INTRODUCTION: St. Jude Riata/Riata ST defibrillator leads were recalled by the FDA in 2011 for an increased rate of failure. More than 227,000 leads were implanted and at least 79,000 @entity1 still have active Riata leads. Studies have examined clinical predictors of @entity177 in Riata leads, but none have addressed the effect of @entity1479 generator exchange on @entity177 . The purpose of this study is to assess the effect of @entity1479 generator exchange on the rate of electrical failure in the Riata lead at 1 year. METHODS: A retrospective chart review was conducted in @entity1 who underwent implantation of a Riata/Riata ST lead at one center. @entity1 with a functioning Riata lead (with/with externalized conductor) at the time of @entity1479 exchange were compared to controls with Riata leads implanted for a comparable amount of time who did not undergo generator replacement. RESULTS: Riata leads were implanted in 1,042 @entity1 prior to the recall and153 of these @entity1 underwent generator exchange without lead replacement. Conductor externalization was noted in 21.5% of Riata leads in the @entity1479 exchange cohort, which was not different from the control group, 19.2% (p = 0.32). Two leads failed in the first year after generator replacement (1.5%) which did not significantly differ from the control group (2.0%), (p = 0.57). At change-out 54% received a commanded shock (18.6    0.9 J) that did not result in any change in the high voltage lead impedance (46.1    1.1 ohms). CONCLUSIONS: Conductor externalization was seen frequently in our cohort of @entity1 . @entity1479 generator exchange did not accelerate the rate of Riata @entity177 at 1 year. Although, both the control and the change-out cohorts failed at a rate much greater than nonrecalled leads, generator exchange did not appear to add to the problem. This article is protected by copyright. All rights reserved.

Pulse generator exchange does not accelerate the rate of electrical failure in a recalled small caliber XXXX lead.

@entity1 :: ('9606', 'Species') :: ['patients', 'Patients'] @entity177 :: ('MESH:D051437', 'Disease') :: ['lead failure'] @entity1479 :: ('OMIM:252500', 'Disease') :: ['ICD']
@entity1479 :: (OMIM:252500,Disease) :: ['ICD']
