Extracellular Matrix Patches for Endarterectomy Repair

Abstract

Patch repair is the preferred method for arteriotomy closure following femoral or carotid endarterectomy. Choosing among available patch options remains a clinical challenge, as current evidence suggests roughly comparable outcomes between autologous grafts and synthetic and biologic materials. Biologic patches have potential advantages over other materials, including reduced risk for infection, mitigation of an excessive foreign body response, and the potential to remodel into healthy, vascularized tissue. Here we review the use of decellularized extracellular matrix (ECM) for cardiovascular applications, particularly endarterectomy repair, and the capacity of these materials to remodel into native, site-appropriate tissues. Also presented are data from two post-market observational studies of patients undergoing iliofemoral and carotid endarterectomy patch repair as well as one histologic case report in a challenging iliofemoral endarterectomy repair, all with the use of small intestine submucosa (SIS)-ECM. In alignment with previously reported studies, high patency was maintained, and adverse event rates were comparable to previously reported rates of patch angioplasty. Histologic analysis from one case identified constructive remodeling of the SIS-ECM, consistent with the histologic characteristics of the endarterectomized vessel. These clinical and histologic results align with the biologic potential described in the academic ECM literature. To our knowledge, this is the first histologic demonstration of SIS-ECM remodeling into site-appropriate vascular tissues following endarterectomy. Together, these findings support the safety and efficacy of SIS-ECM for patch repair of femoral and carotid arteriotomy.

Risk profiles and outcomes of patients receiving antibacterial cardiovascular implantable electronic device envelopes: A retrospective analysis

“…Extensive studies have shown that implanted biologic materials (such as non-crosslinked decellularized SIS-ECM) stimulate the production of site appropriate, functional tissue (termed “constructive remodeling”[ 37 ])[ 20 - 23 , 36 ]. The ability to elicit a remodeling response post-implantation is due to the natural degradation of the implanted ECM by proteases which release intrinsic bioactive peptides and growth factors such as FGF-2 and VEGF in situ [ 22 , 38 - 40 ].…”

“…Synthetic (non-biologic) absorbable and non-absorbable materials have been reported to initiate a strong foreign body reaction, resulting in chronic inflammation leading to hypovascular fibrotic tissue surrounding the implanted material[ 14 - 18 ], which a previously-marketed non-absorbable synthetic envelope leveraged to stabilize the electronic device upon implantation[ 19 ]. Conversely, ECM (the material that the biologic envelope is made from) has been shown to promote constructive remodeling and healthy tissue restoration[ 20 - 23 ]. Both biologic and non-biologic envelopes have been reported to support clinical infection prevention strategies[ 12 , 24 - 26 ].…”

Decellularized fish swim bladder patch loaded with mesenchymal stem cells inhibits neointimal hyperplasia

“…Different vascular substitutes for diseased artery have been developed, but there is still no material has a similar structure like native artery 23 . As for the vascular patch materials, compared to the prosthetic patch, biological patches have reduced risk for infection, reduced foreign body reaction 24 . Decellularized materials have reduced immunogenicity but preserve the native structure of the organ or tissue, the decellularized scaffold allows cells attachment, migration and proliferation after implantation 25 .…”

“…23 As for the vascular patch materials, compared to the prosthetic patch, biological patches have reduced risk for infection, reduced foreign body reaction. 24 Decellularized materials have reduced immunogenicity but preserve the native structure of the organ or tissue, the decellularized scaffold allows cells attachment, migration and proliferation after implantation. 25 Decellularized bovine and porcine pericardium are widely used in clinic, but they are not suitable in some religious F I G U R E 5 Bioinspired fish swim bladder patch decrease neointimal thickness.…”

Immunogenicity of decellularized extracellular matrix scaffolds: a bottleneck in tissue engineering and regenerative medicine

“…Due to the unique properties of each tissue (i.e., specific tissue density), dECM scaffolds from different sources undergo distinctive degradation rates [159]. In this respect, it takes a median of six months for decellularized vessels to undergo ECM regeneration and be fully replaced with new host ECM [25], while SIS-ECM in endarterectomy requires only three months to get fully degraded and replaced with host functional tissues [160]. Therefore, the dECM degradation rate determines the time needed for ECM to be fully replaced with a newly synthesized host ECM.…”