*, *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. 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). 0000003906 00000 n His estimated ejection fraction was markedly decreased at 20% (normal, 55%70%) on a recent echocardiogram. Abiomed Impella RP Information for Use - Food and Drug Administration For patients who become hemodynamically unstable or who have complications during the PCI (eg, no reflow, hypotension, or lethal arrhythmias), the device can remain in place for continued partial circulatory support, and the patient is transported to the critical care setting. Impella Devices 101 - REBEL EM - Emergency Medicine Blog A Review of the Impella Devices | ICR Journal 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. Cardiogenic shock (CS) is a life-threatening condition associated with significant morbidity and mortality. The Impella console powers the microaxial blood pump and monitors the functioning of the device, including the purge pressure and several other parameters. The catheter is not tethered to any internal structure and is prone to migration which occurs more frequently when the catheter is placed percutaneously. 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. Usefulness of Impella support in different clinical settings in cardiogenic shock. At follow-up 12 months later, the patient remained symptom-free with a normal ejection fraction of 55%. As with all current forms of MCS, device-related complications remain a major concern, many of which can be mitigated by adhering to a few fundamental concepts in device management. Percutaneous mechanical support devices are placed in a minimally invasive manner and provide life-saving assistance. Utilization of the Impella for hemodynamic support during percutaneous intervention and cardiogenic shock: an insight. 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). Assign a point person who can oversee and coordinate the program. His ventricular function was poor with a calculated ejection fraction of 20%. The use of inotropic agents and vasopressors was similar in both groups of patients. 2. position is wrong. Curr Cardiol Rep. 2018 Jan 19;20(1):2. doi: 10.1007/s11886-018-0946-2. Quick Reference and Troubleshooting Guide 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. Frequently Asked Questions About Hemolysis | HeartRecovery.com Subramaniam AV, Barsness GW, Vallabhajosyula S, Vallabhajosyula S: Complications of temporary percutaneous. As the Impella RP is not widely used, this review will focus only on the left-sided catheters; however, many of the concepts discussed are transitive. doi: 10.1097/MD.0000000000025159. Highlight selected keywords in the article text. The motor current will be flattened. doi: https://doi.org/10.4037/ccn2011293. Our practice of monitoring and managing RV function relies heavily on invasive hemodynamics and ultrasound imaging. 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.). Our training for staff from the catheterization laboratory consisted of a 3-hour session with didactic and hands-on training. Potential complications include bleeding, vascular injury, hemolysis, infection, sepsis, and device malfunction or failure. Rolling cart carrying components required to run the Impella 2.5. The Impella coordinator is present for implants to assist the catheterization laboratory staff as needed. The most commonly reported complications of Impella 2.5 placement and support include limb ischemia, vascular injury, and bleeding requiring blood transfusion.6,9 Hemolysis has been reported.5,10 Other potential complications include aortic valve damage, displacement of the distal tip of the device into the aorta, infection, and sepsis. A cutdown is performed, and the device is removed by the surgeon. Reports of longer duration of therapy in both the United States and Europe have been published.8,9, The Impella 2.5 has been used for hemodynamic support during high-risk PCI and for hemodynamic support of patients with myocardial infarction complicated by cardiogenic shock or ventricular septal defect, cardiomyopathy with acute decompensation, postcardiotomy shock, off-pump coronary artery bypass grafting surgery, or heart transplant rejection and as a bridge to the next decision.9. If the urine is red, rule out blood in the urine with a simple urinalysis . Correct placement across the aortic valve is critical to avoid complications including hemolysis, suction episodes and inadequate hemodynamic support. 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. Use of the Impella 2.5 in High-Risk - Critical Care Nursing The .gov means its official. Introduction. Context 1. . One patient died before implantation of a device. 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 2.5 catheter shaft size is 9F and is 12F at its largest point, which is the microaxial blood pump. A patient experiencing continuous suction may show systolic LV numbers, shown in white, that are uncoupled from the aortic numbers shown in red. A low purge pressure alarm indicates that the purge pressure to the Impella motor has decreased below 300 mm Hg. PDF PART 9 IMPELLA TROUBLESHOOTING AND RESUSCITATION - European Society of The catheter depth is defined as the distance from the aortic annulus to the ventricular end of the cannula (Figure 4). official website and that any information you provide is encrypted 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. 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. PDF Patient Information for the Impella 2 - Food and Drug Administration Nalluri N, Patel N, Saouma S, Anugu VR, Anugula D, Asti D, Mehta V, Kumar V, Atti V, Edla S, Grewal RK, Khan HM, Kanotra R, Maniatis G, Kandov R, Lafferty JC, Dyal M, Alfonso CE, Cohen MG. The following 3 case studies demonstrate the successful use of Impella 2.5 support during high-risk PCIs at our facility. This site needs JavaScript to work properly. The Rise of Endovascular Mechanical Circulatory Support Use for Cardiogenic Shock and High Risk Coronary Intervention: Considerations and Challenges. The Impella coordinator is present to assist with tubing changes as needed by the nursing staff. Two patients had transient hemolysis that was not clinically significant. At the end of rapid weaning, the Impella device can then be removed as described in the next section. 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. The question that then arises is when to favor escalating inotropes to assist in device weaning. 0000005740 00000 n The Impella 2.5 should not be used in patients with aortic valve disease or known left ventricular thrombus. Support was established at P8. Consider when SBP <90 mmHg sustained for >30 min (or vasopressors required) AND clinical or objective signs of tissue hypoperfusion (see below). Serum level of lactate was lower in patients treated with the Impella. Brenda McCulloch is a member of the Abiomed Administrative Advisory Board. We follow our hospitals protocol for achieving hemostasis, using either manual or mechanical compression. Crit Care Med. 0000003312 00000 n Repositioning is best performed under fluoroscopic guidance, whenever possible. To date, we have placed an Impella 2.5 in about 40 patients. 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. The motor current signal will be flattened. In general, if the patient subsequently develops oliguria, tachycardia, lactate >2 mg/dL, or a cardiac index <2.0 L/min/m2 we will resume the prior level of cardiac support provided by the Impella. 2022 Jan;19(1):1-10. doi: 10.1080/17434440.2022.2015323. : Survey of anticoagulation practices with the, 3. 0000004122 00000 n Following this trial, the Impella 2.5 device received its 510(k) approval from the Food and Drug Administration. An enlarged uvula is often caused by infection, an allergic reaction, or irritation from chemicals or medical procedures. 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). Unable to load your collection due to an error, Unable to load your delegates due to an error. Signs of pulmonary congestion should be monitored, as, at least in theory, high Impella RP support with reduced LV function could cause overflow and pulmonary congestion. Federal government websites often end in .gov or .mil. Free shipping for many products! 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 alarm will read pump position unknown due to low pulsatility. The Impella console is not able to determine the pump position because the patients systolic and diastolic pressures are not very different. Six weeks later, the patient was pain free with no complaints of dyspnea. If the Impella remains in place for continued support after the PCI, the tubing system is changed to 2 separate systems. inlet should be placed approximately 3.5 cm (Impella 2.5, CP and 5.0) or 5.0 cm (Impella 5.5) distal to the aortic valve without being close to the . Our typical hemodynamic targets are a mean arterial pressure of 6070 mm Hg, a right atrial pressure of 812 mm Hg, a pulmonary arterial wedge pressure <15 mm Hg, and a cardiac index >2.0 L/min/m2. 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. Our use of the Impella 2.5 was our first experience with percutaneously placed partial circulatory support devices. Pulmonary artery pressures remained elevated after this stent was placed, and the patient was given furosemide and nitroglycerin to decrease preload and increase diuresis. The Impella is placed percutaneously, most commonly via the femoral or axillary artery, into the aorta, and across the aortic valve. During stent deployment, the patient had severe chest pain and showed ST-segment elevation in the anterior leads. 29. He was experiencing progression of his anginal symptoms, and his functional capacity was poor. Esposito ML, Morine KJ, Annamalai SK, et al. The patient was rapidly weaned from the Impella, which was removed in the catheterization laboratory. This arrangement allows rapid initial setup of the console so that support can be initiated quickly. eCollection 2020 Jan. Barrionuevo-Snchez MI, Ariza-Sol A, Ortiz-Berbel D, Gonzlez-Costello J, Gmez-Hospital JA, Lorente V, Alegre O, Lla I, Snchez-Salado JC, Gmez-Lara J, Blasco-Lucas A, Comin-Colet J. J Geriatr Cardiol. Cardiogenic shock; Impella; Mechanical support devices; intra-aortic balloon pump; mechanical circulatory support; percutaneous ventricular assist device. Three sequential stents were placed in the area of disease. 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. The cannula portion of the catheter is built with a 30 bend (except for the Impella LD, which has a straight design). National Center for Biotechnology Information An SvO2 pulmonary artery catheter showed that the patients baseline pulmonary artery pressures were markedly elevated at 69/4047 mm Hg (normal: 2030/812 mm Hg; mean, 25 mm Hg). Mechanical Circulatory Support for Acute Heart Failure Complicated by Cardiogenic Shock. Visit The necessary images may be particularly difficult to obtain if the Impella device is medially or laterally oriented. As soon as the signal has been established, Impella support is immediately restarted. Purge Screen Displays purge system information displayed as a function of time. Notably, catheter position is best assessed ultrasonographically, as radiography does not accurately identify the cannula position relative to cardiac anatomic structures. Impella Management for the Cardiac Intensivist : ASAIO Journal - LWW 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). A console simulator is available that can be used to practice troubleshooting. government site. Before Introduction: PMC Heparin 9000 units was administered intravenously for anticoagulation, and the Impella 2.5 was advanced into position in the left femoral artery. In cases where transesophageal ultrasound is used for catheter placement or repositioning, the midesophageal long-axis view (120) is the most reliable and accurate to assess catheter depth. 0000000016 00000 n 23. Cardiogenic Shock | Hospital Handbook As the performance level increases, the flow rate and number of revolutions per minute increase. The Impella 2.5 instructions for use recommend a 40-minute manual hold to achieve hemostasis at the arterial access site. Work with pharmacy and nursing staff to develop a standardized time for fluid and tubing changes. Phone, (800) 899-1712 or (949) 362-2050 (ext 532); fax, (949) 362-2049; e-mail, reprints@aacn.org. : Increased plasma-free hemoglobin levels identify hemolysis in patients with, 5. Information about the alarm can be seen on the console screen. The most common Impella-related complications reported are hemolysis, embolic stroke, limb ischemia, access site bleeding, device migration, device malfunction, motor thrombosis, ventricular arrhythmia, and mitral valve disruption.8 Most of these complications are directly related to catheter position and anticoagulation, stressing the importance of frequent clinical assessment. 0000001527 00000 n On arrival, his blood pressure was 105/66 mm Hg with a heart rate of 64/min. 0000007230 00000 n Support was established at P8. Unlike the IABP, the Impella does not require timing, nor is a trigger from an electrocardiographic rhythm or arterial pressure needed (Table 1). A 71-year-old man was referred to our facility for saphenous vein bypass graft (SVG), a high-risk PCI. If hemolysis is suspected, Jess offers the following troubleshooting tips: Address and correct any active position or suction alarms to help prevent hemolysis. Detailed view of distal end of Impella 2.5. Abiomed also provides assistance with troubleshooting via 24-hour-a-day, 7-day-a-week telephone support. 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. Ann Transl Med. 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. Keyword Highlighting Coordination with the perfusionist is essential when patients are being placed on cardiopulmonary bypass. 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. A low purge pressure can allow blood to enter the motor and damage the motor, rendering the device inoperable. At P8, the flow rate is 1.9 to 2.6 L/min and the motor is turning at 50000 revolutions per minute. The SVG was aspirated before a distal protection device was placed. In our facility, this role is filled by the interventional cardiology clinical nurse specialist. She had no further chest pain during her hospitalization and was discharged home in stable condition 3 days later. If you have a swollen uvula, you may also be experiencing a sore throat, trouble swallowing, and maybe even a fever. The purpose of this review is to describe how to manage, reposition, and wean patients from the Impella catheter. 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. 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. Console and infusion pump setup requires 2 to 3 minutes to complete. Methods Cardiogenic shock was induced by injecting microspheres in the left main coronary artery in 18 adult Danish Landrace pigs. In some facilities, the perfusionist manages both the cardiopulmonary bypass and the Impella. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Szymanski TW, Weeks PA, Lee Y, et al. Despite the no-reflow, the arterial pressure, heart rate, and cardiac rhythm remained stable, and the patient had no complaints of shortness of breath or chest discomfort. Complications associated with mechanical circulatory support. At P8, the flow was 2.5 L/min and the patients cardiac index was 2.58 (normal, 2.54). 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. Heparin 7000 units was administered intravenously for anticoagulation. The console uses this pressure measurement to calculate the catheters position. bXSG. We found it helpful for the first few Impella placements to be planned, elective placements for high-risk PCI. FOIA The placement monitoring diagram will show the aortic valve symbols distal to the pump (Figure 9). The morphology of the placement signal resembles that of an arterial waveform, which can be counterintuitive as the peak of the waveform occurs in diastole when the gradient between the LV and aorta is greatest, whereas the nadir occurs during systole when it is least. Impella heart pumps (Abiomed) are intravascular microaxial blood pumps that provide temporary MCS during HRPCI or in the treatment of cardiogenic shock. Some patients on Impella support may be intubated and receiving mechanical ventilation. Please enable it to take advantage of the complete set of features! The proximal port of this lumen is red. Impella - critical care notes Your message has been successfully sent to your colleague. Careers. The catheter is then pulled back from the left ventricle into the ascending aorta and then completely withdrawn. 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 Impella 2.5 catheter has 2 lumens. With respect to weaning order of operations, we generally favor first weaning and decannulation from VA-ECMO (if possible from a pulmonary support perspective), which is based on the higher MCS complication rates and patient immobility associated with VA-ECMO cannulation. Diastolic LV numbers are also very negative and the Max and Min flows displayed on the console are lower than expected. 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. 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. Please try again soon. and transmitted securely. 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 Impella should not be used in patients with a heavily calcified aortic valve. You may search for similar articles that contain these same keywords or you may Search for other works by this author on: Percutaneous left ventricular support devices, A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction, Effects of left ventricular unloading by Impella Recover LP 2.5 on coronary hemodynamics, Nursing care of patients receiving intra-aortic balloon counterpulsation, Safety and feasibility of elective high-risk percutaneous coronary intervention procedures with left ventricular support of the Impella Recover LP 2.5, A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (the PROTECT I trial): Initial U.S. experience, Feasibility and long-term safety of elective Impella-assisted high-risk percutaneous coronary intervention: a pilot two-centre study, Use of Impella Recover LP 2.5 in elective high risk percutaneous coronary intervention [published online ahead of print September 2, 2009], Update on ventricular assist device technology, Impella: Instructions for Use for the Impella 2.5 Circulatory Support System, The coronary no-reflow phenomenon: a review of mechanisms and therapies, 2011 American Association of Critical-Care Nurses, This site uses cookies.