Non-interventional Study Exploring the Composition of the Valvular Microbiota of Patients Undergoing Cardiac Surgery (BIOVALV)

Toulouse University Hospital

Status: Not yet enrolling

Conditions: Cardiac Surgery; Valvulopathy; Microbiota

Treatments: Biological: DNA sequencing; Other: Collection of serious post-operative complications; Biological: Take 1 ml of blood; Procedure: Valve collection (healthcare waste)

Study type: Interventional

Funder types: Other

Identifiers

NCT07075601

2025-A00422-47 (Other Identifier)

RC31/25/0020

Details and patient eligibility

About

The prevalence of aortic valve disease is increasing, with these valvulopathies present in half of individuals over the age of 65.

Oberbach A. et al (1) demonstrated the presence of microbiota in 52% of cases of explanted aortic valves. One current hypothesis is the role of this microbiota in the pathophysiology of these degenerative valve diseases. This microbiota is probably not completely eradicated after resection of the native valve and implantation of a conventional prosthesis; it is even left in place during percutaneous aortic valve implantation, during which the prosthesis is deployed within the native valve. It could therefore also play a role in the occurrence of postoperative complications and the degeneration or thrombosis of a bioprosthesis.

Furthermore, recent clinical and epidemiological studies have shown a link between oral infections and cardiovascular diseases. As recommended by the HAS, these patients require multidisciplinary care, involving cardiologists, cardiac surgeons and general practitioners, as well as careful oral and dental care and monitoring provided by specialists in oral pathologies and oral care. The accumulation of bacterial plaque on the surface of the tooth and certain oral bacteria causes the development of periodontal pockets which are characteristic of periodontitis. Bacteria, microbial products and inflammatory mediators produced locally can then enter the bloodstream and affect distant organs such as the cardiovascular system. The recommendations of the European Society of Cardiology are therefore to carry out regular oral and dental consultations to prevent the risk of infection. Therefore, within the Toulouse University Hospital, a care network has been set up for patients with cardiovascular pathologies, in order to improve their access to dental care, screening and management of oral diseases. For the past year, patients hospitalized in the cardiology departments have been seen in consultation in the dental department of the Toulouse University Hospital.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patient.
• Present an indication for cardiac surgery that requires explantation of the aortic valve.
• Be able to receive information about the study process and understand the study participation information form.
• State their non-opposition to participating in the study.

Exclusion criteria

• Patients infected with HIV
• Age under 18
• Under court supervision, guardianship, or curatorship
• Patients with a history of infective endocarditis.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Patients with an indication for cardiac surgery

Experimental group

Description:

Patients with an indication for cardiac surgery during which the aortic valve is explanted.

Treatment:

Procedure: Valve collection (healthcare waste)

Other: Collection of serious post-operative complications

Biological: Take 1 ml of blood

Biological: DNA sequencing