Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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Aortic stenosis is a frequent valvulopathy in Europe and North America. It occurs mainly over 65 years (2-7% of the population over 65 years). Treatment of symptomatic stenosis is an indication of aortic valve replacement. For patients with high surgical risk (EuroSCORE II> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended. This type of procedure concerns elderly patients (75-80 years on average in the literature) therefore the anesthesia technique must be optimal. The postoperative complications are, on the one hand, well-described surgical complications (Cardiogenic shock, bleeding, rhythm disorders, renal insufficiency) and, on the other hand, those related to anesthesia which are less well characterized. There is no consensus on best anesthesia technique for TAVI procedure managment. Between teams practices are different. It may consist of general anesthesia (GA) or local anesthesia with sedation (LASed). Elderly anesthesia has specific complications, including acute cerebral disturbances (delirium) usually occurring within 24 to 48 hours postoperatively and up to 7 days. It is recommended to screen delirium for patients admitted in intensive care using the CAM-ICU scale. The aim of the study is to observe the impact of the anesthesia technique (GA versus LASed) on delirium in post-operative aortic valve replacement with TAVI procedure

Official Title
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Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation

Conditions
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Delirium, Post-Op Complication, Anesthesia, Aortic Valve Disease

Intervention / Treatment
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* Procedure: anesthesia type


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospital admission for TAVI femoral way Age > 18 years Psychiatric disease Exclusion Criteria: Opposition of the operator (Interventional Cardiologist or Surgeon) to one of the two anesthesia technique Contraindication to local anesthesia with sedation: agitation, delirium, allergy to local anesthetics, risk of inhalation Opposition of the patient to use his data for research

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GA<br>No intervention. General anesthesia is decided by the physicien according to his usual practice | Procedure: anesthesia type<br>* No intervention. General anesthesia or local anesthesia with sedation are decided by the physicien according to his usual practice<br>|
| LASed<br>No intervention. Local anesthesia with sedation is decided by the physicien according to his usual practice | Procedure: anesthesia type<br>* No intervention. General anesthesia or local anesthesia with sedation are decided by the physicien according to his usual practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium | post-operative delirium after TAVI | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU stay | duration of stay in ICU | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Transcatheter aortic valve replacement, Anesthesia technique