|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, 2×2 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: 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.|
|Thiele H, Kurz T, Feistritzer HJ et al.||21 Aug 2020 https://doi.org/10.1161/CIRCULATIONAHA.120.046451|
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