Generator exchange is associated with an increased rate of Sprint Fidelis lead failure Joshua D. Lovelock, MD, Ayesha Patel, BS, Andenet Mengistu, MD, Michael Hoskins, MD, Mikhael El-Chami, MD, Michael S. Lloyd, MD, FHRS, Angel Leon, MD, FHRS, David DeLurgio, MD, FHRS, Jonathan J. Langberg, MD From the Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia. BACKGROUND The Medtronic Sprint Fidelis defibrillator lead is at an increased risk for failure and was recalled in October 2007. Approximately 268,000 leads were implanted, and more than 100,000 patients still have active Fidelis leads. A number of studies have examined the rate and clinical predictors of lead failure, but none has addressed the effect of an implantable cardioverter-defibrillator generator exchange on subsequent lead failure. Although the manufacturer asserts that “Sprint Fidelis performance after device change-out is similar to lead perfor- mance without device change-out,” published data are lacking. OBJECTIVE To assess the effect of implantable cardioverter-defi- brillator generator exchange on the rate of Fidelis lead failure. METHODS A chart review was conducted in patients who under- went implantation of a Fidelis lead. Patients with a functioning Fidelis lead at generator exchange were compared with controls with leads implanted for a comparable amount of time not under- going ICD replacement. RESULTS A total of 1366 patients received a Fidelis lead prior to the recall, of which 479 were still actively followed. Seventy-two patients with a functioning lead underwent generator exchange without lead replacement. Following generator replacement, 15 leads failed. Sixty percent of the Fidelis leads failed within 3 months. Generator exchange increased the rate of lead failure compared with matched controls (20.8% vs 2.54%; P  .001). CONCLUSIONS Generator exchange is associated with a higher than expected rate of Fidelis lead failure, often within 3 months. The risk-benefit ratio of Fidelis lead replacement at the time of generator exchange may be greater than appreciated. KEYWORDS Fidelis Lead; Generator exchange; Lead failure; Sprint Fidelis ABBREVIATION ICD = implantable cardioverter-defibrillator (Heart Rhythm 2012;9:1615–1618) © 2012 Heart Rhythm Society. All rights reserved. Introduction The Sprint Fidelis lead developed by Medtronic was smaller in diameter than previous models and was implanted in large numbers after it was introduced in the United States in September 2004. The lead was withdrawn from the market in October 2007 because of a higher than expected rate of failure during follow-up monitoring. 1 During these 3 years, more than 268,000 Sprint Fidelis leads were implanted, and even today, more than 100,000 patients still have an active Sprint Fidelis lead. 2 Failure of the Sprint Fidelis lead often manifests as oversensing from conductor fracture. Even with the enhanced monitoring recommended by the manu- facturer, lead failure can lead to inappropriate shocks, and in rare instances, death. 3–6 Implantable cardioverter-defibrillator (lCD) lead replacement is also associated with significant risk. Even in experienced hands, ICD lead extraction has a major adverse event rate approaching 1%–1.5%. 7–9 Thus, there is considerable controversy regarding the management of patients with these leads. The difficult decision to reuse or replace a functioning Sprint Fidelis lead is often made at the time of ICD replacement. The manufacturer has asserted that the process of ICD generator replacement does not affect the performance of the Sprint Fidelis lead. 10 How- ever, we noted several instances in which lead failure oc- curred shortly after a generator exchange. Therefore, the purpose of this study was to review our entire experience with this lead and assess the effect of ICD generator ex- change on the rate of subsequent Sprint Fidelis lead failure. Methods All patients with Medtronic Sprint Fidelis (model number 6949) ICD leads followed at Emory University Hospital (Atlanta, GA) and Emory University Hospital Midtown (Atlanta, GA) that were implanted from September 2004 through October 2007 were included in the study. Data regarding ICD lead implantation and follow-up were col- lected prospectively at each center as part of our institu- tional ICD database. Within the study cohort, we identified a subset of patients undergoing generator exchange with a normally functioning Sprint Fidelis lead at the time of the ICD replacement procedure. Data regarding age, sex, ICD lead length, and the duration of the Fidelis implant in this Dr El-Chami has received a grant from Medtronic. Address for re- print requests and correspondence: Dr Jonathan J. Langberg, MD, Sec- tion of Cardiology, Emory University School of Medicine, 1364 Clifton Rd, NE Ste, Atlanta, GA 30322. E-mail address: jlangbe@emory.edu. 1547-5271/$ -see front matter © 2012 Heart Rhythm Society. All rights reserved. http://dx.doi.org/10.1016/j.hrthm.2012.06.009