IMPELLA, Complications and Tolerance

NCT06644963 | Recruiting

• 1 other identifier: 2024-08-120
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Shock

Keywords

Impella; pVAD; Bleeding; Thrombosis; hemocompatibily related adverse events

Outcome Measures

Primary Outcomes (1)

• Hemocompatibility related adverse events (HRAEs)

  Incidence of HRAEs with Impella (CP and/or 5 - 5.5) : Bleeding events (BARC \>3b) and Thrombosis events ( ischemic stroke + pump thrombosis)

  From start of hospitalization until hospital discharge, assessed up to 3 month

Secondary Outcomes (5)

• Early mortality

  From start of hospitalization until hospital discharge, assessed up to 3 month

• Adverse events related to Impella devices

  From start of hospitalization until hospital discharge assessed up to 3 month

• Duration of mechanical ventilation

  From start of hospitalization until hospital discharge, assessed up to 3 month

• Lengh of stay

  From start of hospitalization until hospital discharge, assessed up to 3 month

• Cardiac long-term project

  From start of hospitalization until hospital discharge assessed up to 3 month

Interventions

Impella (5, 5.5 or CP) DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All 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)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier university hospital

Montpellier, 34295, France

RECRUITING

Related Publications (6)

• Van Edom CJ, Gramegna M, Baldetti L, Beneduce A, Castelein T, Dauwe D, Frederiks P, Giustino G, Jacquemin M, Janssens SP, Panoulas VF, Poss J, Rosenberg A, Schaubroeck HAI, Schrage B, Tavazzi G, Vanassche T, Vercaemst L, Vlasselaers D, Vranckx P, Belohlavek J, Gorog DA, Huber K, Mebazaa A, Meyns B, Pappalardo F, Scandroglio AM, Stone GW, Westermann D, Chieffo A, Price S, Vandenbriele C. Management of Bleeding and Hemolysis During Percutaneous Microaxial Flow Pump Support: A Practical Approach. JACC Cardiovasc Interv. 2023 Jul 24;16(14):1707-1720. doi: 10.1016/j.jcin.2023.05.043.

  PMID: 37495347 RESULT

• Vandenbriele C, Arachchillage DJ, Frederiks P, Giustino G, Gorog DA, Gramegna M, Janssens S, Meyns B, Polzin A, Scandroglio M, Schrage B, Stone GW, Tavazzi G, Vanassche T, Vranckx P, Westermann D, Price S, Chieffo A. Anticoagulation for Percutaneous Ventricular Assist Device-Supported Cardiogenic Shock: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 May 17;79(19):1949-1962. doi: 10.1016/j.jacc.2022.02.052.

  PMID: 35550692 RESULT

• Philipson DJ, Cohen DJ, Fonarow GC, Ziaeian B. Analysis of Adverse Events Related to Impella Usage (from the Manufacturer and User Facility Device Experience and National Inpatient Sample Databases). Am J Cardiol. 2021 Feb 1;140:91-94. doi: 10.1016/j.amjcard.2020.10.056. Epub 2020 Nov 2.

  PMID: 33147430 RESULT

• Amin AP, Spertus JA, Curtis JP, Desai N, Masoudi FA, Bach RG, McNeely C, Al-Badarin F, House JA, Kulkarni H, Rao SV. The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support. Circulation. 2020 Jan 28;141(4):273-284. doi: 10.1161/CIRCULATIONAHA.119.044007. Epub 2019 Nov 17.

  PMID: 31735078 RESULT

• Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz A, Masoudi FA, Messenger JC, Parzynski CS, Ngufor C, Girotra S, Amin AP, Shah ND, Desai NR. Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA. 2020 Feb 25;323(8):734-745. doi: 10.1001/jama.2020.0254.

  PMID: 32040163 RESULT

• Moller JE, Engstrom T, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Werner N, Frydland M, Holmvang L, Kjaergaard J, Sorensen R, Lonborg J, Lindholm MG, Udesen NLJ, Junker A, Schmidt H, Terkelsen CJ, Christensen S, Christiansen EH, Linke A, Woitek FJ, Westenfeld R, Mobius-Winkler S, Wachtell K, Ravn HB, Lassen JF, Boesgaard S, Gerke O, Hassager C; DanGer Shock Investigators. Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med. 2024 Apr 18;390(15):1382-1393. doi: 10.1056/NEJMoa2312572. Epub 2024 Apr 7.

  PMID: 38587239 RESULT

MeSH Terms

Conditions

Shock, Cardiogenic; Hemorrhage; Thrombosis

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock; Embolism and Thrombosis

Study Officials

• Aurore UGHETTO, MD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurore UGHETTO, MD

CONTACT

+33622054893; a-ughetto@chu-montpellier.fr

Clément DELMAS, MD, PhD

CONTACT

+330673147951; clement23185@hotmail.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 16, 2024
• Study Start: January 1, 2010
• Primary Completion: January 1, 2023
• Study Completion: January 30, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

FR (1)