Single Centre Experience With the Balloon-Expandable Myval Transcatheter Aortic Valve System in Patients With...

Transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) anatomy remains challenging due to anatomical complexity and limited trial data. New-generation balloon-expandable valves, such as Myval, require further evaluation in this subgroup.

To report 1-year VARC-3 outcomes following TAVI procedure with the Myval transcatheter heart valve (THV) in BAV anatomy.

From December 2019 to July 2023, 52 consecutive BAV patients at moderate-to-high surgical risk or deemed unsuitable for surgery underwent TAVI with the Myval THV. Outcomes, assessed per VARC-3 definitions, were compared to 217 trileaflet aortic valve (TAV) patients in unmatched and propensity score-matched cohorts.

At 1 year, BAV and TAV patients showed no significant differences in all-cause mortality (3.9% vs. 10.2%, p = 0.185), cardiac mortality (0% vs. 2.3%, p = 0.587), or stroke (3.9% vs. 2.8%, p = 0.654) regarding an unmatched comparison. In the matched analysis, all-cause mortality and stroke were 3.9% and 1.9%, respectively, with no cardiac deaths. Endocarditis was rare (1.9% vs. 1.4%, p = 0.579); no valve thrombosis occurred. At 1 year, 94% of matched patients were in NYHA class I. Echocardiographic parameters remained stable; no moderate/severe paravalvular regurgitation was observed in BAV patients. Kaplan-Meier analysis revealed no differences in survival or composite outcomes. Technical and device success rates exceeded 95%; early safety was limited by a high incidence of non-vascular type 2-4 bleeding events. Based on the analyses, the relatively high postprocedural PPI rate (unmatched BAV vs. TAV: 34.0% vs. 30.4%, p = 0.429; matched: 34.0% vs. 24.0%, p = 0.274) is more likely attributable to patient-related characteristics rather than device-related complications, and remained unchanged following hospital discharge.

TAVI with the Myval THV in real-world BAV patients is safe and effective with excellent hemodynamic performance at 1 year follow-up. This may reinforce the use of this device in this anatomically complex population.