Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644963
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
IMPELLA Complications and Tolerance
Sponsor:
None
Organization:
None
Study Overview
Official Title:
IMPELLA Complications and Tolerance
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT
Brief Summary:
Myocardial infarction complicated by cardiogenic shock AMICS is associated with high morbidity and mortality and devices like Impella CP and Impella 50-55 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 patients 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 50-55 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 50 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 patients blood and the device remains a significant challenge despite advances in Impella technology Balancing prothrombotic and prohemorrhagic forces at the blooddevice 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
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 50 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 patients blood and the device remains a significant challenge despite advances in Impella technology Balancing prothrombotic and prohemorrhagic forces at the blooddevice 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None