ORIGINAL RESEARCH article
Front. Cardiovasc. Med.
Sec. Structural Interventional Cardiology
Volume 12 - 2025 | doi: 10.3389/fcvm.2025.1587015
This article is part of the Research TopicAdvance in the Etiology, Imaging Diagnosis and Interventional Treatment of Cardiogenic StrokeView all 3 articles
A Preserved Transseptal Puncture Zone in a Novel PFO Occluder Enables Safe Repeat Left Atrial Interventions: Preclinical Validation in a Porcine Model
Provisionally accepted
Haibin Jiang*
Yanlin SuHao ChenZiqian HeYiting WeiZihe DangSuyan CaoWenlin LuShaoqing CaoChengjian Yang- Jiangnan University Medical Center (JUMC）, Wuxi, China
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Background: Conventional 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.Methods: An 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.Results: All 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.The 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. Keywords：patent foramen ovale (PFO), transseptal puncture, left atrial appendage closure (LAAC), interventional cardiology, preclinical study, device innovation, structural heart disease.
Keywords: Patent foramen ovale (PFO), Transseptal puncture, left atrial appendage closure (LAAC), interventional cardiology, Preclinical study, device innovation, structural heart disease.
Received: 03 Mar 2025; Accepted: 03 Jun 2025.
Copyright: © 2025 Jiang, Su, Chen, He, Wei, Dang, Cao, Lu, Cao and Yang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Haibin Jiang, Jiangnan University Medical Center (JUMC）, Wuxi, China
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