用于卵圆孔未闭封堵的可生物降解Pansy®封堵器：一项多中心、单臂、前瞻性研究。
Biodegradable Pansy® occluder for patent foramen ovale closure: a multicenter, single-arm, prospective study.
作者信息
He Lu, Xie Hang, Gao Yongsheng, Zhang Gangcheng, Shen Qunshan, Wang Minghua, Wang Qiguang, Wang Yujiu, Du Yajuan, Zhu Xianyang, Zhang Yushun
机构信息
Department of Structural Heart Disease, Xi'an Jiaotong University Medical College First Affiliated Hospital, Xi'an, Shaanxi, China.
Department of Cardiac Surgery, The First Bethune Hospital Jilin University, Changchun, Jilin, China.
出版信息
Front Cardiovasc Med. 2025 Apr 4;12:1464712. doi: 10.3389/fcvm.2025.1464712. eCollection 2025.
BACKGROUND
The next-generation closure device for interventional treatment of patent foramen ovale (PFO) is regarded as biodegradable, yet the corresponding biomaterial technique is still challenging. Herein, we report the clinical application of a novel biodegradable PFO occluder [made of the biodegradable material polydioxanone (PDO)] that is finally coming into clinical use.
OBJECTIVES
This study aimed to assess the safety and efficacy of the biodegradable Pansy® occluder (Mallow Medical, Shanghai, China) for PFO closure in patients exhibiting PFO with a substantial right-to-left shunt (RLS).
METHODS
Six centers in China participated in this prospective, multicenter study of PFO closure from June 2019 to September 2020. Serious adverse events occurring in the perioperative period and during follow-up were systematically collected. Contrast transthoracic echocardiography (cTTE), transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) were performed during the preoperative and follow-up periods.
RESULTS
A total of 137 patients with a mean age of 38.1 ± 12.4 years who underwent catheter-based PFO closure with the biodegradable Pansy® occluder were included. The procedural success rate was 99.3%. Except for 2 cases (1.4%) of micropericardial effusion, there were no other complications such as cardiac tamponade, major bleeding, stroke oroccluder embolization. During the 12-month follow-up, serious adverse events occurred in 3 patients (2.2%), all of which were device-related thrombus (DRT). Four patients (2.9%) still had moderate to substantial residual RLS. The complete occlusion rate was 97.1% at 12 months after closure.
CONCLUSIONS
PFO closure with the biodegradable Pansy® occluder can be performed effectively with acceptably low complication rates, low occurrence of adverse events, high procedural success rates and high complete occlusion rates at follow-up.
CLINICAL TRIAL REGISTRATION
http://www.chictr.org.cn/index.aspx; identifier (ChiCTR1900024036).
背景
用于卵圆孔未闭（PFO）介入治疗的下一代封堵装置被认为是可生物降解的，但其相应的生物材料技术仍具有挑战性。在此，我们报告一种新型可生物降解PFO封堵器（由可生物降解材料聚对二氧环己酮（PDO）制成）的临床应用，该封堵器最终进入临床使用阶段。
目的
本研究旨在评估可生物降解的Pansy®封堵器（中国上海迈络医疗）对存在大量右向左分流（RLS）的PFO患者进行封堵的安全性和有效性。
方法
2019年6月至2020年9月，中国6家中心参与了这项关于PFO封堵的前瞻性、多中心研究。系统收集围手术期和随访期间发生的严重不良事件。术前和随访期间进行对比经胸超声心动图（cTTE）、经胸超声心动图（TTE）和经食管超声心动图（TEE）检查。
结果
共纳入137例平均年龄为38.1±12.4岁的患者，他们接受了使用可生物降解的Pansy®封堵器的经导管PFO封堵术。手术成功率为99.3%。除2例（1.4%）微量心包积液外，未发生其他并发症，如心脏压塞、大出血、中风或封堵器栓塞。在12个月的随访期间，3例患者（2.2%）发生严重不良事件，均为与器械相关的血栓（DRT）。4例患者（2.9%）仍有中度至大量残余RLS。封堵术后12个月时完全封堵率为97.1%。
结论
使用可生物降解的Pansy®封堵器进行PFO封堵术可以有效实施，并发症发生率低，不良事件发生率低，手术成功率高，随访时完全封堵率高。
临床试验注册
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