Kasahara Shingo, Yoshimura Yukihiro, Ichikawa Hajime, Hirata Yasutaka, Murayama Hiroomi, Nakano Toshihide, Miura Masaru, Nemoto Shintaro
Department of Cardiovascular Surgery, School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
Department of Cardiovascular Surgery, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
Ann Thorac Surg Short Rep. 2024 May 10;2(4):804-809. doi: 10.1016/j.atssr.2024.04.020. eCollection 2024 Dec.
We have developed a new hybrid warp-knit fabric for induction of in situ tissue regeneration that has shown appropriate antideterioration properties and expandability in preclinical studies. This study was performed to assess the clinical efficacy and safety of this fabric in the early postoperative period after congenital cardiac surgery.
The fabric comprises biodegradable (complete degradation period, 2-3 years) and nonbiodegradable yarns coated with cross-linked gelatin. A multicenter single-arm 3-year study was conducted. The primary end point for regulatory approval was the surgical success rate without death or reintervention related to fabric failure at 1 year after surgery. Secondary end points included the incidence of material-related secondary lesions.
The fabric was implanted at 41 sites (pulmonary artery, n = 18; right ventricular outflow tract, n = 12; atrial septum, n = 7; and ventricular septum, n = 4) in 34 patients of median age 1 year 11 months (range, 4 months-58 years). The surgical success rate was 100%. There were no abnormal findings for the fabric on echocardiography and no serious adverse events in a median follow-up period of 40 months (range, 36-55 months), other than 3 stenotic lesions that were due to the surgical procedure. These results permitted regulatory approval for use of the fabric in Japan.
The new fabric promoting tissue self-organization through a novel technology showed acceptable efficacy and safety in the early postoperative period after congenital cardiac surgery.
我们研发了一种用于诱导原位组织再生的新型混合经编织物，该织物在临床前研究中已显示出适当的抗降解性能和可扩展性。本研究旨在评估这种织物在先天性心脏手术后早期的临床疗效和安全性。
该织物由可生物降解（完全降解期为2 - 3年）和涂有交联明胶的不可生物降解纱线组成。进行了一项多中心单臂3年研究。监管批准的主要终点是术后1年无因织物故障导致的死亡或再次干预的手术成功率。次要终点包括与材料相关的继发性病变的发生率。
在34例中位年龄为1岁11个月（范围为4个月至58岁）的患者中，在41个部位（肺动脉，n = 18；右心室流出道，n = 12；房间隔，n = 7；室间隔，n = 4）植入了该织物。手术成功率为100%。在中位随访期40个月（范围为36至55个月）内，除了3例因手术操作导致的狭窄病变外，超声心动图检查未发现织物有异常，也未发生严重不良事件。这些结果使得该织物在日本获得监管批准使用。
这种通过新技术促进组织自组织的新型织物在先天性心脏手术后早期显示出可接受的疗效和安全性。
