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Long-Term Safety and Effectiveness of the "OptEase" Vena Cava Filter.
MedLine Citation:
PMID:  20820780     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
PURPOSE: To assess the long-term safety and effectiveness of the OptEase inferior vena cava (IVC) filter.
MATERIALS AND METHODS: In this Institutional Review Board-approved, retrospective study, we reviewed data of 71 patients who received an OptEase filter at our institution from 2002 to 2007. Thirty-nine (55%) patients had symptoms of venous thromboembolism before filter placement. The indications for filter included contraindication to anticoagulation in 31 (44%) patients, prophylaxis against pulmonary embolism (PE) in 29 (41%) patients, and failure of anticoagulation in 11 (15%) patients. Procedure-related complications, such as symptomatic post-filter PE, deep venous thrombosis (DVT), IVC occlusion, and incidental imaging-evident filter-related complications, were recorded. Safety was assessed by the occurrence of filter-related complications during placement and follow-up. Effectiveness was assessed by the occurrence of post-filter PE.
RESULTS: Sixty-five (92%) filters were placed under fluoroscopy, and 6 (8%) were placed using intravascular ultrasound guidance. Seventy (99%) filters were placed successfully. Seven (10%) filters were placed in the suprarenal cava. Retrieval was attempted in 14 (20%) patients, and 12 filters were successfully retrieved. Clinical follow-up was available for 20 ± 21 months. Symptoms of postfilter PE and DVT occurred in 15% (n = 11) and 10% (n = 7) patients, respectively. None of these patients had computed tomography (CT)-proven PE, and only one had ultrasound-proven new DVT. One patient had symptomatic IVC occlusion. Follow-up abdominal CT in 20 patients showed thrombus in the filter in two of them. There were no instances of filter migration, filter tilt, or caval wall penetration.
CONCLUSION: The OptEase filter appears to have an acceptable long-term safety profile. The filter was effective against PE.
Authors:
Sanjeeva P Kalva; Theodore C Marentis; Kalpana Yeddula; Bhanusupriya Somarouthu; Stephan Wicky; Michael S Stecker
Publication Detail:
Type:  Journal Article     Date:  2010-09-04
Journal Detail:
Title:  Cardiovascular and interventional radiology     Volume:  34     ISSN:  1432-086X     ISO Abbreviation:  Cardiovasc Intervent Radiol     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-03-16     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8003538     Medline TA:  Cardiovasc Intervent Radiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  331-7     Citation Subset:  IM    
Affiliation:
Department of Radiology, Massachusetts General Hospital, GRB-290, 55 Fruit Street, Boston, MA, 02114, USA, skalva@partners.org.
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