ECLS Versus IMPELLA™ as Bridge to LVAD (ECI-BLAD)

Completed

• Conditions: Cardiogenic Shock; End-stage Heart Failure

• Registration Number: NCT04480151
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

In this retrospective observational multicenter study the authors tested the hypothesis that the use of IMPELLA™ pump as bridge to bridge, by giving the opportunity of active rehabilitation, should improve patient's outcomes after the implantation of Left Ventricular Assist Device (LVAD).

Detailed Description

End stage heart failure patients admitted in Intensive Care Unit (ICU) for refractory cardiogenic shock requiring short-term mechanical circulatory support as a bridge to a long-term LVAD might benefit from early mobilization and rehabilitation with IMPELLA™ inserted via the axillary artery. The aim of this study is to compare the early rehabilitation and outcomes after LVAD implantation between patients previously treated by IMPELLA™ or ExtraCorporeal Life Support (ECLS)

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-21
• Study Start: 2021-01-20
• Primary Completion: 2021-04-21
• Study Completion: 2021-04-21
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-06
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• patients supported with IMPELLA™ or ECLS for refractory cardiogenic shock as a bridge to long duration LVAD

Exclusion Criteria

• Patient refusing to give access to their medical chart
• Guardianship and curactorship
• Deprived of liberty
• short term mechanical circulatory system weaned before LVAD implantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8 at 30 days after the LVAD implantation	Day 30 after Left Ventricular Assist Device (LVAD) implantation	Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8) at 30 days after the LVAD implantation

Secondary Outcome Measures

Name	Time	Method
Organ dysfunction before LVAD implantation	The day before LVAD implantation	Need for mechanical ventilation, Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score \[0= best outcome to 24 = worst outcome\]
SOFA score	Day 7 post LVAD implantation	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score \[0= best outcome to 24 = worst outcome\]
length of stay	up to hospital discharge (not more than 6 months after LVAD implantation)	hospital length of stay
Complication and rehabilitation under Short-term Mechanical Circulatory support	The day of Left Ventricular Assist Device (LVAD) implantation	Duration of support, bleeding, hemolysis, surgical re-exploration, thombus, renal replacement therapy, blood products transfusion, stroke, tracheal extubation, mobilization (chair, walking and ergometry)
complication Under LVAD	The day of Intensive Care Unit (ICU) discharge	bleeding, right ventricular dysfunction, vasoplegia
Vital status	6 months after LVAD implantation	mortality after LVAD implantation

Trial Locations

Locations (5)

CHU de Dijon-Bourgoigne; 🇫🇷 Dijon, France

CHU de Montpellier; 🇫🇷 Montpellier, France

CHU de Bordeaux; 🇫🇷 Pessac, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de Toulouse; 🇫🇷 Toulouse, France