Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI

University Hospitals (UH)

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Diagnostic Test: Skin temperature gradient; Diagnostic Test: Measurement of plasma Vascular Endothelium Growth Factor; Diagnostic Test: Determination of arterial compliance using blood pressure waveform analysis; Diagnostic Test: Vaso-occlusion test; Procedure: Transcatheter aortic valve insertion (TAVI); Diagnostic Test: Photoplethysmography; Diagnostic Test: Transthoracic echocardiography

Study type: Observational

Funder types: Other

Identifiers

NCT06154642

2023-01118

Details and patient eligibility

About

The Physiological Study of Haemodynamic and Microcirculatory Evolution before/after Transcatheter Aortic Valve Replacement (TAVI) aims to investigate the physiological changes induced by the implantation of a prosthetic aortic valve on blood vessels in patients with severe aortic stenosis. The hypothesis of the study is that adaptive microcirculatory phenomena occur during TAVI implantation. The results of preoperative assessment of microcirculatory functional reserve differ according to whether or not organ dysfunction occurs after TAVI. There is a progressive adaptation of the microcirculation to the new cardiovascular load conditions after TAVI. Early features of this adaptation are associated with the occurrence of short- and medium-term complications.

Full description

This is a prospective, physiologic, monocentric, pilot cohort study carried out at the University Hospitals of Geneva on the initiative of the investigator. We are investigating the adaptive mechanisms at work in the blood vessels and their potential impact on clinical outcomes in the month following surgery. In addition to the usual perioperative monitoring, patients enrolled in the study will benefit from vascular monitoring, which consists of a series of additional non-invasive and painless examinations performed before, a few hours after and on the day after surgery. The clinical outcome of the aortic valve implantation will be monitored by a questionnaire on the day after the procedure, a 6-minute walk test during the usual consultation with the cardiologist on the 6th day after the procedure, and a review of patient health events one month after the valve implantation.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All major patients undergoing a femoral TAVI procedure for severe aortic stenosis,

Exclusion criteria

• Non-femoral approach for TAVI implantation,
• Presence of other concomitant severe valve disease,
• Planned procedure under general anesthesia,
• Anticipated inability to perform a 6-minute walk test post-operatively (physical handicap),
• Heart failure with left ventricular ejection fraction <40%,
• Chronic end-stage renal failure,
• Chronic lung disease with home oxygen therapy,
• Acquired changes in serum VEGF levels: recent myocardial infarction or stroke, recent vascular intervention (< 3 months), active cancer, anti-angiogenic immunotherapy,
• Patients with known or identified cognitive disorders,
• Persons deprived of their liberty, persons under protective supervision,
• Pregnant or breast-feeding.