Copyright
©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Feb 16, 2017; 5(2): 27-34
Published online Feb 16, 2017. doi: 10.12998/wjcc.v5.i2.27
Published online Feb 16, 2017. doi: 10.12998/wjcc.v5.i2.27
Externalized conductors and insulation failure in Biotronik defibrillator leads: History repeating or a false alarm?
Elia De Maria, Ambra Borghi, Lorenzo Bonetti, Pier Luigi Fontana, Stefano Cappelli, Cardiology Unit, Ramazzini Hospital, 41012 Carpi (Modena), Italy
Author contributions: De Maria E contributed to conception and design of the work, drafting the article, final approval; Borghi A, Bonetti L, Fontana PL and Cappelli S contributed to drafting and critical revision of the work, final approval.
Conflict-of-interest statement: None to disclose.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Elia De Maria, MD, PhD, Chief of Arrhythmology Lab, Cardiology Unit, Ramazzini Hospital, Via Molinari 1, 41012 Carpi (Modena), Italy. e.demaria@inwind.it
Telephone: +39-05-9659320 Fax: +39-05-9659387
Received: August 19, 2016
Peer-review started: August 20, 2016
First decision: October 21, 2016
Revised: October 29, 2016
Accepted: November 21, 2016
Article in press: November 22, 2016
Published online: February 16, 2017
Processing time: 181 Days and 9.2 Hours
Peer-review started: August 20, 2016
First decision: October 21, 2016
Revised: October 29, 2016
Accepted: November 21, 2016
Article in press: November 22, 2016
Published online: February 16, 2017
Processing time: 181 Days and 9.2 Hours
Core Tip
Core tip: Conductor externalization and insulation failure are frequent complications with the recalled St. Jude Medical Riata implantable cardioverter-defibrillator leads. Cables can externalize through the insulation (“inside-out” abrasion) and appear outside the lead body. Recently similar failure mechanisms have also been described for Biotronik leads. Some studies reported a high rate of electrical dysfunction (including insulation failure) with Biotronik Linox leads and a survival rate between 88% and 91% at 5 years, significantly worse than that of other manufacturers. However, the preliminary results of two ongoing multicenter, prospective registries showed 96% survival rate at 5 years, well within industry standards.