Context 1. . 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. He was discharged home 2 days later. 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. The placement monitoring diagram will continuously scroll through 3 different images because it is not able to differentiate the position of the catheter. The Impella RP can be used in tandem with a left-sided Impella device. He had a long history of diabetes and had undergone coronary artery bypass surgery 20 years prior. 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. 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. 2020 Jan 22;2(1):23-44. doi: 10.36628/ijhf.2019.0015. Patients who have had the device in longer or who were in unstable condition during the procedure may benefit from a slower weaning process. Regular repositioning of patients and assessment of their skin are necessary to prevent skin breakdown. Salmonella is a bacteria that can cause salmonellosis (non-typhoidal Salmonella enteritis), a common foodborne infection that causes watery diarrhea, fever, and abdominal cramps. 8600 Rockville Pike The structural design of each of these LV support catheters is grossly similar (Figure 2). trailer <<4E9C4E69F2794E779C95DF45DA44CC4E>]/Prev 560917/XRefStm 1133>> startxref 0 %%EOF 613 0 obj <>stream modify the keyword list to augment your search. An enlarged uvula is often caused by infection, an allergic reaction, or irritation from chemicals or medical procedures. Review of patient care management strategies, console troubleshooting, and fluid/tubing setup has also been added to our annual VAD skills fair (Table 9). Jo Kajewski, Advanced Impella Trainer, gives an in-depth look at managing Impella positioning using imaging. Bookshelf To understand the hemodynamics of a patient in cardiogenic shock receiving Impella support, a pulmonary arterial catheter is recommended.5 The overall weaning strategy is to achieve adequate organ perfusion at the lowest device power setting to minimize device-related complications and to determine candidacy for device removal. 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). Ann Transl Med. 0000014939 00000 n Routine management of patients after PCI is not addressed. Device failure, although not often reported, can occur. Utilization of the Impella for hemodynamic support during percutaneous intervention and cardiogenic shock: an insight. 0000000636 00000 n Immediately before removal of the device, decrease the performance level to P0. Potential complications include bleeding, vascular injury, hemolysis, infection, sepsis, and device malfunction or failure. In these situations, one must weigh the risk of time-dependent device-related complications with inotrope-related increases in myocardial oxygen demands. Comparing traditional intra-aortic balloon therapy with Impella 2.5 percutaneous ventricular assist device, Potential complications of Impella 2.5 support, Nursing care of patients with an Impella 2.5, Impella 2.5 performance level and flow rate, Physician orders for placement of Impella 2.5, Impella competency checklist for nurses in the cardiac intensive care unit: critical elements for managing patients with an Impella 2.5, Brenda McCulloch is a cardiovascular clinical nurse specialist at Sutter Heart and Vascular Institute, Sutter Medical Center, Sacramento, California. : Anticoagulation of, 4. We follow our hospitals protocol for achieving hemostasis, using either manual or mechanical compression. 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). 0000005740 00000 n The entire LV placement signal waveform shifts downward. The patient was transferred to the CICU for continued monitoring. Please enable it to take advantage of the complete set of features! Federal government websites often end in .gov or .mil. 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. IABP therapy has been in use since the late 1960s and has been widely used in clinical practice since that time. Visit The motor current will be flattened. Cardiogenic shock complicates 5-10% of cases of myocardial infarction 1-3 and mechanical support devices have demonstrated limited benefit with early initiation and appropriate protocols. 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. The Impella console powers the microaxial blood pump and monitors the functioning of the device, including the purge pressure and several other parameters. Epub 2020 Dec 28. 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. *; Barnett, Christopher F.; Tuli, Aakash; Vavilin, Ilan; Kenigsberg, Benjamin B. On the placement signal screen, the waveform will show a ventricular, rather than an aortic, pressure waveform. Train a core group of nurses and cardiovascular technologists from the catheterization laboratory for initial setup of the console, catheter preparation, and assisting with placement of the device. Crit Care Nurse 1 February 2011; 31 (1): e1e16. He was evaluated by our cardiothoracic surgery team and was deemed an extremely poor candidate for surgery. 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. An official website of the United States government. Suction events are mostly due to abnormal device position or insufficient preload. The patients hemodynamic status is assessed after every decrease in performance level. As the patient goes on cardiopulmonary bypass, the performance level of the Impella must be decreased. She returned to the catheterization laboratory 3 days later for high-risk PCI of the left main coronary artery. For this reason, we recommend a conservative approach to catheter manipulation with a the enemy of good is perfect philosophy. 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). 2017 Nov;45(11):1922-1929. doi: 10.1097/CCM.0000000000002676. A 63-year-old woman was admitted to our facility with an acute anteroseptal myocardial infarction. Brenda McCulloch; Use of the Impella 2.5 in High-Risk Percutaneous Coronary Intervention. If the catheter is completely out of the ventricle, it should be repositioned across the valve over a guidewire. 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. 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 TM Device. 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). Placement monitoring screen display shows that pump position is wrong. Suction events may be caused by inadequate LV filling or incorrect Impella positioning with inlet area obstruction by a cardiac structure. Heparin 7000 units was administered intravenously for anticoagulation. 597 0 obj <> endobj xref 0000004122 00000 n %PDF-1.4 % Reed BN, DiDomenico RJ, Allender JE, et al. The proximal port of this lumen is yellow. If the hemolysis is severe, hemoglobinuria will be seen; if the hemolysis is sustained, acute kidney injury will occur. 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). The purpose of this review is to describe how to manage, reposition, and wean patients from the Impella catheter. doi: 10.1371/journal.pone.0247667. and transmitted securely. 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. Notably, the device manufacturer suggests measuring catheter depth from the aortic annulus to the middle of the echolucent inlet area, (i.e., 0.5 cm more than the distances stated above). Epub 2021 Dec 20. 0000001133 00000 n Would you like email updates of new search results? 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. None of the patients had hemodynamic instability develop during the procedure. Background and aim This study aimed to assess right ventricular (RV) function during cardiogenic shock due to acute left ventricular (LV) failure, including during LV unloading with Impella CP and an added moderate dose of norepinephrine. Int J Heart Fail. The performance level was increased from P0 to a maximum of P8 in a matter of minutes. 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 Adequate blood flow was reestablished after the intracoronary administration of 500 g nitroglycerin. The Impella coordinator is present to assist with tubing changes as needed by the nursing staff. 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. Infusion of purge solution alone infrequently results in the desired therapeutic systemic anticoagulation and an additional infusion of parenteral heparin is often required. Accessibility Impella has been proven to be safe and may be superior to other mechanical support devices in CS. The Impella catheter connects to a bedside controller that displays data about device performance, powers the motor, and delivers a heparinized dextrose solution (purge fluid) to the motor housing. doi: https://doi.org/10.4037/ccn2011293. The second indication is to prevent clot formation on the catheter itself and potential embolization into the patient. We have also placed the Impella 5.0 in 3 patients. For more information, please refer to our Privacy Policy. It cannot be used in patients with documented left ventricular thrombus. The 13F arterial sheath was sutured in placed for removal 4 hours later after the patient was returned to the CICU. Medicine (Baltimore). Clipboard, Search History, and several other advanced features are temporarily unavailable. The console has 10 function keys, but not all of the function keys are used for the Impella 2.5. 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. 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. Following this trial, the Impella 2.5 device received its 510(k) approval from the Food and Drug Administration. At P8, the flow rate is 1.9 to 2.6 L/min and the motor is turning at 50000 revolutions per minute. Disclaimer. Function keys that are used with the Impella 2.5 include the P-PERF, MENU, SIGNAL, SCALE, and the ON keys. 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. 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. The Impella is placed percutaneously, most commonly via the femoral or axillary artery, into the aorta, and across the aortic valve. 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. 0000004641 00000 n Potential complications include bleeding, limb ischemia, hemolysis, and infection. 0000003906 00000 n She had a history of hypertension complicated by end-stage renal disease and was receiving dialysis treatments 3 times per week. 2020 Jul;8(13):835. doi: 10.21037/atm.2020.03.152. / Abiomed provides strong clinical support as well as excellent print and Web-based educational materials. The catheter device was connected to the Impella console and support was initiated. 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. The device received 510(k) clearance from the Food and Drug Administration in June 2008 for providing up to 6 hours of partial circulatory support. : Complete hemodynamic profiling with pulmonary artery catheters in, 6. Impella heart pumps have been tested under simulated conditions of inflow and outflow obstruction. The second lumen of the Impella 2.5 is flushed with heparinized saline (500 mL normal saline with 1000 units heparin) by using regular (not infusion pump) intravenous tubing. 6, 7 However, the device may migrate out of . POTENTIAL ADVERSE EVENTS 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. The IABP decreases after-load, decreases myocardial oxygen consumption, increases coronary artery perfusion, and modestly enhances cardiac output.1,2 The IABP cannot provide total circulatory support. The catheter depth is defined as the distance from the aortic annulus to the ventricular end of the cannula (Figure 4). In our facility, we often use transthoracic echocardiography to aid in the assessment of our patients. government site. Assign a point person who can oversee and coordinate the program. 0000009855 00000 n Train a core group of critical care nurses to care for the patient, monitor the device, change tubings, and troubleshoot alarms. The console uses this pressure measurement to calculate the catheters position. The Impella 2.5 device is a blood pump that is placed into your heart through a peripheral artery that will support your circulatory system during your elective or urgent high risk PCI (HRPCI). Diagnostic cardiac catheterization and coronary angiography performed at the referring facility showed severe triple vessel coronary disease and high-grade lesions in 2 SVGs. It should not be used in patients with moderate to severe aortic insufficiency; it may worsen the degree of insufficiency because the aortic valve cannot close completely with the device in place. Because the patient was tolerating the procedure well after this, the physician decided to stent the second diseased SVG. SmartAssist technology on the Impella CP or Impella 5.5 devices can help with this as well. Support was established at P8. If the urine is red, rule out blood in the urine with a simple urinalysis . The cannula appears as two bright echogenic, parallel lines, sometimes referred to as the railroad tracks, which ends at the inlet area. 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. : Simultaneous venoarterial extracorporeal membrane oxygenation and percutaneous left ventricular decompression therapy with, 8. Phone, (800) 899-1712 or (949) 362-2050 (ext 532); fax, (949) 362-2049; e-mail, reprints@aacn.org. One bare metal stent (not a drug eluting stent) was placed in the SVG to the LAD. The Impella device can be withdrawn, leaving the arterial sheath in place. The patient was rapidly weaned from the Impella, which was removed in the catheterization laboratory. 2022 Jan;19(1):1-10. doi: 10.1080/17434440.2022.2015323. Coordination with the perfusionist is essential when patients are being placed on cardiopulmonary bypass. The total duration of Impella support was slightly less than 2 hours. Catheter position should be assessed daily and in response to unexpected clinical changes or specific device alarms. The typical infusion rate for the purge fluid is 7 to 20 mL/h. 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. Before Note: consider the diagnosis of normotensive cardiogenic shock when normal BP but rising lactate and transaminitis. P2 is the lowest performance level that can be used while the distal end of the Impella 2.5 is in the left ventricle. She had no further chest pain during her hospitalization and was discharged home in stable condition 3 days later. b)x""o0``k1h^xyW Mechanical Circulatory Support for Acute Heart Failure Complicated by Cardiogenic Shock. 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). Our facility has a high-volume interventional cardiology program as well as a busy adult and pediatric cardiovascular surgery service. PMC 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. Hemolysis, as measured by the plasma level of free hemoglobin, was higher in patients treated with the Impella. Szymanski TW, Weeks PA, Lee Y, et al. 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. Some patients on Impella support may be intubated and receiving mechanical ventilation. If the patients ventricular function is very poor, a positioning alarm can occur. The Impella coordinator is present for implants to assist the catheterization laboratory staff as needed. 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 necessary images may be particularly difficult to obtain if the Impella device is medially or laterally oriented. Single Access Technique. 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. E-mail: [emailprotected]; Twitter: @AlexPapolos. Shearing of red blood cells is a common and clinically relevant problem with the Impella catheter. Patients in cardiogenic shock supported by venoarterial extracorporeal membrane oxygenation (VA-ECMO) often require an LV unloading strategy to prevent the development of pulmonary edema, thrombus formation in the LV, and reduce LV wall stress.6 The concurrent use of VA-ECMO with the Impella catheter as an unloading strategy (ECPELLA) has become a popular MCS configuration associated with improved cardiogenic shock outcomes over VA-ECMO alone.7 The management of the Impella catheter while in the ECPELLA configuration is no different than described elsewhere in this review. 0000001527 00000 n All patients with this device are observed by this clinical nurse specialist during their hospital stay. When the heart displays a question mark over it with the words "Impella Position Wrong": 1. controller can't determine catheter position. Fluoroscopic guidance in the catheterization laboratory or operating room is required. 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. 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. Crit Care Med. We have gained much knowledge since implementing our Impella program in April 2008. 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. 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. 2022 Feb 28;19(2):115-124. doi: 10.11909/j.issn.1671-5411.2022.02.003. The site is secure. Read below to find out how long a swollen uvula lasts and how to get treatment. His estimated ejection fraction was markedly decreased at 20% (normal, 55%70%) on a recent echocardiogram. 0000000016 00000 n The smaller diameter Impella 2.5 and CP are typically inserted percutaneously under fluoroscopic guidance in the cardiac catheterization laboratory; however, transesophageal echocardiography (TEE) guided placement is also possible.1 The larger diameter Impella 5.0 and 5.5 are typically inserted by surgical cutdown via a prosthetic graft sewn onto the subclavian artery and are positioned under fluoroscopy or by TEE. By continuing to use our website, you are agreeing to our, http://bmctoday.net/citoday/2009/09/supplement/article.asp?f=0909_supp_01.php, https://doi.org/10.1016/j.ijcard.2009.08.003, Potential Complications of Impella Therapy, Nursing Care of Patients With an Impella 2.5 for Circulatory Support, Copyright 2023 American Association of Critical-Care Nurses. 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. 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. The impellar blades of the motor could break up the thrombi, causing arterial embolization. With the physician at the bedside, transthoracic echocardiography is performed and the pumps performance level is decreased. 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. Crowley J, Cronin B, Essandoh M, DAlessandro D, Shelton K, Dalia AA: Transesophageal echocardiography for, 2. While the inability to provide anticoagulation is a contraindication, there is ongoing research into nonanticoagulant purge solution alternatives. One community hospitals approach to establishing a multidisciplinary program for use of the Impella 2.5 is described. To purchase electronic or print reprints, contact The InnoVision Group, 101 Columbia, Aliso Viejo, CA 92656. Weaning from the partial circulatory support provided by the Impella 2.5 can be approached in different ways. 0000002856 00000 n When the Quick Set-Up is used, the 10% to 20% dextrose solution used to purge the motor is not heparinized. The https:// ensures that you are connecting to the Serum level of lactate was lower in patients treated with the Impella. 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 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. A high purge pressure alarm indicates that the purge pressure is greater than 700 mm Hg and generally indicates a kink in the tubing or catheter. It is not uncommon that some patients with severe cardiac dysfunction do not readily demonstrate the ability to wean from the Impella. Two patients had transient hemolysis that was not clinically significant. He declined repeat bypass surgery. 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. The Impella 2.5 instructions for use recommend a 40-minute manual hold to achieve hemostasis at the arterial access site. If the Impella remains in place for continued support after the PCI, the tubing system is changed to 2 separate systems. Our practice of monitoring and managing RV function relies heavily on invasive hemodynamics and ultrasound imaging. The ISAR-SHOCK trial was done to evaluate the safety and efficacy of the Impella 2.5 versus the IAPB in patients with cardiogenic shock due to acute myocardial infarction.5 Patients were randomized to support from an IABP (n=13) or an Impella (n=12). The heparinized saline is placed in a pressure bag that is inflated to 300 mm Hg. The proximal port of this lumen is red. Once perfusion goals are met and proven to be stable at power level P2, the Impella catheter should be removed. Wolters Kluwer Health Free shipping for many products! 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. 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. Hemodynamically, we typically titrate fluid balance goals and inotropes to target a right atrial pressure of 812 mm Hg and a pulmonary artery pulsatility index >1. 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. Regular documentation is essential, and review of trends is useful when troubleshooting. Rolling cart carrying components required to run the Impella 2.5. 0000006172 00000 n Rao P, Khalpey Z, Smith R, Burkhoff D, Kociol RD: Venoarterial extracorporeal membrane oxygenation for, 7. A tubing system called the Quick Set-Up has been developed for use in the catheterization laboratory. The motor current will be flattened. Percutaneous mechanical support devices are placed in a minimally invasive manner and provide life-saving assistance. Garan AR, Kanwar M, Thayer KL, et al. The left main lesion was crossed, and one stent was deployed at the lesion. 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. Like all LV assist devices, the Impella can only pump as much blood as is available to it. Our training for staff from the catheterization laboratory consisted of a 3-hour session with didactic and hands-on training. A 74-year-old man was transferred to our facility after sustaining a nonST-segment elevation myocardial infarction. The Suction alarm is triggered when sudden decreases in the placement signal pressure occur in association with lower than expected flows. In our facility, we have a trained CICU nurse managing the Impella while the patient is in the cardiovascular operating room. The device may cause calcium to break off of the aortic valve and embolize, causing stroke.
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