# Safety and efficacy of a novel biodegradable occluder- Pansy ® occluder compared with traditional nondegradable occluder in the closure of patent foramen ovale

## TL;DR

This study compares a new biodegradable Pansy® occluder with traditional nondegradable ones for closing heart defects, finding similar safety and effectiveness.

## Contribution

The study directly compares a novel biodegradable PFO occluder with traditional nondegradable ones in a clinical setting.

## Key findings

- The Pansy® occluder showed 100% procedural success with no severe adverse events.
- Effective closure rates at 6 and 12 months were comparable between the Pansy® and traditional occluders.
- Device-related thrombosis occurred more frequently in the Pansy® group but resolved without complications.

## Abstract

Traditional nondegradable patent foramen ovale (PFO) occluders pose mechanical complications and may limit potential transseptal access, necessitating biodegradable alternatives without permanent implants. The safety and efficacy of the fully biodegradable Pansy® occluder have not been directly compared with traditional nondegradable devices.

To compare the Pansy® occluder with traditional nondegradable occluders for percutaneous closure of PFO, focusing on complications, adverse events, and closure outcomes during follow-up.

We retrospectively analyzed consecutive patients who underwent PFO closure with the Pansy® occluder (n = 44) or traditional nondegradable occluders (n = 381, predominantly Amplatzer occluder) between June 2019 and June 2020 at the First Affiliated Hospital of Xi'an Jiaotong University. Propensity score matching (1:2) was performed for age, gender, spontaneous right-to-left shunt (RLS) grade, and provokable RLS grade. Outcomes included procedural success, complications, adverse events, effective closure rate, and residual shunt at 6 and 12 months.

Before matching, Pansy® recipients were younger and included fewer female patients. After matching, baseline characteristics were well balanced. Procedural success was 100% in both groups, with no severe adverse events. Device-related thrombosis occurred in three patients in the Pansy® group (6.82% vs. 0.00%, P = 0.01); all cases resolved after 2–3 months of rivaroxaban without embolic complications. This difference may be influenced by more frequent scheduled TEE surveillance in the Pansy® group. Effective closure rates at 6 and 12 months were comparable between groups (88.64% vs. 87.50%, P = 0.85; 95.45% vs. 92.31%, P = 0.77), with no significant differences in residual shunt.

The Pansy® occluder demonstrated comparable safety and efficacy compared to nondegradable devices for PFO closure.