title: A novel endovascular occlusion device with a steerable introducer for embolization in a porcine model.
abstract: OBJECTIVE
  It has been reported that vascular plugging has become a therapeutic alternative to coil embolization in certain cases that require occlusion. However, the use of a relatively large and rigid delivery sheath may be a limiting factor in vascular plug use. In this study, we aimed to determine the safety and efficacy of a novel transcatheter occlusion device with unique design and delivery system in a pig model.
  
  
  METHODS
  The Cera vascular plug was delivered and deployed through the FuStar steerable introducer sheath, which can control tip direction during advancement. Twelve pigs were randomized to undergo an embolization procedure in which the Cera vascular plug was implanted into the left internal iliac artery (IIA) with the FuStar steerable introducer (n = 6) or a control introducer sheath. Another eight pigs were assigned to undergo an embolization procedure in which the test device was implanted into either the splenic artery (SA, n = 4) or the lower segmental branch of left renal artery (LRA, n = 4). Angiography and pathological examinations were performed to evaluate the outcomes.
  
  
  RESULTS
  A total of 20 target vessels were embolized with a total of 22 test plugs. Compared with the control introducer, plug embolization through the FuStar steerable introducer was associated with shorter fluoroscopy time (21.50 ± 3.62 vs. 28.33 ± 2.16 min, P = 0.003) and less contrast medium (129.17 ± 22.68 vs. 162.50 ± 13.69 mL, P = 0.012). At the 2-month follow-up, angiography and pathological examinations did not show any evidence of migration, and persistent occlusion was observed in 18 of the 20 target vessels. Organ ischemia occurred when plugs were deployed within the lower segmental branch of the LRA.
  
  
  CONCLUSIONS
  This novel device is suitable for therapeutic vascular embolization with the use of flexible delivery systems. The different outcomes of SA and LRA plugging suggested that the occluding device should be placed within the appropriate portion of the target vessel to allow the development of collateralization.
authors.affiliation: Department of Vascular Surgery, Zhongshan Hospital of Xiamen University, Xiamen, China.
authors.forename: Weifeng
authors.initials: W
authors.lastname: Lu
authors.affiliation: Department of Vascular Surgery, Zhongshan Hospital of Fudan University, Shanghai, China.
authors.forename: Weiguo
authors.initials: W
authors.lastname: Fu
authors.affiliation: Department of Cardiovascular Surgery, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Si
authors.affiliation: Cancer Research Center, Medical College of Xiamen University, Xiamen, China.
authors.forename: Xiaoli
authors.initials: X
authors.lastname: Chen
authors.affiliation: Department of Vascular Surgery, Zhongshan Hospital of Xiamen University, Xiamen, China.
authors.forename: Qiuni
authors.initials: Q
authors.lastname: Cai
authors.affiliation: Department of Hepatobiliary Surgery, Zhongshan Hospital of Xiamen University, Xiamen, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Xiong
authors.affiliation: Department of Vascular Surgery, Zhongshan Hospital of Xiamen University, Xiamen, China.
authors.forename: Shichai
authors.initials: S
authors.lastname: Hong
authors.affiliation: Department of Vascular Surgery, Zhongshan Hospital of Xiamen University, Xiamen, China.
authors.forename: Donghai
authors.initials: D
authors.lastname: Yang
mesh_terms: D000818:Animals; D004621:Embolization, Therapeutic / Q000009:adverse effects / Q000295:instrumentation*; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D007083:Iliac Artery / Q000000981:diagnostic imaging; D007511:Ischemia / Q000209:etiology; D008297:Male; D023421:Models, Animal; D012077:Renal Artery / Q000000981:diagnostic imaging; D013157:Splenic Artery / Q000000981:diagnostic imaging; D013552:Swine; D062666:Vascular Access Devices
keywords: embolization; steerable introducer; swine model; transcatheter occlusion device