Initial one-year outcomes from the Leadless ARRIVE real-world study, presented by Dr. Kent Nilsson of Piedmont Heart of Athens, Georgia, at the European Heart Rhythm Association (EHRA) meeting in Paris, highlighted the performance of the pacemaker system compared to transvenous pacemakers in patients with sinus node dysfunction (SND). Findings demonstrated that Aveir AR significantly reduces complications and reinterventions for these patients.
According to Abbott, the technology reduced both short- and long-term complications, as well as device-related reinterventions, compared to traditional transvenous pacemakers in SND patients without atrioventricular (AV) block.
Abbott says findings reinforce leadless atrial pacing as a safer, more effective alternative to transvenous pacing. The company already offers Aveir DR, a dual-chamber pacemaker, for treating abnormal heart rhythms. Aveir AR, one of the two devices in the dual-chamber system, paces the atrium by delivering electrical impulses directly to the heart muscle.
More about the Abbott study
The Leadless ARRIVE study, a retrospective observational study of Medicare fee-for-service beneficiaries, included 428 Aveir AR recipients, 39,881 dual-chamber transvenous (DCTV) pacemaker recipients and 389 right-atrial transvenous (RATV) pacemaker recipients.
Investigators say Aveir AR was associated with lower complication and reintervention rates compared with TV pacemakers. Both groups had comparable one-year mortality rates.
At one year, overall complications fell dramatically in the Aveir AR group (adjusted 3.6%). That compared to 8.5% in DCTV, representing a 60% reduction in risk. Aveir AR also showed fewer complications (adjusted 3.3%) than RATV (7.5%).
Device reinterventions, including revisions, removals or replacements, also came in lower for Aveir AR recipients. They had a 60% lower likelihood compared to DCTV and a 70% lower likelihood compared to RATV. Abbott attributes this reduction in large part to the avoidance of lead- and pocket-related issues inherent to transvenous systems.
Despite Aveir AR recipients having a higher comorbidity burden compared to DCTV recipients, one-year all-cause mortality rates proved comparable across all groups. Aveir AR came in at 9.7%, compared to 9.1% in DCTV and 11.9% in RATV.
Commentary from company officials and investigators
Dr. Nilsson, medical director of cardiac electrophysiology at Piedmont Athens, said:
“The number of sick sinus syndrome diagnoses and hospitalizations in the U.S. increases every year due to the aging population.The ARRIVE findings reinforce that Aveir AR significantly reduces complications and reinterventions, which can lead to fewer hospital visits and better outcomes.”
Dr. Leonard Ganz, chief medical officer for Cardiac Rhythm Management at Abbott, said:
“At Abbott, we’re driven to develop technology that addresses real-world issues that patients and their doctors face every day. With the Aveir AR atrial leadless pacemaker, we have been able to revolutionize the field by reducing the lead-related complications typically associated with transvenous pacemakers. The ARRIVE study further reinforces the advancement Aveir AR brings to physicians and patients with sinus node dysfunction by lowering the rate of chronic and device-related complications and requiring fewer device reinterventions than dual-chamber transvenous pacing, which is currently considered the standard of care.”
