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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Extracorporeal Membrane Oxygenation; Cardiogenic Shock; Left Ventricular Assist Device
• Intervention / Treatment: Device: Left Ventricular Assist Device Implantation

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Recruiting
    • Chru Nancy
    • Contact: Caroline FRITZ, MD; Phone Number: +33383157379; Email: c.fritz@chru-nancy.fr
    • Contact: Bruno LEVY, MD-PhD; Phone Number: +33383154469; Email: b.levy@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients between 01.01.2013 and 31.12.2017 in the participating centers implanted with LVAD during VA-ECMO therapy for refractory cardiogenic shock.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-month hospital discharge after LVAD implantation	6-month hospital discharge after LVAD implantation	6 month after LVAD implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	Six month mortality rate after LVAD implantation	up to six month after LVAD implantation
ICU discharge	Days until ICU discharge after LVAD implantation	up to six month after LVAD implantation
Quality of life	ADL and IADL scale	up to six month after LVAD implantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic Failure	Amount of Norepinephrine infused	Before LVAD implantation - up to 28 day - up to 6 month
Cardiogenic failure	Amount of inotrope infused	Before LVAD implantation - up to 28 day - up to 6 month
Cardio-circulatory failure	ECLS assistance	Before LVAD implantation - up to 28 day - up to 6 month
Renal failure	Worst KDIGO stage	Before LVAD implantation - up to 28 day - up to 6 month
Hepatic failure	Worst values of PT/bilirubin/ AST and ALT	Before LVAD implantation - up to 28 day - up to 6 month
Thrombosis complication	Thrombosis event	Before LVAD implantation - up to 28 day - up to 6 month
Haemorragic complication	Haemorragic event	Before LVAD implantation - up to 28 day - up to 6 month
Respiratory failure	Ventilation assistance	Before LVAD implantation - up to 28 day - up to 6 month
Neurological failure	neurological sequelae	Before LVAD implantation - up to 28 day - up to 6 month
Infection complication	documented infection	Before LVAD implantation - up to 28 day - up to 6 month

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Chair: Bruno Levy, MD-PhD, Chru Nancy

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Heart Failure; Shock; Cardiovascular diseases; Myocardial Infarction; Myocardial Ischemia; Extracorporeal Membrane Oxygenation; Left Ventricular Assist Device; Refractory Cardiogenic Shock
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Shock; Myocardial Infarction; Infarction; Heart Failure; Shock, Cardiogenic
• Other Study ID Numbers: PSS2017/LVADECMO-FRITZ/YB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No