths related to PAC use, and no difference for in-hospital plus 30-day mortality (10 [4.7%] vs 11 [5.0%]; OR, 0.97 [95% CI, 0.38-2.22]; P = .97). 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. CONCLUSIONS: Therapy to reduce volume overload during hospitalization for heart failure led to marked improvement in signs and symptoms of elevated filling pressures with or without the PAC. Addition of the PAC to careful clinical assessment increased anticipated adverse events, but did not affect overall mortality and hospitalization. Future trials should test noninvasive assessments with specific treatment strategies that could be used to better tailor therapy for both survival time and survival quality as valued by patients.

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Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

October 5, 2005

Volume

294

Issue

13

Start / End Page

1625 / 1633

Location

United States

Related Subject Headings

  • Survival Analysis
  • Severity of Illness Index
  • Risk
  • Pulmonary Wedge Pressure
  • Middle Aged
  • Male
  • Humans
  • Hospitalization
  • Hospital Mortality
  • Heart Failure
 

Citation

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Binanay, C., Califf, R. M., Hasselblad, V., O’Connor, C. M., Shah, M. R., Sopko, G., … ESCAPE Investigators and ESCAPE Study Coordinators, . (2005). Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial. JAMA, 294(13), 1625–1633. https://doi.org/10.1001/jama.294.13.1625
Binanay, Cynthia, Robert M. Califf, Vic Hasselblad, Christopher M. O’Connor, Monica R. Shah, George Sopko, Lynne W. Stevenson, et al. “Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial.JAMA 294, no. 13 (October 5, 2005): 1625–33. https://doi.org/10.1001/jama.294.13.1625.
Binanay C, Califf RM, Hasselblad V, O’Connor CM, Shah MR, Sopko G, et al. Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial. JAMA. 2005 Oct 5;294(13):1625–33.
Binanay, Cynthia, et al. “Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial.JAMA, vol. 294, no. 13, Oct. 2005, pp. 1625–33. Pubmed, doi:10.1001/jama.294.13.1625.
Binanay C, Califf RM, Hasselblad V, O’Connor CM, Shah MR, Sopko G, Stevenson LW, Francis GS, Leier CV, Miller LW, ESCAPE Investigators and ESCAPE Study Coordinators. Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial. JAMA. 2005 Oct 5;294(13):1625–1633.
Journal cover image

Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

October 5, 2005

Volume

294

Issue

13

Start / End Page

1625 / 1633

Location

United States

Related Subject Headings

  • Survival Analysis
  • Severity of Illness Index
  • Risk
  • Pulmonary Wedge Pressure
  • Middle Aged
  • Male
  • Humans
  • Hospitalization
  • Hospital Mortality
  • Heart Failure