학술논문
Clinical outcomes of the Myval transcatheter heart valve system in patients with severe aortic valve stenosis: a two-year follow-up observational study.
Document Type
Academic Journal
Author
Kilic T; Department of Cardiology, Medical Faculty, Kocaeli University, Kocaeli, Turkey.; Ielasi A; U.O. Cardiologia Ospedalirea, IRCCSOspedale Galeazzi Sant'Ambrogio, Italy.; Ninios V; Department of Cardiology, Interbalkan European Medical Center, Thessaloniki, Greece.; Korkmaz L; Department of Cardiology, University of Health Sciences, Trabzon Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Turkey.; Panagiotakos D; School of Health Sciences and Education, Harokopio University, Athens, Greece.; Yerlikaya G; Department of Cardiology, University of Health Sciences, Trabzon Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Turkey.; Ozderya A; Department of Cardiology, University of Health Sciences, Trabzon Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Turkey.; Montonati C; U.O. Cardiologia Ospedalirea, IRCCSOspedale Galeazzi Sant'Ambrogio, Italy.; Tespili M; U.O. Cardiologia Ospedalirea, IRCCSOspedale Galeazzi Sant'Ambrogio, Italy.; Coskun S; Department of Cardiology, Medical Faculty, Kocaeli University, Kocaeli, Turkey.; Sahin T; Department of Cardiology, Medical Faculty, Kocaeli University, Kocaeli, Turkey.; Ninios I; Department of Cardiology, Interbalkan European Medical Center, Thessaloniki, Greece.; Vlasopoulou K; Department of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital, Athens, Greece.; Konus AH; Department of Cardiology, University of Health Sciences, Trabzon Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Turkey.; Kul S; Department of Cardiology, University of Health Sciences, Trabzon Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Turkey.; Akyuz AR; Department of Cardiology, University of Health Sciences, Trabzon Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Turkey.
Source
Publisher: Termedia Pub. House Country of Publication: Poland NLM ID: 101258257 Publication Model: eCollection Cited Medium: Print ISSN: 1734-1922 (Print) Linking ISSN: 17341922 NLM ISO Abbreviation: Arch Med Sci Subsets: PubMed not MEDLINE
Subject
Language
English
ISSN
1734-1922
Abstract
Introduction: Limited 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 Methods: A 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.
Results: Technical 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%.
Conclusions: In this cohort of patients with SAS, the Myval was found to be safe and effective in up to 2 years of follow-up.
Competing Interests: The authors declare no conflict of interest.
(Copyright: © 2024 Termedia & Banach.)
Material and Methods: A 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.
Results: Technical 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%.
Conclusions: In this cohort of patients with SAS, the Myval was found to be safe and effective in up to 2 years of follow-up.
Competing Interests: The authors declare no conflict of interest.
(Copyright: © 2024 Termedia & Banach.)