WHY THIS STUDY?

The VIVA First-in-Human feasibility study aimed to investigate the safety and efficacy of the pre-mounted dry-pericardium self-expandable Vienna aortic valve TAVI system in patients with severe symptomatic aortic stenosis (SSAS), categorized as intermediate or high surgical risk. The innovation of the dehydrated pericardium facilitates immediate use and potentially reduces procedural errors, time, and resources, making it a practical option in areas where resource constraints are a significant concern.

HOW WAS IT EXECUTED?

This prospective, non-randomized, single-arm, single-center study evaluated the Vienna aortic valve system in 10 patients with SSAS. The Valve Academic Research Consortium 3-defined safety outcomes were evaluated up to 1-year follow-up. The major outcomes included all-cause mortality, neurological events, overt bleeding, cardiac structural complications, valve-related complications, conduction disturbances, myocardial infarction, acute kidney injury and structural valve deterioration. Technical success (at exit from procedure room), device success (at 30 days), early safety (at 30 days) and clinical efficacy (at 1 year) were also evaluated. Hemodynamic outcomes were assessed up to one year. The study was prospectively registered at ClinicalTrials.gov (NCT04861805).

WHAT WERE THE ESSENTIAL RESULTS?

Over one-year, significant hemodynamic improvements were observed: mean aortic valve pressure gradient decreased from 48.7±10.8 mmHg to 8.1±3.09 mmHg, aortic valve area increased from 0.75±0.18 cm² to 1.91±0.19 cm², and maximum jet velocity through the aortic valve reduced from 4.41±0.35 to 1.95±0.36 (p<0.0001). No moderate/severe paravalvular leakage was noted at 12 months. CT scans at 3 months post-TAVI revealed a significant reduction in aortic annular eccentricity from pre-implantation 22.3±7.3% to 10.4±6.5% at the valve inflow (p=0.04) and no evidence of hypoattenuated leaflet thickening in all cases, indicating an absence of subclinical leaflet thrombosis. At the 12-month follow-up, there were no cases of cardiovascular mortality, with one non-cardiovascular death reported, confirmed as unrelated to the device. Complications included one overt bleeding event, two cases requiring post-TAVI pacemaker implantation, and three ischemic events, with only one resulting in lasting neurological impairment. Improvements in quality of life and functional status were observed but were not statistically significant.

WHY IT IS IMPORTANT?

The Vienna aortic valve system demonstrated promising safety and efficacy profiles, as evidenced by the absence of cardiovascular mortality and robust hemodynamic performance in the one-year follow-up. These initial findings suggest that the pre-mounted dry-pericardium Vienna aortic valve is a viable option for further investigation in ongoing long-term multi-center clinical trials. While the economic aspects, such as direct comparisons of different TAVI systems for economic efficiency, were not the focus of the current study, they represent a crucial area for future research. The Vienna valve's unique pre-mounted design suggests a potential reduction in healthcare costs by minimizing the need for extensive human and logistic resources, equipment, and potential procedural errors. This study underscores the critical need for future comparative economic assessments, aiming to optimize healthcare efficiency and affordability.

PLEASE LIST THE DEVICE(S)/TECHNOLOGY(IES) INVOLVED IN THIS TRIAL

Vienna Self-Expandable Aortic Valve (P+F Products + Features GmbH, Vienna, Austria).