Abstract
St. Jude Medical (now Abbott) released the Riata ST Optim lead in 2006 as one of the Durata family of defibrillator leads. These leads were coated with silicone polyurethane copolymer insulation material (Optim) on Riata and Riata ST leads. In 2011, Riata and Riata ST leads were designated to be a class I recall by the United States Food and Drug Administration (FDA) because of lead insulation failure. Since the Riata ST Optim lead increased the insulation thickness by 50% after coating with 0.09-mm Optim,1 the rate of conductor externalization was significantly decreased, from 19%–28% in Riata and Riata ST leads2 to <1% in Riata ST Optim and Durata leads.
Highlights
Even though the rate of conductor externalization and longevity of the lead has improved, the risk of internal insulation breach following failure of shock delivery persists because Optim did not cover a layer between the superior vena cava (SVC) and right ventricular coil in the Riata ST Optim lead
In our previous review,[5] we suggested that the SVC coil should be excluded from the defibrillation system to avoid short circuit–related failure
right ventricular (RV) shocking coil could abrade through the inner silicone from inside to outside and ethylene tetrafluoroethylene would be damaged, allowing that coil to shortcut to the SVC shocking coil
Summary
St. Jude Medical ( Abbott) released the Riata ST Optim lead in 2006 as one of the Durata family of defibrillator leads. Jude Medical ( Abbott) released the Riata ST Optim lead in 2006 as one of the Durata family of defibrillator leads These leads were coated with silicone polyurethane copolymer insulation material (Optim) on Riata and Riata ST leads. Since the Riata ST Optim lead increased the insulation thickness by 50% after coating with 0.09-mm Optim,[1] the rate of conductor externalization was significantly decreased, from 19%–28% in Riata and Riata ST leads[2] to ,1% in Riata ST Optim and Durata leads.[3] As of 2020, Riata Optim leads had been implanted in .19,000 patients in the United States and the 10-year survival rate is approximately 92%, according to an Abbott product performance report.[4] in contrast to improvement of conductor cable externalization, concerns of internal insulation breach, a possible cause of silent lead malfunction or defibrillation failure, remain to be determined. We report a case of defibrillation failure with a lack of effective shock delivery owing to low defibrillation lead resistance (,20 U) in a Riata ST Optim lead, which was not revealed by routine periodic interrogation
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