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

Kasparas Briedis; Vaida Mizariene; Egle Rumbinaite; Martynas Jurenas; Ali Aldujeli; Kamilija Briede; Povilas Jakuska; Antanas Jankauskas; Indre Ceponiene; Tadas Lenkutis; Remigijus Zaliunas; Rimantas Benetis

doi:10.3389/fcvm.2023.1199047

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

Front Cardiovasc Med. 2023 Jul 13:10:1199047. doi: 10.3389/fcvm.2023.1199047. eCollection 2023.

Affiliations

¹ Department of Cardiology, Lithuanian University of Health Sciences, Kaunas, Lithuania.
² Department of Cardiac, Thoracic and Vascular Surgery, Lithuanian University of Health Sciences, Kaunas, Lithuania.
³ Department of Radiology, Lithuanian University of Health Sciences, Kaunas, Lithuania.

Abstract

Background: 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.

Aims: 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).

Methods: 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.

Results: 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 cm² (p < 0.00001). There was no incidence of moderate or severe total AR observed. In the QoL questionnaires, the patients reported a significant improvement from the baseline 12-KCCQ mean score 58 ± 15 to 76 ± 20. NYHA functional class improved in two patients, remained unchanged in one patient. There was an increase in mean 6-min-walk distance from baseline 285 ± 97 to 347 ± 57 m.

Conclusions: This study demonstrates that using Vienna TAVI system has favourable and sustained 6-month safety and performance outcomes in patients with symptomatic severe aortic stenosis.

Keywords: TAVI; VIVA trial; Vienna TAVI; Vienna aortic valve; aortic stenosis; dry-pericardium; first-in-human (FIH); pre-mounted TAVI.

Associated data

ClinicalTrials.gov/NCT04861805

Grants and funding

The authors declare that this study received funding from P+F Products+Features GmbH, Wigandgasse 5, 1190 Vienna, Austria. ClinicalTrials.gov Identifier: NCT04861805. Other Study ID Numbers: CTP-VIE-001. The funder was not involved in the study design, collection, analysis, interpretation of data, writing of this article or the decision to submit it for publication. Publication fee was funded by the Lithuanian University of Health Sciences, Kaunas, Lithuania.