LESSONS LEARNED BEFORE AND AFTER CARDIOMYOPLASTY - RISK SENSITIVE PATIENT SELECTION AND POST PROCEDURE QUALITY-OF-LIFE

Background: This paper unveils some of the clinical lessons we have le arned from caring for cardiomyoplasty patients over the past 7 years. We examine both the clinical and scientific rationale for expanding th e time frame of ''procedural mortality'' from 313 days to 90 days. Met hods: Utilizing this definition of procedural mortality, preoperative patient variables were applied to postoperative patient outcomes in or der to develop a risk sensitive method of patient selection. Preoperat ive atrial fibrillation, elevated pulmonary capillary wedge pressure, decreased peak oxygen consumption, and the requirement of intra-aortic balloon pump at the time of cardiomyoplasty, were all found to be ind ependent risk factors for early death following cardiomyoplasty. Resul ts: This analysis, which has been previously published, is reviewed an d enhanced with the mathematical equations for duplicating these relat ive risk calculations. The mathematical model presented herein allows a method of risk stratification, which obviates the need for randomize d congestive heart failure controls in the future. In the absence of a statistically regulated control population, we also examine the 1-yea r clinical outcomes of the nonrandomized control group of patients, wh o were followed during the North American FDA Phase II Cardiomyoplasty Trial. Conclusions: This quality of life comparison with cardiomyopla sty patients at 1 year revealed a significant decrease in intensive ca re unit patient-days, a significant increase in activity of daily livi ng score, and a significant improvement in New York Heart Association functional class as compared to control.