Potential complications include bleeding, limb ischemia, hemolysis, and infection. The PROTECT I study was done to assess the safety and efficacy of device placement in patients undergoing high-risk PCI.10 Twenty patients were enrolled in that prospective, multicenter study. Detailed view of distal end of Impella 2.5. The Impella 2.5 catheter is placed percutaneously through the common femoral artery and advanced retrograde to the left ventricle over a guidewire. At the end of the procedure, she was symptom free, and she was rapidly weaned from the Impella and the device was removed. The Impella 2.5 should not be used in patients with aortic valve disease or known left ventricular thrombus. 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. 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. Free shipping for many products! 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). SmartAssist technology on the Impella CP or Impella 5.5 devices can help with this as well. / 0000004122 00000 n We recommend that repositioning of the Impella catheter be performed by two people, one to obtain real-time ultrasound images and one to manipulate the catheter. Explore Impella Technology - Abiomed Correct placement across the aortic valve is critical to avoid complications including hemolysis, suction episodes and inadequate hemodynamic support. A console simulator is available that can be used to practice troubleshooting. 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! The device received 510(k) clearance from the Food and Drug Administration in June 2008 for providing up to 6 hours of partial circulatory support. His left ventricular end-diastolic pressure was markedly elevated at 40 mm Hg (normal, 512 mm Hg), and his cardiac index was reduced at 1.98. At first, an effort should be made to identify and treat these conditions (Fig. The physician can evaluate left ventricular size and function and can quickly assess how well the patient tolerates decreases in the performance level. The question that then arises is when to favor escalating inotropes to assist in device weaning. 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. HHS Vulnerability Disclosure, Help official website and that any information you provide is encrypted Assign a point person who can oversee and coordinate the program. We have extensive experience with the IABP and with surgically placed VADs, including the Abiomed AB5000, Thoratec CentriMag, XVE, and HeartMate II. Single Access Technique. Hemolysis, as measured by the plasma level of free hemoglobin, was higher in patients treated with the Impella. The second indication is to prevent clot formation on the catheter itself and potential embolization into the patient. At maximum performance (P9), the pump rotates at 50000 revolutions per minute and delivers a flow rate of 2.1 to 2.6 L/min. sharing sensitive information, make sure youre on a federal The second lumen ends near the motor above the level of the aortic valve and is used to monitor aortic pressure. Cardiogenic shock (CS) is a life-threatening condition associated with significant morbidity and mortality. PDF Patient Information for the Impella 2 - Food and Drug Administration 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. National Center for Biotechnology Information Impella Devices 101 - REBEL EM - Emergency Medicine Blog The Impella coordinator is present for implants to assist the catheterization laboratory staff as needed. The nursing care of patients remaining on Impella 2.5 support requires astute assessment and expert nursing care (Table 4). Conversely, lack of expected pulsatility in the placement signal and/or in the motor current signal may reflect a problem. Keywords: %PDF-1.4 % We recommend the following steps to optimize imaging: minimize the depth and narrow the sector width to the target field of view, angle the ultrasound probe to achieve a horizontally oriented view of the cannula, and adjust the gain to best highlight the target structures. After any adjustment, return the power level back to the desired setting and then reassess catheter depth, orientation, and mitral valve function before tightening the Tuohy-Borst lock and making note of the final vascular access site depth. 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.). We review Impella and other percutaneous devices such as intra-aortic balloon pump, TandemHeart, and extracorporeal membrane oxygenation (ECMO) and the evidence supporting their use in the setting of CS. His ventricular function was poor with a calculated ejection fraction of 20%. Quick Reference and Troubleshooting Guide 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). The Impella (Abiomed Inc.) is an axial flow pump on a pigtail catheter that is placed across the aortic valve to unload the left ventricle by delivering non-pulsatile blood flow to the ascending aorta. The https:// ensures that you are connecting to the The Impella RP has been authorized only for the duration of the declaration that circumstancesexist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of. 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. An additional method to ensure proper depth is to interrogate the aortic root with color Doppler from the parasternal long-axis view. A Review of the Impella Devices | ICR Journal The most reliable and accurate transthoracic acoustic widow to assess catheter position is the parasternal long-axis window because it will provide a view of the catheter from an orthogonal angle of insonation (Figure 4). Support with Impella versus intra-aortic balloon pump in acute myocardial infarction complicated by cardiogenic shock: A protocol for systematic review and meta-analysis. 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). Jo Kajewski, Advanced Impella Trainer, gives an in-depth look at managing Impella positioning using imaging. Two patients had transient hemolysis that was not clinically significant. Mean arterial pressure increased in patients with an Impella more than it increased in patients with an IABP, but the difference was not significant (P=.09). The placement signal will show a normal appearing aortic waveform with systolic and diastolic pressures similar to those shown by the patients arterial catheter. The Impella 2.5 is a percutaneously placed partial circulatory assist device that is increasingly being used in high-risk coronary interventional procedures to provide hemodynamic support. She had a history of hypertension complicated by end-stage renal disease and was receiving dialysis treatments 3 times per week. The performance level was increased from P0 to a maximum of P8 in a matter of minutes. Indications 1. Device-related complications occur more frequently with a longer duration of support. 2017 Oct;14(10):789-804. doi: 10.1080/17434440.2017.1374849. The patient with an Impella 2.5 is at risk of limb ischemia because of the large size of the device. Epub 2021 Dec 20. 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. Currently, the intra-aortic balloon pump (IABP) is the most commonly used device for circulatory support. may email you for journal alerts and information, but is committed In our facility, physicians who can place this device are those who have interventional cardiology and/or cardiac surgery privileges. Work with pharmacy and nursing staff to develop a standardized time for fluid and tubing changes. The arterial sheath can be left in place to be removed separately, or the catheter and the sheath can be removed as a unit, as is common when removing an intra-aortic balloon catheter placed through a sheath. If the Impella 2.5 is completely in the aorta, or if the inlet and outlet areas are in the ventricle and the pressure port is in the aorta, the pump position alarm will sound. 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. Introduction: What Causes a Swollen Uvula? - WebMD The placement monitoring diagram will show the aortic valve symbols distal to the pump (Figure 9). The Impella device can be withdrawn, leaving the arterial sheath in place. When the Quick Set-Up is used, the 10% to 20% dextrose solution used to purge the motor is not heparinized. 0000000016 00000 n The SVG was aspirated before a distal protection device was placed. Impella heart pumps have been tested under simulated conditions of inflow and outflow obstruction. The hemodynamic effects of the Impella catheter are to improve systemic perfusion and provide ventricular unloading in the setting of high-risk percutaneous coronary intervention and in the treatment of cardiogenic shock. In our experience, hemolysis (45%), device-related ventricular tachycardia (18%), and limb ischemia (16%) were the most common complications, and Impella repositioning was required in 26% of cases (Table 1.). None of the patients had hemodynamic instability develop during the procedure. 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). He was experiencing progression of his anginal symptoms, and his functional capacity was poor. 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. Impella - critical care notes Pulmonary artery pressures remained elevated after this stent was placed, and the patient was given furosemide and nitroglycerin to decrease preload and increase diuresis. 2. position is wrong. Four hours later, after the activated clotting time was less than 150 seconds, the venous and arterial sheaths were removed and hemostasis was achieved after 40 minutes of manual compression. Image courtesy ABIOMED Inc, Danvers, Massachusetts. 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. With the physician at the bedside, transthoracic echocardiography is performed and the pumps performance level is decreased. A 74-year-old man was transferred to our facility after sustaining a nonST-segment elevation myocardial infarction. Abbreviations: ABGs, arterial blood gas analysis; AC, alternating current; Batt, battery; P-perf, pump performance level; PRN, as needed; PTT, partial thromboplastin time; RN, registered nurse; RPM, revolutions per minute. Disclosure: The authors have no funding or conflicts of interest to report. Catheters with SmartAssist, however, will more specifically identify the nature of the mispositioning and can distinguish between the ventricular and aortic placement of the inlet and outlet areas (Figure 3C and 3D). 597 0 obj <> endobj xref 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. 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 Impella RP can be used in tandem with a left-sided Impella device. Abiomed also provides assistance with troubleshooting via 24-hour-a-day, 7-day-a-week telephone support. The patient was weaned from the Impella device, the device was removed in the catheterization laboratory, and the venous and arterial sheaths were secured in place. Impella Flashcards | Quizlet A patient experiencing continuous suction may show systolic LV numbers, shown in white, that are uncoupled from the aortic numbers shown in red. 0000001324 00000 n Impella heart pumps (Abiomed) are intravascular microaxial blood pumps that provide temporary MCS during HRPCI or in the treatment of cardiogenic shock. Fluoroscopic image of Impella 2.5 in place in the aorta. Cardiogenic shock; Impella; Mechanical support devices; intra-aortic balloon pump; mechanical circulatory support; percutaneous ventricular assist device. The Impella TM is a percutaneous, microaxial pump that continuously draws blood from its inlet inside the ventricle and expels it in the ascending aorta (Central Illustration) (12-15).Owing its properties, the Impella TM unloads the left ventricle (LV) while simultaneously augmenting cardiac output (CO). In the event of cardiac arrest, standard life-saving procedures should be followed with the caveat that the Impella should be set to power level P2 to prevent a continuous suction event. Percutaneous repositioning of Impella RP: the Snare-Manoeuvre-Prolapse Refractory Impella Suction Alarms in the Setting of Extracorporeal The placement signal will show depressed cardiac function, evidenced by a damped appearing waveform. Xbao}*"&st V4qZz We found performing such changes at a consistent time to be very helpful. Ten different performance levels ranging from P0 to P9 are available (Table 5). The catheter is not tethered to any internal structure and is prone to migration which occurs more frequently when the catheter is placed percutaneously. 6, 7 However, the device may migrate out of . For more information, please refer to our Privacy Policy. He had severe mitral regurgitation. 2020 Jan 22;2(1):23-44. doi: 10.36628/ijhf.2019.0015. The pharmacy prepares the heparinized 20% glucose purge solution and sends it to the unit before our standard change time of 3 pm daily. In the Impella LD, 5.0, and RP, the placement signal is a differential pressure waveform that is measured from the differential pressure sensor. 2 main types of pumps currently used: The catheter depth is defined as the distance from the aortic annulus to the ventricular end of the cannula (Figure 4). Diagnostic cardiac catheterization and coronary angiography performed at the referring facility showed severe triple vessel coronary disease and high-grade lesions in 2 SVGs. echocardiography (right). To understand the hemodynamics of a patient in cardiogenic shock receiving Impella support, a pulmonary arterial catheter is recommended.5 The overall weaning strategy is to achieve adequate organ perfusion at the lowest device power setting to minimize device-related complications and to determine candidacy for device removal. Frontiers | Central Venous Pressure and Clinical Outcomes During Left 2022 Feb 28;19(2):115-124. doi: 10.11909/j.issn.1671-5411.2022.02.003. The impellar blades of the motor could break up the thrombi, causing arterial embolization. Cardiogenic shock - Impella 2.5, CP, 5.0, LD - Temporary VAD for less than or equal to 4 days: 2.5, CP - Temporary VAD for less than or equal to 14 dyas: 5.0, LD The power connections for the pump motor and sensors are . Just before the patients return to the CICU, the pulmonary artery pressure decreased to 70/4148 mm Hg and the cardiac index was 2.69. Parameters to assess regularly include placement signal, placement monitoring (pump position), dual signal, purge pressure, motor current, and speed (Table 6). Because the patient was tolerating the procedure well after this, the physician decided to stent the second diseased SVG. If the urine is red, rule out blood in the urine with a simple urinalysis . The Impella 2.5 is able to unload the left ventricle rapidly and effectively and increase cardiac output more than an intra-aortic balloon catheter can. A broad mosaic color Doppler pattern caused by artifact from the motor will be seen, which should be limited to the aortic side of the valve. One patient died before implantation of a device. If the patients ventricular function is very poor, a positioning alarm can occur. The Impella coordinator is present to assist with tubing changes as needed by the nursing staff. Bookshelf Low purge pressures require immediate intervention by a critical care nurse. Please enable scripts and reload this page. v67z]FcUe7sne[l}g&_}V^7vk~7S/o}AoepY5OTYe>acQ*|o? \-yVJUrM^2E~,d3EN9--u1C~A+ Abiomed has sponsored several of these trials, including PROTECT I, PROTECT II, RECOVER I, RECOVER II, and ISAR-SHOCK. The device may cause calcium to break off of the aortic valve and embolize, causing stroke. Just visit www.ccnonline.org and click Respond to This Article in either the full-text or PDF view of the article. You may search for similar articles that contain these same keywords or you may The arterial access site must be assessed regularly for bleeding and development of a hematoma. He returned to the catheterization laboratory the next day for coronary intervention. : Increased plasma-free hemoglobin levels identify hemolysis in patients with, 5. Develop a nursing protocol that outlines key strategies in patient management and a specific flow sheet (Figure 10) for documentation. 2021 Mar 26;100(12):e25159. Background and aim This study aimed to assess right ventricular (RV) function during cardiogenic shock due to acute left ventricular (LV) failure, including during LV unloading with Impella CP and an added moderate dose of norepinephrine. 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. Quick Reference and Troubleshooting Guide Impella Heart 0000001133 00000 n It cannot be used in patients with documented left ventricular thrombus. It is used for high-risk percutaneous coronary intervention and CS. Federal government websites often end in .gov or .mil. Consider when SBP <90 mmHg sustained for >30 min (or vasopressors required) AND clinical or objective signs of tissue hypoperfusion (see below). The Impella 2.5 can also be removed in the surgical setting with direct visualization of the common femoral artery. There is currently no consensus on best practice regarding its use in these two distinct indications. A fluid challenge test can be useful in difficult cases. In cases of heparin-induced thrombocytopenia, use of argatroban or bivalirudin in place of heparin in the purge solution has been reported to be safe and effective.2,3 Notably, a rising purge pressure may reflect thrombus formation in or around the motor. To purchase electronic or print reprints, contact The InnoVision Group, 101 Columbia, Aliso Viejo, CA 92656. At the end of rapid weaning, the Impella device can then be removed as described in the next section. Sheaths were placed in the right femoral vein, the right femoral artery, and the left femoral artery. Train a core group of critical care nurses to care for the patient, monitor the device, change tubings, and troubleshoot alarms. Pahuja M, Hernandez-Montfort J, Whitehead EH, Kawabori M, Kapur NK. The Impella 2.5 catheter has 2 lumens. Our training for staff from the catheterization laboratory consisted of a 3-hour session with didactic and hands-on training. A cutdown is performed, and the device is removed by the surgeon. Find many great new & used options and get the best deals for Grandchild On Board Car Sign, Suction Cup Baby On Board Sign in Yellow and Black at the best online prices at eBay! Like all LV assist devices, the Impella can only pump as much blood as is available to it. Notably, catheter position is best assessed ultrasonographically, as radiography does not accurately identify the cannula position relative to cardiac anatomic structures. *, *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 provide 1-to-1 staffing for our patients with an Impella 2.5 until they are hemodynamically stable. Echocardiography for Evaluating Impella Catheter Position Following The cannula portion of the catheter is built with a 30 bend (except for the Impella LD, which has a straight design). Unloading using Impella CP during profound cardiogenic - SpringerOpen Infusion of purge solution alone infrequently results in the desired therapeutic systemic anticoagulation and an additional infusion of parenteral heparin is often required. Percutaneous Mechanical Circulatory Support Devices for High-Risk Percutaneous Coronary Intervention. PDF PART 9 IMPELLA TROUBLESHOOTING AND RESUSCITATION - European Society of When the patient is coming off of cardiopulmonary bypass, the performance level of the Impella pump, if the pump remains in place, must be increased to provide adequate flow to the patient. Partner with industry. 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. Additionally, patients are observed by the VAD coordinator. modify the keyword list to augment your search. Transthoracic echocardiography showed increased contractility, and the ejection fraction was 40%. The aortic end of the cannula houses a microaxial motor which spins an Archimedes screw impeller that draws blood through the cannula to the outlet area in the aortic root. The ISAR-SHOCK trial was done to evaluate the safety and efficacy of the Impella 2.5 versus the IAPB in patients with cardiogenic shock due to acute myocardial infarction.5 Patients were randomized to support from an IABP (n=13) or an Impella (n=12). The performance level should be reduced to P2 and the physician should be notified of the need to reposition the Impella. Usefulness of Impella support in different clinical settings in cardiogenic shock. 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). The total duration of Impella support was slightly less than 2 hours. 2021 Feb 26;16(2):e0247667. 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. An enlarged uvula is often caused by infection, an allergic reaction, or irritation from chemicals or medical procedures. Impella use in real-world cardiogenic shock patients: Sobering outcomes. Ongoing practice is essential to develop and maintain competency. 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. The patient was brought to the catheterization laboratory and prepared for the procedure. 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.
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