SAFE-IMPELLA Under Early Bird® Surveillance

Philippe Généreux, MD – Morristown Medical Center

Background

The Early Bird Bleed Monitoring System detects internal bleeding complications, enabling physicians to mitigate downstream consequences by immediately addressing the bleed.

Case

  • 85-year-old male
  • 3Vx disease with severe left main
  • EF25%
  • Severe AS and Severe MR
  • BAV 24mm True Balloon, followed byImpella CP® insertion
  • PCI LM, LAD, LCX and RCA
  • Impella device used in right femoral artery
  • 6F long hydrophilic sheath through Impella sheath
  • Early Bird Bleed Monitoring System (6F) in right femoral vein housing TVP

Results

  • Activation of Early Bird after Impella insertion for bleed detection.
  • Impella removal 4 hours post- intervention in ICU under Early Bird surveillance.
  • Level 1 indicator triggered with no further bleed progression.

Discussion Points

Bleed monitoring during single- access protected PCI with Impella is possible with the Early Bird.

No progression of Early Bird notification beyond Level 1 after 12 hours post-procedure.

No evidence of clinically significant bleeding.