Prospective Evaluation of Enhanced External Counterpulsation in Congestive Heart Failure - PEECH

Description:

The goal of the trial was to evaluate treatment with enhanced external counterpulsation (EECP) among patients with systolic dysfunction, stable heart failure symptoms, and treated with optimal pharmacologic therapy.

Hypothesis:

Use of EECP will be associated with improvements in exercise performance, symptom status, and quality of life among patients with systolic dysfunction, stable heart failure symptoms, and treated with optimal pharmacologic therapy.

Study Design

Study Design:

Patients Enrolled: 187
Mean Follow Up: Six months
Mean Patient Age: Mean age 63 years
Female: 24

Patient Populations:

Stable heart failure with NYHA class II or III symptoms, ischemic or nonischemic etiology, left ventricular ejection fraction ≤35%, optimal pharmacologic therapy, ability to exercise ≥3 minutes, and limited by shortness of breath or fatigue (not by angina)

Primary Endpoints:

Percentage of subjects with: 1) at least a 60-second increase in exercise duration from baseline to six months, or 2) at least 1.25 ml/min/kg increase in peak VO2 from baseline to six months

Secondary Endpoints:

Changes in exercise duration and peak VO2, changes in NYHA classification, changes in quality of life, and adverse events

Drug/Procedures Used:

Patients were randomized to EECP with optimal pharmacologic therapy (n=93) or optimal pharmacologic therapy alone (n=94). EECP therapy consists of a series of inflatable cuffs that are rapidly inflated at the onset of diastole and rapidly deflated at the onset of systole in order to replicate the hemodynamic properties of intra-aortic counterpulsation.

EECP was administered as 35 one-hour sessions and continued for seven weeks. Patients underwent exercise stress test at baseline and three months. Optimal pharmacologic therapy included angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) and beta-blockers.

Concomitant Medications:

ACE inhibitors (76%), ARBs (19%), and beta-blockers (85%)

Principal Findings:

Baseline characteristics were well balanced between treatment groups. Ischemic etiology was present in 69% of patients and 65% had New York Heart Association (NYHA) class II. Baseline ejection fraction was 26%. Increase in exercise duration by at least 60 seconds at six months occurred more frequently in the EECP group compared with control (35.4% vs. 25.3%, p=0.016).

There was no difference in the co-primary endpoint of increase in peak VO2 of at least 1.25 ml/min/kg between groups (22.8% for EECP vs. 24.1% for control, p=NS). Change in exercise duration was longer in the EECP group compared with control as early as one week (26.4-second increase vs. 5.5-second decrease, p=0.01) and maintained through six months (24.7-second increase vs. 9.9-second decrease, p=0.01). Improvement in NYHA class was more common in the EECP group compared with control at one week (33.3% vs. 11.4%, p<0.001) and maintained through six months (31.3% vs. 14.3%, p<0.01).

Change from baseline in Minnesota Living with Heart Failure score was greater in the EECP group at one week (-8.9 vs. -3.4, p=0.01) and three months (-7.1 vs. -2.9, p=0.01), but did not differ at six months (-3.7 vs. -2.9, p=NS). Serious adverse events were reported in 30.3% of the EECP group and 29.5% of the control group (p=NS).

Interpretation:

Among patients with systolic dysfunction, stable heart failure symptoms, and treated with optimal pharmacologic therapy, use of EECP was associated with improvements in exercise duration, NYHA classification, and quality of life, but no difference in change in peak VO2 compared with optimal pharmacologic therapy alone.

EECP therapy has previously been shown to be beneficial for increased time to exercise-induced ischemia and decreased anginal frequency in patients with stable angina. However, data in patients with heart failure are limited to a registry and a pilot trial. The present study demonstrated improvements in exercise duration and quality of life despite optimal medical therapy.

References:

Feldman AM, et al. Enhanced External Counterpulsation Improves Exercise Tolerance in Patients With Chronic Heart Failure. J Am Coll Cardiol 2006;48:1198–205.

Presented by Dr. Arthur M. Feldman at the March 2005 ACC Annual Scientific Session, Orlando, FL.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Stable Ischemic Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and SIHD, Acute Heart Failure, Mechanical Circulatory Support , Chronic Angina

Keywords: Angiotensin Receptor Antagonists, Angina, Stable, Quality of Life, Heart Failure, Stroke Volume, Dyspnea, Diastole, Counterpulsation, Systole, Exercise Test


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