Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Heart Failure, Left Ventricular Assist Device
Conditions
Keywords
Left Ventricular Assist Device, Extracorporeal Membrane Oxygenation, Refractory Cardiogenic Shock, Heart Failure, Cardiovascular diseases, Myocardial Infarction, Myocardial Ischemia, Shock
Brief summary
Cardiogenic shock is an uncommun pathology with a high mortatily rate around 45%. Veno arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary extracorporeal assist device which restore an adequate blood flow when a circulatory failure occures. VA-ECMO main indication is refractory cardiogenic shock whatever the etiology. Current medical care of terminal cardiac failure includes use of long-term mechanical circulatory support devices (MCSD) such as Left Ventricular Assist Device (LVAD). LVAD therapy may lead to heart transplant (bridge to transplantation), to recovery (bridge to recovery) or to permanent implantation (destination therapy). Few patients with refractory cardiogenic shock treated with VA-ECMO may secondarily need a long term MCSD with LVAD. LVAD long-term heart assist showed interesting survival rate when implantation occured (71% after 2 years follow-up and 45% after 4 years follow-up) out of acute heart failure situation. There are only few datas concerning LVAD implantion during refractory cardiogenic shock, with a mortality between 20 to 50% in different studies. In this way, in comparaison of current few datas on the subject of LVAD implantation under VA-ECMO, the investigators (15 french-speacking centers) would retrospectively describe a large population.
Interventions
DEVICELeft Ventricular Assist Device Implantation
Veno-arterial extracorporeal membrane oxygenation prior to left ventricular assist device implantation : initial patients characteristics and 6 Month Follow-up
Sponsors
Central Hospital, Nancy, France
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veno-arterial ExtraCorporeal Membrane Oxygenation prior to left ventricular assist device implantation. * Veno-arterial ExtraCorporeal Membrane Oxygenation at the left ventricular assist device implantation operative time
Exclusion criteria
* ExtraCorporeal Membrane Oxygenation weaving before left ventricular assist device implantation. * Cardiac assist devices other than Veno-arterial ExtraCorporeal Membrane Oxygenation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month hospital discharge after LVAD implantation | 6 month after LVAD implantation | 6-month hospital discharge after LVAD implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | up to six month after LVAD implantation | ADL and IADL scale |
| Mortality rate | up to six month after LVAD implantation | Six month mortality rate after LVAD implantation |
| ICU discharge | up to six month after LVAD implantation | Days until ICU discharge after LVAD implantation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiogenic failure | Before LVAD implantation - up to 28 day - up to 6 month | Amount of inotrope infused |
| Cardio-circulatory failure | Before LVAD implantation - up to 28 day - up to 6 month | ECLS assistance |
| Thrombosis complication | Before LVAD implantation - up to 28 day - up to 6 month | Thrombosis event |
| Haemorragic complication | Before LVAD implantation - up to 28 day - up to 6 month | Haemorragic event |
| Respiratory failure | Before LVAD implantation - up to 28 day - up to 6 month | Ventilation assistance |
| Neurological failure | Before LVAD implantation - up to 28 day - up to 6 month | neurological sequelae |
| Infection complication | Before LVAD implantation - up to 28 day - up to 6 month | documented infection |
| Renal failure | Before LVAD implantation - up to 28 day - up to 6 month | Worst KDIGO stage |
| Hepatic failure | Before LVAD implantation - up to 28 day - up to 6 month | Worst values of PT/bilirubin/ AST and ALT |
| Hemodynamic Failure | Before LVAD implantation - up to 28 day - up to 6 month | Amount of Norepinephrine infused |
Countries
France
Contacts
Primary ContactCaroline Fritz, MD
Outcome results
None listed