Transfermoral aortic valve implantation using self-expanding New Valve Technology (NVT) Allegra bioprosthesis: A pilot prospective study

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become a standard therapeutic option for patients with severe aortic stenosis (AS) at high cardiac surgical risk. The aim of the NAU-TILUS study was to investigate the safety and performance of the New Valve Technology (NVT) Allegra bioprosthesis in high-risk patients undergoing TAVI. METHODS: Twenty seven patients with severe, symptomatic AS at high surgical risk were prospectively enrolled, who underwent treatment using the novel self-expanding NVT Allegra bioprosthesis via transfemoral approach (TF-TAVI). The primary end-point was all-cause mortality at 30 days. RESULTS: Patients were elderly (83 years, range 75–89 years), and predominantly female (70.4%, n = 19). All patients were deemed to be at high surgical risk, with a mean logistic EuroSCORE of 12.4% (range, 2.8–31.8%). The bioprosthesis was successfully implanted in 96% of the cases (n = 25). The echocardiographic assessment confirmed good hemodynamic profile after implantation of the NVT Allegra bioprosthesis. Complications included cardiac tamponade (4%, n = 1) and the need for permanent pacemaker implantation (8%, n = 2). The analysis of procedural aspects showed a short learning effect related to the precise placement of the valve. A significant improvement in clinical symptoms were observed, and no patients died in-hospital or within 30 days of post-discharge observation. CONCLUSIONS: This prospective observation shows that the NVT Allegra bioprosthesis was associated with a satisfactory safety profile and a remarkable hemodynamic performance after implantation.