The Use of Impella 2.5 in Severe Refractory Cardiogenic Shock Complicating an Acute Myocardial Infarction (original) (raw)

The Current Use of Impella 2.5 in Acute Myocardial Infarction Complicated by Cardiogenic Shock: Results from the USpella Registry

Journal of Interventional Cardiology, 2014

Objectives: To evaluate the periprocedural characteristics and outcomes of patients supported with Impella 2.5 prior to percutaneous coronary intervention (pre-PCI) versus those who received it after PCI (post-PCI) in the setting of cardiogenic shock (CS) complicating an acute myocardial infarction (AMI). Background: Early mechanical circulatory support may improve outcome in the setting of CS complicating an AMI. However, the optimal timing to initiate hemodynamic support has not been well characterized. Methods: Data from 154 consecutive patients who underwent PCI and Impella 2.5 support from 38 US hospitals participating in the USpella Registry were included in our study. The primary end-point was survival to discharge. Secondary end-points included assessment of patients' hemodynamics and in-hospital complications. A multivariate regression model was used to identify independent predictors for mortality. Results: Both groups were comparable except for diabetes (P ¼ 0.02), peripheral vascular disease (P ¼ 0.008), chronic obstructive pulmonary disease (P ¼ 0.05), and prior stroke (P ¼ 0.04), all of which were more prevalent in the pre-PCI group. Patients in the pre-PCI group had more lesions (P ¼ 0.006) and vessels (P ¼ 0.01) treated. These patients had also significantly better survival to discharge compared to patients in the post-PCI group (65.1% vs.40.7%, P ¼ 0.003). Survival remained favorable for the pre-PCI group after adjusting for potential confounding variables. Initiation of support prior to PCI with Impella 2.5 was an independent predictor of in-hospital survival (Odds ratio 0.37, 95% confidence interval: 0.17-0.79, P ¼ 0.01) in multivariate analysis. The incidence of inhospital complications included in the secondary end-point was similar between the 2 groups. Conclusions: The results of our study suggest that early initiation of hemodynamic support prior to PCI with Impella 2.5 is associated with more complete revascularization and improved survival in the setting of refractory CS complicating an AMI.

Management and outcome of patients supported with Impella 5.0 for refractory cardiogenic shock

Critical Care, 2015

Introduction Cardiogenic shock refractory to standard therapy with inotropes and/or intra-aortic balloon pump is accompanied with an unacceptable high mortality. Percutaneous left ventricular assist devices may provide a survival benefit for these very sick patients. In this study, we describe our experience with the Impella 5.0 device used in the setting of refractory cardiogenic shock. Methods In this observational, retrospective, single-center study we included all the consecutive patients supported with Impella 5.0, between May 2008 and December 2013, for refractory cardiogenic shock. Patients’ baseline and procedural characteristics, hemodynamics and outcome to the first 48 h of support, to ICU discharge and day-28 visit were collected. Results A total of 40 patients were included in the study. Median age was 57 years and 87.5 % were male. Cardiogenic shock resulted from acute myocardial infarction in 17 patients (43 %), dilated cardiomyopathy in 12 (30 %) and postcardiotomy ca...

Long-term safety and sustained left ventricular recovery: long-term results of percutaneous left ventricular support with Impella LP2.5 in ST-elevation myocardial infarction

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2011

Mechanical left ventricular (LV) unloading may reduce infarct size when combined with primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI). The Impella LP2.5 is a novel percutaneous left ventricular assist device. Although the short-term safety and feasibility of this device have been demonstrated, the long-term effects are unknown. The purpose of the current study was to evaluate the long-term effects of the Impella LP2.5 support on the aortic valve and left ventricular ejection fraction (LVEF). In 2006, 10 patients with anterior STEMI received 3-day support with the Impella LP2.5 after PCI. The control group consisted of 10 comparable patients, treated according to routine care. For the current study, echocardiography was performed and adverse events were recorded. Mean duration of follow-up was 2.9±0.6 years in the Impella group and 3.0±0.3 years in the control group. No differences in aortic valve abnormalities and LVEF wer...

Percutaneous left-ventricular support with the Impella-2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry

Circulation. Heart failure, 2013

Acute cardiogenic shock after myocardial infarction is associated with high in-hospital mortality attributable to persisting low-cardiac output. The Impella-EUROSHOCK-registry evaluates the safety and efficacy of the Impella-2.5-percutaneous left-ventricular assist device in patients with cardiogenic shock after acute myocardial infarction. This multicenter registry retrospectively included 120 patients (63.6±12.2 years; 81.7% male) with cardiogenic shock from acute myocardial infarction receiving temporary circulatory support with the Impella-2.5-percutaneous left-ventricular assist device. The primary end point evaluated mortality at 30 days. The secondary end point analyzed the change of plasma lactate after the institution of hemodynamic support, and the rate of early major adverse cardiac and cerebrovascular events as well as long-term survival. Thirty-day mortality was 64.2% in the study population. After Impella-2.5-percutaneous left-ventricular assist device implantation, la...

The role of different mechanical circulatory support devices and their timing of implantation on myocardial damage and mid‐term recovery in acute myocardial infarction related cardiogenic shock

Journal of Interventional Cardiology, 2018

OBJECTIVES Aim of the study was to assess in-hospital survival rate and the degree of myocardial recovery after MCS treatment (IABP or IMPELLA) at discharge and at 6 months in patients with AMI-CS and planned early percutaneous revascularization. BACKGROUND All studies on MCS for acute myocardial infarction related cardiogenic shock (AMI-CS) focused on its impact on in-hospital mortality; however, few data about its role on myocardial recovery are available. METHODS Retrospective study on 64 patients: 36 patients (56%) received IABP and 28 (44%) Impella 2.5/CP. RESULTS Patients treated with Impella were sicker compared to those treated with IABP as shown by a higher need of catecholamines (93% Impella vs 57% IABP, P = 0.002) and higher inotropic score before procedure: 8 (5-15) versus 4.5 (0-9), P = 0.02. In-hospital survival and MCS-related complications were comparable; hemolysis was more frequent in the Impella group (32% vs 0%, P < 0.0001). Myocardial damage was lower in thos...

A Prospective, Randomized Clinical Trial of Hemodynamic Support With Impella 2.5 Versus Intra-Aortic Balloon Pump in Patients Undergoing High-Risk Percutaneous Coronary Intervention: The PROTECT II Study

Circulation, 2012

Background-Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention with hemodynamic support may be feasible for these patients. Currently, there is no systematic comparative evaluation of hemodynamic support devices for this indication. Methods and Results-We randomly assigned 452 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function to intra-aortic balloon pump (IABP) (nϭ226) or Impella 2.5 (nϭ226) support during nonemergent high-risk percutaneous coronary intervention. The primary end point was the 30-day incidence of major adverse events. A 90-day follow-up was required, as well, by protocol. Impella 2.5 provided superior hemodynamic support in comparison with IABP, with maximal decrease in cardiac power output from baseline of Ϫ0.04Ϯ0.24 W in comparison with Ϫ0.14Ϯ0.27 W for IABP (Pϭ0.001). The primary end point (30-day major adverse events) was not statistically different between groups: 35.1% for Impella 2.5 versus 40.1% for IABP, Pϭ0.227 in the intent-to-treat population and 34.3% versus 42.2%, Pϭ0.092 in the per protocol population. At 90 days, a strong trend toward decreased major adverse events was observed in Impella 2.5-supported patients in comparison with IABP: 40.6% versus 49.3%, Pϭ0.066 in the intent-to-treat population and 40.0% versus 51.0%, Pϭ0.023 in the per protocol population, respectively. Conclusions-The 30-day incidence of major adverse events was not different for patients with IABP or Impella 2.5 hemodynamic support. However, trends for improved outcomes were observed for Impella 2.5-supported patients at 90 days.

The Impella Device for Acute Mechanical Circulatory Support in Patients in Cardiogenic Shock

The Annals of Thoracic Surgery, 2014

Background. Acute cardiogenic shock is associated with high mortality rates. Mechanical circulatory devices have been increasingly used in this setting for hemodynamic support. The Impella device (Abiomed Inc, Danvers, MA) is a microaxial left ventricular assist device that can be inserted using a less invasive technique. This study was conducted to determine the outcome of patients who have undergone placement of the Impella device for acute cardiogenic shock in our institution. Methods. A retrospective record review of 47 patients who underwent placement of the Impella device was performed from January 1, 2006, to December 31, 2011. Records were evaluated for demographics, operative details, and postoperative outcomes. Operative mortality was defined as death within 30 days of the operation. Results. The patients (33 male) were an average age of 60.23 ±13 years. The indication for placement of the Impella device included cardiogenic shock in 15 patients (32%) and postcardiotomy cardiogenic shock in 32 (68%). Of the 47 patients, 38 (80%) received the Impella 5.0 and the rest the 2.5 device. Ventricular function recovered in 34 of 47 patients (72%), and the device was removed, with 4 patients (8%) transitioned to long-term ventricular assist devices. The 30-day mortality was 25% (12 of 47 patients). Complications occurred in 14 patients (30%), consisting of device malfunction, high purge pressures, tube fracture, and groin hematoma. Conclusions. This is one of the largest series of patients undergoing placement of the Impella device for acute cardiogenic shock. Our outcomes showed improved results compared with historical data. Myocardial recovery was accomplished in most patients. Finally, the 30-day mortality and complication rate was acceptable in these critical patients. These benefits were all achieved with the Impella device in a less invasive method.