Transcatheter aortic valve replacement with the SAPIEN 3 valve: preparing the field for the final expansion
The very first transcatheter aortic valve replacement (TAVR) procedure was performed in 2002 (1), and this treatment has now been established as the best option for inoperable patients with symptomatic severe aortic stenosis (2), and as a good alternative for high-risk individuals (3). To date, >200,000 TAVR procedures have already been performed in more than 65 countries (4). As shown in recent publications (5-8), improved transcatheter devices, increasing operator experience, and the very low incidence of significant structural transcatheter heart valve (THV) failure at 5-year follow-up, have provided the rationale for a worldwide shift towards treating lower surgical risk patients with a catheter-based approach. In the 2,032 intermediate risk patients with severe aortic stenosis randomized in the PARTNER 2A trial (9), TAVR was similar to surgical aortic valve replacement (AVR) with respect to the 2-year primary endpoint of death or disabling stroke (19.3% in the TAVR group and 21.1% in the surgery group; HR 0.89; 95% confidence interval: 0.73–1.09; P=0.25). Meanwhile, the results of the prospective randomized all-comers NOTION trial were recently published, showing no significant difference between TAVR and SAVR for the composite outcome of death from any cause, stroke, or myocardial infarction after 1 year in 280 low risk [mean Society of Thoracic Surgeons (STS) score: 3%] patients with aortic stenosis (7). However, the expansion of TAVR towards the treatment of lower risk and younger patients, especially with newer generation devices, definitely mandates continued surveillance and thorough clinical-trial validation.