TY - JOUR
T1 - Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement
AU - SOLVE-TAVI Investigators
AU - Feistritzer, Hans Josef
AU - Kurz, Thomas
AU - Stachel, Georg
AU - Hartung, Philipp
AU - Lurz, Philipp
AU - Eitel, Ingo
AU - Marquetand, Christoph
AU - Nef, Holger
AU - Doerr, Oliver
AU - Vigelius-Rauch, Ursula
AU - Lauten, Alexander
AU - Landmesser, Ulf
AU - Treskatsch, Sascha
AU - Abdel-Wahab, Mohamed
AU - Sandri, Marcus
AU - Holzhey, David
AU - Borger, Michael
AU - Ender, Jörg
AU - Ince, Hüseyin
AU - Öner, Alper
AU - Meyer-Saraei, Roza
AU - Hambrecht, Rainer
AU - Wienbergen, Harm
AU - Fach, Andreas
AU - Augenstein, Thomas
AU - Frey, Norbert
AU - König, Inke R.
AU - Vonthein, Reinhard
AU - Funkat, Anne Kathrin
AU - Berggreen, Astrid E.
AU - Heringlake, Matthias
AU - Desch, Steffen
AU - de Waha-Thiele, Suzanne
AU - Thiele, Holger
N1 - Publisher Copyright:
© 2021 American College of Cardiology Foundation
PY - 2021/5/4
Y1 - 2021/5/4
N2 - 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)
AB - 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)
UR - http://www.scopus.com/inward/record.url?scp=85104453331&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2021.03.007
DO - 10.1016/j.jacc.2021.03.007
M3 - Journal articles
C2 - 33926657
AN - SCOPUS:85104453331
SN - 0735-1097
VL - 77
SP - 2204
EP - 2215
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 17
ER -
