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

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

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 follows: all-cause mortality 3.2% versus 2.3% (rate difference 1.0 [90%CI - 2.9 to 4.8]; Pequivalence<0.001), stroke 2.4% versus 2.8% (rate difference -0.4 [90%CI -3.8 to 3.8]; Pequivalence<0.001), myocardial infarction 0.5% versus 0.0% (rate difference 0.5 [90%CI -3.0 to 3.9]; Pequivalence<0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference -0.9 [90%CI -7.5 to 5.7]; Pequivalence=0.011), acute kidney injury 9.0% versus 9.2% (rate difference - 0.2 [90%CI -5.2 to 4.8]; Pequivalence=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 TAVR, use of CS compared with GA resulted in similar outcomes for the primary efficacy endpoint. These findings suggest that CS can be safely applied for TAVR. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT02737150.