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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Main Authors: Rodolfo San Antonio, Eduard Guasch, Fredy Chipa-Ccasani, José Apolo, Margarida Pujol-López, Hael Fernández, Omar Trotta, Mireia Niebla, Roger Borràs, Emilce Trucco, Elena Arbelo, Ivo Roca-Luque, Josep Brugada, Lluís Mont, José María Tolosana
Format: Article
Language:English
Published: Elsevier 2019-07-01
Series:Indian Pacing and Electrophysiology Journal
Online Access:http://www.sciencedirect.com/science/article/pii/S0972629219300294
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author Rodolfo San Antonio
Eduard Guasch
Fredy Chipa-Ccasani
José Apolo
Margarida Pujol-López
Hael Fernández
Omar Trotta
Mireia Niebla
Roger Borràs
Emilce Trucco
Elena Arbelo
Ivo Roca-Luque
Josep Brugada
Lluís Mont
José María Tolosana
author_facet Rodolfo San Antonio
Eduard Guasch
Fredy Chipa-Ccasani
José Apolo
Margarida Pujol-López
Hael Fernández
Omar Trotta
Mireia Niebla
Roger Borràs
Emilce Trucco
Elena Arbelo
Ivo Roca-Luque
Josep Brugada
Lluís Mont
José María Tolosana
author_sort Rodolfo San Antonio
collection DOAJ
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. Keywords: Implantable cardioverter-defibrillator, Long-term follow-up, Malfunction, Cable externalization, Electrical failure
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spelling doaj.art-19353d993b20468ba363e8cd6c3552992022-12-22T03:40:16ZengElsevierIndian Pacing and Electrophysiology Journal0972-62922019-07-01194140144Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-upRodolfo San Antonio0Eduard Guasch1Fredy Chipa-Ccasani2José Apolo3Margarida Pujol-López4Hael Fernández5Omar Trotta6Mireia Niebla7Roger Borràs8Emilce Trucco9Elena Arbelo10Ivo Roca-Luque11Josep Brugada12Lluís Mont13José María Tolosana14Arrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Madrid, SpainArrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, Spain; Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Catalonia, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Madrid, SpainArrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, SpainArrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, SpainArrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, SpainArrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, SpainArrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, SpainArrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, SpainArrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, SpainArrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, SpainArrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, Spain; Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Catalonia, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Madrid, SpainArrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, SpainArrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, Spain; Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Catalonia, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Madrid, SpainArrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, Spain; Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Catalonia, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Madrid, SpainArrhythmia Section, Cardiovascular Clinic Institute, Hospital Clínic, University of Barcelona, Catalonia, Spain; Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Catalonia, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain; Corresponding author. Arrhythmia Section, Cardiovascular Clinic Institute, Hospital Clinic, University of Barcelona, Villarroel 170, 08036, Barcelona, Catalonia, Spain.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. Keywords: Implantable cardioverter-defibrillator, Long-term follow-up, Malfunction, Cable externalization, Electrical failurehttp://www.sciencedirect.com/science/article/pii/S0972629219300294
spellingShingle Rodolfo San Antonio
Eduard Guasch
Fredy Chipa-Ccasani
José Apolo
Margarida Pujol-López
Hael Fernández
Omar Trotta
Mireia Niebla
Roger Borràs
Emilce Trucco
Elena Arbelo
Ivo Roca-Luque
Josep Brugada
Lluís Mont
José María Tolosana
Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-up
Indian Pacing and Electrophysiology Journal
title 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_short 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
url http://www.sciencedirect.com/science/article/pii/S0972629219300294
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