Balloon- Versus Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 3-Year Results of the LYTEN Trial.
Document Type
Article
Publication Date
2-2-2026
Publication Title
Circulation. Cardiovascular interventions
Abstract
BACKGROUND: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement field have been obtained from retrospective studies. This prespecified secondary analysis of the LYTEN randomized trial (Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprostheses) aims to compare the 3-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in valve-in-valve transcatheter aortic valve replacement.
METHODS: Patients with a failed small (≤23 mm) surgical valve undergoing valve-in-valve transcatheter aortic valve replacement were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler echocardiography) evaluation at 3-year follow-up. Study outcomes were defined according to VARC (Valve Academic Research Consortium)-2/VARC-3 criteria. Intended performance of the valve was defined as mean gradient < 20 mm Hg, peak velocity < 3 m/s, Doppler velocity index ≥0.25, and less than moderate AR.
RESULTS: Ninety-eight patients underwent transcatheter aortic valve replacement (46 BEV-SAPIEN 3/ULTRA-, 52 SEV-Evolut R-PRO-PRO+). At 3 years, patients receiving a SEV had a higher rate of intended valve performance (BEV: 27.6% versus SEV: 82.4%;
CONCLUSIONS: In patients undergoing valve-in-valve transcatheter aortic valve replacement for failed small aortic bioprostheses, SEV demonstrated a superior valve hemodynamic performance at 3-year follow-up, with similar clinical outcomes and functional improvement compared with BEV.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03520101.
First Page
e016255
Recommended Citation
Cepas-Guillén P, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A et al Balloon- versus self-expanding transcatheter valves for failed small surgical aortic bioprostheses: 3-year results of the lyten Trial. Circ Cardiovasc Interv. 2026 Feb 2:e016255. doi: 10.1161/CIRCINTERVENTIONS.125.016255. Epub ahead of print. PMID: 41623058.
DOI
10.1161/CIRCINTERVENTIONS.125.016255
ISSN
1941-7632
PubMed ID
41623058