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. 0000003312 00000 n Unauthorized use of these marks is strictly prohibited. The most common include suction, low purge pressure, and high purge pressure alarms. 0000004020 00000 n H\n0E 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. A 63-year-old woman was admitted to our facility with an acute anteroseptal myocardial infarction. Please try again soon. 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. Impella 2.5 cardiac assist device in left ventricle. The necessary images may be particularly difficult to obtain if the Impella device is medially or laterally oriented. trailer <<4E9C4E69F2794E779C95DF45DA44CC4E>]/Prev 560917/XRefStm 1133>> startxref 0 %%EOF 613 0 obj <>stream There is currently no consensus on best practice regarding its use in these two distinct indications. 0000006172 00000 n Following this trial, the Impella 2.5 device received its 510(k) approval from the Food and Drug Administration. 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 patient was brought to the catheterization laboratory and prepared for the procedure. Abiomed also provides assistance with troubleshooting via 24-hour-a-day, 7-day-a-week telephone support. Rotation can often be difficult and applying more than a full 360 degrees of torque is often necessary. Develop a nursing protocol that outlines key strategies in patient management and a specific flow sheet (Figure 10) for documentation. She was treated with fibrinolytic therapy but continued to have chest pain. For rapid weaning, the performance level is decreased by 1 or 2 levels every 5 to 15 minutes until the pump is set at P2. 2. position is wrong. PMC As the performance level increases, the flow rate and number of revolutions per minute increase. 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. b)x""o0``k1h^xyW Image courtesy ABIOMED Inc, Danvers, Massachusetts. The hemodynamic effects of the Impella catheter are to improve systemic perfusion and provide ventricular unloading in the setting of high-risk percutaneous coronary intervention and in the treatment of cardiogenic shock. Some patients on Impella support may be intubated and receiving mechanical ventilation. The Impella RP is a right ventricular (RV) support system that is percutaneously positioned in the pulmonary artery via the femoral vein under fluoroscopy. Data is temporarily unavailable. This site needs JavaScript to work properly. Intravascular ultrasound was performed to confirm optimal stent placement. 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. Your message has been successfully sent to your colleague. The cannula portion of the catheter is built with a 30 bend (except for the Impella LD, which has a straight design). 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. 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. The patient with an Impella 2.5 is at risk of limb ischemia because of the large size of the device. He was evaluated by our cardiothoracic surgery team and was deemed an extremely poor candidate for surgery. The placement monitoring diagram will continuously scroll through 3 different images because it is not able to differentiate the position of the catheter. The total duration of Impella support was slightly less than 2 hours. Depending on the type of your infection . 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 TM Device. 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. 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. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). The catheter is not tethered to any internal structure and is prone to migration which occurs more frequently when the catheter is placed percutaneously. Abiomed provides strong clinical support as well as excellent print and Web-based educational materials. If the urine is red, rule out blood in the urine with a simple urinalysis . 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. She had no further chest pain during her hospitalization and was discharged home in stable condition 3 days later. The size and function of the left and right ventricles as well as interventricular septal position should also be assessed, as low flow and suction alarms can be caused by over-decompression of the LV, RV failure, and/or obstructive physiology. 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.). Ann Transl Med. In our experience, hemolysis (45%), device-related ventricular tachycardia (18%), and limb ischemia (16%) were the most common complications, and Impella repositioning was required in 26% of cases (Table 1.). 2 main types of pumps currently used: : Simultaneous venoarterial extracorporeal membrane oxygenation and percutaneous left ventricular decompression therapy with, 8. Infusion of purge solution alone infrequently results in the desired therapeutic systemic anticoagulation and an additional infusion of parenteral heparin is often required. 0000005131 00000 n 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. 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. The https:// ensures that you are connecting to the SmartAssist technology on the Impella CP or Impella 5.5 devices can help with this as well. Curr Cardiol Rep. 2018 Jan 19;20(1):2. doi: 10.1007/s11886-018-0946-2. Cardiogenic shock; Impella; Mechanical support devices; intra-aortic balloon pump; mechanical circulatory support; percutaneous ventricular assist device. This should prompt urgent ultrasound assessment as the device may need to be either retracted or advanced. bXSG. 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. Function keys that are used with the Impella 2.5 include the P-PERF, MENU, SIGNAL, SCALE, and the ON keys. Unable to load your collection due to an error, Unable to load your delegates due to an error. Sheaths were placed in the right femoral vein, the right femoral artery, and the left femoral artery. 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. 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 . 597 0 obj <> endobj xref We have extensive experience with the IABP and with surgically placed VADs, including the Abiomed AB5000, Thoratec CentriMag, XVE, and HeartMate II. Low purge pressures require immediate intervention by a critical care nurse. When hemolysis occurs, hemoglobin level and hematocrit decrease, haptoglobin level decreases, and plasma levels of free hemoglobin increase. 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 patient was rapidly weaned from the Impella, which was removed in the catheterization laboratory. A patient experiencing continuous suction may show systolic LV numbers, shown in white, that are uncoupled from the aortic numbers shown in red. Impella has been proven to be safe and may be superior to other mechanical support devices in CS. Accessibility Areas covered: E-mail: [emailprotected]; Twitter: @AlexPapolos. 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. Clipboard, Search History, and several other advanced features are temporarily unavailable. Pahuja M, Hernandez-Montfort J, Whitehead EH, Kawabori M, Kapur NK. Please try after some time. 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 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). 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). None of the patients had hemodynamic instability develop during the procedure. Szymanski TW, Weeks PA, Lee Y, et al. 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. The .gov means its official. The aortic valve symbols will not be seen on the placement monitoring diagram. 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. 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. If you have a swollen uvula, you may also be experiencing a sore throat, trouble swallowing, and maybe even a fever. A fluid challenge test can be useful in difficult cases. Device-related complications occur more frequently with a longer duration of support. He had a history of coronary artery bypass grafting surgery several years prior as well as heart failure. 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. Patients who have had the device in longer or who were in unstable condition during the procedure may benefit from a slower weaning process. 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. We have also placed the Impella 5.0 in 3 patients. A 71-year-old man was referred to our facility for saphenous vein bypass graft (SVG), a high-risk PCI. For continued use, the purge fluid is heparinized (50 units heparin per milliliter of fluid) and infused via an integrated infusion pump, the Braun Vista infusion pump (Figure 5). 1. To purchase electronic or print reprints, contact The InnoVision Group, 101 Columbia, Aliso Viejo, CA 92656. Console and infusion pump setup requires 2 to 3 minutes to complete. Introduction: She returned to the catheterization laboratory 3 days later for high-risk PCI of the left main coronary artery. On arrival, his blood pressure was 151/88 mm Hg with a heart rate of 66/min. Train a core group of critical care nurses to care for the patient, monitor the device, change tubings, and troubleshoot alarms. It is not uncommon that some patients with severe cardiac dysfunction do not readily demonstrate the ability to wean from the Impella. If the Impella remains in place for continued support after the PCI, the tubing system is changed to 2 separate systems. A 74-year-old man was transferred to our facility after sustaining a nonST-segment elevation myocardial infarction. Because the patient was tolerating the procedure well after this, the physician decided to stent the second diseased SVG. Correspondence: Alexander Papolos, MD, Departments of Cardiology and Critical Care, MedStar Washington Hospital Center, 110 Irving St., NW, Rm A127, Washington, DC, 20010. LV Aortic valve Mitral valve Impella 2.5 outlet area Impella 2.5 . In our case, the Impella had already been confirmed to be in the appropriate position. 6, 7 However, the device may migrate out of . 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. Shearing of red blood cells is a common and clinically relevant problem with the Impella catheter. 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 trials primary end point of hemodynamic improvement was defined as improved cardiac index at 30 minutes after implantation. 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. Rao P, Khalpey Z, Smith R, Burkhoff D, Kociol RD: Venoarterial extracorporeal membrane oxygenation for, 7. BX ct6J*0-ni0i6,,&%5y *P Slow weaning is accomplished by decreasing the performance level by 1 or 2 levels every 2 or 3 hours. 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). 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. In Europe, the Impella 2.5 is approved for use up to 5 days. The Impella controller will alarm when it determines that the device may be mispositioned or dysfunctional. ). The VAD coordinators also provide valuable assistance. The catheter is then pulled back from the left ventricle into the ascending aorta and then completely withdrawn. The patients vital signs and cardiac rhythm remained stable throughout the procedure. Our practice of monitoring and managing RV function relies heavily on invasive hemodynamics and ultrasound imaging. 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. 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. Correct placement across the aortic valve is critical to avoid complications including hemolysis, suction episodes and inadequate hemodynamic support. He was discharged home 2 days later. Please enable scripts and reload this page. He declined repeat bypass surgery. With the physician at the bedside, transthoracic echocardiography is performed and the pumps performance level is decreased.
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