Clinical trial NCT04480151: ECLS Versus IMPELLA™ as Bridge to LVAD (ECI-BLAD)
Official title: ExtraCorporeal Life Support (ECLS) Versus IMPELLA™ Pump as Bridge to Left Ventricular Assist Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiogenic Shock
End-stage Heart Failure
Keywords: cardiogenic shock
end stage heart failure
bridge to bridge
bridge to decision
left ventricular assist device
IMPELLA™
ECLS
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Day 30 after Left Ventricular Assist Device (LVAD) implantation
Secondary outcomes:
measure: Complication and rehabilitation under Short-term Mechanical Circulatory support
timeFrame: The day of Left Ventricular Assist Device (LVAD) implantation
measure: Organ dysfunction before LVAD implantation
timeFrame: The day before LVAD implantation
measure: complication Under LVAD
timeFrame: The day of Intensive Care Unit (ICU) discharge
measure: SOFA score
timeFrame: The day of Short Term Mechanical Circulatory Support (STMCS) implantation
measure: SOFA score
timeFrame: The day of LVAD implantation
measure: SOFA score
timeFrame: Day 1 post LVAD implantation
measure: SOFA score
timeFrame: Day 3 post LVAD implantation
measure: SOFA score
timeFrame: Day 5 post LVAD implantation
measure: SOFA score
timeFrame: Day 7 post LVAD implantation
measure: Vital status
timeFrame: 1 month after LVAD implantation
measure: Vital status
timeFrame: 3 months after LVAD implantation
measure: Vital status
timeFrame: 6 months after LVAD implantation
measure: length of stay
timeFrame: up to Intensive Care Unit (ICU) discharge (not more than 6 months after LVAD implantation)
measure: length of stay
timeFrame: up to hospital discharge (not more than 6 months after LVAD implantation)
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon-Bourgoigne
city: Montpellier
country: France
facility: CHU de Montpellier
city: Pessac
country: France
facility: CHU de Bordeaux
city: Rennes
country: France
facility: CHU de Rennes
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Bordeaux
name: Alexandre OUATTARA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: