NCT04775472

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

Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Chonnam National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiogenic Shock

Interventions

Type	Name	Description
PROCEDURE	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. Left atrial septostomy will be done using percutaneous technique.
PROCEDURE	Selective left atrial septostomy	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.

Timeline

• Start date: 2021-03-04
• Primary completion: 2022-03-14
• Completion: 2023-10-31
• First posted: 2021-03-01
• Last updated: 2024-01-12

Locations

1 site across 1 country: South Korea