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Exploring AAI Pacing - Initial Real-World Data on AVEIR™ AR Atrial Leadless Pacemaker

Abbott Cardiac Rhythm Management | January 17, 2025

In the ongoing discussion about pacing modes for patients with sick sinus syndrome (SSS), studies have suggested that AAI pacing offers significant advantages over other pacing methods. Data from several studies demonstrated that compared to DDD, AAI pacing significantly lowered heart failure related hospitalization, significantly lowered atrial fibrillation (AF), decreased mortality, and decreased risk of any cardiovascular disease in SSS patients.^1-4 The introduction of atrial leadless pacemakers, like the AVEIR™ AR Atrial Leadless Pacemaker (LP), has further revolutionized the field by reducing the lead-related complications typically associated with transvenous pacemakers (TVs).^5-7

Currently, the AVEIR AR LP is the only commercially available atrial leadless pacemaker. The early real-world clinical experience with the AVEIR AR LP was recently presented at APHRS 2024 that showed promising results⁸:

• Successful Implantation: A study of 42 patients across three centers showed a 100% implant success rate with no acute complications or perforations. The total procedure duration was less than 30 minutes for 75% of the patients.
• Improved Electrical Performance: The pacing capture thresholds and sensed P-wave amplitudes significantly improved from the time of release to patient discharge, and the impedance remained stable. By the time of patient discharge the capture threshold was 0.6+0.3 V, sensed amplitude was 3.1+1.5 mV, and the impedance was 331+49 Ω indicating stable device functionality.
• Risk Reduction: The AVEIR AR LP's pre-fixation mapping feature avoided repositioning in 83% of patients, reducing the risk of complications like pericardial bleeding, perforations, and other vascular complications.

The combination of leadless pacemaker technology and AAI pacing offers a minimally invasive solution for SND patients by eliminating lead-related complications. The AVEIR AR Atrial leadless pacemakers provide an effective option for these patients, preserving natural heart function and reducing unnecessary ventricular pacing. By improving patient comfort and reducing the risk of infections, the AVEIR AR LP is paving the way for the future of pacing therapy in sinus node dysfunction management.

For more information about AVEIR AR LP and to explore the latest data, visit our AVEIR AR LP page and discover how this leadless pacing solution can benefit your patients.

References

1. Fored CM, Granath F, Gadler F, et al. Atrial vs. dual-chamber cardiac pacing in sinus node disease: a register-based cohort study. Europace. 2008;10(7):825-831. doi:10.1093/europace/eun118
2. Kim WH, Joung B, Shim J, et al. Long-term outcome of single-chamber atrial pacing compared with dual-chamber pacing in patients with sinus-node dysfunction and intact atrioventricular node conduction. Yonsei Med J. 2010;51(6):832-837. doi:10.3349/ymj.2010.51.6.832
3. Masumoto H, Ueda Y, Kato R, et al. Long-term clinical performance of AAI pacing in patients with sick sinus syndrome: a comparison with dual-chamber pacing. Europace. 2004;6(5):444-450. doi:10.1016/j.eupc.2004.05.003
4. Albertsen AE, Nielsen JC. Selecting the appropriate pacing mode for patients with sick sinus syndrome: evidence from randomized clinical trials. Card Electrophysiol Rev. 2003;7(4):406-410. doi:10.1023/B:CEPR.0000023156.58418.2a
5. Oliveira, VMR, et al. The Effectiveness and Safety of Leadless Pacemakers: An Updated Meta-Analysis. Current Cardiology Reports. 2024;26(8):789–799. https://doi.org/10.1007/s11886-024-02079-6
6. Gangannapalle M, Monday O, Rawat A, et al. Comparison of Safety of Leadless Pacemakers and Transvenous Pacemakers: A Meta-Analysis. Cureus. 2023;15(9):e45086. https://doi.org/10.7759/cureus.45086
7. Shtembari J, Shrestha DB, Awal S, et al. Comparative assessment of safety with leadless pacemakers compared to transvenous pacemakers: a systemic review and meta-analysis. J Interv Card Electrophysiol. 2023;66(9):2165-2175. doi:10.1007/s10840-023-01550-8
8. Nair DG, et al. Atrial helix-fixation leadless pacemaker: Initial real-world experience. Presented at: APHRS; September 26-29, 2024; Sydney, Australia.