Song Lin, Shi Peixuan, Zheng Xiaozhou, Hongxin Li, Li Ziang, Lv Meng, Wang Haiyan
Department of Medical Ultrasound, Shandong Medicine and Health Key Laboratory of Abdominal Medical Imaging, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Jinan, China.
Department of Medical Ultrasound, Shandong Provincial Qianfoshan Hospital, Shandong First Medical University, Jinan, China.
Front Cardiovasc Med. 2022 Aug 12;9:945275. doi: 10.3389/fcvm.2022.945275. eCollection 2022.
Transcatheter occlusion of patent foramen ovale (PFO) has become a recognized treatment option for high-risk PFO-related diseases. However, traditional metal occluders have some disadvantages, such as permanent retention in the body, abrasion of tissues, and obstruction of access to the left side of the heart for interventional procedures. With biodegradable occluders that release non-toxic degradation products and are absorbable by the body, the risk of long-term complications could be greatly reduced. The experimental results of using a PFO-degradable occluder in beagle dogs in early stages, independently developed by Shanghai Mallow Medical Instrument Co., Ltd., showed that the occluding umbrella disc network was degraded 6 months after occlusion. The occluder also showed good memory, biocompatibility, and mechanical properties.
As one of the multi-center research units, this prospective Phase III clinical trial study included 16 patients with PFO-related complications who were treated with a degradable occluder. The follow-up period lasted for 12 months to analyze the echocardiographic characteristics and procedural feasibility.
The immediate success rate of the procedure was 100% with no serious complications. Postoperative color Doppler transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) at 12 months showed that one patient with atrial septal aneurysm (ASA) had a residual shunt at the edge of the occluder, and contrast transcranial Doppler (cTCD) showed that all patients were grade I or 0 right-to-left shunts (RLS), indicating that the occlusion success rate was 100%. The occluder gradually degraded after the procedure, particularly when the umbrella disc structure became vague, and the size of the occluder decreased significantly 6 months after occlusion.
PFO closure with a Mallow degradable occluder has a high plugging success rate, is safe and effective, and has no serious complications. However, for PFO closure with special anatomical features, further research with a larger sample size is required. TTE can dynamically, conveniently, and accurately observe the entire degradation process of the occluder.
ChiCTR1900024036.
经导管封堵卵圆孔未闭（PFO）已成为公认的治疗高危PFO相关疾病的选择。然而，传统金属封堵器存在一些缺点，如永久留存于体内、组织磨损以及妨碍介入手术时进入心脏左侧。使用可生物降解封堵器，其释放无毒降解产物且可被人体吸收，可大幅降低长期并发症风险。上海麦罗医疗器械有限公司自主研发的PFO可降解封堵器早期在比格犬身上的实验结果显示，封堵6个月后封堵伞盘网降解。该封堵器还表现出良好的记忆性、生物相容性和机械性能。
作为多中心研究单位之一，这项前瞻性III期临床试验研究纳入了16例接受可降解封堵器治疗的PFO相关并发症患者。随访期持续十二个月，以分析超声心动图特征和手术可行性。
手术即刻成功率为100%，无严重并发症。术后12个月的经胸彩色多普勒超声心动图（TTE）和经食管超声心动图（TEE）显示，1例患有房间隔瘤（ASA）的患者在封堵器边缘存在残余分流，而经颅多普勒造影（cTCD）显示所有患者为I级或0级右向左分流（RLS），表明封堵成功率为100%。术后封堵器逐渐降解，尤其是伞盘结构变得模糊时，封堵6个月后封堵器尺寸显著减小。
使用麦罗可降解封堵器封堵PFO成功率高，安全有效，无严重并发症。然而，对于具有特殊解剖特征的PFO封堵，需要更大样本量的进一步研究。TTE可动态、便捷且准确地观察封堵器的整个降解过程。
ChiCTR1900024036。
