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Newer ICD leads associated with low rates of mechanical failure
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Optim-insulated implantable cardioverter defibrillator leads had low rates of all-cause mechanical failure and no observed externalized conductors in a registry study.
According to the study background, the Riata 8-F and ST 7-F ICD leads (St. Jude Medical) were recalled in 2011 after reports of a new form of insulation abrasion, with protrusion of at least one cable beyond the lead body.
Researchers investigated whether similar problems were observed with a newer family of leads (Riata ST Optim, Durata DF1 and Durata DF4; St. Jude Medical), with silicone insulation coated with Optim, a silicone-polyurethane copolymer with tear- and abrasion-resistant properties, and thicker insulation compared with earlier versions.
John A. Cairns, MD, and colleagues analyzed lead failures of ICDs or cardiac resynchronization therapy defibrillators in patients in three prospective registries established by St. Jude Medical. The OPTIMUM, SCORE and SJ4 PAS registries included 11,016 Riata ST Optim or Durata leads in 10,835 patients (mean age, 65.9 years; 72.8% men; mean left ventricular ejection fraction, 29.3%).
Median follow-up was 3.2 years. The primary outcome was all-cause mechanical failure.
Fifty-one leads (0.46%) had all-cause mechanical failure; 34 (0.31%) had conductor fracture, 11 (0.1%) had insulation abrasion and five (0.05%) had an unclassifiable type of mechanical lead failure.
The researchers found no instances of an externalized conductor, the main problem that had led to the recall of the Riata 8-F and ST 7-F ICD leads.
At 5 years, the estimated lead survival, defined as freedom from any type of mechanical failure, was 99% (95% CI, 98.4-99.3). The survival rate at 5 years with freedom from conductor fracture was 99.4% (95% CI, 98.8-99.6) and from insulation abrasion was 99.8% (95% CI, 99.5-99.9), according to the results.
The data yielded no difference in survival between the different lead types included in the registries.
“Our ongoing analyses now include some patients followed for up to 7 years and support existing data that better performance with Optim leads is a reality,” Cairns, professor of medicine at the division of cardiology of the University of British Columbia in Vancouver, said in a press release. “The data from this study is of great importance to help electrophysiologists make more informed decisions as they relate to the performance of these leads and the management of patients who depend on them.”
Disclosure: The study was funded by St. Jude Medical. The researchers report financial ties with Biotronik, Boston Scientific, Medtronic, Spectranetics and St. Jude Medical.
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