Risk of failure of transvenous implantable cardioverter-defibrillator leads.
BACKGROUND
Despite the positive effect on mortality in selected patients, implantable cardioverter-defibrillator therapy is also associated with potential malfunction of the implanted system. The present study provides the long-term lead failure rate in a large single-center cohort.


RESULTS
Since 1992, a total of 2068 implantable cardioverter-defibrillator patients with 2161 defibrillation leads were prospectively collected. Data of the implant procedure and all follow-up visits were recorded. All cases of lead removal or capping or placing of an additional pace or sense lead were noted and analyzed. Lead models were grouped by manufacturer and approximate lead diameter in French. During a mean follow-up of 36 months, 82 (3.8%) cases of lead failure were identified. Cumulative incidence of lead failure at 1 year was 0.6%; at 5 years, 6.5%; and at 10 years, 16.4%. The highest risk of lead failure was found in small-diameter leads. Adjusted hazard ratio was 6.4 (95% CI, 3.2 to 12.8) for Medtronic 7F leads, when compared with all other leads.


CONCLUSIONS
In this large single-center experience, the overall incidence of lead failure was 1.3 (95% CI, 1.0 to 1.6) per 100 lead-years. Comparison of different groups of leads shows major differences in event rates. Specific manufacturer's small-diameter defibrillation leads may have a higher risk of early lead failure.
Borleffs
C Jan Willem
CJ
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
van Erven
Lieselot
L
van Bommel
Rutger J
RJ
van der Velde
Enno T
ET
van der Wall
Ernst E
EE
Bax
Jeroen J
JJ
Rosendaal
Frits R
FR
Schalij
Martin J
MJ
D000328:Adult; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000453:epidemiology* / Q000628:therapy*; D017147:Defibrillators, Implantable / Q000009:adverse effects* / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012307:Risk Factors