Purpose: To evaluate preliminary clinical experience in humans with the Recovery nitinol filter (RNF) for the inferior vena cava, especially the efficacy of the device and safety of its retrieval.
Materials and methods: Thirty-two patients were followed up to assess for filter efficacy and for ability to remove the filter.
Results: Sixteen men and 16 women aged 18-83 years (mean, 53 years) underwent treatment with the RNF. Indications for placement were recent pulmonary embolism (n = 16), recent deep venous thrombosis (n = 20), and/or prophylaxis (n = 2). Four patients had contraindications to anticoagulant therapy, and four had complications from anticoagulant therapy. The filter was successfully placed in 32 patients. In 24 (100%) of 24 patients, the filter was successfully retrieved with a jugular approach. The mean implantation period was 53 days (range, 5-134 days). Trapped thrombus was seen within the filter in seven cases. In one patient with a large trapped thrombus, the filter was noted to have migrated 4 cm cephalad. There were no episodes of pulmonary embolism or insertion-site thrombosis.
Conclusion: This preliminary experience in humans confirms the efficacy of the RNF. It also demonstrates the feasibility and safety of retrieval up to 134 days after implantation.