Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation
Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation
The objective is to assess the influence of FEops HEARTguide on overall device success in
 TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV)
 platform selection (Cohort B).
rationale:Transcatheter aortic valve implantation (TAVI) is increasingly used to treat
 patients with severe aortic stenosis. However, by extending the indication for TAVI,
 simulation may become increasingly important to improve procedure execution, safety and
 efficacy.

 objective: This study aims to assess the influence of FEops HEARTguide on overall device
 success in challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform
 selection (Cohort B).

 Study design: Prospective, observational multi-center trial with 2 cohorts Study Population:
 Cohort A patients with the following complex anatomy are included: BAV (Sievers 0 or 1) or
 functional bicuspid aortic valves, severely calcified aortic valve and small aortic roots.

 Cohort B consecutive patients eligible for TAVI with Acurate TM and Lotus Edge TM valve

 Study Procedure: Participating sites identifies cases and decide if the patient is eligible
 for cohort A or B. The pre-procedural CT-scan will be uploaded to FEops HEARTguide. Heart
 Team decision 1 is according to the clinical routine, including valve type and size,
 pre-dilatation, post-dilatation, preferred implantation depth and comfort scale level.

 Heart Team decision 2 is after the simulation of FEops HEARTguide for the final
 pre-procedural planning. For Cohort A, FEops HEARTguide will give their information about
 sizing and implantation depth. For Cohort B, FEops HEARTguide will give two simulations, one
 with an Acurate valve and one with a Lotus Edge valve.

 The operator will make the final decision about the valve selection. After the procedure the
 implanted device, size and depth are recorded as standard of care. The follow-up period will
 be 30 days. A new CT-scan is recommended. However, this will not be mandatory for this study.
Inclusion Criteria:

 -  Cohort A:

 1. Patients with a Bicuspid Aortic Valve (Sievers 0 or 1) or functional Bicuspid
 Aortic Valve

 2. Patients with a severely calcified aortic valve (Agatston score > 3000 for men,
 and > 1600 for women)

 3. Patients with small anatomy defined by mean aortic annulus diameter < 20mm

 -  Cohort B:

 1. every patient accepted for TAVI and eligible for Acurate TM and Lotus Edge valve
 TM.

 Exclusion Criteria:

 -  poor CT quality

 -  previous aortic valve replacement

 -  Permanent pacemaker at baseline