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Long-Term Safety and Effectiveness of the “OptEase” Vena Cava Filter

  • Clinical Investigation
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Abstract

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.

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Conflict of interest

Sanjeeva P. Kalva declares receiving a research grant from Angiodynamics and Cook Medical, consulting fees and honoraria from Cordis Endovascular, and royalties from Amirsys and Elsevier. Stephan Wicky reports receiving a research grant from Angiodynamics and Cook Medical as well as consulting fees and honoraria from Cordis Endovascular. Michael S. Stecker reports receiving a research grant from Rex Medical. Theodore C. Marentis, Kalpana Yeddula, and Bhanusupriya Somarouthu report no conflict of interest.

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Authors and Affiliations

  1. Department of Radiology, Massachusetts General Hospital, GRB-290, 55 Fruit Street, Boston, MA, 02114, USA

    Sanjeeva P. Kalva, Kalpana Yeddula, Bhanusupriya Somarouthu & Stephan Wicky

  2. Department of Radiology, Brigham’s Women’s Hospital, Boston, MA, USA

    Michael S. Stecker

  3. Department of Radiology, Harvard Medical School Boston, Boston, MA, USA

    Sanjeeva P. Kalva, Theodore C. Marentis, Kalpana Yeddula, Bhanusupriya Somarouthu, Stephan Wicky & Michael S. Stecker

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  1. Sanjeeva P. Kalva
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  2. Theodore C. Marentis
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  3. Kalpana Yeddula
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  4. Bhanusupriya Somarouthu
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  5. Stephan Wicky
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Correspondence to Sanjeeva P. Kalva.

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Kalva, S.P., Marentis, T.C., Yeddula, K. et al. Long-Term Safety and Effectiveness of the “OptEase” Vena Cava Filter. Cardiovasc Intervent Radiol 34, 331–337 (2011). https://doi.org/10.1007/s00270-010-9969-9

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  • DOI: https://doi.org/10.1007/s00270-010-9969-9

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