Systematic fluoroscopic and electrical assessment of implantable cardioverter-defibrillator patients implanted with silicone-polyurethane copolymer (Optim™) coated leads.

AIMS: Serious concerns have been recently raised about the reliability of the silicone-polyurethane copolymer (Optim™) lead insulation system. We sought to identify insulation defects and Optim-lead failures by systematic fluoroscopic and electrical assessment in a prospectively defined cohort of implantable cardioverter-defibrillator (ICD) patients.

METHODS AND RESULTS: Between July 2007 and December 2011, 234 patients were implanted with 413 optim-coated leads as part of an ICD system at a single centre. Fluoroscopic screening with high-resolution cine-fluoroscopy at 30 frames per second was offered to all patients. In addition, the electrical integrity of all implanted leads was assessed. Durata, Riata ST Optim, and low-voltage Optim leads were implanted in 199, 26, and 188 cases, respectively. During a total follow-up of 10 036 lead-months, there were 7 Optim-lead failures (defined as electrical malfunction resulting in lead replacement) and 31 deaths; no cases of electrical noises were encountered. The overall incidence of lead failure was 1.2 vs. 0.3 per 100 lead-years, for high- and low-voltage leads, respectively (P = 0.1). One hundred fifty-one patients agreed to undergo fluoroscopy screening; none of the 264 analysed Optim leads were found to have any fluoroscopically visible structural defects after an average of 31 months post-implant.

CONCLUSION: This study represents the first systematic screening of Optim-coated leads in a large unselected cohort of ICD patients. Over a 5-year period few lead failures were observed and normal fluoroscopic appearance was present in all patients.