Research ExplorerPublicationsThirty-day outcomes of a novel transcatheter heart valve to ...

Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study

Standard

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, Vol. 15, No. 9, 04.10.2019, p. e757-e763.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Schäfer, U, Butter, C, Landt, M, Frerker, C, Treede, H, Schirmer, J, Koban, C, Allali, A, Schmidt, T, Charitos, E & Conradi, L 2019, 'Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study', EUROINTERVENTION, vol. 15, no. 9, pp. e757-e763. https://doi.org/10.4244/EIJ-D-19-00331

APA

Schäfer, U., Butter, C., Landt, M., Frerker, C., Treede, H., Schirmer, J., Koban, C., Allali, A., Schmidt, T., Charitos, E., & Conradi, L. (2019). Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study. EUROINTERVENTION, 15(9), e757-e763. https://doi.org/10.4244/EIJ-D-19-00331

Vancouver

Schäfer U, Butter C, Landt M, Frerker C, Treede H, Schirmer J et al. Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study. EUROINTERVENTION. 2019 Oct 4;15(9):e757-e763. https://doi.org/10.4244/EIJ-D-19-00331

Bibtex

@article{3fc858bd70d948e3aa60b4490482a0ac,
title = "Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study",
abstract = "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.",
keywords = "Aortic Valve, Aortic Valve Stenosis/surgery, Female, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Humans, Male, Pilot Projects, Prosthesis Design, Surgical Instruments, Transcatheter Aortic Valve Replacement, Treatment Outcome",
author = "Ulrich Sch{\"a}fer and Christian Butter and Martin Landt and Christian Frerker and Hendrik Treede and Johannes Schirmer and Cornel Koban and Abdelhakim Allali and Tobias Schmidt and Efstratios Charitos and Lenard Conradi",
year = "2019",
month = oct,
day = "4",
doi = "10.4244/EIJ-D-19-00331",
language = "English",
volume = "15",
pages = "e757--e763",
journal = "EUROINTERVENTION",
issn = "1774-024X",
publisher = "EUROPA EDITION",
number = "9",

}

RIS

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 -