Performance of an Active Fixation Stylet-Driven Lead in Left Bundle Branch Area Pacing: Results from INSIGHT-LBBA

BackgroundLeft bundle branch area pacing (LBBAP) has been rapidly adopted despite a lack of leads with approved indications for LBBAP.ObjectiveTo study the performance of a 6Fr active fixation, stylet-driven lead in LBBAP.MethodsThe multicenter INSIGHT-LBBA registry analyzed consecutive LBBAP implant attempts with INGEVITY+ leads. Data was retrospectively collected with standardized entry via REDCap. Pre-specified safety (Lead-Related Complication [LRC]-free rate with performance goal >90% at 3-months) and effectiveness (Pacing Capture Threshold [PCT]≤[email protected] and R-waves ≥5mV; 3-month performance goal=80%) endpoints were analyzed. External validation of lead effectiveness was performed on a separate cohort of LBBAP patients from the LATITUDE remote monitoring database.ResultsThe study enrolled 1122 single or dual chamber pacemaker patients from 8 US sites (mean age 76±10 years, 43% female, 48% AV block, 40% sinus node dysfunction). Those successfully implanted had a median follow-up of 302 days. Left bundle or left septal capture was achieved in 95.6% of patients (1073/1122) and 89.6% of leads(1073/1197, 1.07 leads per patient).The 3-month LRC-free rate was 97.7%(lower confidence limit [LCL] 96.6%) with an LRC-free rate of 97.2% at 24-months. At 3-months, 98.8%(LCL 97.7%) of PCTs were ≤2V and 94.8%(LCL 92.7%) of sensed amplitudes were ≥5mV. Results were stable through 24-months. 864 LBBAP implants were analyzed in the external validation cohort and lead effectiveness was clinically indistinguishable across datasets.ConclusionsIn this study of an active fixation, stylet-driven lead, all pre-specified performance goals for pacing, sensing, and LRC rates were met, when used for LBBAP. External validation demonstrated concordant results.Graphical abstract