Multi-Institutional Study of Implantable Defibrillator Lead Performance in Children and Young Adults: Results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) Study
BACKGROUND—Implantable cardioverter-defibrillator (ICD) therapy in children and congenital heart disease patients is hampered by poor long-term lead survival. Lead extraction is technically difficult and carries substantial morbidity. We sought to determine the outcomes of ICD leads in pediatric and...
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| Veröffentlicht in: | Circulation (New York, N.Y.) N.Y.), 2013-06, Vol.127 (24), p.2393-2402 |
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| creator | Atallah, Joseph Erickson, Christopher C Cecchin, Frank Dubin, Anne M Law, Ian H Cohen, Mitchell I LaPage, Martin J Cannon, Bryan C Chun, Terrence U.H Freedenberg, Vicki Gierdalski, Marcin Berul, Charles I |
| description | BACKGROUND—Implantable cardioverter-defibrillator (ICD) therapy in children and congenital heart disease patients is hampered by poor long-term lead survival. Lead extraction is technically difficult and carries substantial morbidity. We sought to determine the outcomes of ICD leads in pediatric and congenital heart disease patients.
METHODS AND RESULTS—The Pediatric Lead Extractability and Survival Evaluation (PLEASE) is a 24-center international registry. Pediatric and congenital heart disease patients with ICD lead implantations from 2005 to 2010 were eligible. Study subjects comprised 878 ICD patients (44% congenital heart disease). Mean±SD age at implantation was 18.6±9.8 years. Of the 965 total leads, 54% were thin (≤7F), of which 57% were Fidelis, and 23% were coated with expanded polytetrafluoroethylene. There were 139 ICD lead failures (14%) in 132 patients (15%) at a mean lead age of 2.0±1.4 years, causing shocks in 53 patients (40%). Independent predictors of lead failure included younger implantation age and Fidelis leads. Actuarial analysis showed an incremental risk of lead failure with younger age at implantation18 years (P=0.015). The actuarial yearly failure rate was 2.3% for non-Fidelis and 9.1% for Fidelis leads. Extraction was performed on 143 leads (80% thin, 7% expanded polytetrafluoroethylene coated), with lead age as the only independent predictor for advanced extraction techniques. There were 6 major extraction complications (4%) but no procedural mortality.
CONCLUSIONS—This study demonstrates that ICD leads in children and congenital heart disease patients have an age-related suboptimal performance, further compounded by a high failure rate of Fidelis leads. Advanced extraction techniques were common and correlated with older lead age.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT00335036. |
| doi_str_mv | 10.1161/CIRCULATIONAHA.112.001120 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1369715717</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1369715717</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3369-d8448952431350c69040db9fa260f4e718fa95a3931ca8123033e6bbed82ed403</originalsourceid><addsrcrecordid>eNpVUc1u1DAQjhCILoVXQOaAVA4p49j5MbdoWWikhVbd9sApcuIJa_AmW9tp2Ufj7XDIAuIytkffz3i-KHpF4ZzSjL5dVtfL23V5U11-Li_K0EvOAUKFR9GCpgmPecrE42gBACLOWZKcRM-c-xaeGcvTp9FJwjLBRZYtop-fRuN1XPXOaz96PfTSkI0f1YEMHal2eyN7LxuD5D12urHaGOkHS9YoFblC2w12J_sWie7JcquNstgT2SvyZRj7r6RUQd69I9fopsuk6bcYiEpLb3U766x-eCvbYKON9off9M1o7_V9mGUVyiinwcjZ1XpVblZv5vmeR086aRy-OJ6n0e2H1c3yIl5ffqyW5TpuWfhlrArOCxGWwihLoc0EcFCN6GSSQccxp0UnRSqZYLSVBU0YMIZZ06AqElQc2Gl0Nuvu7XA3ovP1TrsWwx56HEZX0-CS0zSneYCKGdrawTmLXb23eiftoaZQT8nV_ycXekk9Jxe4L482Y7ND9Zf5J6oAeH0ESNdK09mwdu3-4fIUeMppwPEZ9zAYj9Z9N-MD2nqL0vhtcANgQPM4AcogowXEU0uwX8DJtFs</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1369715717</pqid></control><display><type>article</type><title>Multi-Institutional Study of Implantable Defibrillator Lead Performance in Children and Young Adults: Results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) Study</title><source>MEDLINE</source><source>American Heart Association Journals</source><source>Journals@Ovid Complete</source><source>EZB-FREE-00999 freely available EZB journals</source><creator>Atallah, Joseph ; Erickson, Christopher C ; Cecchin, Frank ; Dubin, Anne M ; Law, Ian H ; Cohen, Mitchell I ; LaPage, Martin J ; Cannon, Bryan C ; Chun, Terrence U.H ; Freedenberg, Vicki ; Gierdalski, Marcin ; Berul, Charles I</creator><creatorcontrib>Atallah, Joseph ; Erickson, Christopher C ; Cecchin, Frank ; Dubin, Anne M ; Law, Ian H ; Cohen, Mitchell I ; LaPage, Martin J ; Cannon, Bryan C ; Chun, Terrence U.H ; Freedenberg, Vicki ; Gierdalski, Marcin ; Berul, Charles I ; Pediatric and Congenital Electrophysiology Society (PACES)</creatorcontrib><description>BACKGROUND—Implantable cardioverter-defibrillator (ICD) therapy in children and congenital heart disease patients is hampered by poor long-term lead survival. Lead extraction is technically difficult and carries substantial morbidity. We sought to determine the outcomes of ICD leads in pediatric and congenital heart disease patients.
METHODS AND RESULTS—The Pediatric Lead Extractability and Survival Evaluation (PLEASE) is a 24-center international registry. Pediatric and congenital heart disease patients with ICD lead implantations from 2005 to 2010 were eligible. Study subjects comprised 878 ICD patients (44% congenital heart disease). Mean±SD age at implantation was 18.6±9.8 years. Of the 965 total leads, 54% were thin (≤7F), of which 57% were Fidelis, and 23% were coated with expanded polytetrafluoroethylene. There were 139 ICD lead failures (14%) in 132 patients (15%) at a mean lead age of 2.0±1.4 years, causing shocks in 53 patients (40%). Independent predictors of lead failure included younger implantation age and Fidelis leads. Actuarial analysis showed an incremental risk of lead failure with younger age at implantation<8 years compared with >18 years (P=0.015). The actuarial yearly failure rate was 2.3% for non-Fidelis and 9.1% for Fidelis leads. Extraction was performed on 143 leads (80% thin, 7% expanded polytetrafluoroethylene coated), with lead age as the only independent predictor for advanced extraction techniques. There were 6 major extraction complications (4%) but no procedural mortality.
CONCLUSIONS—This study demonstrates that ICD leads in children and congenital heart disease patients have an age-related suboptimal performance, further compounded by a high failure rate of Fidelis leads. Advanced extraction techniques were common and correlated with older lead age.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT00335036.</description><identifier>ISSN: 0009-7322</identifier><identifier>EISSN: 1524-4539</identifier><identifier>DOI: 10.1161/CIRCULATIONAHA.112.001120</identifier><identifier>PMID: 23694966</identifier><identifier>CODEN: CIRCAZ</identifier><language>eng</language><publisher>Hagerstown, MD: American Heart Association, Inc</publisher><subject>Adolescent ; Adult ; Age Factors ; Biological and medical sciences ; Blood and lymphatic vessels ; Cardiology. Vascular system ; Child ; Defibrillators, Implantable - adverse effects ; Device Removal - methods ; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous ; Equipment Failure - statistics & numerical data ; Heart Defects, Congenital - therapy ; Heart Diseases - congenital ; Heart Diseases - therapy ; Humans ; International Cooperation ; Medical sciences ; Polytetrafluoroethylene ; Prospective Studies ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Retrospective Studies ; Treatment Outcome ; Young Adult</subject><ispartof>Circulation (New York, N.Y.), 2013-06, Vol.127 (24), p.2393-2402</ispartof><rights>2013 American Heart Association, Inc.</rights><rights>2014 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3369-d8448952431350c69040db9fa260f4e718fa95a3931ca8123033e6bbed82ed403</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,3687,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27504541$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23694966$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Atallah, Joseph</creatorcontrib><creatorcontrib>Erickson, Christopher C</creatorcontrib><creatorcontrib>Cecchin, Frank</creatorcontrib><creatorcontrib>Dubin, Anne M</creatorcontrib><creatorcontrib>Law, Ian H</creatorcontrib><creatorcontrib>Cohen, Mitchell I</creatorcontrib><creatorcontrib>LaPage, Martin J</creatorcontrib><creatorcontrib>Cannon, Bryan C</creatorcontrib><creatorcontrib>Chun, Terrence U.H</creatorcontrib><creatorcontrib>Freedenberg, Vicki</creatorcontrib><creatorcontrib>Gierdalski, Marcin</creatorcontrib><creatorcontrib>Berul, Charles I</creatorcontrib><creatorcontrib>Pediatric and Congenital Electrophysiology Society (PACES)</creatorcontrib><title>Multi-Institutional Study of Implantable Defibrillator Lead Performance in Children and Young Adults: Results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) Study</title><title>Circulation (New York, N.Y.)</title><addtitle>Circulation</addtitle><description>BACKGROUND—Implantable cardioverter-defibrillator (ICD) therapy in children and congenital heart disease patients is hampered by poor long-term lead survival. Lead extraction is technically difficult and carries substantial morbidity. We sought to determine the outcomes of ICD leads in pediatric and congenital heart disease patients.
METHODS AND RESULTS—The Pediatric Lead Extractability and Survival Evaluation (PLEASE) is a 24-center international registry. Pediatric and congenital heart disease patients with ICD lead implantations from 2005 to 2010 were eligible. Study subjects comprised 878 ICD patients (44% congenital heart disease). Mean±SD age at implantation was 18.6±9.8 years. Of the 965 total leads, 54% were thin (≤7F), of which 57% were Fidelis, and 23% were coated with expanded polytetrafluoroethylene. There were 139 ICD lead failures (14%) in 132 patients (15%) at a mean lead age of 2.0±1.4 years, causing shocks in 53 patients (40%). Independent predictors of lead failure included younger implantation age and Fidelis leads. Actuarial analysis showed an incremental risk of lead failure with younger age at implantation<8 years compared with >18 years (P=0.015). The actuarial yearly failure rate was 2.3% for non-Fidelis and 9.1% for Fidelis leads. Extraction was performed on 143 leads (80% thin, 7% expanded polytetrafluoroethylene coated), with lead age as the only independent predictor for advanced extraction techniques. There were 6 major extraction complications (4%) but no procedural mortality.
CONCLUSIONS—This study demonstrates that ICD leads in children and congenital heart disease patients have an age-related suboptimal performance, further compounded by a high failure rate of Fidelis leads. Advanced extraction techniques were common and correlated with older lead age.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT00335036.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Age Factors</subject><subject>Biological and medical sciences</subject><subject>Blood and lymphatic vessels</subject><subject>Cardiology. Vascular system</subject><subject>Child</subject><subject>Defibrillators, Implantable - adverse effects</subject><subject>Device Removal - methods</subject><subject>Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous</subject><subject>Equipment Failure - statistics & numerical data</subject><subject>Heart Defects, Congenital - therapy</subject><subject>Heart Diseases - congenital</subject><subject>Heart Diseases - therapy</subject><subject>Humans</subject><subject>International Cooperation</subject><subject>Medical sciences</subject><subject>Polytetrafluoroethylene</subject><subject>Prospective Studies</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</subject><subject>Retrospective Studies</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0009-7322</issn><issn>1524-4539</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVUc1u1DAQjhCILoVXQOaAVA4p49j5MbdoWWikhVbd9sApcuIJa_AmW9tp2Ufj7XDIAuIytkffz3i-KHpF4ZzSjL5dVtfL23V5U11-Li_K0EvOAUKFR9GCpgmPecrE42gBACLOWZKcRM-c-xaeGcvTp9FJwjLBRZYtop-fRuN1XPXOaz96PfTSkI0f1YEMHal2eyN7LxuD5D12urHaGOkHS9YoFblC2w12J_sWie7JcquNstgT2SvyZRj7r6RUQd69I9fopsuk6bcYiEpLb3U766x-eCvbYKON9off9M1o7_V9mGUVyiinwcjZ1XpVblZv5vmeR086aRy-OJ6n0e2H1c3yIl5ffqyW5TpuWfhlrArOCxGWwihLoc0EcFCN6GSSQccxp0UnRSqZYLSVBU0YMIZZ06AqElQc2Gl0Nuvu7XA3ovP1TrsWwx56HEZX0-CS0zSneYCKGdrawTmLXb23eiftoaZQT8nV_ycXekk9Jxe4L482Y7ND9Zf5J6oAeH0ESNdK09mwdu3-4fIUeMppwPEZ9zAYj9Z9N-MD2nqL0vhtcANgQPM4AcogowXEU0uwX8DJtFs</recordid><startdate>20130618</startdate><enddate>20130618</enddate><creator>Atallah, Joseph</creator><creator>Erickson, Christopher C</creator><creator>Cecchin, Frank</creator><creator>Dubin, Anne M</creator><creator>Law, Ian H</creator><creator>Cohen, Mitchell I</creator><creator>LaPage, Martin J</creator><creator>Cannon, Bryan C</creator><creator>Chun, Terrence U.H</creator><creator>Freedenberg, Vicki</creator><creator>Gierdalski, Marcin</creator><creator>Berul, Charles I</creator><general>American Heart Association, Inc</general><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20130618</creationdate><title>Multi-Institutional Study of Implantable Defibrillator Lead Performance in Children and Young Adults: Results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) Study</title><author>Atallah, Joseph ; Erickson, Christopher C ; Cecchin, Frank ; Dubin, Anne M ; Law, Ian H ; Cohen, Mitchell I ; LaPage, Martin J ; Cannon, Bryan C ; Chun, Terrence U.H ; Freedenberg, Vicki ; Gierdalski, Marcin ; Berul, Charles I</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3369-d8448952431350c69040db9fa260f4e718fa95a3931ca8123033e6bbed82ed403</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Age Factors</topic><topic>Biological and medical sciences</topic><topic>Blood and lymphatic vessels</topic><topic>Cardiology. Vascular system</topic><topic>Child</topic><topic>Defibrillators, Implantable - adverse effects</topic><topic>Device Removal - methods</topic><topic>Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous</topic><topic>Equipment Failure - statistics & numerical data</topic><topic>Heart Defects, Congenital - therapy</topic><topic>Heart Diseases - congenital</topic><topic>Heart Diseases - therapy</topic><topic>Humans</topic><topic>International Cooperation</topic><topic>Medical sciences</topic><topic>Polytetrafluoroethylene</topic><topic>Prospective Studies</topic><topic>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</topic><topic>Retrospective Studies</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Atallah, Joseph</creatorcontrib><creatorcontrib>Erickson, Christopher C</creatorcontrib><creatorcontrib>Cecchin, Frank</creatorcontrib><creatorcontrib>Dubin, Anne M</creatorcontrib><creatorcontrib>Law, Ian H</creatorcontrib><creatorcontrib>Cohen, Mitchell I</creatorcontrib><creatorcontrib>LaPage, Martin J</creatorcontrib><creatorcontrib>Cannon, Bryan C</creatorcontrib><creatorcontrib>Chun, Terrence U.H</creatorcontrib><creatorcontrib>Freedenberg, Vicki</creatorcontrib><creatorcontrib>Gierdalski, Marcin</creatorcontrib><creatorcontrib>Berul, Charles I</creatorcontrib><creatorcontrib>Pediatric and Congenital Electrophysiology Society (PACES)</creatorcontrib><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>Circulation (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Atallah, Joseph</au><au>Erickson, Christopher C</au><au>Cecchin, Frank</au><au>Dubin, Anne M</au><au>Law, Ian H</au><au>Cohen, Mitchell I</au><au>LaPage, Martin J</au><au>Cannon, Bryan C</au><au>Chun, Terrence U.H</au><au>Freedenberg, Vicki</au><au>Gierdalski, Marcin</au><au>Berul, Charles I</au><aucorp>Pediatric and Congenital Electrophysiology Society (PACES)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Multi-Institutional Study of Implantable Defibrillator Lead Performance in Children and Young Adults: Results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) Study</atitle><jtitle>Circulation (New York, N.Y.)</jtitle><addtitle>Circulation</addtitle><date>2013-06-18</date><risdate>2013</risdate><volume>127</volume><issue>24</issue><spage>2393</spage><epage>2402</epage><pages>2393-2402</pages><issn>0009-7322</issn><eissn>1524-4539</eissn><coden>CIRCAZ</coden><abstract>BACKGROUND—Implantable cardioverter-defibrillator (ICD) therapy in children and congenital heart disease patients is hampered by poor long-term lead survival. Lead extraction is technically difficult and carries substantial morbidity. We sought to determine the outcomes of ICD leads in pediatric and congenital heart disease patients.
METHODS AND RESULTS—The Pediatric Lead Extractability and Survival Evaluation (PLEASE) is a 24-center international registry. Pediatric and congenital heart disease patients with ICD lead implantations from 2005 to 2010 were eligible. Study subjects comprised 878 ICD patients (44% congenital heart disease). Mean±SD age at implantation was 18.6±9.8 years. Of the 965 total leads, 54% were thin (≤7F), of which 57% were Fidelis, and 23% were coated with expanded polytetrafluoroethylene. There were 139 ICD lead failures (14%) in 132 patients (15%) at a mean lead age of 2.0±1.4 years, causing shocks in 53 patients (40%). Independent predictors of lead failure included younger implantation age and Fidelis leads. Actuarial analysis showed an incremental risk of lead failure with younger age at implantation<8 years compared with >18 years (P=0.015). The actuarial yearly failure rate was 2.3% for non-Fidelis and 9.1% for Fidelis leads. Extraction was performed on 143 leads (80% thin, 7% expanded polytetrafluoroethylene coated), with lead age as the only independent predictor for advanced extraction techniques. There were 6 major extraction complications (4%) but no procedural mortality.
CONCLUSIONS—This study demonstrates that ICD leads in children and congenital heart disease patients have an age-related suboptimal performance, further compounded by a high failure rate of Fidelis leads. Advanced extraction techniques were common and correlated with older lead age.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT00335036.</abstract><cop>Hagerstown, MD</cop><pub>American Heart Association, Inc</pub><pmid>23694966</pmid><doi>10.1161/CIRCULATIONAHA.112.001120</doi><tpages>10</tpages></addata></record> |
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| source | MEDLINE; American Heart Association Journals; Journals@Ovid Complete; EZB-FREE-00999 freely available EZB journals |
| subjects | Adolescent Adult Age Factors Biological and medical sciences Blood and lymphatic vessels Cardiology. Vascular system Child Defibrillators, Implantable - adverse effects Device Removal - methods Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous Equipment Failure - statistics & numerical data Heart Defects, Congenital - therapy Heart Diseases - congenital Heart Diseases - therapy Humans International Cooperation Medical sciences Polytetrafluoroethylene Prospective Studies Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Retrospective Studies Treatment Outcome Young Adult |
| title | Multi-Institutional Study of Implantable Defibrillator Lead Performance in Children and Young Adults: Results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) Study |
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