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 (original) (raw)
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Supported High-Risk Percutaneous Coronary Intervention With the Impella 2.5 Device
Journal of The American College of Cardiology, 2009
This retrospective multicenter registry evaluated the safety and feasibility of left ventricular (LV) support with the Impella 2.5 (Abiomed Europe GmbH, Aachen, Germany) during high-risk percutaneous coronary intervention (PCI).Patients with complex or high-risk coronary lesions, such as last remaining vessel or left main lesions, are increasingly being treated with PCI. Because periprocedural hemodynamic compromise and complications might occur rapidly, many of these high-risk procedures are being performed with mechanical cardiac assistance, particularly in patients with poor LV function. The Impella 2.5, a percutaneous implantable LV assist device, might be a superior alternative to the traditionally used intra-aortic balloon pump.The Europella registry included 144 consecutive patients who underwent a high-risk PCI. Safety and feasibility end points included incidence of 30-day adverse events and successful device function.Patients were older (62% >70 years of age), 54% had an LV ejection fraction ≤30%, and the prevalence of comorbid conditions was high. Mean European System for Cardiac Operative Risk Evaluation score was 8.2 (SD 3.4), and 43% of the patients were refused for coronary artery bypass grafting. A PCI was considered high-risk due to left main disease, last remaining vessel disease, multivessel coronary artery disease, and low LV function in 53%, 17%, 81%, and 35% of the cases, respectively. Mortality at 30 days was 5.5%. Rates of myocardial infarction, stroke, bleeding requiring transfusion/surgery, and vascular complications at 30 days were 0%, 0.7%, 6.2%, and 4.0%, respectively.This large multicenter registry supports the safety, feasibility, and potential usefulness of hemodynamic support with Impella 2.5 in high-risk PCI.
JACC: Cardiovascular Interventions, 2009
Objectives We sought to evaluate the safety and feasibility of the Impella 2.5 system (Abiomed Inc., Danvers, Massachusetts) in patients undergoing high-risk percutaneous coronary intervention (PCI). Background The Impella 2.5 is a miniaturized percutaneous cardiac assist device, which provides up to 2.5 l/min forward flow from the left ventricle into the systemic circulation. Methods In a prospective, multicenter study, 20 patients underwent high-risk PCI with minimally invasive circulatory support employing the Impella 2.5 system. All patients had poor left ventricular function (ejection fraction Յ35%) and underwent PCI on an unprotected left main coronary artery or last patent coronary conduit. Patients with recent ST-segment elevation myocardial infarction or cardiogenic shock were excluded. The primary safety end point was the incidence of major adverse cardiac events at 30 days. The primary efficacy end point was freedom from hemodynamic compromise during PCI (defined as a decrease in mean arterial pressure below 60 mm Hg for Ͼ10 min). Results The Impella 2.5 device was implanted successfully in all patients. The mean duration of circulatory support was 1.7 Ϯ 0.6 h (range: 0.4 to 2.5 h). Mean pump flow during PCI was 2.2 Ϯ 0.3 l/min. At 30 days, the incidence of major adverse cardiac events was 20% (2 patients had a periprocedural myocardial infarction; 2 patients died at days 12 and 14). There was no evidence of aortic valve injury, cardiac perforation, or limb ischemia. Two patients (10%) developed mild, transient hemolysis without clinical sequelae. None of the patients developed hemodynamic compromise during PCI. Conclusions The Impella 2.5 system is safe, easy to implant, and provides excellent hemodynamic support during high-risk PCI.
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.
The International journal of angiology : official publication of the International College of Angiology, Inc, 2013
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 s...
Catheterization and Cardiovascular Interventions, 2012
Objectives: We report on the real-world, multicenter experience of the Impella 2.5 circulatory support system during high-risk PCI, a subset of the larger USpella Registry. Background: Standard of care for most patients with compromised ventricular function with multivessel or high-risk coronary lesions has been coronary artery bypass grafting. In poor operative candidates, high-risk PCI is increasingly considered, despite an increased risk for periprocedural hemodynamic compromise. Methods: 175 consecutive patients who underwent high-risk PCI with prophylactic support of the Impella 2.5 were evaluated. The primary safety endpoint was the incidence of major adverse cardiac events (MACE) at 30 days. Secondary endpoints included safety and efficacy related to the device and patient outcomes, including survival at 12 months. Results: Overall angiographic revascularization was successful in 99% of patients and in 90% of those with multivessel revascularization, resulting in a reduction of the mean SYNTAX score post-PCI from 36 6 15 to 18 6 15 (P < 0.0001) and an improvement of the ejection fraction (from 31 6 15% to 36 6 14%, P < 0.0001). In 51% of patients, the functional status improved by one or more NYHA class (P < 0.001). At 30-day follow-up, the rate of MACE was 8%, and survival was 96%, 91%, and 88% at 30 days, 6 months, and 12 months, respectively. Conclusions: The use of Impella 2.5 in high-risk PCI appeared feasible and safe in the real-world setting. The utilization of the Impella 2.5 was successful, resulting in favorable short-and midterm angiographic, procedural and clinical outcomes. V
American Heart Journal, 2014
Background The introduction of new medical devices may be accompanied by a learning curve. Methods To evaluate the impact of the device learning curve on the outcomes of PROTECT II trial, comparing Impella 2.5 versus the intra-aortic balloon pump (IABP) during high-risk percutaneous coronary intervention, we report on a prespecified analysis, excluding the first Impella 2.5 and IABP patients at each site. Results A total of 448 patients were enrolled at 74 sites. Among these, 58 patients were the first to receive Impella 2.5 at their site, 62 were the first to receive IABP. A trend toward higher major adverse events (MAEs) at 30 days was observed for the subgroup of first versus remaining Impella 2.5 patients: 44.8% versus 31.7%, P = .072. MAE rates for the first and remaining IABP patients were similar at 30 days. After exclusion of the first patient in each group, MAE rates for Impella 2.5 and IABP were 31.7% versus 40.0% (P = .119) at 30 days and 38.0% versus 50.0% (P = .029) at 90 days. Conclusions Significantly lower 90-day MAE rates were observed with the use of Impella 2.5 compared to the use of IABP after excluding the first patient per group at each site. This prespecified analysis suggests a learning curve associated with initial introduction of the Impella 2.5. Clinical trials should better address the training aspect of new devices, especially when compared with more established devices.
The role of Impella in high-risk percutaneous coronary intervention
Revista portuguesa de cardiologia : orgao oficial da Sociedade Portuguesa de Cardiologia = Portuguese journal of cardiology : an official journal of the Portuguese Society of Cardiology, 2018
Percutaneous coronary intervention (PCI) has been increasingly performed in patients with severely depressed left ventricular function and complex coronary lesions, including multivessel disease. Mechanical ventricular assist devices play an increasingly important role in high-risk PCI. Impella CP (Abiomed, Inc.) is a new percutaneous left ventricular assist device, designed for short-term circulatory support. It is a promising option for hemodynamic support in high-risk procedures and can potentially reduce PCI-related complications. The authors present two case reports of high-risk PCI using the Impella CP device. In the setting of low coronary flow reserve, severely depressed left ventricular function and potential hemodynamic instability, the Impella CP device has made it possible to maintain hemodynamic stability during procedures, without being associated with vascular complications.