Table 3.
Comparison of approved mechanical circulatory support devices and mechanical circulatory support under investigation with publicly available data
| IABP | Impella CP (Abiomed) | Impella 5.5 (Abiomed) | Peripheral VA ECMO | Aortix (Procyrion)a | ModulHeart (Puzzle Medical Devices)a | |
|---|---|---|---|---|---|---|
| Device description | Counter-pulsation balloon | 1 single microaxial pump | 1 single microaxial pump | Extracorporeal centrifugal pumps with oxygenator membrane | 1 single microaxial pump | 3 individual microaxial pumps assembled in parallel in a self-expandable anchor |
| Position | Thoracic aorta | Transvalvular | Transvalvular | Iliofemoral artery and vein | Abdominal aorta | Abdominal aorta |
| Access | 8F catheter, femoral artery | 14F catheter, femoral artery | 23F catheter, axillary artery | ∼15-24F catheter, femoral artery; ∼19-25F catheter, femoral vein |
18F catheter, femoral artery | 22F catheter, femoral artery, 16F catheter next generation |
| Working RPM | N/A | 23,000 RPM for 0.9 L/min, up to 46,000 RPM for 3.7 L/min | 17,000 RPM for up to 1.9 L/min; 33,000 RPM for up to 5.5 L/min | ∼4,000 RPM for ∼4 L/min | 25,000 RPM for ∼3.5 L/min | 14,000 RPM for 4 L/min |
| Maximum flow rate | N/A | Up to 3.7 L/min at 46,000 RPM | Up to 5.5 L/min at 33,000 RPM | Up to ∼8 L/min at ∼5,000 RPM | Up to 5 L/min at 30,000 RPM | Up to 10 L/min at 25,000 RPM |
| Indications | High-risk PCI, cardiogenic shock | High-risk PCI, cardiogenic shock | Cardiogenic shock | Cardiogenic shock | High-risk PCI, ADHF | High-risk PCI, ADHF, CHF |
| Pros | Small insertion profile; low cost; increased coronary flow | Direct LV unloading; approximately small insertion profile | Direct LV unloading | Concomitant gas exchange; high flow rate | Increased renal flow; conceptually no stroke risk | Increased renal flow; self-expandable nitinol anchor; low blood damage; conceptually no stroke risk; high flow rate |
| Cons | Indirect LV unloading; poor degree of unloading | Bleeding; pump stability issues; limited flow rate; hemolysis and vWF degradation; risk of stroke; contraindicated/not ideal in patients with AS, AI, or mechanical AVR; current device not suitable for outpatient use | Large insertion profile; surgical access; pump stability issues; hemolysis and vWF degradation; risk of stroke; contraindicated/not ideal in patients with AS, AI, or mechanical AVR; current device not suitable for outpatient use | Retrograde flow; no LV unloading; large insertion profile; bleeding; limb ischemia | Indirect LV unloading; large insertion profile; risk of blood damage because of a high rotational speed | Indirect LV unloading; large insertion profile in current version (upcoming version <16F and supporting axillary access) |
ADHF, acute decompensated heart failure; AI, aortic insufficiency; AS, aortic stenosis; AVR, aortic valve replacement; CHF, chronic heart failure; VA-ECMO, veno-arterial extracorporeal membrane oxygenation; IABP, intra-aortic balloon pump; LV, left ventricle; N/A, not applicable; PCI, percutaneous coronary intervention; RPM, revolutions per minute; vWF, von Willebrand factor.
a
Investigational devices.