New Valve Technology (Switzerland) recently received CE mark approval for the treatment indication of percutaneous implantation of the ALLEGRA aortic valve in a degenerated bioprosthesis.
The ALLEGRA valve has two main characteristics: firstly, it is a self-expanding supra-annular valve with flexible commissures, and secondly, it has a low frame height that minimizes potential occlusion of the coronary ostium.
This approval came after extensive in vitro research on the behaviour of the ALLEGRA valve when implanted in the more commonly-used bioprostheses,1 followed by some very promising clinical results from the VIVALL study.2
Internationally, close to 100 cases of ALLEGRA valve implantation in degenerated surgical bioprostheses have been performed with very favourable outcomes in terms of residual gradient, paravalvular leak, and pacemaker implantation. In the VIVALL study,2 a reduction in transvalvular gradient (invasive measurement) from 37.1 ± 13.3 mmHg to 11.6 ± 3.7 mmHg was observed, with a 30-day mortality of 0%, and no paravalvular leaks or pacemaker implantations; the effective orifice area increased from 1.18 ± 0.58 cm2 to 1.4 ± 0.52 cm2.
Currently, patients of this type are being recruited for the post-marketing clinical study FOLLOW; when complete, this data will expand the clinical evidence on this percutaneous valve.
1. Sedaghat A, Sinning JM, Werner N et al. In vitro hydrodynamic and acute clinical performance of a novel self-expanding transcatheter heart valve in various surgical bioprostheses. EuroIntervention. 2018;13:2014-2017.
2. Schaefer U, Butter C, Landt M et al. Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves - The “VIVALL” multi-center, single-arm, pilot study. EuroIntervention. 2019;15:e757-e763.
Palabras clave: prótesis valvular percutánea. Keywords: percutaneous valve prothesis.