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The EVOLVE-ECMO(Early Left Atrial Venting Versus Conventional Treatment For Left VEntricular Decompression During Venoarterial ExtraCorporeal Membrane Oxygenation Support) study is a randomized controlled trial to evaluate the prognostic effect of early LA venting(when detect B-line on serial lung ultrasound) on weaning VA-ECMO support in refractory CS who receive VA-ECMO support. The aim of EVOLVE-ECMO trial is to test the hypothesis that early LA venting would result in a significant reduction in failure of weaning ECMO support in refractory CS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early LA venting | Experimental | When detect B-line on serial lung ultrasound, we will perform early LA venting for improving LV distention in patients with refractory cardiogenic shock who received VA-ECMO support. |
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| Conventional LA venting | Active Comparator | When detect refractory pulmonary congestion on chest radiograph or inadequate AV opening on serial echocardiography, we will perform LA venting for improving LV distention in patients with refractory cardiogenic shock who received VA-ECMO support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left atrial venting | Procedure | The contralateral femoral vein is assessed with an 7-French(Fr) sheath() and femoral artery is assessed with 5-Fr sheath( ) for fluoroscopic guidance using 5-Fr pig-tail catheter. In some cases trans-esophageal echo is used. The inter-atrial septum in punctured with a standard BRK™tran-septal needle(St. Jude Medical Inc., St. Paul, MN) under direct visualization via an 8-Fr Mullin sheath(St. Jude Medical Inc.). A SAFARI™(Boston Scientific, Galway, Ireland) guidewire is advanced into the LA. An 8-Fr Mullin-sheath is removed and atrial septostomy is performed using 21-Fr dilator. A 17-Fr or 21-Fr Biomedicus Percutaneous Femoral cannula(Medtronic Inc., Minneapolis, MN) is then placed in the LA and was attached to the ECMO circuit using a Y connector. |
| Measure | Description | Time Frame |
|---|---|---|
| weaning rate of VA-ECMO | Weaning of VA-ECMO support | during index admission |
| Measure | Description | Time Frame |
|---|---|---|
| In hospital mortality | during index admission | |
| Adverse outcome due to LA venting | during index admission | |
| Free days for mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 05505 | South Korea |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D011654 | Pulmonary Edema |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Randomized controlled test
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|
| during index admission |
| Success rate to heart transplantation | during index admission |
| rate of improving for pulmonary edema | during index admission |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |