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First-in-human experience with Aortix intraaortic pump.

Amit N Vora1, William Schuyler Jones1, Adam D DeVore1

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PubMed
Summary

This study shows the novel Aortix percutaneous mechanical circulatory support (pMCS) device is safe and feasible for high-risk percutaneous coronary intervention (PCI) patients, improving urine output and potentially renal function.

Keywords:
first-in-humanhigh-risk PCIleft ventricular dysfunctionpercutaneous mechanical circulatory support

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Area of Science:

  • Cardiology
  • Medical Devices
  • Renal Medicine

Background:

  • Limited percutaneous mechanical circulatory support (pMCS) options exist for high-risk percutaneous coronary intervention (PCI).
  • High-risk PCI patients often have impaired cardiac and renal function.

Purpose of the Study:

  • To evaluate the safety and feasibility of the novel Aortix pMCS device.
  • To assess the Aortix device's impact on hemodynamics, urine output, and renal function in high-risk PCI patients.

Main Methods:

  • First-in-human, single-center study involving six high-risk PCI patients with impaired left ventricular function and renal dysfunction.
  • Aortix device deployed via femoral artery into the descending aorta.
  • Monitored hemodynamic effects, urine output, and followed patients for 30 days post-procedure.

Main Results:

  • Successful deployment and retrieval of the Aortix device in all patients.
  • Mean urine output increased 10-fold during support.
  • Estimated glomerular filtration rate (eGFR) showed improvement post-procedure.
  • No device failures, vascular complications, or significant hemolysis observed.

Conclusions:

  • The Aortix pMCS device is safe and feasible for high-risk PCI.
  • Temporary use of the axial flow device did not cause significant hemolysis.
  • Potential renal protective effects warrant further investigation in patients with cardiac and renal dysfunction.