IMPELLA, Complications and Tolerance

Recruiting

• Conditions: Cardiogenic Shock

• Registration Number: NCT06644963
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed Description

Myocardial infarction complicated by cardiogenic shock (AMICS) is associated with high rates of morbidity and mortality. To provide hemodynamic support in these cases, intravascular microaxial left ventricular assist devices, such as Impella® CP and Impella 5.0-5.5, are frequently used, either alone in cardiogenic shock (CS) or in combination with veno-arterial ECMO (known as ECMELLA) for left ventricular unloading. Recent observational studies and randomized controlled trials have suggested improved survival rates with the use of Impella® in cardiogenic shock patients.

Despite the growing use of these devices, complications in clinical practice remain frequent. Due to the need for deep arterial access (14F for Impella CP and 21F for Impella 5.0) via femoral or axillary routes, as well as the necessity of anticoagulation, hemocompatibility-related adverse events (HRAEs) such as ischemic complications and bleeding are common, occurring in 18% and 44% of patients, respectively. Hemolysis has been reported in up to 32% of cases, while stroke affects up to 13%. Other less frequent complications include device deployment issues, pump thrombosis, implant site infections, and sepsis, all contributing to increased healthcare costs.

Achieving hemocompatibility between the patient's blood and the device remains a significant challenge despite advances in Impella technology. Balancing prothrombotic and prohemorrhagic forces at the blood/device interface is complex. This interface activates the coagulation cascade, generating a prothrombotic state, damaging von Willebrand multimers, and leading to hemolysis. The interplay of pump flow, pump speed, patient risk factors, and clinical management (anticoagulation) further complicates hemocompatibility, often resulting in thrombotic or bleeding events such as hemorrhagic stroke, circuit clots, or ischemic stroke.

Although the occurrence of HRAEs is well documented, particularly in the case of severe events like stroke, there is still an incomplete understanding of the factors driving these complications in modern clinical practice. Further research is needed to better delineate the risk factors and improve outcomes for patients receiving Impella support.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2023-01-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• 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 Criteria

• Absence of Impella
• Impella 2.5
• Impella RP (right)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemocompatibility related adverse events (HRAEs)	From start of hospitalization until hospital discharge, assessed up to 3 month	Incidence of HRAEs with Impella (CP and/or 5 - 5.5) : Bleeding events (BARC \>3b) and Thrombosis events ( ischemic stroke + pump thrombosis)

Secondary Outcome Measures

Name	Time	Method
Early mortality	From start of hospitalization until hospital discharge, assessed up to 3 month	In-hospital all-cause mortality
Adverse events related to Impella devices	From start of hospitalization until hospital discharge assessed up to 3 month	Hemolysis; Bacteremia; Infection of the device insertion site or the device itself
Duration of mechanical ventilation	From start of hospitalization until hospital discharge, assessed up to 3 month	Total duration of invasive mechanical ventilation
Lengh of stay	From start of hospitalization until hospital discharge, assessed up to 3 month	Total and in intensive care unit lenght of stay
Cardiac long-term project	From start of hospitalization until hospital discharge assessed up to 3 month	Rate and % of patients with myocardial recovery, ventricular assist device or/and heart transplantation

Trial Locations

Locations (1)

Montpellier university hospital; 🇫🇷 Montpellier, France