The GORE CARDIOFORM atrial septal defect (ASD) Occluder (GCA) is composed of a platinum-filled nitinol wire frame covered with expanded polytetrafluoroethylene, making it softer and more conformable compared with nitinol mesh devices. After the ASSURED clinical study confirmed the efficacy and safety of the device, it received U.S. Food and Drug Administration approval and a European conformity mark. Our aim was to understand the learning curve implicated in using the GCA for ASD closure in paediatric and adult patients as well as to study the early outcomes. To this end, a review of ASD device closures with GCA in 4 UK centres was conducted between January 2020 and January 2023. Implantation success was the primary outcome; the secondary outcomes were serious adverse events, including new onset arrhythmia. In all, 135 patients were included, and 128 (95%) had successful ASD device closure with GCA. The median patient age was 49 years, the median defect size was 18 mm, and the median device size was 37 mm. The median follow-up time was 6 months (interquartile range 1-14). One device embolisation occurred, and 15 patients (12% of GCA implantations) developed new onset arrhythmia - this was not related to patient age, defect diameter or device oversizing but was positively associated with device size. With growing experience using GCA, the device can be applied to a wide variety of ASD sizes and morphologies. Given the number of successful implantations with an absence of aortic erosion, as well as the ability to perforate through the device should procedures be required in the left atrium, the GCA device is an important addition for interventionists who close atrial septal defects.

中文翻译：

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一种用于房间隔缺损封堵的新型装置（GORE CARDIOFORM）。

GORE CARDIOFORM 房间隔缺损 (ASD) 封堵器 (GCA) 由覆盖有膨胀聚四氟乙烯的铂填充镍钛诺线框组成，与镍钛诺网状装置相比，它更柔软、更舒适。在ASSURED临床研究证实该设备的功效和安全性后，它获得了美国食品和药物管理局的批准和欧洲合格标志。我们的目的是了解使用 GCA 封闭儿科和成人 ASD 的学习曲线，并研究早期结果。为此，2020 年 1 月至 2023 年 1 月期间，GCA 在英国 4 个中心对 ASD 装置封堵进行了审查。植入成功是主要结果；次要结局是严重的不良事件，包括新发心律失常。总共纳入了 135 名患者，其中 128 名患者 (95%) 成功使用 GCA 封堵了 ASD 装置。患者年龄中位数为 49 岁，缺损尺寸中位数为 18 毫米，装置尺寸中位数为 37 毫米。中位随访时间为 6 个月（四分位数范围 1-14）。发生 1 例装置栓塞，15 名患者（GCA 植入的 12%）出现新发心律失常 - 这与患者年龄、缺损直径或装置尺寸过大无关，但与装置尺寸呈正相关。随着 GCA 使用经验的不断增长，该设备可应用于各种 ASD 尺寸和形态。考虑到在没有主动脉糜烂的情况下成功植入的数量，以及在左心房需要手术时穿过该装置的能力，GCA 装置对于闭合房间隔缺损的介入医生来说是一个重要的补充。