Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation

Not Applicable

Completed

• Conditions: Cardiogenic Shock
• Interventions: Procedure: Early left atrial septostomy within 12 hours after VA-ECMO implantation; Procedure: Selective left atrial septostomy

• Registration Number: NCT04775472
• Lead Sponsor: Chonnam National University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-01
• Study Start: 2021-03-04
• Primary Completion: 2022-03-14
• Study Completion: 2023-10-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early left atrial septostomy group	Early left atrial septostomy within 12 hours after VA-ECMO implantation	Early left atrial septostomy group will routinely receive left atrial septostomy within 12 hours after VA-ECMO implantation.
Conventional approach group	Selective left atrial septostomy	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.

Primary Outcome Measures

Name	Time	Method
Cumulative incidence rate of all-cause death	Up to 30 days	Cumulative incidence rate of all-cause death

Secondary Outcome Measures

Name	Time	Method
Lactate clearance rate	Up to 30 days	Lactate clearance rate
Cumulative incidence rate of non-cardiac death	Up to 12 months	Cumulative incidence rate of non-cardiac death
Weaning rate from mechanical ventilator during index admission	Up to 6 months	Weaning rate from mechanical ventilator during index admission
Rate of transient ischemic attack or stroke during index admission	Up to 6 months	Rate of transient ischemic attack or stroke during index admission
Rate of BARC bleeding type 3 or 5 during index admission	Up to 6 months	Rate of BARC bleeding type 3 or 5 during index admission
Cumulative incidence rate of cardiac death	Up to 12 months	Cumulative incidence rate of cardiac death
Rate of all-cause death or left atrial septostomy in conventional approach group	Up to 30 days	Rate of all-cause death or left atrial septostomy in conventional approach group
Rate of left atrial septostomy in conventional approach group	Up to 30 days	Rate of left atrial septostomy in conventional approach group
Incidence rate of all-cause death during index admission	Up to 6 months	Incidence rate of all-cause death during index admission
Hospital length of stay	Up to 6 months	Hospital length of stay
Lactate normalization rate	Up to 30 days	Lactate normalization rate
Rate of renal replacement therapy during index admission	Up to 6 months	Rate of renal replacement therapy during index admission
Rate of bridge to ventricular assist device or heart transplantation during index admission	Up to 6 months	Rate of bridge to ventricular assist device or heart transplantation during index admission
Cumulative incidence rate of all-cause death	Up to 12 months	Cumulative incidence rate of all-cause death
Re-hospitalization rate due to heart failure	Up to 12 months	Re-hospitalization rate due to heart failure
All-cause death or re-hospitalization rate due to heart failure	Up to 12 months	All-cause death or re-hospitalization rate due to heart failure
Weaning rate from venoarterial extracorporeal membrane oxygenation during index admission	Up to 6 months	Weaning rate from venoarterial extracorporeal membrane oxygenation during index admission
Rate of disappearance of pulmonary edema on chest X-ray during index admission	Up to 6 months	Rate of disappearance of pulmonary edema on chest X-ray during index admission
Intensive care unit length of stay during index admission	Up to 6 months	Intensive care unit length of stay during index admission
Rate of limb ischemia during index admission	Up to 6 months	Rate of limb ischemia during index admission
Rate of infection during index admission	Up to 6 months	Rate of infection during index admission
Rate of major vascular injury or cardiac tamponade during left atrial septostomy	Up to 30 days	Rate of major vascular injury or cardiac tamponade during left atrial septostomy

Trial Locations

Locations (1)

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of