The CASPER Registry
The CASPER Registry
The CASPER study is a prospective, international, multicenter registry which aims to evaluate
 the use of an algorithm for choosing the size of the prosthesis to be implanted in patients
 with bicuspid aortic stenosis type I treated by TAVI with Evolut® Pro prostheses (23 -26-29)
 and Evolut® R 34.
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).
Inclusion Criteria:

 1. Age ≥18 years.

 2. NYHA≥2 and/or syncope and/or angina.

 3. Patient judged by the Heart Team as indicated for TAVI.

 4. Anatomical suitability for transfemoral or any alternative access TAVI, based on MSCT
 assessment and local expertise and preference.

 5. Estimated life expectancy>1 year.

 Exclusion Criteria:

 1. Age <18 years

 2. Estimated life expectancy<1 year

 3. Pure aortic regurgitation.

 4. LVEF<20%

 5. No baseline MSCT evaluation.