Research ExplorerPublicationsThe SAVI-TF Registry: 1-Year Outcomes of the European Post-M...

The SAVI-TF Registry: 1-Year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients

Standard

The SAVI-TF Registry: 1-Year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients. / Kim, Won-Keun; Hengstenberg, Christian; Hilker, Michael; Kerber, Sebastian; Schäfer, Ulrich; Rudolph, Tanja; Linke, Axel; Franz, Norbert; Kuntze, Thomas; Nef, Holger; Kappert, Utz; Zembala, Michael O; Toggweiler, Stefan; Walther, Thomas; Möllmann, Helge.

In: JACC-CARDIOVASC INTE, Vol. 11, No. 14, 23.07.2018, p. 1368-1374.

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

Harvard

Kim, W-K, Hengstenberg, C, Hilker, M, Kerber, S, Schäfer, U, Rudolph, T, Linke, A, Franz, N, Kuntze, T, Nef, H, Kappert, U, Zembala, MO, Toggweiler, S, Walther, T & Möllmann, H 2018, 'The SAVI-TF Registry: 1-Year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients', JACC-CARDIOVASC INTE, vol. 11, no. 14, pp. 1368-1374. https://doi.org/10.1016/j.jcin.2018.03.023

APA

Kim, W-K., Hengstenberg, C., Hilker, M., Kerber, S., Schäfer, U., Rudolph, T., Linke, A., Franz, N., Kuntze, T., Nef, H., Kappert, U., Zembala, M. O., Toggweiler, S., Walther, T., & Möllmann, H. (2018). The SAVI-TF Registry: 1-Year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients. JACC-CARDIOVASC INTE, 11(14), 1368-1374. https://doi.org/10.1016/j.jcin.2018.03.023

Vancouver

Kim W-K, Hengstenberg C, Hilker M, Kerber S, Schäfer U, Rudolph T et al. The SAVI-TF Registry: 1-Year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients. JACC-CARDIOVASC INTE. 2018 Jul 23;11(14):1368-1374. https://doi.org/10.1016/j.jcin.2018.03.023

Bibtex

@article{123f593d596242ba81f83cd66ef3514d,
title = "The SAVI-TF Registry: 1-Year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients",
abstract = "OBJECTIVES: The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions.BACKGROUND: The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformit{\'e} Europ{\'e}ene mark in 2014, but only limited clinical data are available so far.METHODS: This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure.RESULTS: Mean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cm2, mean gradient was 7.3 ± 3.7 mm Hg, and greater than mild paravalvular leakage was observed in 3.6% of patients.CONCLUSIONS: Transfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.",
keywords = "Aged, Aged, 80 and over, Aortic Valve/diagnostic imaging, Aortic Valve Stenosis/diagnostic imaging, Bioprosthesis, Calcinosis/diagnostic imaging, Cardiac Pacing, Artificial, Europe, Female, Heart Valve Prosthesis, Hemodynamics, Humans, Male, Postoperative Complications/mortality, Product Surveillance, Postmarketing, Prospective Studies, Prosthesis Design, Recovery of Function, Registries, Risk Factors, Time Factors, Transcatheter Aortic Valve Replacement/adverse effects, Treatment Outcome",
author = "Won-Keun Kim 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 Zembala, {Michael O} and Stefan Toggweiler and Thomas Walther and Helge M{\"o}llmann",
note = "Copyright {\textcopyright} 2018 The Authors. Published by Elsevier Inc. All rights reserved.",
year = "2018",
month = jul,
day = "23",
doi = "10.1016/j.jcin.2018.03.023",
language = "English",
volume = "11",
pages = "1368--1374",
journal = "JACC-CARDIOVASC INTE",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "14",

}

RIS

TY - JOUR

T1 - The SAVI-TF Registry: 1-Year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients

AU - Kim, Won-Keun

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 - Zembala, Michael O

AU - Toggweiler, Stefan

AU - Walther, Thomas

AU - Möllmann, Helge

N1 - Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

PY - 2018/7/23

Y1 - 2018/7/23

N2 - OBJECTIVES: The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions.BACKGROUND: The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformité Européene mark in 2014, but only limited clinical data are available so far.METHODS: This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure.RESULTS: Mean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cm2, mean gradient was 7.3 ± 3.7 mm Hg, and greater than mild paravalvular leakage was observed in 3.6% of patients.CONCLUSIONS: Transfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.

AB - OBJECTIVES: The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions.BACKGROUND: The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformité Européene mark in 2014, but only limited clinical data are available so far.METHODS: This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure.RESULTS: Mean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cm2, mean gradient was 7.3 ± 3.7 mm Hg, and greater than mild paravalvular leakage was observed in 3.6% of patients.CONCLUSIONS: Transfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve/diagnostic imaging

KW - Aortic Valve Stenosis/diagnostic imaging

KW - Bioprosthesis

KW - Calcinosis/diagnostic imaging

KW - Cardiac Pacing, Artificial

KW - Europe

KW - Female

KW - Heart Valve Prosthesis

KW - Hemodynamics

KW - Humans

KW - Male

KW - Postoperative Complications/mortality

KW - Product Surveillance, Postmarketing

KW - Prospective Studies

KW - Prosthesis Design

KW - Recovery of Function

KW - Registries

KW - Risk Factors

KW - Time Factors

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Treatment Outcome

U2 - 10.1016/j.jcin.2018.03.023

DO - 10.1016/j.jcin.2018.03.023

M3 - SCORING: Journal article

C2 - 30025731

VL - 11

SP - 1368

EP - 1374

JO - JACC-CARDIOVASC INTE

JF - JACC-CARDIOVASC INTE

SN - 1936-8798

IS - 14

ER -