Arrhythmias & electrophysiology
Performance of an active fixation stylet-driven lead in left bundle branch area pacing: Results from INSIGHT-LBBA
Authors' conclusion
In this study of an active fixation, stylet-driven lead, all prespecified performance goals for pacing, sensing, and LRC rates were met when used for LBBAP. External validation demonstrated concordant results.
Study context
- Population
- Single- or dual-chamber pacemaker patients undergoing left bundle branch area pacing (LBBAP) implant attempts with INGEVITY+ leads at 8 US sitessingle- or dual-chamber pacemaker patients from 8 US sites, 864 LBBAP implants in the external validation cohort · external validation cohort (LBBAP implants) 864
- Participants
- 1,122 participants
- Exposure
- INSIGHT-LBBA registry vs LATITUDE external validation cohort
- INSIGHT-LBBA registryn = 1,122
- LATITUDE external validation cohortn = 864
- Outcome
- Left bundle or left septal capture
Methodological detailsconsecutive LBBAP implant attempts, Data were retrospectively collected with standardized entry via REDCap, External validation on a separate cohort from the LATITUDE remote monitoring database
- Consecutive LBBAP implant attempts
- Data were retrospectively collected with standardized entry via REDCap
- External validation on a separate cohort from the LATITUDE remote monitoring database
Main finding
As reported in the abstract
Patients (1073 of 1122)
95.6%
Leads (1073 of 1197, 1.07 leads per patient)
89.6%
Observational data: associations, not effects.
Further findings
LRC-free rate (prespecified safety endpoint; performance goal >90% at 3 months) · 3 months; 24 months
- 3-month LRC-free rate (LCL 96.6%)
- 97.7%
- LRC-free rate at 24 months
- 97.2%
Effectiveness: PCT ≤2 V and sensed amplitudes ≥ 5 mV (3-month performance goal = 80%)
- PCTs ≤2 V (LCL 97.7%)
- 98.8%
- Sensed amplitudes ≥ 5 mV (LCL 92.7%)
- 94.8%
- Results were stable through 24 months
External validation of lead effectiveness
- Lead effectiveness was clinically indistinguishable across datasets
Follow-up
- Median follow-up of those successfully implanted
- 302 days
Original publication
Performance of an active fixation stylet-driven lead in left bundle branch area pacing: Results from INSIGHT-LBBA. Heart Rhythm. Published 4 February 2025. doi:10. 1016/ j. hrthm. 2025. 01. 041
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