Sprint Fidelis Lead Fractures in Patients with Cardiac Resynchronization Therapy Devices: Insight from the Resynchronization/Defibrillation for Ambulatory Heart Failure (RAFT) Study
Background—Using data from the Resynchronization/Defibrillation for Ambulatory Heart Failure (RAFT) study, we examined whether Fidelis lead failure was more common in the patients with implantable cardioverter-defibrillator with cardiac resynchronization therapy (ICD-CRT) than patients with ICD only.
Methods and Results—All patients who had a right ventricular defibrillation lead revision in the RAFT study were adjudicated for the presence of lead fracture. Criteria for fracture were at least 2 of: 1) Impedance rise (>50% or >500 ohms in 1 week), 2) Short interval count > 10/day or 300/month or 3) Inappropriate shock due to noise verified by stored electrogram. A total of 1798 patients were enrolled into the RAFT study, with a mean followup of 40±20 months. There were 818 (45.8%) patients that received a Fidelis lead at the original implant, 405 with an ICD only and 413 with an ICD-CRT. There were 47 confirmed defibrillation lead fractures, 45 were Fidelis leads (5.5% of Fidelis leads). The overall rate of fracture in the ICD group was 3.2% compared to 7.8% in the ICD-CRT group (p=0.006, HR 2.42, 95%CI (1.27, 4.61). Significant correlates of lead fracture in this population were undergoing an ICD-CRT implant and having 2 or more leads.
Conclusions—In this analysis of the RAFT study, patients with an ICD-CRT were found to have a significantly higher fracture rate than patients with an ICD. This finding needs to be considered when assessing these patients for possible lead revision at the time of an elective generator replacement.
- Received July 21, 2012.
- Accepted November 2, 2012.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited