Single center experience with the balloon‐expandable Myval transcatheter aortic valve system with the first 100 patients: 30‐day and 1‐year follow‐up

• Published in: Catheterization and cardiovascular interventions Vol. 102; no. 7; pp. 1317 - 1330
• Main Authors: Magyari, Balázs, Kittka, Bálint, Goják, Ilona, Kasza, Gábor, Schönfeld, Kristóf, Szapáry, László Botond, Simon, Mihály, Kiss, Rudolf, Bertalan, Andrea, Várady, Edit, Gyimesi, András, Szokodi, István, Horváth, Iván
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.12.2023
• Subjects: Aged; annular rupture; Aortic valve; Aortic Valve - diagnostic imaging; Aortic Valve - surgery; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - surgery; balloon expendable transcatheter heart valve; Balloon treatment; bicuspid aortic valve; Data collection; Echocardiography; Female; Follow-Up Studies; Heart Valve Prosthesis; Humans; Male; Mortality; paravalvular leak; Patients; permanent pacemaker implantation; Prosthesis Design; Regurgitation; Retrospective Studies; TAVR; Transcatheter Aortic Valve Replacement; Treatment Outcome; balloon expendable transcatheter heart valve; paravalvular leak; annular rupture; permanent pacemaker implantation; bicuspid aortic valve; TAVR
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.30868

Aims To report our single‐center data, regarding the first 100 patients who underwent TAVR procedure with the new balloon‐expandable MYVAL system. We report 30‐day and 1‐year outcomes in low to high‐risk TAVR patient population. Methods From November 2019 to July 2021, 100 consecutive patients underwent TAVR procedure. Patient outcome was classified according to the VARC‐2 definitions. The device performance was assessed using transthoracic echocardiography. Data collection was allowed by the Local Ethical Committee. Results The mean age was 74.7 years, 63 (63%) were male. The mean Euroscore II and STS score were 4.8 ± 4.9 and 5.6 ± 3.9, respectively. Transfemoral access was the most frequent (surgical vs. percutaneous 2% vs. 97%) and in one patient surgical subclavian access was used. VARC‐2 outcomes were as follows: device success 99%, STROKE 1%, major and minor vascular complication was 1% and 11%, respectively, the rate of new permanent pacemaker implantation was 30.7%. At discharge, the incidence of grade I, grade II aortic regurgitation was 39% and 1%, respectively, without relevant PVL. In‐hospital mortality was only 1%. These results included a high proportion (17%) of patients with bicuspid aortic valves. At 1 year, the all‐cause mortality rate was 7% (only two due to cardiac event) and only a single patient had valve‐related dysfunction requiring surgical aortic replacement. Conclusions TAVR procedure with MYVAL transcatheter heart valve system shows excellent 30‐day and 1‐year outcomes regarding patient survival, technical success, and valve‐related adverse events. The limitations of our study comprise a single‐center study with retrospective data collection.