LEAP2: A first-in-human evaluation of a chronically implanted novel leadless pacemaker for conduction system pacing

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Devices

Background:

• Previous acute studies demonstrated the feasibility of leadless pacemaker (LP) for conduction system pacing (CSP) in the interventricular septum.
• The novel LP_CSP technology allows pacing of the deep interventricular septum (IVS).

Purpose of the Study:

• To evaluate the safety and efficacy of chronically implanted leadless pacemaker for conduction system pacing (LP_CSP).
• Assess electrical performance and capture types of LP_CSP at implant and 1-month follow-up.

Main Methods:

• Pacemaker-indicated patients received LP_CSP as a standalone ventricular device or dual-chamber system.
• Implantation was guided by fluoroscopy and intracardiac echocardiography via the right internal jugular vein.
• Safety endpoint was 1-month complication rate; electrical parameters and capture types were assessed.

Main Results:

• Successful LP_CSP implantation in 18 of 19 patients; 1-month complication-free rate was 68.4%.
• Acceptable electrical performance at 1 month: capture threshold 1.3±0.6 V, R-wave amplitude 13.1±4.0 mV, impedance 490±72 Ω.
• Capture types varied (LBBP, LVSP, DSP) with changes noted by 1 month; 3 dislodgements occurred.

Conclusions:

• First-in-human evaluation demonstrates feasibility of leadless conduction system pacing.
• Further improvements in LP_CSP stability and fixation mechanisms are required for clinical optimization.