Abbott (NYSE: ABT) published findings from the AVEIR DR i2i study evaluating the company’s novel dual-chamber leadless pacemaker (LP) system.
The initial results from the study looked at right atrial and right ventricular LPs delivering atrioventricular synchronous pacing. Abbott aimed to look at procedural outcomes and the learning curve for de novo implantation of the dual-chamber LP.
Findings were published in Heart Rhythm Journal.
Aveir DR, the world’s first dual-chamber leadless pacemaker, treats people with abnormal or slow heart rhythms. It enables a beat-to-beat, wireless communication channel between two leadless pacemakers. One paces the right ventricle (Aveir VR) and the other paces the right atrium (Aveir AR). Each device comes in at roughly one-tenth the size of a traditional pacemaker — smaller than a AAA battery.
The system delivers electrical impulses directly to the heart muscle, restoring the normal heart rhythm. Unlike traditional pacemakers, the leadless devices go directly into the heart through a minimally invasive, catheter-based procedure. This eliminates the need for cardiac leads and a pulse generator under the skin.
Using Abbott’s proprietary i2i (implant-to-implant) technology, the system provides synchronized pacing on every heartbeat based on a person’s clinical needs. i2i technology uses high-frequency pulses to relay messages via the naturally conductive characteristics of the body’s blood between the paired, co-implanted devices. This requires less battery current than inductive, radiofrequency or Bluetooth communication.
Abbott announced in July 2023 that it received FDA approval for the dual-chamber pacemaker system. The company completed the first U.S. commercial cases with Aveir DR in November 2023.
A look at the outcomes from the Abbott AVEIR DR i2i study
Investigators analyzed implant procedure metrics during the study, including procedural complications within 30 days of implantation.
De novo dual-chamber LP implantations by 126 physicians proved successful in 446 of 452 (99%) of patients. Mean procedural duration metrics included 90±37 minutes of introducer sheath insertion-to-removal time, 74±32 minutes of dual-chamber procedure duration, 26±17 minutes of right ventricular LP procedure duration, 42±24 minutes of right atrial LP procedure duration, and 20±13 minutes of fluoroscopy duration.
According to the study abstract, investigators saw reductions of 19%-36% in duration metrics between initial and advanced implant experience. The study had 62 procedural complications take place in 50 of 452 patients (11.1%). These complications predominantly involved cardiac arrhythmias.
Freedom from complications significantly improved (89% to 98%) when comparing initial and advanced implant experience.
The Abbott study concluded that advanced implant experience was accompanied by improvements in procedural outcomes including reduced procedural times (introducer sheath insertion to removal, dual-chamber procedure, ventricular LP and atrial LP procedures, and fluoroscopy) and improved freedom from complications.
