Peripheral interventions

Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism

EuroIntervention 2023;18:1201-1212. 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. 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. 

Sign in to read and download the full article

Forgot your password?

No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com

aspiration deviceclinical researchclinical trialspulmonary embolismthrombectomy
Read next article
Reproducibility of bolus versus continuous thermodilution for assessment of coronary microvascular function in patients with ANOCA

Latest news