Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI)

Study Overview
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Brief Summary
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Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. As patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. This, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. This necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. Patient-specific computer simulation may improve outcome of TAVI by proposing the valve size that best fits the individual patient. The aim of this study is to assess the added value of patient-specific computer simulation in valve size selection.

Official Title
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The Value of Patient-specific Computer Simulation in the Planning of TAVI With the Self-expanding Evolut R Valve

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Other: Computer simulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Native severe aortic valve stenosis Planned for TAVI with the Evolut R Valve Exclusion Criteria: Bicuspid aortic valve Extensive subannular calcifications Non-transfemoral access Poor CT quality Lack of written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Computer simulation<br>Patients in whom a computer simulation model will be obtained based on pre procedural CT | Other: Computer simulation<br>* In these patients, a computer simulation model will be obtained based on pre procedural CT<br>|
| Prospective compare group<br>Patients in whom no computer simulation model will be obtained | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision 1- Valve size decision based on pre TAVI MSCT | Valve size decision based on pre TAVI Multislice Computed Tomography (MSCT), which is performed in all patients referred for TAVI in accordance to clinical routine, during the heart team meeting | an average of 2 days before TAVI, before TAVI and computer simulation | 
| Decision 2- Valve size decision after knowledge of the computer simulation results | Valve size decision after availability of the results of computer simulation | an average of 1 day before TAVI, before TAVI but after computer simulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision 3- Change of initial valve size decision during TAVI | Change of valve size decision during TAVI due to computer simulation | an average of 5 minutes after TAVI, directly after TAVI | 
| Decision 3- Change of initial depth of implantation strategy during TAVI | Change of depth of implantation strategy during TAVI due to computer simulation | an average of 5 minutes after TAVI, directly after TAVI | 
| Depth of implantation target | Initial depth of implantation strategy | an average of 2 days before TAVI, before TAVI and computer simulation | 
| Depth of implantation target 2 | Depth of implantation strategy after availability of computer simulation | an average of 1 day before TAVI, before TAVI but after computer simulation | 
| Aortic regurgitation | To compare the predicted (simulation) and observed degree of aortic regurgitation (echo post TAVI - Valve Academic Research Consortium (VARC-2) criteria for aortic regurgitation) | an average of 4 days after TAVI, at hospital discharge | 
| Correlation between predicted contact pressure and observed new conduction abnormality | To compare the predicted maximum contact pressure, contact pressure index and conduction abnormalities with the observed occurrence of new conduction abnormalities after TAVI | an average of 4 days after TAVI, at hospital discharge | 
| MACCE | To assess the incidence of Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | an average of 4 days after TAVI, at hospital discharge | 
| Incidence of the aforementioned outcome measures in a prospective group in whom no computer simulation will be perfomed | To compare the clinical based valve size decision and the angiographic and echocardiographic valve performance, depth of implantation, new conduction disorders and MACCE in a prospectively collected group of patients in whom no computer simulation will be performed | an average of 4 days after TAVI, at hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, Computer simulation