LVAD-ECMO: Veno-arterial Extracorporeal Membrane Oxygenation Prior to Left Ventricular Assist Device Implantation.

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT03583970

Collaborator

(none)

100

Enrollment

Location

28.9

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock Heart Failure Extracorporeal Membrane Oxygenation Left Ventricular Assist Device	Device: Left Ventricular Assist Device Implantation

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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)

Actual Study Start Date :

Jul 5, 2018

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Dec 1, 2020

Outcome Measures

Primary Outcome Measures

6-month hospital discharge after LVAD implantation [6 month after LVAD implantation]
6-month hospital discharge after LVAD implantation

Secondary Outcome Measures

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
Quality of life [up to six month after LVAD implantation]
ADL and IADL scale

Other Outcome Measures

Hemodynamic Failure [Before LVAD implantation - up to 28 day - up to 6 month]
Amount of Norepinephrine infused
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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