OBJECTIVE:
We sought to compare the new
transcatheter aortic valve replacement (TAVR)
device ACURATE neo (ACT) with the already established CoreValve (MCV) and SAPIEN XT (SXT) for the
treatment of severe
aortic stenosis (AS).
BACKGROUND:
Very few data on TAVR
devices are available beyond MCV and SAPIEN and there is no previous study comparing ACT with MCV and SXT.
METHODS:
We prospectively evaluated consecutive
patients who underwent transfemoral TAVR for the
treatment of severe AS. Clinical outcomes were reported following Valve Academic
Research Consortium 2 (VARC-2) criteria.
RESULTS:
A total of 162
patients (ACT n = 49, MCV n = 56, SXT n = 57), were included. MCV group had higher valve embolization/migration rates (ACT none; MCV 9%; SXT 2%; P = 0.034) causing lower
device success rates (ACT 98%; MCV 86%; SXT 95%; P = 0.043). At 30 days, there was no significant difference in all-cause
mortality (P = 0.22), cardiovascular
mortality (P = 0.20), periprocedural
myocardial infarction (P = 0.40),
stroke (P = 0.64), major vascular
complications (P = 0.48),
life-threatening
bleeding (P = 0.29),
acute kidney injury stage 2/3 (P = 0.69), or VARC-2 composite early
safety endpoints (P = 0.21). MCV group had higher rates of new permanent pacemaker implantation (ACT 6%; MCV 25%; SXT 11%; P = 0.013). Follow-up
echocardiography showed no significant difference in
aortic valve mean
pressure gradient (P = 0.73) or moderate/severe
aortic regurgitation (P = 0.19) between groups...