A Multicenter Experience with a Bipolar Tined Polyurethane Ventricular Lead
| Autor: | Mary L. Seebandt, Vera J. Suman, Michael J. Osborn, Linda M. Kallinen, Sharon A. Neubauer, Dan Kincaid, Gail Disler, Mark W. Sweesy, Kevin J. Graham, Humberto Vidaillet, Marleen Irwin, David L. Hayes |
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| Rok vydání: | 1992 |
| Předmět: |
Male
Pacemaker Artificial medicine.medical_specialty Ventricular lead Polyurethanes Lead failure Humans Medicine Pacemaker Placement Lead (electronics) Aged Probability business.industry Follow up studies Failure rate Equipment Design General Medicine Insulation Problem Electrodes Implanted Surgery Multicenter study Equipment Failure Female Cardiology and Cardiovascular Medicine business Follow-Up Studies |
| Zdroj: | Pacing and Clinical Electrophysiology. 15:1033-1039 |
| ISSN: | 1540-8159 0147-8389 |
| Popis: | A multicenter study was undertaken to determine the failure rate of a specific polyurethane bipolar tined 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 nondependent patients. |
| Databáze: | OpenAIRE |
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