Clinical Performance of the St. Jude Medical Riata Defibrillation Lead in a Large Patient Population

Abstract

The purpose of this large multicenter study was to evaluate the long-term reliability of an implantable cardioverter defibrillator (ICD) lead to determine the incidence of adverse events (AEs). A recent concern has been the performance of cardiac defibrillator leads. There have been conflicting reports regarding the rate of lead perforation and other AEs. Medical records from patients implanted from 6-1-2001 to 11-27-2007 with the St. Jude Medical Riata family of RV leads at 23 US (N = 12,969) and 5 German (N = 2,418) centers were reviewed for chronic lead-related AEs. These included perforation, dislodgment, conductor fracture and insulation damage. The mean follow-up period was 18.0 months. AEs were defined as those that required Riata lead revision, extraction, or replacement. The incidence of lead AEs was <1% for each AE type. Perforation occurred in 0.38%, dislodgement in 0.93%, conductor fracture in 0.18%, and insulation damage in 0.21% of patients studied. During the follow-up of the 15,387 patients with Riata leads, the incidence of AEs which included perforation, dislodgement, conductor fraction and insulation damage was low and within the range of what is considered clinically acceptable.