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.
Study Type
OBSERVATIONAL
Enrollment
80
In these patients, a computer simulation model will be obtained based on pre procedural CT
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Rigshospitalet
Copenhagen, Denmark
University Hospital Cologne-Heart Center
Cologne, Germany
Ospedale di San Raffaele
Milan, Italy
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
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
Time frame: 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
Time frame: an average of 1 day before TAVI, before TAVI but after computer simulation
Decision 3- Change of initial valve size decision during TAVI
Change of valve size decision during TAVI due to computer simulation
Time frame: 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
Time frame: an average of 5 minutes after TAVI, directly after TAVI
Depth of implantation target
Initial depth of implantation strategy
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: an average of 4 days after TAVI, at hospital discharge
MACCE
To assess the incidence of Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
Time frame: 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
Time frame: an average of 4 days after TAVI, at hospital discharge
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