Long-term structural failure of coaxial polyurethane implantable cardioverter defibrillator leads

Robert G. Hauser, David Cannom, David L. Hayes, Victor Parsonnet, John Hayes, Norman Ratliff, G. FRANK O. Tyers, Andrew E. Epstein, Stephen C. Vlay, Seymour Furman, Jay Gross

Research output: Contribution to journalArticle

51 Scopus citations

Abstract

Transvene models 6936/6966, a coaxial polyurethane ICD lead, may be prone to structural failure. These models comprise 54% of ICD lead failures in the authors' Multicenter Registry database. Because ICD leads perform a vital function, the clinical features, causes, and probability of Transvene 6936/6966 lead failure were determined. The Registry and United States Food and Drug Administration databases were queried for the clinical features and structural causes of the Transvene 6936/6966 lead failure, and a five-center substudy estimated the survival probability for 521 Transvene 6936/6966 implants. The mean time to failure was 4.8 ± 2.1 years, and the estimated survival at 60 and 84 months after implant were 92% and 84%, respectively. Oversensing was the most common sign of failure (76%), and 24 patients experienced inappropriate shocks. The manufacturer's reports indicated that high voltage coil fracture and 80A polyurethane defects were the predominant causes of lead failure. Transvene models 6936 and 6966 coaxial polyurethane ICD leads are prone to failure over time. Patients who have these leads should be evaluated frequently. Additional studies are needed to identify safe management strategies.

Original languageEnglish (US)
Pages (from-to)879-882
Number of pages4
JournalPACE - Pacing and Clinical Electrophysiology
Volume25
Issue number6
DOIs
StatePublished - Jan 1 2002

Keywords

  • Complications
  • Implantable cardioverter defibrillator
  • Leads
  • Registry

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Hauser, R. G., Cannom, D., Hayes, D. L., Parsonnet, V., Hayes, J., Ratliff, N., Tyers, G. FRANK. O., Epstein, A. E., Vlay, S. C., Furman, S., & Gross, J. (2002). Long-term structural failure of coaxial polyurethane implantable cardioverter defibrillator leads. PACE - Pacing and Clinical Electrophysiology, 25(6), 879-882. https://doi.org/10.1046/j.1460-9592.2002.t01-1-00879.x