STUDY DESIGN
This is an Investigator initiated, international, multicenter, prospective registry,
enrolling 100 consecutive BAV patients who will undergo TAVI with the Evolut R/Pro
(23-26-29)/Evolut R 34THV.
Enrollment will be without limitation for each center (competitive enrollment). The
indication for TAVI will be based on each local Heart Team decision. As per local
institution's regulatory policy, each patient will provide a written informed consent for
the TAVI procedure, anonymous data collection and analysis. Each center will use its own
consent template.
All data will be collected in an electronic clinical report form (eCRF).
STUDY POPULATION Population
All consecutive patients diagnosed with type 0 or type 1 bicuspid aortic valve stenosis
or steno-insufficiency disease, undergoing transcatheter aortic valve implantation, as
per local standard of care.
CASPER algorithm
The sizing of the THV will be performed according to the proposed algorithm.
First step ("calcium impact"): subtract 1 mm in patients with aortic calcium volume ≥300
mm3 (i.e. ≥ Class I); no subtraction in patients with aortic calcium volume <300 mm3
(i.e. Class 0).
Second step ("raphe impact"): subtract 1 mm if the raphe length is ≥50% of the perimeter
derived mean annulus diameter Further 0.5 mm will be subtracted if a high burden of
calcium is distributed predominantly on the raphe site.
In case of bicuspid Type 0 the second step should be skipped.
Transcatheter Aortic Valve Implantation Procedure
TAVI will be performed according to the local standards of care. Balloon
valvuloplastywill be performed to prepare for TAVI deployment, at operator's discretion.
Balloon size should not exceed the minimal diameter of the aortic annulus at baseline.
TAVI deployment will be performed as the current best practices. All Centers will be
encouraged to implant THV according to the two cusp alignment technique. If necessary,
post dilatation will be performed, based on the final hemodynamics and aortic
regurgitation assessment. The postdilatation will be performed according to the calcium
burden with a balloon size diameter equal to the minor annulus diameter or to the mean
diameter.
Post-procedural MSCT scan
The post-procedural MSCT scan must be performed between 2 and 30 days after the index
procedure.
Post implant measurements of THV dimensions (perimeter and area) will be obtained at
inflow level, raphe level, and stent waist level (defined as the smallest dimension
observed at any plane of the implanted prosthesis). If the raphe level corresponds to the
stent waist level, only one measurement will be reported.
Eccentricity index will be calculated for each level. Eccentricity will be defined as
1-(minimal diameter/maximal diameter) and will be calculated both at the inflow and at
the narrowest level.
The post-procedural raphe length (defined as the longest measurable dimension of the
structure) will be measured at the same level of pre-procedural MSCT. The ratio between
the pre and post-procedure raphe length will be calculated for the assessment of raphe
shortening.
Strut separation data will be acquired (maximal strut distance, mean strut distance,
strut eccentricity index, i.e. maximal-minimal strut separation). The stent strut spaces
will be measured separately at the inflow level, with the first stent strut defined as
the strut closest to the commissure between the non-coronary and right coronary sinuses.
The subsequent struts will be numbered clockwise in an ascending order (1-15 for the
Evolut THV).