capillary perfusion, heart perfusion Blood flow in the tiniest blood vessels
Conditions
Interventions
The investigational product is exactly the same device as the previously approved MicroVision system, with the same CE marking, identical instructions for use, and equivalent user experience. This new
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Adult patients (18 years or older) - Use of central cannulated CPB through median sternotomy - Patients undergoing valve surgery or a supracoronary ascending aorta replacement - Good LVEF and RVF, no regional wall motion abnormalities, hypokinesis, or akinesis in the coronary territories - LAVI < 50 ml/m2, and right atrial volume index (RAVI) < 45 ml/m2
Exclusion criteria
Exclusion criteria: - Patients with significant coronary artery disease (i.e., CAD-RADS = 4, and/or stenosis of = 70% as observed in coronary angiogram) or previous infarctions, including ST-elevated myocardial ischemia (STEMI) or non-ST-elevated myocardial ischemia (N-STEMI) - Patients with echocardiographically observed regional wall motion abnormalities, hypokinesis, or akinesis in the coronary territories - Patients undergoing left atrial appendage amputation (LAAA) - Patients with AF - High-risk patients, as defined by a EuroSCORE II = 8%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main capillar perfusion parameters, both sublingual and myocardial, are: Capillary perfusion parameters (sublingual and myocardial): - TVD: The number of small blood vessels (< 20 µm) in a given area. - PVD: The number of small blood vessels that show perfusion, defined by a flow score of 2 or higher (moderate to normal flow). - PPV: The ratio of total vessel length to the length of perfused vessels. - MFI: A semi-quantitative measure that evaluates flow in the capillary perfusion. - HI: The degree of variation in capillary perfusion flow between different areas, calculated as the difference between the highest and lowest MFI, divided by the average MFI. Macrocirculatory parameters: - mean arterial pressure (MAP): the average blood pressure in the arteries during the cardiac cycle. - CI: the cardiac output (CO) per body surface area, a measure of heart function efficiency or in this case the flow rate of the CPB - heartrate (HR): the number of heartbeats per minute. | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographic and clinical variables: - Demographic information: age, gender, body mass index (BMI), etc. - Medical history: pre-existing conditions such as hypertension, diabetes, prior heart surgeries, etc. - Comorbidities: vessel disease other than coronary disease, kidney function, or pulmonary disease. Surgical variables: - type of underlying pathology (i.e. valve regurgitation / stenosis or aneurysm) LV unloading: - capillary perfusion parameters (see primary objectives): with and without LV unloading | — |
Countries
Netherlands
Contacts
Public ContactBU Baldan
Universiteit van Amsterdam
Outcome results
None listed