The Jonas study: evaluation of the retrievability of the Cordis OptEase inferior vena cava filter.

摘要

PURPOSE: To evaluate the success, safety, and efficacy of the retrieval of the OptEase Permanent/Retrievable Vena Cava Filter (Cordis, Warren, NJ), when implanted for temporary protection against venous thromboembolism. MATERIALS AND METHODS: This prospective, multicenter, non-randomized study enrolled 27 patients who needed temporary protection against pulmonary embolism in whom the intent at the time of filter insertion was retrieval of the OptEase filter. Patients presented with deep venous thrombosis (n = 17), pulmonary embolism (PE) (n = 6), and high risk for PE without thromboembolic disease (n = 4). Assessments included duplex sonography of the access site performed within 24 hours of device implantation and retrieval. All patients underwent cavography before and after filter placement and filter retrieval. Contrast-enhanced computed tomography (CT) of the abdomen and clinical follow-up was performed at 1 month after device retrieval. RESULTS: Of the 27 enrolled patients, 21 patients (77.8%) metthe criteria for retrieval and all 21 patients (100%) had filters successfully retrieved with no associated adverse events. Retrieval was not attempted in six patients as a result of ongoing contraindication to anticoagulation (n = 3), large trapped thrombi within the filter (n = 2), and poor patient prognosis (n = 1). Time to retrieval ranged from 5 to 14 days with a mean implantation time of 11.1 days +/- 1.82. No symptomatic pulmonary embolism, vena cava wall injury, vena cava stenosis, significant bleeding, filter fracture, or filter migration was observed. Nineteen of the 21 patients (90.5%) were followed for 1-month post-retrieval with no device-related adverse events or symptomatic PE. Caval patency was documented in 18 of these 19 patients with CT. Two patients were lost to follow-up, and one patient refused to undergo CT examination. CONCLUSION: The OptEase permanent/retrievable vena cava filter can be safely and successfully retrieved up to 14 days in patients who no longer require inferior vena cava filter protection against pulmonary embolism.