Evaluation of a Device Combining an Inferior Vena Cava Filter and a Central Venous Catheter for Preventing Pulmonary Embolism Among Critically Ill Trauma Patients.

PURPOSE: To evaluate efficacy and safety of a novel device that combines an inferior vena cava (IVC) filter and central venous catheter (CVC) for prevention of pulmonary embolism (PE) in critically ill patients. MATERIALS AND METHODS: In a multicenter, prospective, single-arm clinical trial, the device was inserted at the bedside without fluoroscopy and subsequently retrieved before transfer from the intensive care unit (ICU). The primary efficacy endpoint was freedom from clinically significant PE or fatal PE 72 hours after device removal or discharge, whichever occurred first. Secondary endpoints were incidence of acute proximal deep venous thrombosis (DVT), catheter-related thrombosis, catheter-related bloodstream infections, major bleeding events, and clinically significant thrombus (occupying > 25% of volume of filter) detected by cavography before retrieval. RESULTS: The device was placed in 163 critically ill patients with contraindications to anticoagulation; 151 (93%) were critically ill trauma patients, 129 (85%) had head or spine trauma, and 102 (79%) had intracranial bleeding. The primary efficacy endpoint was achieved for all 163 (100%) patients (95% confidence interval [CI], 97.8%-100%, P < .01). Diagnosis of new or worsening acute proximal DVT was time dependent with 11 (7%) occurring during the first 7 days. There were no (0%) catheter-related bloodstream infections. There were 5 (3.1%) major bleeding events. Significant thrombus in the IVC filter occurred in 14 (8.6%) patients. Prophylactic anticoagulation was not initiated for a mean of 5.5 days ± 4.3 after ICU admission. CONCLUSIONS: This novel device prevented clinically significant and fatal PE among critically ill trauma patients with low risk of complications.

Inferior vena cava filter placement at bedside using computed tomography scan information: a new technique for accurate deployment.

BACKGROUND: An inferior vena cava filter (IVCF) is indicated for the prophylaxis of pulmonary embolism where anticoagulation is contraindicated. The majority of these filters are placed using fluoroscopy and venogram. We hypothesized that a computed tomography (CT) scan of the abdomen and pelvis provides sufficient information for successful deployment of an IVCF at bedside without the need for any further imaging during the procedure. METHODS: A retrospective review of prospectively collected data of a bedside IVCF placement technique using measurements from abdominal/pelvic CT scans without additional intraoperative imaging in 38 patients at a level 1 trauma center was conducted. RESULTS: The most common indication for IVCF placement was high-risk patients without deep venous thrombosis. All these procedures were performed at bedside. Nonretrievable (TrapEase) and retrievable (OptEase) type filters were used. All these IVCFs were placed below the renal veins without any complications. CONCLUSIONS: IVCFs can be placed based on measurements from abdominal CT scans without the need for further imaging such as fluoroscopy or an inferior vena cava venogram. This technique is as simple as bedside femoral venous line placement.