In some facilities, the perfusionist manages both the cardiopulmonary bypass and the Impella. 597 0 obj <> endobj xref 0000005740 00000 n Methods Cardiogenic shock was induced by injecting microspheres in the left main coronary artery in 18 adult Danish Landrace pigs. The trials primary end point of hemodynamic improvement was defined as improved cardiac index at 30 minutes after implantation. The site is secure. The console can run on a fully charged battery for up to 1 hour. 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. Learn more about how the FDA-approved Impella, the world's smallest heart pump, is safe, effective and supports your heart during a procedure. and transmitted securely. Salmonella is a bacteria that can cause salmonellosis (non-typhoidal Salmonella enteritis), a common foodborne infection that causes watery diarrhea, fever, and abdominal cramps. a1 The placement signal will show depressed cardiac function, evidenced by a damped appearing waveform. The .gov means its official. The following 3 case studies demonstrate the successful use of Impella 2.5 support during high-risk PCIs at our facility. The total duration of Impella support was slightly less than 2 hours. Our training for staff from the catheterization laboratory consisted of a 3-hour session with didactic and hands-on training. The performance level should be decreased to P2 and the physician should be notified to reposition the device by pulling it back slightly to obtain an aortic waveform. Information about the alarm can be seen on the console screen. Keywords: In our case, the Impella had already been confirmed to be in the appropriate position. Visit 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. 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). We have also placed the Impella 5.0 in 3 patients. ). 2017 Nov;45(11):1922-1929. doi: 10.1097/CCM.0000000000002676. The Impella TM is a percutaneous, microaxial pump that continuously draws blood from its inlet inside the ventricle and expels it in the ascending aorta (Central Illustration) (12-15).Owing its properties, the Impella TM unloads the left ventricle (LV) while simultaneously augmenting cardiac output (CO). 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. 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. Introduction: If hemolysis is suspected, Jess offers the following troubleshooting tips: Address and correct any active position or suction alarms to help prevent hemolysis. Image courtesy ABIOMED Inc, Danvers, Massachusetts. Complications associated with mechanical circulatory support. Abiomed provides strong clinical support as well as excellent print and Web-based educational materials. Ten different performance levels ranging from P0 to P9 are available (Table 5). 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). If the patients ventricular function is very poor, a positioning alarm can occur. The Impella RP can be used in tandem with a left-sided Impella device. Context 1. . A 74-year-old man was transferred to our facility after sustaining a nonST-segment elevation myocardial infarction. 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.). BX ct6J*0-ni0i6,,&%5y *P 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 Accurate Impella placement is essential during all phases of Impella support but it is particularly important for long term support. When hemolysis occurs, hemoglobin level and hematocrit decrease, haptoglobin level decreases, and plasma levels of free hemoglobin increase. 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. The Suction alarm is triggered when sudden decreases in the placement signal pressure occur in association with lower than expected flows. Sheaths were placed in the right femoral vein, the right femoral artery, and the left femoral artery. There is currently no consensus on best practice regarding its use in these two distinct indications. Bookshelf Despite these changes, her blood pressure and cardiac rhythm remained stable. When the heart displays a question mark over it with the words "Impella Position Wrong": 1. controller can't determine catheter position. IABP therapy has been in use since the late 1960s and has been widely used in clinical practice since that time. H\n0E Some facilities may use what is referred to as a preclose method while the patient is still in the catheterization laboratory; that technique uses 2 8F Perclose suture-mediated closure devices (Abbott Laboratories, Abbott Park, Illinois). To purchase electronic or print reprints, contact The InnoVision Group, 101 Columbia, Aliso Viejo, CA 92656. If the patient tolerates this slow weaning by remaining hemodynamically stable while at P2, the device is then removed. 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. (Figure 3F). The structural design of each of these LV support catheters is grossly similar (Figure 2). 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.). Heparin 9000 units was administered intravenously for anticoagulation, and the Impella 2.5 was advanced into position in the left femoral artery. P9 can be activated only for 5-minute intervals when the Impella 2.5 is in use. Please enable it to take advantage of the complete set of features! 597 17 Usefulness of Impella support in different clinical settings in 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. The 13F arterial sheath was sutured in placed for removal 2 hours later, after the patient had returned to the CICU. 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. 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. Conversely, lack of expected pulsatility in the placement signal and/or in the motor current signal may reflect a problem. doi: https://doi.org/10.4037/ccn2011293. None of the patients had hemodynamic instability develop during the procedure. FOIA Notably, catheter position is best assessed ultrasonographically, as radiography does not accurately identify the cannula position relative to cardiac anatomic structures. He declined repeat bypass surgery. Impella heart pumps have been tested under simulated conditions of inflow and outflow obstruction. Expert commentary: The necessary images may be particularly difficult to obtain if the Impella device is medially or laterally oriented. Suction events may be caused by inadequate LV filling or incorrect Impella positioning with inlet area obstruction by a cardiac structure. 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. Indications 1. On arrival, his blood pressure was 105/66 mm Hg with a heart rate of 64/min. If the Impella remains in place for continued support after the PCI, the tubing system is changed to 2 separate systems. The entire LV placement signal waveform shifts downward. 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. 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. Expert Rev Med Devices. This should prompt urgent ultrasound assessment as the device may need to be either retracted or advanced. 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. It is used for high-risk percutaneous coronary intervention and CS. 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. 0000003312 00000 n This arrangement allowed ample time for setting up the console and infusion pump before the Impella was placed. To date, we have placed an Impella 2.5 in about 40 patients. Coordination with the perfusionist is essential when patients are being placed on cardiopulmonary bypass. MeSH In these illustrations, the Impella Catheter is positioned correctly. 3. placement monitoring is suspended or disabled. The arterial access site must be assessed regularly for bleeding and development of a hematoma. Expert Rev Cardiovasc Ther. Int J Heart Fail. Papolos, Alexander I. 29. 0000009855 00000 n The performance level should be reduced to P2 and the physician should be notified of the need to reposition the Impella. - Signs of liver failure - Elevated pulmonary pressures - If a patient is exhibiting signs of right heart failure, assess the need for biventricular support Best echocardiographic views for positioning the Impella Catheter in the left ventricle - Long axis for transesophageal echocardiography (TEE) Device failure, although not often reported, can occur. Before Submitted for consideration June 2021; accepted for publication in revised form December 2021. Correspondence: Alexander Papolos, MD, Departments of Cardiology and Critical Care, MedStar Washington Hospital Center, 110 Irving St., NW, Rm A127, Washington, DC, 20010. HHS Vulnerability Disclosure, Help Additionally, patients are observed by the VAD coordinator. %PDF-1.4 % 0000004122 00000 n Cardiogenic shock (CS) is a life-threatening condition associated with significant morbidity and mortality. 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 . She returned to the catheterization laboratory 3 days later for high-risk PCI of the left main coronary artery. You may search for similar articles that contain these same keywords or you may Reed BN, DiDomenico RJ, Allender JE, et al. The device also cannot be used in patients with severe peripheral arterial disease because of the large sheath size required for its placement, nor can it be used in patients who cannot tolerate anticoagulation with heparin. Some error has occurred while processing your request. Percutaneous Mechanical Circulatory Support Devices for High-Risk Percutaneous Coronary Intervention. Immediately before removal of the device, decrease the performance level to P0. If the hemolysis is severe, hemoglobinuria will be seen; if the hemolysis is sustained, acute kidney injury will occur. 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. It is a single tubing system that bifurcates and connects to each port of the catheter. Catheter position should be assessed daily and in response to unexpected clinical changes or specific device alarms. 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. At first, an effort should be made to identify and treat these conditions (Fig. The Impella 2.5 catheter is placed percutaneously through the common femoral artery and advanced retrograde to the left ventricle over a guidewire. 6, 7 However, the device may migrate out of . sharing sensitive information, make sure youre on a federal Fluoroscopic guidance in the catheterization laboratory or operating room is required. doi: 10.1371/journal.pone.0247667. (NOTE: While the illustrations in this document depict the Impella 2.5 Catheter, the information presented also applies to the Impella 5.0 Catheter and Impella LD Catheter.) 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.
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