General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial.

Autor: Thiele H; Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).; Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.)., Kurz T; University Clinic Schleswig-Holstein and University Heart Center Lübeck, Germany (T.K., I.E., C.M., R.M.-S., A.E.B., M.H., S.d.W.-T.).; German Center for Cardiovascular Research (DZHK), Germany (T.K., I.E., C.M., A.L., U.L., R.M.-S., N.F., I.R.K., S.D., S.d.W.-T.)., Feistritzer HJ; Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).; Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.)., Stachel G; Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).; Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.)., Hartung P; Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).; Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.)., Lurz P; Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).; Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.)., Eitel I; University Clinic Schleswig-Holstein and University Heart Center Lübeck, Germany (T.K., I.E., C.M., R.M.-S., A.E.B., M.H., S.d.W.-T.).; German Center for Cardiovascular Research (DZHK), Germany (T.K., I.E., C.M., A.L., U.L., R.M.-S., N.F., I.R.K., S.D., S.d.W.-T.)., Marquetand C; University Clinic Schleswig-Holstein and University Heart Center Lübeck, Germany (T.K., I.E., C.M., R.M.-S., A.E.B., M.H., S.d.W.-T.).; German Center for Cardiovascular Research (DZHK), Germany (T.K., I.E., C.M., A.L., U.L., R.M.-S., N.F., I.R.K., S.D., S.d.W.-T.)., Nef H; Universitätsklinikum Marburg/Gießen, Gießen, Germany (H.N., O.D., U.V.-R.)., Doerr O; Universitätsklinikum Marburg/Gießen, Gießen, Germany (H.N., O.D., U.V.-R.)., Vigelius-Rauch U; Universitätsklinikum Marburg/Gießen, Gießen, Germany (H.N., O.D., U.V.-R.)., Lauten A; German Center for Cardiovascular Research (DZHK), Germany (T.K., I.E., C.M., A.L., U.L., R.M.-S., N.F., I.R.K., S.D., S.d.W.-T.).; Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany (A.L., U.L., S.T.)., Landmesser U; German Center for Cardiovascular Research (DZHK), Germany (T.K., I.E., C.M., A.L., U.L., R.M.-S., N.F., I.R.K., S.D., S.d.W.-T.).; Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany (A.L., U.L., S.T.)., Treskatsch S; Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany (A.L., U.L., S.T.)., Abdel-Wahab M; Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).; Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.)., Sandri M; Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.)., Holzhey D; Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).; Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.)., Borger M; Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).; Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.)., Ender J; Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).; Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.)., Ince H; Universitätsklinikum Rostock, Germany (H.I., A.Ö.)., Öner A; Universitätsklinikum Rostock, Germany (H.I., A.Ö.)., Meyer-Saraei R; University Clinic Schleswig-Holstein and University Heart Center Lübeck, Germany (T.K., I.E., C.M., R.M.-S., A.E.B., M.H., S.d.W.-T.).; German Center for Cardiovascular Research (DZHK), Germany (T.K., I.E., C.M., A.L., U.L., R.M.-S., N.F., I.R.K., S.D., S.d.W.-T.)., Hambrecht R; Klinikum Links der Weser, Bremen, Germany (R.H., A.F., T.A.)., Fach A; Klinikum Links der Weser, Bremen, Germany (R.H., A.F., T.A.)., Augenstein T; Klinikum Links der Weser, Bremen, Germany (R.H., A.F., T.A.)., Frey N; German Center for Cardiovascular Research (DZHK), Germany (T.K., I.E., C.M., A.L., U.L., R.M.-S., N.F., I.R.K., S.D., S.d.W.-T.).; University Clinic Schleswig-Holstein, Kiel, Germany (N.F.)., König IR; German Center for Cardiovascular Research (DZHK), Germany (T.K., I.E., C.M., A.L., U.L., R.M.-S., N.F., I.R.K., S.D., S.d.W.-T.).; Institut für Medizinische Biometrie und Statistik, University of Lübeck, Germany (I.R.K., R.V.)., Vonthein R; Institut für Medizinische Biometrie und Statistik, University of Lübeck, Germany (I.R.K., R.V.)., Rückert Y; Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.)., Funkat AK; Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.)., Desch S; Heart Center Leipzig at University of Leipzig, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., S.D.).; Leipzig Heart Institute, Germany (H.T., H.-J.F., G.S., P.H., P.L., M.A.-W., M.S., D.H., M.B., J.E., Y.R., A.-K.F., S.D.).; German Center for Cardiovascular Research (DZHK), Germany (T.K., I.E., C.M., A.L., U.L., R.M.-S., N.F., I.R.K., S.D., S.d.W.-T.)., Berggreen AE; University Clinic Schleswig-Holstein and University Heart Center Lübeck, Germany (T.K., I.E., C.M., R.M.-S., A.E.B., M.H., S.d.W.-T.)., Heringlake M; University Clinic Schleswig-Holstein and University Heart Center Lübeck, Germany (T.K., I.E., C.M., R.M.-S., A.E.B., M.H., S.d.W.-T.)., de Waha-Thiele S; University Clinic Schleswig-Holstein and University Heart Center Lübeck, Germany (T.K., I.E., C.M., R.M.-S., A.E.B., M.H., S.d.W.-T.).; German Center for Cardiovascular Research (DZHK), Germany (T.K., I.E., C.M., A.L., U.L., R.M.-S., N.F., I.R.K., S.D., S.d.W.-T.).
Jazyk: angličtina
Zdroj: Circulation [Circulation] 2020 Oct 13; Vol. 142 (15), pp. 1437-1447. Date of Electronic Publication: 2020 Aug 21.
DOI: 10.1161/CIRCULATIONAHA.120.046451
Abstrakt: Background: In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement. However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available.
Methods: The SOLVE-TAVI (Comparison of Second-Generation Self-Expandable Versus Balloon-Expandable Valves and General Versus Local Anesthesia in Transcatheter Aortic Valve Implantation) trial is a multicenter, open-label, 2×2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement comparing CS versus GA. The primary efficacy end point was powered for equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days.
Results: The primary composite end point occurred in 27.2% of CS and 26.4% of GA patients (rate difference, 0.8 [90% CI, -6.2 to 7.8]; P equivalence =0.015). Event rates for the individual components were as follows: all-cause mortality, 3.2% versus 2.3% (rate difference, 1.0 [90% CI, -2.9 to 4.8]; P equivalence <0.001); stroke, 2.4% versus 2.8% (rate difference, -0.4 [90% CI, -3.8 to 3.8]; P equivalence <0.001); myocardial infarction, 0.5% versus 0.0% (rate difference, 0.5 [90% CI, -3.0 to 3.9]; P equivalence <0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference, -0.9 [90% CI, -7.5 to 5.7]; P equivalence =0.011); acute kidney injury, 9.0% versus 9.2% (rate difference, -0.2 [90% CI, -5.2 to 4.8]; P equivalence =0.0005). There was a lower need for inotropes or vasopressors with CS (62.8%) versus GA (97.3%; rate difference, -34.4 [90% CI, -41.0 to -27.8]).
Conclusions: Among patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement, use of CS compared with GA resulted in similar outcomes for the primary efficacy end point. These findings suggest that CS can be safely applied for transcatheter aortic valve replacement. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02737150.
Databáze: MEDLINE
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