The use of inotropic agents and vasopressors was similar in both groups of patients. 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 use of continuous cardiac output monitoring may be useful for patients with cardiogenic shock. *, *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. to maintaining your privacy and will not share your personal information without Curr Cardiol Rep. 2018 Jan 19;20(1):2. doi: 10.1007/s11886-018-0946-2. P9 can be activated only for 5-minute intervals when the Impella 2.5 is in use. The aortic annulus and the ventricular end of the cannula must be well visualized in a single image to make an accurate measurement. Train a core group of critical care nurses to care for the patient, monitor the device, change tubings, and troubleshoot alarms. The trials primary end point of hemodynamic improvement was defined as improved cardiac index at 30 minutes after implantation. Search for Similar Articles Device-related complications occur more frequently with a longer duration of support. Several console alarms may require nursing intervention (Table 7). The necessary images may be particularly difficult to obtain if the Impella device is medially or laterally oriented. Fluoroscopic guidance in the catheterization laboratory or operating room is required. 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. Just visit www.ccnonline.org and click Respond to This Article in either the full-text or PDF view of the article. Serum level of lactate was lower in patients treated with the Impella. This site needs JavaScript to work properly. High-risk PCI - Impella 2.5, CP - < 6 hours (temporary) VAD for use during high-risk percutaneous coronary intervention (prevent hemodynamic instability) 2. The Impella 2.5 catheter (Figure 2) contains a nonpulsatile microaxial continuous flow blood pump (Figure 3) that pulls blood from the left ventricle to the ascending aorta, creating increased forward flow and increased cardiac output. The Suction alarm is triggered when sudden decreases in the placement signal pressure occur in association with lower than expected flows. trailer <<4E9C4E69F2794E779C95DF45DA44CC4E>]/Prev 560917/XRefStm 1133>> startxref 0 %%EOF 613 0 obj <>stream 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. Ongoing practice is essential to develop and maintain competency. Brenda McCulloch is a member of the Abiomed Administrative Advisory Board. Some patients on Impella support may be intubated and receiving mechanical ventilation. 2). 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. Context in source publication. The purpose of this review is to comprehensively describe our strategy for managing, repositioning, and weaning the Impella catheter. Support was established at P8. $L"$ Detailed view of distal end of Impella 2.5. It is a single tubing system that bifurcates and connects to each port of the catheter. After advancement, always remove any slack by slowly pulling back on the catheter until cannula movement is observed. Sheaths were placed in the right femoral vein, the right femoral artery, and the left femoral artery. Partner with industry. The coronary guidewire was advanced through the LIMA graft to the distal LAD. 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. Some error has occurred while processing your request. 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. If the patient tolerates the PCI procedure and hemodynamic instability does not develop, the Impella 2.5 may be removed at the end of the case while the patient is still in the catheterization laboratory. The placement monitoring diagram will continuously scroll through 3 different images because it is not able to differentiate the position of the catheter. The sheath can then be removed later when the patients activated clotting time or partial thromboplastin time has returned to near normal levels. Low purge pressures require immediate intervention by a critical care nurse. 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. %PDF-1.4 % The Impella 2.5 device is an alternative to an IABP that may be beneficial in some patients who need hemodynamic support. There is a pressure sensor built into the aortic end of the cannula that is used to produce a placement signal waveform tracing (Figure 3A). Impella 2.5 cardiac assist device in left ventricle. Advanced Percutaneous Mechanical Circulatory Support Devices for Cardiogenic Shock. 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. Expert commentary: 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. Our training for staff from the catheterization laboratory consisted of a 3-hour session with didactic and hands-on training. Device profile of the Impella 5.0 and 5.5 system for mechanical circulatory support for patients with cardiogenic shock: overview of its safety and efficacy. The 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. Currently, the intra-aortic balloon pump (IABP) is the most commonly used device for circulatory support. Salmonella is a bacteria that can cause salmonellosis (non-typhoidal Salmonella enteritis), a common foodborne infection that causes watery diarrhea, fever, and abdominal cramps. All cases are also followed by the cardiac surgeon who oversees our VAD program and a critical care intensivist. 0000005740 00000 n Xbao}*"&st V4qZz PMC Crowley J, Cronin B, Essandoh M, DAlessandro D, Shelton K, Dalia AA: Transesophageal echocardiography for, 2. 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 (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. may email you for journal alerts and information, but is committed The performance level determines the flow rate and the number of revolutions per minute. Frequent hemodynamic evaluation is needed. If the patients ventricular function is very poor, a positioning alarm can occur. Epub 2021 Dec 20. At first, an effort should be made to identify and treat these conditions (Fig. Esposito ML, Morine KJ, Annamalai SK, et al. If the Impella remains in place for continued support after the PCI, the tubing system is changed to 2 separate systems. 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 Impella 2.5 can also be removed in the surgical setting with direct visualization of the common femoral artery. 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. If the hemolysis is severe, hemoglobinuria will be seen; if the hemolysis is sustained, acute kidney injury will occur. She was taken to the catheterization laboratory, where she was found to have a significant obstruction of the left main coronary artery complicated by plaque rupture. For more information, please refer to our Privacy Policy. This arrangement allowed ample time for setting up the console and infusion pump before the Impella was placed. 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. 0000001324 00000 n National Library of Medicine He was experiencing progression of his anginal symptoms, and his functional capacity was poor. A console simulator is available that can be used to practice troubleshooting. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. Improvements in cardiac index were significantly greater in the patients with the Impella than in patients with the IABP (P=.02). 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). However, in our experience, measuring structures that can be directly visualized with ultrasound is a more practical and reproducible strategy, and thus we recommend measuring from the aortic annulus to the end of the railroad tracks. The 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). 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. The Impella 2.5 catheter is placed percutaneously through the common femoral artery and advanced retrograde to the left ventricle over a guidewire. 2021 Mar 26;100(12):e25159. Suction events may be caused by inadequate LV filling or incorrect Impella positioning with inlet area obstruction by a cardiac structure. The use of two Impella devices concurrently has demonstrated decreased LV filling pressures and improved cardiac output for cardiogenic shock patients, although reported data on this use is limited and future studies are required. IABP therapy has been in use since the late 1960s and has been widely used in clinical practice since that time. 29. On arrival, his blood pressure was 105/66 mm Hg with a heart rate of 64/min. The heparinized saline is placed in a pressure bag that is inflated to 300 mm Hg. 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. Careers. 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. In Europe, the Impella 2.5 has been in wide use for several years.8,9 In the United States, several small trials5,6,912 have been completed or are underway to evaluate the Impella 2.5. Please enable scripts and reload this page. The purpose of this review is to describe how to manage, reposition, and wean patients from the Impella catheter. 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. We have also placed the Impella 5.0 in 3 patients. The console uses this pressure measurement to calculate the catheters position. Learn more about how the FDA-approved Impella, the world's smallest heart pump, is safe, effective and supports your heart during a procedure. If TTE imaging is difficult, fluoroscopy or TEE can also be used. Read below to find out how long a swollen uvula lasts and how to get treatment. When the activated clotting time was higher than 250 seconds, the Impella 2.5 was advanced into position via the left common femoral artery and placed across the aortic valve into the left ventricle. Develop a nursing protocol that outlines key strategies in patient management and a specific flow sheet (Figure 10) for documentation. Conditions mimicking inlet obstruction (continuous or diastolic suction) resulted in an increase in MIH by 2.5 times while conditions of outlet obstruction increased MIH by 6 times. 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. The purpose of the bend is to orient the catheter toward the apical anteroseptal portion of the LV and away from the posterolateral wall, papillary muscles, and mitral apparatus. At the end of rapid weaning, the Impella device can then be removed as described in the next section. The patient was brought to the catheterization laboratory and prepared for the procedure. sharing sensitive information, make sure youre on a federal Additionally, I share our experiences as we developed our Impella program at our community hospital. bXSG. 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. Patients on Impella 2.5 support who may require interrogation of a permanent pacemaker or implantable cardioverter defibrillator present an interesting situation. The catheter device was connected to the Impella console and support was initiated. A low purge pressure can allow blood to enter the motor and damage the motor, rendering the device inoperable. Free shipping for many products! Int J Heart Fail. If hemolysis is suspected, Jess offers the following troubleshooting tips: Address and correct any active position or suction alarms to help prevent hemolysis. None of the patients had hemodynamic instability develop during the procedure. 0000009855 00000 n We have extensive experience with the IABP and with surgically placed VADs, including the Abiomed AB5000, Thoratec CentriMag, XVE, and HeartMate II. 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. Optimizing the spatial relationship between the catheter and adjacent intracardiac structures is necessary to minimize device-related complications. 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. Potential complications include bleeding, limb ischemia, hemolysis, and infection. 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. 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. SyBbhD&,V}R#Ohov]F}9v_c- The components required to run the device are assembled on a rolling cart (Figure 6) and include the power source, the Braun Vista infusion pump, and the Impella console (Figure 7). 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. Intravascular ultrasound was performed to confirm optimal stent placement. Device failure, although not often reported, can occur. The optimal cannula depth of the Impella 5.5 is 4.5 cm +/- 0.5 cm to the beginning of the inlet area, as this model has a longer cannula. 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. In our facility, we have a trained CICU nurse managing the Impella while the patient is in the cardiovascular operating room. 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. If the catheter is completely out of the ventricle, it should be repositioned across the valve over a guidewire. Work with pharmacy and nursing staff to develop a standardized time for fluid and tubing changes. Immediately before removal of the device, decrease the performance level to P0. 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. Regular documentation is essential, and review of trends is useful when troubleshooting. Arterial repair is done at that time, and the incision is covered with a sterile dressing. The physician can evaluate left ventricular size and function and can quickly assess how well the patient tolerates decreases in the performance level. Retract the device until diastolic pressures normalizes. He declined repeat bypass surgery. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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 second indication is to prevent clot formation on the catheter itself and potential embolization into the patient. 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). 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.). Abiomed provides strong clinical support as well as excellent print and Web-based educational materials. 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. On arrival, her blood pressure was 127/72 mm Hg, and her heart rate was 54/min. 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). Optimal imaging often requires off-axis parasternal long-axis views obtained by fanning and rotating the probe until the entire length of the cannula and the aortic annulus are seen. 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. Two patients had transient hemolysis that was not clinically significant. Medicine (Baltimore). Unauthorized use of these marks is strictly prohibited. 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. She returned to the catheterization laboratory 3 days later for high-risk PCI of the left main coronary artery. Disclaimer. He had severe mitral regurgitation. 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. Review of patient care management strategies, console troubleshooting, and fluid/tubing setup has also been added to our annual VAD skills fair (Table 9). 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. The lesser used Impella LD is reserved for direct transaortic placement intraoperatively. doi: 10.1371/journal.pone.0247667. Components of the Impella 2.5 cardiac assist device. The Impella 2.5 catheter has 2 lumens. 0000004122 00000 n Subramaniam AV, Barsness GW, Vallabhajosyula S, Vallabhajosyula S: Complications of temporary percutaneous. 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. We provide 1-to-1 staffing for our patients with an Impella 2.5 until they are hemodynamically stable. 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. 0000014939 00000 n 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. We follow our hospitals protocol for achieving hemostasis, using either manual or mechanical compression. The proximal port of this lumen is red. 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. Context 1. . In Europe, the Impella 2.5 is approved for use up to 5 days. If the urine is red, rule out blood in the urine with a simple urinalysis . The 13F arterial sheath was sutured in placed for removal 4 hours later after the patient was returned to the CICU. 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 . With the physician at the bedside, transthoracic echocardiography is performed and the pumps performance level is decreased. No sound other than alarms is audible during Impella support, unlike the sound heard with an IABP. 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 https:// ensures that you are connecting to the 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. Shearing of red blood cells is a common and clinically relevant problem with the Impella catheter. The patients diastolic pressure increased significantly more with Impella support than with IABP support (P=.002). She was transferred to the CICU and supportive medical therapy was initiated. 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. Before doi: https://doi.org/10.4037/ccn2011293. 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. Function keys that are used with the Impella 2.5 include the P-PERF, MENU, SIGNAL, SCALE, and the ON keys. In our facility, physicians who can place this device are those who have interventional cardiology and/or cardiac surgery privileges. Hemolysis can be mechanically induced when red blood cells are damaged as they pass through the microaxial pump. Distal pulses of the affected leg should be assessed at least hourly. The site is secure. Image courtesy Sutter Medical Center, Sacramento, California. Image courtesy ABIOMED Inc, Danvers, Massachusetts. Important contraindications to use of the Impella MCS system are the presence of: moderate to severe aortic regurgitation, mechanical aortic valve, aortic dissection, LV thrombus, or ventricular sepal defect. 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.

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