High Failure Rate for an Epicardial Implantable Cardioverter-Defibrillator Lead: Implications for Long-Term Follow-Up of Patients With an Implantable Cardioverter-Defibrillator

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 ap...

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Veröffentlicht in:Journal of the American College of Cardiology 1998-03, Vol.31 (3), p.616-622
Hauptverfasser: Brady, Peter A, Friedman, Paul A, Trusty, Jane M, Grice, Suellen, Hammill, Stephen C, Stanton, Marshall S
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container_end_page 622
container_issue 3
container_start_page 616
container_title Journal of the American College of Cardiology
container_volume 31
creator Brady, Peter A
Friedman, Paul A
Trusty, Jane M
Grice, Suellen
Hammill, Stephen C
Stanton, Marshall S
description 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.
doi_str_mv 10.1016/S0735-1097(97)00529-9
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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.</description><identifier>ISSN: 0735-1097</identifier><identifier>EISSN: 1558-3597</identifier><identifier>DOI: 10.1016/S0735-1097(97)00529-9</identifier><identifier>PMID: 9502644</identifier><identifier>CODEN: JACCDI</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Aged ; Biological and medical sciences ; Confounding Factors (Epidemiology) ; Defibrillators, Implantable - statistics &amp; numerical data ; Diseases of the cardiovascular system ; Equipment Failure - statistics &amp; numerical data ; Female ; Follow-Up Studies ; Humans ; Male ; Medical sciences ; Middle Aged ; Pericardium ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. 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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.</description><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Confounding Factors (Epidemiology)</subject><subject>Defibrillators, Implantable - statistics &amp; numerical data</subject><subject>Diseases of the cardiovascular system</subject><subject>Equipment Failure - statistics &amp; numerical data</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pericardium</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. 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Diet therapy and various other treatments (general aspects)</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Brady, Peter A</creatorcontrib><creatorcontrib>Friedman, Paul A</creatorcontrib><creatorcontrib>Trusty, Jane M</creatorcontrib><creatorcontrib>Grice, Suellen</creatorcontrib><creatorcontrib>Hammill, Stephen C</creatorcontrib><creatorcontrib>Stanton, Marshall S</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of the American College of Cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Brady, Peter A</au><au>Friedman, Paul A</au><au>Trusty, Jane M</au><au>Grice, Suellen</au><au>Hammill, Stephen C</au><au>Stanton, Marshall S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>High Failure Rate for an Epicardial Implantable Cardioverter-Defibrillator Lead: Implications for Long-Term Follow-Up of Patients With an Implantable Cardioverter-Defibrillator</atitle><jtitle>Journal of the American College of Cardiology</jtitle><addtitle>J Am Coll Cardiol</addtitle><date>1998-03-01</date><risdate>1998</risdate><volume>31</volume><issue>3</issue><spage>616</spage><epage>622</epage><pages>616-622</pages><issn>0735-1097</issn><eissn>1558-3597</eissn><coden>JACCDI</coden><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.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>9502644</pmid><doi>10.1016/S0735-1097(97)00529-9</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record>
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subjects Aged
Biological and medical sciences
Confounding Factors (Epidemiology)
Defibrillators, Implantable - statistics & numerical data
Diseases of the cardiovascular system
Equipment Failure - statistics & numerical data
Female
Follow-Up Studies
Humans
Male
Medical sciences
Middle Aged
Pericardium
Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)
title High Failure Rate for an Epicardial Implantable Cardioverter-Defibrillator Lead: Implications for Long-Term Follow-Up of Patients With an Implantable Cardioverter-Defibrillator
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