CLINICAL CARDIOMYOPLASTY - REVIEW OF THE 10-YEAR UNITED-STATES EXPERIENCE

Background. Clinical trials of dynamic cardiomyoplasty were pioneered at Allegheny General Hospital beginning in September 1985. Data from 9 years of experience with the procedure at this institution and more r ecent data from newer cardiomyoplasty centers have been analyzed for o utcome analysis and future trends. Methods. Each patient underwent a c ardiomyoplasty procedure using the left or right latissimus dorsi musc le. Thirty-four patients were studied at Allegheny: 5 patients implant ed with dual chamber pacemakers as single stimulus myostimulators, 11 patients composing the phase I Food and Drug Administration trial of t he Medtronic burst myostimulator, and 18 patients entered in the phase II Medtronic trial. Patients from seven additional centers entered th e phase II trial in 1991. Fifty-seven patients completed follow-up stu dies to 1 year after operation in this trial. Results. Operative morta lity was 5/57 (11%) in the American phase II group and 5/34 (15%) in t he Allegheny group (1/18, 6% for Allegheny phase II). Nineteen patient s (19/57, 33%) from the combined phase II population died in the first year, and 10/34 (29%) in the Allegheny study. The predominant cause o f postdischarge death was arrhythmia (12/19, 63% American; 7/10, 70% A llegheny). In all groups significant improvement was seen in quality o f life and functional class. Phase II patients demonstrated significan t increases in ejection fraction and stroke work. Conclusions. Failure to sustain improvement and arrhythmia-related death are complex chall enges for this procedure; however, realistic solutions have been propo sed and are under investigation.