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

ExtraCorporeal Life Support (ECLS) Versus IMPELLA™ Pump as Bridge to Left Ventricular Assist Device

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).

Study Overview

• Status: Completed
• Conditions: Cardiogenic Shock; End-stage Heart Failure
• Intervention / Treatment: Other: standard of care

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 Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • CHU de Dijon-Bourgoigne
  • Montpellier, France, 34295
    • CHU de Montpellier
  • Pessac, France, 33604
    • CHU de Bordeaux
  • Rennes, France, 35000
    • CHU de Rennes
  • Toulouse, France, 31059
    • CHU de Toulouse

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: Probability Sample

Study Population

consecutive patients implanted by IMPELLA™ pump or ECLS as a bridge to long duration LVAD between January 2012 and December 2018 in five university hospital centers.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IMPELLA™ alone as bridge to LVAD; patients assisted by IMPELLA™ pump alone during the days preceding the implantation of long term LVAD (at least 48 hours for patients for whom an ECLS was previously used)	Other: standard of care; retrospective study: standard of care
ECLS alone or with IMPELLA™ as bridge to LVAD; patients assisted by ECLS (ExtraCorporeal life support) alone or simultaneously with IMPELLA™ until the implantation of LVAD	Other: standard of care; retrospective study: standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication and rehabilitation under Short-term Mechanical Circulatory support	Duration of support, bleeding, hemolysis, surgical re-exploration, thombus, renal replacement therapy, blood products transfusion, stroke, tracheal extubation, mobilization (chair, walking and ergometry)	The day of Left Ventricular Assist Device (LVAD) implantation
Organ dysfunction before LVAD implantation	Need for mechanical ventilation, Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]	The day before LVAD implantation
complication Under LVAD	bleeding, right ventricular dysfunction, vasoplegia	The day of Intensive Care Unit (ICU) discharge
SOFA score	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]	The day of Short Term Mechanical Circulatory Support (STMCS) implantation
SOFA score	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]	The day of LVAD implantation
SOFA score	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]	Day 1 post LVAD implantation
SOFA score	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]	Day 3 post LVAD implantation
SOFA score	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]	Day 5 post LVAD implantation
SOFA score	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]	Day 7 post LVAD implantation
Vital status	mortality after LVAD implantation	1 month after LVAD implantation
Vital status	mortality after LVAD implantation	3 months after LVAD implantation
Vital status	mortality after LVAD implantation	6 months after LVAD implantation
length of stay	Intensive Care Unit length of stay	up to Intensive Care Unit (ICU) discharge (not more than 6 months after LVAD implantation)
length of stay	hospital length of stay	up to hospital discharge (not more than 6 months after LVAD implantation)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): April 21, 2021
• Study Completion (Actual): April 21, 2021

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: left ventricular assist device; cardiogenic shock; ECLS; end stage heart failure; bridge to bridge; bridge to decision; IMPELLA™
• 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: CHUBX 2020/37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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