A novel device was able to prevent clinically significant pulmonary embolism (PE) and fatal PE in critically ill trauma patients, according to a study published in the Journal of Vascular and Interventional Radiology.
Prophylactic placement of IVC filters is often delayed, which may lead to higher rates of PE in critically ill patients, and few IVC filters are retrieved from patients. To facilitate more timely placement and consistent retrieval of IVC filters, the device in this prospective, single-arm clinical trial was inserted at bedside without fluoroscopy and retrieved before patients were transferred to the intensive care unit (ICU). The device, the Angel Catheter (Bio2 Medical, San Antonio, Texas), combined an inferior vena cava (IVC) filter and central venous catheter (CVC) and received 510(k) clearance by the US Food and Drug Administration (FDA) in July 2016 as a short-term intravascular IVC filter and CVC.
The trial took place at 20 ICUs in the United States and involved 163 critically ill patients in which anticoagulation medication was contraindicated. Of the patients, 93% were critically ill trauma patients, 85% had head or spine trauma, and 79% had intracranial bleeding.
The researchers found that 100% of patients met the primary endpoint, which meant that no patients had clinically significant PE or fatal PE 72 hours after device removal or discharge.
Cavograms were obtained before the device was retrieved, and these indicated large thrombus in the IVC filter in 14 patients (8.6%). After ICU admission, prophylactic anticoagulation did not begin for a mean of 5.5 days ± 4.3. Eleven patients (7%) were diagnosed as having new or worsening acute proximal DVT during the first 7 days, and 30 (18%) by the end of the study, indicating that the rate is time dependent.
“In conclusion, this trial demonstrated that a novel device combining an IVC filter and CVC can be placed safely at the bedside without fluoroscopy and that the device can prevent clinically significant PE and fatal PE. Future studies in critically ill medical and surgical patients will build on these findings,” the study’s authors wrote.
Tapson VF, Hazelton JP, Myers J, et al. Evaluation of a Device Combining an Inferior Vena Cava Filter and a Central Venous Catheter for Preventing Pulmonary Embolism Among Critically Ill Trauma Patients. J Vasc Interv Radiol. 2017;28(9):1248-1254.