Use of Impella® Devices During High-Risk PCI is Associated with Reduced Occurrence of Acute Kidney Injury
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.
- 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.
- 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.
Impella® Device — Indication & Safety Information
INDICATIONS FOR USE
The Impella 2.5® and Impella CP® Systems are a 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 and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 and Impella CP 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.
The Impella 2.5®, Impella CP®, 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 and Impella CP, and ≤ 6 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 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.
POTENTIAL ADVERSE EVENTS
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
www.protectedpci.com/hcp/information/isi and www.cardiogenicshock.com/hcp/information/isi to learn more.
Right-Side Support – Indication & Safety Info.
INDICATIONS FOR USE
The Impella RP® is indicated for providing circulatory assistance for up to 14 days in pediatric or adult 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 is contraindicated for use with patients experiencing any of the following conditions: Pulmonary artery wall disorders precluding placement or correct positioning of the Impella RP device; Anatomic conditions precluding insertion of the pump; Tricuspid or pulmonic valve abnormalities including: mechanical valves, severe stenosis or regurgitation; Mural thrombus of the right atrium or vena cava; Other illnesses or therapy requirements precluding use 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.
POTENTIAL ADVERSE EVENTS
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 www.abiomed.com/impella/impella-rp to learn more.
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.