Patients at intermediate surgical risk undergoing isolated interventional or surgical aortic valve implantation for severe symptomatic aortic valve stenosis: One-year results from the German aortic valve registry

Nicolas Werner; Ralf Zahn; Andreas Beckmann; Timm Bauer; Sabine Bleiziffer; Christian W. Hamm; Raffi Berkeredjian; Alexander Berkowitsch; Friedrich W. Mohr; Sandra Landwehr; Hugo A. Katus; Wolfgang Harringer; Stephan Ensminger; Christian Frerker; Helge Möllmann; Thomas Walther; Steffen Schneider; Rüdiger Lange

doi:10.1161/CIRCULATIONAHA.117.033048

Patients at intermediate surgical risk undergoing isolated interventional or surgical aortic valve implantation for severe symptomatic aortic valve stenosis: One-year results from the German aortic valve registry

Nicolas Werner^*, Ralf Zahn, Andreas Beckmann, Timm Bauer, Sabine Bleiziffer, Christian W. Hamm, Raffi Berkeredjian, Alexander Berkowitsch, Friedrich W. Mohr, Sandra Landwehr, Hugo A. Katus, Wolfgang Harringer, Stephan Ensminger, Christian Frerker, Helge Möllmann, Thomas Walther, Steffen Schneider, Rüdiger Lange

^*Corresponding author for this work

53 Citations (Scopus)

Abstract

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly being used for treatment of severe aortic valve stenosis in patients at intermediate risk for surgical aortic valve replacement (SAVR). Currently, real-world data comparing indications and clinical outcomes of patients at intermediate surgical risk undergoing isolated TAVR with those undergoing SAVR are scarce. METHODS: We compared clinical characteristics and outcomes of patients with intermediate surgical risk (Society of Thoracic Surgeons score 4%–8%) who underwent isolated TAVR or conventional SAVR within the prospective, all-comers German Aortic Valve Registry. RESULTS: A total of 7613 patients at intermediate surgical risk underwent isolated TAVR (n=6469) or SAVR (n=1144) at 92 sites in Germany between 2012 and 2014. Patients treated by TAVR were significantly older (82.5±5.0 versus 76.6±6.7 years, P<0.001) and had higher risk scores (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 21.2±12.3% versus 14.2±9.5%, P<0.001; Society of Thoracic Surgeons score: 5.6±1.1 versus 5.2±1.0, P<0.001). Multivariable analyses revealed that advanced age, coronary artery disease, New York Heart Association class III/IV, pulmonary hypertension, prior cardiac decompensation, elective procedure, arterial occlusive disease, no diabetes mellitus, and a smaller aortic valve area were associated with performing TAVR instead of SAVR (all P<0.001). Unadjusted in-hospital mortality rates were equal for TAVR and SAVR (3.6% versus 3.6%, P=0.976), whereas unadjusted 1-year mortality was significantly higher in patients after TAVR (17.5% versus 10.8%, P<0.001). After propensity score matching, the difference in 1-year mortality between patients with TAVR and SAVR was no longer significant (17.1% versus 15.7%, P=0.59). CONCLUSIONS: Patients at intermediate risk undergoing TAVR differ significantly from those treated with SAVR with regard to age and baseline characteristics. Isolated TAVR and SAVR were associated with an in-hospital mortality rate of 3.6%. In the propensity score analysis, there was no significant difference in 1-year mortality between patients with TAVR and SAVR.

Original language	English
Journal	Circulation
Volume	138
Issue number	23
Pages (from-to)	2611-2623
Number of pages	13
ISSN	0009-7322
DOIs	https://doi.org/10.1161/CIRCULATIONAHA.117.033048
Publication status	Published - 2018

Funding

This work was funded by the German Cardiac Society, German Society for Thoracic and Cardiovascular Surgery, and German Heart Foundation. Unrestricted grants were received from different medical product manufacturers: Edwards Lifesciences Germany GmbH, Medtronic GmbH, Sorin Group – LivaNova, Abbott GmbH & Co. KG, and Boston Scientific Medizintechnik GmbH. Donations from foundations and medical product manufacturers were Deutsche Herzstif-tung, Dr. Rolf. M. Schreite Stiftung, and the Maquet-Gettinge Group. Dr Zahn received research grants from Medtronic and Edwards. Dr Hamm received speakers’ honoraria from Medtronic and Edwards and serves in the advisory board of Medtronic. Dr Ensminger was a proctor and consultant for Edwards Lifesciences, was a proctor and member of the scientific advisory board of JenaValve, received speakers’ honoraria from Edwards Lifesciences and Symetis, and received travel compensation from Edwards Lifesciences and Symetis. Dr Frerker received a proctors’ salary from Medtronic, St Jude Medical, and Boston Scientific and speakers’ honoraria from Edwards Life-sciences. Dr Möllmann received proctor and/or speakers’ honoraria from Boston Scientific, Edwards Lifesciences, St Jude Medical, and Symetis. Dr Lange reported lecture fees, advisory board membership, and royalties from Medtronic; lecture fees from LivaNova; lecture fees from and shares in Highlife; and lecture fees from St Jude Medical. Drs Werner, Beckmann, Bauer, Mohr, Berkowitsch, Landwehr, Katus, Harringer, Walther, and Schneider report no conflict.

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Werner, N., Zahn, R., Beckmann, A., Bauer, T., Bleiziffer, S., Hamm, C. W., Berkeredjian, R., Berkowitsch, A., Mohr, F. W., Landwehr, S., Katus, H. A., Harringer, W., Ensminger, S., Frerker, C., Möllmann, H., Walther, T., Schneider, S., & Lange, R. (2018). Patients at intermediate surgical risk undergoing isolated interventional or surgical aortic valve implantation for severe symptomatic aortic valve stenosis: One-year results from the German aortic valve registry. Circulation, 138(23), 2611-2623. https://doi.org/10.1161/CIRCULATIONAHA.117.033048

@article{756a0d60fc034b03b4a7f42b4b4cf6cf,

title = "Patients at intermediate surgical risk undergoing isolated interventional or surgical aortic valve implantation for severe symptomatic aortic valve stenosis: One-year results from the German aortic valve registry",

abstract = "BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly being used for treatment of severe aortic valve stenosis in patients at intermediate risk for surgical aortic valve replacement (SAVR). Currently, real-world data comparing indications and clinical outcomes of patients at intermediate surgical risk undergoing isolated TAVR with those undergoing SAVR are scarce. METHODS: We compared clinical characteristics and outcomes of patients with intermediate surgical risk (Society of Thoracic Surgeons score 4\%–8\%) who underwent isolated TAVR or conventional SAVR within the prospective, all-comers German Aortic Valve Registry. RESULTS: A total of 7613 patients at intermediate surgical risk underwent isolated TAVR (n=6469) or SAVR (n=1144) at 92 sites in Germany between 2012 and 2014. Patients treated by TAVR were significantly older (82.5±5.0 versus 76.6±6.7 years, P<0.001) and had higher risk scores (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 21.2±12.3\% versus 14.2±9.5\%, P<0.001; Society of Thoracic Surgeons score: 5.6±1.1 versus 5.2±1.0, P<0.001). Multivariable analyses revealed that advanced age, coronary artery disease, New York Heart Association class III/IV, pulmonary hypertension, prior cardiac decompensation, elective procedure, arterial occlusive disease, no diabetes mellitus, and a smaller aortic valve area were associated with performing TAVR instead of SAVR (all P<0.001). Unadjusted in-hospital mortality rates were equal for TAVR and SAVR (3.6\% versus 3.6\%, P=0.976), whereas unadjusted 1-year mortality was significantly higher in patients after TAVR (17.5\% versus 10.8\%, P<0.001). After propensity score matching, the difference in 1-year mortality between patients with TAVR and SAVR was no longer significant (17.1\% versus 15.7\%, P=0.59). CONCLUSIONS: Patients at intermediate risk undergoing TAVR differ significantly from those treated with SAVR with regard to age and baseline characteristics. Isolated TAVR and SAVR were associated with an in-hospital mortality rate of 3.6\%. In the propensity score analysis, there was no significant difference in 1-year mortality between patients with TAVR and SAVR.",

author = "Nicolas Werner and Ralf Zahn and Andreas Beckmann and Timm Bauer and Sabine Bleiziffer and Hamm, \{Christian W.\} and Raffi Berkeredjian and Alexander Berkowitsch and Mohr, \{Friedrich W.\} and Sandra Landwehr and Katus, \{Hugo A.\} and Wolfgang Harringer and Stephan Ensminger and Christian Frerker and Helge M{\"o}llmann and Thomas Walther and Steffen Schneider and R{\"u}diger Lange",

note = "Funding Information: This work was funded by the German Cardiac Society, German Society for Thoracic and Cardiovascular Surgery, and German Heart Foundation. Unrestricted grants were received from different medical product manufacturers: Edwards Lifesciences Germany GmbH, Medtronic GmbH, Sorin Group – LivaNova, Abbott GmbH \& Co. KG, and Boston Scientific Medizintechnik GmbH. Donations from foundations and medical product manufacturers were Deutsche Herzstif-tung, Dr. Rolf. M. Schreite Stiftung, and the Maquet-Gettinge Group. Funding Information: Dr Zahn received research grants from Medtronic and Edwards. Dr Hamm received speakers{\textquoteright} honoraria from Medtronic and Edwards and serves in the advisory board of Medtronic. Dr Ensminger was a proctor and consultant for Edwards Lifesciences, was a proctor and member of the scientific advisory board of JenaValve, received speakers{\textquoteright} honoraria from Edwards Lifesciences and Symetis, and received travel compensation from Edwards Lifesciences and Symetis. Dr Frerker received a proctors{\textquoteright} salary from Medtronic, St Jude Medical, and Boston Scientific and speakers{\textquoteright} honoraria from Edwards Life-sciences. Dr M{\"o}llmann received proctor and/or speakers{\textquoteright} honoraria from Boston Scientific, Edwards Lifesciences, St Jude Medical, and Symetis. Dr Lange reported lecture fees, advisory board membership, and royalties from Medtronic; lecture fees from LivaNova; lecture fees from and shares in Highlife; and lecture fees from St Jude Medical. Drs Werner, Beckmann, Bauer, Mohr, Berkowitsch, Landwehr, Katus, Harringer, Walther, and Schneider report no conflict. Publisher Copyright: {\textcopyright} 2018 American Heart Association, Inc. Copyright: Copyright 2019 Elsevier B.V., All rights reserved.",

year = "2018",

doi = "10.1161/CIRCULATIONAHA.117.033048",

language = "English",

volume = "138",

pages = "2611--2623",

journal = "Circulation",

issn = "0009-7322",

publisher = "Lippincott Williams and Wilkins",

number = "23",

}

Werner, N, Zahn, R, Beckmann, A, Bauer, T, Bleiziffer, S, Hamm, CW, Berkeredjian, R, Berkowitsch, A, Mohr, FW, Landwehr, S, Katus, HA, Harringer, W, Ensminger, S, Frerker, C, Möllmann, H, Walther, T, Schneider, S & Lange, R 2018, 'Patients at intermediate surgical risk undergoing isolated interventional or surgical aortic valve implantation for severe symptomatic aortic valve stenosis: One-year results from the German aortic valve registry', Circulation, vol. 138, no. 23, pp. 2611-2623. https://doi.org/10.1161/CIRCULATIONAHA.117.033048

Patients at intermediate surgical risk undergoing isolated interventional or surgical aortic valve implantation for severe symptomatic aortic valve stenosis: One-year results from the German aortic valve registry. / Werner, Nicolas; Zahn, Ralf; Beckmann, Andreas et al.
In: Circulation, Vol. 138, No. 23, 2018, p. 2611-2623.

Research output: Journal Articles › Journal articles › Research › peer-review

TY - JOUR

T1 - Patients at intermediate surgical risk undergoing isolated interventional or surgical aortic valve implantation for severe symptomatic aortic valve stenosis: One-year results from the German aortic valve registry

AU - Werner, Nicolas

AU - Zahn, Ralf

AU - Beckmann, Andreas

AU - Bauer, Timm

AU - Bleiziffer, Sabine

AU - Hamm, Christian W.

AU - Berkeredjian, Raffi

AU - Berkowitsch, Alexander

AU - Mohr, Friedrich W.

AU - Landwehr, Sandra

AU - Katus, Hugo A.

AU - Harringer, Wolfgang

AU - Ensminger, Stephan

AU - Frerker, Christian

AU - Möllmann, Helge

AU - Walther, Thomas

AU - Schneider, Steffen

AU - Lange, Rüdiger

N1 - Funding Information: This work was funded by the German Cardiac Society, German Society for Thoracic and Cardiovascular Surgery, and German Heart Foundation. Unrestricted grants were received from different medical product manufacturers: Edwards Lifesciences Germany GmbH, Medtronic GmbH, Sorin Group – LivaNova, Abbott GmbH & Co. KG, and Boston Scientific Medizintechnik GmbH. Donations from foundations and medical product manufacturers were Deutsche Herzstif-tung, Dr. Rolf. M. Schreite Stiftung, and the Maquet-Gettinge Group. Funding Information: Dr Zahn received research grants from Medtronic and Edwards. Dr Hamm received speakers’ honoraria from Medtronic and Edwards and serves in the advisory board of Medtronic. Dr Ensminger was a proctor and consultant for Edwards Lifesciences, was a proctor and member of the scientific advisory board of JenaValve, received speakers’ honoraria from Edwards Lifesciences and Symetis, and received travel compensation from Edwards Lifesciences and Symetis. Dr Frerker received a proctors’ salary from Medtronic, St Jude Medical, and Boston Scientific and speakers’ honoraria from Edwards Life-sciences. Dr Möllmann received proctor and/or speakers’ honoraria from Boston Scientific, Edwards Lifesciences, St Jude Medical, and Symetis. Dr Lange reported lecture fees, advisory board membership, and royalties from Medtronic; lecture fees from LivaNova; lecture fees from and shares in Highlife; and lecture fees from St Jude Medical. Drs Werner, Beckmann, Bauer, Mohr, Berkowitsch, Landwehr, Katus, Harringer, Walther, and Schneider report no conflict. Publisher Copyright: © 2018 American Heart Association, Inc. Copyright: Copyright 2019 Elsevier B.V., All rights reserved.

PY - 2018

Y1 - 2018

N2 - BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly being used for treatment of severe aortic valve stenosis in patients at intermediate risk for surgical aortic valve replacement (SAVR). Currently, real-world data comparing indications and clinical outcomes of patients at intermediate surgical risk undergoing isolated TAVR with those undergoing SAVR are scarce. METHODS: We compared clinical characteristics and outcomes of patients with intermediate surgical risk (Society of Thoracic Surgeons score 4%–8%) who underwent isolated TAVR or conventional SAVR within the prospective, all-comers German Aortic Valve Registry. RESULTS: A total of 7613 patients at intermediate surgical risk underwent isolated TAVR (n=6469) or SAVR (n=1144) at 92 sites in Germany between 2012 and 2014. Patients treated by TAVR were significantly older (82.5±5.0 versus 76.6±6.7 years, P<0.001) and had higher risk scores (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 21.2±12.3% versus 14.2±9.5%, P<0.001; Society of Thoracic Surgeons score: 5.6±1.1 versus 5.2±1.0, P<0.001). Multivariable analyses revealed that advanced age, coronary artery disease, New York Heart Association class III/IV, pulmonary hypertension, prior cardiac decompensation, elective procedure, arterial occlusive disease, no diabetes mellitus, and a smaller aortic valve area were associated with performing TAVR instead of SAVR (all P<0.001). Unadjusted in-hospital mortality rates were equal for TAVR and SAVR (3.6% versus 3.6%, P=0.976), whereas unadjusted 1-year mortality was significantly higher in patients after TAVR (17.5% versus 10.8%, P<0.001). After propensity score matching, the difference in 1-year mortality between patients with TAVR and SAVR was no longer significant (17.1% versus 15.7%, P=0.59). CONCLUSIONS: Patients at intermediate risk undergoing TAVR differ significantly from those treated with SAVR with regard to age and baseline characteristics. Isolated TAVR and SAVR were associated with an in-hospital mortality rate of 3.6%. In the propensity score analysis, there was no significant difference in 1-year mortality between patients with TAVR and SAVR.

AB - BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly being used for treatment of severe aortic valve stenosis in patients at intermediate risk for surgical aortic valve replacement (SAVR). Currently, real-world data comparing indications and clinical outcomes of patients at intermediate surgical risk undergoing isolated TAVR with those undergoing SAVR are scarce. METHODS: We compared clinical characteristics and outcomes of patients with intermediate surgical risk (Society of Thoracic Surgeons score 4%–8%) who underwent isolated TAVR or conventional SAVR within the prospective, all-comers German Aortic Valve Registry. RESULTS: A total of 7613 patients at intermediate surgical risk underwent isolated TAVR (n=6469) or SAVR (n=1144) at 92 sites in Germany between 2012 and 2014. Patients treated by TAVR were significantly older (82.5±5.0 versus 76.6±6.7 years, P<0.001) and had higher risk scores (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 21.2±12.3% versus 14.2±9.5%, P<0.001; Society of Thoracic Surgeons score: 5.6±1.1 versus 5.2±1.0, P<0.001). Multivariable analyses revealed that advanced age, coronary artery disease, New York Heart Association class III/IV, pulmonary hypertension, prior cardiac decompensation, elective procedure, arterial occlusive disease, no diabetes mellitus, and a smaller aortic valve area were associated with performing TAVR instead of SAVR (all P<0.001). Unadjusted in-hospital mortality rates were equal for TAVR and SAVR (3.6% versus 3.6%, P=0.976), whereas unadjusted 1-year mortality was significantly higher in patients after TAVR (17.5% versus 10.8%, P<0.001). After propensity score matching, the difference in 1-year mortality between patients with TAVR and SAVR was no longer significant (17.1% versus 15.7%, P=0.59). CONCLUSIONS: Patients at intermediate risk undergoing TAVR differ significantly from those treated with SAVR with regard to age and baseline characteristics. Isolated TAVR and SAVR were associated with an in-hospital mortality rate of 3.6%. In the propensity score analysis, there was no significant difference in 1-year mortality between patients with TAVR and SAVR.

UR - https://www.scopus.com/pages/publications/85058917569

U2 - 10.1161/CIRCULATIONAHA.117.033048

DO - 10.1161/CIRCULATIONAHA.117.033048

M3 - Journal articles

C2 - 30571255

AN - SCOPUS:85058917569

SN - 0009-7322

VL - 138

SP - 2611

EP - 2623

JO - Circulation

JF - Circulation

IS - 23

ER -

Patients at intermediate surgical risk undergoing isolated interventional or surgical aortic valve implantation for severe symptomatic aortic valve stenosis: One-year results from the German aortic valve registry

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