Percutaneous Catheter Thrombectomy Device for Acute Pulmonary Embolism: In Vitro and in Vivo Testing

Abstract

To evaluate a percutaneous pulmonary embolism (PE) thrombectomy catheter that aspirates, macerates, and removes thrombus. Nine in vitro tests were performed by using porcine thrombi at a PE test station that provides continuous fluid output of 2 L/min at a pressure of 50 mmHg. Macroembolization was defined as embolized particles larger than 1.5 mm in dimension; microembolization was defined as particles that range in size from 0.1 to 1.5 mm. In static in vitro tests, researchers measured plasma-free hemoglobin levels in a 36-year-old man to assess mechanical hemolysis. Investigational review board approval and informed consent were obtained. The Department of Agriculture, Veterinary Bureau, Bern, Switzerland approved in vivo tests. Researchers investigated device effectiveness in 10 pigs that developed cardiogenic shock but survived massive PE after injection of two or three porcine thrombi into the external jugular vein via a surgically implanted 24-F sheath. Pulmonary angiography and hemodynamic measurements, including mean aortic and mean pulmonary artery pressure, heart rate, and mixed venous oxygen saturation, were obtained at baseline, after embolization, and after thrombectomy. Repeated-measures analysis of variance was performed to compare hemodynamic measurements at baseline, after embolization, and after thrombectomy. Cardiovascular structures were examined at necropsy for rupture, perforation, dissection, or hemorrhage. During a mean aspiration time of 69 seconds +/- 19, thrombi were completely extracted from 14-mm test tubes, with an aspirated fluid volume of 201 mL +/- 64. Although no macroembolization was observed, microembolization was quantified at 1.9 g +/- 1.3. Catheter aspiration was not associated with an increase in plasma-free hemoglobin. In 10 animals, aortic pressure increased from 52 mmHg +/- 24 before thrombectomy to 90 mmHg +/- 32 after thrombectomy, mixed venous oxygen saturation increased from 48% +/- 19% to 61% +/- 12%, pulmonary artery pressure decreased from 33 mmHg +/- 9 to 22 mmHg +/- 4, and heart rate decreased from 162 beats per minute +/- 24 to 114 beats per minute +/- 14. We did not observe macro- or microscopic damage to treated or untreated cardiovascular structures. The PE thrombectomy device was highly effective, facilitating rapid reversal of cardiogenic shock without device-related complications.