https://doi.org/10.1007/s00392-024-02526-y
1Universitätsklinikum Schleswig-Holstein Klinik für Rhythmologie Lübeck, Deutschland; 2Universitätsklinikum Schleswig-Holstein Med. Klinik II / Kardiologie, Elektrophysiologie Lübeck, Deutschland; 3Universitätsklinikum Schleswig-Holstein Medizinische Klinik II / Kardiologie, Angiologie, Intensivmedizin Lübeck, Deutschland
Background: Leadless pacemakers are promising alternatives to transvenous systems. The Micra leadless pacemaker, adopting a passive fixation mechanism, has already demonstrated excellent efficacy and safety as VVI and VDD system. The new AVEIR leadless pacemaker adopts an active fixation mechanism. It allows electrogram mapping prior to fixation, theoretically reducing the risk for repositioning, has excellent projected battery longevity data and will be available as a real dual chamber system.
Aim: The aim of this study was to evaluate the safety and performance of the new AVEIR single chamber leadless pacemaker in a real-word population in Germany after market release.
Methods: All consecutive patients undergoing de novo implantation of an AVEIR VR system were prospectively enrolled at a tertiary electrophysiology center between September 2023 and June 2024. Patient characteristics, acute procedural data, as well as safety and efficacy are reported.
Results: A total of eight patients (age 75.6 ±12.6 years, 62.5% male, ejection fraction 49 ± 6%) were implanted with an AVEIR VR. All implant attempts were successful. The primary pacing indication was atrial fibrillation with atrioventricular block (75.0%). Five patients were suffering from an infectious disease. Cardiac surgery was performed in n=4 patients. A prior cardiac electronic implantable device (dual chamber pacemaker) had been extracted in one patient during aortic valve surgery due to a suspicious infection. All procedures were performed in conscious sedation. Median procedure duration was 36 min (28.3; 48.8), median DAP was 407 min (258;661). Intraprocedural repositioning of the ventricular device was necessary in 5 patients with three of them requiring more than one repositioning of the device. Venous vascular closures systems and a Donati stich were used in all patients to close the puncture site of the 25-F venous introducer sheath. No minor or major acute periprocedural or postprocedural complications were observed. During short-term follow-up pacing thresholds for the AVEIR remained stable with a median pacing threshold (PCT) of 0.63 ± 0.3 V at 0.4 ms and impedances ranging from 370 to 860 Ohm.
Conclusion: Implantation of the new single chamber AVEIR VR leadless pacemaker is safe and effective with excellent short-term pacing thresholds. Long-term follow-up data are warranted.