Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI (TAVI)

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Diagnostic test: Determination of arterial compliance using blood pressure waveform analysis; Diagnostic test: Measurement of plasma Vascular Endothelium Growth Factor; Diagnostic test: Skin temperature gradient; Diagnostic test: Vaso-occlusion test; Diagnostic test: Transthoracic echocardiography; Diagnostic test: Photoplethysmography; Procedure: Transcatheter aortic valve insertion (TAVI)

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 Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Switzerland
  • Geneva
    • Geneve, Geneva, Switzerland, 1211
      • Prof Karim Bendjelid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All causes mortality	30 days
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
Functional capacity	Distance covered in a 6-minute walk test and percentage of predicted distance	day 6
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: Stanislas Abrard; Noble Stéphane
• Investigators: Principal Investigator: Karim Bendjelid, Ph.D., University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Actual): June 13, 2024
• Study Completion (Actual): July 13, 2024

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Microcirculation; Endothelium, vascular; Transcatheter Aortic Valve Implantation; Microvascular reactivity
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: 2023-01118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No