Brain Lesions After Transcatheter Aortic Valve Replacement

Study Overview
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Brief Summary
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The Brain lEsions after TrAnscatheter aorTic ValvE Replacement (BETTER) registry is a prospective, observational, multi-center registry aiming to assess the presence of new brain microbleeds assessed on susceptibility-weighted imaging at 3 enrolling sites, in China (West China Hospital, Sichuan University), UK (St Thomas' Hospital) and Denmark (Rigshospitalet, University of Copenhagen). The main study arm is planned to include 100 patients with symptomatic severe aortic stenosis undergoing transfemoral TAVR of any devices and 50 isolated bioprosthetic SAVR patients treated during the enrollment period as a control arm.

Detailed Description
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Silent stroke post-TAVR presents as asymptomatic brain ischemic lesions detected on diffusion-weighted magnetic resonance imaging (DW-MRI), with an incidence ranging from 60% to 100% in different studies. On the contrary, hemorrhagic lesions are not systematically studied given the poor visualization of small hemorrhage (i.e. microbleeds) on traditional T1, T2 or DW-MRI sequences. We have previously identified an incidence of new brain microbleeds early after TAVR of 100% with the routine use of susceptibility-weighted imaging (SWI). We hypothesize that new brain microbleeds are prevalent in patients with aortic stenosis after either TAVR or SAVR. The key objective of this registry is to evaluate the incidence, distribution and clinical impact of new brain microbleeds after transfemoral TAVR in patients with symptomatic severe aortic stenosis, in comparison with SAVR.

Official Title
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Brain Lesions After Transcatheter Aortic Valve Replacement

Conditions
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Aortic Valve Stenosis, Brain Diseases

Intervention / Treatment
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* Other: Brain MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic severe aortic stenosis (>60 years old) being scheduled for either transfemoral TAVR or isolated SAVR Exclusion Criteria: Patients who have been diagnosed with brain cancer, brain haemorrhage, brain abscess, aneurysm, cerebral palsy, encephalitis, nervous system infection, head or neurological injury, or trauma, stroke Contraindications for a magnetic resonance imaging (MRI) scan (i.e. metallic implants, claustrophobia, MR-incompatible pacemakers or prosthetic heart valves) Unremovable dental prostheses that are deemed to affect MRI quality Severe coronary artery disease that is unrevascularized Prior stroke within the last 12 months Expected non-compliance concerning follow-up examinations Have participated in other clinical trials

Ages Eligible for Study
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Minimum Age: 60 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 |
| --- | --- |
| TAVR arm<br>Symptomatic severe aortic stenosis undergoing transfemoral TAVR of any devices | Other: Brain MRI<br>* Brain MRI will be scheduled within three days before the procedure and within seven days after the procedure, as well as at 1-year follow-up. MRI will be preferably performed using a 3.0-Tesla system unless patients are pacemaker-dependent after the procedure. In such case, a 1.5-Tesla system will be used. The MRI protocol consists of standardized conventional diffusion-weighted MRI (DW-MRI), T2-FLAIR (fluid-attenuated recovery inversion) and SWI (susceptibility-weighted imaging) parameters.<br>* Other names: Neurological and cognitive assessments as recommended by NeuroARC;|
| SAVR arm<br>Symptomatic severe aortic stenosis undergoing isolated bioprosthetic surgical aortic valve replacement | Other: Brain MRI<br>* Brain MRI will be scheduled within three days before the procedure and within seven days after the procedure, as well as at 1-year follow-up. MRI will be preferably performed using a 3.0-Tesla system unless patients are pacemaker-dependent after the procedure. In such case, a 1.5-Tesla system will be used. The MRI protocol consists of standardized conventional diffusion-weighted MRI (DW-MRI), T2-FLAIR (fluid-attenuated recovery inversion) and SWI (susceptibility-weighted imaging) parameters.<br>* Other names: Neurological and cognitive assessments as recommended by NeuroARC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of new brain microbleeds detected on MRI | Microbleeds (including the number and size) on SWI after TAVR or SAVR during the index hospitalization and their evolution at the follow-up | Post-procedurally (up to 7 days) and 6 months | 
| The incidence of new brain embolisms detected on MRI | Ischemic infarcts (including the number and size) on DW-MRI after TAVR or SAVR during the index hospitalization and their evolution at the follow-up | Post-procedurally (up to 7 days) and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the neurological and cognitive status of the patients (see description for specific assessments) | NIH Stroke Scale (NIHSS) and Montreal Cognitive Assessment (MoCA, cognitive impairment = score <23/30) for overall cognitive status, and tests for five individual cognitive domains (Attention: Digit Symbol-Coding test [DSST]; Memory: Hopkins Verbal Learning Test-Revised [HVLT-R], Brief Visual Memory Test-Revised [BVMT-R]; Executive Function: Stroop Color-Word Association Test [SCWT], Category and Verbal Fluency [both semantic and phonemic]; Visuospatial Function: BVMT-R). The change of score in each assessment will be calculated. | Post-procedurally (up to 7 days), 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVR, Magnetic resonance imaging, Ischemic infarct, Microbleeds