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 learned from caring for cardiomyoplasty patients over the past 7 years. We examine both the clinical and scientific rationale for expanding the time frame of 'procedural mortality' from 30 days to 90 days. Methods: Utilizing this definition of procedural mortality, preoperative patient variables were applied to postoperative patient outcomes in order to develop a risk sensitive method of patient selection. Preoperative 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 independent risk factors for early death following cardiomyoplasty. Results: This analysis, which has been previously published, is reviewed and enhanced with the mathematical equations for duplicating these relative risk calculations. The mathematical model presented herein allows a method of risk stratification, which obviates the need for randomized congestive heart failure controls in the future. In the absence of a statistically regulated control population, we also examine the 1-year clinical outcomes of the nonrandomizd control group of patients, who were followed during the North American FDA Phase II Cardiomyoplasty Trial. Conclusions: This quality of life comparison with cardiomyoplasty patients at 1 year revealed a significant decrease in intensive care unit patient-days, a significant increase in activity of daily living score, and a significant improvement in New York Heart Association functional class as compared to control.