Öner Alper, Moerke Caroline, Wolff Anne, Kischkel Sabine, Schmidt Wolfram, Grabow Niels, Ince Hüseyin
Department of Cardiology, Rostock University Medical Center, Rostock, Germany.
Medizinische Klinik I im Zentrum für Innere Medizin (ZIM), Ernst-Heydemann-Str. 6, 18057, Rostock, Germany.
Eur J Med Res. 2020 Jul 29;25(1):28. doi: 10.1186/s40001-020-00429-y.
Percutaneous coronary intervention is among the most common therapeutic interventions in cardiology. This procedure may, however, be associated with a rare, though life-threatening complication: acute coronary perforation (CP). CP is primarily treated using covered stents, which are made of bare metal stents with a polytetrafluoroethylene (PTFE) or polyurethane coating. These stents' major limitations include higher rates of thrombus formation and restenosis. Hence, there is a still unmet need for new stents regarding their design and composition. Or, to test new covered stent designs, the rabbit iliac artery has become the best-established animal model. This study sought to present a preclinical animal approach designed to test covered stents that are utilized following vessel perforation.
The animal experiments were performed using New Zealand white rabbits, each weighting 3.5-4.5 kg. The animal models described herein relied on the three most common clinical causes for CP, such as guidewire-induced, balloon catheter bursting, and device oversizing. Moreover, the sealing capacity of covered stent grafts was assessed for each of these models by means of angiography.
We herein report a rabbit iliac artery perforation model using three different types of vessel perforation that closely mimic the clinical setting, such as guidewire-induced, balloon catheter rupture, and device oversizing. Using the same rabbit iliac perforation model, we additionally assessed the sealing capacity of a covered stent graft for each model.
The novel rabbit iliac artery perforation models, as described in this report, represent promising animal testing approaches. While their setting is very similar to the real-life context encountered in humans, all three models are based on an animal model that is ideally suited for evaluating the sealing capacity and performance of new medical devices for humans.
经皮冠状动脉介入治疗是心脏病学中最常见的治疗手段之一。然而，该手术可能会引发一种罕见但危及生命的并发症：急性冠状动脉穿孔（CP）。CP主要采用覆膜支架进行治疗，这种支架由带有聚四氟乙烯（PTFE）或聚氨酯涂层的裸金属支架制成。这些支架的主要局限性包括血栓形成率和再狭窄率较高。因此，在支架的设计和组成方面，对新型支架仍有未满足的需求。或者，为了测试新型覆膜支架设计，兔髂动脉已成为最成熟的动物模型。本研究旨在提出一种临床前动物实验方法，用于测试血管穿孔后使用的覆膜支架。
动物实验使用体重为3.5 - 4.5千克的新西兰白兔进行。本文所述的动物模型基于CP的三种最常见临床病因，如导丝引起的、球囊导管破裂和器械尺寸过大。此外，通过血管造影术评估每种模型中覆膜支架移植物的密封能力。
我们在此报告了一种兔髂动脉穿孔模型，该模型使用三种不同类型的血管穿孔，紧密模拟临床情况，如导丝引起的、球囊导管破裂和器械尺寸过大。使用相同的兔髂动脉穿孔模型，我们还评估了每种模型中覆膜支架移植物的密封能力。
本报告中描述的新型兔髂动脉穿孔模型代表了有前景的动物测试方法。虽然其设置与人类实际情况非常相似，但所有三种模型都基于一种非常适合评估新型人类医疗设备密封能力和性能的动物模型。
