Kucher Nils, Windecker Stephan, Banz Yara, Schmitz-Rode Thomas, Mettler Daniel, Meier Bernhard, Hess Otto M
Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.
Radiology. 2005 Sep;236(3):852-8. doi: 10.1148/radiol.2363041287. Epub 2005 Jul 12.
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.
评估一种用于抽吸、破碎并清除血栓的经皮肺栓塞（PE）血栓切除术导管。
在一个PE测试站使用猪血栓进行了9项体外测试，该测试站能在50 mmHg的压力下提供2 L/分钟的连续液体输出。大栓塞定义为尺寸大于1.5 mm的栓塞颗粒；微栓塞定义为尺寸在0.1至1.5 mm之间的颗粒。在静态体外测试中，研究人员测量了一名36岁男性的无血浆血红蛋白水平，以评估机械性溶血情况。获得了研究审查委员会的批准和知情同意。瑞士伯尔尼农业兽医局批准了体内测试。研究人员在10头猪身上研究了该装置的有效性，这些猪在通过手术植入的24-F鞘管将两三个猪血栓注入颈外静脉后发生了心源性休克但在大面积PE后存活。在基线、栓塞后和血栓切除术后进行了肺血管造影和血流动力学测量，包括平均主动脉压和平均肺动脉压、心率以及混合静脉血氧饱和度。进行重复测量方差分析以比较基线、栓塞后和血栓切除术后的血流动力学测量结果。在尸检时检查心血管结构是否有破裂、穿孔、夹层或出血。
在平均抽吸时间为69秒±19秒的过程中，血栓从14毫米的试管中被完全吸出，抽吸液体体积为201毫升±64毫升。虽然未观察到有大栓塞，但微栓塞的量为1.9克±1.3克。导管抽吸与无血浆血红蛋白的增加无关。在10只动物中，主动脉压从血栓切除术前的52 mmHg±24升高到血栓切除术后的90 mmHg±32，混合静脉血氧饱和度从48%±19%增加到61%±12%，肺动脉压从33 mmHg±9降低到22 mmHg±4，心率从每分钟162次±24降低到每分钟114次±14。我们未观察到治疗或未治疗的心血管结构有宏观或微观损伤。
PE血栓切除装置非常有效，有助于心源性休克的快速逆转且无装置相关并发症。
