Abstract 13983: Long-term Device-Related Adverse Events After Cardiac Resynchronization Therapy: Insights From the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT)
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure hospitalization and mortality in patients with congestive heart failure, low ejection fraction and a wide QRS interval. CRT implantation is technically more complex than typical implantable cardioverter defibrillator (ICD) implantation. In addition, the requirement for constant biventricular stimulation leads to more rapid battery depletion. The purpose of this study was to quantify the risk for device-related adverse events occurring in pts receiving CRT-ICD as compared to those receiving ICD.
Methods: RAFT randomized 1798 pts to ICD vs ICD-CRT and followed these pts for 40±20 mos. All device-related events prolonging hospitalization or resulting in a re-intervention were adjudicated by an event committee and classified as a complication, elective device replacement or device upgrade.
Results: Eleven pts did not undergo device implantation. Overall, 804 events occurred in 581 pts (32%) during follow-up. The majority (>90%) of these events resulted in a re-intervention. A total of 512 events occurred in 358 pts (40.3%) randomized and receiving ICD-CRT as compared to 292 events occurring in 223 pts (24.8%) randomized and receiving an ICD (n=899) (RR=1.6, p<0.0001). The increase in events in ICD-CRT pts was due to both an increase in complications (320 vs 163, p<0.0001) and an increased number of elective device replacements due to battery depletion (191 vs 28, p<0.0001). One hundred and one pts receiving an ICD underwent an upgrade to ICD-CRT during FU. The time course of device-related events is shown in the graph.
Conclusions: ICD-CRT use is associated with a high risk of device-related adverse events. Improved CRT technology including better battery longevity are needed so that more eligible pts receive this life-saving therapy over long term follow-up.
- © 2011 by American Heart Association, Inc.