Safety and performance of the Vienna self-expandable transcatheter aortic valve system: 6-month results of the VIVA first-in-human feasibility study

• Published in: Frontiers in cardiovascular medicine 2023-07, Vol.10, p.1199047-1199047
• Main Authors: Briedis, Kasparas, Mizariene, Vaida, Rumbinaite, Egle, Jurenas, Martynas, Aldujeli, Ali, Briede, Kamilija, Jakuska, Povilas, Jankauskas, Antanas, Ceponiene, Indre, Lenkutis, Tadas, Zaliunas, Remigijus, Benetis, Rimantas
• Format: Article
• Language: English
• Subjects: aortic stenosis; Cardiovascular Medicine; dry-pericardium; first-in-human (FIH); TAVI; Vienna TAVI; VIVA trial
• ISSN: 2297-055X; 2297-055X
• DOI: 10.3389/fcvm.2023.1199047

The novel Vienna TAVI system is repositionable and retrievable, already pre-mounted on the delivery system, eliminating the need for assembly and crimping of the device prior to valve implantation. The purpose of this first-in-human feasibility study was to determine the safety, feasibility, clinical and hemodynamic performance of the Vienna TAVI system at 6-month follow-up. (ClinicalTrials.gov identifier NCT04861805). This is a prospective, non-randomized, single-arm, single-center, first-stage FIH feasibility study, which is followed by a second-stage pivotal, multicenter, multinational study in symptomatic patients with severe aortic stenosis (SAS). The first-stage FIH study evaluated the safety and feasibility, clinical and hemodynamic performance of the device in 10 patients with SAS based on recommendations by the VARC-2. All patients were alive at 3-month follow-up. 1 non-cardiovascular mortality was reported 5 months after implantation. There were no new cerebrovascular events, life-threatening bleeding or conduction disturbances observed at 6-month follow-up. The mean AV gradient significantly decreased from 48.7 ± 10.8 to 7.32 ± 2.0 mmHg and mean AVA increased from 0.75 ± 0.18 to 2.16 ± 0.42 cm (