Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI

Aortic Valve Stenosis Clinical Trial

— TAVI  

Official title:

Physiological Study of Hemodynamic and Microcirculatory Evolution Before/After Transcatheter Aortic Valve Replacement (TAVI)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06154642
• Other study ID #: 2023-01118
• Status: Active, not recruiting
• Start date: May 8, 2024
• Est. completion date: July 13, 2024

Study information

• Verified date: June 2024
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 13, 2024
• Est. primary completion date: June 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Diagnostic Test:
• 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).
• Measurement of plasma Vascular Endothelium Growth Factor
Measurement of plasma Vascular Endothelium Growth Factor levels by ELISA
• 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)
• 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 (?PI 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.
• 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.
• 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.

Procedure:
• 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.

Locations

Country	Name	City	State
Switzerland	Prof Karim Bendjelid	Geneve	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Geneva	Noble Stéphane, Stanislas Abrard

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Modification in plasma Vascular Endothelium Growth Factor levels	Change in plasma Vascular Endothelium Growth Factor levels between preoperative and postoperative measurements.	24 hours
Primary	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
Primary	Modification in reactive hyperemia	Change in reactive hyperemia induced by vaso-occlusion test measured by peak of the perfusion index (?PI Peak), the time to reach the peak (time to peak), and the tissue resaturation rate (rStO2).	24 hours
Secondary	Organ dysfunction	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	7 days
Secondary	Functional capacity	Distance covered in a 6-minute walk test and percentage of predicted distance	day 6
Secondary	Mortality	All causes mortality	30 days
Secondary	Major Adverse Cardiovascular Events (MACE)	Composite: Acute myocardial infarction, unstable angina, postoperative high-sensitivity troponin (= 65 ng/L),; Stroke (including transient),; Death of cardiovascular origin.	30 days
Secondary	Major Adverse Kidney Events (MAKE)	Composite: Dependence on renal replacement therapy,; Decrease in glomerular filtration rate to <75% of baseline,; All causes mortality.	30 days