Key result
In ICD patients with Optim-coated leads, the incidence of lead failure was 1.2 vs. 0.3 per 100 lead-years for high- and low-voltage leads, respectively (P=0.1), with no structural defects observed.
Why the study?
What is the incidence of insulation defects and lead failures in patients implanted with Optim-coated ICD leads?
Cohort (n=234)
No
What is the incidence of insulation defects and lead failures in patients implanted with Optim-coated ICD leads?
Absolute Event Rate: 1.2% vs 0.3%
p-value: p=0.1
In a single-center cohort, Optim-coated ICD leads demonstrated a low rate of electrical failure and no fluoroscopically visible structural defects over an average of 31 months.
Reassuring short-term safety of Optim-coated ICD leads; leaves open long-term comparative durability.
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.
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Forleo et al. (2013) conducted a cohort in Implantable cardioverter-defibrillator (ICD) patients (n=234). High-voltage Optim-coated leads vs. Low-voltage Optim-coated leads was evaluated on Lead failure (electrical malfunction resulting in lead replacement) (p=0.1). In ICD patients with Optim-coated leads, the incidence of lead failure was 1.2 vs. 0.3 per 100 lead-years for high- and low-voltage leads, respectively (P=0.1), with no structural defects observed.
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