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    Interventional procedure overview of surgical insertion of a catheter-based intravascular microaxial flow pump for cardiogenic shock

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    Existing assessments of this procedure

    The European Society of Cardiology 2021 guidelines for the diagnosis and treatment of acute and chronic heart failure recommends 'Short-term MCS should be considered in patients with cardiogenic shock as a BTR, BTD, BTB. Further indications include treatment of the cause of cardiogenic shock or long-term MCS or transplantation.' The class of recommendation is 2a (Conflicting evidence or divergence of opinion; weight of evidence or opinion is in favour of usefulness or efficacy) and the level of evidence is C (Consensus of opinion of the experts or small studies, retrospective studies, registries).

    The Australian Government's Medical Services Advisory Committee (MSAC) assessed transluminal insertion, management and removal of an intravascular microaxial blood pump (Impella), for patients requiring mechanical circulatory support in April 2024. The consumer summary states:

    'MSAC noted that the clinical evidence for IMPELLA and ECPELLA was of high risk of bias, which created uncertainty in the conclusions made on this evidence. However, MSAC acknowledged cardiogenic shock is an emergency condition, which makes it difficult to conduct a low risk of bias trial where the safety and effectiveness of intervention is directly compared to the comparator by randomly assigning patients to either the intervention or comparator arm (i.e. a randomised controlled trial). Overall, MSAC considered that in this small population of high-risk patients, the low certainty evidence indicated that IMPELLA and ECPELLA provided a small but important reduction in mortality in the short-term (i.e. 30 days) and likely resulted in reduced mortality in the longer-term (i.e. at 6 and 12 months). MSAC noted uncertainty when considering whether IMPELLA and ECPELLA represented good value for money. However, MSAC considered that there is a clinical need for the intervention for the proposed small number of high-risk patients who are acutely unwell, and funding the intervention may provide a small cost saving to the MBS and a low financial impact to private health insurers.'

    The American College of Cardiology Foundation and the American Heart Association, Inc. have published a 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. The recommendations state:

    • "In selected patients with STEMI and severe or refractory cardiogenic shock, insertion of a microaxial intravascular flow pump is reasonable to avoid death."

    Class of recommendation: moderate; level of evidence: moderate quality of evidence from 1 or more RCTs, meta-analysis of moderate quality RCTs.

    • "In patients with mechanical complication of ACS, short-term MCS devices are reasonable for hemodynamic stabilization as a bridge to surgery."

    Class of recommendation: moderate; level of evidence: moderate quality of evidence from 1 or more well designed, well executed nonrandomized studies, observational studies or registry studies, or meta-analyses of such studies.

    • "In patients with AMI and cardiogenic shock, the routine use of IABP or VA-ECMO is not recommended due to a lack of survival benefit."

    Class of recommendation: No benefit (moderate); level of evidence: moderate quality of evidence from 1 or more RCTs, meta-analysis of moderate quality RCTs.