A Multicenter Experience with a Bipolar Tined Polyurethane Ventricular Lead

DAVID L. HAYES; KEVIN J. GRAHAM; MARLEEN IRWIN; HUMBERTO VIDAILLET; GAIL DISLER; MARK SWEESY; MICHAEL J. OSBORN; VERA J. SUMAN; SHARON A. NEUBAUER; MARY SEEBANDT; LINDA KALLINEN; CYNTHIA S. CROWSON

doi:10.1111/j.1540-8159.1992.tb03097.x

A Multicenter Experience with a Bipolar Tined Polyurethane Ventricular Lead

DAVID L. HAYES, KEVIN J. GRAHAM, MARLEEN IRWIN, HUMBERTO VIDAILLET, GAIL DISLER, MARK SWEESY, MICHAEL J. OSBORN, VERA J. SUMAN, SHARON A. NEUBAUER, MARY SEEBANDT, LINDA KALLINEN, CYNTHIA S. CROWSON

Quantitative Health Sciences

Research output: Contribution to journal › Article › peer-review

38 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	1033-1039
Number of pages	7
Journal	Pacing and Clinical Electrophysiology
Volume	15
Issue number	7
DOIs	https://doi.org/10.1111/j.1540-8159.1992.tb03097.x
State	Published - Jul 1992

Keywords

Medtronic 4012 pacing lead
pacemaker follow‐up
pacemaker lead failure
polyurethane insulation

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1111/j.1540-8159.1992.tb03097.x

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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. (1992). A Multicenter Experience with a Bipolar Tined Polyurethane Ventricular Lead. Pacing and Clinical Electrophysiology, 15(7), 1033-1039. https://doi.org/10.1111/j.1540-8159.1992.tb03097.x

HAYES, DAVIDL, GRAHAM, KEVINJ, IRWIN, MARLEEN, VIDAILLET, HUMBERTO, DISLER, GAIL, SWEESY, MARK, OSBORN, MICHAELJ, SUMAN, VERAJ, NEUBAUER, SHARONA, SEEBANDT, MARY, KALLINEN, LINDA & CROWSON, CYNTHIAS 1992, 'A Multicenter Experience with a Bipolar Tined Polyurethane Ventricular Lead', Pacing and Clinical Electrophysiology, vol. 15, no. 7, pp. 1033-1039. https://doi.org/10.1111/j.1540-8159.1992.tb03097.x

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abstract = "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.",

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AU - OSBORN, MICHAEL J.

AU - SUMAN, VERA J.

AU - NEUBAUER, SHARON A.

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AU - KALLINEN, LINDA

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AB - 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.

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A Multicenter Experience with a Bipolar Tined Polyurethane Ventricular Lead

Abstract

Keywords

ASJC Scopus subject areas

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