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One Year Outcomes of the VIVO-EU Study of Treatment of Symptomatic Iliofemoral Outflow Obstruction with the Zilver Vena Venous Self-Expanding Stent

  • Clinical Investigation
  • Venous Interventions
  • Published:
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Abstract

Objective

To evaluate the performance of the Zilver® Vena™ Venous Stent in the treatment of patients with symptomatic iliofemoral outflow obstruction.

Methods

Between August 2012 and January 2015, 35 patients (mean age of 45.1 ± 15.5 years; 77.1% female) with symptomatic iliofemoral venous outflow obstruction were treated with the Zilver Vena Venous Stent (Cook Ireland, Ltd.) as part of this prospective, single arm, multicenter study. Study assessments included procedural success, major adverse events (MAEs), freedom from occlusion and qualitative patency at 6 and 12 month post-procedure, clinical symptoms of venous insufficiency, and reintervention with the treated venous segment.

Results

The rate of freedom from occlusion at 6 month and 12 month was 88.2%. The rate of qualitative patency was 88.2% at 6 month and 85.2% at 12 month. Three MAEs were reported: one symptomatic pulmonary embolism and two clinically-driven reinterventions. Following stenting, clinical symptoms of venous insufficiency improved significantly from baseline at each follow-up, as measured by VDS (p < 0.0001), CEAP “C” (p ≤ 0.0001), VCSS (p < 0.0001), and CIVIQ (p < 0.0001).

Conclusion

Clinical results with the Zilver Vena Venous Stent were favorable through 12 month, with high patency rates, reduction of venous insufficiency symptoms, and low morbidity.

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Acknowledgements

The authors thank Chyon Yeh, PhD of Cook Research Incorporated for statistical analyses support.

Funding

The design of the study, data collection, analysis, and interpretation of the data and manuscript writing were funded by Cook Medical.

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Authors and Affiliations

  1. Department of Interventional Radiology, University College Hospital, Galway, Ireland

    Gerard J. O’Sullivan

  2. Department of Interventional Radiology, Guy’s and St Thomas’ Hospitals, NHS Foundation Trust, London, UK

    Narayan Karunanithy

  3. Department of Interventional Radiology, Kantonsspital Winterthur, Winterthur, Switzerland

    Christoph A. Binkert

  4. Angiology, Vascular and Endovascular Surgery Service, Hospital Madrid Monteprincipe, Madrid, Spain

    Marta Ramirez Ortega

  5. Vascular Center, Klinikum Arnsberg GmbH, Arnsberg, Germany

    Michael Lichtenberg

  6. Cook Research Incorporated, West Lafayette, IN, USA

    Jennifer A. McCann-Brown

Authors
  1. Gerard J. O’Sullivan
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  2. Narayan Karunanithy
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  3. Christoph A. Binkert
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  4. Marta Ramirez Ortega
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  5. Michael Lichtenberg
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  6. Jennifer A. McCann-Brown
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Corresponding author

Correspondence to Gerard J. O’Sullivan.

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Conflict of interest

GO: Paid medical advisor/speakers bureau for Cook Medical, BSCI, Bard, Medtronic, Merit, Marvao, Versono, Intact Vascular, Creagh Medical, Vetex. NK: Honoraria/travel bursaries for Cook Medical and BSCI. CB: Consultant CTI vascular; research support: Abbott, Biotronic, Philips. ML: Paid medical advisor for Cook Medical, Volcano, Plusmedica, BD Bard, Medtronic, BSCI, Vetex, Optimed GmbH, Vesper. MRO: Paid medical advisor/speakers bureau for Cook Medical, BD, Medtronic, BSCI, Terumo. JAMB: full-time employee of Cook Research Incorporated, a Cook Group Company.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Ethics committee approval for the study was obtained at each study center.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Consent for Publication

Consent for publication was obtained from all individual participants included in the study.

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O’Sullivan, G.J., Karunanithy, N., Binkert, C.A. et al. One Year Outcomes of the VIVO-EU Study of Treatment of Symptomatic Iliofemoral Outflow Obstruction with the Zilver Vena Venous Self-Expanding Stent. Cardiovasc Intervent Radiol 44, 1930–1936 (2021). https://doi.org/10.1007/s00270-021-02969-0

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  • DOI: https://doi.org/10.1007/s00270-021-02969-0

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