Hemodynamic Effects Of Impella On Renal Circulation And Risk Of CA-AKI Among Patients Undergoing Protected PCI

Study Overview
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Brief Summary
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Patients undergoing Percutaneous Coronary Intervention (PCI) are exposed to the risk of suffering from a damage to the kidneys which goes under the name of Contrast-Associated Acute Kidney Injury (CA-AKI), which is more common if the subject has advanced heart or kidney disease. Up to 1 high risk patient in 3 can suffer from CA-AKI. Impella is a pump which sustain the heart in the course of PCI in high risk individuals. Incidentally, Impella was shown to also reduce the incidence of CA-AKI. The reason why Impella protects the kidneys is not currently known. The investigators aim at understanding it through measurements of kidney blood flow and metabolism.

Detailed Description
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Contrast-associated acute kidney injury (CA-AKI) is among the major determinants of morbidity after percutaneous coronary intervention (PCI). Patients undergoing complex, high-risk indicated procedures (CHIP) are exposed to an increased risk of CA-AKI. Recent observational data suggested that mechanical circulatory support (MCS) with Impella in the course of CHIP PCI, i.e. Impella-protected PCI, may abate the risk of CA-AKI. A direct effect of MCS in improving renal perfusion has been postulated, but mechanistic evidence on the pathophysiologic effects of Impella on kidney hemodynamics is lacking. The investigators hypothesize that such improved renal outcomes during Impella protected PCI are attributable to increased blood flow as well as increased oxygen delivery to the kidneys granted by MCS. The aim of the present study is to fully characterize the renal hemodynamics as well as renal oxygen delivery and consumption during Impella-protected PCI using state-of-the-art invasive measurements, and to correlate those with functional magnetic resonance imaging of the kidney.

Official Title
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Characterization Of The Hemodynamic Effects Of Impella On Renal Blood Flow And Oxygen Delivery And Risk Of Contrast-Associated Acute Kidney Injury Among Patients Undergoing Protected Percutaneous Coronary Intervention

Conditions
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Contrast-induced Acute Kidney Injury (CI-AKI)

Intervention / Treatment
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* Other: Evaluate the blood flow and pressure into kidneys


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Impella-protected PCI selection criteria according to Virginia Commonwealth University (VCU) Complex PCI Program Left ventricular ejection fraction (LVEF) ≤35% and ≥1 complexity feature LVEF ≤45% and estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 and ≥1 complexity feature LVEF ≤45% and eGFR 31-45 ml/min/1.73 m2 and ≥2 complexity features Complexity features Planned treatment of ≥2 vessels Left main PCI Bifurcation intervention with 2-stent strategy Planned use of atherectomy (rotational, orbital, laser) Chronic total occlusion PCI PCI on last remaining vessel LVEDP >18 mmHg Cardiac index <2.0 l/min/m2 or pulmonary artery O2 saturation <55% Exclusion Criteria:- Pregnancy or lactation Presence of non-MRI compatible implanted medical device Known absolute contraindication to Impella insertion, e.g. severe peripheral arterial disease, left ventricular thrombus, aortic mechanical prosthesis, or severe aortic valve stenosis Chronic hemodialysis before the index procedure Status post-renal transplant Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Impella protected Percutaneous coronary intervention (PCI)<br>Patients undergoing Impella protected PCI as deemed necessary by interventional cardiologist - VCU Medical Center case based standard of care | Other: Evaluate the blood flow and pressure into kidneys<br>* Renal artery pressure and flow measures will be obtained using dedicated equipment positioned into the renal artery under fluoroscopic guidance. A pulmonary artery catheter will be used to measure the pressure inside participant's renal vein and to collect small blood samples to measure oxygen content.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal blood flow (RBF) | thermodilution will be used to measure patterns of RBF in milliliters per minute | during PCI up to 5 hours |