Surgery Cardiology and CTVS Medicine

Dual-Chamber Leadless Pacemaker Shown To Be Safe And Effective In Aveir DR I2i Study

• byDoctor News Daily Team
• 18 February, 2025
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USA: A dual-chamber leadless pacemaker system turned in very promising short-term results in patients with standard indications for dual-chamber pacing, Aveir DR i2i Study has shown. The findings were featured in the New England Journal of Medicine on May 20, 2023.
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.
The study showed the following findings:
Among the 300 patients enrolled, 190 had sinus-node dysfunction, and 100 had atrioventricular block as the primary pacing indication.
The implantation procedure was successful (i.e., two functioning leadless pacemakers were implanted and had established implant-to-implant communication) in 98.3% of the patients.
A total of 35 device- or procedure-related serious adverse events occurred in 29 patients.
The primary safety endpoint was met in 271 patients, which exceeded the performance goal of 78%.
The first primary performance endpoint was met in 90.2% of the patients, which exceeded the performance goal of 82.5%.
The mean atrial capture threshold was 0.82 V, and the mean P-wave amplitude was 3.58±1.88 mV. None of the 21 patients (7%) with a P-wave amplitude of less than 1.0 mV required device revision for inadequate sensing.
At least 70% atrioventricular synchrony was achieved in 97.3% of the patients, which exceeded the performance goal of 83%.
"The dual-chamber leadless pacemaker system met the primary safety endpoint and provided atrial pacing and reliable atrioventricular synchrony for three months after implantation," the researchers concluded.
Reference:
The study, "A Dual-Chamber Leadless Pacemaker," was published in the New England Journal of Medicine.