Objective. We reported the 3-year follow-up results of initial clinical experience with the Absnow^TM device, a novel biodegradable occluder for percutaneous closure of atrial septal defect (ASD). Background. The Absnow^TM device is a total biodegradable septal occluder with double-disc poly-L-lactic acid (PLLA) framework and PLLA membranes intergraded into the device to ensure its biodegradability, clinical safety, and efficacy. Methods. Five pediatric patients were enrolled from May to June 2018 in our institution and were followed up for 3 years. A clinical evaluation and transthoracic echocardiography were performed at 24 hr, 1 month, 3 months, 6 months, 12 months, and yearly after implantation. Primary endpoints were a composite clinical success, comprising of clinical closure success and safety at the 36-month follow-up evaluation. Secondary endpoints included technical success, procedure success, closure success, and safety at each of the follow-up visits. Results. The median subject age was 3.6 years (range 3.1–6.5 years). The mean ASD diameter was (13.7 ± 2.9) mm. The median device size was 20 mm (range 14 to 24 mm). Technical and procedure success was achieved in 100% (5/5) of the patients. At 2-year follow-up, 3 of the 5 patients developed new-onset residual shunts and 2 of them reached a moderate degree. At 3-year follow-up, the residual shunt size increased over time in all the 3 patients, and 1 of them had right ventricular enlargement. All of the 5 patients were free from serious adverse events during the 3-year follow-up, with no device embolization, thromboembolization, or reintervention to the target defect. Conclusion. This 3-year follow-up result of initial experience with the biodegradable Absnow^TM device has demonstrated acceptable safety with no procedural complications. Notably, the high rate of residual shunt significantly affected its efficacy. The long-term safety and efficacy of the device should be further evaluated in a large cohort of patients in future studies.

中文翻译：

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用于经皮闭合房间隔缺损的可生物降解 AbsnowTM 装置的初步临床经验：3 年随访

客观。^{我们报告了 Absnow TM}装置的初步临床经验的 3 年随访结果，该装置是一种用于经皮闭合房间隔缺损 (ASD) 的新型可生物降解封堵器。背景。Absnow ^TM装置是一种完全可生物降解的隔膜封堵器，具有双盘聚 L-乳酸 (PLLA) 框架和集成到装置中的 PLLA 膜，以确保其可生物降解性、临床安全性和有效性。方法. 5 名儿科患者于 2018 年 5 月至 2018 年 6 月在我院入组，随访 3 年。在植入后 24 小时、1 个月、3 个月、6 个月、12 个月和每年进行临床评估和经胸超声心动图检查。主要终点是复合临床成功，包括临床关闭成功和 36 个月随访评估的安全性。次要终点包括每次随访时的技术成功、程序成功、闭合成功和安全性。结果. 受试者的中位年龄为 3.6 岁（范围 3.1-6.5 岁）。平均 ASD 直径为 (13.7 ± 2.9) mm。设备尺寸中位数为 20 毫米（范围 14 至 24 毫米）。100% (5/5) 的患者获得了技术和手术成功。随访 2 年，5 例患者中有 3 例出现新发残余分流，其中 2 例达到中度。在 3 年的随访中，所有 3 例患者的残余分流器大小均随时间增加，其中 1 例出现右心室扩大。在 3 年的随访期间，所有 5 名患者均未发生严重不良事件，未发生装置栓塞、血栓栓塞或对目标缺损的再干预。结论。^{这是对可生物降解 Absnow TM}的初步体验的 3 年随访结果设备已证明可接受的安全性，没有程序并发症。值得注意的是，高残留分流率显着影响其疗效。在未来的研究中，应在大量患者中进一步评估该设备的长期安全性和有效性。