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J Am Coll Cardiol, 2003; 41:73-80 © 2003 by the American College of Cardiology Foundation |
* Division of Cardiology, Medical College of Virginia/Virginia Commonwealth University, Richmond, Virginia, USA
Medtronic, Inc., Minneapolis, Minnesota, USA
Manuscript received May 6, 2002; revised manuscript received August 6, 2002, accepted August 19, 2002.
* Reprint requests and correspondence: Dr. Kenneth A. Ellenbogen, Medical College of Virginia, P.O. Box 980053, Richmond, Virginia 23398-0053, USA.
kellenbogen{at}pol.net
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.
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