The JACC-Cardiovascular Intervention published the 1-year outcomes of the perspective and multicentre SAVI-TF registry: in 25 European centers, 1000 patients are enrolled treated with transfemoral access by Boston Scientific’s ACURATE neo valve (Logistic EuroSCORE II 6.6%).
ACURATE neo valve, composed of a self-expanding nitinol stent and porcine pericardial skirt, is designed in order to facilitate the axial self-alignment of the bioprosthesis.
The study shows the “real life” clinical experience with the largest population in literature, treated with ACURATE neo valve e and according to indications of use.
Clinical endpoints, defined under the VARC II criteria, report:
- 8.0% mortality,
- 3.6% paravalvular insufficiency,
- 9.9% pacemaker implantation,
- 0% valvular thrombosis,
- 2.3% disabling strokes.
The echocardiographic results attest to:
- the effective valvular equal to 1.84 cm2
- an average gradient of 7.3 mmHg.
The SAVI-TF register signals the safety and performance of the ACURATE neo valve in a very large population; in particular, the mortality data are in line with other registers for the same population and logistic score, with improved results in terms of pacemaker implantation. The last hemodynamics outcomes observed in this register are for the authors to be attributed to the supra-annular design of the ACURATE neo prosthesis.