High failure rate for an epicardial implantable cardioverter- defibrillator lead

Implications for long-term follow-up of patients with an implantable cardioverter-defibrillator

Peter A. Brady, Paul Andrew Friedman, Jane M. Trusty, Suellen Grice, Stephen C. Hammill, Marshall S. Stanton

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Abstract

Objectives. 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.

Original languageEnglish (US)
Pages (from-to)616-622
Number of pages7
JournalJournal of the American College of Cardiology
Volume31
Issue number3
DOIs
StatePublished - Mar 1998

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Implantable Defibrillators
Lead
Survival Rate
X-Rays

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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. / Brady, Peter A.; Friedman, Paul Andrew; Trusty, Jane M.; Grice, Suellen; Hammill, Stephen C.; Stanton, Marshall S.

In: Journal of the American College of Cardiology, Vol. 31, No. 3, 03.1998, p. 616-622.

Research output: Contribution to journalArticle

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title = "High failure rate for an epicardial implantable cardioverter- defibrillator lead: Implications for long-term follow-up of patients with an implantable cardioverter-defibrillator",
abstract = "Objectives. 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.",
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N2 - Objectives. 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.

AB - Objectives. 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.

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