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

Abstract

<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.