Abstract 14558: Cardiac Resynchronization Therapy Defibrillators: Pre and Postmarket Experience
Introduction In collaboration with the CMS SafeRx Project, FDA aims to build and implement an active surveillance system with administrative and insurance claims data to monitor FDA-regulated products. We sought to determine if baseline characteristics of patients receiving Cardiac Resynchronization Therapy Defibrillators (CRT-D) in Medicare are similar to those reported in the premarket.
Methods We evaluated Medicare patients implanted with CRT-D from July 1, 2002 - December 31, 2008 and continuously enrolled in Medicare Part A and B ≥ 6 months prior to implant. The patient characteristics were compared to premarket trial Summary of Safety and Effectiveness Data from the Comparison of Medical Therapy, Pacing and Defibrilation in Heart Failure (COMPANION) and the Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE ICD).
Results This study of 144,642 Medicare CRT-D patients included 37,167 (26%) women despite women comprising 57% of the entire Medicare population. The premarket trial CRT-D arms had 33% and 24% females in COMPANION and MIRACLE ICD respectively (Table). Compared to women, men in Medicare had a greater burden of co-morbidities (Charlson score >3: 41% vs 38%), ischemic cardiomyopathy (69% vs 53%) and atrial fibrillation (Afib) (56% vs 48%). Afib and hypertension were more prevalent in the Medicare cohort than MIRACLE ICD (54% vs 26% and 85% vs 45% respectively). Medicare women had left bundle branch block (LBBB) more often than men (53% vs 39%). Overall LBBB was less prevalent in Medicare (43%) than COMPANION (73%) or MIRACLE ICD (75%). All differences persisted when the Medicare cohort was restricted to exclude end stage renal disease and disabled patients to be comparable to premarket.
Conclusions Analyzing claims data identifies vast differences in characteristics between pre and postmarket CRT-D populations. This study demonstrates that Medicare data is a useful active surveillance tool for monitoring FDA-regulated medical devices.
- © 2012 by American Heart Association, Inc.