Brain Lesions After Transcatheter Aortic Valve Replacement
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
"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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| TAVR arm Symptomatic severe aortic stenosis undergoing transfemoral TAVR of any devices |
Other: Brain MRI
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.
Other Names:
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| SAVR arm Symptomatic severe aortic stenosis undergoing isolated bioprosthetic surgical aortic valve replacement |
Other: Brain MRI
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- The incidence of new brain microbleeds detected on MRI [Post-procedurally (up to 7 days) and 6 months]
Microbleeds (including the number and size) on SWI after TAVR or SAVR during the index hospitalization and their evolution at the follow-up
- The incidence of new brain embolisms detected on MRI [Post-procedurally (up to 7 days) and 6 months]
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
Secondary Outcome Measures
- Changes in the neurological and cognitive status of the patients (see description for specific assessments) [Post-procedurally (up to 7 days), 6 months and 1 year]
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.
Other Outcome Measures
- Perfusion changes on transcranial doppler during TAVR or SAVR (if obtained) [Intra-procedurally]
Baseline perfusion will be obtained before femoral puncture in TAVR and the start of cardiopulmonary bypass in SAVR, until completion of eventual postimplantation maneuvers in TAVR and the stop of cardiopulmonary bypass in SAVR
Eligibility Criteria
Criteria
Inclusion Criteria:
- Symptomatic severe aortic stenosis (>60 years old) being scheduled for either transfemoral TAVR or isolated SAVR
Exclusion Criteria:
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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
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Contraindications for a magnetic resonance imaging (MRI) scan (i.e. metallic implants, claustrophobia, MR-incompatible pacemakers or prosthetic heart valves)
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Unremovable dental prostheses that are deemed to affect MRI quality
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Severe coronary artery disease that is unrevascularized
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Prior stroke within the last 12 months
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Expected non-compliance concerning follow-up examinations
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Have participated in other clinical trials
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- West China Hospital
- St Thomas' Hospital, London
- Rigshospitalet, Denmark
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021V1