Percutaneous Alginate Hydrogel Endomyocardial Injection with a Novel Dedicated Catheter Delivery System: An Animal Feasibility Study.

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS ACS Applied Bio Materials Pub Date : 2024-08-01 Epub Date: 2024-02-20 DOI:10.1007/s12265-024-10497-8

Bo Wang, Chao Gao, Scott Lim, Rutao Wang, Cun-Jun Zhu, Yoshinobu Onuma, Yunbing Wang, Runlin Gao, Patrick W J C Serruys, Randall J Lee, Ling Tao

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Abstract

The objective of this preclinical study was to evaluate the feasibility and safety of transcatheter endocardial alginate hydrogel injection (TEAi) in a large animal model, utilizing the high-stiffness XDROP® alginate hydrogel in combination with the dedicated EndoWings® catheter-based system. All swine (n = 9) successfully underwent TEAi without complications. Acute results from a subset of animals (n = 5) demonstrated the ability of the catheter to access a wide range of endomyocardial areas and achieve consecutive circumferential hydrogel distribution patterns within the mid-left ventricular wall. Histological examinations at 6 months (n = 4) demonstrated that the XDROP® remained localized within the cardiac tissue. In addition, serial echocardiographic imaging showed that XDROP® had no adverse impacts on LV systolic and diastolic functions. In conclusion, this innovative combination technology has the potential to overcome the translational barriers related to alginate hydrogel delivery to the myocardium.

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使用新型专用导管输送系统进行经皮藻酸水凝胶心内膜注射：动物可行性研究

这项临床前研究的目的是在大型动物模型中评估经导管心内膜藻酸盐水凝胶注射（TEAi）的可行性和安全性，将高硬度 XDROP® 藻酸盐水凝胶与专用的 EndoWings® 导管系统结合使用。所有猪（9 头）均成功接受了 TEAi，未出现并发症。一部分动物（n = 5）的急性结果表明，导管能够进入广泛的心内膜区域，并在左心室中壁实现连续的圆周水凝胶分布模式。6 个月后的组织学检查（n = 4）表明，XDROP® 仍位于心脏组织内。此外，连续超声心动图成像显示，XDROP® 对左心室收缩和舒张功能没有不良影响。总之，这种创新的组合技术有望克服与向心肌输送藻酸盐水凝胶有关的转化障碍。

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