LB-8
First in Human Safety and Feasibility of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (The ENGULF Trial)
Presenter
Tai Kobayashi, M.D., FSCAI, Hospital of the University of Pennsylvania, Philadelphia, PA
Tai Kobayashi, M.D., FSCAI1, Eric Secemsky, MD, MSc, FSCAI2, Andrew J. Klein, M.D., FSCAI3, Salomao Faintuch, MD2, Julie C Bulman, MD2, Jeffrey L Weinstein, MD2, Yonatan Bitton-Faiwiszewski, MD, FSCAI4, Mohannad Bisharat, M.D.5, D. Chris Metzger, M.D.6, Russell D Rosenberg, M.D.7, Ido Weinberg, M.D.8, Venu Vadlamudi, MD9, William Matthai Jr., M.D.10, Amr Saleh, MD11, Ecaterina Cristea, MD12, Alexandra J. Lansky, M.D., MSCAI13 and Jay S. Giri, MD1, (1)Hospital of the University of Pennsylvania, Philadelphia, PA, (2)Beth Israel Deaconess Medical Center, Newton, MA, (3)Piedmont Heart Institute, Atlanta, GA, (4)Adventist Health St. Helena, Saint Helena, CA, (5)Ashchi Heart and Vascular Center, Jacksonville, FL, (6)OhioHealth Heart & Vascular Physicians, Dublin, OH, (7)University of Pennsylvania Health System, Wynnewood, PA, (8)Massachusetts General Hospital, Boston, MA, (9)Virginia Hospital Center, McLean, VA, (10)Presbyterian Hospital, Narberth, PA, (11)Yale University, Weston, CT, (12)Yale School of Medicine, New Haven, CT, (13)Yale University, New Haven, CT
Keywords: Pulmonary Embolism (PE)
Background
:
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.
Methods
:
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.
Results
:
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.
Conclusions
:
In this multicenter FIH experience, the novel Hēlo PE Thrombectomy System was effective and safe in treating acute PE.
