ABSTRACT
PURPOSE: To demonstrate rates of successful filter conversion and 6-month major device-related adverse events in subjects with converted caval filters. MATERIALS AND METHODS: An investigational device exemption multicenter, prospective, single-arm study was performed at 11 sites enrolling 149 patients. The VenaTech Convertible Vena Cava Filter (B. Braun Interventional Systems, Inc, Bethlehem, Pennsylvania) was implanted in 149 patients with venous thromboembolism and contraindication to or failure of anticoagulation (n = 119), with high-risk trauma (n = 14), and for surgical prophylaxis (n = 16). When the patient was no longer at risk for pulmonary embolism as determined by clinical assessment, an attempt at filter conversion was made. Follow-up of converted patients (n = 93) was conducted at 30 days, 3 months, and 6 months after conversion. Patients who did not undergo a conversion attempt (n = 53) had follow-up at 6 months after implant. RESULTS: All implants were successful. One 7-day migration to the right atrium required surgical removal. Technical success rate for filter conversion was 92.7% (89/96). Mean time from placement to conversion was 130.7 days (range, 15-391 d). No major conversion-related events were reported. The mean conversion procedure time was 30.7 minutes (range, 7-135 min). There were 89 converted and 32 unconverted patients who completed 6-month follow-up with no delayed complications. CONCLUSIONS: The VenaTech Convertible filter has a high conversion rate and low 6-month device-related adverse event rate. Further studies are necessary to determine long-term safety and efficacy in both converted and unconverted patients.
Subject(s)
Pulmonary Embolism/etiology , Pulmonary Embolism/prevention & control , Vena Cava Filters , Venous Thromboembolism/complications , Adult , Aged , Female , Humans , Male , Middle Aged , Prospective Studies , Prosthesis Design , Treatment OutcomeABSTRACT
A previously unreported late complication of a transanastomotic stent across a pancreaticotojejunostomy is described. The stent migrated distally into the jejunal lumen, through the biliary anastomis into the bile duct and proximally into the liver where it served as a nidus for infection with abscess formation. A percutaneous transhepatic interventional radiologic approach both drained the abscess and pushed the stent out of the liver and biliary tree and into the bowel, with complete recovery. The decision by the surgeon to use a stent in these patients is discussed, and the complications associated with stenting a pancreaticojejunostomy are reviewed.
