Balloon-vs. Self-Expanding Transcatheter Valve 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.

OBJECTIVE: 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.

RESULTS: A total of 98 patients underwent ViV-TAVR (46-BEV, 52-SEV). Patients receiving a SEV had a lower peak and mean trans-aortic gradients (peak: 42±15 mmHg-BEV vs. 27±14 mmHg-SEV, p˂0.001; mean: 22±8 mmHg-BEV vs. 14±7 mmHg-SEV, p < 0.001), and a higher rate on intended valve hemodynamic 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 class > II, BEV: 7.3%, SEV:4.1%, p=0.505) or quality of life (KCCQ, BEV:77.9±21.2, SEV:81.8±14.8, p=0.334). No differences in all-cause mortality (BEV:6.5%, SEV:3.9%, 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 small failed aortic bioprostheses, a better hemodynamic profile was found after one year in patients receiving a SEV. Differences were not found between SEV and BEV in regard to functional status, quality of life, or clinical outcomes.