A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF)—Coverage of SCAI Scientific Sessions 2024 | SCAI

Why is this study important? 

Current management of pulmonary embolism has shifted from the previous systemic thrombolysis and anticoagulation to either catheter-directed thrombolysis and/or mechanical thrombectomy. 

The current devices used for mechanical thrombectomy have their own challenges, such as ineffective/incomplete thrombus burden removal, vascular injury, significant blood loss due to use of large-bore catheters and difficulty in maneuverability of these catheters. 

What question was this study supposed to answer? 

The ENGULF study was a multicenter first-in-human study performed to evaluate the safety and feasibility of using a new dual mechanism moderate bore Hēlo PE (pulmonary embolism) thrombectomy system. 

What did the study show? 

The ENGULF study was a prospective single-arm safety and feasibility study evaluating a new mechanical thrombectomy system (Hēlo) for treating acute pulmonary embolism. A total of 25 patients from 8 centers were included in this study. All patients underwent successful mechanical thrombectomy with the Hēlo system.  

The mean RV/LV ratio was 1.53±0.27 and 1.15±0.18, at baseline and 48 hours post-procedure, respectively (23.2% mean reduction) on CT scan. There were no major adverse events at 48 hours post-procedure and no deaths at 30 days. No patients met criteria for major life-threatening bleeding by VARC-2 criteria.

The Hēlo PE thrombectomy system appears to be an effective and safe device for treating acute pulmonary embolism.

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