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

Central Hospital, Nancy, France

Status: Unknown

Conditions: Delirium; Post-Op Complication; Aortic Valve Disease; Anesthesia

Treatments: Procedure: anesthesia type

Study type: Observational

Funder types: Other

Identifiers

NCT03323619

PSS2017/DELIRIUMTAVI-MATTEI/YB

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

GA

Description:

No intervention. General anesthesia is decided by the physicien according to his usual practice

Treatment:

Procedure: anesthesia type

LASed

Description:

No intervention. Local anesthesia with sedation is decided by the physicien according to his usual practice

Treatment:

Procedure: anesthesia type