Qin Li, Zhang Gui, Sun Ling, Yu Zhijin, Zhang Zhe, Sun Lifeng, Zhang Wanqian, Fu Wenchao, Ou Yetao, Zhang Wenjing, Shi Xiaoli, Si Zhixiang, Shen Jingfang, Cha Limei, Zhang Zhiwei, Zhang Deyuan
National and Local Joint Engineering Laboratory of Interventional Medical Biotechnology and System, Biotyx Medical (Shenzhen) Co., Ltd., Lifetech Scientific (Shenzhen) Co., Ltd., Shenzhen 518110, China.
Department of Pediatric Cardiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangdong Cardiovascular Institute, Guangzhou 510080, China.
Regen Biomater. 2025 May 13;12:rbaf041. doi: 10.1093/rb/rbaf041. eCollection 2025.
A big diameter bioresorbable scaffold is expected to be used for treatment of vessel stenosis of children with congenital heart disease to adapt the growth characteristics of vessel of children and avoid the late adverse events of permanent stent implanted in children. However, it is challenging to fabricate a big diameter bioresorbable scaffold that is appropriate for percutaneous implantation with enough mechanical performance and can be smoothly delivered in children's small vessel. In this study, a novel iron big and bioresorbable Scaffold (BBS) for pulmonary artery stenosis of children with congenital cardiovascular diseases was fabricated and evaluated. The BBS was made of nitrided iron tube and processed by laser cutting and polishing. The testing results of radial strength, recoil, shortening, maximal expansion diameter and side-branch accessability illustrated the BBS has good mechanical performance. The animal study showed that the percentage of area stenosis of BBSs was 18.1 ± 8.6%, 20.2 ± 5.9% and 20.4 ± 6.1% at 28, 90 and 180 days after implantation in 17 rabbits, and no malposition, thrombus, dissection or tissue necrosis in the rabbit model was detected by micro-CT, STEM and histological examinations. An φ8 × 23 mm BBS was implanted into a 55-month-old child with left pulmonary stenosis, and multiple spiral CT was conducted. No lumen area loss appeared at 1- and 2-year follow-ups in this first-in-man study. It suggested that the BBS might be a new strategy for the therapy of pulmonary artery stenosis in children.
大直径生物可吸收支架有望用于治疗先天性心脏病患儿的血管狭窄，以适应儿童血管的生长特点，并避免永久性支架植入儿童体内带来的晚期不良事件。然而，制造一种大直径生物可吸收支架具有挑战性，这种支架要适合经皮植入，具备足够的机械性能，并且能够在儿童的小血管中顺利输送。在本研究中，制备并评估了一种用于先天性心血管疾病患儿肺动脉狭窄的新型铁基大尺寸生物可吸收支架（BBS）。BBS由渗氮铁管制成，并经过激光切割和抛光处理。径向强度、回缩、缩短、最大扩张直径和侧支血管可及性的测试结果表明，BBS具有良好的机械性能。动物研究显示，在17只兔子体内植入BBS后28、90和180天，支架部位的狭窄面积百分比分别为18.1±8.6%、20.2±5.9%和20.4±6.1%，通过微CT、STEM和组织学检查在兔模型中未检测到错位、血栓、夹层或组织坏死。将一个φ8×23mm的BBS植入一名55个月大的左肺动脉狭窄患儿体内，并进行了多次螺旋CT检查。在这项首例人体研究中，1年和2年随访时均未出现管腔面积丢失。这表明BBS可能是治疗儿童肺动脉狭窄的一种新策略。
