Abstract
PURPOSE: To evaluate the safety and effectiveness of the retrievable Option inferior vena cava (IVC) filter in patients at risk for pulmonary embolism (PE). MATERIALS AND METHODS: This was a prospective, multicenter, single-arm clinical trial. Subjects (N = 100) underwent implantation of the IVC filter and were followed for 180 days; subjects whose filters were later removed were followed for 30 days thereafter. The primary objective was to determine whether the one-sided lower limit of the 95% CI for the observed clinical success rate was at least 80%. Clinical success was defined as technical success (deployment of the filter such that it was judged suitable for mechanical protection from PE) without subsequent PE, significant filter migration or embolization, symptomatic caval thrombosis, or other complications. RESULTS: Technical success was achieved in 100% of subjects. There were eight cases of recurrent PE, two cases of filter migration (23 mm), and three cases of symptomatic caval occlusion/thrombosis (one in a subject who also experienced filter migration). No filter embolization or fracture occurred. Clinical success was achieved in 88% of subjects; the one-sided lower limit of the 95% CI was 81%. Retrieval was successful at a mean of 67.1 days after implantation (range, 1175 d) for 36 of 39 subjects (92.3%). All deaths (n = 17) and deep vein thromboses (n = 18) were judged to have resulted from preexisting or intercurrent illnesses or interventions and unrelated to the filter device; all deaths were judged to be unrelated to PE. CONCLUSIONS: Placement and retrieval of the Option IVC filter were performed safely and with high rates of clinical success.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1153-1163 |
| Number of pages | 11 |
| Journal | Journal of Vascular and Interventional Radiology |
| Volume | 21 |
| Issue number | 8 |
| DOIs | |
| State | Published - 2010 |
Funding
This study was sponsored by Rex Medical (Conshohocken, Pennsylvania). M.S.J. serves as a consultant to Rex Medical, CeloNova BioSciences (Newnan, Georgia), Cook (Bloomington, Indiana), Lutonix (Maple Grove, Minnesota), Boston Scientific Corporation (Natick, Massachusetts), MDS Nordion (Ottawa, Canada), and Sirtex Medical (Lane Cove NSW, Australia). A.A.N. serves as a consultant to B. Braun Interventional (Bethlehem, Pennsylvania). J.F.B serves on the medical advisory boards of Amaranth Medical (Mountain View, California), Cordis Endovascular (Miami Lakes, Florida), and EndoVention (San Francisco, California) and as the Chief Medical Officer for Endovascular Forum (Boston, Massachusetts); and is a stockholder of Ekos (Bothell, Washington). D.S.B. serves on the advisory board of Cordis Endovascular and as a consultant and speaker for Bard Peripheral Vascular (Tempe, Arizona). B.L.D. serves as a consultant and speaker for Bard Peripheral Vascular and as a consultant to Covidien (Mansfield, Massachusetts) and on the medical advisory boards of Vital Access (Salt Lake City, Utah) and Endovascular Forum. J.A.K. serves on the medical board of Hatch Medical (Duluth, Georgia) and as a consultant to AGA Medical (Plymouth, Minnesota) and receives research support from W.L. Gore and Associates (Flagstaff, Arizona), VNUS Medical Technologies (San Jose, California), LeMaitre Vascular (Burlington, Massachusetts), and Rex Medical . Z.JH. serves on the scientific advisory board of W.L. Gore and Associates and on the medical advisory boards of Endovascular Forum and Elcam Medical (Hackensack, New Jersey) and as a consultant for Bard Peripheral Vascular, and receives research support from Bard Peripheral Vascular . R.L.A. is an employee of, and stockholder in, Angiotech Pharmaceuticals (Vancouver, British Columbia, Canada). None of the other authors have identified a conflict of interest.
Keywords
- DVT
- IVC
- PE
- deep vein thrombosis
- inferior vena cava
- pulmonary embolism
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging
- Cardiology and Cardiovascular Medicine
