# Novel transparent patch as an adjunct to adult pulmonary valve replacement

## TL;DR

A new transparent patch material was tested for use in adult pulmonary valve replacement, showing safety and benefits like clear visibility during surgery.

## Contribution

The study introduces a novel transparent synthetic hybrid fabric for adult pulmonary valve replacement with clear visualization benefits.

## Key findings

- The SHF material allowed clear observation of the bioprosthetic valve annulus during surgery.
- No re-interventions or reoperations were needed at a mean follow-up of 4.5 years.
- No SHF-specific complications or adverse events were observed in adult patients.

## Abstract

Patients with congenital heart defects, such as tetralogy of Fallot (TOF) or right ventricular outflow tract stenosis or atresia, often require pulmonary valve replacement (PVR) decades after the primary repair. The purpose of this study was to assess the safety and efficacy of a novel synthetic hybrid fabric (SHF) for PVR in adult congenital heart disease.

SHF, consisting of bio-absorbable and non-absorbable yarns coated with cross-linked gelatin, was used in a prospective, multicenter, single-arm pivotal clinical trial involving subjects with an age range of 0–59 years. The overall study was registered in the Japan Registry of Clinical Trials (jRCT1080224691). This paper specifically presents a subgroup analysis focusing on five adult patients (aged 18–42 years) from the multicenter trial.

The procedures were performed similarly to those using existing products, with no SHF-specific complications observed. The SHF material allowed surgeons to clearly observe the bioprosthetic valve annulus during suturing. None of the patients required blood transfusion or developed adverse events. At a mean follow-up of 4.5 years (range 4.0–4.9 years), no re-interventions or reoperations were needed.

SHF shows promise as a patch material for PVR, offering significant benefits such as clear visualization during surgery, which facilitates precise valve placement. This transparency is crucial for adults with repaired TOF, as it helps reduce surgery time and complication risks. This study suggests that SHF could be a valuable material for adult PVR, extending its potential applications beyond pediatric cardiology.

The online version contains supplementary material available at 10.1007/s11748-025-02154-x.