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Thirty-day VARC-2 and performance data of a new self-expanding transcatheter aortic heart valve

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Thirty-day VARC-2 and performance data of a new self-expanding transcatheter aortic heart valve. / Treede, Hendrik; Lubos, Edith; Conradi, Lenard; Deuschl, Florian; Asch, Federico M; Weissman, Neil J; Schofer, Niklas; Schirmer, Johannes; Koschyk, Dietmar; Blankenberg, Stefan; Reichenspurner, Hermann; Schaefer, Ulrich.

In: EUROINTERVENTION, Vol. 11, No. 7, 11.2015, p. 785-792.

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

Harvard

Treede, H, Lubos, E, Conradi, L, Deuschl, F, Asch, FM, Weissman, NJ, Schofer, N, Schirmer, J, Koschyk, D, Blankenberg, S, Reichenspurner, H & Schaefer, U 2015, 'Thirty-day VARC-2 and performance data of a new self-expanding transcatheter aortic heart valve', EUROINTERVENTION, vol. 11, no. 7, pp. 785-792. https://doi.org/10.4244/EIJY15M05_05

APA

Treede, H., Lubos, E., Conradi, L., Deuschl, F., Asch, F. M., Weissman, N. J., Schofer, N., Schirmer, J., Koschyk, D., Blankenberg, S., Reichenspurner, H., & Schaefer, U. (2015). Thirty-day VARC-2 and performance data of a new self-expanding transcatheter aortic heart valve. EUROINTERVENTION, 11(7), 785-792. https://doi.org/10.4244/EIJY15M05_05

Vancouver

Treede H, Lubos E, Conradi L, Deuschl F, Asch FM, Weissman NJ et al. Thirty-day VARC-2 and performance data of a new self-expanding transcatheter aortic heart valve. EUROINTERVENTION. 2015 Nov;11(7):785-792. https://doi.org/10.4244/EIJY15M05_05

Bibtex

@article{1517f2cb71c84f718d9487f0f1de9d2e,
title = "Thirty-day VARC-2 and performance data of a new self-expanding transcatheter aortic heart valve",
abstract = "AIMS: Transcatheter aortic valve therapy has become an established procedure for patients at high risk for surgical valve replacement. The BIOVALVE-I study aims to assess the safety and performance of a novel self-expanding transcatheter heart valve.METHODS AND RESULTS: In this prospective, single-centre, first-in-human study, 13 patients with severe aortic stenosis suitable for transfemoral transcatheter aortic valve implantation were enrolled. Mean logistic EuroSCORE was 14.4±3.7% and mean STS PROM score was 4.3±1.6%. The primary endpoint, 30-day early safety composite per VARC-2, was observed in two patients (15.4%, one life-threatening bleeding and one valve-in-valve procedure). The implant was aborted in two patients due to unsuitable aortic anatomy. Overall, device success was obtained in nine patients (69.2%, two aborted implants, one valve-in-valve procedure and one patient with moderate aortic regurgitation). As determined by an independent core laboratory, all but one patient had less than moderate total aortic regurgitation at 30-day follow-up, mean aortic gradient was 6.7±2.3 mmHg and effective orifice area 1.8±0.3 cm. Pacemakers were implanted in three patients (23.1%), and no death, stroke, myocardial infarction or acute kidney failure was observed.CONCLUSIONS: In this first-in-human study, the feasibility of implantation of the BIOVALVE system and its re-sheathing functionality was demonstrated, and short-term safety data were encouraging. Larger studies are required to confirm the performance of the device.",
keywords = "Aged, Aged, 80 and over, Aortic Valve/diagnostic imaging, Aortic Valve Stenosis/diagnosis, Cardiac Catheterization/instrumentation, Coronary Angiography, Feasibility Studies, Female, Germany, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation/instrumentation, Humans, Male, Prospective Studies, Prosthesis Design, Severity of Illness Index, Time Factors, Treatment Outcome",
author = "Hendrik Treede and Edith Lubos and Lenard Conradi and Florian Deuschl and Asch, {Federico M} and Weissman, {Neil J} and Niklas Schofer and Johannes Schirmer and Dietmar Koschyk and Stefan Blankenberg and Hermann Reichenspurner and Ulrich Schaefer",
year = "2015",
month = nov,
doi = "10.4244/EIJY15M05_05",
language = "English",
volume = "11",
pages = "785--792",
journal = "EUROINTERVENTION",
issn = "1774-024X",
publisher = "EUROPA EDITION",
number = "7",

}

RIS

TY - JOUR

T1 - Thirty-day VARC-2 and performance data of a new self-expanding transcatheter aortic heart valve

AU - Treede, Hendrik

AU - Lubos, Edith

AU - Conradi, Lenard

AU - Deuschl, Florian

AU - Asch, Federico M

AU - Weissman, Neil J

AU - Schofer, Niklas

AU - Schirmer, Johannes

AU - Koschyk, Dietmar

AU - Blankenberg, Stefan

AU - Reichenspurner, Hermann

AU - Schaefer, Ulrich

PY - 2015/11

Y1 - 2015/11

N2 - AIMS: Transcatheter aortic valve therapy has become an established procedure for patients at high risk for surgical valve replacement. The BIOVALVE-I study aims to assess the safety and performance of a novel self-expanding transcatheter heart valve.METHODS AND RESULTS: In this prospective, single-centre, first-in-human study, 13 patients with severe aortic stenosis suitable for transfemoral transcatheter aortic valve implantation were enrolled. Mean logistic EuroSCORE was 14.4±3.7% and mean STS PROM score was 4.3±1.6%. The primary endpoint, 30-day early safety composite per VARC-2, was observed in two patients (15.4%, one life-threatening bleeding and one valve-in-valve procedure). The implant was aborted in two patients due to unsuitable aortic anatomy. Overall, device success was obtained in nine patients (69.2%, two aborted implants, one valve-in-valve procedure and one patient with moderate aortic regurgitation). As determined by an independent core laboratory, all but one patient had less than moderate total aortic regurgitation at 30-day follow-up, mean aortic gradient was 6.7±2.3 mmHg and effective orifice area 1.8±0.3 cm. Pacemakers were implanted in three patients (23.1%), and no death, stroke, myocardial infarction or acute kidney failure was observed.CONCLUSIONS: In this first-in-human study, the feasibility of implantation of the BIOVALVE system and its re-sheathing functionality was demonstrated, and short-term safety data were encouraging. Larger studies are required to confirm the performance of the device.

AB - AIMS: Transcatheter aortic valve therapy has become an established procedure for patients at high risk for surgical valve replacement. The BIOVALVE-I study aims to assess the safety and performance of a novel self-expanding transcatheter heart valve.METHODS AND RESULTS: In this prospective, single-centre, first-in-human study, 13 patients with severe aortic stenosis suitable for transfemoral transcatheter aortic valve implantation were enrolled. Mean logistic EuroSCORE was 14.4±3.7% and mean STS PROM score was 4.3±1.6%. The primary endpoint, 30-day early safety composite per VARC-2, was observed in two patients (15.4%, one life-threatening bleeding and one valve-in-valve procedure). The implant was aborted in two patients due to unsuitable aortic anatomy. Overall, device success was obtained in nine patients (69.2%, two aborted implants, one valve-in-valve procedure and one patient with moderate aortic regurgitation). As determined by an independent core laboratory, all but one patient had less than moderate total aortic regurgitation at 30-day follow-up, mean aortic gradient was 6.7±2.3 mmHg and effective orifice area 1.8±0.3 cm. Pacemakers were implanted in three patients (23.1%), and no death, stroke, myocardial infarction or acute kidney failure was observed.CONCLUSIONS: In this first-in-human study, the feasibility of implantation of the BIOVALVE system and its re-sheathing functionality was demonstrated, and short-term safety data were encouraging. Larger studies are required to confirm the performance of the device.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve/diagnostic imaging

KW - Aortic Valve Stenosis/diagnosis

KW - Cardiac Catheterization/instrumentation

KW - Coronary Angiography

KW - Feasibility Studies

KW - Female

KW - Germany

KW - Heart Valve Prosthesis

KW - Heart Valve Prosthesis Implantation/instrumentation

KW - Humans

KW - Male

KW - Prospective Studies

KW - Prosthesis Design

KW - Severity of Illness Index

KW - Time Factors

KW - Treatment Outcome

U2 - 10.4244/EIJY15M05_05

DO - 10.4244/EIJY15M05_05

M3 - SCORING: Journal article

C2 - 25983028

VL - 11

SP - 785

EP - 792

JO - EUROINTERVENTION

JF - EUROINTERVENTION

SN - 1774-024X

IS - 7

ER -