Habbe Kirsten J, Kohlhaas Markus, Langwieder Claus, Fili Sofia
Department of Ophthalmology at St., Johannes Hospital in Dortmund, Johannesstraße 9-13, 44137, Dortmund, Germany.
Dr. Claus Langwieder, Dr. Martin Rees, Pathological Institut in Dortmund, Amalienstraße 21, 44137, Dortmund, Germany.
Graefes Arch Clin Exp Ophthalmol. 2023 Feb;261(2):513-520. doi: 10.1007/s00417-022-05767-7. Epub 2022 Aug 19.
To retrospectively assess the histopathological particularities of explanted CyPass® Micro-Stent of patients with significant loss of endothelial cell density.
This is a case series of fourteen eyes from eleven patients who underwent CyPass® Micro-Stent implantation due to mild to moderate glaucoma and who subsequently suffered from loss of endothelial cell density. Therefore, the explantation of the device was necessary. In addition to the retrospective evaluation of the intraocular pressure and the endothelial cell density at the time of implantation and explantation, every surgically removed implant was histologically examined and evaluated.
Fourteen eyes of eleven patients were in total analysed. The patients-seven males and four females-had a mean age of 62.9 years. The average time between CyPass implantation and explantation was 3.7 years. Eight patients suffered from primary-open-angle glaucoma (POAG), while two patients had a pseudoexfoliation glaucoma (PXG) and one patient had low-pressure glaucoma. Ten of the patients were already pseudophakic before the CyPass implantation and four patients underwent previously glaucoma interventions. There was a significant reduction in the intraocular pressure from 18.57 ± 5.27 mmHg at the time of implantation to 14.78 ± 3.32 mmHg at the time of explantation (p = 0.037). The average endothelial cell density decreased from 1843.67 ± 421.81 to 932.92 ± 412.86/mm at the time of explantation (p < 0.01). The histological findings showed a fibrous obliteration of the CyPass accompanied by a chronic granulomatous inflammation with giant cell macrophages. Histologically, these findings were consistent with a foreign body granuloma.
Implants made of polyimides such as the CyPass® Micro-Stent are considered to be biocompatible, but there is no guarantee not to be obliterated or encapsulated. This is the first case series that has detected a foreign body granuloma in multiple eyes after CyPass implantation. However, there is no connection with the type of glaucoma, the extent of previous operations or with the presence of a prolonged postoperative inflammatory reaction.
回顾性评估内皮细胞密度显著降低的患者所植入的CyPass®微型支架的组织病理学特征。
这是一个病例系列研究，纳入了11例患者的14只眼，这些患者因轻度至中度青光眼接受了CyPass®微型支架植入术，随后出现内皮细胞密度降低，因此需要取出该装置。除了回顾性评估植入和取出时的眼压及内皮细胞密度外，对每个手术取出的植入物进行了组织学检查和评估。
共分析了11例患者的14只眼。患者中7例男性，4例女性，平均年龄62.9岁。CyPass植入与取出之间的平均时间为3.7年。8例患者患有原发性开角型青光眼（POAG），2例患者患有剥脱性青光眼（PXG），1例患者患有低压性青光眼。10例患者在植入CyPass之前已为假晶状体眼，4例患者曾接受过青光眼干预。眼压从植入时的18.57±5.27 mmHg显著降低至取出时的14.78±3.32 mmHg（p = 0.037）。取出时平均内皮细胞密度从1843.67±421.81降至932.92±412.86/mm（p < 0.01）。组织学检查结果显示CyPass出现纤维性闭塞，并伴有巨细胞巨噬细胞的慢性肉芽肿性炎症。从组织学上看，这些结果与异物肉芽肿一致。
聚酰亚胺制成的植入物如CyPass®微型支架被认为具有生物相容性，但不能保证不被闭塞或包裹。这是首个在CyPass植入后多只眼中检测到异物肉芽肿的病例系列。然而，这与青光眼类型、既往手术范围或术后长期炎症反应的存在无关。
