Safety and performance of a novel defibrillation lead for left bundle branch area placement: Primary results of the LEADR LBBAP clinical trial.
Pugazhendhi Vijayaraman, Xingbin Liu, Russell Denman et al.
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In 30 seconds
The multicentre LEADR LBBAP clinical trial evaluated defibrillation efficacy and safety of the OmniaSecure defibrillation lead when used for left bundle branch area pacing in patients undergoing de novo ICD or CRT-D implantation. Of 307 patients with an implant attempt, 293 (95.4%) were implanted per protocol. The primary efficacy objective was met: 100% of patients were defibrillated to protocol. Freedom from lead-related major complications at 3 months was 97.9% (95% confidence interval 95.8-100), with stable electrical parameters over short-term follow-up.
Key findings
- Per-protocol implantation was successful in 293 of 307 patients (95.4%).
- The primary efficacy objective was met, with 100% of patients defibrillated to protocol.
- Freedom from OmniaSecure lead-related major complications at 3 months was 97.9% (95% confidence interval 95.8-100).
- There were zero study lead fractures and no oversensing adverse events; electrical parameters remained stable through 2.6 ± 2.5 months' follow-up.
Why it matters
Defibrillation leads used for LBBAP must provide effective defibrillation while maintaining acceptable lead performance and safety. These trial results support the feasibility of the OmniaSecure lead for this purpose in patients receiving an ICD or CRT-D, while providing short-term evidence on implant success, defibrillation efficacy, and lead-related complications.
What to keep in mind
Safety follow-up was short, with the primary safety endpoint assessed at 3 months; electrical parameters were reported through 2.6 ± 2.5 months.