Clinical trial NCT04775472: Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation
Official title: Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiogenic Shock
Keywords: Extracorporeal membrane oxygenation
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Coronary Disease
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 116
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Cumulative incidence rate of all-cause death
timeFrame: Up to 30 days
Secondary outcomes:
measure: Rate of all-cause death or left atrial septostomy in conventional approach group
timeFrame: Up to 30 days
measure: Rate of left atrial septostomy in conventional approach group
timeFrame: Up to 30 days
measure: Incidence rate of all-cause death during index admission
timeFrame: Up to 6 months
measure: Cumulative incidence rate of cardiac death
timeFrame: Up to 30 days
measure: Cumulative incidence rate of non-cardiac death
timeFrame: Up to 30 days
measure: Weaning rate from venoarterial extracorporeal membrane oxygenation during index admission
timeFrame: Up to 6 months
measure: Rate of disappearance of pulmonary edema on chest X-ray during index admission
timeFrame: Up to 6 months
measure: Weaning rate from mechanical ventilator during index admission
timeFrame: Up to 6 months
measure: Intensive care unit length of stay during index admission
timeFrame: Up to 6 months
measure: Hospital length of stay
timeFrame: Up to 6 months
measure: Lactate normalization rate
timeFrame: Up to 30 days
measure: Lactate clearance rate
timeFrame: Up to 30 days
measure: Rate of renal replacement therapy during index admission
timeFrame: Up to 6 months
measure: Rate of limb ischemia during index admission
timeFrame: Up to 6 months
measure: Rate of infection during index admission
timeFrame: Up to 6 months
measure: Rate of transient ischemic attack or stroke during index admission
timeFrame: Up to 6 months
measure: Rate of BARC bleeding type 3 or 5 during index admission
timeFrame: Up to 6 months
measure: Rate of bridge to ventricular assist device or heart transplantation during index admission
timeFrame: Up to 6 months
measure: Rate of major vascular injury or cardiac tamponade during left atrial septostomy
timeFrame: Up to 30 days
measure: Cumulative incidence rate of all-cause death
timeFrame: Up to 12 months
measure: Cumulative incidence rate of cardiac death
timeFrame: Up to 12 months
measure: Cumulative incidence rate of non-cardiac death
timeFrame: Up to 12 months
measure: Re-hospitalization rate due to heart failure
timeFrame: Up to 12 months
measure: All-cause death or re-hospitalization rate due to heart failure
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Min Chul Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References: