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Long-term Electrical Survival Analysis of Riata and Riata ST Silicone Leads—National VA Experience



Long-term Electrical Survival Analysis of Riata and Riata ST Silicone Leads—National VA Experience







A medical device advisory issued by St. Jude Medical in November 2011 estimated 0.63% all-cause abrasion rate on their Riata and silicone Riata ST family of high voltage leads (Riata/ST), leading to FDA class I recall. We performed an independent comparative, long-term electrical survival analysis of Riata/ST and 3 other high voltage lead families in a large national cohort of patients. Evaluate long-term Riata/ST electrical survival relative to other commonly evaluated high voltage leads. Failure rates between Riata/ST, Sprint Quattro Secure (Quattro), Sprint Fidelis (Fidelis), and Endotak Reliance G/SG (Endotak) from the VA National Cardiac Device Surveillance Center database, consisting of 24,145 patients with remote transmissions since 2003 were analyzed. Survival probability was determined with Kaplan-Meier survival analysis with log-rank test. Out of 1,403 Riata/ST, 5,608 Quattro, 5,076 Fidelis, and 2,401 Endotak leads identified, 5-year survival probability of Riata/ST (97.5%) was significantly lower than Quattro (99.2%) and Endotak (99.5%) (p < 0.0001), but higher than Fidelis (89.6%) (p < 0.0001). Riata ST showed a 6-year survival of 91.4% (CI 81.3-96.2) versus 97.0% (CI 92.2-98.1) in Riata (p = 0.003). There is decreased survival probability of Riata/ST versus other contemporary high voltage leads, with decreased survival of silicone Riata ST versus Riata series. Careful long-term follow-up should be maintained in patients with Riata/ST in order to prevent inappropriate shocks or failed device interventions. Our results were determined in advance of FDA class 1 recall, and suggest that large-scale remote monitoring may be an effective tool for continued ICD system surveillance.

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Accession: 036530077

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