Pre-clinical Evolution of a Novel Transcatheter Bioabsorbable ASD/PFO Occluder Device
Pre-clinical Evolution of a Novel Transcatheter Bioabsorbable ASD/PFO Occluder Device
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新型经导管生物可吸收 ASD/PFO 封堵器的临床前进展
DOI：
10.1007/s00246-021-02809-5
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发表时间：
2022
影响因子：
1.6
通讯作者：
Shinoka Toshiharu
中科院分区：
文献类型：
--
作者：
Matsuzaki Yuichi;Berman Darren P.;Kurobe Hirotsugu;Kelly John M.;Iwaki Ryuma;Blum Kevin;Toshihiro Shoji;Harrison Andrew;Cheatham John P.;Shinoka Toshiharu
到目前为止，使用临床相关的大型动物模型对可生物吸收的房间隔缺损(ASD)或卵圆孔未闭(PFO)封堵器的研究有限。本研究的目的是探讨生物可吸收ASD封堵器(BAO)经导管封堵PFO和/或继发孔型ASD的功能和安全性。采用绵羊模型，用心内回声(ICE)评价房间隔。如果不存在PFO，则通过经间隔穿刺法建立心房连通。在透视和ICE引导下，通过房内通道口植入人工血管。我们的第一代装置由细聚(L-丙交酯-异丙交酯-己内酯)纤维(PLCL)的主体结构和内部的聚乙醇酸(PGA)织物组成。四种程序验证了程序的可行性。随后，设备设计进行了改进，以改进经导管给药。第二代装置具有双层结构，并被植入六只羊体内。结果显示，9/10(90%)的动物手术成功。随着部署，第一代装置没有改造成其原始的圆盘形状，并不能很好地符合房间隔。第二代装置被植入了6只动物体内，6只动物中有3只存活了1年。植入后1年，ICE证实无残余分流。通过尸检，生物材料已经部分降解，移植样本的组织学显示显著的装置内皮化和用胶原层替代生物材料。我们的结果表明，我们改进的第二代BAO可以通过微创经皮导管技术进行部署。BAO在1年内部分降解，并被宿主天然组织取代。在临床试验之前，还需要进一步的研究。
To date, there has been limited investigation of bioabsorbable atrial septal defect (ASD) or patent foramen ovale (PFO) closure devices using clinically relevant large animal models. The purpose of this study is to explore the function and safety of a bioabsorbable ASD occluder (BAO) system for PFO and/or secundum ASD transcatheter closure. Using a sheep model, the intra-atrial septum was evaluated by intracardiac echo (ICE). If a PFO was not present, atrial communication was created via transseptal puncture. Device implantation across the intra-atrial communication was performed with fluoroscopic and ICE guidance. Our 1st generation device consisted of a main structure of thin Poly(l-lactide-co-epsilon-caprolactone) (PLCL) fibers, and an internal Poly glycolic acid (PGA) fabric. Four procedures validated procedure feasibility. Subsequently, device design was modified for improved transcatheter delivery. The 2nd generation device has a two-layered structure and was implanted in six sheep. Results showed procedural success in 9/10 (90%) animals. With deployment, the 1st generation device did not reform into its original disk shape and did not conform nicely along the atrial septum. The 2nd generation device was implanted in six animals, 3 out of 6 survived out to 1 year. At 1 year post implantation, ICE confirmed no residual shunting. By necropsy, biomaterials had partially degraded, and histology of explanted samples revealed significant device endothelialization and biomaterial replacement with a collagen layer. Our results demonstrate that our modified 2nd generation BAO can be deployed via minimally invasive percutaneous transcatheter techniques. The BAO partially degrades over 1 year and is replaced by host native tissues. Future studies are needed prior to clinical trials.
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