Optimal Oversizing With the New-Generation Evolut (PRO/PRO+/FX) Self-Expanding Valves: A Multicenter Study.

Background: Paravalvular leaks (PVLs) after transcatheter aortic valve replacement have a significant prognostic impact, and valve oversizing, particularly with self-expanding valves, may prevent postprocedural PVL occurrence. Recent iterations of the Evolut valve system are intended to reduce PVL, but the effects of oversizing with such valves on PVL are largely unknown. We aimed to assess, in a real-world contemporary setting, the impact of Evolut valve oversizing on PVL after transcatheter aortic valve replacement.

Methods: This was a multicenter observational ambispective study of patients undergoing transcatheter aortic valve replacement with the Evolut PRO/PRO+/FX valves. Aortic annulus perimeter, as determined by multidetector computed tomography, was used to estimate the oversizing degree. The primary end point was the presence of PVL (mild/moderate-severe), as determined by echocardiography at hospital discharge. Secondary end points included in-hospital outcomes as defined by the Valve Academic Research Consortium-3 recommendations.

Results: A total of 762 patients were included (Evolut PRO/PRO+/FX, 55.5%/34.8%/9.7%), and the median valve oversizing was 20 (17-25)%, with no differences in baseline characteristics between low (≤20%, n=381) and high (>20%, n=381) valve oversizing recipients. In-hospital mortality and stroke rates were 2.4% and 4.3%, respectively, with no oversizing-related differences in clinical outcomes. Permanent pacemaker rates were similar in patients with low (19.4%) and high (15.8%) valve oversizing, P=0.21. PVL was found in 35.6% of patients (mild: 32.6%, moderate-severe: 3.0%), with a higher incidence of PVL in patients with low (40.9%) versus high (30.2%) oversizing, P=0.002. In a multivariable analysis, a higher oversizing degree was associated with a lower risk of PVL (odds ratio, 0.95 [0.92-0.99] for each 1% increase in oversizing, P=0.006).

Conclusions: In transcatheter aortic valve replacement with recent Evolut valve iterations (PRO/PRO+/FX), a higher oversizing degree was associated with a lower frequency of PVL without increasing the risk of other complications (including permanent pacemaker). These data suggest that a low degree of valve oversizing should probably be avoided when using Evolut valves, particularly in borderline cases.