First-in-Human Study with Eight Patients Using an Absorbable Vena Cava Filter for the Prevention of Pulmonary Embolism |
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Affiliation: | 1. Department of Radiology, Hospital Universitario Dr. José Eleuterio González, Monterrey, Mexico;2. Adient Medical, 12234 Shadow Creek Parkway, Building 8, Pearland, TX 77584;3. Department of Radiology, Medical Clinic of Houston, Houston, Texas;4. Department of Radiology, Stanford University, Stanford, California;5. Department of Interventional Radiology, The University of Texas MD Anderson Cancer Center, Houston, Texas;1. Department of Radiology, The Tenth People’s Hospital, Shanghai, China;2. Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Olymphic-ro 43 gil 88, Songpa-Gu, Seoul 138-735, Korea;3. Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Olymphic-ro 43 gil 88, Songpa-Gu, Seoul 138-735, Korea;4. Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Olymphic-ro 43 gil 88, Songpa-Gu, Seoul 138-735, Korea;1. School of Medicine, University of North Carolina at Chapel Hill, 321 South Columbia Street, Chapel Hill, NC 27516;2. RAD-AID International, Chevy Chase, Maryland;3. Department of Diagnostic Imaging and Radiation Medicine, University of Nairobi, Nairobi, Kenya;4. Department of Radiology, Mercy Hospital, Miami, Florida;5. Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina;1. Department of Radiology, University of Michigan, Ann Arbor, Michigan;2. Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan;3. Section of Plastic Surgery, Department of Surgery, University of Michigan, Ann Arbor, Michigan;1. Department of Radiology, Gifu University School of Medicine, 1-1 Yanagido, Gifu 501-1194, Japan;2. Department of Surgical Oncology, Gifu University School of Medicine, 1-1 Yanagido, Gifu 501-1194, Japan;3. Department of Diagnostic Radiology and Nuclear Medicine, Hamamatsu University School of Medicine, Shizuoka, Japan |
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Abstract: | PurposeTo prospectively evaluate the initial human experience with an absorbable vena cava filter designed for transient protection from pulmonary embolism (PE).Materials and MethodsThis 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.ResultsNo 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.ConclusionsImplantation 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. |
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