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.
Implantation Success, Electrical Performance, and Safety of an Active Fixation Stylet-Driven Lead for LBBAP in Clinical Practice: A Multicenter Experience / Santoro, A.; Ziacchi, M.; Calvanese, R.; Rapacciuolo, A.; Volpicelli, M.; Poggio, L.; Nocerino, P.; Castagno, D.; Bianchi, V.; Magliano, P. L.; Dell'Era, G.; Mandurino, C.; Mirizzi, G.; Savarese, G.; Marinaccio, L.; La Greca, C.; Covino, G.; Zingarini, G.; Varalda, M.; Vitali, F.; Baiocchi, C.; Campari, M.; Valsecchi, S.; Bertini, M.. - In: JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. - ISSN 1045-3873. - (2025). [10.1111/jce.70237]
Implantation Success, Electrical Performance, and Safety of an Active Fixation Stylet-Driven Lead for LBBAP in Clinical Practice: A Multicenter Experience
Rapacciuolo A.;Nocerino P.;La Greca C.;Zingarini G.;
2025
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.


