title: What did we learn from Riata™?
abstract: The Riata™ 8 French (Fr) and Riata ST™ 7 Fr families of silicone leads have experienced a specific form of insulation abrasion characterized by externalization of conductor cables outside the lead body. Design differences between the 8 Fr and 7 Fr leads make conductor externalization less likely in the smaller diameter lead. The Riata Lead Evaluation Study (RLES) reported on the prevalence of externalized conductors (EC) in patients implanted with Riata™ and Riata ST™ silicone leads and provided details on the incidence of electrical abnormalities in Riata™ and Riata ST™ leads with and without EC. The prevalence of EC was significantly lower for the Riata ST™ leads (7 Fr) as compared with Riata™ leads (8 Fr) (24/259 (9.3 %) vs. 125/517 (24.2 %), P < 0.001), and the majority of leads with EC were not associated with electrical malfunction. The aim of this manuscript is to describe the design of the Riata™ and Riata ST™ families of leads, provide details regarding the mechanisms and rates of lead failure, and discuss recommendations for patient management.
authors.affiliation: St. Jude Medical, 15900 Valley View Court, 91342, Sylmar, CA, USA, afischer@sjm.com.
authors.forename: Avi
authors.initials: A
authors.lastname: Fischer
authors.forename: C
authors.initials: C
authors.lastname: Jenney
mesh_terms: D017147:Defibrillators, Implantable / Q000009:adverse effects*; D020878:Device Removal / Q000379:methods*; D004553:Electric Conductivity; D004556:Electric Injuries / Q000209:etiology* / Q000517:prevention & control*; D004867:Equipment Design; D004868:Equipment Failure; D019544:Equipment Failure Analysis; D004869:Equipment Safety; D057052:Medical Device Recalls; D018570:Risk Assessment