Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement.

Autor:	Feistritzer HJ; Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany. Electronic address: https://twitter.com/feistritzerH_J., Kurz T; University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany; German Center for Cardiovascular Research (DZHK), Lübeck, Germany., Stachel G; Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany., Hartung P; Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany., Lurz P; Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany., Eitel I; University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany; German Center for Cardiovascular Research (DZHK), Lübeck, Germany., Marquetand C; University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany; German Center for Cardiovascular Research (DZHK), Lübeck, Germany., Nef H; Medizinische Klinik I, Abteilung für Kardiologie, Universitätsklinikum Marburg/Gießen, Gießen, Germany., Doerr O; Medizinische Klinik I, Abteilung für Kardiologie, Universitätsklinikum Marburg/Gießen, Gießen, Germany., Vigelius-Rauch U; Medizinische Klinik I, Abteilung für Kardiologie, Universitätsklinikum Marburg/Gießen, Gießen, Germany., Lauten A; German Center for Cardiovascular Research (DZHK), Lübeck, Germany; Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany., Landmesser U; German Center for Cardiovascular Research (DZHK), Lübeck, Germany; Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany., Treskatsch S; Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany., Abdel-Wahab M; Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany., Sandri M; Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany., Holzhey D; Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany., Borger M; Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany., Ender J; Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany., Ince H; Medizinische Klinik I im Zentrum für Innere Medizin, Universitätsklinikum Rostock, Rostock, Germany., Öner A; Medizinische Klinik I im Zentrum für Innere Medizin, Universitätsklinikum Rostock, Rostock, Germany., Meyer-Saraei R; University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany; German Center for Cardiovascular Research (DZHK), Lübeck, Germany., Hambrecht R; Klinikum Links der Weser, Herzzentrum Bremen, Bremen, Germany., Wienbergen H; Klinikum Links der Weser, Herzzentrum Bremen, Bremen, Germany., Fach A; Klinikum Links der Weser, Herzzentrum Bremen, Bremen, Germany., Augenstein T; Klinikum Links der Weser, Herzzentrum Bremen, Bremen, Germany., Frey N; Department of Cardiology, Angiology and Pulmology, University Hospital Heidelberg, Heidelberg, Germany., König IR; German Center for Cardiovascular Research (DZHK), Lübeck, Germany; Institut für Medizinische Biometrie und Statistik, University of Lübeck, Lübeck, Germany., Vonthein R; Institut für Medizinische Biometrie und Statistik, University of Lübeck, Lübeck, Germany; Institut für Statistik, Ludwig-Maximilians-Universität München, Munich, Germany., Funkat AK; Leipzig Heart Institute, Leipzig, Germany., Berggreen AE; University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany., Heringlake M; University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany., Desch S; Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany; German Center for Cardiovascular Research (DZHK), Lübeck, Germany., de Waha-Thiele S; University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany; German Center for Cardiovascular Research (DZHK), Lübeck, Germany., Thiele H; Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany. Electronic address: holger.thiele@medizin.uni-leipzig.de.
Jazyk:	angličtina
Zdroj:	Journal of the American College of Cardiology [J Am Coll Cardiol] 2021 May 04; Vol. 77 (17), pp. 2204-2215.
DOI:	10.1016/j.jacc.2021.03.007
Abstrakt:	Background: The randomized SOLVE-TAVI (compariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anesthesia in Transcatheter Aortic Valve Implantation) trial compared newer-generation self-expanding valves (SEV) and balloon-expandable valves (BEV) as well as local anesthesia with conscious sedation (CS) and general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). Both strategies showed similar outcomes at 30 days. Objectives: The purpose of this study was to compare clinical outcomes during 1-year follow-up in the randomized SOLVE-TAVI trial. Methods: Using a 2 × 2 factorial design 447 intermediate- to high-risk patients with severe, symptomatic aortic stenosis were randomly assigned to transfemoral TAVR using either the SEV (Evolut R, Medtronic Inc., Minneapolis, Minnesota) or the BEV (Sapien 3, Edwards Lifesciences, Irvine, California) as well as CS or GA at 7 sites. Results: In the valve-comparison strategy, rates of the combined endpoint of all-cause mortality, stroke, moderate or severe paravalvular leakage, and permanent pacemaker implantation were similar between the BEV and SEV group (n = 84, 38.3% vs. n = 87, 40.4%; hazard ratio: 0.94; 95% confidence interval: 0.70 to 1.26; p = 0.66) at 1 year. Regarding the anesthesia comparison, the combined endpoint of all-cause mortality, stroke, myocardial infarction, and acute kidney injury occurred with similar rates in the GA and CS groups (n = 61, 25.7% vs. n = 54, 23.8%; hazard ratio: 1.09; 95% confidence interval: 0.76 to 1.57; p = 0.63). Conclusions: In intermediate- to high-risk patients undergoing transfemoral TAVR, newer-generation SEV and BEV as well as CS and GA showed similar clinical outcomes at 1 year using a combined clinical endpoint. (SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI [SOLVE-TAVI]; NCT02737150). Competing Interests: Funding Support and Author Disclosures This study was supported by the German Heart Research Foundation, and Leipzig Heart Institute. The authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu