Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI

NCT06154642 | Completed

• 1 other identifier: 2023-01118
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Keywords

Transcatheter Aortic Valve Implantation; Microcirculation; Endothelium, vascular; Microvascular reactivity

Outcome Measures

Primary Outcomes (4)

• Modification in arterial stiffness in large- and small-caliber arteries

  Change in arterial stiffness of large/small caliber arteries between preoperative and postoperative measurements.

  24 hours

• Modification in plasma Vascular Endothelium Growth Factor levels

  Change in plasma Vascular Endothelium Growth Factor levels between preoperative and postoperative measurements.

  24 hours

• Modification in skin surface temperature gradient

  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)

  24 hours

• Modification in reactive hyperemia

  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).

  24 hours

Secondary Outcomes (5)

• Organ dysfunction

  7 days

• Functional capacity

  day 6

• Mortality

  30 days

• Major Adverse Cardiovascular Events (MACE)

  30 days

• Major Adverse Kidney Events (MAKE)

  30 days

Interventions

Determination of arterial compliance using blood pressure waveform analysis DIAGNOSTIC_TEST

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).

Also known as: Arterial tonometry

Measurement of plasma Vascular Endothelium Growth Factor DIAGNOSTIC_TEST

Measurement of plasma Vascular Endothelium Growth Factor levels by ELISA

Also known as: Vascular Endothelium Growth Factor

Skin temperature gradient DIAGNOSTIC_TEST

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)

Also known as: Forearm-to-fingertip temperature gradient

Vaso-occlusion test DIAGNOSTIC_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.

Also known as: Reactive hyperemia

Transthoracic echocardiography DIAGNOSTIC_TEST

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.

Photoplethysmography DIAGNOSTIC_TEST

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.

Also known as: Perfusion index

Transcatheter aortic valve insertion (TAVI) PROCEDURE

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

Also known as: Transcatheter Aortic Valve Replacement (TAVR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Selection from patients with severe aortic stenosis referred to the Geneva tertiary university hospital for minimally invasive procedures.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Stanislas Abrard: collaborator
• Noble Stéphane: collaborator

Study Sites (1)

Prof Karim Bendjelid

Geneva, Canton of Geneva, 1211, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

ethylenediaminetetraacetic acid plasma

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Echocardiography; Photoplethysmography; Perfusion Index; Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Plethysmography; Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Karim Bendjelid, Ph.D.

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 4, 2023
• Study Start: May 8, 2024
• Primary Completion: June 13, 2024
• Study Completion: July 13, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)