This study will compare the amount of cerebral microembolization during transcatheter aortic valve implantation (TAVI) between two commonly used types of transcatheter aortic valves: balloon-expandable valves and self-expanding valves.
Cerebral microembolization refers to small particles or material that may travel to the brain during the procedure. These signals can be detected using transcranial Doppler ultrasound, a non-invasive method for monitoring blood flow in the brain. Although clinically apparent stroke after TAVI is relatively uncommon, small silent brain lesions may occur, and their mechanisms are not fully understood.
Adult patients with severe symptomatic aortic valve stenosis who are scheduled for TAVI will be included. Participants will be randomly assigned to receive either a balloon-expandable or a self-expanding valve, both of which are established and routinely used treatment options. Transcranial Doppler monitoring will be performed before, during, and after the procedure to record the number of microembolic signals. The study will also record neurological events and procedural characteristics, such as procedure duration and the need for balloon dilatation.
The aim of the study is to determine whether the type of valve is associated with a different burden of cerebral microembolization during TAVI. The results may help improve understanding of procedural factors related to cerebral embolization and may support future strategies for reducing neurological risk in patients undergoing TAVI.
Age 18 years or older
Severe symptomatic aortic valve stenosis
Clinical indication for transcatheter aortic valve implantation
Feasibility of transcranial Doppler ultrasound monitoring
Recent stroke or transient ischemic attack
Significant cerebrovascular disease preventing reliable transcranial Doppler -assessment
Previous aortic valve implantation
Active endocarditis
Parallel
Balloon-expandable transcatheter aortic valve
DeviceA balloon-expandable transcatheter aortic valve will be implanted during a standard transcatheter aortic valve implantation procedure in participants randomized to this intervention arm. This valve type is an established and routinely used treatment option for severe symptomatic aortic valve stenosis. Cerebral microembolization will be monitored using transcranial Doppler ultrasound before, during, and after the procedure.
Self-expanding transcatheter aortic valve
DeviceA self-expanding transcatheter aortic valve will be implanted during a standard transcatheter aortic valve implantation procedure in participants randomized to this intervention arm. This valve type is an established and routinely used treatment option for severe symptomatic aortic valve stenosis. Cerebral microembolization will be monitored using transcranial Doppler ultrasound before, during, and after the procedure.
Change in Number of Cerebral Microembolic Signals During TAVI
he primary outcome is the difference between study groups in the change in the number of cerebral microembolic signals detected by transcranial Doppler ultrasound before, during, and after transcatheter aortic valve implantation. The comparison will be made between participants receiving balloon-expandable valves and those receiving self-expanding valves.
Number of Cerebral Microembolic Signals Within Each Study Group
Change in the number of cerebral microembolic signals detected by transcranial Doppler ultrasound before, during, and after TAVI will be assessed separately within each valve group.
Distribution of Cerebral Microembolic Signals by Procedural Phase
The number of cerebral microembolic signals will be analyzed according to procedural phase, including instrumentation, valvuloplasty, valve implantation, and the post-implantation period.
Occurrence of New Cerebral Microembolic Signals After TAVI
he occurrence and number of new cerebral microembolic signals detected after completion of the TAVI procedure will be recorded and compared between the study groups.
Incidence of Clinical Neurological Events
The association between procedural characteristics, including procedure duration, vascular access route, predilatation, postdilatation, and procedural complications, and the number of cerebral microembolic signals will be assessed.
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Ivan Zeljkovic
Lead sponsor
University Hospital Dubrava
Sponsor institution
University Hospital Dubrava
Collaborator
Sisters of Mercy University Hospital
Collaborator
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