Department of Fetal-Maternal Medicine, Nagara Medical Center, Gifu, Japan.
Prenat Diagn. 2012 Dec;32(13):1282-7. doi: 10.1002/pd.3994. Epub 2012 Nov 8.
To describe the safety and efficacy of thoracoamniotic shunting for fetal pleural effusion using a double-basket catheter with a very small diameter (1.47 mm).
In this 2-year multicenter, prospective single-arm clinical study registered with the University hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN00001095); shunting was performed between 18w0d and 33w6d of gestation with this catheter in cases of fetal pleural effusions reaccumulating after thoracocentesis. The primary endpoint measures were maternal and fetal adverse effects and survival in the neonatal period.
A total of 24 cases were included, of which 17 had hydrops (71%). The median gestational ages at shunting and delivery were 27.4 and 34.8 weeks, respectively. There were no fetal deaths, lung injuries, or severe maternal complications. Preterm rupture of the membranes occurred in 7/24 (29%) cases at a median of 62 days after the shunting. Preterm rupture of the membranes within 28 days of the procedure occurred in 1/24 (4%) cases. Catheter displacement towards the fetal thoracic cavity occurred in 4/42 (10%) cases. The overall survival rate was 79% (19/24), whereas it was 71% (12/17) in the cases with hydrops.
Drainage of fetal pleural effusions with a double-basket shunt is safe and effective, and the shunt could be an alternative device.
描述使用非常小直径（1.47mm）的双篮导管进行胎儿胸腔积液分流的安全性和有效性。
这项为期 2 年的多中心前瞻性单臂临床研究在大学医院医疗信息网络（UMIN）临床试验注册处（UMIN00001095）注册；在胸腔穿刺后胸腔积液再次积聚的情况下，于 18w0d 至 33w6d 妊娠期间使用该导管进行分流。主要终点指标是母婴不良反应和新生儿期存活率。
共纳入 24 例病例，其中 17 例有水肿（71%）。分流和分娩的中位孕龄分别为 27.4 周和 34.8 周。无胎儿死亡、肺损伤或严重的母亲并发症。7/24（29%）例在分流后中位 62 天发生胎膜早破。24 例中有 1 例（4%）在术后 28 天内发生胎膜早破。4/42（10%）例导管向胎儿胸腔移位。总存活率为 79%（19/24），而水肿病例的存活率为 71%（12/17）。
双篮引流管引流胎儿胸腔积液安全有效，可作为替代装置。
