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

## TL;DR

A new PFO occluder allows safe repeat heart procedures by preserving a puncture zone, validated in a pig model.

## Contribution

A novel PFO occluder with a preserved puncture zone was developed and preclinically validated for repeat interventions.

## Key findings

- All PFO closures were successful with device stability confirmed by DSA and TEE.
- Transseptal LAAC was achieved in all cases through the preserved puncture zone.
- Histology showed complete endothelialization and intact framework with no structural compromise.

## Abstract

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.

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.

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.