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

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• Paravalvular leaks (PVLs) are a significant complication after transcatheter aortic valve replacement (TAVR).
• Valve oversizing, especially with self-expanding valves, may reduce PVL occurrence.
• The impact of oversizing with newer Evolut valve iterations on PVL is not well-established.

Purpose of the Study:

• To evaluate the effect of Evolut valve oversizing on PVL rates in a real-world setting.
• To assess the relationship between valve oversizing and post-TAVR PVL incidence.
• To determine if oversizing impacts other clinical outcomes.

Main Methods:

• A multicenter, ambispective study included patients undergoing TAVR with Evolut PRO/PRO+/FX valves.
• Oversizing degree was calculated using aortic annulus perimeter from multidetector computed tomography.
• Primary endpoint was PVL presence (mild/moderate-severe) by echocardiography; secondary endpoints included Valve Academic Research Consortium-3 defined in-hospital outcomes.

Main Results:

• 762 patients were analyzed; median oversizing was 20%.
• Higher oversizing (>20%) was associated with a lower incidence of PVL (30.2% vs. 40.9%, P=0.002).
• Increased oversizing correlated with reduced PVL risk (OR 0.95 per 1% increase, P=0.006) without affecting mortality, stroke, or permanent pacemaker rates.

Conclusions:

• Higher Evolut valve oversizing is linked to a decreased frequency of PVL after TAVR.
• This association holds true without increasing risks of other complications like permanent pacemaker implantation.
• Avoiding low oversizing degrees is recommended for Evolut valves, particularly in borderline cases.