A preserved transseptal puncture zone in a novel PFO occluder enables safe repeat left atrial interventions: preclinical validation in a porcine model

BackgroundConventional nickel-titanium patent foramen ovale (PFO) occluders hinder transseptal puncture due to septal obstruction, limiting access for left-heart interventions. To address this, we developed a modified PFO occluder with a designated puncturable zone.MethodsAn artificial PFO model was...

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Main Authors: Hao Chen, Yanlin Su, Ziqian He, Yiting Wei, Zihe Dang, Suyan Cao, Wenlin Lu, Shaoqing Cao, Chengjian Yang, Haibin Jiang
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-06-01
Series:Frontiers in Cardiovascular Medicine
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Online Access:https://www.frontiersin.org/articles/10.3389/fcvm.2025.1587015/full
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author Hao Chen
Yanlin Su
Ziqian He
Yiting Wei
Zihe Dang
Suyan Cao
Wenlin Lu
Shaoqing Cao
Chengjian Yang
Haibin Jiang
author_facet Hao Chen
Yanlin Su
Ziqian He
Yiting Wei
Zihe Dang
Suyan Cao
Wenlin Lu
Shaoqing Cao
Chengjian Yang
Haibin Jiang
author_sort Hao Chen
collection DOAJ
description BackgroundConventional nickel-titanium patent foramen ovale (PFO) occluders hinder transseptal puncture due to septal obstruction, limiting access for left-heart interventions. To address this, we developed a modified PFO occluder with a designated puncturable zone.MethodsAn artificial PFO model was created in six pigs by puncturing and dilating the fossa ovalis. A novel PFO occluder preserving a central puncture area was implanted and validated intraoperatively via digital subtraction angiography (DSA) and transesophageal echocardiography (TEE). Transthoracic echocardiography and histology were performed 3 months post-implantation. Transseptal left atrial appendage closure (LAAC) was subsequently attempted through the occluder's puncturable zone.ResultsAll PFO closures were successful, with DSA/TEE confirming device stability. At 3 months, transseptal LAAC via the occluder's preserved area was achieved in all cases (6/6), validated by imaging. Histology revealed complete endothelialization of both occluders, intact nitinol framework, and precise puncture tracks within the designated zone without structural compromise.ConclusionThe novel PFO occluder with a dedicated puncture zone enables effective PFO closure while permitting safe transseptal access for subsequent left-heart interventions. This study demonstrates the occluder's feasibility, reliability, and clinical potential for aging populations requiring sequential cardiac procedures.
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spelling doaj-art-9971bb714f4f4c62bf6793baef2bf17b2025-08-20T02:35:33ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2025-06-011210.3389/fcvm.2025.15870151587015A preserved transseptal puncture zone in a novel PFO occluder enables safe repeat left atrial interventions: preclinical validation in a porcine modelHao ChenYanlin SuZiqian HeYiting WeiZihe DangSuyan CaoWenlin LuShaoqing CaoChengjian YangHaibin JiangBackgroundConventional nickel-titanium patent foramen ovale (PFO) occluders hinder transseptal puncture due to septal obstruction, limiting access for left-heart interventions. To address this, we developed a modified PFO occluder with a designated puncturable zone.MethodsAn artificial PFO model was created in six pigs by puncturing and dilating the fossa ovalis. A novel PFO occluder preserving a central puncture area was implanted and validated intraoperatively via digital subtraction angiography (DSA) and transesophageal echocardiography (TEE). Transthoracic echocardiography and histology were performed 3 months post-implantation. Transseptal left atrial appendage closure (LAAC) was subsequently attempted through the occluder's puncturable zone.ResultsAll PFO closures were successful, with DSA/TEE confirming device stability. At 3 months, transseptal LAAC via the occluder's preserved area was achieved in all cases (6/6), validated by imaging. Histology revealed complete endothelialization of both occluders, intact nitinol framework, and precise puncture tracks within the designated zone without structural compromise.ConclusionThe novel PFO occluder with a dedicated puncture zone enables effective PFO closure while permitting safe transseptal access for subsequent left-heart interventions. This study demonstrates the occluder's feasibility, reliability, and clinical potential for aging populations requiring sequential cardiac procedures.https://www.frontiersin.org/articles/10.3389/fcvm.2025.1587015/fullpatent foramen ovale (PFO)transseptal punctureleft atrial appendage closure (LAAC)interventional cardiologypreclinical studydevice innovation
spellingShingle Hao Chen
Yanlin Su
Ziqian He
Yiting Wei
Zihe Dang
Suyan Cao
Wenlin Lu
Shaoqing Cao
Chengjian Yang
Haibin Jiang
A preserved transseptal puncture zone in a novel PFO occluder enables safe repeat left atrial interventions: preclinical validation in a porcine model
Frontiers in Cardiovascular Medicine
patent foramen ovale (PFO)
transseptal puncture
left atrial appendage closure (LAAC)
interventional cardiology
preclinical study
device innovation
title A preserved transseptal puncture zone in a novel PFO occluder enables safe repeat left atrial interventions: preclinical validation in a porcine model
title_full A preserved transseptal puncture zone in a novel PFO occluder enables safe repeat left atrial interventions: preclinical validation in a porcine model
title_fullStr A preserved transseptal puncture zone in a novel PFO occluder enables safe repeat left atrial interventions: preclinical validation in a porcine model
title_full_unstemmed A preserved transseptal puncture zone in a novel PFO occluder enables safe repeat left atrial interventions: preclinical validation in a porcine model
title_short A preserved transseptal puncture zone in a novel PFO occluder enables safe repeat left atrial interventions: preclinical validation in a porcine model
title_sort preserved transseptal puncture zone in a novel pfo occluder enables safe repeat left atrial interventions preclinical validation in a porcine model
topic patent foramen ovale (PFO)
transseptal puncture
left atrial appendage closure (LAAC)
interventional cardiology
preclinical study
device innovation
url https://www.frontiersin.org/articles/10.3389/fcvm.2025.1587015/full
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