Enhanced External Counterpulsation in Patients With Heart Failure: A Multicenter Feasibility Study

Ozlem Soran, MD, Bruce Fleishman, MD, Theresa Demarco, MD, William Grossman, MD, Virginia M. Schneider, RN, Karen Manzo, RN, Paul-André de Lame, MD, Arthur M. Feldman, MD, PhD

Disclosures

CHF. 2002;8(4) 

In This Article

Abstract and Introduction

To assess the feasibility of using enhanced external counterpulsation to treat patients with heart failure, 26 patients with stable heart failure (New York Heart Association classes II-III), with a left ventricular ejection fraction at or below 35%, and without fluid overload, were treated with enhanced external counterpulsation (1 hour daily, 5 days a week, to a total of 35 hours). Patients were followed for 6 months after completing the course of enhanced external counterpulsation. The primary parameter was safety as reflected by adverse events or by changes in laboratory parameters. Secondary end points included changes in exercise capacity and quality of life. There were no clinically significant problems associated with the administration of enhanced external counterpulsation. Significant improvements were seen in exercise capacity (peak oxygen uptake and exercise duration), and in quality of life assessments, at 1 week and 6 months after the course of enhanced external counterpulsation. This study suggests that enhanced external counterpulsation is safe and well tolerated in patients with stable heart failure, and that a randomized, controlled study of enhanced external counterpulsation in these patients is warranted.

Enhanced external counterpulsation (EECP; Vasomedical Inc., Westbury, NY) is a noninvasive therapy for patients with stable angina secondary to coronary artery disease[1] and normal or near-normal left ventricular function. By sequentially inflating a series of compressive cuffs wrapped around the lower legs, thighs, and upper thighs upon diastole, and then rapidly deflating the cuffs at end diastole, EECP increases diastolic and decreases systolic blood pressure. In this manner, EECP lowers systemic vascular resistance, decreases afterload, and increases cardiac output.[2,3,4,5,6] These effects achieve a significant reduction in left ventricular oxygen consumption and are accompanied by a transient increase in right ventricular filling pressures,[7] a decrease in serum endothelin, and an increase in serum induced nitric oxide synthetase. In a multicenter, randomized, controlled trial, EECP was effective in relieving angina and increasing time to exercise-induced ST-segment depression in patients with chronic angina pectoris.[8] Salutary effects of EECP have been associated with a significant decrease in reversible perfusion defects as seen on thallium scintigraphy.[6,9]

Because EECP increases right ventricular filling pressures by augmenting venous return during diastole, clinicians have conjectured that its use in patients with left ventricular dysfunction and heart failure would be contraindicated. However, the hemodynamic effects of EECP are similar to those of intra-aortic balloon counterpulsation, with similar diastolic augmentation and afterload reduction. Anecdotal reports have stated that EECP benefits patients with coronary disease and left ventricular dysfunction and an analysis of patients enrolled in the International EECP Patient Registry showed that a left ventricular ejection fraction of less than 35% was not associated with an increase in adverse events during treatment. Furthermore, benefits were similar when compared to patients with preserved left ventricular function.[10]

However, the long-term safety of EECP in patients with symptomatic heart failure and coronary disease and its role in patients with nonischemic heart failure secondary to left ventricular dysfunction have not been evaluated. The present feasibility/safety trial was designed to address these questions.

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