Abstract
Introduction: Transcatheter aortic valve replacement (TAVR) was recently approved by the Food and Drug Administration (FDA) after a large clinical trial and a collaborative technology development process involving professional medical societies, the medical device industry, and the FDA. This study compares risk-adjusted mortality between hospitals with and without clinical trial experience. Methods: All Medicare fee-for-service patients undergoing TAVR (n=5003) between January 1, 2011 and November 30, 2012. Kaplan-Meier and risk-adjusted 30-day and 180-day survival were compared between patients undergoing TAVR at 68 clinical trial hospitals (n=3617) versus patients at 140 non-clinical trial hospitals (n=1392). Results: The preoperative characteristics of patients at trial versus non-trial hospitals were similar in age and other comorbidities, with only modest differences observed in the prevalence of chronic heart failure (93% trial hospitals, 89% non-trial hospitals, p<0.01) and peripheral vascular disease (80% trial hospitals, 84% non-trial hospitals, p<0.01). There was no significant difference in risk adjusted 30-day mortality (Odds Ratio [OR] 0.88, 95% CI 0.66 - 1.15, p=0.34) or 180 day mortality (OR 0.99 95% CI 0.75 - 1.3, p=0.94). There was also no difference in mortality in the first ten cases performed at non-trial institutions versus subsequent cases (OR 1.08, 95% CI 0.51 - 2.21, p=0.83). Conclusions: There were no significant differences in the mortality between clinical trial versus non-clinical trial hospitals. This is an unusual finding compared to other new cardiovascular devices and procedures for which higher mortality has been observed at hospitals that did not participate in the clinical trials that preceded FDA approval. The unique policy and regulatory environment governing TAVR development therefore could serve as a model for future cardiovascular technology development and dissemination.
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