Externalized conductors and insulation failure in Biotronik defibrillator leads: History repeating or a false alarm?

Abstract

Conductor externalization and insulation failure are frequent complications with the recalled St. Jude Medical Riata implantable cardioverter-defibrillator (ICD) leads. Conductor externalization is a “unique” failure mechanism: Cables externalize through the insulation (“inside-out” abrasion) and appear outside the lead body. Recently, single reports described a similar failure also for Biotronik leads. Moreover, some studies reported a high rate of electrical dysfunction (not only insulation failure) with Biotronik Linox leads and a reduced survival rate in comparison with the competitors. In this paper we describe the case of a patient with a Biotronik Kentrox ICD lead presenting with signs of insulation failure and conductor externalization at fluoroscopy. Due to the high risk of extraction we decided to implant a new lead, abandoning the damaged one; lead reimplant was uneventful. Subsequently, we review currently available literature about Biotronik Kentrox and Linox ICD lead failure and in particular externalized conductors. Some single-center studies and a non-prospective registry reported a survival rate between 88% and 91% at 5 years for Linox leads, significantly worse than that of other manufacturers. However, the preliminary results of two ongoing multicenter, prospective registries (GALAXY and CELESTIAL) showed 96% survival rate at 5 years after implant, well within industry standards. Ongoing data collection is needed to confirm longer-term performance of this family of ICD leads.

Keywords: Implantable cardioverter defibrillator, Biotronik implantable cardioverter defibrillator lead, Externalized conductors, Insulation failure

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.