The Value of Patient-specific Computer Simulation in the Planning of TAVI With the Self-expanding Evolut R Valve
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Erasmus Medical Center
- Enrollment
- 80
- Locations
- 5
- Primary Endpoint
- Decision 2- Valve size decision after knowledge of the computer simulation results
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
P de Jaegere
MD, PhD, Professor
Erasmus Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Decision 2- Valve size decision after knowledge of the computer simulation results
Time Frame: an average of 1 day before TAVI, before TAVI but after computer simulation
Valve size decision after availability of the results of computer simulation
Decision 1- Valve size decision based on pre TAVI MSCT
Time Frame: 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
Secondary Outcomes
- Depth of implantation target 2(an average of 1 day before TAVI, before TAVI but after computer simulation)
- Correlation between predicted contact pressure and observed new conduction abnormality(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(an average of 4 days after TAVI, at hospital discharge)
- MACCE(an average of 4 days after TAVI, at hospital discharge)
- Decision 3- Change of initial valve size decision during TAVI(an average of 5 minutes after TAVI, directly after TAVI)
- Decision 3- Change of initial depth of implantation strategy during TAVI(an average of 5 minutes after TAVI, directly after TAVI)
- Depth of implantation target(an average of 2 days before TAVI, before TAVI and computer simulation)
- Aortic regurgitation(an average of 4 days after TAVI, at hospital discharge)