Long-term electrical survival analysis of Riata and Riata ST silicone leads: National Veterans Affairs experience
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.
- SourceAvailable from: Melanie MaytinHeart rhythm: the official journal of the Heart Rhythm Society 09/2012; 9(12). DOI:10.1016/j.hrthm.2012.09.014 · 4.92 Impact Factor
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ABSTRACT: BACKGROUND: Small-diameter ICD leads Sprint Fidelis and Riata have been recalled owing to an increased risk of lead failure, thus arousing the suspicion that lead size might be a critical issue. OBJECTIVE: to compare the incidence of failure of small-diameter (≤8Fr) and standard-diameter (>8Fr) ICD leads implanted in a single center. METHODS: From January 2003 to December 2010, 190 Sprint Fidelis, 182 Riata/Riata ST, 99 Optim (Riata Optim/Durata) and 419 standard-diameter leads were implanted in our center. RESULTS: During a median follow-up of 33 months, the overall failure rate was 6.3%. Follow-up duration was similar for Sprint Fidelis, Riata and standard-diameter leads, but shorter for the Optim group. The failure rate was significantly higher in Sprint Fidelis leads compared to both standard-diameter (4.8%/year vs. 0.8%/year, P<0.001) and Riata/Riata ST leads (4.8%/year vs. 2.6%/year, P=0.03). The incidence of lead failure in Riata/Riata ST proved significantly higher than in standard-diameter leads (2.6%/year vs. 0.8%/year, P=0.001). No cases of lead failure were recorded in the Optim group. On multivariable analyses, small diameter (HR 5.03, 2.53-10.01, p<0.001), or Sprint Fidelis (HR 6.3, 3.1-13.3, P<0.001), Riata/Riata ST (HR 4.5, 1.9-10.5, P=0.001), and age<60years (HR 2.3, 1.3-4.3, P=0.005), were found to independently increase the risk of lead failure. CONCLUSIONS: Compared to standard-diameter leads, both Sprint Fidelis and Riata/Riata ST small-diameter ICD leads are at increased risk of failure, although the incidence of events is significantly lower in the Riata than in the Sprint Fidelis group.Heart rhythm: the official journal of the Heart Rhythm Society 10/2012; 10(2). DOI:10.1016/j.hrthm.2012.10.017 · 4.92 Impact Factor
- Heart rhythm: the official journal of the Heart Rhythm Society 10/2012; 10(2). DOI:10.1016/j.hrthm.2012.10.026 · 4.92 Impact Factor