Sensing and detection performance of the novel, small-diameter omniasecure defibrillation lead: leadr trial analysis

Abstract Introduction The Lead EvaluAtion for Defibrillation and Reliability (LEADR) trial evaluated the small-diameter (4.7Fr), integrated bipolar OmniaSecure defibrillation lead. The trial exceeded primary safety and efficacy endpoint thresholds, demonstrating favorable performance and zero fractures through ~12 mo; patients remain in ongoing follow-up. Purpose To report on chronic electrical performance of the OmniaSecure lead through midterm follow-up of the LEADR trial. Methods Patients with indication for de novo ICD/CRT-D were implanted with the OmniaSecure lead in standard RV locations and followed at prespecified intervals along with CareLink. Results As reported, a total of 643 patients were implanted with the OmniaSecure lead; the lead continues to show favorable safety, efficacy, and reliability with zero fractures through midterm follow-up (18.2 ± 5.5 mo). Electrical measurements (Pacing capture threshold, pacing impedance, and R-wave amplitude) were chronically stable through follow-up; average R-wave amplitudes were >10mV throughout (Figure 1). Nineteen patients had reports of P-wave oversensing (PWOS), however there were zero inappropriate shocks due to PWOS. Among those with associated adverse events, 3 resulted in system modification and 1 in reprogramming. The remaining 15 patients had instances of PWOS noted by physicians via monitoring that were not associated with an adverse event; resolved via repositioning at implant (1) and reprogramming (14). Thirty-eight patients had reports of T-wave oversensing (TWOS). Among these, 1 patient had a system modification and 3 patients had reprogramming after inappropriate shock after which no further IAS was reported. The remaining 34 patients had instances of TWOS noted by physicians at device checks that were not associated with an adverse event; 1 resulted in unsuccessful implant and 1 had no action taken for lack of clinical concern, the others were resolved via repositioning at implant (1) and reprogramming (31). Additionally, 1 patient reported both TWOS and PWOS; both resolved via reprogramming with no further reports of TWOS/PWOS. During induced VF sensing at implant, 98% (119/122) of patients showed appropriate detection at the least sensitive setting (1.2mV) and the remaining were successful at more sensitive settings. There were 670 ambulatory VT/VF episodes appropriately treated in 94 patients, all of which were successfully detected across a variety of programmed sensitivities (Table 1) with no reported undersensing. Conclusion Chronic sensing performance of the OmniaSecure defibrillation lead demonstrated R-wave stability with a low rate of PWOS and TWOS, predominantly resolved by reprogramming RV sensitivity. Furthermore, VT/VF detection was successful in all patients and was not impacted when reprogrammed to less sensitive settings. The OmniaSecure lead shows a robustness of sensing and detection performance and programmability.Figure 1:Chronic electrical stability o Table 1:Proportion of successfully trea