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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Cardiogenic Shock, End-stage Heart Failure

Intervention / Treatment
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* Other: standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IMPELLA™ alone as bridge to LVAD<br>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<br>* retrospective study: standard of care<br>|
| ECLS alone or with IMPELLA™ as bridge to LVAD<br>patients assisted by ECLS (ExtraCorporeal life support) alone or simultaneously with IMPELLA™ until the implantation of LVAD | Other: standard of care<br>* retrospective study: standard of care<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiogenic shock, end stage heart failure, bridge to bridge, bridge to decision, left ventricular assist device, IMPELLA™, ECLS