Midterm results of the LEADR trial confirm ongoing safety, efficacy, and reliability of the novel, small-diameter OmniaSecure defibrillation lead

Abstract Introduction Defibrillation leads remain the weak point of implantable cardioverter-defibrillators due to potential lead failure that may result in adverse patient outcomes. Thus, modern defibrillation leads that are safe, efficacious, and reliable are needed. The Lead EvaluAtion for Defibrillation and Reliability (LEADR) trial evaluated the novel, lumenless, catheter-delivered, small-diameter (4.7Fr), OmniaSecure defibrillation lead designed for reliability and targeted placement, based on the established SelectSecure SureScan MRI Model 3830 pacing lead. The trial exceeded primary safety and efficacy objective performance goals, demonstrating favorable safety and efficacy profile as well as zero lead fractures through ~1 year follow-up; patients remain in follow-up. Purpose To report ongoing safety, efficacy, and reliability of the OmniaSecure defibrillation lead based on midterm LEADR trial results. Methods This pivotal trial enrolled patients with guideline-directed indications for de novo primary or secondary prevention ICD/CRT-D. Safety is assessed through freedom from RV-lead related major complications via Kaplan-Meier, efficacy is assessed as ambulatory therapy efficacy (shock and ATP) during all available device data follow-up, and reliability is assessed through electricals and fracture-free performance of the OmniaSecure lead. The rates of appropriate and inappropriate therapy were also determined via Kaplan-Meier. Results In total, 643/657 patients were successfully implanted with the OmniaSecure defibrillation lead in the standard RV location (26% female; 61.9 ± 12.9 years); midterm follow-up time of 18.2 ± 5.5 months. Freedom from RV-lead related major complications was 97.1% at 12 months and 96.9% at 24 months (Figure 1); presently there has been 1 RV-lead related major complication after 12 months. Among the 670 spontaneous episodes that received appropriate therapy, there was a 96.2% (127/132) successful shock termination/slowing of rhythm by shock to be ATP terminated with the remainder self-terminated or in context of storm or other patient factors. ATP efficacy was 76.5% (485/634 episodes), with ATP preventing shock in 59 patients. Appropriate therapy was delivered in 10.7% of patients by 12 months and 17.6% by 24 months. The inappropriate shock rate was 2.7% at 12 months and 3.8% at 24 months. There have been zero fractures of the OmniaSecure lead through follow-up (17.8±6.0 mo.). Electricals (R-wave amplitude, pacing capture threshold, and pacing impedance) are within expected ranges and stable throughout. There have been no reports of adverse events related to the RV lead associated with tricuspid valve regurgitation. Conclusion(s) The LEADR trial demonstrates ongoing safety, efficacy, and reliability of the novel, small-diameter OmniaSecure lead, with low complication rates, high ambulatory efficacy, and reliable performance.OmniaSecure lead safety through 24 mo.