IMPELLA, Complications and Tolerance
University Hospital, Montpellier
800 participants
Jan 1, 2010
OBSERVATIONAL
Conditions
Summary
Myocardial infarction complicated by cardiogenic shock (AMICS) is associated with high morbidity and mortality, and devices like Impella® CP and Impella 5.0-5.5 are often used for hemodynamic support, either alone or combined with veno-arterial ECMO (ECMELLA). While recent studies suggest improved survival with Impella® in cardiogenic shock, complications remain common, particularly due to deep arterial access and the need for anticoagulation. Hemocompatibility-related adverse events (HRAEs) such as ischemia, bleeding (44%), hemolysis (32%), and stroke (13%) frequently occur. Achieving hemocompatibility between the patient's blood and the device is challenging, as pump flow, anticoagulation, and patient factors contribute to both thrombotic and hemorrhagic complications. Despite advances, further research is required to better understand and reduce these risks in clinical practice.
Eligibility
Inclusion Criteria1
- Adult patients admitted for cardiogenic shock supported by Impella (5, 5.5 or CP) between January 1, 2010, and December 31, 2022 (as an isolated circulatory support or combined with others Temporary Mechanical Circulatory Support)
Exclusion Criteria3
- Absence of Impella
- Impella 2.5
- Impella RP (right)
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Interventions
Impella (5, 5.5 or CP) as an isolated circulatory support or combined with others Temporary Mechanical Circulatory Support
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06644963