RecruitingNCT06644963

IMPELLA, Complications and Tolerance


Sponsor

University Hospital, Montpellier

Enrollment

800 participants

Start Date

Jan 1, 2010

Study Type

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

Min Age: 18 Years

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

DEVICEImpella (5, 5.5 or CP)

Impella (5, 5.5 or CP) as an isolated circulatory support or combined with others Temporary Mechanical Circulatory Support


Locations(1)

Montpellier university hospital

Montpellier, France

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NCT06644963


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