Why the study?
Does transcatheter aortic valve implantation (TAVI) improve survival and symptoms compared to standard therapy in patients with severe aortic stenosis who are not candidates for surgery?
Does transcatheter aortic valve implantation (TAVI) improve survival and symptoms compared to standard therapy in patients with severe aortic stenosis who are not candidates for surgery?
TAVI has emerged as a viable and life-saving alternative to standard therapy for patients with severe aortic stenosis who are ineligible for surgical valve replacement, despite an increased risk of stroke and vascular events.
May inform decisions for inoperable severe AS; leaves open strategies to reduce stroke and vascular risks.
Aortic valve replacement (AVR) is a treatment of choice for patients with symptomatic severe aortic stenosis (AS). However, a significant proportion of these patients do not undergo surgical AVR due to high-risk features. Transcatheter aortic valve implantation (TAVI) has emerged as an alternative for patients with severe AS who are not candidates for open-heart surgery. Since the introduction of TAVI to the medical community in 2002, there has been an explosive growth in procedures. The balloon-expandable Edwards SAPIEN valve and the self-expanding CoreValve ReValving(TM) system contribute the largest patient experience with more than 10,000 patients treated with TAVI to date. Clinical outcomes have stabilized in experienced hands, with 30-day mortality less than 10%. Careful patient selection, growing operator experience, and an integrated multidisciplinary team approach contribute to notable improvement in outcomes. In the first randomized pivotal PARTNER trial, in patients with severe AS not suitable candidates for surgical AVR, TAVI compared with standard therapy, significantly improved survival and cardiac symptoms, but was associated with higher incidence of major strokes and major vascular events. The results of randomized comparison of TAVI with AVR among high-risk patients with AS for whom surgery is a viable option are eagerly awaited to provide further evidence on the applicability of TAVI in these patients.
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Leon et al. (2010) studied this question.
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