Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI

Completed

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT06154642
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-11-23
• Study First Submitted QC: 2023-12-01
• Study First Posted: 2023-12-04
• Study Start: 2024-05-08
• Primary Completion: 2024-06-13
• Study Completion: 2024-07-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modification in reactive hyperemia	24 hours	Change in reactive hyperemia induced by vaso-occlusion test measured by peak of the perfusion index (ΔPI Peak), the time to reach the peak (time to peak), and the tissue resaturation rate (rStO2).
Modification in arterial stiffness in large- and small-caliber arteries	24 hours	Change in arterial stiffness of large/small caliber arteries between preoperative and postoperative measurements.
Modification in plasma Vascular Endothelium Growth Factor levels	24 hours	Change in plasma Vascular Endothelium Growth Factor levels between preoperative and postoperative measurements.
Modification in skin surface temperature gradient	24 hours	Change in skin surface temperature gradient, defined as the difference in temperature between the skin surface of the forearm and that of the fingertip (forearm-to-fingertip)

Secondary Outcome Measures

Name	Time	Method
Major Adverse Kidney Events (MAKE)	30 days	Composite: * Dependence on renal replacement therapy,; * Decrease in glomerular filtration rate to \<75% of baseline,; * All causes mortality.
Organ dysfunction	7 days	Organ dysfunction: Composite including one of the following events: * Acute Kidney Injury (KDIGO classification 1 and above),; * Acute lung injury (measured or estimated arterial oxygen pressure / inspired oxygen fraction ratio \<200),; * Postoperative cardiovascular failure (need for vasopressor or inotropic support for more than 2 hours),; * Postoperative neurocognitive impairment assessed using the 3D-Confusion Assessment Method
Functional capacity	day 6	Distance covered in a 6-minute walk test and percentage of predicted distance
Major Adverse Cardiovascular Events (MACE)	30 days	Composite: * Acute myocardial infarction, unstable angina, postoperative high-sensitivity troponin (≥ 65 ng/L),; * Stroke (including transient),; * Death of cardiovascular origin.
Mortality	30 days	All causes mortality

Trial Locations

Locations (1)

Prof Karim Bendjelid; 🇨🇭 Geneve, Geneva, Switzerland