Why the study?
Local anesthesia with conscious sedation is commonly used in transcatheter aortic valve replacement, but randomized data comparing its safety and efficacy with general anesthesia were lacking.
Does local anesthesia with conscious sedation result in equivalent outcomes compared to general anesthesia in patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement?
Population
447 patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement
Comparison
Conscious sedation vs general anesthesia
Design
Multicenter open-label 2x2 factorial randomized equivalence trial
Follow-up
30 days
Authors
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Conscious sedation is equivalent to general anesthesia for the primary composite in transfemoral TAVR; confirms equivalence and supports preference to reduce inotrope/vasopressor needs.
Does local anesthesia with conscious sedation result in equivalent outcomes compared to general anesthesia in patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement?
In patients undergoing transfemoral TAVR, conscious sedation is equivalent to general anesthesia regarding a 30-day composite of mortality, stroke, MI, infection, and AKI, and is associated with a lower need for inotropes or vasopressors.
Thiele et al. (2020) studied this question.
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