SAFETY OF DIFFERENT BIOPROSTHESIS TYPES IN TRANSCATHETER IMPLANTATION IN PATIENTS WITH BICUSPID AORTIC VALVE

Gaik V. Mardanyan; Marina V. Karuk; Roman S. Polyakov; Mikhail V. Puretskiy; Yurii M. Saakyan; Aleksandra A. Pirkova; Kiazim A. Kur-ipa; Shota G. Chargaziya; Sergey O. Popov; Sergey A. Abugov

SAFETY OF DIFFERENT BIOPROSTHESIS TYPES IN TRANSCATHETER IMPLANTATION IN PATIENTS WITH BICUSPID AORTIC VALVE

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Abstract

Highlights

The use of balloon-expandable and self-expanding bioprostheses in bicuspid anatomy is characterized by a comparable safety profile.
Hemodynamic advantages of self-expanding systems are negated in the presence of massive calcification of the left ventricular outflow tract.
The use of balloon-expandable prostheses in favorable anatomy is associated with a significantly lower risk of conduction disturbances and pacemaker implantation.

Aim. To conduct a comparative analysis of the immediate safety and efficacy outcomes of balloon-expandable and self-expanding bioprostheses in patients with bicuspid aortic valve stenosis, including those with severe calcification of the left ventricular outflow tract (LVOT).

Methods. This single-center study included 102 patients with severe bicuspid aortic valve stenosis. Based on the device type and anatomy, patients were divided into three groups: Group 1 (n = 32) received a balloon-expandable valve (BEV, Myval); Group 2 (n = 41) received a self-expanding valve (SEV, Evolut PRO/PRO+); Group 3 (SEV-2, n = 29) included patients with massive LVOT calcification who underwent SEV implantation. Patients with severe LVOT calcification were excluded from the BEV group to prevent annular rupture. Endpoints were evaluated according to VARC-3 criteria.

Results. No statistically significant differences were found between the groups regarding primary safety and efficacy endpoints at 30 days. The SEV group demonstrated superior hemodynamic parameters (mean gradient 8.9 ± 3.1 mm Hg) compared to the BEV group (11.6 ± 4.2 mm Hg, p = 0.003). However, in the SEV-2 group, the presence of calcification negated this advantage (mean gradient 12.3 ± 2.8 mm Hg) and was associated with a trend towards a higher incidence of paravalvular regurgitation ≥ grade 2 (13.8%). The permanent pacemaker implantation rate was lower in the BEV group (6.3%) compared to the SEV (12.2%) and SEV-2 (17.2%) groups. The incidence of new left bundle branch block was statistically significantly higher in the SEV-2 group compared to the BEV group (31.0% vs. 9.4%, p = 0.050). Analysis of neurological complications showed that the majority of stroke cases were non-disabling with full regression of symptoms.

Conclusion. The use of balloon-expandable and self-expanding bioprostheses in bicuspid aortic valve stenosis is characterized by a comparable safety profile. Device selection requires a differentiated approach: self-expanding systems are the method of choice for massive LVOT calcification, whereas balloon-expandable prostheses are preferred to minimize the risk of conduction disturbances in patients with favorable anatomy.