Boczar, Krzysztof

Chmielewska-Michalak, Lidia

Grabowski, Marcin

Gąsior, Mariusz

Kalarus, Zbigniew

Lenarczyk, Radosław

Lewandowski, Michał

Michalak, Marcin

Mitkowski, Przemysław

Oręziak, Artur

Przybylski, Andrzej

Romanek, Janusz

Sokal, Adam

Sterliński, Maciej

Syska, Paweł

Szumowski, Łukasz

Tajstra, Mateusz

Zakrzewska-Koperska, Joanna

Ząbek, Andrzej

Via Medica Journals

w w w . j o u r n a l s . v i a m e d i c a . p l / p o l i s h _ h e a r t _ j o u r n a l 791  S H O R T  C O M M U N I C A T I O NSingle-chamber leadless pacemaker Aveir VR implantation: Pioneer experience in Poland. Insights and preliminary report from a multicenter national registryMaciej Sterliński1, Krzysztof Boczar2, Andrzej Ząbek3, 4, Michał Lewandowski5, Paweł Syska5, Andrzej Przybylski6, 7, Janusz Romanek6, 7, Artur Oręziak1, Joanna Zakrzewska-Koperska1, Przemysław Mitkowski8,  Lidia Chmielewska-Michalak8, Marcin Michalak9, Marcin Grabowski9, Radosław Lenarczyk10, 11,  Zbigniew Kalarus11, Adam Sokal12, 13, Łukasz Szumowski1, Mariusz Gąsior14, Mateusz Tajstra1411st Department of Arrhythmia, National Institute of Cardiology, Warszawa, Poland2Department of Electrocardiology, The John Paul II Hospital, Kraków, Poland3Department of Electrocardiology, John Paul II Hospital, Kraków, Poland4Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland52nd Department of Cardiac Arrhythmia, National Institute of Cardiology, Warszawa, Poland. 6Clinical Department of Cardiology with the Acute Coronary Syndromes Subdivision, Clinical Provincial Hospital No. 2, Rzeszów, Poland7Faculty of Medicine, University of Rzeszow, Rzeszów, Poland81st Department of Cardiology, Poznan University of Medical Science, University Hospital in Poznan, Poznań, Poland91st Chair and Department of Cardiology, Medical University of Warsaw, Warszawa, Poland10Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland11Silesian Center for Heart Diseases in Zabrze, Zabrze, Poland12Department of Cardiology and Angiology, Silesian Centre for Heart Diseases, Zabrze, Poland13 Department of Dietetics, Faculty of Public Health in Bytom, Medical University of Silesia, Bytom, Poland143rd Department of Cardiology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia in Katowice, Silesian Center for Heart Diseases, Zabrze, PolandCorrespondence to:Mateusz Tajstra, MD, PhD,3rd Department of Cardiology, Faculty of Medical Sciences  in Zabrze, Medical University of Silesia  in Katowice, Silesian Center for Heart Diseases,Curie-Skłodowskiej 9,  41–800 Zabrze, Poland,phone: +48 32 373 36 19,e-mail: mateusztajstra@wp.plCopyright by the Author(s), 2024DOI: 10.33963/v.phj.101020Received:  March 28, 2023Accepted:  June 04, 2024Early publication date:  June 7, 2024INTRODUCTIONConventional pacemakers (PMs) consist of a surgically implanted pulse generator connected with transvenous leads. Notwith-standing high effectiveness, technological advances, and knowledge about optimal implantation routines, conventional PMs are strongly and continually affected by lead- and pocket-related complications [1]. Leadless pacemakers (LPM) are designed to prevent the abovementioned complications of trans-venous PMs [2, 3]. The Aveir VR (Abbott, Sylmar, CA, US) pacemaker was approved by the Food and Drug Administration in April 2022 [4]. The Aveir VR LP is 38 mm long, weighs less than 3 grams, and is delivered by a 25-French inner (27 French outer) diameter sheath. It utilizes an active fixation mechanism, which allows for mapping R wave sensing, impedance, and initial pacing capture threshold before fixation, which facilitates early identification of the need for repositioning and prevents complications [5].The first implantation of LPM Aveir in Poland was performed on September 20, 2023. Moreover, reimbursement for LPMs has recently been introduced in Poland, which leads to the belief that the number of LPM implantations will increase. In this study, we aimed to evaluate the initial experiences of nearly thirty procedures, particularly,  the safe-ty and success rates of Aveir VR implantations.METHODSWe evaluated the LPM single-chamber system (Aveir VR, Abbott Medical) in a retrospective, national, multicenter, investigator-driven reg-istry. All consecutive patients who underwent LPM Aveir implantation were enrolled in the registry. No sponsorship from the industry was involved. The implantation technique was standard [5]. The procedures were per-formed via the right femoral vein using local anesthesia. The implantation target was the interventricular septum. Once a position with good electrical measurements was achieved, the device was fixated to the myocardium by P O L I S H  H E A R T  J O U R N A Lw w w . j o u r n a l s . v i a m e d i c a . p l / p o l i s h _ h e a r t _ j o u r n a l792slow clockwise rotation of the delivery catheter grip with 1−1.25 clockwise rotations as evaluated by the radiopaque chevron maker on the device’s body. A post-procedural threshold <2 V at 0.4 ms was considered optimal. A decision to reposition was at the implanter’s discretion, after con-sidering the electrical measurement and fixation security demonstrated in the deflection test. After the device was released, assessment of electrical parameters was repeated. The study was approved by an appropriate institutional review board and ethics committee. Statistical analysis The categorical variables were presented as absolute numbers and percentages. Numerical variables, after as-sessment for normality with the use of the Shapiro–Wilk test, were presented either as medians and quartiles 1 and 3 for non-normal distribution or means and standard deviations for normally distributed variables. STATISTICA 13 (StatSoft Inc., Tulsa, OK, US) software was used for all calculations, and a two-sided P  <0.05 was considered statistically significant.RESULTS AND DISCUSSIONThe study included 28 consecutive patients who under-went Aveir VR implantation procedure at tertiary cardiology centers in Kraków, Poznań, Rzeszów, Warszawa, and Zabrze between September 2023 and February 2023 (Supplemen-tary material, Figure S1). The cohort had a median age of 75, and 42.9% were females. The most common indication for pacing was the third-degree atrioventricular block in pa-tients with persistent atrial fibrillation (AF) (64.3%), whereas the main reason for choosing LPM was the high risk of PM infection (35.7%). Analysis of risk-benefits justified the use of LPM in 4 patients (14.3%) with the leading diagnosis of sick sinus syndrome.The median procedural time was 55 minutes. All procedures were successful, and acceptable electrical parameters were observed with a mean post-procedural threshold of 0.75 V/0.4 ms. No serious adverse events, including device dislodgment, were recorded. One pa-tient experienced a local hematoma and another patient developed a post-procedural arteriovenous fistula treated conservatively. It should be emphasized, that during the Aveir implantation procedure, large bore venous access is needed. Therefore, the operator should be familiar with anatomical variations, equipment requirements, and po-tential complications and their prevention, including the routine ultrasound guidance used for venous access [6]. Details about baseline characteristics, indications for PM and LPM, procedure findings, and electrical parameters are shown in Table 1 and Supplementary material, Figure S2. Since the introduction of cardiac PMs, efforts towards their improvement and boosting the efficacy, durability, and safety of pacing therapy have been undertaken. Leadless pacemakers are utterly self-contained devices to pace the endocardium to reduce many short and long-term complications of transvenous PMs in adequately selected patients. Currently, two LPMs are commercially available: Micra (Medtronic) and Aveir (Abbott). The first LPM assessed in a clinical study was the Nano-stim (St. Jude Medical) in 2013 [7]. However, the device was removed from the market due to the reported technical issues [8]. Therefore, the Nanostim LPM was redesigned and re-named Aveir VR LPM (Abbott). In the LEADLESS-II (phase II) trial encompassing 200 patients, the mean age was 75.6 years, 62.5% of the participants were male, and pacemaker indication was AF with an atrioventricular block (52.5%). The implant success rate was 98%, which is in line with our outcomes [9]. The presented study con-firmed the satisfactory feasibility and safety of Aveir VR implantation in a cohort of real-life, all-comer patients, as Table 1. Baseline clinical and procedural characteristicsVariable Overall popula-tion (n = 28)Age, years, median (IQR) 75 (70–80)Female gender, n (%) 12 (42.9)History of any ablation, n (%) 1 (3.6)History of TAVI, n (%) 3 (10.7)Severe tricuspid regurgitation, n (%) 4 (14.3)LVEF, %, median (IQR) 55 (50–61)IndicationsSick sinus syndrome, n (%) 4 (14.3)AV IIº degree/advanced block, n (%) 6 (21.4)AV IIIº degree block, n (%) 18 (64.3)Baseline rhythmSinus rhythm, n (%) 6 (21.4)Paroxysmal atrial fibrillation, n (%) 2 (7.1)Persistent atrial fibrillation, n (%) 20 (71.4)Primary indication for leadless pacing (more than one may have occurred in some patients)High risk of CIED infection, n (%) 10 (35.7)Prior CIED infection, n (%) 9 (32.1)Vascular access issues, n (%) 2 (7.1)Chronic kidney disease on dialyses, n (%) 2 (7.1)Chronic inflammatory state, n (%) 3 (10.7)Immunosuppressive therapy, n (%) 1 (3.6)Patient’s preference, n (%) 3 (10.7)Procedural characteristicsRoutine ultrasonography guided approach for venous access, n/n (%)14/24 (50.0)Total procedural time, minutes, median (IQR) 55 (40–70)Total fluoroscopy time, minutes, median (IQR) 12 (8–18)Total fluoroscopy dose, mGy, median (IQR) 146 (61–231)Post-procedural impedance, Ohm, median (IQR) 760 (572–928)Post-procedural sensing, mV, median (IQR) 8.0 (5.5–9.5)Post-procedural threshold, V/ms, median (IQR) 0.75/0.4 (0.7–0.88)Threshold higher or equal to 1.0 V/0.4 ms, n (%) 7 (25.0)Need for device reposition, n (%) 6 (21.4)aDevice landing zone in the low-IVSc, n (%) 22 (78.6)Device landing zone in the mid-IVSc, n (%) 6 (21.4)Postprocedural stay (days), median (IQR) 3 (3–7)aIn 2 patients, more than one periprocedural reposition was necessary. bBased on: [13]. cBased on fluoroscopyAbbreviations: CIED, cardiac implantable electronic device; IQR, interquartile range; IVS, intraventricular septum; LVEF, left ventricular ejection fraction; SD, standard deviation; TAVI, transcatheter aortic valve implantationw w w . j o u r n a l s . v i a m e d i c a . p l / p o l i s h _ h e a r t _ j o u r n a l 793Maciej Sterliński et al., Leadless pacemaker Aveir VR implantation: Pioneer experience in Polandreported by Tam et al. [10]. The limitation of the present study is its design: a relatively small and rather “typical” group of patients treated and the peri-procedural device performance studied. The safety and effectiveness of the new leadless pacemaker, its cost-effectiveness [11], and its applications in rare challenging clinical cases [12] warrant further observations.Supplementary material Supplementary material is available at https://journals.viamedica.pl/polish_heart_journal.Article informationConflict of interest: MS — investigator, proctoring, trainer and lectur-er’s fees: Abbott, Biotronik, Hammermed, Medtronic, Zoll, European Union’s Horizon 2020 research and innovation program under grant agreement No 945260 — EHRA-PATHS Project; AP — proctoring fees: Abbott Polska; AO — traveling and lecture fees: Biotronik Polska, Abbott Polska, traveling fees from Medtronic Polska, Hammermed, Philips; JZK — traveling fees from Biotronik Polska, Medtronic Pol-ska, Hammermed, Philips; PM — fees, advisory: Medtronic, Abbott; LCM — fees: Medtronic, Abbott; MM — speaking fees and educational grants: Abbott; MG — speaking fees and educational grants: Abbott; RL — Abbott, Boston Scientific — consultant and lecture fees, Euro-pean Union’s Horizon 2020 research and innovation program under grant agreement no 847999 — PROFID-EHRA Project; MT — speaking fees and educational grants: Abbott. Other authors none declared. Funding: None.Open access: This article is available in open access under Creative Common Attribution-Non-Commercial-No Derivatives 4.0 Interna-tional (CC BY-NC-ND 4.0) license, which allows downloading and sharing articles with others as long as they credit the authors and the publisher, but without permission to change them in any way or use them commercially. For commercial use, please contact the journal office at polishheartjournal@ptkardio.plREFERENCES1. Burri H, Starck C, Auricchio A, et al. EHRA expert consensus statement and practical guide on optimal implantation technique for conventional pace-makers and implantable cardioverter-defibrillators: endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), and the Latin-American Heart Rhythm Society (LAHRS). EP Europace. 2021; 23(7): 983–1008, doi: 10.1093/europace/euaa367.2. 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 Car-diología (English Edition). 2022; 75(5): 430, doi: 10.1016/j.rec.2022.04.004, indexed in Pubmed: 35525571.3. Kempa M, Mitkowski P, Kowalski O, et al. Expert opinion of a Working Group on Leadless Pacing appointed by the National Consultant in Car-diology and the Board of the Heart Rhythm Section of the Polish Cardiac Society. Kardiol Pol. 2021; 79(5): 604–608, doi: 10.33963/KP.15982, indexed in Pubmed: 34125944.4. 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-devic-es/recentlyapproved-devices/aveir-leadless-pacing-system-aveir-lead-lesspacemaker-model-lsp112v-right-ventricular-aveir-delivery (assessed: 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, doi: 10.1111/jce.15785, indexed in Pubmed: 36542756.6. 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, doi: 10.1177/0885066619868164, indexed in Pubmed: 31387439.7. Reddy VY, Exner DV, Cantillon DJ, et al. Percutaneous implantation of an entirely intracardiac leadless pacemaker. N Engl J Med. 2015; 373(12): 1125–1135, doi:  10.1056/NEJMoa1507192, indexed in Pubmed: 26321198.8. 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, doi: 10.1016/j.hrthm.2017.07.004, indexed in Pubmed: 28705736.9. 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, doi: 10.1016/j.jacep.2021.11.002, indexed in Pubmed: 34863657.10. 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), doi: 10.1093/europace/euae051, indexed in Pubmed: 38457487.11. 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 implanta-tion. Kardiol Pol. 2022; 80(12): 1260–1262, doi: 10.33963/KP.a2022.0284, indexed in Pubmed: 36573599.12. Tajstra M, Adamowicz-Czoch E, Kurek A, et al. Leadless pacemaker im-plantation 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, doi: 10.33963/KP.a2023.0082, indexed in Pubmed: 36999725.13. Blomström-Lundqvist C, Traykov V, Erba PA, et al. 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 Infec-tious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Europace. 2020; 22(4): 515–549, doi: 10.1093/europace/euz246, indexed in Pubmed: 31702000.

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

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

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