Related Experiment Video
Updated: Aug 20, 2025
In Vitro Thrombosis Test for Ventricular Assist Devices
Published on: March 21, 2025
Randomized Trials of Percutaneous Microaxial Flow Pump Devices: JACC State-of-the-Art Review
Mohit Pahuja1, Adam Johnson2, Ryan Kabir3
1Department of Cardiology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, USA. Electronic address: https://twitter.com/MohitpahujaMD.
Insights
Mechanical circulatory support devices, like the Impella pump, are increasingly used for heart conditions. However, limited trials and concerns about complications like bleeding and stroke warrant further investigation.
Area of Science:
- Cardiovascular Medicine
- Medical Devices
- Interventional Cardiology
Background:
- Mechanical circulatory support (MCS) devices have seen a significant rise in cardiovascular practice.
- These devices provide hemodynamic support for conditions including cardiogenic shock, high-risk percutaneous coronary intervention, and right ventricular failure.
- Impella percutaneous microaxial flow pumps are gaining popularity.
Purpose of the Study:
- To review the current landscape of Impella devices in cardiovascular practice.
- To summarize existing randomized clinical trial (RCT) data and highlight upcoming RCTs.
- To address concerns regarding complication rates associated with these devices.
Main Methods:
- Review of historical data and mechanism of action for Impella devices.
- Analysis of previously published randomized clinical trial (RCT) data.
- Identification and summary of ongoing and upcoming RCTs.
- Compilation of reported complication rates, including vascular issues and cardiac events.
Main Results:
- Increasing utilization of Impella devices for various cardiovascular indications.
- Limited availability of robust randomized clinical trial (RCT) evidence supporting therapeutic benefits.
- Noted complication rates, including vascular problems (bleeding, acute limb ischemia), cardiac perforations, mitral chordae rupture, and stroke.
Conclusions:
- While Impella devices offer potential hemodynamic support, evidence from RCTs is limited.
- Concerns regarding complication rates necessitate careful patient selection and monitoring.
- Further high-quality RCTs are crucial to establish the definitive benefits and risks of Impella therapy.
Abstract:
The use of mechanical circulatory support devices in cardiovascular practice has risen exponentially over the past decade. These devices are currently used for hemodynamic support in patients with cardiogenic shock, high-risk percutaneous coronary intervention, left ventricular unloading, protection of kidneys, and right ventricular failure. The Impella (Abiomed) percutaneous microaxial flow pump devices are rapidly gaining popularity. However, despite their increasing use, there are limited randomized clinical trials (RCTs) to support the benefits of the therapy and growing concern regarding complication rates. Vascular problems, including bleeding and acute limb ischemia, are associated with the devices, but published reports also highlight risks for cardiac perforations, mitral chordae rupture, and stroke. In this review, we summarize the history, mechanism of action, previously published RCT data, and upcoming RCTs on these devices.
