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An Implantable Bioprosthetic Venous Valve to Establish Deep Vein Competence for Post-Thrombotic Syndrome

To identify the key insights or developments described in this article
1 Credit CME

VenoValve is a bioprosthetic device designed to improve valvular competence in the deep venous system of the lower extremities and treat deep venous insufficiency (DVI). First-in-human studies have focused on use in patients with DVI stemming from post-thrombotic syndrome, although design features portend utility in those with primary disease as well. The innovation consists of a porcine aortic valve leaflet dissected and structured in a nonexpandable 10-mm stainless-steel frame forming a monocusp, unidirectional valve (Figure, A). The device is preserved with glutaraldehyde, which maintains the tissue's anatomic integrity, strength, and flexibility properties,1 packaged in normal saline and sterilized by gamma radiation. VenoValve is implanted in the femoral vein through a thigh incision and secured with monofilament sutures (Figure, B). Early studies have required a vein of at least 8-mm diameter and, in some cases, a limited focal endovenectomy or bovine pericardial patch to close the venotomy. Proximal venous obstruction should be ruled out or treated prior to use of the device, and Duplex should be used to ensure adequate unidirectional flow after implantation.

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Article Information

Corresponding Author: Todd E. Rasmussen, MD, Department of Surgery, Mayo Clinic, Rochester, MN 55905 (rasmussen.todd@mayo.edu).

Published Online: January 18, 2023. doi:10.1001/jamasurg.2022.6362

Conflict of Interest Disclosures: Dr Cifuentes reported work as a research fellow with Dr Ulloa as principal investigator. Dr Ulloa reported grants from EnVVeno Medical Corporation and Hancock Jaffe Laboratories. No other disclosures were reported.

References
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Kabbani  L , Escobar  GA , Mansour  F , Wakefield  TW , Henke  PK .  Longevity and outcomes of axillary valve transplantation for severe lower extremity chronic venous insufficiency.   Ann Vasc Surg. 2011;25(4):496-501. doi:10.1016/j.avsg.2011.02.002PubMedGoogle ScholarCrossref
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Ulloa  JH , Glickman  M .  Human trial using the novel bioprosthetic VenoValve in patients with chronic venous insufficiency.   J Vasc Surg Venous Lymphat Disord. 2021;9(4):938-944. doi:10.1016/j.jvsv.2020.10.017PubMedGoogle ScholarCrossref
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Ulloa  JH , Glickman  M .  One-year first-in-human success for VenoValve in treating patients with severe deep venous insufficiency.   Vasc Endovascular Surg. 2022;56(3):277-283. doi:10.1177/15385744211073730PubMedGoogle ScholarCrossref
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AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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