Ichikawa Hajime, Iwai Shigemitsu, Nishiwaki Yasumi, Kikuchi Kousuke
Department of Pediatric Cardiovascular Surgery, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan.
Cardiovascular Surgery, Japan Community Health Care Organization Osaka Hospital, 4-2-78 Fukushima, Fukushima-ku, Osaka, 553-0003, Japan.
Gen Thorac Cardiovasc Surg. 2025 May 11. doi: 10.1007/s11748-025-02154-x.
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.
患有先天性心脏缺陷的患者，如法洛四联症（TOF）、右心室流出道狭窄或闭锁，在初次修复数十年后通常需要进行肺动脉瓣置换术（PVR）。本研究的目的是评估一种新型合成混合织物（SHF）用于成人先天性心脏病PVR的安全性和有效性。
由涂有交联明胶的生物可吸收和不可吸收纱线组成的SHF，被用于一项前瞻性、多中心、单臂关键临床试验，该试验涉及年龄在0至59岁之间的受试者。整个研究已在日本临床试验注册中心（jRCT1080224691）注册。本文特别呈现了针对该多中心试验中五名成年患者（年龄在18至42岁之间）的亚组分析。
手术操作与使用现有产品的操作类似，未观察到与SHF相关的并发症。SHF材料使外科医生在缝合过程中能够清晰地观察到生物人工瓣膜环。所有患者均无需输血，也未发生不良事件。平均随访4.5年（范围为4.0至4.9年），无需再次干预或再次手术。
SHF作为PVR的补片材料显示出前景，具有显著优势，如手术期间可视化清晰，有助于精确放置瓣膜。这种透明度对于TOF修复后的成年人至关重要，因为它有助于减少手术时间和并发症风险。本研究表明，SHF可能是成人PVR的一种有价值的材料，其潜在应用范围超出了小儿心脏病学领域。
