Update on Small-Diameter Implantable Cardioverter-Defibrillator Leads Performance
Background: The performance of small diameter implantable cardioverter defibrillator (ICD) leads is questionable. However, data on performance during long‐term follow‐up are scarce. The aim of this study is to provide an update for the lead failure and cardiac perforation rate of Medtronic's Sp...
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Veröffentlicht in: | Pacing and clinical electrophysiology 2012-06, Vol.35 (6), p.652-658 |
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creator | VAN REES, JOHANNES B. VAN WELSENES, GUIDO H. BORLEFFS, C. JAN WILLEM THIJSSEN, JOEP VAN DER VELDE, ENNO T. VAN DER WALL, ERNST E. VAN ERVEN, LIESELOT SCHALIJ, MARTIN J. |
description | Background:
The performance of small diameter implantable cardioverter defibrillator (ICD) leads is questionable. However, data on performance during long‐term follow‐up are scarce. The aim of this study is to provide an update for the lead failure and cardiac perforation rate of Medtronic's Sprint Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) and St. Jude Medical's Riata ICD lead (St. Jude Medical Inc., St. Paul, MN, USA).
Methods:
Since 1996, all ICD system implantations at the Leiden University Medical Center, the Netherlands, are registered. For this study, data up to February 2011 on 396 Sprint Fidelis leads (follow‐up 3.4 ± 1.5 years), 165 8‐French (F) Riata leads (follow‐up 4.6 ± 2.6 years), and 30 7‐F Riata leads (follow‐up 2.9 ± 1.3 years) were compared with a benchmark cohort of 1,602 ICD leads (follow‐up 3.4 ± 2.7 years) and assessed for the occurrence of lead failure and cardiac perforation.
Results:
During follow‐up, the yearly lead failure rate of the Sprint Fidelis lead, 7‐F Riata lead, 8‐F Riata lead, and the benchmark cohort was 3.54%, 2.28%, 0.78%, and 1.14%, respectively. In comparison to the benchmark cohort, the adjusted hazard ratio of lead failure was 3.7 (95% confidence interval [CI] 2.4–5.7, P < 0.001) for the Sprint Fidelis lead and 4.2 (95% CI 1.0–18.0, P < 0.05) for the 7‐F Riata lead. One cardiac perforation was observed (3.3%) in the 7‐F Riata group versus none in the 8‐F Riata and Sprint Fidelis lead population.
Conclusion:
The current update demonstrates that the risk of lead failure during long‐term follow‐up is significantly increased for both the Sprint Fidelis and the 7‐F Riata lead in comparison to the benchmark cohort. Only one cardiac perforation occurred.
(PACE 2012; 35:652–658) |
doi_str_mv | 10.1111/j.1540-8159.2011.03338.x |
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fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1019613134</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1019613134</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4388-cd201871961bfbb744fe8ad30a99a3048146c6fb18370ca1c001eae233d596e13</originalsourceid><addsrcrecordid>eNqNkMFO3DAQhi1UBFvoK6BcKvWS1F7biXNBoguloBUFUQQ3a-JMJC_OZrGzsLx9nWa7vdYXH-abf359hCSMZiy-r4uMSUFTxWSZTSljGeWcq2yzRya7wQcyoUwUqeKqPCQfQ1hQSnMq5AE5nE65nMaNCbl7WNXQY9Itk_sWnEvPLbTYo0-u2pWDZQ-Vw2QGvrbdK_o4SM-xsZW3zkHf-WSOUIfkFn3T-RaWBo_JfgMu4Kftf0Qevl_8mv1I5z8vr2Zn89QIrlRq6lhcFazMWdVUVSFEgwpqTqEsgVOhmMhN3lRM8YIaYIZShoCxdS3LHBk_Il_G3JXvXtYYet3aYDDWWmK3DprRIZszLiKqRtT4LgSPjV5524J_j5AehOqFHrzpwZsehOo_QvUmrp5sr6yrFuvd4l-DEfi8BSAYcI2PDmz4x8lSilIMHU5H7s06fP_vAvr2bHbBx0PpGGBDj5tdAPhnnRe8kPrx5lJfP90I-nQn9Tf-G9Sjn8w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1019613134</pqid></control><display><type>article</type><title>Update on Small-Diameter Implantable Cardioverter-Defibrillator Leads Performance</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>VAN REES, JOHANNES B. ; VAN WELSENES, GUIDO H. ; BORLEFFS, C. JAN WILLEM ; THIJSSEN, JOEP ; VAN DER VELDE, ENNO T. ; VAN DER WALL, ERNST E. ; VAN ERVEN, LIESELOT ; SCHALIJ, MARTIN J.</creator><creatorcontrib>VAN REES, JOHANNES B. ; VAN WELSENES, GUIDO H. ; BORLEFFS, C. JAN WILLEM ; THIJSSEN, JOEP ; VAN DER VELDE, ENNO T. ; VAN DER WALL, ERNST E. ; VAN ERVEN, LIESELOT ; SCHALIJ, MARTIN J.</creatorcontrib><description>Background:
The performance of small diameter implantable cardioverter defibrillator (ICD) leads is questionable. However, data on performance during long‐term follow‐up are scarce. The aim of this study is to provide an update for the lead failure and cardiac perforation rate of Medtronic's Sprint Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) and St. Jude Medical's Riata ICD lead (St. Jude Medical Inc., St. Paul, MN, USA).
Methods:
Since 1996, all ICD system implantations at the Leiden University Medical Center, the Netherlands, are registered. For this study, data up to February 2011 on 396 Sprint Fidelis leads (follow‐up 3.4 ± 1.5 years), 165 8‐French (F) Riata leads (follow‐up 4.6 ± 2.6 years), and 30 7‐F Riata leads (follow‐up 2.9 ± 1.3 years) were compared with a benchmark cohort of 1,602 ICD leads (follow‐up 3.4 ± 2.7 years) and assessed for the occurrence of lead failure and cardiac perforation.
Results:
During follow‐up, the yearly lead failure rate of the Sprint Fidelis lead, 7‐F Riata lead, 8‐F Riata lead, and the benchmark cohort was 3.54%, 2.28%, 0.78%, and 1.14%, respectively. In comparison to the benchmark cohort, the adjusted hazard ratio of lead failure was 3.7 (95% confidence interval [CI] 2.4–5.7, P < 0.001) for the Sprint Fidelis lead and 4.2 (95% CI 1.0–18.0, P < 0.05) for the 7‐F Riata lead. One cardiac perforation was observed (3.3%) in the 7‐F Riata group versus none in the 8‐F Riata and Sprint Fidelis lead population.
Conclusion:
The current update demonstrates that the risk of lead failure during long‐term follow‐up is significantly increased for both the Sprint Fidelis and the 7‐F Riata lead in comparison to the benchmark cohort. Only one cardiac perforation occurred.
(PACE 2012; 35:652–658)</description><identifier>ISSN: 0147-8389</identifier><identifier>EISSN: 1540-8159</identifier><identifier>DOI: 10.1111/j.1540-8159.2011.03338.x</identifier><identifier>PMID: 22352338</identifier><language>eng</language><publisher>Malden, USA: Blackwell Publishing Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Biological and medical sciences ; cardiac lead perforation ; Defibrillators, Implantable - statistics & numerical data ; Diseases of the cardiovascular system ; Electrodes, Implanted - statistics & numerical data ; Equipment Failure - statistics & numerical data ; Female ; Heart Injuries - epidemiology ; Humans ; implantable cardioverter defibrillator ; lead failure ; Male ; Medical sciences ; Middle Aged ; Netherlands - epidemiology ; Postoperative Complications - epidemiology ; Prevalence ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Riata ; Risk Factors ; Sprint Fidelis</subject><ispartof>Pacing and clinical electrophysiology, 2012-06, Vol.35 (6), p.652-658</ispartof><rights>2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4388-cd201871961bfbb744fe8ad30a99a3048146c6fb18370ca1c001eae233d596e13</citedby><cites>FETCH-LOGICAL-c4388-cd201871961bfbb744fe8ad30a99a3048146c6fb18370ca1c001eae233d596e13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1540-8159.2011.03338.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1540-8159.2011.03338.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25954944$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22352338$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>VAN REES, JOHANNES B.</creatorcontrib><creatorcontrib>VAN WELSENES, GUIDO H.</creatorcontrib><creatorcontrib>BORLEFFS, C. JAN WILLEM</creatorcontrib><creatorcontrib>THIJSSEN, JOEP</creatorcontrib><creatorcontrib>VAN DER VELDE, ENNO T.</creatorcontrib><creatorcontrib>VAN DER WALL, ERNST E.</creatorcontrib><creatorcontrib>VAN ERVEN, LIESELOT</creatorcontrib><creatorcontrib>SCHALIJ, MARTIN J.</creatorcontrib><title>Update on Small-Diameter Implantable Cardioverter-Defibrillator Leads Performance</title><title>Pacing and clinical electrophysiology</title><addtitle>Pacing Clin Electrophysiol</addtitle><description>Background:
The performance of small diameter implantable cardioverter defibrillator (ICD) leads is questionable. However, data on performance during long‐term follow‐up are scarce. The aim of this study is to provide an update for the lead failure and cardiac perforation rate of Medtronic's Sprint Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) and St. Jude Medical's Riata ICD lead (St. Jude Medical Inc., St. Paul, MN, USA).
Methods:
Since 1996, all ICD system implantations at the Leiden University Medical Center, the Netherlands, are registered. For this study, data up to February 2011 on 396 Sprint Fidelis leads (follow‐up 3.4 ± 1.5 years), 165 8‐French (F) Riata leads (follow‐up 4.6 ± 2.6 years), and 30 7‐F Riata leads (follow‐up 2.9 ± 1.3 years) were compared with a benchmark cohort of 1,602 ICD leads (follow‐up 3.4 ± 2.7 years) and assessed for the occurrence of lead failure and cardiac perforation.
Results:
During follow‐up, the yearly lead failure rate of the Sprint Fidelis lead, 7‐F Riata lead, 8‐F Riata lead, and the benchmark cohort was 3.54%, 2.28%, 0.78%, and 1.14%, respectively. In comparison to the benchmark cohort, the adjusted hazard ratio of lead failure was 3.7 (95% confidence interval [CI] 2.4–5.7, P < 0.001) for the Sprint Fidelis lead and 4.2 (95% CI 1.0–18.0, P < 0.05) for the 7‐F Riata lead. One cardiac perforation was observed (3.3%) in the 7‐F Riata group versus none in the 8‐F Riata and Sprint Fidelis lead population.
Conclusion:
The current update demonstrates that the risk of lead failure during long‐term follow‐up is significantly increased for both the Sprint Fidelis and the 7‐F Riata lead in comparison to the benchmark cohort. Only one cardiac perforation occurred.
(PACE 2012; 35:652–658)</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biological and medical sciences</subject><subject>cardiac lead perforation</subject><subject>Defibrillators, Implantable - statistics & numerical data</subject><subject>Diseases of the cardiovascular system</subject><subject>Electrodes, Implanted - statistics & numerical data</subject><subject>Equipment Failure - statistics & numerical data</subject><subject>Female</subject><subject>Heart Injuries - epidemiology</subject><subject>Humans</subject><subject>implantable cardioverter defibrillator</subject><subject>lead failure</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Netherlands - epidemiology</subject><subject>Postoperative Complications - epidemiology</subject><subject>Prevalence</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</subject><subject>Riata</subject><subject>Risk Factors</subject><subject>Sprint Fidelis</subject><issn>0147-8389</issn><issn>1540-8159</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkMFO3DAQhi1UBFvoK6BcKvWS1F7biXNBoguloBUFUQQ3a-JMJC_OZrGzsLx9nWa7vdYXH-abf359hCSMZiy-r4uMSUFTxWSZTSljGeWcq2yzRya7wQcyoUwUqeKqPCQfQ1hQSnMq5AE5nE65nMaNCbl7WNXQY9Itk_sWnEvPLbTYo0-u2pWDZQ-Vw2QGvrbdK_o4SM-xsZW3zkHf-WSOUIfkFn3T-RaWBo_JfgMu4Kftf0Qevl_8mv1I5z8vr2Zn89QIrlRq6lhcFazMWdVUVSFEgwpqTqEsgVOhmMhN3lRM8YIaYIZShoCxdS3LHBk_Il_G3JXvXtYYet3aYDDWWmK3DprRIZszLiKqRtT4LgSPjV5524J_j5AehOqFHrzpwZsehOo_QvUmrp5sr6yrFuvd4l-DEfi8BSAYcI2PDmz4x8lSilIMHU5H7s06fP_vAvr2bHbBx0PpGGBDj5tdAPhnnRe8kPrx5lJfP90I-nQn9Tf-G9Sjn8w</recordid><startdate>201206</startdate><enddate>201206</enddate><creator>VAN REES, JOHANNES B.</creator><creator>VAN WELSENES, GUIDO H.</creator><creator>BORLEFFS, C. JAN WILLEM</creator><creator>THIJSSEN, JOEP</creator><creator>VAN DER VELDE, ENNO T.</creator><creator>VAN DER WALL, ERNST E.</creator><creator>VAN ERVEN, LIESELOT</creator><creator>SCHALIJ, MARTIN J.</creator><general>Blackwell Publishing Inc</general><general>Wiley</general><scope>BSCLL</scope><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>201206</creationdate><title>Update on Small-Diameter Implantable Cardioverter-Defibrillator Leads Performance</title><author>VAN REES, JOHANNES B. ; VAN WELSENES, GUIDO H. ; BORLEFFS, C. JAN WILLEM ; THIJSSEN, JOEP ; VAN DER VELDE, ENNO T. ; VAN DER WALL, ERNST E. ; VAN ERVEN, LIESELOT ; SCHALIJ, MARTIN J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4388-cd201871961bfbb744fe8ad30a99a3048146c6fb18370ca1c001eae233d596e13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Biological and medical sciences</topic><topic>cardiac lead perforation</topic><topic>Defibrillators, Implantable - statistics & numerical data</topic><topic>Diseases of the cardiovascular system</topic><topic>Electrodes, Implanted - statistics & numerical data</topic><topic>Equipment Failure - statistics & numerical data</topic><topic>Female</topic><topic>Heart Injuries - epidemiology</topic><topic>Humans</topic><topic>implantable cardioverter defibrillator</topic><topic>lead failure</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Netherlands - epidemiology</topic><topic>Postoperative Complications - epidemiology</topic><topic>Prevalence</topic><topic>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</topic><topic>Riata</topic><topic>Risk Factors</topic><topic>Sprint Fidelis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>VAN REES, JOHANNES B.</creatorcontrib><creatorcontrib>VAN WELSENES, GUIDO H.</creatorcontrib><creatorcontrib>BORLEFFS, C. JAN WILLEM</creatorcontrib><creatorcontrib>THIJSSEN, JOEP</creatorcontrib><creatorcontrib>VAN DER VELDE, ENNO T.</creatorcontrib><creatorcontrib>VAN DER WALL, ERNST E.</creatorcontrib><creatorcontrib>VAN ERVEN, LIESELOT</creatorcontrib><creatorcontrib>SCHALIJ, MARTIN J.</creatorcontrib><collection>Istex</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>Pacing and clinical electrophysiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>VAN REES, JOHANNES B.</au><au>VAN WELSENES, GUIDO H.</au><au>BORLEFFS, C. JAN WILLEM</au><au>THIJSSEN, JOEP</au><au>VAN DER VELDE, ENNO T.</au><au>VAN DER WALL, ERNST E.</au><au>VAN ERVEN, LIESELOT</au><au>SCHALIJ, MARTIN J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Update on Small-Diameter Implantable Cardioverter-Defibrillator Leads Performance</atitle><jtitle>Pacing and clinical electrophysiology</jtitle><addtitle>Pacing Clin Electrophysiol</addtitle><date>2012-06</date><risdate>2012</risdate><volume>35</volume><issue>6</issue><spage>652</spage><epage>658</epage><pages>652-658</pages><issn>0147-8389</issn><eissn>1540-8159</eissn><abstract>Background:
The performance of small diameter implantable cardioverter defibrillator (ICD) leads is questionable. However, data on performance during long‐term follow‐up are scarce. The aim of this study is to provide an update for the lead failure and cardiac perforation rate of Medtronic's Sprint Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) and St. Jude Medical's Riata ICD lead (St. Jude Medical Inc., St. Paul, MN, USA).
Methods:
Since 1996, all ICD system implantations at the Leiden University Medical Center, the Netherlands, are registered. For this study, data up to February 2011 on 396 Sprint Fidelis leads (follow‐up 3.4 ± 1.5 years), 165 8‐French (F) Riata leads (follow‐up 4.6 ± 2.6 years), and 30 7‐F Riata leads (follow‐up 2.9 ± 1.3 years) were compared with a benchmark cohort of 1,602 ICD leads (follow‐up 3.4 ± 2.7 years) and assessed for the occurrence of lead failure and cardiac perforation.
Results:
During follow‐up, the yearly lead failure rate of the Sprint Fidelis lead, 7‐F Riata lead, 8‐F Riata lead, and the benchmark cohort was 3.54%, 2.28%, 0.78%, and 1.14%, respectively. In comparison to the benchmark cohort, the adjusted hazard ratio of lead failure was 3.7 (95% confidence interval [CI] 2.4–5.7, P < 0.001) for the Sprint Fidelis lead and 4.2 (95% CI 1.0–18.0, P < 0.05) for the 7‐F Riata lead. One cardiac perforation was observed (3.3%) in the 7‐F Riata group versus none in the 8‐F Riata and Sprint Fidelis lead population.
Conclusion:
The current update demonstrates that the risk of lead failure during long‐term follow‐up is significantly increased for both the Sprint Fidelis and the 7‐F Riata lead in comparison to the benchmark cohort. Only one cardiac perforation occurred.
(PACE 2012; 35:652–658)</abstract><cop>Malden, USA</cop><pub>Blackwell Publishing Inc</pub><pmid>22352338</pmid><doi>10.1111/j.1540-8159.2011.03338.x</doi><tpages>7</tpages></addata></record> |
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subjects | Adult Aged Aged, 80 and over Biological and medical sciences cardiac lead perforation Defibrillators, Implantable - statistics & numerical data Diseases of the cardiovascular system Electrodes, Implanted - statistics & numerical data Equipment Failure - statistics & numerical data Female Heart Injuries - epidemiology Humans implantable cardioverter defibrillator lead failure Male Medical sciences Middle Aged Netherlands - epidemiology Postoperative Complications - epidemiology Prevalence Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Riata Risk Factors Sprint Fidelis |
title | Update on Small-Diameter Implantable Cardioverter-Defibrillator Leads Performance |
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