Vascular Response on a Novel Fibrin-Based Coated Flow Diverter

Abstract

Purpose Due to thromboembolic complications and in-stent-stenosis after flow diverter (FD) treatment, the long-term use of dual antiplatelet treatment (DAPT) is mandatory. The tested nano-coating has been shown to reduce material thrombogenicity and promote endothelial cell proliferation in vitro. We compared the biocompatibility of coated (Derivo Heal) and non-coated (Derivo bare) FDs with DAPT in an animal model. Methods Derivo® bare (n = 10) and Derivo® Heal (n = 10) FD were implanted in the common carotid arteries (CCAs) of New Zealand white rabbits. One additional FD, alternately a Derivo bare (n = 5) or Derivo Heal (n = 5), was implanted in the abdominal aorta (AA) for assessment of the patency of branch arteries. Histopathological examinations were performed after 28 days. Angiography was performed before and after FD implantation and at follow-up. Results Statistical analysis of the included specimens showed complete endothelialization of all FDs with no significant differences in neointima thickness between Derivo® bare and Derivo® Heal (CCA: p = 0.91; AA: p = 0.59). A significantly reduced number of macrophages in the vessel wall of the Derivo Heal was observed for the CCA (p = 0.02), and significantly reduced fibrin and platelet deposition on the surface of the Derivo Heal was observed for the AA. All branch arteries of the stented aorta remained patent. Conclusion In this animal model, the novel fibrin-based coated FD showed a similar blood and tissue compatibility as the non-coated FD.

The DERIVO 2heal embolisation device: A technical report using single antiplatelet therapy for intracranial pseudoaneurysm treatment

“…9 Whether the heal coating affects aneurysm thrombosis has not yet been evaluated in detail, but a similar biocompatibility of the DERIVO 2heal to uncoated counterparts indicate a similar treatment efficacy. 7 In the presented case, the 5 mm large pseudoaneurysm was completely occluded within 5 days after treatment. Progressive aneurysm thrombosis might have been accelerated by SAPT compared to DAPT.…”

“…[4][5][6] These surface modifications mainly reduce platelet adhesion. 7 In a clinical study on the DED with BlueXide finishing under DAPT, the cumulative ischemic stroke rate was 3.4% and the morbidity rate was 1.7% at 1 year. 9 In a registry study, Taschner et al reported ischemic stroke in 4.2% and morbidity in 3.1%.…”

“…For the fibrin-based heal coating, Mühl-Benninghaus et al reported similar blood and tissue compatibility compared to non-coated counterparts and there were no adverse effects on neo-endothelialization under DAPT in the histological analysis, which is necessary for the clinical efficacy of FD treatment. 7 In this report, we used the DERIVO with heal coating for the emergency treatment of a rapidly growing extradural ICA pseudoanerysm, which carried a very high rupture risk with consecutive potentially life-threatening hemorrhage, assuming a reduced thrombogenicity of this device. FD treatment under a SAPT regimen was favored assuming 1) faster progressive aneurysm occlusion due to reduced anti-thrombogenic efficiency and hence reduced risk of aneurysm rupture and 2) a potentially less pronounced hemorrhage and a better surgical control in case of aneurysm rupture.…”

“…For the fibrin-based heal coating, Mühl-Benninghaus et al reported similar blood and tissue compatibility compared to non-coated counterparts and there were no adverse effects on neo-endothelialization under DAPT in the histological analysis, which is necessary for the clinical efficacy of FD treatment. 7…”

“…The DERIVO 2heal Embolisation Device (Acandis, Pforzheim, Germany) is a novel flow-diverter featuring a novel surface modification with fibrin-based nano-coating, which is supposed to be less thrombotic than its uncoated counterpart. 7 In this paper, we report the first clinical case of DERIVO 2heal implantation under ASA monotherapy.…”