Journal of Vascular and Interventional Radiology
Volume 21, Issue 8 , Pages 1173-1184, August 2010

The Safety and Effectiveness of the Retrievable Option Inferior Vena Cava Filter: A United States Prospective Multicenter Clinical Study

  • Matthew S. Johnson, MD

      Affiliations

    • Department of Radiology, Indiana University School of Medicine, 550 University Blvd., Indianapolis, IN 46202
    • Corresponding Author InformationAddress correspondence to M.S.J.
    • ,
  • Albert A. Nemcek Jr, MD

      Affiliations

    • Department of Radiology, Section of Interventional Radiology, Northwestern Memorial Hospital, Chicago, Illinois
    • ,
  • James F. Benenati, MD

      Affiliations

    • Baptist Cardiac and Vascular Institute, Miami, Florida
    • ,
  • Dirk S. Baumann, MD

      Affiliations

    • Peninsula Vein Clinic, Mill–Peninsula Medical Center, Burlingame, California
    • ,
  • Bart L. Dolmatch, MD

      Affiliations

    • Division of Interventional Radiology, University of Texas Southwestern Medical Center, Dallas, Texas
    • ,
  • John A. Kaufman, MD

      Affiliations

    • Dotter Interventional Institute, Oregon Health and Science University, Portland, Oregon
    • ,
  • Mark J. Garcia, MD

      Affiliations

    • Section of Vascular and Interventional Radiology, Christiana Hospital, Newark, Delaware
    • ,
  • Michael S. Stecker, MD

      Affiliations

    • Department of Radiology, Brigham and Women's Hospital, Boston, Massachusetts
    • ,
  • Anthony C. Venbrux, MD

      Affiliations

    • Department of Radiology, George Washington University, Washington DC
    • ,
  • Ziv J. Haskal, MD

      Affiliations

    • Division of Vascular and Interventional Radiology, University of Maryland Medical Center, Baltimore, Maryland
    • ,
  • Rui L. Avelar, MD

      Affiliations

    • Angiotech Pharmaceuticals, Vancouver, British Columbia, Canada

Received 17 November 2009; received in revised form 27 February 2010; accepted 3 April 2010. published online 02 July 2010.

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, 1–175 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.

Abbreviations: DVT, deep vein thrombosis, IVC, inferior vena cava, PE, pulmonary embolism

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 From the SIR 2009 Annual Meeting.

 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.

PII: S1051-0443(10)00328-3

doi:10.1016/j.jvir.2010.04.004

Journal of Vascular and Interventional Radiology
Volume 21, Issue 8 , Pages 1173-1184, August 2010

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