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

University Hospital of Bordeaux

Status: Completed

Conditions: End-stage Heart Failure; Cardiogenic Shock

Treatments: Other: standard of care

Study type: Observational

Funder types: Other

Identifiers

NCT04480151

CHUBX 2020/37

Details and patient eligibility

About

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).

Full 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)

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

92 participants in 2 patient groups

IMPELLA™ alone as bridge to LVAD

Description:

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)

Treatment:

Other: standard of care

ECLS alone or with IMPELLA™ as bridge to LVAD

Description:

patients assisted by ECLS (ExtraCorporeal life support) alone or simultaneously with IMPELLA™ until the implantation of LVAD

Treatment:

Other: standard of care