Indian heart journal · 2026
Early outcomes of balloon-expandable Myval, Sapien-3, and self-expandable valves in aortic stenosis: Propensity score-matched analysis.
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Rao Ravinder Singh, Sharma Govind Narayan, Chandra Kailash
Аннотация
OBJECTIVE: Balloon-expandable (BE) Myval transcatheter heart valve (THV) series demonstrated safety and efficacy in aortic stenosis (AS) in low, intermediate/high surgical risk patients. However, there is a limited comparative data with other contemporary valves. The study aimed to compare the early clinical outcomes of next-generation BE Myval THV series with Sapien-3 THV and self-expandable (SE) valves in severe AS patients.
METHODS: This retrospective study included 315 AS patients who underwent transcatheter aortic valve implantation (TAVI) with BE Myval THV series (n = 108), or BE Sapien-3 THV (n = 99) or SE valves (n = 108). Propensity-matching data (86 pairs) compared the clinical and hemodynamic outcomes at 30 days.
RESULTS: No intraprocedural death/complications were reported post-TAVI. Aortic valve area was significantly improved in BE Myval THV series (0.57 ± 0.18 cm2 to 2.93 ± 0.49 cm2) and SE valves (0.60 ± 0.23 cm2 to 2.66 ± 0.92 cm2) cohorts from baseline to 30 days, and peak and mean aortic gradients were significantly (p < 0.0001) reduced. Permanent pacemaker implantations (PPI) requirement was 1.16% in BE Myval THV series, 4.65% in Sapien-3 THV and 10.47% in SE valves, whereas 3.49% death observed in SE valves, 2.33 % in Myval THV series and 1.19% in Sapien-3 THV at 30 days. SE valves had 13.04% moderate and severe paravalvular regurgitation (PVR), while Myval THV series and Sapien-3 THV cohort had none.
CONCLUSION: Safety and efficacy outcomes were comparable among three cohorts, except for higher PPI rate in SE valves cohort. At 30 days, clinical outcomes showed acceptable rates of stroke and death. Valve hemodynamics were excellent, with low rate of PVR in Myval THV series cohort.
METHODS: This retrospective study included 315 AS patients who underwent transcatheter aortic valve implantation (TAVI) with BE Myval THV series (n = 108), or BE Sapien-3 THV (n = 99) or SE valves (n = 108). Propensity-matching data (86 pairs) compared the clinical and hemodynamic outcomes at 30 days.
RESULTS: No intraprocedural death/complications were reported post-TAVI. Aortic valve area was significantly improved in BE Myval THV series (0.57 ± 0.18 cm2 to 2.93 ± 0.49 cm2) and SE valves (0.60 ± 0.23 cm2 to 2.66 ± 0.92 cm2) cohorts from baseline to 30 days, and peak and mean aortic gradients were significantly (p < 0.0001) reduced. Permanent pacemaker implantations (PPI) requirement was 1.16% in BE Myval THV series, 4.65% in Sapien-3 THV and 10.47% in SE valves, whereas 3.49% death observed in SE valves, 2.33 % in Myval THV series and 1.19% in Sapien-3 THV at 30 days. SE valves had 13.04% moderate and severe paravalvular regurgitation (PVR), while Myval THV series and Sapien-3 THV cohort had none.
CONCLUSION: Safety and efficacy outcomes were comparable among three cohorts, except for higher PPI rate in SE valves cohort. At 30 days, clinical outcomes showed acceptable rates of stroke and death. Valve hemodynamics were excellent, with low rate of PVR in Myval THV series cohort.