Aortic Valve Stenosis
Conditions
Keywords
TAVI, Computer simulation
Brief summary
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.
Interventions
OTHERComputer simulation
In these patients, a computer simulation model will be obtained based on pre procedural CT
Sponsors
Feops
Cardialysis B.V.
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision 1- Valve size decision based on pre TAVI MSCT | an average of 2 days before TAVI, before TAVI and computer simulation | 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 |
| Decision 2- Valve size decision after knowledge of the computer simulation results | an average of 1 day before TAVI, before TAVI but after computer simulation | Valve size decision after availability of the results of computer simulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depth of implantation target | an average of 2 days before TAVI, before TAVI and computer simulation | Initial depth of implantation strategy |
| Depth of implantation target 2 | an average of 1 day before TAVI, before TAVI but after computer simulation | Depth of implantation strategy after availability of computer simulation |
| Aortic regurgitation | an average of 4 days after TAVI, at hospital discharge | To compare the predicted (simulation) and observed degree of aortic regurgitation (echo post TAVI - Valve Academic Research Consortium (VARC-2) criteria for aortic regurgitation) |
| Decision 3- Change of initial valve size decision during TAVI | an average of 5 minutes after TAVI, directly after TAVI | Change of valve size decision during TAVI due to computer simulation |
| MACCE | an average of 4 days after TAVI, at hospital discharge | To assess the incidence of Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) |
| Incidence of the aforementioned outcome measures in a prospective group in whom no computer simulation will be perfomed | an average of 4 days after TAVI, at hospital discharge | 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 |
| Correlation between predicted contact pressure and observed new conduction abnormality | an average of 4 days after TAVI, at hospital discharge | To compare the predicted maximum contact pressure, contact pressure index and conduction abnormalities with the observed occurrence of new conduction abnormalities after TAVI |
| Decision 3- Change of initial depth of implantation strategy during TAVI | an average of 5 minutes after TAVI, directly after TAVI | Change of depth of implantation strategy during TAVI due to computer simulation |
Countries
Belgium, Denmark, Germany, Italy, Netherlands
Outcome results
None listed