TAVI with the Myval valve showed comparable 30-day death (2.33%) to Sapien-3 (1.19%) and self-expandable valves (3.49%), but lower pacemaker implantation rates (1.16% vs 4.65% and 10.47%).
Cohort (n=315)
Does the balloon-expandable Myval THV series improve early clinical and hemodynamic outcomes compared to Sapien-3 and self-expandable valves in patients with severe aortic stenosis?
In patients with severe aortic stenosis undergoing TAVI, the Myval THV series demonstrated comparable 30-day clinical outcomes to Sapien-3 and self-expandable valves, with lower rates of pacemaker implantation and paravalvular regurgitation than self-expandable valves.
Absolute Event Rate: 1.16% vs 4.65%
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's 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 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 (n=99) or SE valves (n=108). Propensity-matching data (86 pairs) compared the clinical and hemodynamic outcomes at 30 days. RESULTS: ) 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 Myval, 4.65% in Sapien-3 and 10.47% in SE valves, whereas 3.49% death observed in SE valves, 2.33 % in Myval and 1.19% in Sapien-3 at 30 days. SE valves had 13.04% moderate and severe paravalvular regurgitation (PVR), while Myval and Sapien-3 cohorts 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 cohort.
Rao et al. (Fri,) conducted a cohort in Severe aortic stenosis (n=315). Balloon-expandable Myval transcatheter heart valve vs. Balloon-expandable Sapien-3 and self-expandable valves was evaluated on permanent pacemaker implantation (PPI) at 30 days. TAVI with the Myval valve showed comparable 30-day death (2.33%) to Sapien-3 (1.19%) and self-expandable valves (3.49%), but lower pacemaker implantation rates (1.16% vs 4.65% and 10.47%).