Inflammatory Reaction Developed around Embolisation Microspheres in Sheep

Trisacryl-Gelatin and Polyvinyl-Alcohol Microspheres

Presented during
Embolisation

Abstract Number
220

Authors
A. Laurent, M. Wassef, J.P. Pelage, E. Velzenberger, I. Schwartz-Cornil, J.J. Merland

Institution
Center for Research in Interventional Imaging APHP-INRA, Jouy en Josas, France

Purpose

To determine the cell types present in the inflammatory reaction developed around trisacryl-gelatin (TG) and polyvinyl alcohol (PVA) microspheres , and to analyse their evolution during time.

Materials & Methods

Eighteen hormonally cycled ewes (9 in each product group) were embolised in uterus arteries with .25ml of 500-700 m microspheres. Products and animals were randomised. Animals were sacrificed at three periods 8 days (8D), 3 weeks (3W), 2 months (2M). Samplings of uteruses were analysed in for congelation and Formalin fixation and HES staining of uteruses.

The inflammatory cells were typed with specific sheep CD antibody markers: CD2 (T-lymphocytes and NK cells), CD4 (T-Helper lymphocytes), CD8 (cytotoxic T-lymphocytes, CD21 (B-lymphocytes), CD14 (macrophages and giant cells). and CD68 (activated macrophages and giant cells). The CD antibodies had been previously validated in sheep lymph node samples. The CD intensity was measured (Axoplan microscope (Zeiss), motorized plate (Märzauser), video camera (Sony DXC 930, 3 CCD), Histolab version 5.7.1 (Microvision). The ratio of the CD marking around the microspheres vs at a distance was calculated. Statview SAS 2000 :Mann-Whitney and univariate non paramatric tests.

Results

The inflammatory cell types present around the two microspheres were T-lymphocytes and NK cells, T-Helper lymphocytes, macrophages and giant cells.There was no B-lymphocytes. In general the number of the various cell types was maximum at 3W. The populations of each cell type were not identical for the two biomaterials. PVA inflammatory reaction contained significantly more CD14 macrophages and giant cells at 3W (p=.0061), more CD2 at 3W (p=.0048), more CD4 lymphocytes at three periods (p=.0041p>.0001, p=.0003), and more CD8 (p=.0003) at 3W, comparatively with TG. At 3W and 2M, inflammatory cells were often observed within the cavities of PVA microsphere core . No cell was present in the TG.

Conclusion

The inflammatory reaction was mild on the two products and evolved during time, with a maximum at 3W. The higher inflammatory response on PVA than on TG, and the presence of activated macrophages and T8 lymphocytes on PVA suggest a slow resorbtion of this material.

Regulatory notices and product safety data

Worldwide (excluding USA)

Bead Block™ is CE marked and indicated for the treatment of a variety of hypervascular tumours (including Uterine Fibroids) and arteriovenous malformations (AVMs). Bead Blockā„¢ may not be indicated for the treatment of Uterine Fibroids in your country, please check with your local distributor. For full prescribing information please refer to Bead Block instructions for use.

USA

Bead Block is intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs)

Bead Block Cautions:

  • Do not use if the syringe or packaging appear damaged
  • Sterile and single use product.  Do not reuse
  • Select the size and quantity of Bead Block microspheres appropriate for the pathology to be treated
  • Embolization with Bead Block microspheres should only be performed by physicians who have received appropriate interventional occlusion training in the region intended to be embolized

For instructions for use, please refer to www.biocompatibles.com/beadblock-ifu

Bead Block Potential Complications:

  • Undesirable reflux or passage of Bead Block into normal arteries adjacent to the targeted lesion or through the lesion into other arteries or arterial beds, such as the internal carotid artery, pulmonary, or coronary circulations
  • Pulmonary embolization
  • Ischemia at an undesirable location
  • Capillary bed saturation and tissue damage
  • Ischemic stroke or ischemic infarction
  • Vessel or lesion rupture and haemorrhage
  • Neurological deficits including cranial nerve palsies
  • Vasospasm
  • Death
  • Recanalization
  • Foreign body reactions necessitating medical intervention
  • Infection necessitating medical intervention
  • Clot formation at the tip of the catheter and subsequent dislodgement