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 ∼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™ 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.