Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-up

Aims: Riata® implantable cardioverter-defibrillator (ICD) leads from St. Jude Medical are prone to malfunction. This study aimed to describe the rate of this lead's malfunction in a very long-term follow-up. Methods: This single-centre observational study included 50 patients who received a Ria...

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Autores: San Antonio, Rodolfo, Guasch i Casany, Eduard, Chipa Ccasani, Fredy, Apolo, José, Pujol López, Margarida, Fernandez, Hael, Trotta, Omar, Niebla Bellido, Mireia, Borràs, Roger, Trucco, Emilce, Arbelo, Elena, Roca Luque, Ivo, Brugada Terradellas, Josep, 1958-, Mont Girbau, Lluís, Tolosana, José M. (José María)
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2019
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/162063
Acceso en línea:https://hdl.handle.net/2445/162063
Access Level:acceso abierto
Palabra clave:Desfibril·ladors cardioversors implantables
Productes defectuosos
Plom
Implantable cardioverter-defibrillators
Defects in manufactures
Lead
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spelling Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-upSan Antonio, RodolfoGuasch i Casany, EduardChipa Ccasani, FredyApolo, JoséPujol López, MargaridaFernandez, HaelTrotta, OmarNiebla Bellido, MireiaBorràs, RogerTrucco, EmilceArbelo, ElenaRoca Luque, IvoBrugada Terradellas, Josep, 1958-Mont Girbau, LluísTolosana, José M. (José María)Desfibril·ladors cardioversors implantablesProductes defectuososPlomImplantable cardioverter-defibrillatorsDefects in manufacturesLeadAims: Riata® implantable cardioverter-defibrillator (ICD) leads from St. Jude Medical are prone to malfunction. This study aimed to describe the rate of this lead's malfunction in a very long-term follow-up. Methods: This single-centre observational study included 50 patients who received a Riata 7Fr dual-coil lead between 2003 and 2008. Follow-up was conducted both in person and remotely, and analysed at 8-month intervals. We evaluated the rates of cable externalization (CE), electrical failure (EF), and the interaction of these two complications. Structural lead failure was defined as radiographic CE. Oversensing of non-cardiac signal or sudden changes in impedance, sensing, or pacing thresholds constituted EF. Results: During a mean follow-up of 10.2 ± 2.9 years, 16 patients (32%) died. We observed lead malfunction in 13 patients (26%): three (23%) due to CE, six (46%) to EF and four (31%) to both complications. Of the malfunctioning leads, 77% failed after seven years of follow-up. The incidence rate (IR) of overall malfunction per 100 patients per year was 0.9 during the first seven years post-implantation, increased to 7.0 after the 7th year and more than doubled (to 16.7) after 10 years. Beyond seven years post-implantation, IR per 100 patient-years increased in both EF and CE (from 0.6 to 5.6 vs. 0.3 to 4.2, respectively). Presence of CE was associated with a 4-fold increase in the proportion of EF. Conclusion: The incidence of Riata ICD lead malfunction, both for EF and CE, increased dramatically after seven years and then more than doubled after 10 years post-implantation.Elsevier B.V.2019info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/162063Articles publicats en revistes (Medicina)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1016/j.ipej.2019.02.005Indian Pacing and Electrophysiology Journal, 2019, vol. 19, num. 4, p. 140-144https://doi.org/10.1016/j.ipej.2019.02.005info:eu-repo/grantAgreement/EC/H2020/633196cc-by-nc-nd (c) Indian Heart Rhythm Society, 2019http://creativecommons.org/licenses/by-nc-nd/3.0/esinfo:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1620632026-05-27T06:46:51Z
dc.title.none.fl_str_mv Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-up
title Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-up
spellingShingle Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-up
San Antonio, Rodolfo
Desfibril·ladors cardioversors implantables
Productes defectuosos
Plom
Implantable cardioverter-defibrillators
Defects in manufactures
Lead
title_short Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-up
title_full Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-up
title_fullStr Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-up
title_full_unstemmed Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-up
title_sort Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-up
dc.creator.none.fl_str_mv San Antonio, Rodolfo
Guasch i Casany, Eduard
Chipa Ccasani, Fredy
Apolo, José
Pujol López, Margarida
Fernandez, Hael
Trotta, Omar
Niebla Bellido, Mireia
Borràs, Roger
Trucco, Emilce
Arbelo, Elena
Roca Luque, Ivo
Brugada Terradellas, Josep, 1958-
Mont Girbau, Lluís
Tolosana, José M. (José María)
author San Antonio, Rodolfo
author_facet San Antonio, Rodolfo
Guasch i Casany, Eduard
Chipa Ccasani, Fredy
Apolo, José
Pujol López, Margarida
Fernandez, Hael
Trotta, Omar
Niebla Bellido, Mireia
Borràs, Roger
Trucco, Emilce
Arbelo, Elena
Roca Luque, Ivo
Brugada Terradellas, Josep, 1958-
Mont Girbau, Lluís
Tolosana, José M. (José María)
author_role author
author2 Guasch i Casany, Eduard
Chipa Ccasani, Fredy
Apolo, José
Pujol López, Margarida
Fernandez, Hael
Trotta, Omar
Niebla Bellido, Mireia
Borràs, Roger
Trucco, Emilce
Arbelo, Elena
Roca Luque, Ivo
Brugada Terradellas, Josep, 1958-
Mont Girbau, Lluís
Tolosana, José M. (José María)
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Desfibril·ladors cardioversors implantables
Productes defectuosos
Plom
Implantable cardioverter-defibrillators
Defects in manufactures
Lead
topic Desfibril·ladors cardioversors implantables
Productes defectuosos
Plom
Implantable cardioverter-defibrillators
Defects in manufactures
Lead
description Aims: Riata® implantable cardioverter-defibrillator (ICD) leads from St. Jude Medical are prone to malfunction. This study aimed to describe the rate of this lead's malfunction in a very long-term follow-up. Methods: This single-centre observational study included 50 patients who received a Riata 7Fr dual-coil lead between 2003 and 2008. Follow-up was conducted both in person and remotely, and analysed at 8-month intervals. We evaluated the rates of cable externalization (CE), electrical failure (EF), and the interaction of these two complications. Structural lead failure was defined as radiographic CE. Oversensing of non-cardiac signal or sudden changes in impedance, sensing, or pacing thresholds constituted EF. Results: During a mean follow-up of 10.2 ± 2.9 years, 16 patients (32%) died. We observed lead malfunction in 13 patients (26%): three (23%) due to CE, six (46%) to EF and four (31%) to both complications. Of the malfunctioning leads, 77% failed after seven years of follow-up. The incidence rate (IR) of overall malfunction per 100 patients per year was 0.9 during the first seven years post-implantation, increased to 7.0 after the 7th year and more than doubled (to 16.7) after 10 years. Beyond seven years post-implantation, IR per 100 patient-years increased in both EF and CE (from 0.6 to 5.6 vs. 0.3 to 4.2, respectively). Presence of CE was associated with a 4-fold increase in the proportion of EF. Conclusion: The incidence of Riata ICD lead malfunction, both for EF and CE, increased dramatically after seven years and then more than doubled after 10 years post-implantation.
publishDate 2019
dc.date.none.fl_str_mv 2019
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/162063
url https://hdl.handle.net/2445/162063
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1016/j.ipej.2019.02.005
Indian Pacing and Electrophysiology Journal, 2019, vol. 19, num. 4, p. 140-144
https://doi.org/10.1016/j.ipej.2019.02.005
info:eu-repo/grantAgreement/EC/H2020/633196
dc.rights.none.fl_str_mv cc-by-nc-nd (c) Indian Heart Rhythm Society, 2019
http://creativecommons.org/licenses/by-nc-nd/3.0/es
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by-nc-nd (c) Indian Heart Rhythm Society, 2019
http://creativecommons.org/licenses/by-nc-nd/3.0/es
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Elsevier B.V.
publisher.none.fl_str_mv Elsevier B.V.
dc.source.none.fl_str_mv Articles publicats en revistes (Medicina)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.198674

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