Evaluation of Endothelial Dysfunction During Aortic Valvular Replacement by Bioprosthesis With and Without Extracorporeal Circulation

Completed

• Conditions: Endothelial Dysfunction; Aortic Valve Disease
• Interventions: Other: Study of endothelial function biological markers

• Registration Number: NCT03135496
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Patients with aortic stenosis present many risk factors for endothelial dysfunction (arterial hypertension, arteriosclerosis, dyslipidemia, chronic renal insufficiency, etc.). It is likely that a significant number of patients suffer from pre-existing endothelial dysfunction that can be evaluated by a molecular approach.

To date, the replacement of the aortic valve can be performed by surgery with extracorporeal circulation (CEC) or percutaneous (Transcatheter Aortic Valve ImplantationTAVI) without CEC.

Two recent studies have demonstrated a sustained improvement in endothelial function with TAVI. On the contrary, studies have demonstrated that post-operative complications (coagulopathy, capillary leak syndrome, acute vasoplastic disorder and acute renal failure) after surgery with extracorporeal circulation (CEC) could be the result of the interaction between pre-existing endothelial dysfunction And the "operative" aggression associated with the CEC.

Thus, patients with preexisting involvement of endothelial function would develop vascular dysfunction after valvular replacement due to "endothelial activation" related to CEC. This phenomenon would not exist in TAVI, and would explain the absence of so-called vascular dysfunction complications (Systemic inflammatory response syndrome, vasoplastic syndrome, disseminated intravascular coagulation).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-05
• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-05-01
• Primary Completion: 2019-01-04
• Study Completion: 2019-01-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Patient ≥ 18 years.
• Patient operated on aortic valvular replacement by bioprosthesis in surgery + CEC or TAVI
• Signed consent.
• Affiliation to Social Security

Exclusion Criteria

• Any other cardiac surgery
• Mechanical aortic valve replacement
• Permanent Ac / Fa.
• Pregnant woman.
• Curative anticoagulation (AVK, NANCO, heparin).
• Patient under tutelage or curatelle.
• Refusal of the patient.
• Participation in another study.
• Preoperative sepsis
• Minor or adult, under guardianship or curatorship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Without CEC	Study of endothelial function biological markers	-
Surgery with CEC	Study of endothelial function biological markers	-

Primary Outcome Measures

Name	Time	Method
Analysis of the variation of the following endothelial function markers: angiopoetin 1 and 2 depending on whether or not extracorporeal circulation	1 week

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France