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Title: Failure-free survival of the Riata implantable cardioverter-defibrillator lead after a very long-term follow-up
Author: 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)
Keywords: Desfibril·ladors cardioversors implantables
Productes defectuosos
Implantable cardioverter-defibrillators
Defects in manufactures
Issue Date: 19-Feb-2019
Publisher: Elsevier B.V.
Abstract: 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.
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It is part of: Indian Pacing and Electrophysiology Journal, 2019, vol. 19, num. 4, p. 140-144
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ISSN: 0972-6292
Appears in Collections:Publicacions de projectes de recerca finançats per la UE
Articles publicats en revistes (Medicina)
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)

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