Biodegradable Pansy® occluder for patent foramen ovale closure: a multicenter, single-arm, prospective study
BackgroundThe 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 biodeg...
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Frontiers Media S.A.
2025-04-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2025.1464712/full |
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| author | Lu He Hang Xie Yongsheng Gao Gangcheng Zhang Qunshan Shen Minghua Wang Qiguang Wang Yujiu Wang Yajuan Du Xianyang Zhu Yushun Zhang |
| author_facet | Lu He Hang Xie Yongsheng Gao Gangcheng Zhang Qunshan Shen Minghua Wang Qiguang Wang Yujiu Wang Yajuan Du Xianyang Zhu Yushun Zhang |
| author_sort | Lu He |
| collection | DOAJ |
| description | BackgroundThe 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.ObjectivesThis 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).MethodsSix 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.ResultsA 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.ConclusionsPFO 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 Registrationhttp://www.chictr.org.cn/index.aspx; identifier (ChiCTR1900024036). |
| format | Article |
| id | doaj-art-8a0fc7ce7b5c47fe9a5c6fe7cfbed825 |
| institution | DOAJ |
| issn | 2297-055X |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj-art-8a0fc7ce7b5c47fe9a5c6fe7cfbed8252025-08-20T03:06:27ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2025-04-011210.3389/fcvm.2025.14647121464712Biodegradable Pansy® occluder for patent foramen ovale closure: a multicenter, single-arm, prospective studyLu He0Hang Xie1Yongsheng Gao2Gangcheng Zhang3Qunshan Shen4Minghua Wang5Qiguang Wang6Yujiu Wang7Yajuan Du8Xianyang Zhu9Yushun Zhang10Department of Structural Heart Disease, Xi'an Jiaotong University Medical College First Affiliated Hospital, Xi'an, Shaanxi, ChinaDepartment of Structural Heart Disease, Xi'an Jiaotong University Medical College First Affiliated Hospital, Xi'an, Shaanxi, ChinaDepartment of Cardiac Surgery, The First Bethune Hospital Jilin University, Changchun, Jilin, ChinaDepartment of Cardiac Surgery, Wuhan Asia Heart Hospital, Wuhan, Hubei, ChinaDepartment of Cardiac Surgery, Wuhan Asia Heart Hospital, Wuhan, Hubei, ChinaDepartment of Cardiac Surgery, Shandong Province Qianfushan Hospital, Jinan, Shandong, ChinaDepartment of Congenitial Heart Disease, General Hospital of Northern Theater Command, Shenyang, Liaoning, ChinaDepartment of Cardiac Surgery, Binzhou Medicial University Hospitial, Yantai, Shandong, ChinaDepartment of Structural Heart Disease, Xi'an Jiaotong University Medical College First Affiliated Hospital, Xi'an, Shaanxi, ChinaDepartment of Congenitial Heart Disease, General Hospital of Northern Theater Command, Shenyang, Liaoning, ChinaDepartment of Structural Heart Disease, Xi'an Jiaotong University Medical College First Affiliated Hospital, Xi'an, Shaanxi, ChinaBackgroundThe 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.ObjectivesThis 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).MethodsSix 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.ResultsA 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.ConclusionsPFO 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 Registrationhttp://www.chictr.org.cn/index.aspx; identifier (ChiCTR1900024036).https://www.frontiersin.org/articles/10.3389/fcvm.2025.1464712/fullpatent foramen ovalebiodegradableoccluderinterventionaltherapy |
| spellingShingle | Lu He Hang Xie Yongsheng Gao Gangcheng Zhang Qunshan Shen Minghua Wang Qiguang Wang Yujiu Wang Yajuan Du Xianyang Zhu Yushun Zhang Biodegradable Pansy® occluder for patent foramen ovale closure: a multicenter, single-arm, prospective study Frontiers in Cardiovascular Medicine patent foramen ovale biodegradable occluder interventional therapy |
| title | Biodegradable Pansy® occluder for patent foramen ovale closure: a multicenter, single-arm, prospective study |
| title_full | Biodegradable Pansy® occluder for patent foramen ovale closure: a multicenter, single-arm, prospective study |
| title_fullStr | Biodegradable Pansy® occluder for patent foramen ovale closure: a multicenter, single-arm, prospective study |
| title_full_unstemmed | Biodegradable Pansy® occluder for patent foramen ovale closure: a multicenter, single-arm, prospective study |
| title_short | Biodegradable Pansy® occluder for patent foramen ovale closure: a multicenter, single-arm, prospective study |
| title_sort | biodegradable pansy r occluder for patent foramen ovale closure a multicenter single arm prospective study |
| topic | patent foramen ovale biodegradable occluder interventional therapy |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2025.1464712/full |
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