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Heart Rhythm. 2012 Dec;9(12):1954-61. doi: 10.1016/j.hrthm.2012.08.006. Epub 2012 Aug 4.

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

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1
Department of Medicine, Division of Cardiology, Electrophysiology Section, University of California, San Francisco, California, USA.

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 Probabilities 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 Quattro (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 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.

PMID:
22871583
DOI:
10.1016/j.hrthm.2012.08.006
[Indexed for MEDLINE]
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