Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study
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Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study. / Schäfer, Ulrich; Butter, Christian; Landt, Martin; Frerker, Christian; Treede, Hendrik; Schirmer, Johannes; Koban, Cornel; Allali, Abdelhakim; Schmidt, Tobias; Charitos, Efstratios; Conradi, Lenard.
in: EUROINTERVENTION, Jahrgang 15, Nr. 9, 04.10.2019, S. e757-e763.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study
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, Efstratios
AU - Conradi, Lenard
PY - 2019/10/4
Y1 - 2019/10/4
N2 - 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.
AB - 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.
KW - Aortic Valve
KW - Aortic Valve Stenosis/surgery
KW - Female
KW - Heart Valve Prosthesis
KW - Heart Valve Prosthesis Implantation
KW - Humans
KW - Male
KW - Pilot Projects
KW - Prosthesis Design
KW - Surgical Instruments
KW - Transcatheter Aortic Valve Replacement
KW - Treatment Outcome
U2 - 10.4244/EIJ-D-19-00331
DO - 10.4244/EIJ-D-19-00331
M3 - SCORING: Journal article
C2 - 31355750
VL - 15
SP - e757-e763
JO - EUROINTERVENTION
JF - EUROINTERVENTION
SN - 1774-024X
IS - 9
ER -