Balloon- Versus Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 3-Year Results of the LYTEN Trial

BACKGROUND: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (TAVR) 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 TAVR. METHODS: Patients with a failed small (≤23 mm) surgical valve undergoing valve-in-valve TAVR 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 aortic regurgitation. RESULTS: Ninety-eight patients underwent TAVR (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%; P <0.001), with lower mean gradients (BEV: 20±9 versus SEV: 13±9 mm Hg; P =0.002), and larger indexed effective orifice area (BEV: 0.69±0.27 versus SEV: 0.93±0.32 cm 2 /m 2 ; P =0.002). The rate of moderate aortic regurgitation was 0% in the BEV group versus 2.9% in the SEV group ( P =0.582). Functional status and quality of life improved similarly in both groups. No differences were observed in the composite end point of death, stroke, or heart failure–related hospitalization (BEV: 32.6% versus SEV: 25.5%; P =0.489). Mortality was also not statistically different between groups (BEV: 23.3% versus SEV: 15.7%; P =0.375). No significant differences were observed in other adverse events. CONCLUSIONS: In patients undergoing valve-in-valve TAVR 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.