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. 2019 Jul-Aug;19(4):140-144.
doi: 10.1016/j.ipej.2019.02.005. Epub 2019 Feb 19.

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

Rodolfo San Antonio  1 , Eduard Guasch  2 , Fredy Chipa-Ccasani  3 , José Apolo  3 , Margarida Pujol-López  3 , Hael Fernández  3 , Omar Trotta  3 , Mireia Niebla  3 , Roger Borràs  3 , Emilce Trucco  3 , Elena Arbelo  2 , Ivo Roca-Luque  3 , Josep Brugada  2 , Lluís Mont  2 , José María Tolosana  4
Affiliations

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

Rodolfo San Antonio et al. Indian Pacing Electrophysiol J. 2019 Jul-Aug.

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.

Keywords: Cable externalization; Electrical failure; Implantable cardioverter-defibrillator; Long-term follow-up; Malfunction.

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Figures

Fig. 1
Fig. 1
A. Cable externalization between both coils (zones A1-A2). Yellow arrow indicates the affected area. Fig. 1B. Cable externalization sub-classified according to the topography of the mechanical dysfunction: D, clavicle to pulse generator; C, near clavicle; B, distal to clavicle including SVC-coil; A, distal to SVC-coil. In turn, that area between both coils is divided into: SVC-coil to the tricuspid valve annulus (A3); just in the tricuspid valve annulus level (A2); tricuspid valve annulus to the right ventricle-coil (A1) [14]. SVC, superior vena cava.
Fig. 2
Fig. 2
This flow diagram illustrates the number of patients included in this study. ICD, implantable cardioverter-defibrillator; CE, cable externalization; EF, electrical failure; IE, infective endocarditis; PO, physiological oversensing; LSVO, left subclavian vein occluded.
Fig. 3
Fig. 3
Kaplan-Meier survival curve. The incidence of lead malfunctions dramatically increased after the 7th year post-implantation (blue line) and was especially evident after 10 years (red line).
See this image and copyright information in PMC

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