title: Biocompatibility screening in cardiovascular implants.
abstract: BACKGROUND
  Interest in information on biocompatibility of implants is increasing. The purpose of this paper is to discuss methods and results of pathological biocompatibility screening of explanted cardiovascular implants.
  
  
  METHODS
  Use of standard histology after embedding in paraffin is limited since metallic implants have to be removed during workup with disruption of the specimen. Alternatively, tissue blocks containing an implant can be embedded in methylmethacrylate or hydroxyethylmethacrylate and processed by sectioning with a diamond cutter and grinding, thus leaving the implant in situ and saving the tissue/implant interface for detection of local inflammatory reactions. Another important aspect of evaluation is the progress of thrombus organisation after initial fibrin clotting on the metal surface or in the inner part of occlusion devices. New methacrylate resins and embedding techniques allow for specific immunohistochemical staining of the specimen thus enabling characterisation of tissues surrounding the implant. Information on endothelialisation of the vascular surface of the implant can be obtained by means of immunohistochemistry or by scanning electron microscopy.
  
  
  RESULTS
  Illustrating the use of these technologies, we demonstrate findings in tissue specimens from animal studies with different types of devices (i.e. stents, occlusion devices). We present corresponding findings in human specimens with implants that were removed during corrective surgery for congenital heart defects. Early endothelialisation of the vascular surface was seen after implantation in all types of devices. Cells within occlusion devices could be characterised histologically and immunohistochemically as fibromuscular cells as seen in intimal hyperplasia after stent implantation. Inflammatory implant-host reactions ranged from mild to moderate (medical grade stainless steel, nitinol) to severe (polytetrafluoroethylene [PTFE]).
  
  
  CONCLUSIONS
  With an optimal work-up of cardiovascular implants, ingrowth and endothelialisation as well as inflammatory reactions in the surrounding tissue can be assessed. This information allows evaluation of individual tissue reactions to the implant and may serve as valuable basis for optimisation of biocompatibility by implant modification.
authors.affiliation: Herzzentrum Göttingen, Pädiatrische Kardiologie und Intensivmedizin, Georg-August-Universität Göttingen, 37099 Göttingen, Germany. msigler@gwdg.de
authors.forename: M
authors.initials: M
authors.lastname: Sigler
authors.forename: T
authors.initials: T
authors.lastname: Paul
authors.forename: R G
authors.initials: RG
authors.lastname: Grabitz
mesh_terms: D000818:Animals; D001672:Biocompatible Materials / Q000009:adverse effects*; D001807:Blood Vessel Prosthesis / Q000009:adverse effects*; D013504:Cardiovascular Surgical Procedures / Q000295:instrumentation; D002319:Cardiovascular System / Q000473:pathology*; D019544:Equipment Failure Analysis / Q000379:methods*; D005549:Foreign-Body Reaction / Q000209:etiology / Q000473:pathology*; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D006801:Humans; D016459:Prosthesis-Related Infections / Q000209:etiology / Q000473:pathology*; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors; D016707:Tissue Fixation / Q000379:methods; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials