risk of AKI study

Use of Impella® Devices During High-Risk PCI is Associated with Reduced Occurrence of Acute Kidney Injury

May 15, 2017

Patients undergoing complex coronary revascularization are at risk for periprocedural and postprocedural acute kidney injury (AKI), a complication which correlates with an increased risk of death, major bleeding, and myocardial infarction (MI).1 A reduction in cardiac output and renal hypoperfusion, which in turn leads to a decrease in glomerular filtration rate, may partly explain the increased risk for AKI during high-risk percutaneous coronary intervention (HRPCI).1

Currently, there are few published studies which examine the impact of micro-axial percutaneous left ventricular assist devices on AKI in patients undergoing HRPCI.

Study Objective and Design

In the journal Circulation Research, Flaherty MP et al examined whether partial hemodynamic support with the Impella 2.5® device protected patients from developing AKI during HRPCI.1 The retrospective, single-center study enrolled 230 patients undergoing HRPCI and included 115 patients receiving Impella 2.5® support matched with a control group of 115 patients not receiving the device. On average, patients had a left ventricular ejection fraction (LVEF) of ≤35%. Typically, patients with severely reduced LVEF are at a greater risk for AKI because they require longer procedures, more complete revascularization, and greater contrast administration.

The primary outcome for this study was in-hospital AKI during a 72-hour periprocedural time frame.


Patients receiving hemodynamic support with Impella 2.5® had a significantly greater number of comorbidities and longer procedure time, factors which predisposed them to a higher risk for AKI. This patient group is also more likely to receive greater contrast, which further increases their risk.

Despite a greater number of risk factors, Impella®-supported patients experienced significantly less AKI than patients not receiving support (5.2% vs 27.8%, respectively). Only 0.9% of patients receiving the Impella® device required post-procedural hemodialysis vs 6.1% of patients without Impella® (p<0.05).

Those receiving the Impella® heart pump also had a shorter length of stay compared with unsupported patients, despite there being a greater baseline hazard for the patients in the Impella® arm. Nonetheless, supported patients had a lower rate of contrast nephropathy.

Greater Comorbidities, Lower Risk for AKI in Impella® Arm

Patients with a greater incidence of comorbidities, including diabetes and baseline renal insufficiency, are at an even higher risk for AKI. An analysis of the patient population studied in this retrospective, single-center study demonstrated that the subgroup supported by the Impella® device had far greater comorbidities than unsupported patients, yet supported patients experienced greater overall protection. This finding suggests the importance of considering Impella® device support during HRPCI in select patients.


Researchers agreed that Impella 2.5® successfully protected against AKI during HRPCI, and using this device in Protected PCI provides an added value for renal protection. The findings of this study, which are consistent with the PROTECT II2 randomized control trial, may bolster interventionalists’ confidence in performing complete revascularization in patients with complex coronary artery disease who are also at risk for AKI.

Although it isn’t entirely clear how the Impella® heart pump provides a protective benefit against AKI, there is speculation that it may relate to the device’s ability to provide continuous flow, thus reducing periprocedural renal hypoperfusion.

To learn more about this study, read Abiomed’s official press release. Also, click here to watch Dr. Seth Bilazarian expand on key points related to the study’s methodology and outcomes.


  1. Flaherty MP, Pant S, Patel SV, et al. Hemodynamic Support With a Microaxial Percutaneous Left Ventricular Assist Device (Impella) Protects Against Acute Kidney Injury in Patients Undergoing High-Risk Percutaneous Coronary Intervention. Circ Res. 2017;120(4):692-700.
  2. O'Neill WW, Kleiman NS, Moses J, et al. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation. 2012;126(14):1717-1727.

# IM2-023-17

Impella® Device — Indication & Safety Information



High-Risk PCI

The Impella 2.5®, Impella CP® and Impella CP® with SmartAssist® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5, Impella CP, and Impella CP with SmartAssist Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Cardiogenic Shock

The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist®, Impella 5.0® and Impella LD® Catheters, in conjunction with the Automated Impella® Controller (collectively, "Impella® System Therapy"), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5, Impella CP, and the Impella CP with SmartAssist, and ≤ 14 days for the Impella 5.0, and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.


Important Risk Information for Impella devices


The Impella 2.5, Impella CP, Impella 5.0 and Impella LD are contraindicated for use with patients experiencing any of the following conditions: Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe peripheral arterial disease precluding placement of the Impella System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD)*; Left ventricular rupture*; Cardiac tamponade*

* This condition is a contraindication for the cardiogenic shock indication only.


Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. Visit http://www.abiomed.com/important-safety-information to learn more.


Impella Connect®

The Impella Connect® transfers the video image of the screen on the Automated Impella® Controller to an authorized remote user. The transmitted image can be viewed by authorized remote users. The users can include the hospital’s clinicians, Abiomed local support staff, and Customer Support Center (CSC) team members.

Impella Connect Precautions

  • Impella Connect is not intended to provide real-time information for monitoring patient status on the Automated Impella® Controller.
  • During use of the Impella Connect, there will be a delay between when an image appears on the controller screen and when it is displayed at a remote viewing location.
  • The Impella Connect is not a source of patient alarms, nor is its use intended as a replacement for monitoring the controller’s alarms.
  • During use of the Impella Connect, receipt of the displayed controller information is not confirmed by the Automated Impella® Controller, nor is the delivery of the displayed controller information to the authorized remote users guaranteed.
  • The Impella Connect is not designed for use during transport.
  • Radiated and conducted electromagnetic interference can affect the performance of the Impella Connect, causing a temporary loss of connectivity. To clear interference, either increase the distance between system components and the EMI source or turn off the EMI source. Any electromagnetic interference related to the Impella Connect will have no impact on any of the controller functional specifications.
  • Portable and mobile RF communications equipment can affect medical electrical equipment.

Right-Side Support – Indication & Safety Info.


The Impella RP® System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Important Risk Information for Impella RP


The Impella RP System is contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP device. Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid or pulmonary valve. Mural thrombus of the right atrium or vena cava. Anatomic conditions precluding insertion of the pump. Presence of a vena cava filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter.


The potential adverse effects (eg, complications) associated with the use of the Impella RP System: Arrhythmia, Atrial fibrillation, Bleeding, Cardiac tamponade, Cardiogenic shock, Death, Device malfunction, Hemolysis, Hepatic failure, Insertion site infection, Perforation, Phlegmasia cerulea dolens (a severe form of deep venous thrombosis), Pulmonary valve insufficiency, Respiratory dysfunction, Sepsis, Thrombocytopenia, Thrombotic vascular (non-central nervous system) complication, Tricuspid valve injury, Vascular injury, Venous thrombosis, Ventricular fibrillation and/or tachycardia.

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP®. Visit http://www.abiomed.com/impella/impella-rp to learn more.

General Indication and Safety Information

To learn more about the Impella platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/

Subscribe to the Digital Community

Receive weekly updates including case review videos, tips and tricks, specialists opinions, and resources and downloads regarding Protected PCI and Cardiogenic Shock.

Subscribe to the Digital Community

Receive weekly updates including case review videos, tips and tricks, specialists opinions, and resources and downloads regarding Protected PCI and Cardiogenic Shock.