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General Session VI

General Session VI - Pelvic Venous Disorders and Venous Thromboembolism

Quickshot: In Vivo Evaluation of Safety and Performance of a Novel Microbubble Enhanced Ultrasound Pharmacomechanical Procedure in an Acute Porcine DVT Model

Tuesday, March 5, 2024
2:07 PM – 2:13 PM EST
Location: Tampa Bay Ballroom Salons 1-4
Objective: Deep vein thrombosis (DVT) is a common event that can cause pulmonary embolism (PE), which is reported to cause up to 100,000 deaths annually in the U.S. alone.  Endovascular treatments are available for the treatment of DVT; however, current devices are associated with vessel trauma, blood loss or the need for prolonged ICU management. This study evaluated the safety and performance of a novel, multi-modal single session pharmaco-mechanical procedure specifically designed for proximal DVT in an animal model of acute thrombosis.  The ST system* consists of 2 treatment devices: an ultrasound catheter used in combination commercially available microbubbles and tPA (microbubble-mediated sonothrombolysis – MMS), and a mechanical thrombus retriever (ST). 

Methods: The study evaluated the ST system* for initial safety and performance in Yorkshire swine.  Two swine had thrombi created in both of their iliac veins via an occlusive balloon catheter and thrombin injection yielding 4 acute iliac vein thrombi.  Fluoroscopy was performed to evaluate the iliofemoral venous segment prior to and after thrombus creation, and to evaluate the iliofemoral segment following the completion of the ST procedure.  After crossing the thrombus with an .018 wire, treatment was performed through a 12F sheath with MMS and then were treated with a mechanical retriever if needed (16F sheath) to remove any residual thrombus.  Safety was evaluated by gross examination of the treated vessels following necropsy of the animals to identify intimal injury or disruption.

Results: After balloon inflation and thrombin infusion, thrombus in the iliac vessels matured for 105 ± 35 minutes prior to beginning the ST procedure. Complete vessel occlusion was achieved in all veins with a mean diameter of 11.0 ± 0.9 mm and mean clot length of 10.9 ± 1.0 cm. Ultrasound/microbubble therapy was performed on clot using a specified tPA dose. The MMS procedure was then followed by mechanical thrombus retrieval. After MMS and mechanical extraction, two vessels achieved complete clot resolution with no residual stenosis, while two vessels had small amounts of narrowing of 10% and 30%.  Gross evaluation of the treated vessel segments following necropsy revealed no significant damage to the vessel walls from either the MMS catheter or mechanical retriever. 

Conclusions:

In a porcine DVT model, a new microbubble enhanced ultrasound device combined with a mechanical retriever was found to significantly reduce thrombus burden while preserving the vessel walls.  This data supports evaluation of this novel technology in additional pre-clinical models to support first-in-human trials.

* SonoThrombectomyTM  - Sonovascular Inc.

    Abstract Podium Presenter(s)

  • William A. Marston, MD

    Professor, Division of Vascular Surgery
    University of North Carolina Hospitals
    Chapel Hill, North Carolina, United States