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

University Hospital, Bordeaux92 enrolled

Overview

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).

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

Conditions

Cardiogenic Shock End-stage Heart Failure

Interventions

standard of careOTHER

retrospective study: standard of care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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

Time frame: Day 30 after Left Ventricular Assist Device (LVAD) implantation

Secondary Outcomes

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)

Time frame: 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 \[0= best outcome to 24 = worst outcome\]

Time frame: The day before LVAD implantation

complication Under LVAD

bleeding, right ventricular dysfunction, vasoplegia

Time frame: The day of Intensive Care Unit (ICU) discharge

SOFA score

Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score \[0= best outcome to 24 = worst outcome\]

Time frame: The day of Short Term Mechanical Circulatory Support (STMCS) implantation

SOFA score

Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score \[0= best outcome to 24 = worst outcome\]

Data from ClinicalTrials.gov

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