Implantation Success, Electrical Performance, and Safety of an Active Fixation Stylet-Driven Lead for LBBAP in Clinical Practice: A Multicenter Experience.

BACKGROUND

Left bundle branch area pacing (LBBAP) has emerged as a promising physiological pacing strategy. However, its feasibility and safety using conventional stylet-driven leads (SDL) such as INGEVITY+ remain under investigation.

OBJECTIVE

To evaluate the clinical performance, safety, and follow-up outcomes of LBBAP using the INGEVITY+ lead in a real-world electrophysiology setting.

METHODS

From 2021 to 2024, 207 consecutive patients underwent LBBAP implant attempts using the INGEVITY+ lead across 19 centers. Of these, 146 had bradycardia indications, and 61 had heart failure indications. A control group of 200 patients received standard right ventricular (RV) pacing with the same lead. Procedural outcomes, electrical parameters, complications, and mid-term lead performance were assessed.

RESULTS

LBBAP was successfully achieved in 201 (97%) cases. Procedural and fluoroscopy times were slightly longer for LBBAP than for RV pacing. Acute complications included one helix fracture, one atrioventricular block, and one septal perforation. During a median follow-up of 9 months, no lead fractures were reported; lead dislodgment occurred in three cases. Kaplan-Meier analysis showed no significant difference in time to first lead-related complication between the LBBAP and RV pacing groups (hazard ratio: 4.69, 95%CI: 0.63-34.90, p = 0.139). Electrical performance remained stable, with 98% of retained leads maintaining capture thresholds ≤ 2 V and 92% with sensed amplitudes ≥ 5 mV.

CONCLUSIONS

LBBAP using the INGEVITY + SDL is feasible and safe in clinical practice, with excellent implant success and stable mid-term electrical performance. These findings support its use as a viable conduction system pacing strategy.