Nicolas Werner1, Ralf Zahn2, Andreas Beckmann3, Timm Bauer, Sabine Bleiziffer4, Christian W Hamm5, Raffi Berkeredjian6, Alexander Berkowitsch5, Friedrich W Mohr7, Sandra Landwehr8, Hugo A Katus6, Wolfgang Harringer9, Stephan Ensminger10, Christian Frerker11, Helge Möllmann12, Thomas Walther13, Steffen Schneider14, Rüdiger Lange4. 1. Medizinische Klinik B, Klinikum Ludwigshafen, Germany (N.W., R.Z.). 2. Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie, Langenbeck-Virchow-Haus Berlin, Germany (A. Beckmann). 3. Kardiologie-Angiologie, Universitätsklinikum Gießen, Germany (T.B., C.W.H.). 4. Klinik für Herz- und Gefäßchirurgie, Deutsches Herzzentrum München, Germany (S.B., R.L.). 5. Kardiologie, Kerckhoff Klinik, Bad Nauheim, Germany (C.W.H., A. Berkowitsch). 6. Klinik für Kardiologie, Angiologie, Pneumologie, Universitätsklinikum Heidelberg, Germany (R.B., H.A.K.). 7. Herzzentrum Leipzig, Universitätsklinik Leipzig, Germany (F.W.M.). 8. Bundesgeschäftsstelle Qualitätssicherung Institut für Qualität und Patientensicherheit GmbH, Düsseldorf, Germany (S.L.). 9. Herzchirurgie, Klinikum Braunschweig, Germany (W.H.). 10. Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum Nordrhein-Westfalen, Universitätsklinik der Ruhr-Universität Bochum, Bad Oeynhausen, Germany (S.E.). 11. Kardiologie, Asklepios Klinik St. Georg, Hamburg, Germany (C.F.). 12. Klinik für Innere Medizin I, St.-Johannes-Hospital Dortmund, Germany (H.M.). 13. Herzchirurgie, Kerckhoff Klinik, Bad Nauheim, Germany (T.W.). 14. Institut für Herzinfarktforschung, Ludwigshafen, Germany (S.S.).
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.
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.
Authors: Luise Gaede; Johannes Blumenstein; Christoph Liebetrau; Oliver Dörr; Won-Keun Kim; Holger Nef; Oliver Husser; Jan Gülker; Albrecht Elsässer; Christian W Hamm; Stephan Achenbach; Helge Möllmann Journal: Clin Res Cardiol Date: 2019-06-24 Impact factor: 5.460