Cable externalization and electrical failure of the Riata family of implantable cardioverter-defibrillator leads: A systematic review and meta-analysis.
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2015-06
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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.Type
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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.
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Scholars@Duke

Sean Pokorney
Robert Kenneth Lewis

James Patrick Daubert
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

Jonathan Paul Piccini
Jonathan P. Piccini, MD, MHS, FACC, FAHA, FHRS is a clinical cardiac electrophysiologist and Professor of Medicine and Population Health at Duke University Hospital and the Duke Clinical Research Institute. He is the Director of the Cardiac Electrophysiology section at the Duke Heart Center. His focus is on the care of patients with atrial fibrillation and complex arrhythmias, with particular emphasis on catheter ablation, pacing, and lead extraction. His research interests include the development and evaluation of innovative cardiovascular interventions for the treatment of heart rhythm disorders. He serves on the Board of Trustees of the Heart Rhythm Society, is an Associate Editor at JACC: Clinical Electrophysiology, and is an elected member of the American Society for Clinical Investigation. Dr. Piccini has more than 600 publications in the field of heart rhythm medicine and has been the recipient of several teaching and mentorship awards.
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