Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 1-Year Results of the LYTEN Trial.

BACKGROUND: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies. OBJECTIVES: The authors sought to compare the 1-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 ViV-TAVR. METHODS: Patients with a failed small (≤23 mm) surgical valve undergoing ViV-TAVR were randomized to receive a SEV or a BEV. Patients had a clinical and valve hemodynamic (Doppler echocardiography) evaluation at 1-year follow-up. Study outcomes were defined according to VARC-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: A total of 98 patients underwent ViV-TAVR (46 BEV, 52 SEV). At 1-year follow-up, patients receiving a SEV had a lower mean transaortic gradient (22 ± 8 mm Hg BEV vs 14 ± 7 mm Hg SEV; P < 0.001), and a higher rate of intended valve performance (BEV: 30%, SEV:76%; P < 0.001). There were no cases of greater than mild aortic regurgitation. There were no differences in functional status (NYHA functional class >II, BEV: 7.3%, SEV: 4.1%; P = 0.505) or quality of life (Kansas City Cardiomyopathy Questionnaire, BEV: 77.9 ± 21.2, SEV: 81.8 ± 14.8; P = 0.334). No differences in all-cause mortality (BEV: 6.5%, SEV: 3.8; P = 0.495), heart failure hospitalization (BEV: 6.5%, SEV: 1.9%; P = 0.214), stroke (BEV: 0%, SEV: 1.9%; P = 0.369), myocardial infarction (BEV: 0%, SEV: 1.9%; P = 0.347), or pacemaker implantation (BEV: 2.2%, SEV: 1.9%; P = 0.898) were found. CONCLUSIONS: In patients who underwent ViV-TAVR for failed small aortic bioprostheses, those receiving a SEV exhibited a better valve hemodynamic profile at 1-year follow-up. There were no differences between SEV and BEV regarding functional status, quality of life, or clinical outcomes.