Veno-arterial Extracorporeal Membrane Oxygenation Support Prior to Left Ventricular Assist Device Implantation : Initial Patients Characteristics and 6 Month Follow-up, a Retrospective Study (2013-2017) (LVAD-ECMO)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 6-month hospital discharge after LVAD implantation
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •ExtraCorporeal Membrane Oxygenation weaving before left ventricular assist device implantation.
- •Cardiac assist devices other than Veno-arterial ExtraCorporeal Membrane Oxygenation
结局指标
主要结局
6-month hospital discharge after LVAD implantation
时间窗: 6 month after LVAD implantation
6-month hospital discharge after LVAD implantation
次要结局
- Mortality rate(up to six month after LVAD implantation)
- ICU discharge(up to six month after LVAD implantation)
- Quality of life(up to six month after LVAD implantation)
研究者
Caroline FRITZ
MD
Central Hospital, Nancy, France
