Powering Hearts
Beat to Beat

Conduction system pacing (CSP), including left bundle branch area pacing (LBBAP), is increasingly used to preserve coordinated ventricular activation. However, current CSP approaches rely on transvenous leads, exposing patients to risks related to lead durability and pocket-related infection.  A novel leadless pacemaker (AVEIR^™ CSP) designed for conduction system pacing offers the potential to combine physiologic pacing with the benefits of a completely leadless system. This first in‑human study evaluated the safety, feasibility, and short‑term performance of chronically implanted AVEIR CSP devices.

Patients with pacing indications received the AVEIR CSP system either as a standalone ventricular device or as part of a dual-chamber leadless system paired with an atrial device. The primary safety endpoint was complications at one month, with secondary assessment of electrical performance and capture type, including LBBAP, left ventricular septal pacing (LVSP), and deep septal pacing (DSP).

Of 20 enrolled patients, one was withdrawn due to challenging anatomy. Implantation was successful in 18 of 19 (95%) patients. At one month, electrical parameters remained within acceptable ranges (Figure 1). Capture at implant was classified as LBBP in 9 patients, LVSP in 5, and DSP in 4, with changes observed in 6 patients at follow-up. In dual-chamber systems, implant-to-implant communication remained stable through one month. The one month complication-free rate was 68.4%, with six patients experiencing adverse events, including internal jugular access hematoma, pericardial effusion, and device dislodgement or dislocation. 

Figure 1:

Overall, this first in‑human experience demonstrates that leadless conduction system pacing is feasible and can deliver acceptable short‑term electrical performance with functional dual-chamber communication. However, device fixation stability and consistency of conduction system capture requiring further refinement.