Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI

NCT ID: NCT06154642

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2024-07-13

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.

Conditions

Aortic Valve Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Determination of arterial compliance using blood pressure waveform analysis

Measurement of arterial stiffness using a non-invasive pressure transducer placed on the skin of the wrist, which records the pulse wave at the level of the radial artery in order to analyze the characteristics of the arterial wall. The parameters of interest are the arterial stiffness of large- and small-caliber arteries (ml/mmHg).

Intervention Type: DIAGNOSTIC_TEST

Measurement of plasma Vascular Endothelium Growth Factor

Measurement of plasma Vascular Endothelium Growth Factor levels by ELISA

Intervention Type: DIAGNOSTIC_TEST

Skin temperature gradient

Measurement of 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)

Intervention Type: DIAGNOSTIC_TEST

Vaso-occlusion test

Measurement of endothelial function by a vaso-occlusion test performed by inflating a cuff on the arm to occlude arterial flow for 3 min. Reactive hyperemia on deflation of the cuff is measured by photoplethysmography placed on the index finger, and tissue oxygen saturation (StO2) by near-infrared spectroscopy (NIRS). The amplitude of the reperfusion flow corresponding to the peak of the perfusion index (ΔPI Peak) and the time to reach this peak (time to peak) are the parameters recorded by photoplethysmography. Tissue resaturation rate (rStO2) is the parameter recorded by NIRS.

Intervention Type: DIAGNOSTIC_TEST

Transthoracic echocardiography

The diameter of the left ventricular outflow tract is measured in the tele systolic parasternal long-axis view. The pulsed Doppler flow profile is acquired at the level of the left ventricular chamber in the apical five-chamber view. The time-velocity integral of the aortic flow is then calculated. Left ventricular end-diastolic and end-systolic volumes are also measured using Simpson's method in the 4-cavity monoplane view. Measurements of vena cava diameter and respiratory variability of vena cava diameter provide an estimate of right atrial pressure. These measurements estimate cardiac output and systemic vascular resistance.

Intervention Type: DIAGNOSTIC_TEST

Photoplethysmography

The perfusion index (PI) is derived from the signal and represents the ratio between the absorbance or reflectance of pulsatile and non-pulsatile light of the photoplethysmography signal. PI is measured non-invasively using a photoplethysmographic sensor placed on the earlobe or finger.

Intervention Type: DIAGNOSTIC_TEST

Transcatheter aortic valve insertion (TAVI)

TAVI is a treatment for aortic valve stenosis. A new valve is inserted with minimally invasive procedure without removing the old, damaged valve.

Intervention Type: PROCEDURE

Other Intervention Names

Arterial tonometry; Vascular Endothelium Growth Factor; Forearm-to-fingertip temperature gradient; Reactive hyperemia; Perfusion index; Transcatheter Aortic Valve Replacement (TAVR)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanislas Abrard

UNKNOWN

Sponsor Role: collaborator

Noble Stéphane

UNKNOWN

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Karim Bendjelid

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karim Bendjelid, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Prof Karim Bendjelid

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

Other Identifiers

2023-01118

Identifier Type: -

Identifier Source: org_study_id