TY - JOUR JO - EuroIntervention TI - Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study AB - <p><strong>Aims:</strong> 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).</p> <p><strong>Methods and results:</strong> 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&plusmn;6.0 years, 50% female, STS score 4.5&plusmn;2.1% and EuroSCORE II 9.2&plusmn;4.3%), the majority (90%) had a small SAV (true inner diameter &le;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&plusmn;13.3 mmHg to 11.6&plusmn;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&plusmn;0.58 cm2 at baseline to 1.4&plusmn;0.52 cm2. Paravalvular regurgitation was &ldquo;none or trace&rdquo; in 100% of the cases.</p> <p><strong>Conclusions:</strong> 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.</p> AU - Schäfer Ulrich AU - Butter Christian AU - Landt Martin AU - Frerker Christian AU - Treede Hendrik AU - Schirmer Johannes AU - Koban Cornel AU - Allali Abdelhakim AU - Schmidt Tobias AU - Charitos I. Efstratios AU - Conradi Lenard VL - 15 IS - 9 Y1 - 04/10/2019 Y1 - 2019 DOI - 10.4244/EIJ-D-19-00331 SP - e757 EP - e763 KW - tavi KW - valve-in-valve KW - prior cardiovascular surgery PB - Europa Digital & Publishing SE - Interventions for valvular disease and heart failure UR - https://eurointervention.pcronline.com/article/thirty-day-outcomes-of-a-novel-transcatheter-heart-valve-to-treat-degenerated-surgical-valves-the-vivall-multi-center-single-arm-pilot-study SN - 1774-024X ER -