End-Points
Primary end-points were implantation success and 30-day
mortality16.
Secondary end-points were postoperative stroke, AV-block requiring a
permanent pacemaker and paravalvular leak, according to recommendation
from Akins et al.16.
Perceval-S valve hemodynamics (effective orifice area, mean and peak
gradients) were evaluated via transthoracic echocardiography (TTE),
around post-operative Day 5 (MV, blinded for valve size, reviewed all
TTE images) and patient-prosthesis mismatch was calculated according to
Pibarot et al.17. We excluded hemodynamics of the
patients in whom Perceval-S implantation finally failed.