Arrhythmias & electrophysiologyResearch article
Safety, efficacy, and functional outcomes using a novel small-diameter defibrillation lead for left bundle branch area pacing: Final results of the LEADR left bundle branch area pacing (LBBAP) clinical trial
- clinical trial
Authors' conclusion
The final study results of the lead evaluation for defibrillation and reliability in left bundle branch area pacing (LEADR LBBAP) clinical trial demonstrate continued stable electrical performance, a low rate of lumenless defibrillation lead-related major complications, and the benefit of LOT-CRT when a lumenless defibrillation lead is implanted for LBBAP.
Study context
- Population
- Patients with a de novo indication for an implantable cardioverter-defibrillator or CRT-D undergoing LBBAP with the OmniaSecure defibrillation leadpatients with an LBBAP implantation attempt · LBBAP-optimized CRT (LOT-CRT) 143
- Participants
- 316 patients
Main finding
As reported in the abstract
- Remained stable
Further findings
Freedom from study lead-related major complications · 6 and 12 months
- 6 months
- 97.7%
- 12 months
- 96.8%
Appropriate therapy (shock or antitachycardia pacing) · 1 year
- Patients receiving appropriate therapy
- 7.9%
Inappropriate shock rate · 1 year
- Inappropriate shock rate
- 2.1%
Paced QRS duration (QRSd) vs intrinsic QRSd (LOT-CRT patients) · 6 months
- Significant reduction in paced QRSd compared with intrinsic QRSd
- P < 0.001
Left ventricular ejection fraction (LOT-CRT patients) · baseline to 6 months
- Improved
- P < 0.001
Indexed left ventricular end-systolic volume (LOT-CRT patients) · baseline to 6 months
- Reduced
- P < 0.001
Quality of life (LOT-CRT patients) · baseline to 6 months
- Kansas City Cardiomyopathy Questionnaire improved
- P < 0.001
- Clinical composite score: improved or stabilized
- 85%
Original publication
Summarised from the published abstract; every number is checked against it