• Teoman Kilic, Alfonso Ielasi, Vlasis Ninios, Levent Korkmaz, Demosthenes Panagiotakos, Gokhan Yerlikaya, Ahmet Ozderya, Carolina Montonati, Maurizio Tespili, Senol Coskun, Tayfun Sahin, Ilias Ninios, Konstantina Vlasopoulou, Ali Hakan Konus, Selim Kul, and Ali Riza Akyuz.
• Department of Cardiology, Medical Faculty, Kocaeli University, Kocaeli, Turkey.
• Arch Med Sci. 2024 Jan 1; 20 (2): 410419410-419.

IntroductionLimited data exist on long-term follow-up of severe aortic stenosis (SAS) patients who have undergone transcatheter aortic valve implantation (TAVI) with a new generation, balloon expandable Myval transcatheter heart valve (THV). Thus, we sought to investigate the performance and 2-year clinical outcome of the Myval THV system based on Valve Academic Research Consortium-3 (VARC-3) criteria.Material And MethodsA multi-centre, registry-based, observational study was conducted, which included 207 consecutive degenerative SAS patients, from Turkey (n = 128), Italy (n = 58), and Greece (n = 21) (mean [standard deviation] 81 (7) years, 94 [45%] men; 73% NYHA III or IV; EuroSCORE II 5.2% [2.4%]); all patients underwent TAVI with Myval. Patients were followed up at 1 year and 2 years after implantation. Clinical and procedural outcomes were defined according to VARC-3 criteria.ResultsTechnical success was observed in 204 (99%), device success was observed in 189 (91%), early safety was observed in 161 (78%), and clinical efficacy was observed in 163 (79%) patients. The 30-day death rate was 7.7%; of these, 3.4% were due to cardiovascular reasons. All-cause and cardiovascular mortality rates were 9.7% and 4.3% at 1-year follow-up, and 17.4% and 9.7% at 2-year follow-up, respectively. Incidence of ≥ moderate paravalvular leak (PVL) at 30 days, 1 year and 2 years of follow-up were 3.4%, 4.3% and 4.8%. A total of 11.1% of patients required a permanent pacemaker implantation (PPI) at 30 days after implantation, while the cumulative rate of PPI at 2 years was 12.1%.ConclusionsIn this cohort of patients with SAS, the Myval was found to be safe and effective in up to 2 years of follow-up.Copyright: © 2024 Termedia & Banach.

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