January 10, 2026Journal of Cardiovascular Electrophysiology0 citations

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

ASAmato SantoroUniversity of Siena MZMatteo ZiacchiElectrophysiology RCRaimondo CalvaneseElectrophysiology

Key Result

LBBAP using the INGEVITY+ lead was successfully achieved in 97% of cases, with no lead fractures and stable electrical performance during 9 months follow-up.

Key Points

To assess the clinical performance, safety, and follow-up outcomes of LBBAP with the INGEVITY+ lead.
207 patients underwent LBBAP implant attempts with the INGEVITY+ lead across 19 centers.
146 patients had bradycardia and 61 had heart failure indications.
A control group of 200 patients received standard right ventricular pacing.
Procedural outcomes and complications were analyzed during a median follow-up of 9 months.
LBBAP successfully achieved in 201 cases (97%).
Acute complications included one lead fracture, one block, and one perforation.
Lead dislodgment occurred in three cases with no fractures reported during follow-up.
Electrical parameters showed 98% of retained leads maintained thresholds ≤ 2 V.

Structured PICO

Does left bundle branch area pacing using an active fixation stylet-driven lead provide comparable safety and electrical performance to standard right ventricular pacing?

Population

407 patients requiring pacing (207 undergoing LBBAP attempts [146 with bradycardia indications, 61 with heart failure indications] and 200 receiving standard RV pacing) across 19 centers.

Intervention

Left bundle branch area pacing (LBBAP) using an active fixation stylet-driven lead (INGEVITY+).

Comparator

Standard right ventricular (RV) pacing using the same active fixation stylet-driven lead.

Outcome

Procedural outcomes (implant success), electrical parameters, complications, and mid-term lead performance.safety

Left bundle branch area pacing using a conventional stylet-driven lead is highly successful (97%) and demonstrates comparable mid-term safety and electrical stability to standard right ventricular pacing.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

ABSTRACT 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.

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