Nationwide Longitudinal Follow-Up of Riata Leads Under Advisory at 3 Annual Screenings: Report From the Netherlands Heart Rhythm Association Device Advisory Committee.

Objectives: This study sought to determine prospectively the rate of conductor externalization (CE), and whether this was associated with electrical failure.

Background: The Riata family of defibrillator leads was placed under U.S. Food and Drug Administration advisory as of November 28, 2011 because of high rates of CE.

Methods: A nationwide cohort established in 2012 of 1,029 patients with recalled Riata leads with 147 CE were followed until death, lead discontinuation, or 3 annual screenings with fluoroscopy and device interrogation.

Results: Follow-up of 882 patients with normal baseline fluoroscopy revealed incident overt CE in 95 leads (11%) after median risk time of 2.9 years, yielding an incidence rate of 4.9 (95% confidence interval [CI]: 3.9 to 5.9) per 100 patient-years. The incidence rate was significantly higher in 8-F Riata leads than in 7-F Riata ST leads (7.0 vs. 3.2 per 100 patient-years; p < 0.001). Electrical follow-up demonstrated electrical abnormality in 77 leads, resulting in an incidence rate of 4.0 (95% CI: 3.2 to 5.0) per 100 patient-years. The incidence rate of electrical abnormalities was not different between leads without CE and those with CE (3.9 vs. 5.2 per 100 patient-years; p = 0.39).

Conclusions: The development of CE is progressive in nature with an incidence rate of new CE of 4.9 per 100 patient-years, with a higher rate for 8-F Riata leads than for 7-F Riata ST leads. Despite the high rate of structural failure, no association between development of CE and electrical failure was observed.