Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement
| Autor: | Christoph Marquetand, Sascha Treskatsch, Michael A. Borger, Astrid Ellen Berggreen, Rainer Hambrecht, Ursula Vigelius-Rauch, David Holzhey, Matthias Heringlake, Georg Stachel, Roza Meyer-Saraei, Ingo Eitel, Suzanne de Waha-Thiele, Andreas Fach, Marcus Sandri, Norbert Frey, Alexander Lauten, Ulf Landmesser, Anne-Kathrin Funkat, Mohamed Abdel-Wahab, Hüseyin Ince, H. Wienbergen, Holger Thiele, Jörg Ender, Hans-Josef Feistritzer, Philipp Hartung, Thomas Kurz, O Doerr, Inke R. König, Alper Öner, Reinhard Vonthein, Solve-Tavi Investigators, Steffen Desch, Philipp Lurz, Thomas Augenstein, Holger Nef |
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| Rok vydání: | 2021 |
| Předmět: |
Male
Sedation medicine.medical_treatment 030204 cardiovascular system & hematology Transcatheter Aortic Valve Replacement 03 medical and health sciences 0302 clinical medicine Postoperative Complications Valve replacement Germany medicine Clinical endpoint Humans Local anesthesia Anesthesia 030212 general & internal medicine Myocardial infarction Stroke Aged 80 and over business.industry Incidence Hazard ratio Aortic Valve Stenosis medicine.disease Confidence interval Treatment Outcome Female medicine.symptom Cardiology and Cardiovascular Medicine business Follow-Up Studies |
| Zdroj: | Journal of the American College of Cardiology. 77(17) |
| ISSN: | 1558-3597 |
| Popis: | 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 ) |
| Databáze: | OpenAIRE |
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