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

• Published in: Circulation (New York, N.Y.) N.Y.), 2020-10, Vol.142 (15), p.1437-1447
• Main Authors: Thiele, Holger, Kurz, Thomas, Feistritzer, Hans-Josef, Stachel, Georg, Hartung, Philipp, Lurz, Philipp, Eitel, Ingo, Marquetand, Christoph, Nef, Holger, Doerr, Oliver, Vigelius-Rauch, Ursula, Lauten, Alexander, Landmesser, Ulf, Treskatsch, Sascha, Abdel-Wahab, Mohamed, Sandri, Marcus, Holzhey, David, Borger, Michael, Ender, Jörg, Ince, Hüseyin, Öner, Alper, Meyer-Saraei, Roza, Hambrecht, Rainer, Fach, Andreas, Augenstein, Thomas, Frey, Norbert, König, Inke R., Vonthein, Reinhard, Rückert, Yvonne, Funkat, Anne-Kathrin, Desch, Steffen, Berggreen, Astrid E., Heringlake, Matthias, de Waha-Thiele, Suzanne
• Format: Article
• Language: English
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/CIRCULATIONAHA.120.046451

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 to 7.8]; Pequivalence=0.015). Event rates for the individual components were as followsall-cause mortality 3.2% versus 2.3% (rate difference 1.0 [90%CI -2.9 to 4.8]; Pequivalence