Department of Pediatric Cardiovascular surgery, Children's Medical Center, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Department of Pediatric Cardiovascular surgery, Children's Medical Center, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Semin Thorac Cardiovasc Surg. 2022 Autumn;34(3):972-980. doi: 10.1053/j.semtcvs.2021.02.026. Epub 2021 Mar 7.
We developed a handmade expanded polytetrafluoroethylene (ePTFE) pulmonary valvular conduit (PVC) with bulging sinuses and a fan-shaped ePTFE valve for right ventricular outflow tract (RVOT) reconstruction. We aimed to investigate the results of this device in this multicenter study. From 2001 to 2020, 1776 patients underwent RVOT reconstruction using ePTFE PVCs at 65 institutions in Japan. The median age and body weight were 4.1 years (range, 3 days to 67.1 years) and 13.3 (range, 1.8-91.3) kg, respectively. The median PVC size was 18 (range, 8-24) mm. The median Z-value of the ePTFE PVC was 1.1 (range, -3.8 to 5.0). The ePTFE PVC conditions were investigated by cardiac echocardiography and catheterization. The median follow-up period was 3.3 years (range, 0 day to 16.2 years). There were only 9 cases (0.5%) with PVC-related unknown deaths. Reintervention was performed in 283 patients (15.9%), and 190 patients (10.7%) required explantation. Freedom from reintervention and explantation at 5/10 years were 86.7/61.5% and 93.0/69.1%, respectively. At the latest echocardiography, PVC regurgitation grade was better than mild in 88.4% patients. The average peak RVOT gradient was 15.7 ± 15.9 mm Hg at the latest cardiac catheterization. ePTFE PVC infection was detected in only 8 patients (0.5%). Relative stenosis due to somatic growth was the most common cause of PVC explantation. The performance of ePTFE in terms of durability, valvular performance, and the resistance against infection is considerable and may replace conventional prosthetic materials. Further improvement of the ePTFE membrane is essential to prevent valvular dysfunction.
我们开发了一种手工制作的膨体聚四氟乙烯（ePTFE）肺动脉瓣带窦膨出和扇形 ePTFE 瓣的管道，用于右心室流出道（RVOT）重建。我们旨在通过这项多中心研究来调查该设备的结果。2001 年至 2020 年，日本 65 家机构的 1776 名患者接受了使用 ePTFE PVC 进行 RVOT 重建。患者的中位年龄和体重分别为 4.1 岁（范围 3 天至 67.1 岁）和 13.3 公斤（范围 1.8-91.3 公斤）。PVC 的中位尺寸为 18 毫米（范围 8-24 毫米）。ePTFE PVC 的中位 Z 值为 1.1（范围-3.8 至 5.0）。通过心脏超声心动图和心导管术检查 ePTFE PVC 的状况。中位随访时间为 3.3 年（范围 0 天至 16.2 年）。仅 9 例（0.5%）因 PVC 相关的不明原因死亡。283 例患者（15.9%）接受了再介入治疗，190 例患者（10.7%）需要进行瓣膜置换。5/10 年的无再介入和无瓣膜置换生存率分别为 86.7/61.5%和 93.0/69.1%。在最新的超声心动图检查中，88.4%的患者的 PVC 反流程度好于轻度。最新的心导管检查显示，平均 RVOT 峰值梯度为 15.7±15.9mmHg。仅 8 例患者（0.5%）检测到 ePTFE PVC 感染。由于躯体生长导致的相对狭窄是 PVC 瓣膜置换的最常见原因。ePTFE 在耐用性、瓣膜性能和抗感染方面的表现相当出色，可能取代传统的人工合成材料。进一步改善 ePTFE 膜的性能对于防止瓣膜功能障碍至关重要。
