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Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registry

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Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registry. / Möllmann, Helge; Hengstenberg, Christian; Hilker, Michael; Kerber, Sebastian; Schäfer, Ulrich; Rudolph, Tanja; Linke, Axel; Franz, Norbert; Kuntze, Thomas; Nef, Holger; Kappert, Utz; Walther, Thomas; Zembala, Michael O; Toggweiler, Stefan; Kim, Won-Keun.

In: EUROINTERVENTION, Vol. 13, No. 15, 02.02.2018, p. e1764-e1770.

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

Harvard

Möllmann, H, Hengstenberg, C, Hilker, M, Kerber, S, Schäfer, U, Rudolph, T, Linke, A, Franz, N, Kuntze, T, Nef, H, Kappert, U, Walther, T, Zembala, MO, Toggweiler, S & Kim, W-K 2018, 'Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registry', EUROINTERVENTION, vol. 13, no. 15, pp. e1764-e1770. https://doi.org/10.4244/EIJ-D-17-00628

APA

Möllmann, H., Hengstenberg, C., Hilker, M., Kerber, S., Schäfer, U., Rudolph, T., Linke, A., Franz, N., Kuntze, T., Nef, H., Kappert, U., Walther, T., Zembala, M. O., Toggweiler, S., & Kim, W-K. (2018). Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registry. EUROINTERVENTION, 13(15), e1764-e1770. https://doi.org/10.4244/EIJ-D-17-00628

Vancouver

Möllmann H, Hengstenberg C, Hilker M, Kerber S, Schäfer U, Rudolph T et al. Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registry. EUROINTERVENTION. 2018 Feb 2;13(15):e1764-e1770. https://doi.org/10.4244/EIJ-D-17-00628

Bibtex

@article{de09ef33392246808855abfa342ae44c,
title = "Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registry",
abstract = "AIMS: The aim of the SAVI TF registry was to assess the safety and performance of the self-expanding ACURATE neo transfemoral transcatheter heart valve in a large patient population with severe aortic stenosis and to investigate whether the outcomes obtained in the CE-mark cohort can be replicated in an unselected all-comers population.METHODS AND RESULTS: From October 2014 until April 2016, 1,000 patients were enrolled in this prospective, European multicentre registry. Patients were 81.1±5.2 years and had a logistic EuroSCORE II and STS score of 6.6±7.5% and 6.0±5.6%, respectively. Predilatation was performed in 96.1% of patients and postdilatation in 44.8%. Procedural and device success were both obtained in 98.7%; failure comprised nine valve-in-valve procedures, three conversions to surgery, and one aborted procedure. The primary endpoint was 30-day mortality, which was observed in 14 patients (1.4% [95% CI: 0.7-2.1]). Disabling stroke was seen in 1.2% (95% CI: 0.5-1.9) and new pacemaker implantation in 8.3% (95% CI: 6.6-10.0). At discharge, mean effective orifice area was 1.77±0.46 cm² and mean gradient 8.4±4.0 mmHg; 4.1% of patients had a more than mild paravalvular leak.CONCLUSIONS: In this initial experience, treatment with the ACURATE neo prosthesis resulted in good clinical outcomes with very low complication rates.",
keywords = "Aged, Aged, 80 and over, Aortic Valve/diagnostic imaging, Aortic Valve Stenosis/diagnostic imaging, Arrhythmias, Cardiac/epidemiology, Balloon Valvuloplasty, Bioprosthesis, Cardiac Pacing, Artificial, Catheterization, Peripheral/methods, Disability Evaluation, Europe/epidemiology, Female, Femoral Artery, Heart Valve Prosthesis, Humans, Male, Pacemaker, Artificial, Prospective Studies, Prosthesis Design, Registries, Risk Factors, Severity of Illness Index, Stroke/diagnosis, Time Factors, Transcatheter Aortic Valve Replacement/adverse effects, Treatment Outcome",
author = "Helge M{\"o}llmann and Christian Hengstenberg and Michael Hilker and Sebastian Kerber and Ulrich Sch{\"a}fer and Tanja Rudolph and Axel Linke and Norbert Franz and Thomas Kuntze and Holger Nef and Utz Kappert and Thomas Walther and Zembala, {Michael O} and Stefan Toggweiler and Won-Keun Kim",
year = "2018",
month = feb,
day = "2",
doi = "10.4244/EIJ-D-17-00628",
language = "English",
volume = "13",
pages = "e1764--e1770",
journal = "EUROINTERVENTION",
issn = "1774-024X",
publisher = "EUROPA EDITION",
number = "15",

}

RIS

TY - JOUR

T1 - Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registry

AU - Möllmann, Helge

AU - Hengstenberg, Christian

AU - Hilker, Michael

AU - Kerber, Sebastian

AU - Schäfer, Ulrich

AU - Rudolph, Tanja

AU - Linke, Axel

AU - Franz, Norbert

AU - Kuntze, Thomas

AU - Nef, Holger

AU - Kappert, Utz

AU - Walther, Thomas

AU - Zembala, Michael O

AU - Toggweiler, Stefan

AU - Kim, Won-Keun

PY - 2018/2/2

Y1 - 2018/2/2

N2 - AIMS: The aim of the SAVI TF registry was to assess the safety and performance of the self-expanding ACURATE neo transfemoral transcatheter heart valve in a large patient population with severe aortic stenosis and to investigate whether the outcomes obtained in the CE-mark cohort can be replicated in an unselected all-comers population.METHODS AND RESULTS: From October 2014 until April 2016, 1,000 patients were enrolled in this prospective, European multicentre registry. Patients were 81.1±5.2 years and had a logistic EuroSCORE II and STS score of 6.6±7.5% and 6.0±5.6%, respectively. Predilatation was performed in 96.1% of patients and postdilatation in 44.8%. Procedural and device success were both obtained in 98.7%; failure comprised nine valve-in-valve procedures, three conversions to surgery, and one aborted procedure. The primary endpoint was 30-day mortality, which was observed in 14 patients (1.4% [95% CI: 0.7-2.1]). Disabling stroke was seen in 1.2% (95% CI: 0.5-1.9) and new pacemaker implantation in 8.3% (95% CI: 6.6-10.0). At discharge, mean effective orifice area was 1.77±0.46 cm² and mean gradient 8.4±4.0 mmHg; 4.1% of patients had a more than mild paravalvular leak.CONCLUSIONS: In this initial experience, treatment with the ACURATE neo prosthesis resulted in good clinical outcomes with very low complication rates.

AB - AIMS: The aim of the SAVI TF registry was to assess the safety and performance of the self-expanding ACURATE neo transfemoral transcatheter heart valve in a large patient population with severe aortic stenosis and to investigate whether the outcomes obtained in the CE-mark cohort can be replicated in an unselected all-comers population.METHODS AND RESULTS: From October 2014 until April 2016, 1,000 patients were enrolled in this prospective, European multicentre registry. Patients were 81.1±5.2 years and had a logistic EuroSCORE II and STS score of 6.6±7.5% and 6.0±5.6%, respectively. Predilatation was performed in 96.1% of patients and postdilatation in 44.8%. Procedural and device success were both obtained in 98.7%; failure comprised nine valve-in-valve procedures, three conversions to surgery, and one aborted procedure. The primary endpoint was 30-day mortality, which was observed in 14 patients (1.4% [95% CI: 0.7-2.1]). Disabling stroke was seen in 1.2% (95% CI: 0.5-1.9) and new pacemaker implantation in 8.3% (95% CI: 6.6-10.0). At discharge, mean effective orifice area was 1.77±0.46 cm² and mean gradient 8.4±4.0 mmHg; 4.1% of patients had a more than mild paravalvular leak.CONCLUSIONS: In this initial experience, treatment with the ACURATE neo prosthesis resulted in good clinical outcomes with very low complication rates.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve/diagnostic imaging

KW - Aortic Valve Stenosis/diagnostic imaging

KW - Arrhythmias, Cardiac/epidemiology

KW - Balloon Valvuloplasty

KW - Bioprosthesis

KW - Cardiac Pacing, Artificial

KW - Catheterization, Peripheral/methods

KW - Disability Evaluation

KW - Europe/epidemiology

KW - Female

KW - Femoral Artery

KW - Heart Valve Prosthesis

KW - Humans

KW - Male

KW - Pacemaker, Artificial

KW - Prospective Studies

KW - Prosthesis Design

KW - Registries

KW - Risk Factors

KW - Severity of Illness Index

KW - Stroke/diagnosis

KW - Time Factors

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Treatment Outcome

U2 - 10.4244/EIJ-D-17-00628

DO - 10.4244/EIJ-D-17-00628

M3 - SCORING: Journal article

C2 - 29131801

VL - 13

SP - e1764-e1770

JO - EUROINTERVENTION

JF - EUROINTERVENTION

SN - 1774-024X

IS - 15

ER -