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EKOS™ Endovascular System

OPTALYSE-3D

OPTALYSE-3D results

Loss of volume in the distal pulmonary vessels has been described as a marker of PE severity. OPTALYSE-3D examined changes in the small vessel volumes in response to treatment with ultrasound-assisted, catheter-directed thrombolysis (USCDT; EKOS), large-bore mechanical thrombectomy (LBMT), or anticoagulation only (AC).


Methods

3D reconstruction using clinical CT data and automated lung segmentation were performed to compute total vascular volume (TBV), small vessel volume (<5mm2, BVsmall) and medium vessel volume (>5mm2 and <20mm2, BVmed). All vascular measures were normalized by total lung volume.

CT based 3D reconstruction of patient undergoing USCDT

Graph of RV/LV reduction after 48 hours

More complete visualization of the distal vessels in the yellow box demonstrates reperfusion following USCDT treatment.

Conclusions

  • There was an observed increase in both small and medium sized venous vessels volumes following treatment with EKOS
  • There was no difference in vessel volume response to the dose of thrombolytic administered; i.e., response was retained in the lower dose OPTALYSE cohorts
  • No statistically significant differences in vascular volumes were detected following treatment with LBMT or AC

USCDT

Vascular measures* BaselinePostp-value
Small size arterial volume7.3 [3.6-15.3]7.6 [3.4-16.1]0.86
Small size venous volume4.3 [2.9-10.1]7.4 [3.1-11.3]0.0009
Medium size arterial volume14.6 [10.8-20.0]15.7 [11.2-19.2]0.54
Medium size venous volume8.9 [6.7-12.3]10.6 [8.5-13.7]<0.000

* all vascular measures represent ml of vascular volume per liters of lung


Hear from investigator Gregory Piazza, MD, as he discusses the novel approach of OPTALYSE-3D

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Reference
Farbod N. Rahaghi, Gregory Piazza, Behnood Bikdeli, Umberto Campia, Syed M. Hassan, Ruben San Jose Estepar, Michael J. Cuttica, Ruben Mylvaganam, George R. Washko, Pietro Nardelli, Samuel Z. Goldhaber, Raul San Jose Estepar. Brigham and Women’s Hosptal, Boston, MA