Sustained Use of the Impella 5.0 Heart Pump Enables Bridge to Clinical Decisions in 34 Patients

We studied whether sustained hemodynamic support (>7 d) with the Impella 5.0 heart pump can be used as a bridge to clinical decisions in patients who present with cardiogenic shock, and whether such support can improve their outcomes.We retrospectively reviewed cases of patients who had Impella 5.0 support at our hospital from August 2017 through May 2019. Thirty-four patients (23 with cardiogenic shock and 11 with severely decompensated heart failure) underwent sustained support for a mean duration of 11.7 ± 9.3 days (range, ≤48 d). Of 29 patients (85.3%) who survived to next therapy, 15 were weaned from the Impella, 8 underwent durable left ventricular assist device placement, 4 were escalated to venoarterial extracorporeal membrane oxygenation support, and 2 underwent heart transplantation. The 30-day survival rate was 76.5% (26 of 34 patients). Only 2 patients had a major adverse event: one each had an ischemic stroke and flail mitral leaflet. None of the devices malfunctioned.Sustained hemodynamic support with the Impella 5.0 not only improved outcomes in patients who presented with cardiogenic shock, but also provided time for multidisciplinary evaluation of potential cardiac recovery, or the need for durable left ventricular assist device implantation or heart transplantation. Our study shows the value of using the Impella 5.0 as a bridge to clinical decisions.     

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.     

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.     

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.     

Left ventricular support with the Impella LP 5.0 for cardiogenic shock following cardiac surgery

We report the first Australian use of the Impella LP 5.0, a minimally invasive, high-output left ventricular assist device. The device was inserted intra-operatively for cardiac failure following coronary artery grafting. Although it facilitated a temporary post-operative recovery, the patient ultimately succumbed due to left ventricular failure more than 30 days after the original procedure. This device has several advantages over existing forms of left ventricular support, and has the potential for widespread use in Australian centres.     

Axillary Impella insertion under regional nerve block: A case report

Percutaneous coronary interventions with the Impella (Abiomed, MA) catheter‐based, micro‐axial mechanical left ventricular assist device is a safe option for patients undergoing higher risk interventions. However, severe peripheral arterial disease limits vascular access for Impella insertion. Upper extremity arterial access has been traditionally obtained under general anesthesia. We present the first case, to our knowledge, of using peripheral nerve blocks for Impella 3.5 CP insertion into the axillary artery.     

Left ventricular perforation after Impella® placement in a patient with cardiogenic shock

Mechanical cardiovascular support devices are now widely used both in the setting of cardiogenic shock as well as during high risk cardiac catheterization procedures. We report a case of a young female patient who presented with presumed myocarditis and rapidly deteriorating decompensated heart failure requiring the implantation of an Impella Circulatory Support System. Upon transfer to our facility it was discovered that during transport, the Impella device had migrated through the left ventricle. She was emergently taken to the operating room where the Impella was surgically removed and biventricular support devices were placed. The patient eventually expired after weeks of treatment in the intensive care unit. We believe this is the first recorded case of an Impella device perforating the left ventricle. Particularly in cases of newly discovered pericardial effusion, change in waveform on the Impella controller placement signal or rapid decompensation, physicians should consider this rare but potentially catastrophic complication associated with mechanical left ventricular support devices.     

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.     

Right ventricular failure following placement of a percutaneous left ventricular assist device

Right ventricular (RV) dysfunction following surgical implantation of a left ventricular assist device (LVAD) is a well-documented phenomenon, and it is associated with poor outcomes. We are reporting a 25-year-old male patient who presented to the hospital with flu-like symptoms, hypotension and acute hypoxic respiratory failure. The patient's Laboratory data was significant for elevated troponin, and his Chest X-ray showed acute pulmonary edema. Echocardiogram revealed reduced left ventricular (LV) ejection fraction and normal RV function. Coronary angiography was normal, and the cardiac index was 1.3?L/min/m². Impella 5.0 (Abiomed, MA) was placed through the left axillary artery graft and 4.5?L/min flow was achieved with an improvement in blood pressure. Thirty minutes later, he developed hypotension, the device flow dropped to 3.0?L/min, and right atrial pressure increased. The Pulmonary artery pulsatility index was consistent with RV failure. Possible causes of RV failure include unmasking of RV dysfunction with high LVAD flow and altered RV geometry due to ventricular septum shift. Impella RP (Abiomed, MA) was placed for RV support achieving a flow of 3.8?L/min with a significant improvement in impella LV flow, cardiac output and blood pressure (mean 90?mmHg). Ventricular support devices were weaned off on day 9. The patient was discharged on day 15. Conclusion: our case highlights the risk of RV failure following percutaneous LVAD placement. Early identification and appropriate mechanical support is imperative.     

Transthoracic real time three-dimensional echocardiography in Impella placement

A 33-year-old patient with nonischemic cardiomyopathy presented with cardiogenic shock requiring percutaneous left ventricular assist device placement despite inotropic support. Under transthoracic two-dimensional echocardiographic guidance, an Impella 2.5 L heart pump was placed. The inflow catheter was distal to the aortic valve, however patient remained in shock. Real time three-dimensional transthoracic echocardiography showed the inflow catheter imbedded into the papillary muscle causing inlet occlusion. By cropping 3D data set in multiple planes, a better spatial visualization of the inflow catheter and its distance from the aortic valve was easily obtained and the device was adjusted.     

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.     

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.     

Safety and feasibility of elective high-risk percutaneous coronary intervention procedures with left ventricular support of the Impella Recover LP 2.5

Currently, the most used left ventricular (LV) support device is intra-aortic balloon counterpulsation. The percutaneous implantable Impella Recover LP 2.5 system is a novel LV (unloading) assist device. We studied the feasibility and safety of LV support with the percutaneous implantable Impella Recover LP 2.5 system in 19 consecutive high-risk patients with percutaneous coronary intervention. Procedural success using the device and percutaneous coronary intervention was achieved in all 19 patients, who were very poor candidates for surgery. The patients were elderly (84% were >60 years of age), 74% had previous myocardial infarction, 63% had LV ejection fractions of < or =25%, and all had LV ejection fractions of < or =40%. There were no procedural deaths and 2 device-unrelated in-hospital late deaths. Mean decrease in hemoglobin level was 0.7 +/- 0.4 mmol/L. The device did not induce or increase aortic valve regurgitation. There were no important device-related adverse events during LV support with the Impella Recover LP 2.5 system. However, these encouraging findings must be confirmed by larger studies, longer assist times, and in other patient categories.     

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).     

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.     

Left ventricular unloading and concomitant total cardiac output increase by the use of percutaneous Impella Recover LP 2.5 assist device during high-risk coronary intervention.

A number of techniques have been proposed for circulatory support during high-risk percutaneous coronary interventions (PCI), but no single approach has achieved wide acceptance so far. We report on a patient with severe left ventricular (LV) impairment who underwent a PCI with the use of a new left ventricular assist device, the Impella Recover LP 2.5 system. The effects on global cardiac output were determined by thermodilution (TD) and LV pressure-volume loops obtained by conductance catheter. The activation of the pump resulted in a rapid and sustained unloading effect of the LV. At the same time, the continuous expulsion of blood into ascending aorta throughout the cardiac cycle produced by the pump resulted in an increase of systemic overall CO, measured by the TD technique, of 1.43 L/min. The procedure was uncomplicated and the patient remained uneventful at follow-up. Our single experience gives new input for future trials to assess the effect of the Impella Recover LP 2.5 assist device on outcome in this subset of patients.     

Continuous-Flow Left Ventricular Assist Device Explantation After More Than 5 Years of Circulatory Support and Ventricular Reconditioning

Continuous-flow left ventricular assist devices have proved to be effective, durable, life-saving tools in patients with end-stage heart failure. However, because of the risks associated with mechanical circulatory support (including stroke, infection, gastrointestinal bleeding, and device malfunction), the optimal goal of device therapy is myocardial recovery and device removal. Ventricular reconditioning and pump explantation after continuous-flow support have been reported; however, little is known about variables that govern the pace and degree of myocardial response in patients who experience such recovery. We describe our long-term pump-weaning strategy for a 25-year-old man who had a continuous-flow device implanted and then needed more than 5 years of support from it before developing cardiac reserve sufficient to enable pump explantation. To our knowledge, this is the longest period of uninterrupted continuous-flow device support to end in successful pump deactivation and a return to medical therapy. This case highlights the importance of actively and persistently pursuing a device-weaning strategy in all patients who need left ventricular assist device therapy.     

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.     

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.     

Functional mitral stenosis: a rare complication of the Impella assist device

In patients with left ventricular output failure, the Impellaleft ventricular assist device increases total cardiac outputdespite a drop in output provided by the left ventricle itself.We present a patient with cardiogenic shock after myocardialinfarction in whom an Impella recover 2.5 was implanted. Correctplacement was ensured by fluoroscopy, pressure and current signalsdisplayed on the console of the system, and transthoracic echocardiography.On follow-up, the Impella device was dislocated with the shaftof the device lying on the anterior mitral leaflet causing afunctional mitral stenosis evident by an increased transmitraldiastolic flow gradient. After removing the device, the patients'haemodynamics improved within minutes. Other than a mild regurgitation,mitral valve was without pathological findings. Although infrequent,this case shows a possible complication of the Impella ventricularassist device and highlights the importance of periodical echocardiographicsurveillance, especially in patients who show a poor responseto therapy.