Sensing failure associated with the Medtronic Sprint Fidelis defibrillator lead.

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 <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.

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.