Clinical Indications of IMPELLA Short-Term Mechanical Circulatory Support in a Tertiary Centre

IntroductionThe Impella family of devices are short-term mechanical circulatory support (MCS) pumps that hold promise in treating patients with acute cardiogenic shock, acting as bridge to recovery, transplant or durable left ventricular assist device. We assessed the clinical utility, indications and outcomes of the Impella family of devices in a tertiary centre.MethodsIn the current study we present our initial 2-year experience with different Impella types. We explored the indications for device implantation, initial hemodynamic and biochemical response and mid-term survival.ResultsA total of 57 patients underwent Impella implantation; 36 Impella CP, 14 Impella 5.0 and 7 Impella RP. Mean age was 54.2 ± 15.2 whereas 78.9% were males. The main indications for left sided MCS included cardiogenic shock secondary to ACS, decompensated dilated or ischemic end stage cardiomyopathy and myocarditis. Mean LVEF pre-Impella implantation was 23 ± 13.7%. PCI was performed in 24 (54.5%) patients. Main indication for Impella RP was RV failure following LVAD implantation.The median duration of support was 5 days (IQR 1 to 10.5 days). 24 h following Impella implantation, there was significant improvement in all hemodynamic parameters as well as renal and liver function. Patients presenting with INTERMACS I had a 30-day survival of 40% whereas patients with INTEMACS 2 or above had a 30-day survival of 82.4%.ConclusionsThe Impella short-term mechanical assist device provides immediate improvement in hemodynamic parameters and end organ function recovery. Patient outcomes are heavily influenced by the stage of shock and the timely insertion of MCS.     

Successful Use of Surgically Placed Impella 5.0 and Central Extracorporeal Membrane Oxygenation Circuit in a Patient with Postcardiotomy Shock

The Impella 5.0, a percutaneously inserted left ventricular assist device, has been used to support patients who have severe heart failure or who are undergoing high-risk percutaneous coronary intervention. We report our surgical placement of the Impella 5.0, through a graft sewn to the aorta, to unload the left ventricle of a 59-year-old man who was undergoing venoarterial extracorporeal membrane oxygenation for postcardiotomy shock. The patient underwent successful placement of a long-term left ventricular assist device before his discharge from the hospital. The versatility of the Impella 5.0 is exemplified in this patient who was successfully bridged to long-term support.     

Biventricular Impella placement via complete venous access

Impella (Abiomed, Danvers, MA) is an effective option for emergent treatment of critical refractory cardiogenic shock. However, in patients who have inadequate peripheral arterial access, Impella for left ventricular support sometimes requires surgical access, leading to disadvantages for emergent procedures or invasiveness for very sick patients. In addition, Impella for right ventricular support was recently reported to contribute to the management of severe biventricular dysfunction. In this report, we describe a case of refractory cardiogenic shock in a patient with inadequate vascular access who was treated with biventricular Impella via venous and caval‐aortic access under conscious sedation. This technique can be used as a bridge to surgical ventricular assist device or heart transplantation. © 2017 Wiley Periodicals, Inc.     

Percutaneous Hemodynamic Support (Impella) in Patients with Advanced Heart Failure and/or Cardiogenic Shock Not Eligible to PROTECT II Trial

PROTECT I and II trials have tested the efficacy of Impella in patents with high-risk percutaneous coronary intervention (PCI). However, patients with severe hemodynamic instability such as cardiac arrest, ST-segment elevated myocardial infarction (STEMI), or cardiogenic shock were excluded. The objective was to investigate the efficacy of Impella in sicker patient population who were not included in PROTECT trials. These patients merit high-risk PCI who had cardiogenic shock and unstable or decompensated heart failure (HF). From December 2010 to March 2012, 10 consecutive patients with extremely high surgical risk and hemodynamic instability underwent urgent PCI with Impella 2.5 support (Abiomed Inc., Danvers, MA). These patients were presented with advance HF and/or cardiogenic shock. Among the 10 included patients, 3 patients were with cardiac arrest and 1 patient was with acute myocardial infarction. All patients had successful Impella implantation and remained hemodynamically stable during high-risk PCI. Among the 10 patients 2 patients (20%) died within 1 month and 1 patient developed limb ischemia. In high-risk population nonrandomizable to PROTECT trials with advance HF/cardiogenic shock, Impella could be an important tool for hemodynamic support to PCI or could be a bridge to left ventricle assist device to achieve good recovery. Larger studies need to be conducted on this high-risk population.     

Initial experience with the Impella left ventricular assist device for postcardiotomy cardiogenic shock and unprotected left coronary artery angioplasty in patients with a low left ventricular ejection fraction

Low-output syndrome is one of the leading causes of death following open-heart surgery or high-risk angioplasty. Ventricular assist devices have been used to treat patients who suffer from postoperative cardiogenic shock despite use of an intraaortic balloon pump and maximum inotropic support. The Impella pump (Impella Cardiosystems AG, Aachen, Germany) is a newly introduced left ventricular assist device that has been shown to reduce infarct size and to accelerate recovery of stunned myocardium. We report our initial experience using the Impella device for the treatment of cardiogenic shock following cardiopulmonary bypass and for maintaining hemodynamic stability in high-surgical-risk patients undergoing unprotected left coronary artery angioplasty.     

Use of Impella Recover 2.5 left ventricular assist device in patients with cardiogenic shock or undergoing high-risk percutaneous coronary intervention procedures: experience of a high-volume center

AIM: Percutaneous coronary interventions are increasingly applied to high-risk patients. The availability of hemodynamic support devices offers a promising option to prevent and treat low-output syndrome in these patients. The aim of this study was to evaluate the feasibility, safety and efficacy of the Impella Recover' LP 2.5 left ventricular assist device in patients with cardiogenic shock or undergoing high-risk percutaneous coronary interventions. METHODS: Eleven patients presenting cardiogenic shock (N=6) or scheduled for high-risk percutaneous revascularization (N=5) were evaluated. The Impella pump was successfully implanted in all patients, except one. When implanted, the device was correctly positioned in the left ventricle and remained in a stable position. RESULTS: Bleedings occurred in 7 patients (5 of them presented cardiogenic shock), while renal failure and severe thrombocytopenia were observed in 4 and 1 patients respectively, all with cardiogenic shock. During high-risk procedures, the Impella pump succeeded in obtaining hemodynamic stability, while in only two patients with cardiogenic shock the device determined a significant improvement of hemodynamic variables. All elective patients and two patients with cardiogenic shock were discharged from the hospital and were still alive at 30-day follow-up. CONCLUSION: These data, although preliminary due to the limited sample size, demonstrated the feasibility, safety and efficacy of the Impella Recover(R) LP 2.5 during high-risk percutaneous procedures, even though the benefits of prophylactic deployment of such a system have to be further investigated. The use of Impella Recover(R) LP 2.5 in patients with cardiogenic shock is feasible and safe, however it maybe insufficient in reversing an advanced cardiogenic shock which, probably, has to be treated with more powerful left ventricular assist devices.     

Use of a Vascular Sheath in the Axillary Artery as an Alternative Access Approach for Placing an Impella 5.0 Device

Many patients who are in cardiogenic shock need mechanical support for clinical stabilization after acute insults such as myocardial infarction. However, the placement of advanced devices can be hindered by anatomic constraints or the physiologic sequelae of shock, as we describe in this report.A 67-year-old woman with prior coronary artery bypass grafting and extensive chest-wall scarring from previous defibrillator implantations presented with myocardial infarction and refractory cardiogenic shock. The patient''s vascular anatomy and prior surgery precluded conventional percutaneous implantation of an Impella 5.0 ventricular support device. We delivered the Impella device through the patient''s tortuous, vasoconstricted axillary artery with use of a vascular sheath and other percutaneous techniques. The success of this approach suggests that combining the expertise of cardiologists and cardiovascular surgeons can improve the outcomes of patients with complex anatomic issues.     

Successful use of the Impella device in giant cell myocarditis as a bridge to permanent left ventricular mechanical support

Idiopathic giant cell myocarditis is a rare condition with a poor prognosis. Patients with giant cell myocarditis typically die of refractory ventricular arrhythmias or progressive congestive heart failure in about 3 months. The benefit of immunosuppressive therapy varies among patients with giant cell myocarditis, and no factors that would predict which patients will respond to therapy have been identified. Mechanical circulatory support devices, from intra-aortic balloon pumps to more permanent systems, have been used for ventricular support in cases of acute heart failure.Herein, we describe a case of giant cell myocarditis in a previously healthy 44-year-old woman who presented with cardiogenic shock. She was supported hemodynamically with the Impella Recover LP 2.5 left ventricular assist device until a permanent device could be surgically implanted. To our knowledge, this is the 1st reported case of the successful use of the Impella device for hemodynamic support in a patient with giant cell myocarditis until more definitive treatment could be instituted.     

Use of Impella Ventricular Assist Device in Patients with Severe Coronary Artery Disease Presenting with Cardiac Arrest

Impella (Abiomed, Danvers, MA) is a percutaneously inserted ventricular assist device (VAD). It has been increasingly used in patients with severe heart failure, cardiogenic shock, and high-risk percutaneous intervention (PCI). However, the use and efficacy of Impella in patients with severe coronary artery disease (CAD) presenting with cardiac arrest has rarely been reported.The objective of this study is to report our center experience in using Impella VAD in CAD patients presenting with cardiac arrest. From December 2010 to March 2011, three patients with severe CAD presented to our center with cardiac arrest underwent PCI with Impella support. We reported three cases of severe CAD presenting with cardiac arrest successfully treated with PCI and Impella support. Our experience demonstrated that Impella VAD may play an adjunctive role in obtaining hemodynamic stability in these high-risk patients undergoing PCI. One of the patients was supported to left VAD implantation, and the other two had excellent neurological and functional recovery. Our reports suggest an important role of Impella in cardiac arrest population. Earlier Impella implantation after cardiac arrest might provide cardiac support and tissue perfusion until recovery or high-risk PCI.     

First Canadian experience with high-risk percutaneous coronary intervention with assistance of a percutaneously deployed left ventricular assist device

Mechanical assist devices play an increasing role in high-risk percutaneous coronary intervention (PCI) in highly complex and critically ill patients. The Impella Recover LP 2.5 is a minimally invasive left ventricular assist device that is inserted percutaneously via a 13 Fr sheath. The device is engineered to provide a significant increase in cardiac output in patients with severe left ventricular impairment as well as in patients undergoing high-risk coronary intervention, and may provide substantive circulatory support when severe hemodynamic compromise occurs. It can potentially be maintained in situ for five to seven days. Canada's first implantations of an Impella device providing circulatory support in patients undergoing complex, high-risk PCI are reported. Larger studies will be required to identify whether a survival benefit or improvement in left ventricular function can be achieved when using the Impella device to support patients undergoing high-risk PCI or those in cardiogenic shock.     

Treatment With Impella Increases the Risk of De Novo Aortic Insufficiency Post Left Ventricular Assist Device Implant

BackgroundImpella (Abiomed Inc, Danvers, MA) is a temporary mechanical support device positioned across the aortic valve, and can be used to support patient before LVAD implantation. There are no data on the incidence of aortic insufficiency (AI) in patients supported with Impella as a bridge to durable LVAD implantation. We sought to assess the incidence of AI in patients with Impella support as a bridge to durable left ventricular assist device (LVAD) implantation.MethodsWe reviewed all patients undergoing primary LVAD implantation at the University of Pennsylvania from January 2015 onward, comparing those supported with Impella as temporary mechanical support with those supported by either venoarterial extracorporeal life support or an intra-aortic balloon pump. We reviewed transthoracic echocardiography preoperatively, as well as at 1 week, 1, 3, 6, 9, and 12 months after LVAD implantation.ResultsA total of 215 echocardiograms were analyzed in 41 patients. Eleven patients were supported with Impella before LVAD implant—6 patients with Impella alone (5 with Impella CP, 1 with Impella 5.0) and 5 with Impella in conjunction with venoarterial extracorporeal life support (2 with Impella 2.5, 2 with Impella CP, and 1 with Impella 5.0). After LVAD implant, mild or moderate AI developed in 82% of patients supported with Impella (9 of 11) compared with 43% of those without Impella (13 of 30) (P = .038).ConclusionsPatients supported by Impella as a bridge to durable LVAD have a higher risk of developing AI. Further studies are needed to assess this risk as the use of the Impella increases.     

Elusive Diagnosis of Eosinophilic Myocarditis: A Case Series

We present 2 relevant cases of eosinophilic myocarditis (EM) in patients that presented with cardiogenic shock, one of whom received a durable ventricular assist device followed by heart transplantation, with the diagnosis of EM being made based on analysis of the excisional biopsy obtained during implantation of the ventricular assist device. The second patient was initially misdiagnosed with peripartum cardiomyopathy and underwent abortion, to later being diagnosed with EM through endomyocardial biopsy. These two cases highlight the importance of high clinical suspicion for EM based on eosinophilia, comorbidities, and presentation, as well as the value of early diagnosis and therapeutic interventions, including corticosteroids, and advanced heart failure therapies, such as mechanical circulatory support and heart transplantation.     

Bridge to transplantation with the TandemHeart: bending the indications in a chronic aortic dissection patient with postcardiotomy shock

Herein, we report a successful bridge to heart transplantation by use of the TandemHeart percutaneous ventricular assist device (pVAD) in a chronic aortic dissection patient who was experiencing postcardiotomy shock. The patient had undergone an aortocoronary bypass to treat an acute, extensive myocardial infarction that had resulted from severe stenosis of a Cabrol-like graft to the left main coronary artery. The TandemHeart was used successfully, despite classic contraindications for pVAD support. The outcome shows that, in critically ill cardiogenic shock patients, a permissive approach to pVAD use is valuable in screening candidates for long-term ventricular assist device support or for heart transplantation. This case also reveals the validity of direct bridging to transplantation from a pVAD in carefully selected patients.     

Use of Impella 5L for acute allograft rejection postcardiac transplant

The contribution of acute allograft rejection to posttransplant mortality has decreased over time primarily due to improvements in maintenance immunosuppression and in the diagnosis and treatment of rejection. Nevertheless, acute heart allograft rejection remains an important clinical problem.2 In the setting of an acute allograft rejection, mechanical circulatory support has been provided by a variety of devices, ranging from intra-aortic balloon pumps (IABP) to extracorporeal membrane oxygenators (ECMO), left ventricular assist devices (LVADs) and biventricular assist devices (BIVADs).2 We present a 45-year-old patient with cardiogenic shock secondary to acute allograft rejection after orthotopic heart transplantation. Patient continued to have poor hemodynamics and low cardiac output despite being on high doses of inotropes and an aggressive immunosuppression. Hence, a decision was made to support the hemodynamics with an Impella LP 5.0 (Abiomed Inc, Danvers, MA) left ventricular assist device (LVAD).     

The Impella Microaxial Flow Catheter Is Safe and Effective for Treatment of Myocarditis Complicated by Cardiogenic Shock: An Analysis From the Global cVAD Registry

Background

Myocarditis complicated by cardiogenic shock remains a complex problem. The use of acute mechanical circulatory support devices for cardiogenic shock is growing. We explored the utility of Impella transvalvular microaxial flow catheters in the setting of myocarditis with cardiogenic shock.

Heart transplantation after short-term mechanical circulatory support

IntroductionShort-term ventricular assist device (VAD) implantation is a life-saving procedure in patients with refractory cardiogenic shock. The present paper provides our experience with patients we were able to bridge from this critical condition directly to heart transplantation.MethodOur group comprises 11 patients implanted a Levitronix CentriMag short-term ventricular assist device from April 2009 to October 2012 as a bridge to heart transplantation. Six (55%) patients received a biventricular assist device while five (45%) had a left-ventricular assist device implanted. The mean age of patients was 41.2 years (20–63 years). Our group of patients included eight men (73%). The underlying diagnoses included dilated cardiomyopathy (5 patients), coronary heart disease (4 patients), infective endocarditis, and primary graft failure (1 patient each). Prior to implantation, all patients received high doses of inotropes, and eight (73%) patients had mechanical ventilatory support. Six (55%) patients showed laboratory signs of liver and kidney failure, and metabolic acidosis.ResultsThe mean time from VAD implantation to putting the patient on the urgent waiting list for heart transplantation was 7.6 days (1–54 days) depending on organ function recovery. The mean duration of mechanical circulatory support was 26.7 days (8–72 days). The mean time from inclusion into the waiting list to transplantation was 19.1 days (4–52 days). One-month, six-months and one-year survivals post-transplant were 91%, 82%, and 73%, respectively.ConclusionImplantation of the CentriMag short-term ventricular assist device in patients with refractory cardiogenic shock and otherwise grim prognosis markedly increases their chances for survival. Given the relatively short waiting time in the Czech Republic, the CentriMag ventricular assist device can thus serve as a direct bridge to heart transplantation.     

Percutaneous left ventricular support devices

Patients undergoing percutaneous coronary intervention (PCI) who have severely compromised left ventricular systolic function and complex coronary lesions including multivessel disease, left main disease, or bypass graft disease are at higher risk of adverse outcomes from hemodynamic collapse. The TandemHeart percutaneous left ventricular assist device and the Impella Recover LP 2.5 System may provide rapid circulatory support in high-risk PCI patients and in those who have cardiogenic shock. Identification of patients who are at high risk for severe hemodynamic compromise and most likely to benefit from mechanical circulatory support is crucial to derive the most benefit from this therapy. Multicenter randomized clinical trials are needed to clearly define the role of these two devices in providing circulatory support in a variety of clinical settings.     

Percutaneous ventricular assist device placement during active cardiopulmonary resuscitation for severe refractory cardiogenic shock after acute myocardial infarction

Cardiogenic shock after acute myocardial infarction is associated with a high mortality rate despite modern reperfusion methods and intra-aortic balloon pump support. For myocardial infarction patients in cardiogenic shock that is refractory to intra-aortic ballon pump counterpulsation and pressors (severe refractory cardiogenic shock), there are limited means to rapidly provide additional hemodynamic support. We present the case of a 49-year-old man who presented with an anterior wall acute myocardial infarction complicated by cardiogenic shock. After resuscitation and stabilization with intra-aortic balloon pump and pressor support, the patient underwent successful emergent percutaneous transluminal coronary angioplasty and stenting of the left anterior descending coronary artery. Forty-eight hours later, the patient again went into severe refractory cardiogenic shock; pulseless electrical activity arrest followed. Cardiopulmonary resuscitation was started, and the patient underwent urgent placement of a TandemHeart percutaneous ventricular assist device. The device enabled the reversal of terminal hemodynamic collapse during active cardiopulmonary resuscitation, subsequent stabilization of the patient, and discharge of the patient from the hospital after device removal. In this patient, the percutaneous ventricular assist device was successful in the treatment of severe refractory cardiogenic shock after acute myocardial infarction.     

Managing Patients With Short-Term Mechanical Circulatory Support: JACC Review Topic of the Week

The use of mechanical circulatory support for patients presenting with cardiogenic shock is rapidly increasing. Currently, there is only limited and conflicting evidence available regarding the role of the Impella (a microaxial, continuous-flow, short-term, left or right ventricular assist device) in cardiogenic shock; further randomized trials are needed. Patient selection, timing of implantation, and post-implantation management in the cardiac intensive care unit are crucial elements for success. Particular challenges at the bedside include the practical management of anticoagulation, evaluation of correct device position, and the approach to use in a patient with signs of insufficient hemodynamic support. Profound knowledge of these issues is required to enable the maximal potential of the device. This review provides a comprehensive overview of the short-term assist device and describes a practical approach to optimize care for patients supported with the device.