Rao P S, Sideris E B, Haddad J, Rey C, Hausdorf G, Wilson A D, Smith P A, Chopra P S
Department of Pediatrics, University of Wisconsin Medical School, Madison.
Circulation. 1993 Sep;88(3):1119-26. doi: 10.1161/01.cir.88.3.1119.
Several devices are available for transcatheter occlusion of patent ductus arteriosus. Most of these devices either require complicated intracardiac maneuvering, have not been tried in humans, or need a large-sized sheath for implantation of the device.
During a 26-month period ending November 1992, 14 patients underwent transcatheter closure of patent ductus arteriosus with an adjustable buttoned device delivered via a 7F sheath under an institutional review board-approved custom-made device protocol. The children were 15 months to 8 years of age with weight range of 7.2 to 19 kg. The patent ductus arteriosus measured from 2 to 7.5 mm (median, 3 mm) at the narrowest diameter and was conical, short, or tubular. They were occluded with devices measuring 15 to 20 mm. The ratio of pulmonary to systemic flow decreased (P < .01) from 1.9 +/- 0.6 (mean +/- SD; range, 1.3 to 3.2) to 1.05 +/- 0.1 (1 to 1.3). Continuous murmur of patent ductus arteriosus disappeared in all except 1 patient. Small residual shunts were detected by color Doppler studies in 4 of 14 patients (29%). All patients were followed for 1 to 24 months (mean, 6 +/- 7 months). The device was intact in all patients, and no breakage of the wires was noted. No shunts were seen in 12 of 14 patients (86%), and minute residual shunts were seen in 2 children. No major complications were encountered.
It is concluded that transcatheter closure of patent ductus arteriosus with the adjustable buttoned device is feasible and effective and can be accomplished via small 7F sheaths; a 7F sheath is adequate for all ductal sizes; and the adjustable length of the loop accommodated all types of patent ductus arteriosus. Clinical trials on a larger number of patients are warranted.
有多种装置可用于经导管封堵动脉导管未闭。这些装置大多要么需要复杂的心内操作，要么尚未在人体进行试验，要么需要大型鞘管来植入装置。
在截至1992年11月的26个月期间，14例患者根据机构审查委员会批准的定制装置方案，通过7F鞘管使用可调节纽扣式装置进行经导管动脉导管未闭封堵术。患儿年龄为15个月至8岁，体重范围为7.2至19千克。动脉导管未闭最窄直径为2至7.5毫米（中位数为3毫米），呈圆锥形、短管状或管状。使用尺寸为15至20毫米的装置将其封堵。肺循环与体循环血流量之比从1.9±0.6（平均值±标准差；范围为1.3至3.2）降至1.05±0.1（1至1.3）（P<0.01）。除1例患者外，其余患者动脉导管未闭的连续性杂音均消失。14例患者中有4例（29%）经彩色多普勒检查发现小的残余分流。所有患者均随访1至24个月（平均6±7个月）。所有患者装置均完整，未发现钢丝断裂。14例患者中有12例（86%）未见分流情况，2例患儿可见微量残余分流。未发生重大并发症。
得出结论，使用可调节纽扣式装置经导管封堵动脉导管未闭是可行且有效的，可通过小型7F鞘管完成；7F鞘管对所有导管大小均适用；环的可调节长度可适应所有类型的动脉导管未闭。有必要对更多患者进行临床试验。
