Treatment of Acute Pulmonary Embolism: Local Effects of Three Hydrodynamic Thrombectomy Devices in an Ex Vivo Porcine Model

PURPOSE: To report an ex vivo study on the local effects of hydrodynamic thrombectomy for the treatment of acute pulmonary embolism (off-label use). METHODS: Three devices (6-F AngioJet Xpeedior and 6-F and 8-F Oasis) were used for hydrodynamic thrombectomy inside the arteries of 24 inflated and perfused porcine lung explants. Each system was used at multiple positions inside 4 intact and 4 embolized lungs in vessels measuring 2 to 4 mm, 4 to 6 mm, 6 to 8 mm, and 8 to 10 mm. Angiograms prior to, during, and after catheter positioning and system operation were used to detect arterial wall trauma and to measure local clot removal per 30-second cycle. A total of 21 vessel wall samples were subjected to scanning electron microscopy (SEM) to evaluate non-perforating lesions. RESULTS: All systems were able to remove clot material. The average recanalized vessel length normalized to 30 seconds for vessel diameters of 2 to 4 and 8 to 10 mm, respectively, was 1.17 and 1.75 cm (AngioJet), 0.97 and 0.25 cm (6-F Oasis), and 2.2 and 1.05 cm (8-F Oasis). Perforations occurred during positioning of the 6-F Oasis (4/78 maneuvers) and 8-F Oasis (13/60), but not the AngioJet (0/89); perforations were also seen during system operation (AngioJet: 21/89 activations, 6-F Oasis: 4/78, and 8-F Oasis: 9/60; all lesions inside vessels <6 mm in diameter). SEM showed 35 lesions, 14 with perforation (contrast extravasation) and 21 without perforation (induced by the tip of the guidewire). CONCLUSION: The AngioJet was most efficient in clot removal, followed by the 8-F Oasis. The 6-F Oasis was least efficient, but had fewest complications. According to these experiments, the tested hydrodynamic thrombectomy devices may cause perforations in vessels <6 mm in diameter. Changes in catheter design to reduce system-specific complication rates or to improve the efficacy of clot removal are warranted.