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Updated: Jul 1, 2025

Full-root Aortic Valve Replacement by Stentless Aortic Xenografts in Patients with Small Aortic Roots
Published on: May 21, 2017
Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry.
Andrea Scotti1, Matteo Sturla1, Giuliano Costa2
1Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
In patients with small aortic annuli, latest transcatheter aortic valve replacement devices showed similar effectiveness. Self-expanding valves had better device performance but increased stroke and leak risks compared to balloon-expandable valves.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Transcatheter aortic valve replacement (TAVR) is a key treatment for aortic stenosis.
- The performance of newer TAVR platforms in patients with small aortic annuli is not well understood.
Purpose of the Study:
- To compare the effectiveness and performance of self-expanding (SE) Evolut PRO/PRO+ and balloon-expandable (BE) SAPIEN ULTRA TAVR devices in patients with small aortic annuli.
Main Methods:
- Analysis of the OPERA-TAVI registry data.
- Propensity score matching (1:1) of 251 patient pairs with aortic annular area <430 mm².
- Primary endpoints: 1-year composite effectiveness and 30-day device-related outcomes.
Main Results:
- No significant difference in 1-year primary effectiveness composite outcomes between SE and BE groups (10.8% vs 11.2%, P=0.91).
- SE Evolut valves showed more favorable 30-day device-oriented outcomes (4.8% vs 10.4%, P=0.027) but higher rates of disabling stroke and paravalvular leaks.
- BE SAPIEN ULTRA had higher rates of prosthesis-patient mismatch and residual gradients.
Conclusions:
- TAVR with latest iteration devices is safe in patients with small aortic annuli.
- SE platforms demonstrate superior hemodynamic performance but carry higher risks of stroke and paravalvular leak.
- Further randomized trials are necessary to confirm these findings and guide clinical decision-making.
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