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

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

Study Overview

• Status: Unknown
• Conditions: Delirium; Aortic Valve Disease; Anesthesia; Post-Op Complication
• Intervention / Treatment: Procedure: anesthesia type

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• France
  • Lorraine
    • Nancy, Lorraine, France, 54000
      • Recruiting
      • CHRU - Hopital de Brabois
      • Contact: FRITZ Caroline; Phone Number: +33383157379; Email: fritzcaro@gmail.com
      • Contact: MATTEI Matthieu; Phone Number: +33383153521; Email: m.mattei@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patient admitted for TAVI intervention

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GA; No intervention. General anesthesia is decided by the physicien according to his usual practice	Procedure: anesthesia type; No intervention. General anesthesia or local anesthesia with sedation are decided by the physicien according to his usual practice
LASed; No intervention. Local anesthesia with sedation is decided by the physicien according to his usual practice	Procedure: anesthesia type; No intervention. General anesthesia or local anesthesia with sedation are decided by the physicien according to his usual practice

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: MATTEI Mathieu, MD, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2017
• Primary Completion (ANTICIPATED): August 2, 2020
• Study Completion (ANTICIPATED): November 2, 2020

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (ACTUAL): October 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Delirium; Transcatheter aortic valve replacement; Anesthesia technique
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Heart Valve Diseases; Delirium; Postoperative Complications; Aortic Valve Disease; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: PSS2017/DELIRIUMTAVI-MATTEI/YB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No