The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
Acute Outcomes for the Full US Cohort of the FLASH Mechanical Thrombectomy Registry in Pulmonary Embolism
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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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.