title: Evaluation of Effectiveness of Embolization in Pelvic Congestion Syndrome with the New Vascular Occlusion Device (ArtVentive EOS™): Preliminary Results.
abstract: OBJECTIVE
  This study aimed to collect confirmatory data in support of the safety and efficiency of the ArtVentive EOS™ for the treatment of the pelvic congestion syndrome (PCS). This study was based on the OCCLUDE 1 Study Protocol approved by the Local Ethics Committee.
  
  
  METHODS
  A prospective study carried out in June and July 2014 included 12 women aged 21-48 years (mean 31 years) scheduled for PCS embolization using the ArtVentive EOS™. The inclusion criteria were clinical symptoms of PCS documented by transvaginal Doppler ultrasound and pelvic MRI. The pelvic pain was assessed by VAS score from 0 to 10 (0 represents lack of pain and 10 unbearable pain). A decrease in pelvic pain intensity based on the VAS was considered a clinical success.
  
  
  RESULTS
  Successful embolization procedures with ArtVentive EOS™ were performed in 11 out of 12 patients. Nine patients underwent unilateral embolization of the left ovarian vein, and two had bilateral embolization of the ovarian veins. Complete ovarian vein occlusion confirmed by post deployment venography was achieved in all 11 patients. Procedures lasted from 19 to 45 min (average 28 min). Pain intensity decrease was observed in all 11 patients-a decrease of 5.6 points-from 7.3 pre-procedure to 1.6 post-embolization (standard deviation: 0.67). In one case, the left ovarian vein was injured by guide wire manipulation with contrast extravasation-not clinically significant.
  
  
  CONCLUSIONS
  The use of ArtVentive EOS™ for occlusion of the ovarian veins in PCS patients is safe and effective.
authors.affiliation: Department of Interventional Radiology and Neuroradiology, Medical University of Lublin, Jaczewskiego 8 Street, 20-954, Lublin, Poland. k.pyra@poczta.fm.
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Pyra
authors.affiliation: III Gynecology Clinic, Medical University of Lublin, Jaczewskiego 8 Street, 20-954, Lublin, Poland.
authors.forename: Sławomir
authors.initials: S
authors.lastname: Woźniak
authors.affiliation: Department of Interventional Radiology and Neuroradiology, Medical University of Lublin, Jaczewskiego 8 Street, 20-954, Lublin, Poland.
authors.forename: Anna
authors.initials: A
authors.lastname: Drelich-Zbroja
authors.affiliation: Department of Interventional Radiology and Neuroradiology, Medical University of Lublin, Jaczewskiego 8 Street, 20-954, Lublin, Poland.
authors.forename: Andrzej
authors.initials: A
authors.lastname: Wolski
authors.affiliation: Department of Interventional Radiology and Neuroradiology, Medical University of Lublin, Jaczewskiego 8 Street, 20-954, Lublin, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Jargiełło
mesh_terms: D000328:Adult; D004621:Embolization, Therapeutic / Q000295:instrumentation* / Q000379:methods*; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D010049:Ovarian Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D010053:Ovary / Q000098:blood supply* / Q000000981:diagnostic imaging; D017699:Pelvic Pain / Q000209:etiology / Q000628:therapy; D010690:Phlebography / Q000379:methods; D011446:Prospective Studies; D013577:Syndrome; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler; D014652:Vascular Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D055815:Young Adult
keywords: Embolization; Pelvic congestion syndrome; Vascular occluder