The Heart Center, Rigshospitalet University Hospital, Copenhagen, Denmark.
EuroIntervention. 2013 Dec;9(8):959-63. doi: 10.4244/EIJV9I8A160.
A new GORE® septal occluder (GSO) was granted CE mark in Europe in June 2011 for the treatment of patent foramen ovale and atrial septal defect. Major changes have been made to the device and delivery system compared to the HELEX® device. The new delivery system has simplified the implantation procedure and the retrievability of the device after deployment if needed. The design of the GSO has improved the device apposition ability and tissue response whilst keeping its atraumatic design, low septal profile with minimal septal distortion and long-term biocompatibility. The first three clinical cases of GSO use in the world are briefly described and the immediate and short-term outcome of the first eleven patients who underwent PFO or ASD closure using GSO in our centre are reported.
The mean age of the eleven patients was 53±9 years and six of them were women. Ten of these patients had patent foramen ovale and one had secundum atrial septal defect. In all the cases, the GSO devices were successfully deployed in the first attempt without any complication. Only one patient had a minor residual shunt detected immediately after the device deployment. All the patients were re-assessed 70±33 days later and no residual shunt was detected in any of them. One of the patients had an episode of paroxysmal atrial fibrillation. There was no device fracture found in the six patients who also had a fluoroscopic examination during follow-up.
Our initial experience with GSO shows promise in handling and occlusion rate. Larger-scale and longer-term outcome on the performance of GSO is required to ensure safety and efficacy.
一种新型戈尔（GORE）隔瓣缺损封堵器（GSO）于 2011 年 6 月在欧洲获得 CE 标志，用于治疗卵圆孔未闭和房间隔缺损。与 HELEX 装置相比，该装置在器械和输送系统方面进行了重大改进。新的输送系统简化了植入程序，如果需要，还可在部署后回收装置。GSO 的设计提高了器械贴附能力和组织反应能力，同时保持其无创伤设计、低位隔瓣、最小的隔瓣变形和长期生物相容性。简要描述了全球首例 GSO 的三个临床应用病例，并报告了在我们中心使用 GSO 对 11 例 PFO 或 ASD 患者进行即刻和短期随访的结果。
11 例患者的平均年龄为 53±9 岁，其中 6 例为女性。这些患者中有 10 例存在卵圆孔未闭，1 例存在继发房间隔缺损。所有病例均首次尝试成功植入 GSO 装置，无任何并发症。仅 1 例患者在植入后即刻发现轻微残余分流。所有患者均在 70±33 天后重新评估，均未发现残余分流。1 例患者发生阵发性心房颤动。在随访期间进行了荧光透视检查的 6 例患者中，均未发现器械断裂。
我们使用 GSO 的初步经验表明，该器械在处理和封堵率方面具有良好的效果。需要更大规模和更长期的 GSO 性能结果来确保安全性和有效性。
