Why the study?
Conventional nickel-titanium PFO occluders hinder transseptal puncture due to septal obstruction, limiting access for left-heart interventions.
Does a novel PFO occluder with a designated puncturable zone enable safe transseptal access for subsequent left atrial interventions in a porcine model?
Does a novel PFO occluder with a designated puncturable zone enable safe transseptal access for subsequent left atrial interventions in a porcine model?
A novel PFO occluder with a dedicated puncture zone demonstrates preclinical feasibility for allowing future transseptal access for left-heart interventions.
Novel puncturable PFO occluder feasible in pigs; leaves open human transseptal access and safety.
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. Conclusion: 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.
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Chen et al. (2025) studied this question.
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