Abstract 16623: Interim Acute and 30-day Results of the Flash Registry

Abstract

Introduction: FLASH, a prospective multi-center all-comers registry, is designed to evaluate real-world outcomes in pulmonary embolism (PE) patients treated with the FlowTriever System (Inari Medical, Irvine, CA). The FlowTriever System is designed to extract large PE thrombus without a need for thrombolytic drugs. Methods: FLASH will enroll up to 500 patients who will be evaluated through 6 months. The primary endpoint is a major adverse events composite of device-related death and major bleeding at 48 hours, and periprocedural device or procedure-related AEs. Secondary endpoints include changes in acute hemodynamics, utility measures, and longer-term clinical outcomes. Acute data in 203 patients and 30-day data in 170 patients has been analyzed. Results and Conclusion: This analyzed cohort included 10% high-risk and 90% intermediate-risk PE patients. The mean RV/LV ratio was 1.54±0.47, sPESI was 1.54±1.06, concomitant DVT was present in 72% and elevated biomarkers in 97% of patients. The primary endpoint occurred in 2 patients (1%) both were major bleeds (non-ICH). There were no periprocedural device related injuries or clinical deteriorations. No deaths (0% mortality) were reported at 48 hours. Significant on-table improvement in hemodynamics were seen, including an average reduction in mean PA pressure of 20% (6.1 mmHg, p<0.0001) and a reduction in heart rate from a pre-procedure high of 111.9±16.9 bpm to 90.5±16.6 bpm (p<0.0001). Patients with low cardiac index (<2l/min/m 2 ) experienced an 18% on table improvement (0.3 l/min/m 2 , p<0.0001). At 30-day follow-up, one patient had died, unrelated to the procedure (0.6% mortality) and 10 patients were readmitted (1 related, 9 unrelated to the procedure). Dyspnea significantly improved from a pre-procedure Modified Medical Research Council Dyspnea Scale average grade of 2.6±1.4 to 0.76±1.1 at 30 days, and 0.54±1 at 6 months (p<0.0001). In conclusion, early results demonstrate excellent safety with immediate improvements in hemodynamics and low 30-day mortality. Data analysis is ongoing and additional results will be presented at the conference.