Following this trial, the Impella 2.5 device received its 510(k) approval from the Food and Drug Administration. Abiomed provides strong clinical support as well as excellent print and Web-based educational materials. SmartAssist technology on the Impella CP or Impella 5.5 devices can help with this as well. Context in source publication. Comparing traditional intra-aortic balloon therapy with Impella 2.5 percutaneous ventricular assist device, Potential complications of Impella 2.5 support, Nursing care of patients with an Impella 2.5, Impella 2.5 performance level and flow rate, Physician orders for placement of Impella 2.5, Impella competency checklist for nurses in the cardiac intensive care unit: critical elements for managing patients with an Impella 2.5, Brenda McCulloch is a cardiovascular clinical nurse specialist at Sutter Heart and Vascular Institute, Sutter Medical Center, Sacramento, California. Like all LV assist devices, the Impella can only pump as much blood as is available to it. The necessary images may be particularly difficult to obtain if the Impella device is medially or laterally oriented. The structural design of each of these LV support catheters is grossly similar (Figure 2). 2020 Jan 22;2(1):23-44. doi: 10.36628/ijhf.2019.0015. The second lumen ends near the motor above the level of the aortic valve and is used to monitor aortic pressure. Patients who undergo high-risk percutaneous coronary intervention (PCI), such as procedures on friable saphenous vein grafts or the left main coronary artery, may have an intra-aortic balloon catheter placed if they require hemodynamic support during the procedure. All cases are also followed by the cardiac surgeon who oversees our VAD program and a critical care intensivist. The tip of the catheter has a flexible pigtail, intended to prevent mechanical injury of the ventricle (absent on the larger LD and 5.5 models). Because the patient was tolerating the procedure well after this, the physician decided to stent the second diseased SVG. IABP therapy has been in use since the late 1960s and has been widely used in clinical practice since that time. Optimal imaging often requires off-axis parasternal long-axis views obtained by fanning and rotating the probe until the entire length of the cannula and the aortic annulus are seen. : Simultaneous venoarterial extracorporeal membrane oxygenation and percutaneous left ventricular decompression therapy with, 8. Shearing of red blood cells is a common and clinically relevant problem with the Impella catheter. We developed preprinted orders for physicians to use for patients remaining on support to ensure consistency in care (Table 8). After careful evaluation and optimization of pharmacological therapy for heart failure, the decision was made to proceed with high-risk PCI of the SVG to the left anterior descending (LAD) artery with an Impella 2.5 used to provide partial circulatory support during the PCI. She returned to the catheterization laboratory 3 days later for high-risk PCI of the left main coronary artery. Notably, low native heart pulsatility may similarly trigger either the Impella Position Wrong or the Impella Position Unknown alarm, as the software cannot interpret the dampened amplitude of the placement signal and motor current (Figure 3E). Once the imager has a nonforeshortened image of the catheter in the parasternal long-axis view, the Impella motor speed should be temporarily set to power level P2, which reduced the risk of damaging the submitral apparatus during the catheter manipulation. On arrival, her blood pressure was 127/72 mm Hg, and her heart rate was 54/min. Impella use in real-world cardiogenic shock patients: Sobering outcomes. Hemolysis can occur in patients who are on the Impella 2.5. The performance level was increased from P0 to a maximum of P8 in a matter of minutes. The placement signal will show depressed cardiac function, evidenced by a damped appearing waveform. Regular documentation is essential, and review of trends is useful when troubleshooting. Fluoroscopic guidance in the catheterization laboratory or operating room is required. Disclosure: The authors have no funding or conflicts of interest to report. Additionally, a gross assessment of cannula depth can be inferred by contrasting the placement signal and LV pressure waveforms on SmartAssist capable devices (see controller alarm section.). In the Impella LD, 5.0, and RP, the placement signal is a differential pressure waveform that is measured from the differential pressure sensor. The proximal port of this lumen is yellow. Additionally, cardiac resuscitation can cause device migration and as such, post-arrest ultrasound confirmation of position is recommended. It is important to recognize that adjustments from the vascular access site are not necessarily transmitted to the cannula in a 1:1 fashion due to slack and/or torque that may exist or be introduced into the catheter. Catheters with SmartAssist have an upgraded optical pressure sensor that directly measures aortic pressure and uses changes in motor current to infer an estimated LV pressure waveform. The pigtail attaches to a radiopaque/echogenic structure termed the teardrop which is contiguous with the inlet area, through which blood enters the ventricular end of the catheters cannula. One lumen carries fluid to the impellar blades and continuously purges the motor to prevent the formation of thrombus. 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. Low purge pressures require immediate intervention by a critical care nurse. The use of pulmonary artery catheters with ongoing RP has not been thoroughly evaluated, and evaluation should also rely on clinical evaluation, oxygen demand, chest X-ray, etc. hbb2d`b``3 1x(@ % endstream endobj 598 0 obj <>/Metadata 60 0 R/PageLabels 55 0 R/PageLayout/TwoColumnRight/Pages 57 0 R/StructTreeRoot 62 0 R/Type/Catalog/ViewerPreferences<>>> endobj 599 0 obj >/PageTransformationMatrixList<0[1.0 0.0 0.0 1.0 0.0 -297.638]>>/PageUIDList<0 21587>>/PageWidthList<0 419.528>>>>>>/Resources<>/Font<>/ProcSet[/PDF/Text]/XObject<>>>/Rotate 0/StructParents 0/TrimBox[0.0 0.0 419.528 595.276]/Type/Page>> endobj 600 0 obj <> endobj 601 0 obj <> endobj 602 0 obj <> endobj 603 0 obj <> endobj 604 0 obj <>stream When hemolysis occurs, hemoglobin level and hematocrit decrease, haptoglobin level decreases, and plasma levels of free hemoglobin increase. Furthermore, crowding of the inlet or outlet areas increases shear stress on the red blood cells pumped through the cannula, accelerating the rate of hemolysis caused by the device. When the Quick Set-Up is used, the 10% to 20% dextrose solution used to purge the motor is not heparinized. 2. position is wrong. The catheter is not tethered to any internal structure and is prone to migration which occurs more frequently when the catheter is placed percutaneously. Inotropic agents, such as dobutamine and milrinone, and vasopressors, such as dopamine and norepinephrine, may still be needed after the Impella 2.5 is placed to maintain a cardiac index of at least 2 and systolic blood pressure at 90 mm Hg or higher. The patient with an Impella 2.5 is at risk of limb ischemia because of the large size of the device. Some facilities may use what is referred to as a preclose method while the patient is still in the catheterization laboratory; that technique uses 2 8F Perclose suture-mediated closure devices (Abbott Laboratories, Abbott Park, Illinois). Despite these changes, her blood pressure and cardiac rhythm remained stable. 0000001133 00000 n At the end of rapid weaning, the Impella device can then be removed as described in the next section. and transmitted securely. An official website of the United States government. The device may cause calcium to break off of the aortic valve and embolize, causing stroke. Depending on the type of your infection . *, *Departments of Cardiology and Critical Care, MedStar Washington Hospital Center, Washington, DC, Department of Medicine, University of California, San Francisco, USA; Division of Cardiology, San Francisco, California, Department of Medicine, MedStar Georgetown University, Washington, DC. We have 2 nurses at the bedside for the tubing change. Optimal hemodynamic effect from the IABP is dependent on several factors, including the balloons position in the aorta, the blood displacement volume, the balloon diameter in relation to aortic diameter, the timing of balloon inflation in diastole and deflation in systole, and the patients own blood pressure and vascular resistance.3,4, The Impella 2.5 (Figure 1) aspirates up to 2.5 L/min of blood from the left ventricle and displaces it into the ascending aorta, rapidly unloading the left ventricle and increasing forward flow. Epub 2017 Sep 11. While a small amount of hemolysis is unavoidable, significant hemolysis can quickly cause pigment nephropathy and further complicate the management of an already critically ill patient. Several console alarms may require nursing intervention (Table 7). As the performance level increases, the flow rate and number of revolutions per minute increase. The Impella controller will alarm when it determines that the device may be mispositioned or dysfunctional. She was treated with fibrinolytic therapy but continued to have chest pain. Cardiogenic shock was defined as a (1) systolic blood pressure 90 mm Hg or need for inotropes or vasopressors to maintain systolic blood pressures 90 mm Hg, (2) signs of peripheral hypoperfusion, and (3) cardiac index <2.2 L/min/m 2 and pulmonary capillary wedge pressure 15 mm Hg. The cannula portion of the catheter is built with a 30 bend (except for the Impella LD, which has a straight design). The nursing care of patients remaining on Impella 2.5 support requires astute assessment and expert nursing care (Table 4). A multi-beat acquisition of the catheter should be obtained while panning through the LV cavity, to avoid catheter foreshortening and consequent incorrect assessment of catheter depth. The Impella is a really cool piece of equipment, a percutaneous ventricular assist device (primarily used for the LV, but can be used for the RV). Diagnostic cardiac catheterization showed severe triple vessel disease as well as severe diffuse distal disease of his left internal mammary artery (LIMA) graft, his only remaining patent graft. Patients on Impella 2.5 support who may require interrogation of a permanent pacemaker or implantable cardioverter defibrillator present an interesting situation. Implementation of the ventilator bundle is required for these patients, including elevation of the head of the bed to decrease the risk of ventilator-associated pneumonia, as well as deep venous thrombosis and peptic ulcer prophylaxis. Results from additional clinical trials are available (Table 2), but continuing clinical trials are essential to evaluate the effectiveness of the Impella 2.5 device in various subgroups. Additionally, I share our experiences as we developed our Impella program at our community hospital. The coronary guidewire was advanced through the LIMA graft to the distal LAD. We follow our hospitals protocol for achieving hemostasis, using either manual or mechanical compression. If both the placement signal and motor current waveforms have minimal variability, the Impella Position Wrong alarm will display, indicating that both the inlet and outlet areas may be on the same side of the aortic valve (Figure 3B). The components required to run the device are assembled on a rolling cart (Figure 6) and include the power source, the Braun Vista infusion pump, and the Impella console (Figure 7). This arrangement allows rapid initial setup of the console so that support can be initiated quickly. LV Aortic valve Mitral valve Impella 2.5 outlet area Impella 2.5 . Important contraindications to use of the Impella MCS system are the presence of: moderate to severe aortic regurgitation, mechanical aortic valve, aortic dissection, LV thrombus, or ventricular sepal defect. The pharmacy prepares the heparinized 20% glucose purge solution and sends it to the unit before our standard change time of 3 pm daily. The Impella 2.5 catheter is placed percutaneously through the common femoral artery and advanced retrograde to the left ventricle over a guidewire. The patients diastolic pressure increased significantly more with Impella support than with IABP support (P=.002). 2017 Oct;14(10):789-804. doi: 10.1080/17434440.2017.1374849. Partner with industry. After advancement, always remove any slack by slowly pulling back on the catheter until cannula movement is observed. The .gov means its official. E-mail: [emailprotected]; Twitter: @AlexPapolos. If the catheter is incorrectly oriented, the pigtail can become caught in the mitral apparatus, a segment of the catheter may restrict mitral valve opening, or mobile portions of the mitral apparatus may be drawn into the inlet area. Xbao}*"&st V4qZz A low purge pressure can allow blood to enter the motor and damage the motor, rendering the device inoperable. 29. Patel SM, Lipinski J, Al-Kindi SG, et al. Read below to find out how long a swollen uvula lasts and how to get treatment. The heparinized saline is placed in a pressure bag that is inflated to 300 mm Hg. She was evaluated by our cardiac surgery team, who thought that she was a very high-risk candidate for surgery based on the recent fibrinolytic therapy, her renal failure, and the remote history of stroke. Potential complications include bleeding, vascular injury, hemolysis, infection, sepsis, and device malfunction or failure. By continuing to use our website, you are agreeing to our, http://bmctoday.net/citoday/2009/09/supplement/article.asp?f=0909_supp_01.php, https://doi.org/10.1016/j.ijcard.2009.08.003, Potential Complications of Impella Therapy, Nursing Care of Patients With an Impella 2.5 for Circulatory Support, Copyright 2023 American Association of Critical-Care Nurses. 2021 Feb 26;16(2):e0247667. Consider when SBP <90 mmHg sustained for >30 min (or vasopressors required) AND clinical or objective signs of tissue hypoperfusion (see below). Suboptimal Impella flow and suction events can be caused by anything that reduces blood flow to the device, which is most commonly due to hypovolemia, RV failure, ventricular arrhythmias, and obstructive physiology (tamponade, pulmonary embolism, etc.). The use of two Impella devices concurrently has demonstrated decreased LV filling pressures and improved cardiac output for cardiogenic shock patients, although reported data on this use is limited and future studies are required. Hear the stories of patients and explore the latest innovations in Impella technology. Introduction: Include the cardiovascular surgery staff and perfusion staff in the initial training. echocardiography (right). The Impella catheter must be adequately positioned to provide optimal hemodynamic support while minimizing the risk of complications, including hemolysis, interference with the mitral apparatus, suction events, or provocation of ventricular arrhythmias. The MedStar Washington Hospital Center institutional review board approved the electronic medical record extraction and publication of this data. In order for the interrogator to connect with the permanent pacemaker or implantable cardioverter defibrillator, the Impella console must be turned off for a few seconds while the signal is established. As with all forms of MCS, device-related complications remain a major concern, the incidence of which can be mitigated by adhering to a few fundamental concepts in device management. doi: 10.1371/journal.pone.0247667. Epub 2020 Dec 28. At P8, the flow rate is 1.9 to 2.6 L/min and the motor is turning at 50000 revolutions per minute. If the patient tolerates the PCI procedure and hemodynamic instability does not develop, the Impella 2.5 may be removed at the end of the case while the patient is still in the catheterization laboratory. The performance level determines the flow rate and the number of revolutions per minute. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 3. placement monitoring is suspended or disabled. Conversely, lack of expected pulsatility in the placement signal and/or in the motor current signal may reflect a problem. hb```b``ac`a` B@EY k2T>`(zM]us:nqO8.c,BD|s+eSd:[$spK| B^0F:TXSY&D{|!3:EOT$Z^ELkzIGX;&XY Our training for our cardiac intensive care unit (CICU) nurses consisted of a series of three 1-hour sessions, encompassing a review of pertinent physiology and hemodynamics, Impella console management and troubleshooting, and tubing changes with hands-on practice and documentation practice. Find many great new & used options and get the best deals for Toddler On Board Car Sign, Suction Cup Baby On Board Sign, Child On Board Sign at the best online prices at eBay! In our case, the Impella had already been confirmed to be in the appropriate position. Cardiogenic shock (CS) is a life-threatening condition associated with significant morbidity and mortality. Device profile of the Impella 5.0 and 5.5 system for mechanical circulatory support for patients with cardiogenic shock: overview of its safety and efficacy. The Impella console powers the microaxial blood pump and monitors the functioning of the device, including the purge pressure and several other parameters. P9 can be activated only for 5-minute intervals when the Impella 2.5 is in use. Improvements in cardiac index were significantly greater in the patients with the Impella than in patients with the IABP (P=.02). Based upon these metrics we make changes to the device power level, inopressor dose, afterload reduction regimen, and diuresis goals as indicated to maintain sufficient but not excessive cardiac support while optimizing RV and LV filling pressures. The console has 10 function keys, but not all of the function keys are used for the Impella 2.5. There are currently five Impella catheters that provide left ventricular (LV) support (Figure 1). Correspondence: Alexander Papolos, MD, Departments of Cardiology and Critical Care, MedStar Washington Hospital Center, 110 Irving St., NW, Rm A127, Washington, DC, 20010. The Suction alarm is triggered when sudden decreases in the placement signal pressure occur in association with lower than expected flows. Percutaneous Mechanical Circulatory Support Devices for High-Risk Percutaneous Coronary Intervention. : Survey of anticoagulation practices with the, 3. 0000000636 00000 n The Impella MCS system is a relatively new technology that has become widely used for the treatment of cardiogenic shock in medical and surgical cardiac intensive care units. Console and infusion pump setup requires 2 to 3 minutes to complete. Cardiogenic shock complicates 5-10% of cases of myocardial infarction 1-3 and mechanical support devices have demonstrated limited benefit with early initiation and appropriate protocols. However, in our experience, measuring structures that can be directly visualized with ultrasound is a more practical and reproducible strategy, and thus we recommend measuring from the aortic annulus to the end of the railroad tracks. The IABP decreases after-load, decreases myocardial oxygen consumption, increases coronary artery perfusion, and modestly enhances cardiac output.1,2 The IABP cannot provide total circulatory support. Brenda McCulloch; Use of the Impella 2.5 in High-Risk Percutaneous Coronary Intervention. To monitor the severity of hemolysis we recommend daily monitoring of serum creatinine, and plasma-free hemoglobin (PFH) or lactate dehydrogenase (LDH). The patient was transferred to the CICU for continued monitoring. H\n0E At follow-up 12 months later, the patient remained symptom-free with a normal ejection fraction of 55%. Our practice is to integrate clinical factors, such as mean arterial pressure, heart rate, and urine output with invasive hemodynamics, and lab dataspecifically, serum lactate and pulmonary arterial oxygen saturation every 6 hours. Impella heart pumps (Abiomed) are intravascular microaxial blood pumps that provide temporary MCS during HRPCI or in the treatment of cardiogenic shock. Search for Similar Articles Careers. The Impella 2.5 device is a blood pump that is placed into your heart through a peripheral artery that will support your circulatory system during your elective or urgent high risk PCI (HRPCI). The Impella device can be withdrawn, leaving the arterial sheath in place. Infusion of purge solution alone infrequently results in the desired therapeutic systemic anticoagulation and an additional infusion of parenteral heparin is often required. To purchase electronic or print reprints, contact The InnoVision Group, 101 Columbia, Aliso Viejo, CA 92656. The device also cannot be used in patients with severe peripheral arterial disease because of the large sheath size required for its placement, nor can it be used in patients who cannot tolerate anticoagulation with heparin. For more Impella resources, subscribe to our wee. It is used for high-risk percutaneous coronary intervention and CS. The performance level should be decreased to P2 and the physician should be notified to reposition the device by pulling it back slightly to obtain an aortic waveform. During stent deployment, the patient had severe chest pain and showed ST-segment elevation in the anterior leads. The Impella 2.5 catheter (Figure 2) contains a nonpulsatile microaxial continuous flow blood pump (Figure 3) that pulls blood from the left ventricle to the ascending aorta, creating increased forward flow and increased cardiac output. : Increased plasma-free hemoglobin levels identify hemolysis in patients with, 5. 2020 Jul;8(13):835. doi: 10.21037/atm.2020.03.152. Abiomed has sponsored several of these trials, including PROTECT I, PROTECT II, RECOVER I, RECOVER II, and ISAR-SHOCK. Suction events are mostly due to abnormal device position or insufficient preload. The Impella 2.5 should not be used in patients with aortic valve disease or known left ventricular thrombus. The placement signal will show a normal appearing aortic waveform with systolic and diastolic pressures similar to those shown by the patients arterial catheter. Additionally, patients are observed by the VAD coordinator. Parameters to assess regularly include placement signal, placement monitoring (pump position), dual signal, purge pressure, motor current, and speed (Table 6). We have extensive experience with the IABP and with surgically placed VADs, including the Abiomed AB5000, Thoratec CentriMag, XVE, and HeartMate II. An axial pump is one that is made up of impellar blades, or rotors, that spin around a central shaft; the spinning of these blades is what moves blood through the device.13 The distal tip of pigtail curve is 6F in size (Figure 4). If the urine is red, rule out blood in the urine with a simple urinalysis . Frequent hemodynamic evaluation is needed. Areas covered: 6, 7 However, the device may migrate out of . The recommended maximum performance level for continuous use is P8. In this article, I discuss the Impella 2.5, review indications and contraindications for its use, delineate potential complications of the Impella 2.5, and discuss implications for nursing care for patients receiving extended support from an Impella 2.5. 0000004020 00000 n On imaging, if the LV appears overly decompressed due to a significant interventricular septal shift, then reducing the Impella speed, escalating inotropy to support the RV, and increasing volume removal is commonly the best course of action. 0000006172 00000 n The console uses this pressure measurement to calculate the catheters position. This should prompt urgent ultrasound assessment as the device may need to be either retracted or advanced. It is used for high-risk percutaneous coronary intervention and CS. cardiac intensive care unit; cardiogenic shock; Impella; mechanical circulatory support. Develop a nursing protocol that outlines key strategies in patient management and a specific flow sheet (Figure 10) for documentation. At first, an effort should be made to identify and treat these conditions (Fig. After the device is properly positioned, it is activated and blood is rapidly withdrawn by the microaxial blood pump from the inlet valve in the left ventricle and moved to the aorta via the outlet area, which sits above the aortic valve in the aorta (Figure 8). modify the keyword list to augment your search. Standard therapeutic anticoagulation targets are; an activated clotting time of 160180 sec, a heparin antifactor Xa of 0.3-0.5, and/or activated partial thromboplastin time of 6090 sec. The use of continuous cardiac output monitoring may be useful for patients with cardiogenic shock. A newer option that is now available for select patients is the Impella 2.5, a short-term partial circulatory support device or percutaneous ventricular assist device (VAD). v67z]FcUe7sne[l}g&_}V^7vk~7S/o}AoepY5OTYe>acQ*|o? \-yVJUrM^2E~,d3EN9--u1C~A+ 0000001527 00000 n With correct positioning and function, the placement signal and motor current are pulsatile, reflecting the dynamic pressure gradient between the aorta and LV, as well as the cyclical variation in energy required to maintain the desired motor speed over the cardiac cycle (Figure 3A). Some patients on Impella support may be intubated and receiving mechanical ventilation. The typical infusion rate for the purge fluid is 7 to 20 mL/h. The PCI procedure of the LAD SVG was then started. The most common causes of Impella suction alarms include: malposition of the Impella, hypovolemia, RV failure, and pericardial tamponade. Disclaimer. eCollection 2021. The SVG was aspirated before a distal protection device was placed. After a family conference that included the patient, the decision was made to proceed with high-risk PCI of the LIMA graft, using the Impella 2.5 for hemodynamic support during the procedure. Submitted for consideration June 2021; accepted for publication in revised form December 2021. She was transferred to the CICU and supportive medical therapy was initiated. To date, we have placed an Impella 2.5 in about 40 patients. Abdullah KQA, Roedler JV, Vom Dahl J, Szendey I, Haake H, Eckardt L, Topf A, Ohnewein B, Jirak P, Motloch LJ, Wernly B, Larbig R. PLoS One. The use of inotropic agents and vasopressors was similar in both groups of patients. Unable to load your collection due to an error, Unable to load your delegates due to an error. Image courtesy Sutter Medical Center, Sacramento, California. 0000005131 00000 n a1 This arrangement ensured that new purge fluid was ready when needed and that the nurses had more staffing resources to assist with the tubing change. 2). 597 17 In our facility, we often use transthoracic echocardiography to aid in the assessment of our patients. $L"$ doi: https://doi.org/10.4037/ccn2011293. We have gained much knowledge since implementing our Impella program in April 2008. The Impella catheter has become a common MCS device used in medical and surgical cardiac intensive care units, and as such intensivists must have a core competency with its management. sharing sensitive information, make sure youre on a federal Some were designed to support future versions of Impella catheters. The Impella 2.5 cannot be used on all acutely ill patients who require hemodynamic support.14 Because the device is designed to sit across the aortic valve in the left ventricle, it should not be used in patients who have prosthetic aortic valves, so as to prevent damage to the valve. Free shipping for many products! He had a long history of diabetes and had undergone coronary artery bypass surgery 20 years prior. When the heart displays a question mark over it with the words "Impella Position Wrong": 1. controller can't determine catheter position. The size and function of the left and right ventricles as well as interventricular septal position should also be assessed, as low flow and suction alarms can be caused by over-decompression of the LV, RV failure, and/or obstructive physiology. The symptoms usually last about four to seven days and don't typically require a trip to the healthcare provider, unless it affects an infant or if complications develop. If the patient tolerates this slow weaning by remaining hemodynamically stable while at P2, the device is then removed. The entire LV placement signal waveform shifts downward.