Reliable AV synchrony
Fred M. Kusumoto, MD, Mayo Clinic, Jacksonville, Fla., lauded what seems to be the system’s “incredibly reliable AV synchrony in different conditions, albeit in a very controlled environment.”
Of interest will be whether its performance, including maintenance of AV synchrony, holds up in “a more long-term evaluation in the outpatient setting,” said Dr. Kusumoto, speaking as the invited discussant for Dr. Cantillon’s presentation.
Also missing or in short supply from the study, he observed, are insights about long-term efficacy and complications, battery longevity, effectiveness of its rate-responsive capability, and any effect on clinical outcomes.
Local body network
Of the study’s 300 patients (mean age 69 years; 38% female) at 55 sites in Canada, Europe, and the United States, 63.3% had sinus-node dysfunction and 33.3% had AV block as their primary dual-chamber pacing indication; 298 were successfully implanted with both devices.
About 45% had a history of supraventricular arrhythmia, 4.3% had prior ventricular arrhythmia, and 20% had a history of arrhythmia ablation.
By 3 months, the group reported, the primary safety endpoint (freedom from device- or procedure-related serious adverse events) occurred in 90.3%, compared with the performance goal of 78% (P < .001).
The first of two primary performance endpoints (adequate atrial capture threshold and sensing amplitude by predefined criteria) was met in 90.2%, surpassing the 82.5% performance goal (P < .001).
The second primary performance goal (at least 70% AV synchrony with the patient sitting) was seen in 97.3% against the performance goal of 83% (P < .001).
What shouldn’t be “glossed over” from the study, Dr. Kusumoto offered, is that it’s possible to achieve a wireless connection “between two devices that are actually intracardiac.” That raises the prospect of a “local body network” that could be “expanded even more dramatically with other types of devices. I mean, think of the paradigm shift.”
The AVEIR DR i2i trial was funded by Abbott. Dr. Cantillon discloses receiving honoraria or fees for speaking or consulting from Abbott Laboratories, Boston Scientific, Biosense Webster, and Shockwave Medical, as well as holding royalty rights with AirStrip. Dr. Piccini has disclosed relationships with Abbott, Medtronic, Biotronik, Boston Scientific, and other drug and medical device companies. Dr. Kusumoto reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.