Survival of implantable pacemaker leads. The Implantable Lead Registry. 1990

S Furman, and Z M Benedek
Department of Cardiothoracic Surgery, Montefiore Medical Center, Bronx, New York 10467.

Early polyurethane leads were reported to have a high incidence of materials failure. In 1979 a six-center registry was begun. By October 31, 1989, 7,311 leads had been registered and lead longevity was calculated by individual manufacturer, cumulatively for all manufacturers and for individual leads. Each lead was registered at implant and at removal from service as having been removed for materials failure or for unrelated reasons. Calculations were made for 23 models and for a total of three manufacturers with more than 100 leads implanted. Four thousand seven hundred and sixty three leads (65.1%) were from Medtronic; 2,177 (29.8%) from Cordis; 297 (4.1%) from Intermedics; and 77 (1.0%) were from all others. The 10-year cumulative survival of Medtronic leads was 96.6 +/- 0.4%; for Cordis leads it was 99.9 +/- 0.1% and for Intermediates leads 97.7 +/- 0.9%. Three lead models registered over 100 units and had poorer survival at 5 years than the remainder of all manufacturers' experience. They were #6972 (n = 107) with 78.6 +/- 4.5%; #6991U (n = 294) with 90.6 +/- 1.9%; and #4012 (n = 288) with 97.3 +/- 1.5%. Other possibly failed models did not achieve statistical significance. It can be anticipated that a lead which survives to the seventh year will have prolonged longevity as thereafter additional failures are uncommon.

UI MeSH Term Description Entries
D010138 Pacemaker, Artificial A device designed to stimulate, by electric impulses, contraction of the heart muscles. It may be temporary (external) or permanent (internal or internal-external). Cardiac Pacemaker, Artificial,Artificial Cardiac Pacemaker,Artificial Cardiac Pacemakers,Artificial Pacemaker,Artificial Pacemakers,Cardiac Pacemakers, Artificial,Pacemaker, Artificial Cardiac,Pacemakers, Artificial,Pacemakers, Artificial Cardiac
D011140 Polyurethanes A group of thermoplastic or thermosetting polymers containing polyisocyanate. They are used as ELASTOMERS, as coatings, as fibers and as foams. Polyisocyanates,Ostamer,Pellethane,Spandex,Ostamers,Pellethanes,Polyisocyanate,Polyurethane,Spandices
D012042 Registries The systems and processes involved in the establishment, support, management, and operation of registers, e.g., disease registers. Parish Registers,Population Register,Parish Register,Population Registers,Register, Parish,Register, Population,Registers, Parish,Registers, Population,Registry
D004567 Electrodes, Implanted Surgically placed electric conductors through which ELECTRIC STIMULATION is delivered to or electrical activity is recorded from a specific point inside the body. Implantable Electrodes,Implantable Stimulation Electrodes,Implanted Electrodes,Implanted Stimulation Electrodes,Electrode, Implantable,Electrode, Implantable Stimulation,Electrode, Implanted,Electrode, Implanted Stimulation,Electrodes, Implantable,Electrodes, Implantable Stimulation,Electrodes, Implanted Stimulation,Implantable Electrode,Implantable Stimulation Electrode,Implanted Electrode,Implanted Stimulation Electrode,Stimulation Electrode, Implantable,Stimulation Electrode, Implanted,Stimulation Electrodes, Implantable,Stimulation Electrodes, Implanted
D004867 Equipment Design Methods and patterns of fabricating machines and related hardware. Design, Equipment,Device Design,Medical Device Design,Design, Medical Device,Designs, Medical Device,Device Design, Medical,Device Designs, Medical,Medical Device Designs,Design, Device,Designs, Device,Designs, Equipment,Device Designs,Equipment Designs
D004868 Equipment Failure Failure of equipment to perform to standard. The failure may be due to defects or improper use. Defects, Equipment,Device Failure,Failure, Equipment,Malfunction, Equipment,Medical Device Failure,Misuse, Equipment,Device Failure, Medical,Device Failures, Medical,Failure, Medical Device,Failures, Medical Device,Defect, Equipment,Device Failures,Equipment Defect,Equipment Defects,Equipment Failures,Equipment Malfunction,Equipment Malfunctions,Equipment Misuse,Equipment Misuses,Failure, Device,Failures, Device,Failures, Equipment,Malfunctions, Equipment,Misuses, Equipment
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D013997 Time Factors Elements of limited time intervals, contributing to particular results or situations. Time Series,Factor, Time,Time Factor

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