Acute Outcomes for the Full US Cohort of the FLASH Mechanical Thrombectomy Registry in Pulmonary Embolism

DOI: 10.4244/EIJ-D-22-00732

Catalin Toma
Catalin Toma1, MD; Wissam A. Jaber2, MD; Mitchell D. Weinberg3, MD, MBA; Matthew C. Bunte4, MD, MS; Sameer Khandhar5, MD; Brian Stegman6, MD; Sreedevi Gondi7, MD; Jeffrey Chambers8, MD; Rohit Amin9, MD; Daniel A. Leung10, MD; Herman Kado11, MD; Michael A. Brown12, MD; Michael G. Sarosi13, MD; Ambarish P. Bhat14, MD; Jordan Castle15, MD; Michael Savin16, MD; Gary Siskin17, MD; Michael Rosenberg18, MD; Christina Fanola19, MD, MSc; James M. Horowitz20, MD; Jeffrey S. Pollak21, MD
1. UPMC: UPMC Presbyterian, United states; 2. Emory University Hospital, Atlanta, GA, United states; 3. Department of Cardiology, Northwell Health, Zucker School of Medicine at Hofstra/Northwell, Staten Island University Hospital, Staten Island, NY, United states; 4. Saint Luke’s Mid America Heart Institute, Kansas City, MO, United states; 5. Division of Cardiology at Penn Presbyterian Medical Center, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United states; 6. CentraCare Heart and Vascular Center, St. Cloud, MN, United states; 7. Baptist Health, Louisville, KY, United states; 8. Interventional Cardiology, Metropolitan Heart and Vascular Institute, Minneapolis, MN, United states; 9. Ascension Sacred Heart Hospital Pensacola, Pensacola, FL, United states; 10. Christiana Care Health System, Newark, DE, United states; 11. Ascension Providence Hospital, Southfield, MI, United states; 12. Missouri Cardiovascular Specialists, Columbia, MO, United states; 13. St. Joseph Mercy Hospital, Ann Arbor, MI, United states; 14. Department of Radiology, Section of Vascular and Interventional Radiology, University of Missouri, Columbia, MO, United states; 15. Inland Imaging, Providence Sacred Heart, Spokane, WA, United states; 16. Department of Radiology, Oakland University William Beaumont School of Medicine, Royal Oak, MI, United states; 17. Department of Radiology, Albany Medical Center, Albany, NY, United states; 18. Department of Radiology, University of Minnesota, Minneapolis, MN, United states; 19. Department of Cardiology, University of Minnesota, Minneapolis, MN, United states; 20. Division of Cardiology, Department of Medicine, NYU Grossman School of Medicine, New York, NY, United states; 21. Department of Radiology and Biomedical Imaging, Yale University School of Medicine, New Haven, CT, United states
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Abstract

Background: Evidence supporting interventional pulmonary embolism (PE) treatment is needed. Aims: To evaluate acute safety and effectiveness of mechanical thrombectomy for intermediate- and high-risk PE in a large real-world population. Methods: FLASH is a multicenter, prospective registry enrolling up to 1,000 US and European PE patients treated with mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, CA). The primary safety endpoint is a major adverse event composite including device-related death and major bleeding at 48 hours, and intraprocedural adverse events. Acute mortality and 48-hour outcomes are reported. Multivariate regression analyzed characteristics associated with pulmonary artery pressure and dyspnea improvement. Results: Among 800 patients in the full US cohort, 76.7% had intermediate-high risk PE, 7.9% had high-risk PE, and 32.1% had thrombolytic contraindications. Major adverse events occurred in 1.8% of patients. All-cause mortality was 0.3% at 48-hour follow-up and 0.8% at 30-day follow-up, with no device-related deaths. Immediate hemodynamic improvements included a 7.6 mmHg mean drop in mean pulmonary artery pressure (-23.0%, P<0.0001) and a 0.3 L/min/m2 mean increase in cardiac index (18.9%, P<0.0001) in patients with depressed baseline values. Most (62.6%) patients had no overnight intensive care unit stay post-procedure. At 48 hours, echocardiographic right ventricle/left ventricle ratio decreased from 1.23±0.36 to 0.98±0.31 (P<0.0001 for paired values) and patients with severe dyspnea decreased from 66.5% to 15.6% (P<0.0001). Conclusions: Mechanical thrombectomy with the FlowTriever System demonstrates a favorable safety profile, improvements in hemodynamics and functional outcomes, and low 30-day mortality for intermediate- and high-risk PE.

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