title: Systematic fluoroscopic and electrical assessment of implantable cardioverter-defibrillator patients implanted with silicone-polyurethane copolymer (Optim™) coated leads.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Internal Medicine, Division of Cardiology, University Hospital of Tor Vergata, Viale Oxford, 81, 00133 Rome, Italy.
authors.forename: Giovanni B
authors.initials: GB
authors.lastname: Forleo
authors.forename: Luigi
authors.initials: L
authors.lastname: Di Biase
authors.forename: Germana
authors.initials: G
authors.lastname: Panattoni
authors.forename: Alessandro
authors.initials: A
authors.lastname: Politano
authors.forename: Giulia
authors.initials: G
authors.lastname: Magliano
authors.forename: Luca
authors.initials: L
authors.lastname: Santini
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
authors.forename: Francesco
authors.initials: F
authors.lastname: Romeo
mesh_terms: D000368:Aged; D020099:Coated Materials, Biocompatible; D017147:Defibrillators, Implantable; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D019544:Equipment Failure Analysis; D005260:Female; D005471:Fluoroscopy; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D011140:Polyurethanes; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012189:Retrospective Studies; D012828:Silicones; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D020099:Coated Materials, Biocompatible; D011140:Polyurethanes; D012828:Silicones
keywords: Durata; Fluoroscopy; Implantable cardioverter-defibrillator; Insulation breach; Lead failure; Riata