A Novel Transcatheter Suture Closure System for Patent Foramen Ovale:An Experimental Study in SwineOA
This study aimed to evaluate the feasibility,safety,and efficacy of a noveltranscatheter suture closure system(HaloStitch^(®))for patent foramen ovale(PFO)closure in a swine model.Methods:Thirteen swine underwentexperimental PF0 model creation.All animals received implantationof the transcatheter suture closure system to evaluate procedural success.Comprehensive follow-up over sixmonths included serial ultrasound imaging,histopathological analysis,and gross anatomical exaninationof cardiac specimens.Results:Successful HaloStitch^(®)device implantation was adhieved in 11 of 13 swine.Gross anatomical examination confirrned secure positioning of all sutures in the atrial septum,with noredundancy or thrombus formation.Postoperative ultrasound demonstrated stable suture and staplepositions throughout follow-up,with no evidence of suture breakage,displacement,or thrombus.Stapleswere clearly visualized under ultrasound imaging,Both the atrial septal defect orifice diameter and residualseptal shunt flow velocity decreased significantly during the observation period.Histopathological analysisrevealed partially organized thrombi at the implant head and fibrous connective tissue encapsulation withlocalized inflammatory cell infiltration surrounding the polymer material.Conclsions:The transcathetersuture closure system(HaloStitch^(®))demonstrated feasibility,safety,and biocompatib ility for PFO closure ina swine model,supporting its potential for clinical translation.
Su Ye;Luxi Guan;Dong Luo;Fengwen Zhang;Jianhua Lv;Qizong Xie;Qiao Huang;Haiming Wu;Haibo Hu;Xiangbing Pan
Center of Structural Heart Disease,State Key Laboratotry of Cardiovasculat Disease,Fuwai Hospital,NationalCentetfor Cardiovascular Diseases,Chinese Acadermy ofMedic al Sciences and Pekirg UnionMedical College,Beijing,100037,ChinaCenter of Structural Heart Disease,State Key Laboratotry of Cardiovasculat Disease,Fuwai Hospital,NationalCentetfor Cardiovascular Diseases,Chinese Acadermy ofMedic al Sciences and Pekirg UnionMedical College,Beijing,100037,ChinaCenter of Structural Heart Disease,State Key Laboratotry of Cardiovasculat Disease,Fuwai Hospital,NationalCentetfor Cardiovascular Diseases,Chinese Acadermy ofMedic al Sciences and Pekirg UnionMedical College,Beijing,100037,ChinaCenter of Structural Heart Disease,State Key Laboratotry of Cardiovasculat Disease,Fuwai Hospital,NationalCentetfor Cardiovascular Diseases,Chinese Acadermy ofMedic al Sciences and Pekirg UnionMedical College,Beijing,100037,ChinaCenter of Structural Heart Disease,State Key Laboratotry of Cardiovasculat Disease,Fuwai Hospital,NationalCentetfor Cardiovascular Diseases,Chinese Acadermy ofMedic al Sciences and Pekirg UnionMedical College,Beijing,100037,ChinaHalocinch Medical Technology(Shenzhen)Co,Ltd.,Yifernghua Innovation Industrial Park,Dalang Street,Longhua District,Shenzhen,518109,ChinaHalocinch Medical Technology(Shenzhen)Co,Ltd.,Yifernghua Innovation Industrial Park,Dalang Street,Longhua District,Shenzhen,518109,ChinaHalocinch Medical Technology(Shenzhen)Co,Ltd.,Yifernghua Innovation Industrial Park,Dalang Street,Longhua District,Shenzhen,518109,ChinaCenter of Structural Heart Disease,State Key Laboratotry of Cardiovasculat Disease,Fuwai Hospital,NationalCentetfor Cardiovascular Diseases,Chinese Acadermy ofMedic al Sciences and Pekirg UnionMedical College,Beijing,100037,ChinaCenter of Structural Heart Disease,State Key Laboratotry of Cardiovasculat Disease,Fuwai Hospital,NationalCentetfor Cardiovascular Diseases,Chinese Acadermy ofMedic al Sciences and Pekirg UnionMedical College,Beijing,100037,China
医药卫生
Patent foramen ovaletranscatheter suture closure systemexperimental study
《Congenital Heart Disease》 2025 (2)
P.181-193,13
supported by grants from National High-Level Hospital Clinical Research Funding(2023-GSP-RC-04).
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