The use of venoarterial-extracorporeal membrane oxygenation(VA-ECMO) was associated with lower in-hospital mortality in patients with cardiogenic shock. However, VA-ECMO has a deleterious effect for hemodynamics. It can increase left ventricular end-diastolic pressure(LVEDP), followed by left ventricular dilatation, abnormal opening of aortic valve and jeopardizes of myocardial recovery. Therefore, several methods have been used to reduce LVEDP. Among these, left atrial septostomy is effective, but less invasive than surgical left ventricular unloading. However, there is few data regarding this issue. Therefore, the investigators will evaluate the effect of routine, early left atrial septostomy in patients with VA-ECMO for the treatment of cardiogenic shock.
Study Objectives: To determine the effect of early left atrial septostomy versus conventional approach(left atrial septostomy only in cases of significant changes due to left ventricular end-diastolic pressure increase) in patients who received venoarterial-extracorporeal membrane oxygenation(VA-ECMO) for the treatment of cardiogenic shock. Study Background: Cardiogenic shock is due to myocardial dysfunction from multifactorial causes, which has high mortality. The treatment for cardiogenic shock includes early coronary revascularization, inotropes, vasopressors, or mechanical circulatory support, such as intraaortic balloon pump(IABP), VA-ECMO. However, the routine use of IABP is not recommended for the treatment of cardiogenic shock in recent guidelines. VA-ECMO can be easily implanted, and can maintain high cardiac output. In several studies, The use of VA-ECMO was associated with lower in-hospital mortality in patients with cardiogenic shock. However, VA-ECMO has a deleterious effect for hemodynamics. It can increase left ventricular end-diastolic pressure(LVEDP), followed by left ventricular dilatation, abnormal opening of aortic valve and jeopardizes of myocardial recovery. Therefore, several methods have been used to reduce LVEDP. Among these, left atrial septostomy is effective, but less invasive than surgical left ventricular unloading. However, there is few data regarding this issue. Therefore, the investigators will evaluate the effect of routine, early left atrial septostomy in patients with VA-ECMO for the treatment of cardiogenic shock. Study Hypothesis: Early, routine left atrial septostomy for left heart unloading is superior compared to conventional approach to reduce in-hospital mortality and the duration of VA-ECMO.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
Early left atrial septostomy group will routinely receive left atrial septostomy within 12 hours after VA-ECMO implantation. Left atrial septostomy will be done using percutaneous technique.
Left atrial septostomy will be done in cases of deleterious effect of increased LVEDP after VA-ECMO implantation, such as refractory pulmonary edema, abnormal opening of aortic valve, left ventricular dilatation, refractory ventricular tachycardia or fibrillation.
Chonnam National University Hospital
Gwangju, South Korea
Cumulative incidence rate of all-cause death
Cumulative incidence rate of all-cause death
Time frame: Up to 30 days
Rate of all-cause death or left atrial septostomy in conventional approach group
Rate of all-cause death or left atrial septostomy in conventional approach group
Time frame: Up to 30 days
Rate of left atrial septostomy in conventional approach group
Rate of left atrial septostomy in conventional approach group
Time frame: Up to 30 days
Incidence rate of all-cause death during index admission
Incidence rate of all-cause death during index admission
Time frame: Up to 6 months
Cumulative incidence rate of cardiac death
Cumulative incidence rate of cardiac death
Time frame: Up to 30 days
Cumulative incidence rate of non-cardiac death
Cumulative incidence rate of non-cardiac death
Time frame: Up to 30 days
Weaning rate from venoarterial extracorporeal membrane oxygenation during index admission
Weaning rate from venoarterial extracorporeal membrane oxygenation during index admission
Time frame: Up to 6 months
Rate of disappearance of pulmonary edema on chest X-ray during index admission
Rate of disappearance of pulmonary edema on chest X-ray during index admission
Time frame: Up to 6 months
Weaning rate from mechanical ventilator during index admission
Weaning rate from mechanical ventilator during index admission
Time frame: Up to 6 months
Intensive care unit length of stay during index admission
Intensive care unit length of stay during index admission
Time frame: Up to 6 months
Hospital length of stay
Hospital length of stay
Time frame: Up to 6 months
Lactate normalization rate
Lactate normalization rate
Time frame: Up to 30 days
Lactate clearance rate
Lactate clearance rate
Time frame: Up to 30 days
Rate of renal replacement therapy during index admission
Rate of renal replacement therapy during index admission
Time frame: Up to 6 months
Rate of limb ischemia during index admission
Rate of limb ischemia during index admission
Time frame: Up to 6 months
Rate of infection during index admission
Rate of infection during index admission
Time frame: Up to 6 months
Rate of transient ischemic attack or stroke during index admission
Rate of transient ischemic attack or stroke during index admission
Time frame: Up to 6 months
Rate of BARC bleeding type 3 or 5 during index admission
Rate of BARC bleeding type 3 or 5 during index admission
Time frame: Up to 6 months
Rate of bridge to ventricular assist device or heart transplantation during index admission
Rate of bridge to ventricular assist device or heart transplantation during index admission
Time frame: Up to 6 months
Rate of major vascular injury or cardiac tamponade during left atrial septostomy
Rate of major vascular injury or cardiac tamponade during left atrial septostomy
Time frame: Up to 30 days
Cumulative incidence rate of all-cause death
Cumulative incidence rate of all-cause death
Time frame: Up to 12 months
Cumulative incidence rate of cardiac death
Cumulative incidence rate of cardiac death
Time frame: Up to 12 months
Cumulative incidence rate of non-cardiac death
Cumulative incidence rate of non-cardiac death
Time frame: Up to 12 months
Re-hospitalization rate due to heart failure
Re-hospitalization rate due to heart failure
Time frame: Up to 12 months
All-cause death or re-hospitalization rate due to heart failure
All-cause death or re-hospitalization rate due to heart failure
Time frame: Up to 12 months
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