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Single-chamber leadless pacemaker Aveir VR implantation: pioneer experience in Poland. Insights from a multicenter national registry: A preliminary report

Maciej Sterliński1, Krzysztof Boczar2, Andrzej Ząbek34, Michał Lewandowski5, Paweł Syska5, Andrzej Przybylski67, Janusz Romanek67, Artur Oręziak1, Joanna Zakrzewska-Koperska1, Przemysław Mitkowski8, Lidia Chmielewska-Michalak8, Marcin Michalak9, Marcin Grabowski9, Radosław Lenarczyk1011, Zbigniew Kalarus1011, Adam Sokal1213, Łukasz Szumowski1, Mariusz Gąsior14, Mateusz Tajstra14

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References

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  2. Glikson M, Nielsen J, Kronborg M, et al. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: Developed by the Task Force on cardiac pacing and cardiac resynchronization therapy of the European Society of Cardiology (ESC) With the special contribution of the European Heart Rhythm Association (EHRA). Revista Española de Cardiología (English Edition). 2022; 75(5): 430.
  3. Kempa M, Mitkowski P, Kowalski O, et al. Expert opinion of a Working Group on Leadless Pacing appointed by the National Consultant in Cardiology and the Board of the Heart Rhythm Section of the Polish Cardiac Society. Kardiol Pol. 2021; 79(5): 604–608.
  4. Aveir Leadless Pacing System – Aveir Leadless Pacemaker, Model LSP112V (Right Ventricular); Aveir Delivery Catheter, Model LSCD111; and Aveir Link Module, Module LSL02 – P150035. https://www.fda.gov/medical-devices/recentlyapproved-devices/aveir-leadless-pacing-system-aveir-leadlesspacemaker-model-lsp112v-right-ventricular-aveir-delivery (05.06.2024).
  5. Laczay B, Aguilera J, Cantillon DJ. Leadless cardiac ventricular pacing using helix fixation: Step-by-step guide to implantation. J Cardiovasc Electrophysiol. 2023; 34(3): 748–759.
  6. Leibowitz A, Oren-Grinberg A, Matyal R. Ultrasound guidance for central venous access: current evidence and clinical recommendations. J Intensive Care Med. 2020; 35(3): 303–321.
  7. Reddy VY, Exner DV, Cantillon DJ, et al. LEADLESS II Study Investigators. Percutaneous implantation of an entirely intracardiac leadless pacemaker. N Engl J Med. 2015; 373(12): 1125–1135.
  8. Lakkireddy D, Knops R, Atwater B, et al. A worldwide experience of the management of battery failures and chronic device retrieval of the Nanostim leadless pacemaker. Heart Rhythm. 2017; 14(12): 1756–1763.
  9. Reddy VY, Exner DV, Doshi R, et al. LEADLESS II Investigators. Primary results on safety and efficacy from the LEADLESS ii-phase 2 worldwide clinical trial. JACC Clin Electrophysiol. 2022; 8(1): 115–117.
  10. Tam MTK, Cheng YW, Chan JYS, et al. Aveir VR real-world performance and chronic pacing threshold prediction using mapping and fixation electrical data. Europace. 2024; 26(3).
  11. Syska P, Farkowski MM, Raulinajtys-Grzybek M, et al. How to decrease the cost of pacemaker infection treatment by adopting seemingly costly innovation? A budget impact analysis of a leadless pacemaker implantation. Kardiol Pol. 2022; 80(12): 1260–1262.
  12. Tajstra M, Adamowicz-Czoch E, Kurek A, et al. Leadless pacemaker implantation in a univentricular heart in a patient with a double-inlet left ventricle and L-transposition of the great arteries. Kardiol Pol. 2023; 81(5): 528–529.
  13. Blomström-Lundqvist C, Traykov V, Erba PA, et al. ESC Scientific Document Group. European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Europace. 2020; 22(4): 515–549.



Polish Heart Journal (Kardiologia Polska)