Abstract 14091: Outcomes of Patients With Recalled Defibrillator Leads: Results From the NCDR-ICD Registry

Abstract

Introduction: Whether to reuse, abandon, or extract functioning, recalled ICD leads at the time of generator replacement is an area of uncertainty as lead failure is more common following generator replacement, and long term failure rates of recalled ICD leads are unknown. We sought to evaluate outcomes following various lead management strategies at the time of generator replacement. Hypothesis: Functional St. Jude Riata and Medtronic Sprint Fidelis leads at the time of elective generator replacement are more frequently reused than replaced, and extracting them poses significant procedural risk. Methods: We queried the NCDR ICD Registry for Medicare patients undergoing elective generator replacement with a normal Fidelis or Riata lead from 2010-2016 and categorized patients based on the fate of the recalled lead: reused, abandoned, or extracted. We report pre-discharge complications by group. Results: There were 9937 generator replacement patients between 2010-2016 with a functioning Riata or Fidelis lead in which lead management was reported. The lead was reused in 9806 (98%) patients, extracted in 55 (0.6%), and abandoned in 76 (0.8%). Compared with the reused group, extracted patients were >10 years younger, had less heart failure and fewer comorbidities. In-hospital death occurred in 4 (7.3%) patients in the extracted group and 7 (0.07%) in the reused group (P<0.0001). The combination of death or any pre-discharge event occurred in 11% of extracted patients compared with 0.3% and 0% in the reused and abandoned groups, respectively.(Table) Conclusions: At the time of generator replacement, a small percentage of functional Riata and Fidelis leads were extracted. Even in this highly selected extraction population, extraction posed significant risk of in-hospital mortality and severe complications. Future work will help clarify whether these peri-procedural risks may be justified by improved medium and long term outcomes.