Sensing and detection performance of the novel, small-diameter OmniaSecure defibrillation lead: in-depth analysis from the LEADR trial

Abstract

Aims The Lead EvaluAtion for Defibrillation and Reliability (LEADR) trial evaluated the small-diameter (4.7 Fr), integrated bipolar OmniaSecure defibrillation lead. As previously reported, the trial exceeded primary safety and efficacy objective thresholds, demonstrating favourable performance and zero fractures through similar to 12 months follow-up, with patients in ongoing follow-up. Longer-term follow-up of the LEADR trial with emphasis on the sensing and detection capabilities of the OmniaSecure lead is reported here.Methods and results Patients with indications for de novo implantable cardioverter-defibrillators/cardiac resynchronisation therapy defibrillators were implanted with the OmniaSecure lead in standard right ventricle (RV) locations and followed at pre-specified intervals along with CareLink (TM) remote monitoring transmissions, where available. Throughout follow-up, the lead was evaluated for safety, efficacy, and reliability along with sensing and detection performance. There were 643/657 (97.9%) patients successfully implanted with the OmniaSecure lead with mean follow-up of 18.2 +/- 5.5 months. There was a 96.9% freedom from major study lead-related complications at 24 months. Inappropriate shock rate was 2.7 and 3.8% at 12 and 24 months, respectively. At 24 months, 17.6% of patients received appropriate therapies (shock and/or ATP) with a 76.5% ATP efficacy. There have been zero fractures during follow-up along with chronically stable pacing capture threshold, pacing impedance, and R-wave amplitudes. There were four patients with an adverse event related to PWOS (0.6%), none of which was associated with inappropriate shock. There were four patients with an adverse event related to TWOS (0.6%), of which three patients were associated with inappropriate shock (0.5%). Oversensing was resolved predominantly by programming the RV sensitivity to less sensitive settings. During VF induction at implant, 97.6% (120/123) of patients showed appropriate VF episode detection at the least sensitive setting of 1.2 mV, with the remaining having detection at more sensitive settings. In follow-up, 670 VT/VF episodes were appropriately detected and treated in 94 patients with a variety of RV sensitivities and no reports of under-detected episodes. Moreover, a virtual sensitivity analysis also showed no under-detection across different RV sensitivity programming.Conclusion Chronic sensing performance of the OmniaSecure defibrillation lead demonstrated R-wave stability with a low rate of P-wave and T-wave oversensing, resolved predominantly by adjusting RV sensitivity. Further, VT/VF detection was successful and was not impacted when programmed to less sensitive settings. The OmniaSecure lead shows robust sensing and detection performance and programmability in ongoing follow-up.