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If the patients ventricular function is very poor, a positioning alarm can occur. Introduction. It is useful in patients undergoing high-risk PCIs. 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. Note: consider the diagnosis of normotensive cardiogenic shock when normal BP but rising lactate and transaminitis. 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. The Rise of Endovascular Mechanical Circulatory Support Use for Cardiogenic Shock and High Risk Coronary Intervention: Considerations and Challenges. P9 can be activated only for 5-minute intervals when the Impella 2.5 is in use. A console simulator is available that can be used to practice troubleshooting. As soon as the signal has been established, Impella support is immediately restarted. Our practice of monitoring and managing RV function relies heavily on invasive hemodynamics and ultrasound imaging. 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 purpose of this review is to describe how to manage, reposition, and wean patients from the Impella catheter. Cardiogenic shock (CS) is a life-threatening condition associated with significant morbidity and mortality. LV Aortic valve Mitral valve Impella 2.5 outlet area Impella 2.5 . government site. The catheter depth is defined as the distance from the aortic annulus to the ventricular end of the cannula (Figure 4). Free shipping for many products! 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. We found it helpful for the first few Impella placements to be planned, elective placements for high-risk PCI. Support was established at P8. Data is temporarily unavailable. 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). Console and infusion pump setup requires 2 to 3 minutes to complete. Additional torque can be achieved by rotating the red Impella plug (Figure 5) at the proximal end of the catheter in the desired direction. Impella 2.5 cardiac assist device in left ventricle. If the Impella remains in place for continued support after the PCI, the tubing system is changed to 2 separate systems. 0000003312 00000 n 2021 Feb;19(2):151-164. doi: 10.1080/14779072.2021.1863147. 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. The trials primary end point of hemodynamic improvement was defined as improved cardiac index at 30 minutes after implantation. Abiomed provides strong clinical support as well as excellent print and Web-based educational materials. She was transferred to the CICU and supportive medical therapy was initiated. If the urine is red, rule out blood in the urine with a simple urinalysis . In one trial5 in which an IABP was compared with an Impella in cardiogenic shock patients, after 30 minutes of therapy, the cardiac index (calculated as cardiac output in liters per minute divided by body surface area in square meters) increased by 0.5 in the patients with the Impella compared with 0.1 in the patients with an IABP. In some facilities, the perfusionist manages both the cardiopulmonary bypass and the Impella. She returned to the catheterization laboratory 3 days later for high-risk PCI of the left main coronary artery. A multidisciplinary approach to establishing a program for the Impella is useful in ensuring competency and good outcomes for patients. 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). You may be trying to access this site from a secured browser on the server. %PDF-1.4 % 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). 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. The performance level was increased from P0 to a maximum of P8 in a matter of minutes. 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). 0000006172 00000 n The second lumen ends near the motor above the level of the aortic valve and is used to monitor aortic pressure. Bethesda, MD 20894, Web Policies During stent deployment, the patient had severe chest pain and showed ST-segment elevation in the anterior leads. It is important to note that this derived ventricular pressure is not an accurate measure of the true LV pressure and thus may not directly replace the value of monitoring the pulmonary arterial capillary wedge pressure via a pulmonary artery catheter. Diastolic LV numbers are also very negative and the Max and Min flows displayed on the console are lower than expected. modify the keyword list to augment your search. Serial assessment of native cardiac function and organ perfusion using clinical, hemodynamic, imaging, and laboratory data should be performed as the Impella support is weaned. Weaning from the partial circulatory support provided by the Impella 2.5 can be approached in different ways. Epub 2020 Dec 28. Our facility has a high-volume interventional cardiology program as well as a busy adult and pediatric cardiovascular surgery service. 0000001133 00000 n If the catheter is completely out of the ventricle, it should be repositioned across the valve over a guidewire. The MedStar Washington Hospital Center institutional review board approved the electronic medical record extraction and publication of this data. Clipboard, Search History, and several other advanced features are temporarily unavailable. The Impella 2.5 catheter is placed percutaneously through the common femoral artery and advanced retrograde to the left ventricle over a guidewire. doi: 10.1371/journal.pone.0247667. HHS Vulnerability Disclosure, Help 2022 Jan;19(1):1-10. doi: 10.1080/17434440.2022.2015323. Device-related complications occur more frequently with a longer duration of support. The partial thromboplastin time should be monitored every 4 to 8 hours and maintained at about 45 to 55 seconds, unless a higher partial thromboplastin time is required for some other reason. 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. Impella use in real-world cardiogenic shock patients: Sobering outcomes. The VAD coordinators also provide valuable assistance. In cases of RV failure, Impella flows can be limited by poor RV output as well as by RV distention that shifts the interventricular septum toward the LV, which can precipitate suction events. The first is to prevent clot formation on the motor, a potentially catastrophic event that is avoided by delivering a heparinized dextrose purge solution to the motor which creates a liquid interface between the motor housing and the patients blood. The patients hemodynamic status is assessed after every decrease in performance level. Crit Care Nurse 1 February 2011; 31 (1): e1e16. The 13F arterial sheath was sutured in placed for removal 2 hours later, after the patient had returned to the CICU. 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). Patients who have had the device in longer or who were in unstable condition during the procedure may benefit from a slower weaning process. When hemolysis occurs, hemoglobin level and hematocrit decrease, haptoglobin level decreases, and plasma levels of free hemoglobin increase. The aortic valve symbols will not be seen on the placement monitoring diagram. Brenda McCulloch; Use of the Impella 2.5 in High-Risk Percutaneous Coronary Intervention. 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. If the device advances too far and both the inflow and outflow areas are fully in the left ventricle, the pump position wrong alarm will occur. Hemolysis, as measured by the plasma level of free hemoglobin, was higher in patients treated with the Impella. v67z]FcUe7sne[l}g&_}V^7vk~7S/o}AoepY5OTYe>acQ*|o? \-yVJUrM^2E~,d3EN9--u1C~A+ If Impella malposition is suspected, use echo to look for inlet or outlet obstructions. Medicine (Baltimore). Please enable it to take advantage of the complete set of features! A low purge pressure alarm indicates that the purge pressure to the Impella motor has decreased below 300 mm Hg. A cutdown is performed, and the device is removed by the surgeon. 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. If a significant color Doppler signal is observed below the valve (in the absence of significant aortic regurgitation), the device is likely too deep. Jo Kajewski, Advanced Impella Trainer, gives an in-depth look at managing Impella positioning using imaging. A PFH >40 mg/dL or acute increase in either PFH or LDH suggests increasing hemolysis and warrants intervention.4 The main causes of Impella-related hemolysis are crowding or partial obstruction of the inlet or outlet areas due to poor positioning, thrombus formation in the cannula, operating at the higher range of the power settings, and subtherapeutic anticoagulation. 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. Serum level of lactate was lower in patients treated with the Impella. All patients with this device are observed by this clinical nurse specialist during their hospital stay. bXSG. The PCI procedure of the LAD SVG was then started. 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. Expert Rev Med Devices. Unable to load your collection due to an error, Unable to load your delegates due to an error. 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. When the heart displays a question mark over it with the words "Impella Position Wrong": 1. controller can't determine catheter position. The sheath can then be removed later when the patients activated clotting time or partial thromboplastin time has returned to near normal levels. Sheaths were placed in the right femoral vein, the right femoral artery, and the left femoral artery. During this time, transient no-reflow developed. Other components of the Impella 2.5 catheter include the cable that connects the catheter to the console and a repositioning sheath for bedside repositioning of the Impella 2.5. Consider when SBP <90 mmHg sustained for >30 min (or vasopressors required) AND clinical or objective signs of tissue hypoperfusion (see below). Our training for staff from the catheterization laboratory consisted of a 3-hour session with didactic and hands-on training. Routine management of patients after PCI is not addressed. The cannula appears as two bright echogenic, parallel lines, sometimes referred to as the railroad tracks, which ends at the inlet area. The Impella 2.5 can also be removed in the surgical setting with direct visualization of the common femoral artery. At the end of the procedure, she was symptom free, and she was rapidly weaned from the Impella and the device was removed. We developed preprinted orders for physicians to use for patients remaining on support to ensure consistency in care (Table 8). 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. In Europe, the Impella 2.5 is approved for use up to 5 days. 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). Transthoracic echocardiography should be used to visualize the device. After making note of the catheter depth from the vascular access site, the nonimager should then loosen the vascular access site Tuohy-Borst lock (Figure 5) and rotate, advance, or withdraw the catheter as appropriate to optimize its position. The purpose of this review is to comprehensively describe our strategy for managing, repositioning, and weaning the Impella catheter. 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. The pharmacy prepares the heparinized 20% glucose purge solution and sends it to the unit before our standard change time of 3 pm daily. Would you like email updates of new search results? The Impella console powers the microaxial blood pump and monitors the functioning of the device, including the purge pressure and several other parameters. Correspondence: Alexander Papolos, MD, Departments of Cardiology and Critical Care, MedStar Washington Hospital Center, 110 Irving St., NW, Rm A127, Washington, DC, 20010. Ann Transl Med. 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. He had severe mitral regurgitation. At the end of rapid weaning, the Impella device can then be removed as described in the next section. 0000005131 00000 n 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. 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. In these situations, one must weigh the risk of time-dependent device-related complications with inotrope-related increases in myocardial oxygen demands. Unlike the IABP, the Impella does not require timing, nor is a trigger from an electrocardiographic rhythm or arterial pressure needed (Table 1). Introduction: 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. A patient experiencing continuous suction may show systolic LV numbers, shown in white, that are uncoupled from the aortic numbers shown in red. The device may cause calcium to break off of the aortic valve and embolize, causing stroke. Device failure, although not often reported, can occur. Correct placement across the aortic valve is critical to avoid complications including hemolysis, suction episodes and inadequate hemodynamic support. Despite these changes, her blood pressure and cardiac rhythm remained stable. His ventricular function was poor with a calculated ejection fraction of 20%. There are two indications for anticoagulation when using the Impella catheter. Advanced Percutaneous Mechanical Circulatory Support Devices for Cardiogenic Shock. The proximal port of this lumen is red. / Phone, (800) 899-1712 or (949) 362-2050 (ext 532); fax, (949) 362-2049; e-mail, reprints@aacn.org. The patients vital signs and cardiac rhythm remained stable throughout the procedure. The motor current will be flattened. In our facility, we have a trained CICU nurse managing the Impella while the patient is in the cardiovascular operating room. The Impella controller will alarm when it determines that the device may be mispositioned or dysfunctional. This should prompt urgent ultrasound assessment as the device may need to be either retracted or advanced. If the patient tolerates this slow weaning by remaining hemodynamically stable while at P2, the device is then removed. This arrangement allowed ample time for setting up the console and infusion pump before the Impella was placed. 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. 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. 0000004122 00000 n 4, 5 Right ventricular failure occurs in 25% of patients after left ventricular assist device insertion, thus the advent of Impella RP. Fluoroscopic guidance in the catheterization laboratory or operating room is required. The heparinized saline is placed in a pressure bag that is inflated to 300 mm Hg. : Increased plasma-free hemoglobin levels identify hemolysis in patients with, 5. The performance level determines the flow rate and the number of revolutions per minute. A culprit oriented approach should be used when troubleshooting the Impella supported patient with signs of persistent circulatory failure. If the hemolysis is severe, hemoglobinuria will be seen; if the hemolysis is sustained, acute kidney injury will occur. The motor current signal will be flattened. While the inability to provide anticoagulation is a contraindication, there is ongoing research into nonanticoagulant purge solution alternatives. Impella heart pumps have been tested under simulated conditions of inflow and outflow obstruction. Work with pharmacy and nursing staff to develop a standardized time for fluid and tubing changes. doi: https://doi.org/10.4037/ccn2011293. 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. The nursing care of patients remaining on Impella 2.5 support requires astute assessment and expert nursing care (Table 4). Utilization of the Impella for hemodynamic support during percutaneous intervention and cardiogenic shock: an insight. It reduces myocardial oxygen consumption, improves mean arterial pressure, and reduces pulmonary capillary wedge pressure.2 The Impella provides a greater increase in cardiac output than the IABP provides. An additional method to ensure proper depth is to interrogate the aortic root with color Doppler from the parasternal long-axis view. 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). 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. Before He had a long history of diabetes and had undergone coronary artery bypass surgery 20 years prior. 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. There are currently five Impella catheters that provide left ventricular (LV) support (Figure 1). 2). Six weeks later, the patient was pain free with no complaints of dyspnea. 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 PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Suction events may be caused by inadequate LV filling or incorrect Impella positioning with inlet area obstruction by a cardiac structure. 597 0 obj <> endobj xref Immediately before removal of the device, decrease the performance level to P0. Read below to find out how long a swollen uvula lasts and how to get treatment. 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.). 0000005740 00000 n *; Barnett, Christopher F.; Tuli, Aakash; Vavilin, Ilan; Kenigsberg, Benjamin B. That waveform depicts the pressure gradient across the intra- and extraluminal surface of the cannula, and when the device is correctly positioned, the intra- and extraluminal pressures reflect the pressure within LV and aortic root, respectively. Retract the device until diastolic pressures normalizes. Limit the physicians who can place and manage the device and have them proctor one another. 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. The most common include suction, low purge pressure, and high purge pressure alarms. The placement monitoring diagram will show the aortic valve symbols distal to the pump (Figure 9). Areas covered: Like all LV assist devices, the Impella can only pump as much blood as is available to it. The arterial access site must be assessed regularly for bleeding and development of a hematoma. Garan AR, Kanwar M, Thayer KL, et al. Currently, the intra-aortic balloon pump (IABP) is the most commonly used device for circulatory support. He returned to the catheterization laboratory the next day for coronary intervention. High-risk PCI - Impella 2.5, CP - < 6 hours (temporary) VAD for use during high-risk percutaneous coronary intervention (prevent hemodynamic instability) 2. The motor current will be flattened. Hear the stories of patients and explore the latest innovations in Impella technology. 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).