Safety, efficacy and functional outcomes using a novel, small-diameter defibrillation lead for left bundle branch area pacing: Final results of the LEADR LBBAP clinical trial

BACKGROUND: Therapeutic delivery with left bundle branch area pacing (LBBAP) has continued to grow. However, limited data exists with LBBAP in de novo ICD or CRT-D indicated patients. OBJECTIVE: The aim of this analysis was to assess longer-term outcomes with the OmniaSecure defibrillation lead for LBBAP in ICD and CRT-D indicated patients. METHODS: The Kaplan-Meier method was used to determine the study lead-related major complication and appropriate therapy delivery rates up to 12-months post-implant. Electrical performance was summarized. QRSd, LVEF, LVESVi and quality of life were characterized in LOT-CRT patients at baseline and 6 months. RESULTS: A total of 316 patients had a LBBAP implant attempt (age: 64.9±12.2 years; 29.1% female). Pacing capture threshold, impedance and R-wave amplitude remained stable (follow-up: 9.9±4.0 months). The freedom from study lead-related major complications at 6 and 12 months were 97.7% and 96.8%, respectively. At 1 year, 7.9% of patients received appropriate therapy (shock or ATP) and the inappropriate shock rate was 2.1%. For LOT-CRT patients (n=143), there was a significant reduction in paced QRSd at 6 months compared to intrinsic (p<0.001), improved LVEF from baseline to 6 months (p<0.001) and reduced LVESVi from baseline to 6 months (p<0.001). Additionally, QoL improved from baseline to 6 months (KCCQ: p<0.001; CCS: 85% improved or stabilized). CONCLUSIONS: The final study results of the LEADR LBBAP clinical trial demonstrate a continued stable electrical performance, low rate of lumenless defibrillation lead-related major complications, and LOT-CRT therapy benefit when a lumenless defibrillation lead is implanted for LBBAP. CLINICAL TRIAL REGISTRATION NUMBER: NCT04863664.