title: Animal experimental evaluation of a new sealing device for indwelling arterial catheters.
abstract: BACKGROUND
  Hematoma is a common complication following arterial puncture. To date no device that allows sealing of an arterial puncture site with in-situ catheter has been developed.
  
  
  OBJECTIVE
  To evaluate a newly developed arterial sealing device for endovascular catheters in an in-vivo experimental setting.
  
  
  METHODS
  A peelable collagen-based vascular sealing device for endovascular catheters was tested in acute (follow-up: 4 h; n = 2) and chronic (follow-up: 1 week; n = 4) settings in the femoral artery (FA) of sheep. After implantation correct position of the device as well as patency of the FA were verified angiographically. In the chronic group, hematoma was excluded and patency of FA was assured using color Doppler ultrasound 1 and 3 days after the procedure. After 1 week a final ultrasound and an angiography were performed for final evaluation. Thereafter, the animals were sacrificed and the puncture site was dissected and analyzed macroscopically.
  
  
  RESULTS
  Sufficient sealing of the puncture site could be observed in all animals. In acute and chronic experiments, neither a hematoma at the puncture site nor other complications were observed after positioning the sealing device. Follow-up color Doppler ultrasounds (CDUS) and final angiography revealed patent FAs in all animals. Macroscopic evaluation of dissection material proved collagen plug and catheter being in place.
  
  
  CONCLUSIONS
  Our preliminary in-vivo results demonstrate a safe and convenient vascular sealing system for endovascular catheters. No acute or chronic complications were observed.
authors.affiliation: Department of Diagnostic and Interventional Radiology, RWTH Aachen University Hospital, Aachen isfort@ukaachen.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Isfort
authors.affiliation: Department of Cardiovascular Engineering (CVE), Institute of Applied Medical Engineering (AME) - Helmholtz Institute, RWTH Aachen University, Aachen, Germany.
authors.forename: Ute
authors.initials: U
authors.lastname: Urban
authors.affiliation: Department of Diagnostic and Interventional Radiology, RWTH Aachen University Hospital, Aachen.
authors.forename: Andreas Horst
authors.initials: AH
authors.lastname: Mahnken
authors.affiliation: Department of Diagnostic and Interventional Radiology, RWTH Aachen University Hospital, Aachen.
authors.forename: Tobias
authors.initials: T
authors.lastname: Penzkofer
authors.affiliation: Department of Diagnostic and Interventional Radiology, RWTH Aachen University Hospital, Aachen.
authors.forename: Philipp
authors.initials: P
authors.lastname: Bruners
authors.affiliation: Department of Diagnostic and Interventional Radiology, RWTH Aachen University Hospital, Aachen.
authors.forename: Joachim
authors.initials: J
authors.lastname: Pfeffer
authors.affiliation: Department of Cardiovascular Engineering (CVE), Institute of Applied Medical Engineering (AME) - Helmholtz Institute, RWTH Aachen University, Aachen, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Steinseifer
authors.affiliation: Department of Diagnostic and Interventional Radiology, RWTH Aachen University Hospital, Aachen.
authors.forename: Rolf Wilhelm
authors.initials: RW
authors.lastname: Günther
authors.affiliation: Department of Cardiovascular Engineering (CVE), Institute of Applied Medical Engineering (AME) - Helmholtz Institute, RWTH Aachen University, Aachen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Schmitz-Rode
mesh_terms: D000792:Angiography; D000818:Animals; D002408:Catheters, Indwelling; D003287:Contrast Media; D004195:Disease Models, Animal; D004867:Equipment Design; D005263:Femoral Artery; D005471:Fluoroscopy; D006406:Hematoma / Q000517:prevention & control; D006488:Hemostasis, Surgical / Q000295:instrumentation*; D007472:Iohexol / Q000031:analogs & derivatives; D011677:Punctures; D034561:Sheep, Domestic; D065506:Vascular Closure Devices
chemical_list: D003287:Contrast Media; D007472:Iohexol; C038192:iopromide
keywords: Vascular sealing; invasive monitoring; long-term indwelling catheters