Prospective long-term evaluation of Optim-insulated (Riata ST Optim and Durata) implantable cardioverter-defibrillator leads.

BACKGROUND: St Jude Medical Optim-insulated implantable cardioverter-defibrillator leads were designed to impart lubricity, strength, and abrasion resistance while maintaining flexibility and biostability. No long-term prospective follow-up data have been published.

OBJECTIVE: The objective of this study was to determine the rates of all-cause mechanical failure and its subtypes (conductor fracture, insulation abrasion, externalized conductors, and other mechanical failures) in a prospective cohort of Optim-insulated implantable cardioverter-defibrillator leads.

METHODS: St Jude Medical established 3 prospective registries and enrolled 11,016 leads implanted in 10,835 patients beginning in 2006. There was standardized baseline documentation, 6-monthly follow-up, adverse events reports (verified by expert staff using detailed algorithms), and documentation of lead revisions or inactivation, study withdrawal, and death. The Population Health Research Institute (McMaster University) was engaged to review database functions, adjudicate all potential mechanical lead failures, and conduct independent analyses of the data.

RESULTS: During a median follow-up of 3.2 years, there were 51 mechanical failures (0.46%), with 99.0% survival free of this outcome by 5 years of follow-up. Freedom from conductor fracture was identified in 99.4% and from all-cause abrasion in 99.8% of the leads, and there were no reports of externalized conductors. There were no significant differences in survival among Durata DF4, Durata DF1, and Riata ST Optim leads.

CONCLUSION: Over a mean follow-up of 3.2 years, Optim-insulated leads have low rates of all-cause mechanical failure and no observed externalized conductors. Independent analyses of these registries are designed to provide reliable long-term follow-up information and are ongoing.