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High failure rate for an epicardial implantable cardioverter-defibrillator lead: implications for long-term follow-up of patients with an implantable cardioverter-defibrillator. 1998

P A Brady, and P A Friedman, and J M Trusty, and S Grice, and S C Hammill, and M S Stanton
Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota 55905, USA.

OBJECTIVE The purpose of this study was to determine the risk of epicardial lead failure during long-term follow-up and its mode of presentation. BACKGROUND Despite the high prevalence of epicardial lead-based implantable cardioverter-defibrillators, their long-term performance is unknown, and appropriate follow-up has not been established. METHODS The study group comprised all patients in whom an epicardial lead system was implanted at the Mayo Clinic between October 31, 1984 and November 3, 1994. The number of lead fractures and leads with fluid within the insulation and the mode of presentation were determined retrospectively by review of patient visits, radiographs of lead systems and data derived from formal lead testing. RESULTS At 4 years, the survival rate free of lead malfunction, using formal lead testing, for 160 Medtronic epicardial patches (models 6897 and 6921) was 72% compared with 92.5% for the 179 Cardiac Pacemaker, Inc. (CPI) patches (models 0040 and 0041) (p = 0.01). In addition, five Medtronic patches in three patients had fluid within the lead insulation but no obvious fracture. No CPI patches had fluid identified within the leads. Of 330 Medtronic epicardial pace/sense leads (model 6917), the 4-year survival rate free of lead malfunction as assessed by lead testing was 96%. In all, 19 presentations of lead malfunction were found in 17 patients (2 patients had more than one lead fracture at different times). In 11 (58%) of these presentations, the patients were asymptomatic despite the presence of obvious lead fracture. CONCLUSIONS Epicardial lead malfunction is common on long-term follow-up, and some leads have a failure rate of 28% at 4 years. Many patients with fractured leads remain asymptomatic, despite involvement of multiple leads in some cases. Therefore, consideration should be given to regular periodic lead testing in addition to routine X-ray examination, as asymptomatic lead malfunction can present with normal chest X-ray findings.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010496 Pericardium A conical fibro-serous sac surrounding the HEART and the roots of the great vessels (AORTA; VENAE CAVAE; PULMONARY ARTERY). Pericardium consists of two sacs: the outer fibrous pericardium and the inner serous pericardium. The latter consists of an outer parietal layer facing the fibrous pericardium, and an inner visceral layer (epicardium) resting next to the heart, and a pericardial cavity between these two layers. Epicardium,Fibrous Pericardium,Parietal Pericardium,Pericardial Cavity,Pericardial Space,Serous Pericardium,Visceral Pericardium,Cavities, Pericardial,Cavity, Pericardial,Pericardial Cavities,Pericardial Spaces,Pericardium, Fibrous,Pericardium, Parietal,Pericardium, Serous,Pericardium, Visceral,Pericardiums, Fibrous,Pericardiums, Serous,Serous Pericardiums,Space, Pericardial,Spaces, Pericardial
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
D005260 Female Females
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D015986 Confounding Factors, Epidemiologic Factors that can cause or prevent the outcome of interest but are not intermediate variables of the factor(s) under investigation. Confounding Factor, Epidemiologic,Confounding Factors, Epidemiological,Confounding Factors, Epidemiology,Confounding Variables,Confounding Variables, Epidemiologic,Confounding Variables, Epidemiological,Confounding Factor, Epidemiological,Confounding Factor, Epidemiology,Confounding Variable,Confounding Variable, Epidemiologic,Confounding Variable, Epidemiological,Epidemiologic Confounding Factor,Epidemiologic Confounding Factors,Epidemiologic Confounding Variable,Epidemiologic Confounding Variables,Epidemiological Confounding Factor,Epidemiological Confounding Factors,Epidemiological Confounding Variable,Epidemiological Confounding Variables,Epidemiology Confounding Factor,Epidemiology Confounding Factors,Variable, Confounding,Variable, Epidemiologic Confounding,Variable, Epidemiological Confounding,Variables, Confounding,Variables, Epidemiologic Confounding,Variables, Epidemiological Confounding
D017147 Defibrillators, Implantable Implantable devices which continuously monitor the electrical activity of the heart and automatically detect and terminate ventricular tachycardia (TACHYCARDIA, VENTRICULAR) and VENTRICULAR FIBRILLATION. They consist of an impulse generator, batteries, and electrodes. Cardioverter-Defibrillators, Implantable,Implantable Cardioverter Defibrillator,Implantable Cardioverter-Defibrillators,Implantable Defibrillators,Cardioverter Defibrillator, Implantable,Cardioverter Defibrillators, Implantable,Cardioverter-Defibrillator, Implantable,Defibrillator, Implantable,Defibrillator, Implantable Cardioverter,Defibrillators, Implantable Cardioverter,Implantable Cardioverter Defibrillators,Implantable Cardioverter-Defibrillator,Implantable Defibrillator

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