This study presents preliminary results obtained from a new permanent filter, based on Greenfield's filter design, with prolongations on three of six struts to stabilize it centrally in the vena caval lumen. The preliminary clinical evaluation of the filter with regard to feasibility, efficacy and safety is reported. From August 2004 to December 2006, 15 vena cava filters were deployed in nine men and six women, who ranged in age from 38 to 79 years (mean, 57.8 years). The approach used was always transjugular. Indications for filter placement were proximal deep venous thrombosis with a contraindication to anticoagulation in 12 patients; hemorrhagic complications with anticoagulation in two patients; and pulmonary embolism, despite adequate anticoagulation in one patient. New vena cava filters were evaluated for releasing, tilting, malpositioning and caval perforation. Follow-up included assessment of access site thrombosis and filter migration, recurrent venous thromboembolism, and caval thrombosis by duplex ultrasound. No patient received anticoagulants in the follow-up. In all patients the filter was successfully released, with no malpositioning, tilting, perforation or access thrombosis. The patients were followed for 3 to 23 months (mean = 11 months). No patient developed recurrent venous thromboembolism. No other patients developed inferior vena cava thrombosis or filter migration. Death occurred in seven patients, all related to baseline illness. This preliminary study suggests good feasibility and safety of the new filter up to the observation period.
Vena cava filters; prosthesis design; pulmonary embolism; pulmonary embolism; venous thrombosis
