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Early results of a real-world series with two transapical transcatheter mitral valve replacement devices

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Early results of a real-world series with two transapical transcatheter mitral valve replacement devices. / Ludwig, S; Kalbacher, D; Schofer, N; Schäfer, A; Koell, B; Seiffert, M; Schirmer, J; Schäfer, U; Westermann, D; Reichenspurner, H; Blankenberg, S; Lubos, E; Conradi, L.

In: CLIN RES CARDIOL, Vol. 110, No. 3, 03.2021, p. 411-420.

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

Harvard

Ludwig, S, Kalbacher, D, Schofer, N, Schäfer, A, Koell, B, Seiffert, M, Schirmer, J, Schäfer, U, Westermann, D, Reichenspurner, H, Blankenberg, S, Lubos, E & Conradi, L 2021, 'Early results of a real-world series with two transapical transcatheter mitral valve replacement devices', CLIN RES CARDIOL, vol. 110, no. 3, pp. 411-420. https://doi.org/10.1007/s00392-020-01757-z

APA

Ludwig, S., Kalbacher, D., Schofer, N., Schäfer, A., Koell, B., Seiffert, M., Schirmer, J., Schäfer, U., Westermann, D., Reichenspurner, H., Blankenberg, S., Lubos, E., & Conradi, L. (2021). Early results of a real-world series with two transapical transcatheter mitral valve replacement devices. CLIN RES CARDIOL, 110(3), 411-420. https://doi.org/10.1007/s00392-020-01757-z

Vancouver

Ludwig S, Kalbacher D, Schofer N, Schäfer A, Koell B, Seiffert M et al. Early results of a real-world series with two transapical transcatheter mitral valve replacement devices. CLIN RES CARDIOL. 2021 Mar;110(3):411-420. https://doi.org/10.1007/s00392-020-01757-z

Bibtex

@article{4d4a25c25b494b3bae57e6d686789b1a,
title = "Early results of a real-world series with two transapical transcatheter mitral valve replacement devices",
abstract = "AIMS: Transcatheter mitral valve replacement (TMVR) with dedicated devices promises to fill the treatment gap between open-heart surgery and edge-to-edge repair for patients with severe mitral regurgitation (MR). We herein present a single-centre experience of a TMVR series with two transapical devices.METHODS AND RESULTS: A total of 11 patients were treated with the Tendyne{\texttrademark} (N = 7) or the Tiara{\texttrademark} TMVR systems (N = 4) from 2016 to 2020 either as compassionate-use procedures or as commercial implants. Clinical and echocardiographic data were collected at baseline, discharge and follow-up and are presented in accordance with the Mitral Valve Academic Research Consortium (MVARC) definitions. The study cohort [age 77 years (73, 84); 27.3% male] presented with primary (N = 4), secondary (N = 5) or mixed (N = 2) MR etiology. Patients were symptomatic (all NYHA III/IV) and at high surgical risk [logEuroSCORE II 8.1% (4.0, 17.4)]. Rates of impaired RV function (72.7%), severe pulmonary hypertension (27.3%), moderate or severe tricuspid regurgitation (63.6%) and prior aortic valve replacement (63.6%) were high. Severe mitral annulus calcification was present in two patients. Technical success was achieved in all patients. In 90.9% (N = 10) MR was completely eliminated (i.e. no or trace MR). Procedural and 30-day mortality were 0.0%. At follow-up NYHA class was I/II in the majority of patients. Overall mortality after 3 and 6 months was 10.0% and 22.2%.CONCLUSIONS: TMVR was performed successfully in these selected patients with complete elimination of MR in the majority of patients. Short-term mortality was low and most patients experienced persisting functional improvement.",
author = "S Ludwig and D Kalbacher and N Schofer and A Sch{\"a}fer and B Koell and M Seiffert and J Schirmer and U Sch{\"a}fer and D Westermann and H Reichenspurner and S Blankenberg and E Lubos and L Conradi",
year = "2021",
month = mar,
doi = "10.1007/s00392-020-01757-z",
language = "English",
volume = "110",
pages = "411--420",
journal = "CLIN RES CARDIOL",
issn = "1861-0684",
publisher = "D. Steinkopff-Verlag",
number = "3",

}

RIS

TY - JOUR

T1 - Early results of a real-world series with two transapical transcatheter mitral valve replacement devices

AU - Ludwig, S

AU - Kalbacher, D

AU - Schofer, N

AU - Schäfer, A

AU - Koell, B

AU - Seiffert, M

AU - Schirmer, J

AU - Schäfer, U

AU - Westermann, D

AU - Reichenspurner, H

AU - Blankenberg, S

AU - Lubos, E

AU - Conradi, L

PY - 2021/3

Y1 - 2021/3

N2 - AIMS: Transcatheter mitral valve replacement (TMVR) with dedicated devices promises to fill the treatment gap between open-heart surgery and edge-to-edge repair for patients with severe mitral regurgitation (MR). We herein present a single-centre experience of a TMVR series with two transapical devices.METHODS AND RESULTS: A total of 11 patients were treated with the Tendyne™ (N = 7) or the Tiara™ TMVR systems (N = 4) from 2016 to 2020 either as compassionate-use procedures or as commercial implants. Clinical and echocardiographic data were collected at baseline, discharge and follow-up and are presented in accordance with the Mitral Valve Academic Research Consortium (MVARC) definitions. The study cohort [age 77 years (73, 84); 27.3% male] presented with primary (N = 4), secondary (N = 5) or mixed (N = 2) MR etiology. Patients were symptomatic (all NYHA III/IV) and at high surgical risk [logEuroSCORE II 8.1% (4.0, 17.4)]. Rates of impaired RV function (72.7%), severe pulmonary hypertension (27.3%), moderate or severe tricuspid regurgitation (63.6%) and prior aortic valve replacement (63.6%) were high. Severe mitral annulus calcification was present in two patients. Technical success was achieved in all patients. In 90.9% (N = 10) MR was completely eliminated (i.e. no or trace MR). Procedural and 30-day mortality were 0.0%. At follow-up NYHA class was I/II in the majority of patients. Overall mortality after 3 and 6 months was 10.0% and 22.2%.CONCLUSIONS: TMVR was performed successfully in these selected patients with complete elimination of MR in the majority of patients. Short-term mortality was low and most patients experienced persisting functional improvement.

AB - AIMS: Transcatheter mitral valve replacement (TMVR) with dedicated devices promises to fill the treatment gap between open-heart surgery and edge-to-edge repair for patients with severe mitral regurgitation (MR). We herein present a single-centre experience of a TMVR series with two transapical devices.METHODS AND RESULTS: A total of 11 patients were treated with the Tendyne™ (N = 7) or the Tiara™ TMVR systems (N = 4) from 2016 to 2020 either as compassionate-use procedures or as commercial implants. Clinical and echocardiographic data were collected at baseline, discharge and follow-up and are presented in accordance with the Mitral Valve Academic Research Consortium (MVARC) definitions. The study cohort [age 77 years (73, 84); 27.3% male] presented with primary (N = 4), secondary (N = 5) or mixed (N = 2) MR etiology. Patients were symptomatic (all NYHA III/IV) and at high surgical risk [logEuroSCORE II 8.1% (4.0, 17.4)]. Rates of impaired RV function (72.7%), severe pulmonary hypertension (27.3%), moderate or severe tricuspid regurgitation (63.6%) and prior aortic valve replacement (63.6%) were high. Severe mitral annulus calcification was present in two patients. Technical success was achieved in all patients. In 90.9% (N = 10) MR was completely eliminated (i.e. no or trace MR). Procedural and 30-day mortality were 0.0%. At follow-up NYHA class was I/II in the majority of patients. Overall mortality after 3 and 6 months was 10.0% and 22.2%.CONCLUSIONS: TMVR was performed successfully in these selected patients with complete elimination of MR in the majority of patients. Short-term mortality was low and most patients experienced persisting functional improvement.

U2 - 10.1007/s00392-020-01757-z

DO - 10.1007/s00392-020-01757-z

M3 - SCORING: Journal article

C2 - 33074368

VL - 110

SP - 411

EP - 420

JO - CLIN RES CARDIOL

JF - CLIN RES CARDIOL

SN - 1861-0684

IS - 3

ER -