Heparin 7000 units was administered intravenously for anticoagulation. He had a long history of diabetes and had undergone coronary artery bypass surgery 20 years prior. Additional torque can be achieved by rotating the red Impella plug (Figure 5) at the proximal end of the catheter in the desired direction. PDF Patient Information for the Impella 2 - Food and Drug Administration 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. 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. Xbao}*"&st V4qZz Medicine (Baltimore). The cannula portion of the catheter is built with a 30 bend (except for the Impella LD, which has a straight design). ?(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 He returned to the catheterization laboratory the next day for coronary intervention. Cardiogenic shock; Impella; Mechanical support devices; intra-aortic balloon pump; mechanical circulatory support; percutaneous ventricular assist device. a1 The patient with an Impella 2.5 is at risk of limb ischemia because of the large size of the device. Fluoroscopic guidance in the catheterization laboratory or operating room is required. 6, 7 However, the device may migrate out of . 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.). In our facility, physicians who can place this device are those who have interventional cardiology and/or cardiac surgery privileges. The Impella device can be withdrawn, leaving the arterial sheath in place. Include the cardiovascular surgery staff and perfusion staff in the initial training. With the physician at the bedside, transthoracic echocardiography is performed and the pumps performance level is decreased. The VAD coordinators also provide valuable assistance. It cannot be used in patients with documented left ventricular thrombus. 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). With respect to weaning order of operations, we generally favor first weaning and decannulation from VA-ECMO (if possible from a pulmonary support perspective), which is based on the higher MCS complication rates and patient immobility associated with VA-ECMO cannulation. 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 placement monitoring diagram will continuously scroll through 3 different images because it is not able to differentiate the position of the catheter. 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). Please enable scripts and reload this page. 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. 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. Bookshelf The purpose of this review is to describe how to manage, reposition, and wean patients from the Impella catheter. : Simultaneous venoarterial extracorporeal membrane oxygenation and percutaneous left ventricular decompression therapy with, 8. *, *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. MeSH Consider when SBP <90 mmHg sustained for >30 min (or vasopressors required) AND clinical or objective signs of tissue hypoperfusion (see below). We have gained much knowledge since implementing our Impella program in April 2008. 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. In some facilities, the perfusionist manages both the cardiopulmonary bypass and the Impella. 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. 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. 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 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. 1. Cardiogenic shock was defined as a (1) systolic blood pressure 90 mm Hg or need for inotropes or vasopressors to maintain systolic blood pressures 90 mm Hg, (2) signs of peripheral hypoperfusion, and (3) cardiac index <2.2 L/min/m 2 and pulmonary capillary wedge pressure 15 mm Hg. Console and infusion pump setup requires 2 to 3 minutes to complete. The patients diastolic pressure increased significantly more with Impella support than with IABP support (P=.002). She was treated with fibrinolytic therapy but continued to have chest pain. 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. The PROTECT I study was done to assess the safety and efficacy of device placement in patients undergoing high-risk PCI.10 Twenty patients were enrolled in that prospective, multicenter study. 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. 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. Support was established at P8. 2017 Oct;14(10):789-804. doi: 10.1080/17434440.2017.1374849. Reed BN, DiDomenico RJ, Allender JE, et al. 0000005131 00000 n A console simulator is available that can be used to practice troubleshooting. 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. 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). to maintaining your privacy and will not share your personal information without The catheter is not tethered to any internal structure and is prone to migration which occurs more frequently when the catheter is placed percutaneously. Patel SM, Lipinski J, Al-Kindi SG, et al. 2020 Jul;8(13):835. doi: 10.21037/atm.2020.03.152. 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). On arrival, his blood pressure was 105/66 mm Hg with a heart rate of 64/min. E-mail: [emailprotected]; Twitter: @AlexPapolos. She had a history of hypertension complicated by end-stage renal disease and was receiving dialysis treatments 3 times per week. 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. Pump flow setting and assessment of unloading in clinical practice The performance level should be reduced to P2 and the physician should be notified of the need to reposition the Impella. Diagnostic cardiac catheterization and coronary angiography performed at the referring facility showed severe triple vessel coronary disease and high-grade lesions in 2 SVGs. Transthoracic echocardiography should be used to visualize the device. A low purge pressure alarm indicates that the purge pressure to the Impella motor has decreased below 300 mm Hg. b)x""o0``k1h^xyW Methods Cardiogenic shock was induced by injecting microspheres in the left main coronary artery in 18 adult Danish Landrace pigs. Device-related complications occur more frequently with a longer duration of support. The sheath can then be removed later when the patients activated clotting time or partial thromboplastin time has returned to near normal levels. The catheter device was connected to the Impella console and support was initiated. ). Hemolysis can be mechanically induced when red blood cells are damaged as they pass through the microaxial pump. LV Aortic valve Mitral valve Impella 2.5 outlet area Impella 2.5 . The left main lesion was crossed, and one stent was deployed at the lesion. Before Percutaneous Mechanical Circulatory Support Devices for High-Risk Percutaneous Coronary Intervention. doi: 10.1097/MD.0000000000025159. 2021 Feb;19(2):151-164. doi: 10.1080/14779072.2021.1863147. Limit the physicians who can place and manage the device and have them proctor one another. 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. Potential complications include bleeding, limb ischemia, hemolysis, and infection. The device was successfully placed in all patients, and the duration of support ranged from 0.4 to 2.5 hours. The Suction alarm is triggered when sudden decreases in the placement signal pressure occur in association with lower than expected flows. doi: 10.1371/journal.pone.0247667. Inotropic agents, such as dobutamine and milrinone, and vasopressors, such as dopamine and norepinephrine, may still be needed after the Impella 2.5 is placed to maintain a cardiac index of at least 2 and systolic blood pressure at 90 mm Hg or higher. Note: consider the diagnosis of normotensive cardiogenic shock when normal BP but rising lactate and transaminitis. Advanced Percutaneous Mechanical Circulatory Support Devices for Cardiogenic Shock. The arterial access site must be assessed regularly for bleeding and development of a hematoma. As the Impella RP is not widely used, this review will focus only on the left-sided catheters; however, many of the concepts discussed are transitive. There is currently no consensus on best practice regarding its use in these two distinct indications. There are currently five Impella catheters that provide left ventricular (LV) support (Figure 1). After advancement, always remove any slack by slowly pulling back on the catheter until cannula movement is observed. After a family conference that included the patient, the decision was made to proceed with high-risk PCI of the LIMA graft, using the Impella 2.5 for hemodynamic support during the procedure. 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). The necessary images may be particularly difficult to obtain if the Impella device is medially or laterally oriented. Bivalirudin was administered for anticoagulation, and the Impella 2.5 was advanced into position in the left femoral artery. Crowley J, Cronin B, Essandoh M, DAlessandro D, Shelton K, Dalia AA: Transesophageal echocardiography for, 2. 0000004641 00000 n The performance level was increased from P0 to a maximum of P8 in a matter of minutes. We have also placed the Impella 5.0 in 3 patients. This arrangement allowed ample time for setting up the console and infusion pump before the Impella was placed. 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. The motor current will be flattened. A tubing system called the Quick Set-Up has been developed for use in the catheterization laboratory. 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. When hemolysis occurs, hemoglobin level and hematocrit decrease, haptoglobin level decreases, and plasma levels of free hemoglobin increase. SyBbhD&,V}R#Ohov]F}9v_c- 0000001527 00000 n Explore Impella Technology - Abiomed Impella use in real-world cardiogenic shock patients: Sobering outcomes. Some were designed to support future versions of Impella catheters. Wolters Kluwer Health The optimal depth for the Impella 2.5, CP, 5.0, and LD is 3 cm to the beginning of the inlet area, and readjustment should be considered if the depth is more than 0.5 cm from this target. The physician can evaluate left ventricular size and function and can quickly assess how well the patient tolerates decreases in the performance level. Conductance catheters were . Grandchild On Board Car Sign, Suction Cup Baby On Board Sign in - eBay The structural design of each of these LV support catheters is grossly similar (Figure 2). Percutaneous repositioning of Impella RP: the Snare-Manoeuvre-Prolapse 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. If a significant color Doppler signal is observed below the valve (in the absence of significant aortic regurgitation), the device is likely too deep. Notably, catheter position is best assessed ultrasonographically, as radiography does not accurately identify the cannula position relative to cardiac anatomic structures. It is used for high-risk percutaneous coronary intervention and CS. 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. Arterial repair is done at that time, and the incision is covered with a sterile dressing. Int J Heart Fail. An enlarged uvula is often caused by infection, an allergic reaction, or irritation from chemicals or medical procedures. Additionally, patients are observed by the VAD coordinator. 0000001324 00000 n 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. Standard therapeutic anticoagulation targets are; an activated clotting time of 160180 sec, a heparin antifactor Xa of 0.3-0.5, and/or activated partial thromboplastin time of 6090 sec. After the device is properly positioned, it is activated and blood is rapidly withdrawn by the microaxial blood pump from the inlet valve in the left ventricle and moved to the aorta via the outlet area, which sits above the aortic valve in the aorta (Figure 8). The most common include suction, low purge pressure, and high purge pressure alarms. Suction events are mostly due to abnormal device position or insufficient preload. Search for Similar Articles 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. In our facility, we have a trained CICU nurse managing the Impella while the patient is in the cardiovascular operating room. FACT SHEET FOR HEALTHCARE PROVIDERS - Food and Drug Administration PMC Papolos, Alexander I. The placement signal will show depressed cardiac function, evidenced by a damped appearing waveform. 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. Potential complications of use of the Impella 2.5 are detailed in Table 3. Our practice of monitoring and managing RV function relies heavily on invasive hemodynamics and ultrasound imaging.