FLASH—Coverage of TCT Connect 2020 | SCAI

The FLASH prospective, multicenter, registry evaluated the safety and effectiveness of the FlowTriever System for treatment of pulmonary embolism in a real-world patient population. It found that the device has excellent safety outcomes (no deaths at 48h, 1.3% 48h MAE rate, and only 1 access site complication) and significant on-table hemodynamic improvement compared to baseline (Mean PAP decrease: 7.0 mmHg; HR decrease: 22.7 bpm). These findings provide real-world insights on an unmet treatment need for this at-risk patient population. This registry study showed a remarkably low mortality rate at 0% @ 48 hours and only 3 major bleeds (non-ICH) at the same timepoint. The immediate removal of thrombus with mechanical thrombectomy using the INARI device in the pulmonary artery rapidly normalizes evidence of RV strain as manifested by a drop-in heart rate (20.1% drop in HR pre to post procedure, pre-procedural high of 113.2+/- 16.8 to 90.5 bpm +/- 16.5 bpm). The pulmonary artery pressure also dropped 21.9% (32 +/- 8.2 mmHg preprocedural to 25 +/-8.2 post-procedure. Consistent with the removal of thrombus, patients showed significant improvement in dyspnea scores. The device time (median of 46 minutes) and only one access site complication demonstrates the proficiency of the highly skilled operators who are in this registry.

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