Arrhythmias & electrophysiologySecondary analysis
Sensing and detection performance of the novel, small-diameter OmniaSecure defibrillation lead: in-depth analysis from the LEADR trial
- Secondary analysis of the LEADR trial
- single-group
- longer-term follow-up
- Mean follow-up 18.2 ± 5.5 months
Authors' 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.
Study context
- Population
- Patients with indications for de novo ICD/CRT-D643 (97.9%) successfully implanted
- Participants
- 657 patients
- Primary endpoint
- Sensing and detection performance of the OmniaSecure lead
Primary result
As reported in the abstract
- PWOS-related adverse event, none with inappropriate shock
- 4 patients (0.6%)
- TWOS-related adverse event
- 4 patients (0.6%)
- TWOS with inappropriate shock
- 3 patients (0.5%)
- Appropriate VF detection at implant at least sensitive setting of 1.2 mV
- 97.6% (120/123)
- VT/VF episodes appropriately detected and treated in follow-up, no under-detected episodes
- 670 episodes in 94 patients
Further findings
Freedom from major study lead-related complications · 24 months
- Freedom from major study lead-related complications at 24 months
- 96.9%
Appropriate therapies (shock and/or ATP) · 24 months
- Patients receiving appropriate therapies (shock and/or ATP) at 24 months
- 17.6%
- ATP efficacy
- 76.5%
Lead fractures
- Fractures during follow-up
- 0
VF detection at implant (least sensitive setting 1.2 mV)
- Appropriate VF episode detection at 1.2 mV
- 97.6% (120/123)
VT/VF detection in follow-up
- VT/VF episodes appropriately detected and treated in 94 patients; no under-detected episodes
- 670
Safety
Inappropriate shock · 12 and 24 months
- Inappropriate shock rate at 12 months
- 2.7%
- Inappropriate shock rate at 24 months
- 3.8%
P-wave oversensing (PWOS) adverse events
- Patients with AE related to PWOS; none associated with inappropriate shock
- 4 (0.6%)
T-wave oversensing (TWOS) adverse events
- Patients with AE related to TWOS
- 4 (0.6%)
- TWOS with inappropriate shock
- 3 (0.5%)
Original publication
Summarised from the published abstract; every number is checked against it