@Article{chd.2025.063297,
AUTHOR = {Su Ye, Luxi Guan, Dong Luo, Fengwen Zhang, Jianhua Lv, Qizong Xie, Qiao Huang, Haiming Wu, Haibo Hu, Xiangbing Pan},
TITLE = {A Novel Transcatheter Suture Closure System for Patent Foramen Ovale: An Experimental Study in Swine},
JOURNAL = {Structural and Congenital Heart Disease},
VOLUME = {20},
YEAR = {2025},
NUMBER = {2},
PAGES = {181--193},
URL = {http://www.techscience.com/schd/v20n2/60820},
ISSN = {3071-1738},
ABSTRACT = {Objectives: This study aimed to evaluate the feasibility, safety, and efficacy of a novel transcatheter suture closure system (HaloStitch®) for patent foramen ovale (PFO) closure in a swine model. Methods: Thirteen swine underwent experimental PFO model creation. All animals received implantation of the transcatheter suture closure system to evaluate procedural success. Comprehensive follow-up over six months included serial ultrasound imaging, histopathological analysis, and gross anatomical examination of cardiac specimens. Results: Successful HaloStitch® device implantation was achieved in 11 of 13 swine. Gross anatomical examination confirmed secure positioning of all sutures in the atrial septum, with no redundancy or thrombus formation. Postoperative ultrasound demonstrated stable suture and staple positions throughout follow-up, with no evidence of suture breakage, displacement, or thrombus. Staples were clearly visualized under ultrasound imaging. Both the atrial septal defect orifice diameter and residual septal shunt flow velocity decreased significantly during the observation period. Histopathological analysis revealed partially organized thrombi at the implant head and fibrous connective tissue encapsulation with localized inflammatory cell infiltration surrounding the polymer material. Conclusions: The transcatheter suture closure system (HaloStitch®) demonstrated feasibility, safety, and biocompatibility for PFO closure in a swine model, supporting its potential for clinical translation.},
DOI = {10.32604/chd.2025.063297}
}