Long-term electrical survival analysis of Riata and Riata ST silicone leads: National Veterans Affairs experience Raphael K. Sung, MD,* Barry M. Massie, MD, †‡ Paul D. Varosy, MD, FHRS, § Hans Moore, MD, FHRS, ¶ John Rumsfeld, MD, § Byron K. Lee, MD,* Edmund Keung, MD †‡¶ From the *Department of Medicine, Division of Cardiology, Electrophysiology Section, University of California, San Francisco, California, † Division of Cardiology, San Francisco VA Medical Center, San Francisco, California, ‡ Department of Medicine, University of California, San Francisco, California, § VA Eastern Colorado Health Care System, Cardiovascular Outcomes Research (CCOR) Group, University of Colorado, Denver, Colorado,  Division of Cardiology, Washington DC VA Medical Center, Washington, District of Columbia, and ¶ VA National Cardiac Device Surveillance Program, San Francisco, California and Washington, DC. BACKGROUND A medical device advisory issued by St Jude Med- ical 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 sur- vival 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 (Quat- tro), 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 Proba- bilities were determined with Kaplan-Meier survival analysis and compared using the log-rank test. RESULTS Of 1,403 Riata/ST, 6,091 Quattro, 5,073 Fidelis, and 2,401 Endotak leads identified, 5-year survival probability of Riata/ST leads (97.5%) was significantly lower than that of Quat- tro (99.3%) and Endotak (99.4%) leads (P .0001) but higher than that of Fidelis leads (89.6%) (P .0001). Riata ST leads showed a 5-year survival of 95.5% (95% confidence interval 92.4 – 97.4) compared to 98.4% (95% confidence interval 97.1–99.1) in Riata leads (P = .003). CONCLUSIONS There is decreased survival probability of Riata/ST leads compared to other contemporary high-voltage leads, with de- creased 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. KEYWORDS ICD; High-voltage leads; Lead failure; Ventricular tachycardia; Lead extraction ABBREVIATIONS FDA = Food and Drug Administration; ICD = im- plantable cardioverter-defibrillator; p/s = pace/sense; SVC = supe- rior vena cava; VA = Veterans Affairs; VANCDSC = Veterans Admin- istration’s National Cardiac Device Surveillance Center (Heart Rhythm 2012;9:1954 –1961) Published by Elsevier Inc. on behalf of the Heart Rhythm Society. Introduction Although implantable cardioverter-defibrillator (ICD) sys- tems provide valuable, lifesaving therapies for patients with life-threatening tachyarrhythmias, 1 mechanical problems and failure of high-voltage leads can compromise device function, cause inappropriate shocks, and, in rare cases, lead to loss of pacing, failure of defibrillation, or fatal proar- rhythmia. 2–4 Medtronic’s Sprint Fidelis (Fidelis) lead fail- ure is the prototypical example of modern lead failure, with one study reporting 87% survival of Fidelis leads at 4 years compared to 98.7% survival of Medtronic’s Quattro Secure (Quattro) leads, 5 resulting in inappropriate shocks that may lead to increased morbidity and mortality. 6–8 The inade- quacy of current postmarket approval device surveillance is highlighted by the fact that more than 172,000 Fidelis leads were implanted in the United States alone before the Food and Drug Administration (FDA) issued a class I recall of the device. 9 In 2002, St Jude Medical introduced the Riata lead, an 8-F high-voltage lead, followed by the Riata ST silicone lead, a smaller caliber 7-F high-voltage lead. Although initial concerns with this family of leads were mainly lim- ited to perforation risk, particularly with Riata ST This study was funded by the VA’s Health Services Research and Development Service Research Grant IIR 04-046 (to Dr Massie). Dr Lee received moderate consulting fees and honorarium from Biotronik and moderate research funding from Medtronic. Address reprint requests and correspondence: Dr Edmund Keung, MD, Division of Cardiology, San Francisco VA Medical Center, 4150 Clement Str, San Francisco, CA 94121. E-mail address: edmund.keung@ucsf.edu. 1547-5271/$ -see front matter. Published by Elsevier Inc. on behalf of the Heart Rhythm Society. http://dx.doi.org/10.1016/j.hrthm.2012.08.006