Lessons learned before and after cardiomyoplasty: risk sensitive patient selection and post procedure quality of life

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.

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.

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.

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.