Mechanical Thrombectomy for High-Risk Pulmonary Embolism: Insights From the US Cohort of the FLASH Registry.

Autor: Horowitz JM; Division of Cardiology, Department of Medicine, NYU Grossman School of Medicine, New York, New York., Jaber WA; Emory University Hospital, Atlanta, Georgia., Stegman B; CentraCare Heart and Vascular Center, St. Cloud, Minnesota., Rosenberg M; Department of Radiology, University of Minnesota, Minneapolis, Minnesota., Fanola C; Department of Cardiology, University of Minnesota, Minneapolis, Minnesota., Bhat AP; Section of Vascular and Interventional Radiology, Department of Radiology, University of Missouri, Columbia, Missouri., Gondi S; Baptist Health, Louisville, Kentucky., Castle J; Inland Imaging, Providence Sacred Heart, Spokane, Washington., Ahmed M; UAB Division of Cardiovascular Disease, Birmingham, Alabama., Brown MA; Missouri Cardiovascular Specialists, Columbia, Missouri., Amin R; Ascension Sacred Heart Hospital Pensacola, Pensacola, Florida., Bisharat M; HCA Florida Memorial Hospital Jacksonville, Jacksonville, Florida., Butros P; Inova Health System, Fairfax, Virginia.; Southpark Vascular Center, Colonial Heights, Virginia., DuCoffe A; Inova Health System, Fairfax, Virginia., Savin M; Section of Interventional Radiology, Department of Radiology, Corewell Health William Beaumont University Hospital, Royal Oak, Michigan., Pollak JS; Department of Radiology and Biomedical Imaging, Yale University, New Haven, Connecticut., Weinberg MD; Department of Cardiology, Northwell Health, Zucker School of Medicine at Hofstra/Northwell, Staten Island University Hospital, Staten Island, New York., Brancheau D; Ascension Genesys Hospital, Grand Blanc, Michigan., Toma C; University of Pittsburgh Medical Center Heart and Vascular Institute, Pittsburgh, Pennsylvania.
Jazyk: angličtina
Zdroj: Journal of the Society for Cardiovascular Angiography & Interventions [J Soc Cardiovasc Angiogr Interv] 2023 Oct 31; Vol. 3 (1), pp. 101124. Date of Electronic Publication: 2023 Oct 31 (Print Publication: 2024).
DOI: 10.1016/j.jscai.2023.101124
Abstrakt: Background: Acute mortality for high-risk, or massive, pulmonary embolism (PE) is almost 30% even when treated using advanced therapies. This analysis assessed the safety and effectiveness of mechanical thrombectomy (MT) for high-risk PE.
Methods: The prospective, multicenter FlowTriever All-comer Registry for Patient Safety and Hemodynamics (FLASH) study is designed to evaluate real-world PE patient outcomes after MT with the FlowTriever System (Inari Medical). In this study, acute outcomes through 30 days were evaluated for the subset of patients with high-risk PE as determined by the sites and following European Society of Cardiology guidelines. An independent medical monitor adjudicated adverse events (AEs), including major AEs: device-related mortality, major bleeding, or intraprocedural device-related or procedure-related AEs.
Results: Of the 799 patients in the US cohort, 63 (7.9%) were diagnosed with high-risk PE; 30 (47.6%) patients showed a systolic blood pressure <90 mm Hg, 29 (46.0%) required vasopressors, and 4 (6.3%) experienced cardiac arrest. The mean age of patients with high-risk PE was 59.4 ± 15.6 years, and 34 (54.0%) were women. At baseline, 45 (72.6%) patients were tachycardic, 18 (54.5%) showed elevated lactate levels of ≥2.5 mM, and 21 (42.9%) demonstrated depressed cardiac index of <2 L/min/m 2 . Immediately after MT, heart rate improved to 93.5 ± 17.9 bpm. Twenty-five (42.4%) patients did not require an overnight stay in the intensive care unit, and no mortalities or major AEs occurred through 48 hours. Moreover, no mortalities occurred in 61 (96.8%) patients followed up through the 30-day visit.
Conclusions: In this cohort of 63 patients with high-risk PE, MT was safe and effective, with no acute mortalities reported. Further prospective data are needed in this population.
Competing Interests: James Horowitz is a consultant for Inari Medical and Penumbra. Ambarish Bhat and Mohannad Bisharat are consultants for Inari Medical. Michael Savin owns stock in Inari Medical. Mitchell Weinberg is a consultant for Magneto Thrombectomy Solutions and Boston Scientific. The other authors reported no financial interests.
(© 2023 The Author(s).)
Databáze: MEDLINE