Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement |
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| Authors: | Hans-Josef Feistritzer Thomas Kurz Georg Stachel Philipp Hartung Philipp Lurz Ingo Eitel Christoph Marquetand Holger Nef Oliver Doerr Ursula Vigelius-Rauch Alexander Lauten Ulf Landmesser Sascha Treskatsch Mohamed Abdel-Wahab Marcus Sandri David Holzhey Michael Borger Jörg Ender Holger Thiele |
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| Institution: | 1. Heart Center Leipzig at University of Leipzig, Leipzig, Germany;2. Leipzig Heart Institute, Leipzig, Germany;3. University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany;4. German Center for Cardiovascular Research (DZHK), Lübeck, Germany;5. Medizinische Klinik I, Abteilung für Kardiologie, Universitätsklinikum Marburg/Gießen, Gießen, Germany;6. Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany;7. Medizinische Klinik I im Zentrum für Innere Medizin, Universitätsklinikum Rostock, Rostock, Germany;8. Klinikum Links der Weser, Herzzentrum Bremen, Bremen, Germany;9. Department of Cardiology, Angiology and Pulmology, University Hospital Heidelberg, Heidelberg, Germany;10. Institut für Medizinische Biometrie und Statistik, University of Lübeck, Lübeck, Germany;11. Institut für Statistik, Ludwig-Maximilians-Universität München, Munich, Germany |
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| Abstract: | BackgroundThe 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.ObjectivesThe purpose of this study was to compare clinical outcomes during 1-year follow-up in the randomized SOLVE-TAVI trial.MethodsUsing 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.ResultsIn 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).ConclusionsIn 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) |
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| Keywords: | anesthesia aortic stenosis prognosis transcatheter aortic valve implantation transcatheter aortic valve replacement BEV"} {"#name":"keyword" "$":{"id":"kwrd0040"} "$$":[{"#name":"text" "_":"balloon-expandable valve CI"} {"#name":"keyword" "$":{"id":"kwrd0050"} "$$":[{"#name":"text" "_":"confidence interval CS"} {"#name":"keyword" "$":{"id":"kwrd0060"} "$$":[{"#name":"text" "_":"conscious sedation GA"} {"#name":"keyword" "$":{"id":"kwrd0070"} "$$":[{"#name":"text" "_":"general anesthesia HR"} {"#name":"keyword" "$":{"id":"kwrd0080"} "$$":[{"#name":"text" "_":"hazard ratio IQR"} {"#name":"keyword" "$":{"id":"kwrd0090"} "$$":[{"#name":"text" "_":"interquartile range PVL"} {"#name":"keyword" "$":{"id":"kwrd0100"} "$$":[{"#name":"text" "_":"paravalvular leakage SEV"} {"#name":"keyword" "$":{"id":"kwrd0110"} "$$":[{"#name":"text" "_":"self-expanding valve STS"} {"#name":"keyword" "$":{"id":"kwrd0120"} "$$":[{"#name":"text" "_":"Society of Thoracic Surgeons TAVI"} {"#name":"keyword" "$":{"id":"kwrd0130"} "$$":[{"#name":"text" "_":"transcatheter aortic valve implantation TAVR"} {"#name":"keyword" "$":{"id":"kwrd0140"} "$$":[{"#name":"text" "_":"transcatheter aortic valve replacement |
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