Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation (EARLY-UNLOAD)

Chonnam National University

Status: Completed

Conditions: Cardiogenic Shock

Treatments: Procedure: Selective left atrial septostomy; Procedure: Early left atrial septostomy within 12 hours after VA-ECMO implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04775472

CNUH-2020-390

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 116 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Age more than 18 years old 2) Cardiogenic shock* 3) Successful VA-ECMO implantation

• The definition of cardiogenic shock All these criteria should be met

  1. Systolic blood pressure < 90 mmHg for 30 minutes, or needing inotrope or vasopressor to maintain systolic blood pressure > or = 90 mmHg

  2. Pulmonary congestion on chest X-ray or increased left ventricular filling pressure by cardiac catheterization

  3. At least one criteria of organ dysfunction

     • mental obtundation, clammy skin, oliguria, renal dysfunction, increased level of blood lactate

     Exclusion Criteria:

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  1. VA-ECMO after open heart surgery
  2. VA-ECMO for the treatment of non-cardiac shock
  3. Severe bleeding*
  4. Terminal malignancy
  5. Irreversible brain damage
  6. Pregnancy or lactation

• The definition of severe bleeding Hemoglobin decrease after VA-ECMO or cannulation site bleeding is not a exclusion criteria

  1. Hypovolemic shock due to definite bleeding cause
  2. Identifiable bleeding causes: gastrointestinal bleeding, hemothorax, traumatic bleeding, central nervous system hemorrhage, pulmonary hemorrhage

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Early left atrial septostomy group

Experimental group

Description:

Early left atrial septostomy group will routinely receive left atrial septostomy within 12 hours after VA-ECMO implantation.

Treatment:

Procedure: Early left atrial septostomy within 12 hours after VA-ECMO implantation

Conventional approach group

Active Comparator group

Description:

Conventional approach group will receive left atrial septostomy 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.

Treatment:

Procedure: Selective left atrial septostomy