Long-term results of patent foramen ovale occlusion with the Pansy ? biodegradable occluder: a single-center clinical trial with 36-month follow-up
10.3760/cma.j.cn112434-20240126-00026
- VernacularTitle:Pansy生物可降解封堵器治疗卵圆孔未闭的远期疗效：36个月随访的单中心临床研究
- Author:
Ziang LI
1
;
Xiaozhou ZHENG
;
Qiang MIAO
;
Yinsheng LEI
;
Minghua WANG
;
Xiankun LIU
;
Zhigang GUO
Author Information
1. 山东第一医科大学第一附属医院 山东省千佛山医院心外科，济南 250014
- Keywords:
Patent foramen ovale;
Novel biodegradable occluder;
Closure therapy;
Clinical trials
- From:
Chinese Journal of Thoracic and Cardiovascular Surgery
2024;40(11):664-671
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To test the feasibility, efficacy and safety of percutaneous patent foramen ovale(PFO) closure utilizing the Pansy biodegradable occluder(PBO) at 1-, 3-, 6-, 12-, 24-, and 36-month follow-up.Methods:In this single-center prospective clinical study, we enrolled 15 patients with PFO eligible for closure, all treated with the PBO, with device sizes ranging 24-34 mm. All clinical data were recorded in a 36-month follow-up period. Patients were summoned to the hospital in the 1, 3, 6, 12, 24, and 36 months after closure for transthoracic echocardiography(TTE), or transesophageal echocardiography(TEE), contrast transcranial doppler(cTCD) or contrast transthoracic echocardiography(cTTE), and a routine fasting blood sample.Results:The mean age was 27-68(44.0±16.4) years old. Indications for closure were cryptogenic stroke in 6 patients and migraine in 9 patients. Procedures were technically successful in 100%(15/15), in which course TTE showed that the position and shape of occluders were satisfactory. Small residual shunt was found by TTE in 2 patients with ASA in 1 month and 6 months after closure, respectively. 1 patient with cryptogenic stroke had another recurrent stroke 8 months after closure. At 12-month follow-up, 11 cases were closure. At 36-month follow-up, 13 cases were closure. 12 patients without atrial septal aneurysm(ASA) were closure. 1 patients with ASA was complete closure. No device-related complications occurred during the follow-up.Conclusion:PBO has good biocompatibility and suitable degradation time. A high technical success rate and closure rate can be achieved in those patients without ASA. Percutaneous closure of PFO using PBO is feasible, effective, and safe.
