Percutaneous Extracorporeal Life Support in Circulatory Failure
Objectives Mortality rates remain high in patients with cardiogenic shock or acute refractory circulatory failure. Extracorporeal life support (ECLS) has been recently introduced into clinical practice for treatment of refractory hypotension in selected patients in combination with rapid restoration of gas exchange. The aim of this study was to evaluate the procedural performance and safety of the automated Lifebridge ECLS system (Zoll Lifebridge GmbH).
Methods A total of five tertiary cardiovascular centers located in Germany contributed data to this registry (n = 54 patients). Data were collected using a standardized case report form to record clinical characteristics, demographic, procedural, and follow-up data. Patients were included if they were in circulatory crisis (caused by cardiogenic shock or ongoing resuscitation) in an acute setting or in an elective setting during high-risk percutaneous intervention.
Results The Lifebridge device was successfully used in all patients. During elective use, no complications occurred besides 1 minor vascular injury. All elective patients were successfully weaned from the device and alive at the primary endpoint after 30 days. In the emergency setting, 85% of the patients were successfully weaned from the device and 49% of the patients were alive after 30 days. Relevant bleeding resulting in transfusion of red blood cells occurred in 5% of patients.
Conclusion In this observational study, we report data from the real-world use of a novel automated ECLS system. Elective use of Lifebridge was feasible and safe without major side effects. In the emergency setting, mortality rates were high; however, stabilization of the selected patients was safe and feasible.
Despite recent advances in the treatment of patients with cardiogenic shock and acute refractory circulatory failure, mortality rates remain high. The majority of patients with severe cardiogenic shock suffer from an acute myocardial infarction (AMI). However, intraaortic balloon pulsation (IABP) has often been used for postinterventional support of cardiac perfusion, but has failed to show any significant improvement in patient outcomes after successful revascularization. As a consequence, clinical guidelines have been adapted for IABP use from class IB to class IIB recommendation for the treatment of refractory cardiogenic shock complicating myocardial infarction.
In contrast to IABP, the concept of extracorporeal life support (ECLS) is based on the acute hemodynamic stabilization of refractory hypotension in combination with a rapid restoration of gas exchange. ECLS is capable of substantially improving survival among patients in circulatory arrest, especially if the duration of proceeding cardiopulmonary resuscitation is not too long. In addition, ECLS does not require any sustained left ventricular function and has the potential to reverse circulatory failure in patients with complete acute failure of cardiac function. Since mortality strongly increases with longer duration of cardiopulmonary resuscitation (CPR), rapid initiation of ECLS immediately reverses organ dysfunction improving outcome in such patients who would otherwise have an extremely impaired prognosis.
Another clinical situation in which mechanical cardiac assist devices have been used is during high-risk percutaneous coronary intervention (PCI). Although this remains controversial, mechanical assist devices may be considered in highly selected patients with impaired left ventricular function, significant ischemia risk affecting a large fraction of the myocardium, or impending hemodynamic instability. Numerous case reports and patient series as well as small non-randomized studies suggest a liberal prophylactic use, although this does not translate directly into reduced in-hospital mortality or reduced major cardiovascular event rate.
The novel automated Lifebridge ECLS system (Zoll Lifebridge GmbH) is capable of rapid, secure initiation of full extracorporeal support. It allows mobile use of ECLS in non-specialized departments, intensive care units, and emergency rooms. This offers an option for rapid stabilization of patients in refractory circulatory arrest. The aim of this study was to evaluate the procedural performance and safety of the Lifebridge system in acute (cardiac arrest, severe, refractory cardiogenic shock) and elective (high-risk PCI) settings.
Abstract and Introduction
Abstract
Objectives Mortality rates remain high in patients with cardiogenic shock or acute refractory circulatory failure. Extracorporeal life support (ECLS) has been recently introduced into clinical practice for treatment of refractory hypotension in selected patients in combination with rapid restoration of gas exchange. The aim of this study was to evaluate the procedural performance and safety of the automated Lifebridge ECLS system (Zoll Lifebridge GmbH).
Methods A total of five tertiary cardiovascular centers located in Germany contributed data to this registry (n = 54 patients). Data were collected using a standardized case report form to record clinical characteristics, demographic, procedural, and follow-up data. Patients were included if they were in circulatory crisis (caused by cardiogenic shock or ongoing resuscitation) in an acute setting or in an elective setting during high-risk percutaneous intervention.
Results The Lifebridge device was successfully used in all patients. During elective use, no complications occurred besides 1 minor vascular injury. All elective patients were successfully weaned from the device and alive at the primary endpoint after 30 days. In the emergency setting, 85% of the patients were successfully weaned from the device and 49% of the patients were alive after 30 days. Relevant bleeding resulting in transfusion of red blood cells occurred in 5% of patients.
Conclusion In this observational study, we report data from the real-world use of a novel automated ECLS system. Elective use of Lifebridge was feasible and safe without major side effects. In the emergency setting, mortality rates were high; however, stabilization of the selected patients was safe and feasible.
Introduction
Despite recent advances in the treatment of patients with cardiogenic shock and acute refractory circulatory failure, mortality rates remain high. The majority of patients with severe cardiogenic shock suffer from an acute myocardial infarction (AMI). However, intraaortic balloon pulsation (IABP) has often been used for postinterventional support of cardiac perfusion, but has failed to show any significant improvement in patient outcomes after successful revascularization. As a consequence, clinical guidelines have been adapted for IABP use from class IB to class IIB recommendation for the treatment of refractory cardiogenic shock complicating myocardial infarction.
In contrast to IABP, the concept of extracorporeal life support (ECLS) is based on the acute hemodynamic stabilization of refractory hypotension in combination with a rapid restoration of gas exchange. ECLS is capable of substantially improving survival among patients in circulatory arrest, especially if the duration of proceeding cardiopulmonary resuscitation is not too long. In addition, ECLS does not require any sustained left ventricular function and has the potential to reverse circulatory failure in patients with complete acute failure of cardiac function. Since mortality strongly increases with longer duration of cardiopulmonary resuscitation (CPR), rapid initiation of ECLS immediately reverses organ dysfunction improving outcome in such patients who would otherwise have an extremely impaired prognosis.
Another clinical situation in which mechanical cardiac assist devices have been used is during high-risk percutaneous coronary intervention (PCI). Although this remains controversial, mechanical assist devices may be considered in highly selected patients with impaired left ventricular function, significant ischemia risk affecting a large fraction of the myocardium, or impending hemodynamic instability. Numerous case reports and patient series as well as small non-randomized studies suggest a liberal prophylactic use, although this does not translate directly into reduced in-hospital mortality or reduced major cardiovascular event rate.
The novel automated Lifebridge ECLS system (Zoll Lifebridge GmbH) is capable of rapid, secure initiation of full extracorporeal support. It allows mobile use of ECLS in non-specialized departments, intensive care units, and emergency rooms. This offers an option for rapid stabilization of patients in refractory circulatory arrest. The aim of this study was to evaluate the procedural performance and safety of the Lifebridge system in acute (cardiac arrest, severe, refractory cardiogenic shock) and elective (high-risk PCI) settings.
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