Clinical Options for Minimizing Contrast Exposure and Reducing Contrast-Induced Kidney Injury Risk
- Contrast-induced acute kidney injury caused by iodinated contrast medium is associated with high morbidity and mortality in at-risk patients.
- Previous studies note that automated contrast injectors, removal of contrast from the coronary sinus, and pressure-sensitive diversion devices may help reduce contrast exposure and lower the risk for AKI.
Contrast-induced nephropathy (CIN), one of the prime causes of contrast-induced acute kidney injury (CI-AKI),1 is now the third most frequent cause of hospital-acquired renal failure.2
Characteristics of the patient and/or procedure can increase risk of CI-AKI. Patients with diabetes or preexisting chronic kidney disease must be approached with care as these conditions increase the likelihood of CIN.3 Hemodynamic instability is also another contributing risk factor for the development of CI-AKI. The type of iodinated contrast used as well as the amount administered also influences risk.
CI-AKI prophylaxis is imperative since there is no definitive treatment strategy for the condition once it’s occurred. Risk stratification represents an important preventative approach to CI-AKI and one that has been previously studied. Volume expansion via intravenous 0.9% sodium chloride solution at 1 mL/kg/hr for 12 hrs prior to and following procedure is recommended for high-risk acutely ill patients in minimizing CI-AKI.4
Options for Decreasing Contrast Exposure
Automated contrast injectors may help reduce contrast use during therapeutic and/or diagnostic procedures when compared with manual injection. According to one meta-analysis, a 15% relative reduction of CI-AKI was observed with the use of automated contrast injectors and an average 45 mL decrease in contrast use.5
An invasive method for minimizing renal exposure to contrast involves removing contrast from the coronary sinus. A study by Danenberg et al was able to successfully recover 44% of contrast after the removal and discarding of 60 mL of blood.6
Pressure-sensitive diversion devices may reduce as much as 40% of contrast, according to one study.7
In another study, approximately ⅓ of administered contrast was recovered in patients undergoing coronary angiography.8 Serum hemoglobin levels saw a 0.5 g/dL decrease due to the removal of 169 mL of blood during aspiration. The small sample sizes in these studies were unable to demonstrate a clear reduction in CI-AKI; however, one study by Diab et al found a significant reduction of CI-AKI with coronary sinus aspiration (5.5% vs 36%).9
There is speculation that lower serum sodium, which correlates with higher inflammatory cytokines, can increase the risk for kidney damage and CIN occurrence. A study by Yin W et al demonstrated a clear association between decreased serum sodium and increased risk of CIN in patients receiving contrast.10 Lower sodium may also be a marker for heart failure, a condition that also increases the risk for CIN following contrast administration.
A retrospective, single-center study by Flaherty MP et al also provides insight into how micro-axial percutaneous left ventricular assist devices, namely the Impella® heart pump, may offer protection against AKI in high-risk PCI patients.11 According to the retrospective, single-center study, the Impella 2.5® device was associated with a decreased risk for AKI despite depressed ejection fraction and underlying chronic kidney disease. This option, as well as the many others mentioned above, may assist in improving patient care and outcomes, particularly among high-risk patients.
- Goldfarb S, McCullough PA, McDermott J, Gay SB. Contrast-induced acute kidney injury: specialty-specific protocols for interventional radiology, diagnostic computed tomography radiology, and interventional cardiology. Mayo Clin Proc. 2009 Feb;84(2):170-9.
- Thomson VS, Narayanan K, Singh JC. Contrast induced nephropathy in urology. Indian J Urol. 2009;25(4):437-445.
- SN Heyman, Rosenberger C, Rosen S, Khamaisi M. Why Is Diabetes Mellitus a Risk Factor for Contrast-Induced Nephropathy? Biomed Res Int. 2013;2013:123589.
- Prevention of Contrast Induced Acute Kidney Injury (CI-AKI) In Adult Patients. The Renal Association. Accessed March 17, 2017.
- Minsinger KD, Kassis HM, Block CA, Sidhu M, Brown JR. Meta-analysis of the effect of automated contrast injection devices versus manual injection and contrast volume on risk of contrast-induced nephropathy. Am J Cardiol. 2014;113:49–53. Doi: 10.1016/j.amjcard.2013.08.040.
- Danenberg HD, Lotan C, Varshitski B, Rosenheck S, Weiss AT. Removal of contrast medium from the coronary sinus during coronary angiography: feasibility of a simple and available technique for the prevention of nephropathy. Cardiovasc Revasc Med. 2008;9:9–13. doi: 10.1016/j. Carrev.2007.05.003.
- Prasad A, Ortiz-Lopez C, Kaye DM, et al. The use of the AVERT system to limit contrast volume administration during peripheral angiography and intervention. Catheter Cardiovasc Interv. 2015;86:1228–1233. doi: 10.1002/ccd.26155.
- Duffy SJ, Ruygrok P, Juergens CP, et al. Removal of contrast media from the coronary sinus attenuates renal injury after coronary angiography and intervention. J Am Coll Cardiol. 2010;56(6):525-526.
- Diab OA, Helmy M, Gomaa Y, El-Shalakany R. Efficacy and Safety of Coronary Sinus Aspiration During Coronary Angiography to Attenuate the Risk of Contrast-Induced Acute Kidney Injury in Predisposed Patients. Circ Cardiovasc Interv. 2017 Jan;10(1):e004348.
- Yin WJ, Yi YH, Guan XF, et al. Preprocedural Prediction Model for Contrast-Induced Nephropathy Patients. J Am Heart Assoc. 2017;6(2).
- 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.
Impella® Device — Indication & Safety Information
INDICATIONS FOR USE
IMPELLA® LEFT-SIDE DEVICES INDICATION & SAFETY INFORMATION
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.
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.
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 http://www.abiomed.com/important-safety-information to learn more.
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.
INDICATIONS FOR USE
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.
POTENTIAL ADVERSE EVENTS
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/