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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Contrast-induced Acute Kidney Injury (CI-AKI)
• Intervention / Treatment: Other: Evaluate the blood flow and pressure into kidneys

Detailed Description

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are scheduled to undergo Impella assisted PCI procedure

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Impella protected Percutaneous coronary intervention (PCI); 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Kidney Injury (AKI)	Change in creatine will be used to identify AKI	up to 72 hours after PCI
Anatomical changes	Pre and post-procedural kidney magnetic resonance imaging (MRI) will be used to explore any changes in acute renal ischemia due to the procedure	3 days
Renal oxygen delivery (ROD)	ROD is defined as O2 content (CaO2) (RBF x CaO2). Blood samples during the procedure will be used to observe the patterns.	during PCI up to 5 hours
Renal oxygen consumption (ROC)	ROC is defined as CaO2 and renal vein oxygen content (CvO2) as RBF x (CaO2 - CvO2). Blood samples during the procedure will be used to observe the patterns.	during PCI up to 5 hours
Renal oxygen extraction (ROE)	ROE is defined as CaO2 and CvO2 as (CaO2 - CvO2)/CaO2. Blood samples during the procedure will be used to observe the patterns.	during PCI up to 5 hours
Renal vascular resistance (RVR)	RVR will be calculated using mean arterial pressure (MAP) and renal vein pressure (RVP) as (MAP - RVP)/RBF.	during PCI up to 5 hours

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Abiomed Inc.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): October 1, 2024

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (ACTUAL): June 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: HM20021800

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