title: Proof-of-Concept Evaluation of the SailValve Self-Expanding Deep Venous Valve System in a Porcine Model.
abstract: To evaluate the SailValve, a new self-expanding deep venous valve concept based on a single polytetrafluoroethylene cusp floating up and down in the bloodstream like a sail, acting as a flow regulator and allowing minimal reflux to reduce thrombogenicity.
  
  
  
  Both iliac veins of 5 pigs were implanted with SailValve devices; the first animal was an acute pilot experiment to show the feasibility of accurately positioning the SailValve via a femoral access. The other 4 animals were followed for 2 weeks (n=2) or 4 weeks (n=2) under a chronic implantation protocol. Patency and valve function were evaluated directly in all animals using ascending and descending phlebography after device placement and at termination in the chronic implant animals. For reasons of clinical relevance, a regimen of clopidogrel and calcium carbasalate was administered. Histological analysis was performed according to a predefined protocol by an independent pathologist.
  
  
  
  Deployment was technically feasible in all 10 iliac veins, and all were patent directly after placement. No perioperative or postoperative complications occurred. Ascending phlebograms in the follow-up animals confirmed the patency of all valves after 2 or 4 weeks. Descending phlebograms showed full function in 5 of 8 valves. Limited reflux was seen in 1 valve (4-week group), and the function in the remaining 2 valves (2-week group) was insufficient because of malpositioning. No macroscopic thrombosis was noted on histology. Histology in the follow-up groups revealed a progressive inflammatory reaction to the valves.
  
  
  
  This animal study shows the potential of the SailValve concept with sufficient valve function after adequate positioning and no (thrombogenic) occlusions after short-term follow-up. Future research is essential to optimize valve material and long-term patency.
authors.affiliation: 1 Department of Vascular Surgery, University Medical Centre, Utrecht, the Netherlands.|2 Department of Surgery, Jeroen Bosch Ziekenhuis, Den Bosch, the Netherlands.
authors.forename: Doeke
authors.initials: D
authors.lastname: Boersma
authors.affiliation: 3 Department of Pathology, University Medical Centre, Utrecht, the Netherlands.
authors.forename: Aryan
authors.initials: A
authors.lastname: Vink
authors.affiliation: 1 Department of Vascular Surgery, University Medical Centre, Utrecht, the Netherlands.
authors.forename: Frans L
authors.initials: FL
authors.lastname: Moll
authors.affiliation: 1 Department of Vascular Surgery, University Medical Centre, Utrecht, the Netherlands.
authors.forename: Gert J
authors.initials: GJ
authors.lastname: de Borst
mesh_terms: D000818:Animals; D001706:Biopsy; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D005260:Female; D006083:Graft Occlusion, Vascular / Q000209:etiology; D007084:Iliac Vein / Q000000981:diagnostic imaging / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D023421:Models, Animal; D010690:Phlebography; D010865:Pilot Projects; D011138:Polytetrafluoroethylene; D000075082:Proof of Concept Study; D011474:Prosthesis Design; D034421:Sus scrofa; D013997:Time Factors; D014654:Vascular Patency; D020246:Venous Thrombosis / Q000209:etiology; D055422:Venous Valves
chemical_list: D011138:Polytetrafluoroethylene
keywords: animal model; deep venous thrombosis; endovascular techniques; histology; in vivo study; porcine model; prosthesis; varicose vein; venous insufficiency; venous valve