Silent and Apparent Neurological Injury in Transcatheter Aortic Valve Implantation (TAVI)
In patients with severe Aortic Stenosis undergoing Transcatheter Aortic Valve Implantation (TAVI), what associated neurological injury exists as measured radiologically (magnetic resonance imaging), serological markers of neurological injury (s100B and GFAP) and clinically (neurological assessment, neurocognitive assessment, health-related quality of life scales).
Critical Care Research Group (CCRG)
80 participants
Jan 30, 2014
Observational
Conditions
Summary
Transcatheter Aortic Valve Implantation (TAVI) offers an exciting management option for patients with severe aortic stenosis, many of whom are considered too high-risk for traditional surgical aortic valve replacement (SAVR). It has been noted, however, that patients undergoing TAVI have an increased rate of stroke compared to those undergo in alternative management options (namely, medical therapy and SAVR). In these high-risk patients the functional, quality of life and mortality improvement of TAVI outweigh this risk and thus TAVI has had a favourable risk-benefit analysis. As TAVI practice extends in to lower-risk and younger populations, as is being seen in many of the large studies currently recruiting, this risk-benefit analysis may shift due to the better outcomes with SAVR in this group. A better understanding of stroke and neurocognitive impairment in TAVI is required to characterise and understand this risk better allowing for more accurate risk assessments and highlighting strategies for stroke minimisation.
Eligibility
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Interventions
1. Diffusion-weighted magnetic resonance imaging (DW-MRI) prior to, 4 (+/-2) days and 6 months following TAVI. 2. Continuous cerebral oximetry monitoring with near infra-red spectroscopy (NIRS) following induction of anaesthesia through to completion of TAVI. 3. Serological tests (s100B, NSE, Urea, Creatinine, LFTs, BNP) prior to and following procedure (time intervals based on characteristic serum 'wash-out' curves. 4. Objective neurocognitive assessment prior to and 3 days, 6 weeks and 6 months following the procedure. 5. Structured neurological examination prior to and 3 days, 6 weeks and 6 months following the procedure. 6. Computed tomography scanning of the chest to facilitate calcification scoring of aorta, aortic arch and valve. 7. Carotid Duplex ultrasonography pre-procedure to assess pre-existing carotid disease. This is an observational study of all patients selected as eligible candidates for the TAVI procedure (at the discretion of the treating "Heart Team" and the patient). Usually the procedure is reserved for patients with severe Aortic Stenosis who are deemed too high-risk for traditional surgical aortic valve surgery. More recently, TAVI use has extended into intermediate risk populations who are otherwise suitable for surgical aortic valve replacement. The TAVI procedure is considered lower risk as the replacement aortic valve is delivered in a less invasive way than in traditional aortic valve surgery and generally does not require the heart-lung machine (cardiopulmonary bypass). Access to the heart is via the blood vessels through wires and catheters delivered either through the groin or through a small incision in the chest wall. Once appropriately positioned the TAVI prosthesis is deployed and assumes the function of the native aortic valve. The duration of this procedure varies according to approach, however generally is between 30 to 90 minutes. Anaesthetic is required and may be either complete general anesthesia or conscious sedation.
Locations(2)
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ACTRN12613000083796