Safety and performance of the Vienna self-expandable transcatheter aortic valve system: three-month follow-up results of the first-in-man feasibility study

Abstract

AIMS: The purpose of this first-in-human (FIH) feasibility study was to determine the safety, feasibility, and clinical and hemodynamic performance of the transfemoral Vienna self-expandable (SE) supra-annular aortic valve system, which is intended for use in patients with calcific symptomatic severe aortic valve stenosis. The Vienna Aortic Valve SE System is repositionable and retrievable, allowing more optimal prosthesis positioning. The valve comes already pre-mounted on the delivery system, ready to be used, eliminating the need for assembly and crimping of the device prior to valve implantation.

METHODS AND RESULTS: Methods. This is a prospective, non-randomized, single-arm, single-centre, first-stage FIH feasibility study, which will be followed by a second-stage pivotal, multicentre, multinational study in symptomatic patients with severe aortic stenosis (SAS). The first-stage FIH study evaluated the safety, feasibility, and clinical and hemodynamic performance of the Vienna Aortic Valve SE System in 10 patients with symptomatic SAS based on the recommendations given by the Valve Academic Research Consortium-2 (VARC-2) for TAVIs. An ethics committee and competent authority approval were obtained prior to the study’s commencement. Results. The mean patient age was 79 ± 5 years, 60% were male, 6 patients (60%) were in New York Heart Association (NYHA) functional class II and 4 patients (40%) in class III. The mean NT-pro-BNP levels were 419.3 ± 342.1 ng/l. Four (40%) patients had syncope events within the last 12 months. The mean aortic valve area (AVA) at screening was 0.75 ± 0.18 cm2, indexed AVA 0.4 ± 0.1 cm2/m2 and the mean aortic valve gradient was 48.7 ± 10.8 mmHg. The primary safety endpoint was successful, and all patients were alive at 30-day follow-up. Device and technical success were observed in all patients. One patient (10%) had an acute stroke, and one patient (10%) had a sub-acute stroke. New permanent pacemakers were implanted in 2 patients (20%), of which only 1 was related to device implantation. Only one patient (10%) had moderate or severe paravalvular leakage. At 3-month follow-up, all patients were alive and not only did the mean aortic valve gradient improve significantly, from 48.7 ± 10.8 mmHg to 7.3 ± 3.8 mmHg, but also a decrease in NT-pro-BNP levels from 419.3 ± 342.1 ng/l to 254.5 ± 125.4 ng/l was observed. Consequently, an improvement in 6 minute-walk test from 285 ± 15 meters to 339 ± 50 meters and Kansas City Cardiomyopathy quality-of-life questionnaire scores from 58 ± 15 to 79 ± 14 were observed at 3-month follow-up.

CONCLUSION: This first-in-human feasibility study in a real-world population of patients with symptomatic severe aortic stenosis at intermediate to high surgical risk demonstrates high procedural feasibility and excellent device implantation success, leading to amelioration of heart failure symptoms and increased quality of life with no risk of mortality at 3-month follow-up.