Multicenter trial of dynamic cardiomyoplasty for chronic heart failure

Objectives. The purpose of this study was to prospectively assess the effect o Background. Since the first procedure was performed in 1985, dynamic cardiomyoplasty has been developed for use in patients with chronic heart failure. The aging population in developed countries has made heart failure a growing public health concern, Heart transplantation is appropriate or available for only a small proportion of these patients because of limited donor supply, Effective alternatives to transplantation are needed. Methods. Eight centers in North and South America performed 68 cardiomyoplasty procedures between May 1991 and September 1993, Data were prospectively collected every 6 months and compared with preoperative values using paired t tests, chi-square tests and actuarial survival analyses. Results. Patients had a mean (+/-SD) age of 57 +/- 1 years and were predominantly male (53 [78%] of 68), Heart failure etiology was classified as idiopathic in 47 (69%) of 68 patients and ischemic in 21 (31%), The in hospital mortality rate was 12% (8 of 68), and the survival rate at 6 and 12 months was 75 +/- 5% and 68 +/- 6%, respectively, Objective improvements mere seen at 6 months (n = 49) in left ventricular ejection fraction (23 +/- 1% vs, 25 +/- 1%, p = 0.05), stroke volume (50 +/- 2 vs. 56 +/- 3 ml/beat, p = 0.02) and left ventricular stroke work index (26 +/- 1 vs. 30 +/- 2 g/m(2) per beat, p = 0.01), Improvements in mean New York Heart Association functional class (3 +/- 0.04 vs, 1.8 +/- 0.1, p = 0.0001) and activity of daily living score (59 +/- 3 vs, 80 +/- 2, p = 0.0001) were also observed, There were no significant changes at 6 months in peak oxygen consumption (15 +/- 1 vs. 16 +/- 1 ml/kg per min), cardiac index (2.26 +/- 0.08 vs, 2.33 +/- 0.08 liters/min per m(2)), pulmonary capillary wedge pressure (19 +/- 2 vs, 18 +/- 1 mm Hg) or heart rate (87 +/- 2 vs, 82 +/- 3 beats/min). Conclusions. These data suggest that dynamic cardiomyoplasty improves ventricular systolic function, reduces symptoms of heart failure and improves objective measures of quality of life in patients with congestive heart failure. This improvement occurred without changes in peak exercise capacity, ventricular filling pressure or actuarial survival.