Surgical Applications

Clinical Evidence

Clinical Evidence for Impella® Heart Pumps in Cardiac Surgery

Find out all about the current clinical evidence for Impella heart pumps in cardiac surgery. Discover video reports, our clinical guidelines and the EAPCI/ACVC expert consensus document.

RECOVER I Data¹

Haemodynamic parameters improved immediately after placement of the Impella 5.0® heart pump, resulting in an increase in the mean cardiac index (CI) from 1.4 to 2.5 L/min/m2 and a MAD increase from 71 mmHg to 83 mmHg.

94 %

survival to 1 month
81 %

survival to 6 months
75%

survival to 1 month after cardiogenic shock following cardiotomy

EACTS 2021 - 5.5 New Opportunities in Validation – The Impact Trial

Prof. Reichenspurner from Hamburg (Germany) presented the study design of the initial pilot trial of the IMpella Protected cArdiac surgery Trial (IMPACT).

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Current And Future Clinical Trials

Study by the National Cardiogenic Shock Initiative (NCSI)

By using the NCSI study algorithm, this study aims to improve mortality in patients with cardiogenic shock after AMI. The algorithm includes early detection of shock, use of Impella® therapy prior to PCI, reduction in the use of inotropes and the use of invasive haemodynamic monitoring to aid escalation and weaning.

IMPACT: study on protected cardiac surgery with Impella

This upcoming study will evaluate the perioperative use of Impella 5.5® with SmartAssist® in high-risk surgical patients.

Pivotal randomised, controlled trial of door-to-unloading (DTU) in STEMI

In this study, patients undergoing treatment for ST-elevation myocardial infarction (STEMI) and who are not in cardiogenic shock will be randomised to either 30 minutes of Impella CP® unloading before reperfusion or the standard of care with immediate PCI.

Surgical Best Practices and Algorithms for Treatments for Cardiogenic Shock

Cardiothoracic surgeon Mark Anderson, MD, discussed improving patient outcomes in cardiogenic shock through the early use of mechanical circulatory support and developing shock protocols with a cardiac team.

Clinical Guidelines

Here you can download clinical guidelines for Impella heart pumps in cardiac surgery.

Additional Resources

Patient Identification

Find out which patients are eligible for support with Impella heart pumps.

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Patient Management

Learn more about patient management topics such as mobilisation or checklists.

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Procedure

Discover information on how to use Impella heart pumps, with step-by-step instructions.

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References

Griffith B.P., et al., (2013). J Thorac Cardiovasc Surg. 145(2), 548-554.

Clinical Evidence