L'implantation valvulaire aortique par cathéter : évolution des résultats cliniques suite aux avancées technologiques et techniques
Context: Transcatheter aortic valve implantation (TAVI) is a relatively young procedure intended to treat patients with severe aortic stenosis who are at high risk for conventional surgery, or inoperable. This procedure underwent multiple technological improvements (successive generations of devices) and multiple technical improvements (simplification of various steps in the procedure).  Objective: We intend to describe the clinical impact of a technological improvement (the transition from the second to the third generation of the Edwards device in a high-volume center) and that of a technical improvement (TAVI without pre-dilatation, known as direct TAVI). Methods: We first describe, through a meta-analysis, the state of TAVI at the beginning of its widespread use, in 2012. Next, we describe, through a single-center retrospective study, the clinical impact of the transition from the second to the third generation of the Edwards device in 507 patients. Finally, in a retrospective study with matching, we tested three pre-dilatation strategies: systematic pre-dilatation, selective pre-dilatation, and direct TAVI. Results: In the article describing the initial TAVI experience, the 30-day mortality rate was between 5 and 18%. One-year mortality was estimated at 23% by meta-analysis (random effects model). Stroke rate at 30 days was between 0 and 6.7% and major vascular complication rate was between 2 and 16%. The transition from SAPIEN XT to SAPIEN 3 resulted in a non-significant reduction in 30-day mortality (from 8.7 to 3.5%; p=0.21) and 30-day stroke rate (from 2.8 to 1.4%; p=0.6), and a significant reduction in major vascular complications (from 9.9 to 2.8%; p<0.0001). However, there was a significant increase in permanent pacemaker rate (from 9.8 to 17.3%; p=0.03). Next, we found no adverse effect of performing direct TAVI in terms of mortality or vascular complications at 30 days. We found a trend towards a reduction in stroke rate with direct TAVI (3 vs. 1%; p=0.11), particularly in patients with mildly or moderately calcified valves. However, in those with extensive valvular calcification, the risk of device malposition was numerically higher. In all three studies presented, there was little variation in 1-year mortality (20 to 25%).  Conclusions: Short-term adverse events were reduced by the transition towards the third-generation Edwards device. Direct TAVI is feasible and safe. However, both of these improvements have limitations and should be considered carefully.
TAVI Edwards SAPIEN XT Edwards SAPIEN 3 Transcatheter aortic valve implantation Aortic valvuloplasty Technological improvement Technical improvement