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

Abstract

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.