Sigler Matthias, Jux Christian
Department of Paediatric Cardiology and Paediatric Intensive Care Medicine, Georg-August University Goettingen, Goettingen, Germany.
Heart. 2007 Apr;93(4):444-9. doi: 10.1136/hrt.2006.098103. Epub 2006 Oct 11.
Despite their clinical introduction 10 years ago, no human series on the healing response to Amplatzer and Starflex devices in humans have been reported yet. We sought to investigate the biocompatibility of Amplatzer and Cardioseal/Starflex septal occluder devices in humans and compare the findings to results in experimental animals.
The healing response of Amplatzer and Cardioseal/Starflex septal occluder devices in humans (n = 12, follow-up periods from 5 days to 4 years) and in experimental animals (n = 32, follow-up periods from 4 days to 1 year) was studied using a uniform work up protocol. Histological sections of paraffin-wax-embedded or methacrylate-embedded specimen and scanning electron microscopy were used for biocompatibility screening.
Neoendothelialisation of all examined devices was complete after 3 months in vivo. Protruding metal frame parts, like screw threads and spring arms, were covered last. The initial deposition of fibrin and blood cells on the polyester fabric was subsequently organised by ingrown fibroblastic cells. Loosely arranged and poorly vascularised young granulation tissue was transformed time-dependently into quiescent fibre-rich connective repair tissue poor of cellular and capillary vessel components. Consistently, a mild chronic inflammatory response directed against textile fibres of both types of implants characterised by lymphocytic infiltration and multinucleated foreign body giant cells was observed equally in human and animal explants.
Systematic biocompatibility screening in a series of explanted human septal occluder devices showed results corresponding to findings in animal studies with regard to neoendothelialisation, cellular organisation of initial thrombus and persisting immune response.
尽管Amplatzer和Starflex装置在临床上已应用了10年，但尚未有关于人类对其愈合反应的系列报道。我们试图研究Amplatzer和Cardioseal/Starflex房间隔封堵器在人体中的生物相容性，并将结果与实验动物的结果进行比较。
采用统一的检查方案，研究了Amplatzer和Cardioseal/Starflex房间隔封堵器在人体（n = 12，随访期5天至4年）和实验动物（n = 32，随访期4天至1年）中的愈合反应。使用石蜡包埋或甲基丙烯酸酯包埋标本的组织学切片以及扫描电子显微镜进行生物相容性筛选。
所有检查装置在体内3个月后新内皮化完成。突出的金属框架部分，如螺纹和弹簧臂，最后被覆盖。聚酯织物上纤维蛋白和血细胞的初始沉积随后由向内生长的成纤维细胞进行组织化。疏松排列且血管化不良的年轻肉芽组织随时间逐渐转变为静止的富含纤维的结缔组织修复组织，细胞和毛细血管成分较少。同样，在人和动物的植入物外植体中均观察到针对两种植入物纺织纤维的轻度慢性炎症反应，其特征为淋巴细胞浸润和多核异物巨细胞。
在一系列植入人体的房间隔封堵器装置中进行的系统生物相容性筛选显示，在新内皮化、初始血栓的细胞组织化和持续免疫反应方面，结果与动物研究结果相符。
