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Heart 1998;80:606-611 ( December )
a Institute of
Experimental Clinical Research, Department of Cardiothoracic and
Vascular Surgery and Department of Cardiology, Skejby Sygehus, Aarhus
University Hospital, Denmark, b Department of Pediatric Cardiology, Charitè Hospital,
Humboldt Universität, Berlin, Germany
Correspondence to: Dr A Bloch Thomsen, Department of Research in Cardiothoracic and Vascular Surgery, Skejby Sygehus, DK-8200 Aarhus N, Denmark.
Accepted for publication 13 May 1998
Objective
To establish the implantation technique
for the atrial septal defect occluder system (ASDOS) device in an
experimental animal model and to determine long term mechanical
stability of the device and its in vivo properties in terms of
biocompatibility and tissue reaction.
Materials and methodsAn atrial septal defect was
created and the device implanted in 17 pigs (mean weight 30 kg). The
implantation technique was refined and modified because of initial
technical and anatomical complications during nine acute pilot studies.
The technique proved to be feasible in eight subsequent survival
studies. Four pigs were electively killed three months after
implantation (group 1). The remaining four pigs were killed six months
after implantation (group 2).
ResultsNecropsy showed all devices were embedded
in soft tissue three months after implantation. Microscopic examination
of atrial septal tissue showed an acute granulomatous inflammatory
reaction in group 1 and fibrosis in group 2. The intensity of the
inflammatory reaction around the device was clearly milder in group 2, indicating a decline in the inflammatory response with time. Clinical
and biochemical investigations indicated acceptable biocompatibility of
the device.
ConclusionThe implantation technique for the
ASDOS device in a chronic pig model has been established.
Biocompatibility of the device was acceptable.
This article has been cited by other articles:
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  M. Sigler and C. Jux Biocompatibility of septal defect closure devices Heart, April 1, 2007; 93(4): 444 - 449. [Abstract] [Full Text] [PDF]
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 C. Jux, H. Bertram, P. Wohlsein, M. Bruegmann, and T. Paul Interventional Atrial Septal Defect Closure Using a Totally Bioresorbable Occluder Matrix: Development and Preclinical Evaluation of the BioSTAR Device J. Am. Coll. Cardiol., July 4, 2006; 48(1): 161 - 169. [Abstract] [Full Text] [PDF]
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