Evaluation of Endothelial Dysfunction During Aortic Valvular Replacement by Bioprosthesis With and Without Extracorporeal Circulation (DYVA2)

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Endothelial Dysfunction; Aortic Valve Disease

Treatments: Other: Study of endothelial function biological markers

Study type: Observational

Funder types: Other

Identifiers

NCT03135496

PI2016_843_0029

Details and patient eligibility

About

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).

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

51 participants in 2 patient groups

Surgery with CEC

Treatment:

Other: Study of endothelial function biological markers

Without CEC

Treatment:

Other: Study of endothelial function biological markers