Long-term electrical survival analysis of Riata and Riata ST silicone leads: National Veterans Affairs experience

ArticleinHeart rhythm: the official journal of the Heart Rhythm Society 9(12) · August 2012with5 Reads
Impact Factor: 5.08 · DOI: 10.1016/j.hrthm.2012.08.006 · Source: PubMed

    Abstract

    BACKGROUND: A medical device advisory issued by St Jude Medical in November 2011 estimated 0.63% all-cause abrasion rate on their Riata and Riata ST silicone high-voltage lead families (Riata/ST), leading to Food and Drug Administration 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. OBJECTIVE: To evaluate long-term electrical survival of Riata/ST leads relative to other commonly evaluated high-voltage leads. METHODS: Failure rates of Riata/ST, Sprint Quattro Secure (Quattro), Sprint Fidelis (Fidelis), and Endotak Reliance G/SG (Endotak) leads from the Veterans Administration's 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 the log-rank test. RESULTS: Of 1403 Riata/ST, 5608 Quattro, 5076 Fidelis, and 2401 Endotak leads identified, 5-year survival probability of Riata/ST leads (97.5%) was significantly lower than that of Quattro (99.2%) and Endotak (99.5%) leads (P <.0001) but higher than that of Fidelis leads (89.6%) (P <.0001). Riata ST leads showed a 6-year survival of 91.4% (95% confidence interval 81.3-96.2) compared to 97.0% (95% confidence interval 92.2-98.1) in Riata leads (P = .003). CONCLUSIONS: There is decreased survival probability of Riata/ST leads compared to other contemporary high-voltage leads, with decreased survival of Riata ST silicone compared to Riata lead series. Careful long-term follow-up should be maintained in patients with Riata/ST leads in order to prevent inappropriate shocks or failed device interventions. Our results were determined in advance of Food and Drug Administration class I recall, which suggested that large-scale remote monitoring may be an effective tool for continued implantable cardioverter-defibrillator system surveillance.