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

General versus Local Anesthesia with Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial. Circulation. 2020 Aug 21;: Authors: Thiele H, Kurz T, Feistritzer HJ, Stachel G, Hartung P, Lurz P, Eitel I, Marquetand C, Nef H, Doerr O, Vigelius-Rauch U, Lauten A, Landmesser U, Treskatsch S, Abdel-Wahab M, Sandri M, Holzhey D, Borger M, Ender J, Ince H, Öner A, Meyer-Saraei R, Hambrecht R, Fach A, Augenstein T, Frey N, König IR, Vonthein R, Rückert Y, Funkat AK, Desch S, Desch S, Berggreen AE, Heringlake M, de Waha-Thiele S, SOLVE-TAVI Investigators Abstract Background: In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement (TAVR). However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available. Methods: SOLVE-TAVI is a multicenter, open-label, 2x2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVR comparing CS versus GA. The primary efficacy endpoint 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 endpoint occurred in 27.2% of CS and 26.4% of GA patients (rate difference 0.8 [90%CI -6.2 t...
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research

Related Links:

More News: Anesthesia | Anesthesiology | Aortic Stenosis | Cardiology | Clinical Trials | Heart Attack | Heart Valve Surgery | Stroke | Urology & Nephrology