We developed preprinted orders for physicians to use for patients remaining on support to ensure consistency in care (Table 8). Quick Reference and Troubleshooting Guide 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. The Impella (Abiomed, Danvers, MA) mechanical circulatory support (MCS) system is a catheter-based continuous flow pump that is typically placed percutaneously or by surgical cutdown into the femoral or subclavian artery. Additionally, cardiac resuscitation can cause device migration and as such, post-arrest ultrasound confirmation of position is recommended. Cardiogenic shock; Impella; Mechanical support devices; intra-aortic balloon pump; mechanical circulatory support; percutaneous ventricular assist device. Epub 2021 Dec 20. A low purge pressure can allow blood to enter the motor and damage the motor, rendering the device inoperable. LV Aortic valve Mitral valve Impella 2.5 outlet area Impella 2.5 . He was discharged home 2 days later. Abiomed has sponsored several of these trials, including PROTECT I, PROTECT II, RECOVER I, RECOVER II, and ISAR-SHOCK. Potential complications include bleeding, vascular injury, hemolysis, infection, sepsis, and device malfunction or failure. For rapid weaning, the performance level is decreased by 1 or 2 levels every 5 to 15 minutes until the pump is set at P2. 6, 7 However, the device may migrate out of . In some facilities, the perfusionist manages both the cardiopulmonary bypass and the Impella. The aortic valve symbols will not be seen on the placement monitoring diagram. An additional method to ensure proper depth is to interrogate the aortic root with color Doppler from the parasternal long-axis view. The optimal depth for the Impella 2.5, CP, 5.0, and LD is 3 cm to the beginning of the inlet area, and readjustment should be considered if the depth is more than 0.5 cm from this target. 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. Several console alarms may require nursing intervention (Table 7). 4, 5 Right ventricular failure occurs in 25% of patients after left ventricular assist device insertion, thus the advent of Impella RP. 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. Learn more about how the FDA-approved Impella, the world's smallest heart pump, is safe, effective and supports your heart during a procedure. 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.). Wolters Kluwer Health The question that then arises is when to favor escalating inotropes to assist in device weaning. Suction alarms can occur if the performance level is too high for the patient; for example, in a patient who is hypovolemic or if the device is emptying the ventricle. Note: consider the diagnosis of normotensive cardiogenic shock when normal BP but rising lactate and transaminitis. your express consent. We follow our hospitals protocol for achieving hemostasis, using either manual or mechanical compression. Epub 2017 Sep 11. No reflow is a phenomenon in PCI that can cause severe hemodynamic compromise because myocardial perfusion through a given segment of the coronary circulation is inadequate, yet no angiographic evidence of mechanical obstruction of the vessel is apparent.15 The patients pulmonary artery pressures increased to 93/4058 mm Hg and the cardiac index decreased to 2.2. At follow-up 12 months later, the patient remained symptom-free with a normal ejection fraction of 55%. 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. 2021 Feb 26;16(2):e0247667. With the physician at the bedside, transthoracic echocardiography is performed and the pumps performance level is decreased. 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 heparinized saline is placed in a pressure bag that is inflated to 300 mm Hg. If the catheter is completely out of the ventricle, it should be repositioned across the valve over a guidewire. On arrival, her blood pressure was 127/72 mm Hg, and her heart rate was 54/min. The necessary images may be particularly difficult to obtain if the Impella device is medially or laterally oriented. Following this trial, the Impella 2.5 device received its 510(k) approval from the Food and Drug Administration. 23. Cardiogenic Shock | Hospital Handbook The Impella is placed percutaneously, most commonly via the femoral or axillary artery, into the aorta, and across the aortic valve. Additional torque can be achieved by rotating the red Impella plug (Figure 5) at the proximal end of the catheter in the desired direction. 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. In Europe, the Impella 2.5 is approved for use up to 5 days. 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. Unloading using Impella CP during profound cardiogenic - SpringerOpen Advanced Percutaneous Mechanical Circulatory Support Devices for Cardiogenic Shock. It cannot be used in patients with documented left ventricular thrombus. Impella Flashcards | Quizlet The sheath can then be removed later when the patients activated clotting time or partial thromboplastin time has returned to near normal levels. We provide 1-to-1 staffing for our patients with an Impella 2.5 until they are hemodynamically stable. An audible alarm also will sound. An enlarged uvula is often caused by infection, an allergic reaction, or irritation from chemicals or medical procedures. 0000003312 00000 n The second indication is to prevent clot formation on the catheter itself and potential embolization into the patient. PDF PART 9 IMPELLA TROUBLESHOOTING AND RESUSCITATION - European Society of a small tube that carries blood out of the heart into a pump then blood pumped back into the aorta (LVAD) or pulmonary artery (RVAD) can be continuous flow (cf-VAD) rather than pulsatile (generally older models); cf-VADs are smaller, quieter, and durable. Infusion of purge solution alone infrequently results in the desired therapeutic systemic anticoagulation and an additional infusion of parenteral heparin is often required. The Impella TM Device. A multidisciplinary approach to establishing a program for the Impella is useful in ensuring competency and good outcomes for patients. Submitted for consideration June 2021; accepted for publication in revised form December 2021. An official website of the United States government. National Center for Biotechnology Information A Review of the Impella Devices | ICR Journal 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. For more Impella resources, subscribe to our wee. If the urine is red, rule out blood in the urine with a simple urinalysis . 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. Because the patient was tolerating the procedure well after this, the physician decided to stent the second diseased SVG. 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 MedStar Washington Hospital Center institutional review board approved the electronic medical record extraction and publication of this data. A console simulator is available that can be used to practice troubleshooting. Fluoroscopic image of Impella 2.5 in place in the aorta. However, in severe cases of RV failure or when pre-capillary pulmonary hypertension is a contributing factor, right-sided MCS and pulmonary vasodilator titration may be required, respectively. The performance level should be reduced to P2 and the physician should be notified of the need to reposition the Impella. 29. The second lumen ends near the motor above the level of the aortic valve and is used to monitor aortic pressure. The console uses this pressure measurement to calculate the catheters position. If you have a swollen uvula, you may also be experiencing a sore throat, trouble swallowing, and maybe even a fever. The Impella 2.5 should not be used in patients with aortic valve disease or known left ventricular thrombus. 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. Salmonella: Signs, Symptoms, and Complications - Verywell Health 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 VAD coordinators also provide valuable assistance. Clipboard, Search History, and several other advanced features are temporarily unavailable. Visit 0000005740 00000 n 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. Ongoing practice is essential to develop and maintain competency. 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. 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 The cannula appears as two bright echogenic, parallel lines, sometimes referred to as the railroad tracks, which ends at the inlet area. 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. 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). 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. Troubleshooting Suspected Hemolysis in Patients Supported with Impella Rotation can often be difficult and applying more than a full 360 degrees of torque is often necessary. His ventricular function was poor with a calculated ejection fraction of 20%. v67z]FcUe7sne[l}g&_}V^7vk~7S/o}AoepY5OTYe>acQ*|o? \-yVJUrM^2E~,d3EN9--u1C~A+ 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. H\n0E Bivalirudin was administered for anticoagulation, and the Impella 2.5 was advanced into position in the left femoral artery. Additionally, I share our experiences as we developed our Impella program at our community hospital. 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. Limit the physicians who can place and manage the device and have them proctor one another. One lumen carries fluid to the impellar blades and continuously purges the motor to prevent the formation of thrombus. Expert commentary: 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. The patients vital signs and cardiac rhythm remained stable throughout the procedure. Using the LV Waveform to Troubleshoot Suction Events - Heart Recovery 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). Data is temporarily unavailable. 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. 0000004122 00000 n Improvements in cardiac index were significantly greater in the patients with the Impella than in patients with the IABP (P=.02). SyBbhD&,V}R#Ohov]F}9v_c- 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. hb```b``ac`a` B@EY k2T>`(zM]us:nqO8.c,BD|s+eSd:[$spK| B^0F:TXSY&D{|!3:EOT$Z^ELkzIGX;&XY 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. Abiomed Impella 2.5 Flashcards | Quizlet 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. The Impella mechanical circulatory support (MCS) system is a catheter-based continuous flow cardiac assist device that is widely used in the treatment of cardiogenic shock in medical and surgical cardiac intensive care units. The https:// ensures that you are connecting to the 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 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. 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. %PDF-1.4 % Percutaneous mechanical support devices are placed in a minimally invasive manner and provide life-saving assistance. 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). 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. If Impella malposition is suspected, use echo to look for inlet or outlet obstructions. Support was established at P8. At P8, the flow was 2.5 L/min and the patients cardiac index was 2.58 (normal, 2.54). The PCI procedure of the LAD SVG was then started. 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. 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 The aortic annulus and the ventricular end of the cannula must be well visualized in a single image to make an accurate measurement. Keywords: Coordination with the perfusionist is essential when patients are being placed on cardiopulmonary bypass. 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). Accessibility 0000006172 00000 n Our training for staff from the catheterization laboratory consisted of a 3-hour session with didactic and hands-on training. The purpose of this review is to describe how to manage, reposition, and wean patients from the Impella catheter. The device was successfully placed in all patients, and the duration of support ranged from 0.4 to 2.5 hours. On arrival, his blood pressure was 105/66 mm Hg with a heart rate of 64/min. Accurate Impella placement is essential during all phases of Impella support but it is particularly important for long term support. 2017 Oct;14(10):789-804. doi: 10.1080/17434440.2017.1374849. 0000009855 00000 n When the device has been in only for support during high-risk PCI and the patients condition is stable after the procedure is completed, rapid weaning can be done. 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. It is used for high-risk percutaneous coronary intervention and CS. Frontiers | Central Venous Pressure and Clinical Outcomes During Left 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. When the Quick Set-Up is used, the 10% to 20% dextrose solution used to purge the motor is not heparinized. 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. SmartAssist technology on the Impella CP or Impella 5.5 devices can help with this as well. On arrival, his blood pressure was 151/88 mm Hg with a heart rate of 66/min. Components of the Impella 2.5 cardiac assist device. In these illustrations, the Impella Catheter is positioned correctly. Heparin 9000 units was administered intravenously for anticoagulation, and the Impella 2.5 was advanced into position in the left femoral artery. Federal government websites often end in .gov or .mil. Introduction. Disclosure: The authors have no funding or conflicts of interest to report. In our facility, physicians who can place this device are those who have interventional cardiology and/or cardiac surgery privileges. 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. Patients with an Impella may go to the cardiovascular operating room for bypass surgery or valve repair/replacement. Careers. 2). The patients remaining hospital course was uneventful and he was discharged 2 days later taking appropriate medications for after PCI and to treat heart failure. Serum level of lactate was lower in patients treated with the Impella. 0000004641 00000 n Curr Cardiol Rep. 2018 Jan 19;20(1):2. doi: 10.1007/s11886-018-0946-2. 0000000636 00000 n Single Access Technique. Highlight selected keywords in the article text. 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. 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. doi: 10.1097/MD.0000000000025159. Conversely, lack of expected pulsatility in the placement signal and/or in the motor current signal may reflect a problem. This arrangement allows rapid initial setup of the console so that support can be initiated quickly. It is not uncommon that some patients with severe cardiac dysfunction do not readily demonstrate the ability to wean from the Impella. 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). Placement monitoring screen display shows that pump position is wrong. Potential complications of use of the Impella 2.5 are detailed in Table 3. Nursing care is directed toward support of critically ill patients, including frequent hemodynamic assessment, titration of vasoactive medications as indicated, Impella console troubleshooting, and monitoring for potential complications. If the catheter pigtail is hooked on the mitral apparatus and/or papillary muscle, it may be necessary to first advance the catheter deeper into the ventricle and then rotate the catheter to disengage it from the valvular structures. The cannula portion of the catheter is built with a 30 bend (except for the Impella LD, which has a straight design). 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.
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