Sensing Failure Associated with the Medtronic Sprint Fidelis Defibrillator Lead

Virginia Commonwealth University Medical Center, Richmond, Virginia 23298-0053, USA.
Journal of Cardiovascular Electrophysiology (Impact Factor: 2.96). 03/2008; 19(3):270-4. DOI: 10.1111/j.1540-8167.2007.01058.x
Source: PubMed


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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    • "Pacing threshold development was heterogeneously distributed during follow up independent of the type of endocardial potential at implant. No episodes of oversensing or short RR cycle lengths were noticed in our cohort within the three months follow up period in regard to previously published early lead failure [9]. "
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