The effectiveness of Abbott’s AVEIR™ VR Leadless Pacemaker (LP), which recently earned both FDA and CMS approval, was evaluated during a clinical study that proved both the safety and efficacy of this trailblazing device2.
The Leadless II IDE study evaluated the clinical safety and efficacy of the AVEIR VR LP in patients who were indicated for a VVI(R) – or ventricular demand pacing – pacemaker, which stimulates the heart only if the heart rate falls below a set level.
People who experience slower-than-normal heart rates may receive a pacemaker to restore a more normal heart rate.
What is different about leadless pacemakers is, unlike traditional pacemakers, they do not require an incision in the chest to implant the device or insulated wires – known as cardiac leads – to deliver energy to the heart. Instead, leadless pacemakers are implanted directly into the heart's right ventricle via a minimally invasive procedure, requiring no cardiac leads to deliver therapy.
Abbott’s AVEIR VR LP was designed with key improvements, including the use of standard transvenous pacemaker battery chemistry (lithium carbon-monofluoride) with high capacity (243 mAh) designed to offer up to twice the longevity of current VR leadless pacemakers based on ISO standard settings1,3**; a solid docking button that enables for chronic retrieval with a dedicated retrieval catheter; and new device electronics designed to be enabled by future software, upon regulatory approval, to support dual chamber pacing in the future. (The dual chamber pacing system is currently in clinical trial (ClinicalTrials.gov NCT #05252702) and limited to investigational use only.)
In the first in-human experience with AVEIR VR LP during the LEADLESS II–Phase 2 Investigational Device Exemption Study, the safety and efficacy of the AVEIR VR LP system in patients with standard VVI(R) pacing indications were evaluated.
The Leadless II IDE study was a global, prospective, non-randomized, multicenter study, approved by the Food and Drug Administration (FDA), in which all patients were followed for six weeks post-implant to evaluate potentially serious adverse device effects.
Data from the study evaluated AVEIR VR LP in patients with certain abnormal heart rhythms. The data shows that AVEIR met its pre-specified primary endpoints and suggests that the device offers benefits for patients who require the use of a pacemaker to treat slow heart rhythms.
During the study, efficacy was measured as both acceptable pacing capture threshold (≤ 2.0 V at 0.4 msec) and sensing amplitude (R wave ≥ 5.0 mV, or a value equal to or greater than the value at implantation).
The study enrolled 200 patients across 43 sites in the United States, Canada, and Europe between November 2020 and June 2021, with a mean follow-up of 3.92 ± 1.87 subject-months. The mean age at enrollment was 75.6 ± 11.3 years, and 62.5% of the participants were male.
Implant success was 98% (196 of 200) with 0 dislodgments. Of the successful implants, 83.2% (163 of 196) did not require repositioning, and 96.4 required 1 or less repositioning (189 of 196). The low repositioning rate was attributed to AVEIR VR LP’s electrical mapping capability prior to LP fixation.
The primary safety endpoint was freedom from serious adverse device effects (also referred to as complications) through six weeks of follow-up. An independent Clinical Events Committee adjudicated adverse events. The rates of safety and efficacy endpoints were compared with performance goals (on the basis of historical data) of 86% and 85%, respectively.
The primary safety end point was met in 190 of 198 evaluable participants (96.0%; 95% CI: 92.2%-98.2%).
The primary efficacy endpoint was met in 96% of evaluated participants when using a composite score of acceptable pacing thresholds (#2.0 V at 0.4 ms) and R-wave amplitudes ($5.0 mV or an equal or greater value at implantation) through six weeks of follow-up. Efficacy endpoint based on pacing thresholds only was 98.0% (184 of 196).
Find more specifics and information about the device and the study.
Reddy V, Exner D, Doshi R, et al. Primary Results on Safety and Efficacy From the LEADLESS II–Phase 2 Worldwide Clinical Trial. J Am Coll Cardiol EP. 2022 Jan, 8 (1) 115–117. https://doi.org/10.1016/j.jacep.2021.11.002
MAT-2211385 v4.0 | Item is approved for US use only