Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 1 de 1
Filter
Add more filters










Database
Language
Publication year range
1.
J Vasc Interv Radiol ; 31(11): 1817-1824, 2020 Nov.
Article in English | MEDLINE | ID: mdl-33008719

ABSTRACT

PURPOSE: To prospectively evaluate the initial human experience with an absorbable vena cava filter designed for transient protection from pulmonary embolism (PE). MATERIALS AND METHODS: This was a prospective, single-arm, first-in-human study of 8 patients with elevated risk of venous thromboembolism (VTE). Seven absorbable IVC filters (made of polydioxanone that breaks down into H2O and CO2 in 6 mo) were placed prophylactically before orthopedic (n = 5) and gynecologic (n = 2) surgeries, and 1 was placed in a case of deep vein thrombosis. Subjects underwent CT cavography and abdominal radiography before and 5, 11, and 36 weeks after filter placement to assess filter migration, embolization, perforation, and caval thrombosis and/or stenosis. Potential PE was assessed immediately before and 5 weeks after filter placement by pulmonary CT angiography. RESULTS: No symptomatic PE was reported throughout the study or detected at the planned 5-week follow-up. No filter migration was detected based on the fixed location of the radiopaque markers (attached to the stent section of the filter) relative to the vertebral bodies. No filter embolization or caval perforation was detected, and no caval stenosis was observed. Throughout the study, no filter-related adverse events were reported. CONCLUSIONS: Implantation of an absorbable vena cava filter in a limited number of human subjects resulted in 100% clinical success. One planned deployment was aborted as a result of stenotic pelvic veins, resulting in 89% technical success. No PE or filter-related adverse events were observed.


Subject(s)
Absorbable Implants , Polydioxanone/chemistry , Prosthesis Implantation/instrumentation , Pulmonary Embolism/therapy , Vena Cava Filters , Aged , Female , Humans , Male , Middle Aged , Prospective Studies , Prosthesis Design , Prosthesis Implantation/adverse effects , Pulmonary Embolism/diagnostic imaging , Pulmonary Embolism/etiology , Risk Factors , Time Factors , Treatment Outcome
SELECTION OF CITATIONS
SEARCH DETAIL
...