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- Title
Sensing Failure Associated with the Medtronic Sprint Fidelis Defibrillator Lead.
- Authors
KENIGSBERG, DAVID N.; MIRCHANDANI, SUNIL; DOVER, AMANDA N.; KOWALSKI, MARCIN; WOOD, MARK A.; SHEPARD, RICHARD K.; KALAHASTY, GAUTHAM; STEIN, KENNETH M.; MARKOWITZ, STEVEN M.; IWAI, SEI; SHAH, BINDI K.; LERMAN, BRUCE B.; MITTAL, SUNEET; ELLENBOGEN, KENNETH A.
- Abstract
Introduction: 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. Methods: 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. Results: 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 ≤ 5 mV measured through the device at implant. Of those patients with an R-wave amplitude ≤ 5 mV at implant measured through the device, 63% (n = 26) remained ≤ 5 mV for the duration of follow-up. The mean time to R-wave amplitude ≤ 5 mV was 96.2 ± 123 days . During follow-up, 65 (18%) patients developed R-wave ≤ 5 mV. Overall 10 lead revisions (2.8%) were performed during the first year of follow-up. Conclusion: 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.
- Subjects
IMPLANTABLE cardioverter-defibrillators; ARTIFICIAL implants; LEAD in the body; MEDICAL equipment; MEDTRONIC PLC
- Publication
Journal of Cardiovascular Electrophysiology, 2008, Vol 19, Issue 3, p270
- ISSN
1045-3873
- Publication type
Article
- DOI
10.1111/j.1540-8167.2007.01058.x