Publication

Very late follow-up of a passive defibrillator lead under recall: do failure rates increase during long-term observation

Journal Paper/Review - Jan 20, 2015

Units
PubMed
Doi

Citation
Frey S, Sticherling C, Kraus R, Ammann P, Kühne M, Osswald S, Schaer B. Very late follow-up of a passive defibrillator lead under recall: do failure rates increase during long-term observation. Pacing Clin Electrophysiol 2015; 38:306-10.
Type
Journal Paper/Review (English)
Journal
Pacing Clin Electrophysiol 2015; 38
Publication Date
Jan 20, 2015
Issn Electronic
1540-8159
Pages
306-10
Brief description/objective

BACKGROUND
The Medtronic Sprint Fidelis lead (SFL; Medtronic Inc., Minneapolis, MN, USA) has a significantly impaired long-term survival, and active fixation leads fare worse than passive leads. The goal of this study was to present data of a series of passive SFL only with very long mean follow-up of more than 6 years.

METHODS
Patients in whom a passive SFL was implanted in two large Swiss centers were followed. We excluded eight (5.5%) patients with a follow-up of <6 months. Patients who died or were lost during follow-up were censored at death or last device check, all others on January 31, 2014. We employed two different definitions of failure: strict = fracture with inappropriate discharge; sudden increase in impedance >1,500 or high-voltage impedance >100 Ohm; >300 nonphysiological short interventricular-intervals. Lenient = any of the above plus a linear increase in impedance >1,500 Ohm or a linear decrease in sensing to a level that treating cardiologists considered inappropriate.

RESULTS
We included 137 patients. Age was 60 ± 12 years. Mean and median follow-up were 6.2 ± 2.1 and 6.8 (interquartile range 4.8-7.8) years. Applying the strict definition, 12 leads (8.8%) were replaced after 4.9 ± 2.4 years (range 1.2-8.1). Applying the lenient definition, 14 leads (10.2%) failed. Cumulative lead survival was 98.5% at 3, 96.9% at 4, 94.2% at 5, and 93.1% at 6 years. Leads "at risk" were: n = 122 (89%), 115 (84%), 101 (74%), and 88 (64%).

CONCLUSIONS
In this population with passive SFLs, 5-year lead survival is impaired with 94.2% based on 74% of leads "at risk" at this time point.