Research ExplorerPublicationsTranscatheter aortic valve implantation using the ACURATE TA...

Transcatheter aortic valve implantation using the ACURATE TA™ system: 1-year outcomes and comparison of 500 patients from the SAVI registries

Standard

Transcatheter aortic valve implantation using the ACURATE TA™ system: 1-year outcomes and comparison of 500 patients from the SAVI registries. / Börgermann, Jochen; Holzhey, David M; Thielmann, Matthias; Girdauskas, Evaldas; Schroefel, Holger; Hofmann, Steffen; Treede, Hendrik; Matschke, Klaus; Hilker, Michael; Strauch, Justus T; Carrel, Thierry; Wahlers, Thorsten; Diegeler, Anno; Kempfert, Jörg; Walther, Thomas.

In: EUR J CARDIO-THORAC, Vol. 51, No. 5, 01.05.2017, p. 936-942.

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

Harvard

Börgermann, J, Holzhey, DM, Thielmann, M, Girdauskas, E, Schroefel, H, Hofmann, S, Treede, H, Matschke, K, Hilker, M, Strauch, JT, Carrel, T, Wahlers, T, Diegeler, A, Kempfert, J & Walther, T 2017, 'Transcatheter aortic valve implantation using the ACURATE TA™ system: 1-year outcomes and comparison of 500 patients from the SAVI registries', EUR J CARDIO-THORAC, vol. 51, no. 5, pp. 936-942. https://doi.org/10.1093/ejcts/ezw423

APA

Börgermann, J., Holzhey, D. M., Thielmann, M., Girdauskas, E., Schroefel, H., Hofmann, S., Treede, H., Matschke, K., Hilker, M., Strauch, J. T., Carrel, T., Wahlers, T., Diegeler, A., Kempfert, J., & Walther, T. (2017). Transcatheter aortic valve implantation using the ACURATE TA™ system: 1-year outcomes and comparison of 500 patients from the SAVI registries. EUR J CARDIO-THORAC, 51(5), 936-942. https://doi.org/10.1093/ejcts/ezw423

Vancouver

Börgermann J, Holzhey DM, Thielmann M, Girdauskas E, Schroefel H, Hofmann S et al. Transcatheter aortic valve implantation using the ACURATE TA™ system: 1-year outcomes and comparison of 500 patients from the SAVI registries. EUR J CARDIO-THORAC. 2017 May 1;51(5):936-942. https://doi.org/10.1093/ejcts/ezw423

Bibtex

@article{2820d757b294479f8898de5feb3dc59e,
title = "Transcatheter aortic valve implantation using the ACURATE TA{\texttrademark} system: 1-year outcomes and comparison of 500 patients from the SAVI registries",
abstract = "OBJECTIVES: The ACURATE TA TM system is a self-expanding transcatheter heart valve system designed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials. The SAVI-1 and SAVI-2 registries aimed to assess whether these promising outcomes can be translated into all-comers clinical routine.METHODS: From November 2011 to 2012 (SAVI-1), and November 2013 to 2014 (SAVI-2), a total of 500 patients were enrolled in the prospective, all-comers, multicentre, multinational SAVI registries. Patients were treated according to the standard of care at their respective hospitals. We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2.RESULTS: Patients were 80.8 ± 6.1 years old, the mean logistic EuroSCORE-I was 23.4 ± 14.3%. Valves were deployed under rapid pacing in 71.3% of the procedures in SAVI-1, and in 3.6% in SAVI-2. There was no relevant difference in clinical and echocardiographic outcomes between SAVI-1 and SAVI-2. Overall mortality at 30 days and 1 year was 6.8% and 19.9%, the stroke rate was 2.2% and 3.7%, respectively; 10.2% of patients had received a permanent pacemaker, and no transcatheter valve-related complications after discharge were observed. Paravalvular leakage ≥2+ was reported in 1.9% of the patients at the early follow-up, and in 2.6% at the 1-year follow-up.CONCLUSIONS: The SAVI-registries have confirmed that transapical implantation using the ACURATE TA TM device is safe and effective in an all-comers setting with low complication rates and stable performance outcomes at short-term and 1 year; outcomes were similar between SAVI-1 and -2.",
keywords = "Aged, Aged, 80 and over, Aortic Valve/surgery, Female, Heart Valve Prosthesis, Humans, Kaplan-Meier Estimate, Male, Prospective Studies, Prosthesis Design, Registries, Transcatheter Aortic Valve Replacement/instrumentation, Treatment Outcome",
author = "Jochen B{\"o}rgermann and Holzhey, {David M} and Matthias Thielmann and Evaldas Girdauskas and Holger Schroefel and Steffen Hofmann and Hendrik Treede and Klaus Matschke and Michael Hilker and Strauch, {Justus T} and Thierry Carrel and Thorsten Wahlers and Anno Diegeler and J{\"o}rg Kempfert and Thomas Walther",
note = "{\textcopyright} The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.",
year = "2017",
month = may,
day = "1",
doi = "10.1093/ejcts/ezw423",
language = "English",
volume = "51",
pages = "936--942",
journal = "EUR J CARDIO-THORAC",
issn = "1010-7940",
publisher = "Elsevier",
number = "5",

}

RIS

TY - JOUR

T1 - Transcatheter aortic valve implantation using the ACURATE TA™ system: 1-year outcomes and comparison of 500 patients from the SAVI registries

AU - Börgermann, Jochen

AU - Holzhey, David M

AU - Thielmann, Matthias

AU - Girdauskas, Evaldas

AU - Schroefel, Holger

AU - Hofmann, Steffen

AU - Treede, Hendrik

AU - Matschke, Klaus

AU - Hilker, Michael

AU - Strauch, Justus T

AU - Carrel, Thierry

AU - Wahlers, Thorsten

AU - Diegeler, Anno

AU - Kempfert, Jörg

AU - Walther, Thomas

N1 - © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.

PY - 2017/5/1

Y1 - 2017/5/1

N2 - OBJECTIVES: The ACURATE TA TM system is a self-expanding transcatheter heart valve system designed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials. The SAVI-1 and SAVI-2 registries aimed to assess whether these promising outcomes can be translated into all-comers clinical routine.METHODS: From November 2011 to 2012 (SAVI-1), and November 2013 to 2014 (SAVI-2), a total of 500 patients were enrolled in the prospective, all-comers, multicentre, multinational SAVI registries. Patients were treated according to the standard of care at their respective hospitals. We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2.RESULTS: Patients were 80.8 ± 6.1 years old, the mean logistic EuroSCORE-I was 23.4 ± 14.3%. Valves were deployed under rapid pacing in 71.3% of the procedures in SAVI-1, and in 3.6% in SAVI-2. There was no relevant difference in clinical and echocardiographic outcomes between SAVI-1 and SAVI-2. Overall mortality at 30 days and 1 year was 6.8% and 19.9%, the stroke rate was 2.2% and 3.7%, respectively; 10.2% of patients had received a permanent pacemaker, and no transcatheter valve-related complications after discharge were observed. Paravalvular leakage ≥2+ was reported in 1.9% of the patients at the early follow-up, and in 2.6% at the 1-year follow-up.CONCLUSIONS: The SAVI-registries have confirmed that transapical implantation using the ACURATE TA TM device is safe and effective in an all-comers setting with low complication rates and stable performance outcomes at short-term and 1 year; outcomes were similar between SAVI-1 and -2.

AB - OBJECTIVES: The ACURATE TA TM system is a self-expanding transcatheter heart valve system designed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials. The SAVI-1 and SAVI-2 registries aimed to assess whether these promising outcomes can be translated into all-comers clinical routine.METHODS: From November 2011 to 2012 (SAVI-1), and November 2013 to 2014 (SAVI-2), a total of 500 patients were enrolled in the prospective, all-comers, multicentre, multinational SAVI registries. Patients were treated according to the standard of care at their respective hospitals. We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2.RESULTS: Patients were 80.8 ± 6.1 years old, the mean logistic EuroSCORE-I was 23.4 ± 14.3%. Valves were deployed under rapid pacing in 71.3% of the procedures in SAVI-1, and in 3.6% in SAVI-2. There was no relevant difference in clinical and echocardiographic outcomes between SAVI-1 and SAVI-2. Overall mortality at 30 days and 1 year was 6.8% and 19.9%, the stroke rate was 2.2% and 3.7%, respectively; 10.2% of patients had received a permanent pacemaker, and no transcatheter valve-related complications after discharge were observed. Paravalvular leakage ≥2+ was reported in 1.9% of the patients at the early follow-up, and in 2.6% at the 1-year follow-up.CONCLUSIONS: The SAVI-registries have confirmed that transapical implantation using the ACURATE TA TM device is safe and effective in an all-comers setting with low complication rates and stable performance outcomes at short-term and 1 year; outcomes were similar between SAVI-1 and -2.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve/surgery

KW - Female

KW - Heart Valve Prosthesis

KW - Humans

KW - Kaplan-Meier Estimate

KW - Male

KW - Prospective Studies

KW - Prosthesis Design

KW - Registries

KW - Transcatheter Aortic Valve Replacement/instrumentation

KW - Treatment Outcome

U2 - 10.1093/ejcts/ezw423

DO - 10.1093/ejcts/ezw423

M3 - SCORING: Journal article

C2 - 28175264

VL - 51

SP - 936

EP - 942

JO - EUR J CARDIO-THORAC

JF - EUR J CARDIO-THORAC

SN - 1010-7940

IS - 5

ER -