背景:本综述的目的是创建统一的方案,以进行和公开生物二尖瓣置换的首次临床试验和初步临床试验。通过观察不同研究中使用的方法和方案的显着差异,强调了在这些早期试验中需要一致的方法。
方法:对六个主要数据库进行了广泛的搜索,以检索评估二尖瓣位置手术植入的生物假体的首次人体(FIH)临床研究。
结果:遵循PRISMA指南,一项系统的搜索确定了2082篇发表的文章,直到2023年3月。删除重复项(189)后,筛选了1862篇引文,共纳入22项符合条件的研究,纳入3332例患者进行分析。这些研究中的二尖瓣假体范围为21至37毫米,29毫米的尺寸是最普遍的。患者人数各不相同,FIH亚组包括31例患者,老年亚组包括163例患者。平均研究持续时间不同:年龄较大的亚组持续4.57年,FIH亚组2.85年,早期研究平均跨越8.05年。
结论:FIH临床报告对于评估“从头”外科植入物所需的临床数据的重要性至关重要。此外,了解设备的性能,认识到与创新相关的困难是重要的教训。这些见解可能有利于生物人工心脏瓣膜的开发和制定FIH临床试验的方案。
BACKGROUND: The aim of this
review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve replacement. The need for consistent methodology in these early trials was highlighted by the observation of significant variability in the methods and protocols used across different research.
METHODS: An extensive search through six major databases was carried out to retrieve First-In-Human (FIH) clinical studies evaluating surgically implanted bio-prostheses in the mitral position.
RESULTS: Following the PRISMA guideline, a systematic search identified 2082 published articles until March 2023. After removing duplicates (189), 1862 citations were screened, resulting in 22 eligible studies with 3332 patients for analysis. The mitral valve prostheses in these studies ranged from 21 to 37 mm, with the 29 mm size being most prevalent. Patient numbers varied, with the FIH subgroup including 31 patients and the older subgroup including 163 patients. Average study durations differed: the older subgroup lasted 4.57 years, the FIH subgroup 2.85 years, and the early phase studies spanned 8.05 years on average.
CONCLUSIONS: FIH clinical report is essential to assess the significance of clinical data required for a \"de novo\" surgical implant. In addition, understanding the performance of the device, and recognizing the difficulties associated with the innovation constitute important lessons. These insights could be beneficial for the development of bioprosthetic heart valves and formulating a protocol for an FIH clinical trial.