Abiomed has sponsored several of these trials, including PROTECT I, PROTECT II, RECOVER I, RECOVER II, and ISAR-SHOCK. a1 She was transferred to the CICU and supportive medical therapy was initiated. 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. 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 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). 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. your express consent. The necessary images may be particularly difficult to obtain if the Impella device is medially or laterally oriented. More blood products were administered to patients treated with the Impella. As the performance level increases, the flow rate and number of revolutions per minute increase. Hemolysis can be mechanically induced when red blood cells are damaged as they pass through the microaxial pump. 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. Your message has been successfully sent to your colleague. 2020 Jan 22;2(1):23-44. doi: 10.36628/ijhf.2019.0015. At P8, the flow was 2.5 L/min and the patients cardiac index was 2.58 (normal, 2.54). 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. As the patient goes on cardiopulmonary bypass, the performance level of the Impella must be decreased. Brenda McCulloch is a member of the Abiomed Administrative Advisory Board. Six weeks later, the patient was pain free with no complaints of dyspnea. In order for the interrogator to connect with the permanent pacemaker or implantable cardioverter defibrillator, the Impella console must be turned off for a few seconds while the signal is established. He was evaluated by our cardiothoracic surgery team and was deemed an extremely poor candidate for surgery. At the end of rapid weaning, the Impella device can then be removed as described in the next section. 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. Arterial repair is done at that time, and the incision is covered with a sterile dressing. The purpose of this review is to comprehensively describe our strategy for managing, repositioning, and weaning the Impella catheter. Jo Kajewski, Advanced Impella Trainer, gives an in-depth look at managing Impella positioning using imaging. 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. 4, 5 Right ventricular failure occurs in 25% of patients after left ventricular assist device insertion, thus the advent of Impella RP. 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. 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. 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. All had poor ventricular function (ejection fraction =35%) and had PCI on an unprotected left main coronary artery or the last remaining patent coronary artery or graft. A multidisciplinary approach to establishing a program for the Impella is useful in ensuring competency and good outcomes for patients. Patients with an Impella may go to the cardiovascular operating room for bypass surgery or valve repair/replacement. The patient was weaned from the Impella device, the device was removed in the catheterization laboratory, and the venous and arterial sheaths were secured in place. If a significant color Doppler signal is observed below the valve (in the absence of significant aortic regurgitation), the device is likely too deep. to maintaining your privacy and will not share your personal information without 2017 Nov;45(11):1922-1929. doi: 10.1097/CCM.0000000000002676. : Simultaneous venoarterial extracorporeal membrane oxygenation and percutaneous left ventricular decompression therapy with, 8. 1. 6, 7 However, the device may migrate out of . The Impella console powers the microaxial blood pump and monitors the functioning of the device, including the purge pressure and several other parameters. MeSH 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. Conductance catheters were . Unauthorized use of these marks is strictly prohibited. If the patient tolerates this slow weaning by remaining hemodynamically stable while at P2, the device is then removed. P9 can be activated only for 5-minute intervals when the Impella 2.5 is in use. Szymanski TW, Weeks PA, Lee Y, et al. If the patients ventricular function is very poor, a positioning alarm can occur. 0000000016 00000 n 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. At the end of the procedure, she was symptom free, and she was rapidly weaned from the Impella and the device was removed. The patients hemodynamic status is assessed after every decrease in performance level. The total duration of Impella support was slightly less than 2 hours. Federal government websites often end in .gov or .mil. Catheters with SmartAssist have an upgraded optical pressure sensor that directly measures aortic pressure and uses changes in motor current to infer an estimated LV pressure waveform. The aortic annulus and the ventricular end of the cannula must be well visualized in a single image to make an accurate measurement. In our facility, we have a trained CICU nurse managing the Impella while the patient is in the cardiovascular operating room. Expert Rev Cardiovasc Ther. As soon as the signal has been established, Impella support is immediately restarted. 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. : Complete hemodynamic profiling with pulmonary artery catheters in, 6. Three sequential stents were placed in the area of disease. The following 3 case studies demonstrate the successful use of Impella 2.5 support during high-risk PCIs at our facility. The Impella MCS system is a relatively new technology that has become widely used for the treatment of cardiogenic shock in medical and surgical cardiac intensive care units. The device was successfully placed in all patients, and the duration of support ranged from 0.4 to 2.5 hours. Conversely, lack of expected pulsatility in the placement signal and/or in the motor current signal may reflect a problem. 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. National Library of Medicine Additionally, patients are observed by the VAD coordinator. It is used for high-risk percutaneous coronary intervention and CS. Before Expert Rev Med Devices. Expert commentary: The placement monitoring diagram will continuously scroll through 3 different images because it is not able to differentiate the position of the catheter. Percutaneous Mechanical Circulatory Support Devices for High-Risk Percutaneous Coronary Intervention. It is not uncommon that some patients with severe cardiac dysfunction do not readily demonstrate the ability to wean from the Impella. 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. IABP therapy has been in use since the late 1960s and has been widely used in clinical practice since that time. 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. He was experiencing progression of his anginal symptoms, and his functional capacity was poor. 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. PMC The patients vital signs and cardiac rhythm remained stable throughout the procedure. Highlight selected keywords in the article text. If the data suggests that the patient is over-supported, the Impella is weaned by one or two power levels. 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. Adequate blood flow was reestablished after the intracoronary administration of 500 g nitroglycerin. Now that youve read the article, create or contribute to an online discussion about this topic using eLetters. 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. If the hemolysis is severe, hemoglobinuria will be seen; if the hemolysis is sustained, acute kidney injury will occur. 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). Patel SM, Lipinski J, Al-Kindi SG, et al. 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. This site needs JavaScript to work properly. 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 use of continuous cardiac output monitoring may be useful for patients with cardiogenic shock. The cannula appears as two bright echogenic, parallel lines, sometimes referred to as the railroad tracks, which ends at the inlet area. Crit Care Med. Patients who undergo high-risk percutaneous coronary intervention (PCI), such as procedures on friable saphenous vein grafts or the left main coronary artery, may have an intra-aortic balloon catheter placed if they require hemodynamic support during the procedure. Hemolysis can occur in patients who are on the Impella 2.5. It is a single tubing system that bifurcates and connects to each port of the catheter. 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. To monitor the severity of hemolysis we recommend daily monitoring of serum creatinine, and plasma-free hemoglobin (PFH) or lactate dehydrogenase (LDH). Introduction: Function keys that are used with the Impella 2.5 include the P-PERF, MENU, SIGNAL, SCALE, and the ON keys. The placement monitoring diagram will show the aortic valve symbols distal to the pump (Figure 9). Develop a nursing protocol that outlines key strategies in patient management and a specific flow sheet (Figure 10) for documentation. Search for Similar Articles Support was established at P8. Improvements in cardiac index were significantly greater in the patients with the Impella than in patients with the IABP (P=.02). ?(x$2pD] 9A =9@w E" endstream endobj 612 0 obj <>/Filter/FlateDecode/Index[62 535]/Length 41/Size 597/Type/XRef/W[1 1 1]>>stream For more information, please refer to our Privacy Policy. Depending on the type of your infection . Note: consider the diagnosis of normotensive cardiogenic shock when normal BP but rising lactate and transaminitis. The use of anticoagulation is required, and bleeding may develop in some patients. 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. 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. Additionally, I share our experiences as we developed our Impella program at our community hospital. 0000006172 00000 n cardiac intensive care unit; cardiogenic shock; Impella; mechanical circulatory support. Infusion of purge solution alone infrequently results in the desired therapeutic systemic anticoagulation and an additional infusion of parenteral heparin is often required. She had a history of hypertension complicated by end-stage renal disease and was receiving dialysis treatments 3 times per week. 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. Image courtesy Sutter Medical Center, Sacramento, California. 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. 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 Patients who have had the device in longer or who were in unstable condition during the procedure may benefit from a slower weaning process. He returned to the catheterization laboratory the next day for coronary intervention. The aortic valve symbols will not be seen on the placement monitoring diagram. Ten different performance levels ranging from P0 to P9 are available (Table 5). The cannula portion of the catheter is built with a 30 bend (except for the Impella LD, which has a straight design). Parameters to assess regularly include placement signal, placement monitoring (pump position), dual signal, purge pressure, motor current, and speed (Table 6). LV Aortic valve Mitral valve Impella 2.5 outlet area Impella 2.5 . 0000001133 00000 n 2021 Feb 26;16(2):e0247667. Catheter position should be assessed daily and in response to unexpected clinical changes or specific device alarms. may email you for journal alerts and information, but is committed There is currently no consensus on best practice regarding its use in these two distinct indications. 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 Rolling cart carrying components required to run the Impella 2.5. The catheter device was connected to the Impella console and support was initiated. 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. A patient experiencing continuous suction may show systolic LV numbers, shown in white, that are uncoupled from the aortic numbers shown in red. It is important to recognize that adjustments from the vascular access site are not necessarily transmitted to the cannula in a 1:1 fashion due to slack and/or torque that may exist or be introduced into the catheter. The Impella 2.5 device is an alternative to an IABP that may be beneficial in some patients who need hemodynamic support. 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). Xbao}*"&st V4qZz The left main lesion was crossed, and one stent was deployed at the lesion. The pharmacy prepares the heparinized 20% glucose purge solution and sends it to the unit before our standard change time of 3 pm daily. 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. The placement signal will display either an aortic pressure waveform (correct position) or ventricular pressure waveform (incorrect position) depending on the position of the fiber-optic sensor. 0000014939 00000 n A low purge pressure alarm indicates that the purge pressure to the Impella motor has decreased below 300 mm Hg. A multi-beat acquisition of the catheter should be obtained while panning through the LV cavity, to avoid catheter foreshortening and consequent incorrect assessment of catheter depth. Please enable scripts and reload this page. 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. 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 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. Areas covered: Image courtesy ABIOMED Inc, Danvers, Massachusetts. The Impella 2.5 should not be used in patients with aortic valve disease or known left ventricular thrombus. 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. H\n0E 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. Some error has occurred while processing your request. Some were designed to support future versions of Impella catheters. She had no further chest pain during her hospitalization and was discharged home in stable condition 3 days later. Assign a point person who can oversee and coordinate the program. 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. 0000004122 00000 n Retract the device until diastolic pressures normalizes. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. Free shipping for many products! Epub 2021 Dec 20. : Anticoagulation of, 4. 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. Currently, the intra-aortic balloon pump (IABP) is the most commonly used device for circulatory support. Regular repositioning of patients and assessment of their skin are necessary to prevent skin breakdown. In cases where transesophageal ultrasound is used for catheter placement or repositioning, the midesophageal long-axis view (120) is the most reliable and accurate to assess catheter depth. Introduction. The Impella controller will alarm when it determines that the device may be mispositioned or dysfunctional. Salmonella is a bacteria that can cause salmonellosis (non-typhoidal Salmonella enteritis), a common foodborne infection that causes watery diarrhea, fever, and abdominal cramps. She returned to the catheterization laboratory 3 days later for high-risk PCI of the left main coronary artery. 29. 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). You may search for similar articles that contain these same keywords or you may The Suction alarm is triggered when sudden decreases in the placement signal pressure occur in association with lower than expected flows. Percutaneous mechanical support devices are placed in a minimally invasive manner and provide life-saving assistance. *, *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. You can get a swollen uvula from infections including the flu, mononucleosis, croup, and strep throat. In our facility, we often use transthoracic echocardiography to aid in the assessment of our patients. Identification of Cardiogenic Shock Heparin 9000 units was administered intravenously for anticoagulation, and the Impella 2.5 was advanced into position in the left femoral artery. Just before the patients return to the CICU, the pulmonary artery pressure decreased to 70/4148 mm Hg and the cardiac index was 2.69. The 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. 2022 Feb 28;19(2):115-124. doi: 10.11909/j.issn.1671-5411.2022.02.003. 0000003312 00000 n Correspondence: Alexander Papolos, MD, Departments of Cardiology and Critical Care, MedStar Washington Hospital Center, 110 Irving St., NW, Rm A127, Washington, DC, 20010. The purpose of this review is to describe how to manage, reposition, and wean patients from the Impella catheter. 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. It is useful in patients undergoing high-risk PCIs. v67z]FcUe7sne[l}g&_}V^7vk~7S/o}AoepY5OTYe>acQ*|o? \-yVJUrM^2E~,d3EN9--u1C~A+ If TTE imaging is difficult, fluoroscopy or TEE can also be used. At first, an effort should be made to identify and treat these conditions (Fig. One patient died before implantation of a device. Bethesda, MD 20894, Web Policies The arterial access site must be assessed regularly for bleeding and development of a hematoma.
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