Back to 2016 Annual Symposium ePosters
Initial clinical and histologic results of lower extremity bypass involving a novel biologic material
Richard F. Neville, MD, Kendall Endicott, MD, Ashley Rickey, MD, Arnold Schwartz, MD, Joshua Adams, MD.
George Washington University MFA, Washington, DC, USA.
OBJECTIVES: Myointimal hyperplasia with restenosis leads to failure of lower extremity revascularization (LE) procedures. A biologic material based on extracellular matrix substrate derived from porcine small intestinal submucosa (SIS) has shown promise as a scaffold to foster a stem cell mediated regenerative remodeling of vascular tissue. We present initial clinical results using this material for LE revascularization with histologic findings.
METHODS: Over a 15-month period, 40 LE vascular reconstructions were performed with the SIS vascular material (Cormatrix, Roswell, GA). A retrospective analysis of prospectively collected data was performed with institutional IRB approval. Patient demographics included; DM (48%), renal failure (22%), and active tobacco use (35%). Indications for intervention were claudication (13%), rest pain (35%), tissue loss (37%), and graft stenosis (15%). Procedures included ilio-femoral thromboendarterectomy with patch angioplasty (n=16), Distal Vein Patch bypass (n=13), bypass graft revision (n=6), and profundaplasty (n=5). Follow-up included ABI and duplex ultrasound in all patients.
RESULTS: Follow up ranged from one to fifteen months with a mean of 6.3 months. There were no acute episodes of vascular dehiscence, thrombosis, infection, or pseudoaneurysm formation. Primary procedural patency was maintained in 92.5% of reconstructions with three vascular thromboses, one anastomotic pseudoaneurysm, one wound dehiscence, and two mortalities during follow-up. Anastomotic tissue was harvested during revision of a bypass graft. Histologic analysis of this tissue demonstrated a neo-intima consisting of macrophages and fibroblasts with endothelial cell migration, a neo-media composed of vascular smooth muscle with a mild inflammatory response, sparse collagen fibers, prominent elastic fibers, as well as an outer neo-adventitial layer with an intense inflammatory reaction and granulation tissue.
CONCLUSION: Initial clinical results for LE revascularization performed with SIS biologic material demonstrated no acute complications with one pseudoaneurysm in follow-up. Histologic analysis demonstrated formation of neo-intima, media, and adventitia with regenerative characteristics; thereby showing promise to generate favorable vascular healing, decreasing failure due to the hyperplastic reparative response.
Back to 2016 Annual Symposium ePosters
|
