Single Centre Experience With the Balloon-Expandable Myval Transcatheter Aortic Valve System in Patients With Bicuspid Anatomy: 1 Year Follow-Up.

BACKGROUND: 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.

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

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.