Aims: The VIVALL study aims to investigate the technical feasibility, safety and performance of the ALLEGRA transcatheter heart valve (THV) for the treatment of failing surgical aortic valves (SAV).
Methods and results: Thirty patients with failing SAV were investigated. An independent combined Data Safety Monitoring-Clinical Events Committee (DSM-CEC) and core lab adjudicated adverse events, patient safety and echocardiograms, respectively. Primary endpoints were invasive post-procedure mean pressure gradient (performance) and 30-day survival (safety). Of the treated patients (78.6±6.0 years, 50% female, STS score 4.5±2.1% and EuroSCORE II 9.2±4.3%), the majority (90%) had a small SAV (true inner diameter ≤22 mm). Implantation was successful in all but one patient (96.7%). Overall, the invasively assessed preoperative mean pressure gradient was significantly reduced from 37.1±13.3 mmHg to 11.6±3.7 mmHg. At 30 days, all-cause mortality and new pacemaker implantation were both 0% and the effective orifice area increased from 1.18±0.58 cm2 at baseline to 1.4±0.52 cm2. Paravalvular regurgitation was “none or trace” in 100% of the cases.
Conclusions: Transfemoral implantation of the ALLEGRA THV is feasible and safe in patients with failing SAV. Haemodynamic outcomes and a 100% survival rate after 30 days suggest that the ALLEGRA THV might be a valid option for valve-in-valve treatment.