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Multicenter Study
. 2025 Mar 28;27(4):euaf062.
doi: 10.1093/europace/euaf062.

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

Prashanthan Sanders  1 , Pamela K Mason  2 , Bert Hansky  3 , Paolo De Filippo  4 , Maully J Shah  5 , Darius P Sholevar  6 , John S Zakaib  7 , Francois Philippon  8 , Bernice Tsang  9 , Rajeev K Pathak  10 , Travis D Richardson  11 , Meir Friedman  12 , Robert D Schaller  13 , Ignasi Anguera  14 , Attila Mihalcz  15 , Babak Bozorgnia  16 , Amy E Thompson  17 , Katherin Arias  17 , Baerbel Maus  18 , Chad Bounds  17 , George H Crossley  11
Affiliations
Multicenter Study

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

Prashanthan Sanders et al. Europace. .

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.

Keywords: Anti-tachycardia pacing; Implantable cardioverter-defibrillator; Inappropriate shocks; Lumenless leads; P-wave oversensing.

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Conflict of interest statement

Conflict of interest: P.S.: reports having served on the advisory boards of Medtronic, Abbott, Boston Scientific, PaceMate, and CathRx; the University of Adelaide has received on his behalf lecture and/or consulting fees from Medtronic, Abbott, and Boston Scientific; and the University of Adelaide has received on his behalf research funding from Medtronic, Abbott, Boston Scientific, and Becton-Dickson. P.K.M.: consultant for Medtronic, Boston Scientific, and Cook as well as honoraria from Medtronic and Cook. B.H.: reports funding from Medtronic and CVRx. P.D.F.: consultant fees and travel support from Medtronic, Boston Scientific, Abbott, and Biotronik as well as honoraria and advisory board participation for Medtronic and Abbott. M.J.S.: consultant for Medtronic and Tenaya Therapeutics. D.P.S.: institutional funding from Medtronic. J.S.Z.: consultant for Medtronic. F.P.: speaker at Medtronic and Boston Scientific; consultant for Medtronic and Boston Scientific; research funding from Medtronic and Boston Scientific. B.T.: honorarium from Boston scientific. R.K.P.: reports that Canberra Heart Rhythm Foundation has received on his behalf lecture and/or consulting fees from Medtronic, Abbott Medical, Boston Scientific, and Biotronik. T.D.R.: consultant for Medtronic, Johnson and Johnson, and Philips; research funding from Medtronic and Abbott. M.F.: consultant for Medtronic. R.D.S: consultant for Medtronic as well as speaking honoraria. I.A.: consultant for Medtronic. A.M.: consultant fees and travel support from Medtronic, Boston Scientific, Abbott, Biotronik and Microport, advisory board participation for Medtronic and Boston. B.B.: consultant for Medtronic. A.E.T., K.A., B.M., and C.B.: employees of Medtronic, Inc. G.H.C.: speaker at Medtronic and Philips; consultant for Medtronic and Boston Scientific.

Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
Cross-sectional view of the OmniaSecure defibrillation lead, adapted from Crossley et al.
Figure 2
Figure 2
Kaplan-Meier estimated freedom from study lead-related major complications through 2 years post-implant.
Figure 3
Figure 3
Kaplan-Meier estimated incidence of first appropriate shock, ATP, or any therapy through 2 years. Values in Figure provide rates at 12 and 24 months.
Figure 4
Figure 4
Electrical measurements for pacing impedance, pacing capture threshold, and R-wave amplitude through 24 months. Mean ± standard deviation is presented for each visit. The values in the figure provide the mean while the errors bars represent the standard deviation.
See this image and copyright information in PMC

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