Abstract 18506: Management and Outcomes of Recalled Medtronic Sprint Fidelis and St Jude Riata ICD Leads at the Time of Generator Change or Lead Revision Surgery

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Abstract

Introduction: Management options for recalled ICD leads include lead extraction with replacement, lead abandonment with replacement or continued use of the functional lead at time of generator change. Whether one option has better long-term outcomes compared to the others is unclear.

Hypothesis: In a multicenter study, we evaluated how recalled leads were managed at the time of generator replacement and the incidence of periprocedural and long term outcomes associated with each management strategy.

Methods: We retrospectively analyzed patients who had recalled Medtronic Sprint Fidelis and St. Jude Riata ICD leads who underwent generator exchange or lead revision at two academic centers. Patients were divided into 3 groups: Lead extraction (LE) group where recalled lead was extracted (n=14), lead abandonment (LA) group where recalled lead was capped & new ICD lead placed (n=31) & lead unchanged group (LU) where recalled lead continued to be used (n=73). Baseline characteristics, periprocedural complications & 1 year outcomes (survival, cardiac hospitalizations & ICD shocks) were compared between groups.

Results: Baseline characteristics (at time of intervention) are shown in Table 1. The proportion of Fidelis and Riata leads were comparable across groups. Mean duration (years) from ICD implant to intervention was shorter in the LE group (3.2±2 vs 6.1±2 vs 6±2, in LE, LA and LU groups, p<0.001) whereas the LA group had more ICD shocks at baseline (p<0.01). Periprocedural complications did not differ between LE (7.1%), LA (3.2%) and LU (1.4%) groups (p=0.4). At 1 year follow-up, the LE, LA, and LU groups had similar survival as well as incidences of appropriate and inappropriate ICD shocks and cardiac hospitalizations (Table 2).

Conclusions: In patients with recalled Sprint Fidelis and Riata ICD leads, lead abandonment as well as continuing to use a functioning lead at generator change had similar periprocedural and long-term outcomes as lead-extraction.

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