Cable externalization and electrical failure of the Riata family of implantable cardioverter-defibrillator leads: A systematic review and meta-analysis.

Abstract

Background

The Riata class of defibrillator leads were placed under US Food and Drug Association (FDA) advisory as of November 2011 because of high rates of cable externalization (CE) and electrical failure (EF). The overall rates of these complications remain unknown.

Objective

The purpose of this study was to systematically search the literature for rates of Riata lead failure and to perform a meta-analysis to estimate failure rates.

Methods

We conducted a meta-analysis of observational studies examining the rates of EF, CE, and the interaction of the two. We identified 23 English language manuscripts addressing 1 or more of these questions.

Results

Across 23 studies, the overall CE rate was 23.1% (95% confidence interval [CI] 19.0%-27.6%). The overall EF rate was 6.3% (95% CI 4.7%-8.2%). The presence of CE was associated with a more than 6-fold increase in the rate of EF compared to no CE (17.3% [95% CI 11.2%-25.9%] vs 2.7% [95% CI 1.4%-5.2%], respectively). The rate of CE was 3-fold higher for 8Fr leads compared to 7Fr leads, but rates of EF were similar (4.6%; 95% CI 3.2-6.6] and 3.9%; 95% CI 2.4-6.1], respectively). Rates of both CE and EF were higher in dual coil vs single coil leads, but confidence intervals overlapped.

Conclusion

In clinical practice, rates of CE in Riata leads are substantial. While CE is associated with a significant increase in the risk of EF, the incidence of EF without externalization is not trivial.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1016/j.hrthm.2015.03.005

Publication Info

Zeitler, Emily P, Sean D Pokorney, Ke Zhou, Robert K Lewis, Ruth Ann Greenfield, James P Daubert, David B Matchar, Jonathan P Piccini, et al. (2015). Cable externalization and electrical failure of the Riata family of implantable cardioverter-defibrillator leads: A systematic review and meta-analysis. Heart rhythm, 12(6). pp. 1233–1240. 10.1016/j.hrthm.2015.03.005 Retrieved from https://hdl.handle.net/10161/23846.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Pokorney

Sean Pokorney

Assistant Professor of Medicine

Robert Kenneth Lewis

Assistant Professor of Medicine
Daubert

James Patrick Daubert

Professor of Medicine

Atrial fibrillation ablation.
Cardiac resynchronization therapy.
Implantable defibrillator, including inappropriate shocks.
Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy
Hypertrophic cardiomyopathy.
Long QT syndrome
Sudden cardiac arrest and resuscitation.
Ventricular tachycardia


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