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Original Articles

Risk of Failure of Transvenous Implantable Cardioverter-Defibrillator Leads

C. Jan Willem Borleffs, MD; Lieselot van Erven, MD, PhD; Rutger J. van Bommel, MD; Enno T. van der Velde, PhD; Ernst E. van der Wall, MD, PhD; Jeroen J. Bax, MD, PhD; Frits R. Rosendaal, MD, PhD and Martin J. Schalij, MD, PhD

From the Department of Cardiology (C.J.W.B., L.v.E., R.J.v.B., E.T.v.d.V., E.v.d.W., J.J.B., M.J.S.), the Department of Clinical Epidemiology (F.R.R.), and the Department of Thrombosis and Hemostasis (F.R.R.), Leiden University Medical Center, Leiden, The Netherlands.

Correspondence to Martin J. Schalij, MD, Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands. E-mail m.j.schalij{at}lumc.nl

Received November 6, 2008; accepted April 9, 2009.

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.

Methods and 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.

Key Words: implantable cardioverter-defibrillator • lead • failure • defibrillation

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CLINICAL PERSPECTIVE