LB-8 | First in Human Safety and Feasibility of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (The ENGULF Trial)

Le résumé fourni par la source

Despite advances in therapeutic options, pulmonary embolism (PE) carries a high risk of mortality and morbidity. Currently, there are 2 FDA-cleared thrombectomy catheters for intermediate-risk PE. Hēlo is a novel embolectomy catheter system for the treatment of acute PE with a steerable and collapsible funnel and an internal agitator. We report the first in human (FIH) safety and feasibility of the Hēlo PE Thrombectomy System in patients with acute PE. A prospective single-arm safety and feasibility study evaluating Hēlo was conducted in acute intermediate-risk PE patients. Patients underwent a pre- and 48 h post-procedural CT scan. The primary efficacy outcome was the % difference in the pre-to-post procedural RV/LV ratios. Primary and secondary safety outcomes were all-cause mortality, major life-threatening bleeding, device-related serious AEs, pulmonary or cardiac injury, and clinical decompensation at 48 h and 30 d post-procedure. 25 patients from 8 centers were included in the study. All patients underwent successful embolectomy. 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%±12.81% change). Adjunctive intervention with an alternative device was used in 2 patients. Anemia requiring transfusion but not meeting major bleeding criteria occurred in 2 patients post-procedure. There were no major adverse events at 48 h and no deaths at 30 d. In this multicenter FIH experience, the novel Hēlo PE Thrombectomy System was effective and safe in treating acute PE.

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