Department of Radiology, Section of Interventional Radiology, Boston Medical Center/Boston University School of Medicine, 820 Harrison Avenue, Boston, MA 02118.
Instylla, Bedford, Massachusetts.
J Vasc Interv Radiol. 2021 Jun;32(6):813-818. doi: 10.1016/j.jvir.2021.02.018. Epub 2021 Mar 4.
To evaluate a novel aqueous-based liquid embolic (Embrace Hydrogel Embolic System, [HES]) that has been developed to embolize hypervascular tumors by filling the tumor vascular bed and solidifying into a hydrogel. HES was evaluated for embolization safety and efficacy relative to microspheres in a preclinical rabbit kidney model.
A renal embolization model in New Zealand white rabbits was utilized. Twenty-four rabbits underwent unilateral kidney embolization via the main renal artery with either HES or 40-μm microspheres. Twenty-two rabbits survived the procedure and were monitored for 2, 12, 17.5, or 26 weeks before sacrifice. All rabbits underwent a repeat renal angiogram before necropsy. HES was evaluated for nontarget embolization, safety, and embolization effectiveness as measured by recanalization and viability of embolized tissue.
Both embolization materials were found to be safe, with targeted tissue necrosis and absence of nontarget embolization. Prenecropsy angiograms found vascular recanalization in 0/14 (0%) HES-embolized kidneys and in 3/8 (38%) microsphere-embolized kidneys (P = .036). Viable kidney tissue was observed in 2/14 (14%) kidneys embolized with HES and 5/8 (63%) kidneys embolized with microspheres (P = .052). All kidneys embolized with microspheres that showed vascular recanalization had viable tissue on histological sections. HES was observed in vessels as small as 10 μm in diameter in histological analysis.
HES provided deep, durable vascular bed embolization that resulted in less recanalization and, on an average, less viable target tissue compared with 40-μm microspheres. No systemic effects or nontarget tissue embolization was identified.
评估一种新型水基液体栓塞剂（Embrace Hydrogel Embolic System，[HES]），该栓塞剂旨在通过填充肿瘤血管床并固化为水凝胶来栓塞富血管肿瘤。在临床前兔肾模型中，评估 HES 相对于微球的栓塞安全性和疗效。
利用新西兰白兔的肾栓塞模型。24 只兔子通过主肾动脉进行单侧肾栓塞，栓塞材料分别为 HES 或 40-μm 微球。22 只兔子在手术后存活，并在 2、12、17.5 或 26 周后处死前进行监测。所有兔子在尸检前均进行重复肾血管造影。评估 HES 的非靶向栓塞、安全性以及栓塞效果，通过再通和栓塞组织的活力来衡量。
两种栓塞材料均被证明是安全的，具有靶向组织坏死和无非靶向栓塞。术前血管造影发现，HES 栓塞的 14 个肾脏中有 0/14（0%）发生血管再通，而微球栓塞的 8 个肾脏中有 3/8（38%）发生血管再通（P =.036）。HES 栓塞的 14 个肾脏中有 2/14（14%）有存活的肾组织，而微球栓塞的 8 个肾脏中有 5/8（63%）有存活的肾组织（P =.052）。所有微球栓塞后发生血管再通且有存活组织的肾脏，其组织学切片上均可见微球。组织学分析显示，HES 可栓塞直径小至 10 μm 的血管。
HES 提供了深度持久的血管床栓塞，与 40-μm 微球相比，再通率更低，目标组织的活力更低。未发现全身影响或非靶向组织栓塞。
