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. University of Pittsburgh Medical Center Heart and Vascular Institute, Pittsburgh, PA, USA; 2. Emory University Hospital, Atlanta, GA, USA; 3. Department of Cardiology, Northwell Health, Zucker School of Medicine at Hofstra/Northwell, Staten Island University Hospital, Staten Island, NY, USA; 4. Saint Luke’s Mid America Heart Institute, Kansas City, MO, USA; 5. Division of Cardiology, Penn Presbyterian Medical Center, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; 6. CentraCare Heart and Vascular Center, St. Cloud, MN, USA; 7. Baptist Health Louisville, Louisville, KY, USA; 8. Interventional Cardiology, Metropolitan Heart and Vascular Institute, Minneapolis, MN, USA; 9. Ascension Sacred Heart Hospital Pensacola, Pensacola, FL, USA; 10. Christiana Care Health System, Newark, DE, USA; 11. Ascension Providence Hospital, Southfield, MI, USA; 12. Missouri Cardiovascular Specialists, Columbia, MO, USA; 13. St. Joseph Mercy Hospital, Ann Arbor, MI, USA; 14. Department of Radiology, Section of Vascular and Interventional Radiology, University of Missouri, Columbia, MO, USA; 15. Inland Imaging, Providence Sacred Heart, Spokane, WA, USA; 16. Department of Radiology, Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA; 17. Department of Radiology, Albany Medical Center, Albany, NY, USA; 18. Department of Radiology, University of Minnesota, Minneapolis, MN, USA; 19. Department of Cardiology, University of Minnesota, Minneapolis, MN, USA; 20. Division of Cardiology, Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA; 21. Department of Radiology and Biomedical Imaging, Yale University School of Medicine, New Haven, CT, USA
Background: Evidence supporting interventional pulmonary embolism (PE) treatment is needed.
Aims: We aimed to evaluate the acute safety and effectiveness of mechanical thrombectomy for intermediate- and high-risk PE in a large real-world population.
Methods: FLASH is a multicentre, prospective registry enrolling up to 1,000 US and European PE patients treated with mechanical thrombectomy using the FlowTriever System. 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 analysed characteristics associated with pulmonary artery pressure and dyspnoea 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 haemodynamic 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 patients (62.6%) had no overnight intensive care unit stay post-procedure. At 48 hours, the 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 dyspnoea decreased from 66.5% to 15.6% (p<0.0001).
Conclusions: Mechanical thrombectomy with the FlowTriever System demonstrates a favourable safety profile, improvements in haemodynamics and functional outcomes, and low 30-day mortality for intermediate- and high-risk PE.
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aspiration deviceclinical researchclinical trialspulmonary embolismthrombectomy
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