Sensing Failure Associated with the Medtronic Sprint Fidelis Defibrillator Lead
ABSTRACT The diameter of implantable cardioverter-defibrillator (ICD) leads has become progressively smaller over time. However, the long-term performance characteristics of these smaller ICD leads are unknown.
We retrospectively evaluated 357 patients who underwent implantation of a Medtronic Sprint Fidelis defibrillating lead at two separate centers between September 2004 and October 2006. Lead characteristics were measured at implant, at early follow-up (1-4 days post implant), and every 3-6 months thereafter.
During the study period, 357 patients underwent implantation of the Medtronic Sprint Fidelis lead. The mean R-wave measured at implant through the device was not different (P = NS) when compared with that measured at first follow-up (10.5 +/- 5.0 mV vs 10.7 +/- 5.1 mV). Forty-one patients (13%) had an R-wave amplitude <or= 5 mV measured through the device at implant. Of those patients with an R-wave amplitude <or= 5 mV at implant measured through the device, 63% (n = 26) remained <or= 5 mV for the duration of follow-up. The mean time to R-wave amplitude <or= 5 mV was 96.2 +/- 123 days. During follow-up, 65 (18%) patients developed R-wave <or= 5 mV. Overall 10 lead revisions (2.8%) were performed during the first year of follow-up.
Abnormal R-wave sensing is frequently observed during follow-up with the Medtronic Fidelis ICD lead. Lead revision was necessary in 2.8% of the patients, most often (8 of 10) due to abnormal R-wave sensing along with elevated pacing threshold. Whether this issue is limited to this lead or reflects a potential problem with all downsized ICD leads merits further investigation.
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ABSTRACT: Background The structures composing implantable cardioverter-defibrillator (ICD) leads have become more complicated and thinner with technological advances. Silicon insulation defects with and without clinically manifested electrical abnormalities have been reported in Riata leads (St. Jude Medical). Objective The aim of this study was to assess the incidence and clinical implications of insulation defects in Riata leads implanted at our hospital. Methods The subjects included 10 consecutive patients who received 8-French Riata ICD leads with dual-coil conductors (model 1580 or 1581) between 2006 and 2010 at our hospital. Operative records, chest X-rays and interrogation data were reviewed. Results In all cases, Atlas+ (St. Jude Medical) was used as an ICD generator and the Riata leads were implanted transvenously and fixed to the right ventricular apex. During a mean follow-up period of 52±9 (36-70) months, chest X-rays revealed insulation defects in Riata leads and conductor wires projecting from the bodies of the Riata leads in two of 10 (20%) patients. One of the patients received inappropriate ICD therapies due to T-wave oversensing based on attenuation of R waves and augmentation of T waves 41 months after implantation. In the other patient, an insulation defect without any clinically manifested electrical troubles was detected 50 months after implantation. Conclusion Riata leads have a high incidence of insulation defects, which may be occasionally accompanied by inappropriate ICD discharges. For patients with Riata leads, careful observation of any changes in the lead-electrical measurements and a routine chest X-ray follow-up are necessary.Internal Medicine 01/2012; 51(19):2689-94. DOI:10.2169/internalmedicine.51.7805 · 0.97 Impact Factor
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ABSTRACT: Riata (RT) and Sprint Fidelis (SF) leads were recalled by the Food and Drug Administration because of an increased rate of failure mainly due to conductor fracture or insulation abrasion. According to lead design and type of failure, extraction complexity may be different, potentially affecting procedural outcomes and indications. Aim of this study was to assess the extraction profile of RT leads with and without cable externalization in comparison to SF Leads. From January 1997 to April 2014, we analyzed all the consecutive RT and SF extracted transvenously. Among 661 consecutive patients with 705 ventricular ICD leads extracted, we identified 194 patients with 134 RT (RT Group) and 61 SF (SF Group). Removal indications were often infective (64%); extracted leads had a prevalence of dual coil design (89%). Baseline patients and lead characteristics were comparable between groups. Success rate was high in both groups (97.8% RT vs 100% SF) without major complications. Mechanical dilatation was comparable between groups but RT leads required often larger sheaths (11.7±1.4 vs 11.3±1.4), a more frequent crossover to the internal transjugular approach (ITA) (14% vs 3%), and a longer procedural time (23±33 vs 12±16). Implantation time [OR 4.84, 95% CI 1.05-22.2, p=0.042] and RT leads [OR 1.04, 95% CI 1.02-1.06, p<0.001] were independent predictors of ITA. Extraction of RT leads is feasible and effective. However, extraction of RT leads is more complex than SF leads. Lack of coil backfilling and cable externalization in RT group may account for these differences. Copyright © 2014. Published by Elsevier Inc.Heart rhythm: the official journal of the Heart Rhythm Society 12/2014; 12(3). DOI:10.1016/j.hrthm.2014.12.013 · 4.92 Impact Factor
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ABSTRACT: Clinical Performance of the St. Jude Medical Riata Defibrillation Lead in a Large Patient Population. Objective: The purpose of this large multicenter study was to evaluate the long-term reliability of an implantable cardioverter defibrillator (ICD) lead to determine the incidence of adverse events (AEs).Background: A recent concern has been the performance of cardiac defibrillator leads. There have been conflicting reports regarding the rate of lead perforation and other AEs.Methods: Medical records from patients implanted from 6-1-2001 to 11-27-2007 with the St. Jude Medical Riata family of RV leads at 23 US (N = 12,969) and 5 German (N = 2,418) centers were reviewed for chronic lead-related AEs. These included perforation, dislodgment, conductor fracture and insulation damage. The mean follow-up period was 18.0 months. AEs were defined as those that required Riata lead revision, extraction, or replacement.Results: The incidence of lead AEs was <1% for each AE type. Perforation occurred in 0.38%, dislodgement in 0.93%, conductor fracture in 0.18%, and insulation damage in 0.21% of patients studied.Conclusions: During the follow-up of the 15,387 patients with Riata leads, the incidence of AEs which included perforation, dislodgement, conductor fraction and insulation damage was low and within the range of what is considered clinically acceptable. (J Cardiovasc Electrophysiol, Vol. 21, pp. 551-556, May 2010)Journal of Cardiovascular Electrophysiology 04/2010; 21(5):551 - 556. DOI:10.1111/j.1540-8167.2009.01651.x · 2.88 Impact Factor