Objectives: This study evaluated the long-term reliability of an implantable cardioverter defibrillator (ICD) lead to determine the incidence, clinical presentation, and management of lead failure.
Background: Despite recent advances in ICD technology, the long-term reliability of ICD leads remains a significant problem.
Methods: Concern about long-term reliability of coaxial polyurethane ICD leads caused us to systematically study all patients implanted with Medtronic (Minneapolis, Minnesota) 6936 lead at our institution. We performed follow-up of 74 patients with 76 ICD leads that were implanted from February 28, 1995 to September 8, 1997. Thirty-seven patients underwent routine clinical ICD follow-up testing and ventricular fibrillation induction to determine the status of their ICD lead after a mean follow-up of 68.6 +/- 8.2 months.
Results: The lead survival analysis shows a cumulative failure probability of 37% (confidence interval, 24% to 54%) at 68.6 months. Six patients demonstrated a previously undescribed mode of ICD lead failure: prolonged oversensing immediately after shock therapy. The use of short interval counters to monitor nonphysiologic R-R intervals and the measurement of ring-to-coil impedance detected early lead failures in five patients.
Conclusions: This analysis shows: 1) problems with ICD leads may not become apparent until late during follow-up and may become a significant late problem, 2) a "signature" mode of lead failure for the 6936 consisting of oversensing of electrical noise following shocks, 3) early detection of lead failure with a short interval counter algorithm or measurement of ring-to-coil impedance may be clinically useful.