Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial |
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| Authors: | Akhilesh K. Sista James M. Horowitz Victor F. Tapson Michael Rosenberg Mahir D. Elder Brian J. Schiro Suhail Dohad Nancy E. Amoroso David J. Dexter Christopher T. Loh Daniel A. Leung Bruce Kirke Bieneman Paul E. Perkowski Michael L. Chuang James F. Benenati |
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| Affiliation: | 1. From the Department of Radiology, NYU Grossman School of Medicine, New York, New York, USA;2. Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA;3. Department of Radiology, University of Minnesota, Minneapolis, Minnesota, USA;4. Cardiovascular Institute, Detroit Medical Center, Wayne State University, Detroit, Michigan, USA;5. School of Medicine, Michigan State University, East Lansing, Michigan, USA;6. Miami Cardiac and Vascular Institute, Baptist Hospital of Miami, Miami, Florida, USA;7. Department of Vascular Surgery, Sentara Norfolk General Hospital, Norfolk, Virginia, USA;8. Department of Vascular and Interventional Radiology, St. Joseph Health, Orange, California, USA;9. Department of Vascular Interventional Radiology, Christiana Care Health, Newark, Delaware, USA;10. Department of Radiology, Mercy Health System, St. Louis, Missouri, USA;11. Department of Vascular Surgery, Our Lady of the Lake Regional Medical Center, Baton Rouge, Louisiana, USA;12. Cardiovascular Imaging Core Laboratory, Beth Israel Deaconess Medical Center, Boston Massachusetts, USA |
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| Abstract: | ObjectivesThis study sought to prospectively evaluate the safety and efficacy of the Indigo aspiration system in submassive acute pulmonary embolism (PE).BackgroundPE treatment with thrombolytics has bleeding risks. Aspiration thrombectomy can remove thrombus without thrombolytics, but data are lacking.MethodsThis study was a prospective, single-arm, multicenter study that enrolled patients with symptomatic acute PE ≤14 days, systolic blood pressure ≥90 mm Hg, and right ventricular-to-left ventricular (RV/LV) ratio >0.9. The primary efficacy endpoint was change in RV/LV ratio from baseline to 48 h post-procedure on core lab–adjudicated computed tomography angiography. The primary safety endpoint was a composite of 48-h major adverse events: device-related death, major bleeding, and device-related serious adverse events (clinical deterioration, pulmonary vascular, or cardiac injury). All sites received Institutional Review Board approval.ResultsA total of 119 patients (mean age 59.8 ± 15.0 years) were enrolled at 22 U.S. sites between November 2017 and March 2019. Median device insertion to removal time was 37.0 (interquartile range: 23.5 to 60.0) min. Two (1.7%) patients received intraprocedural thrombolytics. Mean RV/LV ratio reduction from baseline to 48 h post-procedure was 0.43 (95% confidence interval: 0.38 to 0.47; p < 0.0001). Two (1.7%) patients experienced 3 major adverse events. Rates of cardiac injury, pulmonary vascular injury, clinical deterioration, major bleeding, and device-related death at 48 h were 0%, 1.7%, 1.7%, 1.7%, and 0.8%, respectively.ConclusionsIn this prospective, multicenter study the Indigo aspiration system was associated with a significant reduction in the RV/LV ratio and a low major adverse event rate in submassive PE patients. Intraprocedural thrombolytic drugs were avoided in 98.3% of patients. (Evaluating the Safety and Efficacy of the Indigo aspiration system in Acute Pulmonary Embolism [EXTRACT-PE]; NCT03218566) |
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| Keywords: | mechanical aspiration pulmonary embolism thrombectomy CI" },{" #name" :" keyword" ," $" :{" id" :" kwrd0040" }," $$" :[{" #name" :" text" ," _" :" confidence interval CTA" },{" #name" :" keyword" ," $" :{" id" :" kwrd0050" }," $$" :[{" #name" :" text" ," _" :" computed tomography angiography IRB" },{" #name" :" keyword" ," $" :{" id" :" kwrd0070" }," $$" :[{" #name" :" text" ," _" :" Institutional Review Board ITT" },{" #name" :" keyword" ," $" :{" id" :" kwrd0080" }," $$" :[{" #name" :" text" ," _" :" intention to treat mITT" },{" #name" :" keyword" ," $" :{" id" :" kwrd0090" }," $$" :[{" #name" :" text" ," _" :" modified intention to treat LV" },{" #name" :" keyword" ," $" :{" id" :" kwrd0100" }," $$" :[{" #name" :" text" ," _" :" left ventricular PA" },{" #name" :" keyword" ," $" :{" id" :" kwrd0110" }," $$" :[{" #name" :" text" ," _" :" pulmonary artery PE" },{" #name" :" keyword" ," $" :{" id" :" kwrd0120" }," $$" :[{" #name" :" text" ," _" :" pulmonary embolism RV" },{" #name" :" keyword" ," $" :{" id" :" kwrd0130" }," $$" :[{" #name" :" text" ," _" :" right ventricular SAE" },{" #name" :" keyword" ," $" :{" id" :" kwrd0140" }," $$" :[{" #name" :" text" ," _" :" serious adverse event sPESI" },{" #name" :" keyword" ," $" :{" id" :" kwrd0150" }," $$" :[{" #name" :" text" ," _" :" Simplified Pulmonary Embolism Severity Index tPA" },{" #name" :" keyword" ," $" :{" id" :" kwrd0160" }," $$" :[{" #name" :" text" ," _" :" tissue type plasminogen activator |
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