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

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  1 , Vaida Mizariene  1 , Egle Rumbinaite  1   2 , Martynas Jurenas  1 , Ali Aldujeli  1 , Kamilija Briede  1 , Povilas Jakuska  2 , Antanas Jankauskas  3 , Indre Ceponiene  1 , Tadas Lenkutis  2 , Remigijus Zaliunas  1 , Rimantas Benetis  2
Affiliations

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 et al. Front Cardiovasc Med. .

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.

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Conflict of interest statement

KB is a consultant and proctor for P+F Products+Features GmbH and has received honoraria from P+F Products+Features GmbH. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Vienna aortic valve in outflow view (A), inflow view (B) and Side view (C).
Figure 2
Figure 2
Study flow chart. Non-CV, non-cardiovascular.
Figure 3
Figure 3
Echocardiographic parameters from baseline to 6 months: mean aortic valve gradient and mean effective orifice area.
Figure 4
Figure 4
Echocardiographic parameters from discharge to 6 months: total aortic regurgitation.
Figure 5
Figure 5
12-KCCQ mean score and NYHA classification at baseline and 6 months. In the Quality-of-Life questionnaires the patients reported a significant improvement, also NYHA functional class improved in two patients, remained unchanged in one patient, was not reported in one patient due to prolonged recovery, and one patient died due to non-cardiovascular cause. KCCQ-12, 12-item Kansas City Cardiomyopathy Questionnaire; NYHA, New York Heart Association.
See this image and copyright information in PMC

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