This prospective, randomized, multicenter study included 447 patients with severe aortic stenosis and intermediate or high surgical risk randomized in a 2×2 factorial design to general vs. conscious sedation with local anesthesia and also to receiving the Sapien 3 valve (balloon-expandable) vs. CoreValve Evolut R (self-expandable).
Primary end point was a composite of all-cause mortality, stroke, moderate or severe paravalvular leak and definite pacemaker implantation at 30 days.
This occurred in 27.2% of the Evolut R group vs. 26.1% of the Sapien 3 group, which resulted in equivalent outcomes. On separate assessment of each point, pacemaker implantation and paravalvular leak rates resulted similar, with a higher rate of stroke with Sapien 3, though this study does not have statistical power to determine differences on this point.
End point for type of anesthesia combined death, stroke, infarction, infection and acute kidney failure at 30 days. This happened in 27% of patients in the local anesthesia group vs. 25.5% in the general anesthesia group. Again, outcomes were equivalent, though general anesthesia required more inotropic agents, with no effect on procedural time, valve related outcomes or other clinical factors. Mean hospitalization stay was 9 days, which seems too long, regardless type of anesthesia.
Original title: SOLVE-TAVI Trial: A 2×2 Randomized Trial of Self-Expandable vs Balloon-Expandable Valves and General vs Local Anesthesia in Patients Undergoing Transcatheter Aortic Valve Implantation.
Presenter: Holger Thiele.
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