First-in-human study of a leadless pacemaker system for left bundle branch area pacing.

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Devices

Background:

• Leadless pacemakers (LPs) currently cannot perform left bundle branch area pacing (LBBAP).
• LBBAP is a promising pacing strategy for certain cardiac conditions.

Purpose of the Study:

• To evaluate the safety and performance of a novel helix-based LP with an extended electrode for LBBAP (LP_CSP).
• This was a first-in-human acute feasibility study.

Main Methods:

• The LP_CSP was temporarily deployed in patients undergoing LP implantation via the right internal jugular vein.
• Implantation into the interventricular septum (IVS) was guided by fluoroscopy and intracardiac echocardiography.
• Primary endpoints included freedom from serious adverse events and intraprocedural electrical parameters.

Main Results:

• The LP_CSP was successfully implanted in 10 out of 14 patients.
• Acceptable pacing thresholds, R-wave amplitudes, and impedance were recorded.
• Left bundle branch area pacing (LBBAP) capture was achieved in 5 patients, with others showing deep septal pacing.

Conclusions:

• The novel LP_CSP demonstrated acute successful implantation.
• The device showed clinically acceptable intraprocedural electrical performance and safety.
• This study supports the feasibility of using this device for LBBAP.