Overview
The goal of this multicenter, randomized trial is to compare early early left ventricular unloading by Intra-aortic Balloon Pump (IABP) versus conventional approach in patients with cardiogenic shock (CS) undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO). The main question it aims to answer is :
• If left ventricular unloading by IABP as compared with the conventional approach will improve the outcomes in patients undergoing VA-ECMO.
Description
The role of IABP combined with VA-ECMO in patients with CS remains unclear. Therefore, investigators will conduct a prospective randomized clinical trial to explore the effect of early IABP use for LV unloading after VA-ECMO on outcomes in patients with CS. Investigators will randomly assign 358 patients receiving peripheral VA-ECMO to the ECMO+IABP group (n=179) or the ECMO group (n=179). The primary end point was the 30-day mortality.
Eligibility
Inclusion Criteria:
- Age of ≥18
- Cardiogenic shock(defined as a systolic blood pressure of less than 90 mm Hg for more than 30 minutes or the initiation of catecholamines to maintain a systolic pressure of more than 90 mm Hg, an arterial lactate level of more than 3 mmol per liter, and signs of impaired organ perfusion)
- Successful implantation of VA-ECMO
- Informed consent
Exclusion Criteria:
- SCAI shock stage A or B
- Presence of moderate to severe aortic insufficiency or aortic dissection
- Severe peripheral vascular disease
- Post-cardiotomy cardiogenic shock(non-CABG procedure) or bridging to cardiac procedure(heart transplantation or LVAD).
- VA-ECMO for definite non-cardiac causes
- Isolated right ventricular failure
- V-A ECMO usage confined to the period during surgery or other interventions
- Ischemic mechanical complications(eg Ventricular septal defect, papillary muscle rupture)
- Extracorporeal cardiopulmonary resuscitation
- LVAD, Impella or IABP in situ.
- Severe bleeding
- Terminal malignancy
- Irreversible neurologic injury
- Pregnancy or lactation
