A Multicenter Experience with a Bipolar Tined Polyurethane Ventricular Lead

multicenter study was undertaken to determine the failure rate of a specific polyurethane bipolar lined pacing lead, the Medtronic 4012 pacing lead. Six centers in the United States and Canada implanted 1,190 Medtronic 4012 pacing leads. The study was designed to determine the probability and clinic...

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Bibliographic Details
Published in:Pacing and clinical electrophysiology 1992-07, Vol.15 (7), p.1033-1039
Main Authors: HAYES, DAVID L., GRAHAM, KEVIN J., IRWIN, MARLEEN, VIDAILLET, HUMBERTO, DISLER, GAIL, SWEESY, MARK, OSBORN, MICHAEL J., SUMAN, VERA J., NEUBAUER, SHARON A., SEEBANDT, MARY, KALLINEN, LINDA, CROWSON, CYNTHIA S.
Format: Article
Language:English
Subjects:
Aged
Electrodes, Implanted
Equipment Design
Equipment Failure
Female
Follow-Up Studies
Humans
Male
Medtronic 4012 pacing lead
pacemaker follow-up
pacemaker lead failure
Pacemaker, Artificial
polyurethane insulation
Polyurethanes
Probability
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Summary:multicenter study was undertaken to determine the failure rate of a specific polyurethane bipolar lined pacing lead, the Medtronic 4012 pacing lead. Six centers in the United States and Canada implanted 1,190 Medtronic 4012 pacing leads. The study was designed to determine the probability and clinical manifestations of lead failure. Only failures compatible with an insulation problem were included. The probability of a 4012 lead failure by Kaplan‐Meier analysis was 20.9% at 6 years after implantation. Failures were manifested as sensing abnormalities, failure to capture, early battery depletion, and significant decrease in measured impedance compared with the previous impedance measurements. Of the 95 definite lead failures, 16 (16.8%) were associated with symptoms similar to those experienced before pacemaker placement. The observed failure rate is unacceptable, and strong consideration should be given to replacing the 4012 pacing lead in pacemaker‐dependent patients and closely monitoring nonde‐pendent patients.
ISSN:0147-8389
1540-8159
DOI:10.1111/j.1540-8159.1992.tb03097.x