Dual-chamber leadless pacemaker shown to be safe and effective in Aveir DR i2i Study

The study revealed that the implantation procedure comprising two functioning leadless pacemakers that established implant-to-implant communication met the primary safety endpoint and provided atrial pacing and reliable atrioventricular synchrony for three months. The procedure was successful in 98.3% (n=295 of 300) of trial patients, researchers reported at the Heart Rhythm Society (HRS) meeting.

Previous studies have shown that single-chamber ventricular leadless pacemakers are not favourable for atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system comprising percutaneous implantation of two devices, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for many indications.

Daniel Cantillon, MD, of Masimo in Irvine, California, and colleagues conducted a multicenter, prospective, ingle-group study to assess the performance and safety of a dual-chamber leadless pacemaker system. Patients with a conventional indication for dual-chamber pacing were included. Freedom from complications (procedure or device-related serious adverse events) was determined at 90 days (primary safety endpoint). A combination of adequate atrial capture threshold and sensing amplitude at three months was the first primary performance endpoint. The second primary performance endpoint was at least 70% atrioventricular synchrony at three months while the patient sat.