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Biodegradable Pansy® occluder for patent foramen ovale closure: a multicenter, single-arm, prospective study
Lu He1, Hang Xie1, Yongsheng Gao2
1Department of Structural Heart Disease, Xi'an Jiaotong University Medical College First Affiliated Hospital, Xi'an, Shaanxi, China.
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).
