A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF).

Autor:	Kobayashi T; Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.; Cardiovascular Outcomes, Quality, and Evaluative Research (CAVOQER) Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania., Secemsky EA; Smith Center for Cardiovascular Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts., Klein AJ; Piedmont Heart Interventional Cardiology, Atlanta, Georgia., Faintuch S; Division of Interventional Radiology, Department of Radiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts., Bulman JC; Smith Center for Cardiovascular Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts., Weinstein JL; Smith Center for Cardiovascular Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts., Bitton-Faiwiszewski Y; Adventist Heart and Vascular Institute, St Helena, California., Bisharat M; Ashchi Heart and Vascular Center, Jacksonville, Florida., Metzger DC; Ballad Health CVA Heart and Vascular Institute, Kingsport, Tennessee., Rosenberg RD; Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania., Weinberg I; VasCore, Massachusetts General Hospital, Boston, Massachusetts., Vadlamudi V; Vascular/Interventional Radiology and Neurointerventional Surgery, Beacon Medical Group, South Bend, Indiana., Matthai WH Jr; Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania., Saleh A; Yale Cardiovascular Research Group, Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut., Cristea E; Yale Cardiovascular Research Group, Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut., Lansky AJ; Yale Cardiovascular Research Group, Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut., Giri J; Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.; Cardiovascular Outcomes, Quality, and Evaluative Research (CAVOQER) Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Jazyk:	angličtina
Zdroj:	Journal of the Society for Cardiovascular Angiography & Interventions [J Soc Cardiovasc Angiogr Interv] 2024 May 03; Vol. 3 (6), pp. 102049. Date of Electronic Publication: 2024 May 03 (Print Publication: 2024).
DOI:	10.1016/j.jscai.2024.102049
Abstrakt:	Background: Despite advances in therapy options, pulmonary embolism (PE) continues to carry a high risk of mortality and morbidity. Currently, therapeutic options are limited with only 2 US Food and Drug Administration-cleared catheter-based embolectomy devices approved for the treatment of intermediate-risk PE. The novel Hēlo PE thrombectomy catheter (Endovascular Engineering, Inc) has a flexible and collapsible funnel with an internal agitator for a dual mechanism of treatment for acute PE. We sought to investigate the safety and feasibility of the novel Hēlo PE thrombectomy catheter in intermediate-risk PE. Methods: A prospective, single-arm feasibility study evaluating the Hēlo PE catheter was performed in patients presenting with intermediate-risk PE. Patients underwent preprocedural and postprocedural computed tomography angiography. Primary efficacy was the difference in preprocedural to postprocedural right ventricle/left ventricle (RV/LV) ratio. Primary and secondary safety outcomes were all-cause mortality, major life-threatening bleeding, device-related serious adverse events, pulmonary or cardiac injury, and clinical decompensation at 48 hours postprocedure and at 30 days. Results: A total of 25 patients from 8 centers were consented and included in the analysis. Preprocedural computed tomography angiography revealed an RV/LV ratio of 1.53 ± 0.27. All patients underwent a successful thrombectomy procedure. Postprocedure, the RV/LV ratio was reduced to 1.15 ± 0.18, translating into a 23.2 ± 12.81% decrease from baseline. No patients underwent adjunctive thrombolysis. Two patients had adjunctive catheter-directed embolectomy with an alternative device. Two patients had postprocedural anemia requiring transfusion but did not meet criteria for major life-threatening bleeding by VARC-2 criteria. There were no major adverse events including no deaths, major bleeding, pulmonary injury, or vascular complications at 48 hours or 30 days post procedure. Conclusions: In this multicenter first-in-human study, use of the Hēlo PE thrombectomy catheter was feasible and safe for the treatment of acute PE. (© 2024 The Author(s).)
Databáze:	MEDLINE
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