Arrhythmias & electrophysiology

Performance of an active fixation stylet-driven lead in left bundle branch area pacing: Results from INSIGHT-LBBA

Heart RhythmPublished multicenter INSIGHT-LBBA registry

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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