国产动脉导管未闭封堵器的临床应用及疗效评价

The clinical application and effect evaluation of home-made duct occluder in patent ductus arteriosus

目的 评价应用国产心健牌动脉导管未闭 (PDA)封堵器的临床疗效。方法 2 0 0 0年 6月至 2 0 0 2年 7月 ,182例患者 (男 63例 ,女 119例 )成功地采用国产心健牌动脉导管未闭封堵器进行了PDA的封堵术。年龄 3个月至 16岁 ,平均 (5 2 3± 4 0 2 )岁 ,体重 5～ 50kg ,平均 (17 0 9± 8 11)kg。PDA最窄处直径为 1 3 2～ 9 0 0mm ,平均 (4 3 0± 1 0 2 )mm。输送长鞘为 6～ 10F。手术时间为 45～ 13 5min ,平均 (73 3 1± 2 1 44)min ;X线曝光时间为 2 60～ 2 6 90min ,平均 (7 0 9± 4 55)min。术后即时、2 4h、1个月、3个月、6个月、1年及 2年行彩色多普勒超声心动图检查。结果 182例均成功地置入心健牌PDA封堵器。 182例即时心血管造影显示 10 9例 (59 89% )即时完全堵闭 ,3 0例有少量残余分流 ,43例仅有微量的残余分流 ,残余分流率为 40 11% ;2 4h后的彩色多普勒超声心动图检查显示 163例(89 60 % )完全堵闭 ;1个月后 8例仍有少量残余分流。术后 3个月及 6个月仅 4例有残余分流 ,79例完成术后 1年的随诊 ,仅 2例仍有残余分流。术后 2年仍有 1例残余分流。全部病例均无严重并发症。结论 应用国产心健牌PDA封堵器对PDA进行介入治疗 ,疗效确切 ,远期效果满意 。

Objectives To evaluate the cli nical application and effect of transcatheter closure of patent ductus arteriosus (PDA) by using the home-made Xinjian duct occluder Methods From June, 2000 to July, 2002, 182 patients (63 male, 119 female) underwent attempted transcatheter closure of patent ductus arteriosus by using the Xinjian duct occluder at a median age of 5 23 years (range 0 3 to 16) and a median weight of 17 09 kg (range 5 to 50) The mean PDA diameter in the narrowest segment was 4 30 mm (range 1 32 to 9 00) The delivery sheath was 6 to 10 F The median operation time was 73 31 min (range 45 to 135), and the median fluoroscopy time was 7 09 min (range 2 60 to 26 90) Follow-up evaluation was performed with color flow mapping immediately, at 24 h, 1 month, 3 months, 6 months, 1 year, and 2 years after closure, respectively Results The Xinjian device was successfully placed in all 182 cases Angiography showed immediate closure in 109 patients (59 89%), small residual shunt in 30, and trace shunt in 43 At 24 h, color Doppler revealed complete closure in 163 patients Only 8 patients still had a residual shunt after 1 month A residual shunt was observed in 4 at 3 months and 6 months, 2 at 1 year, 1 at 2 years There were no severe complications Conclusions Transcatheter closure of PDA using the home-made Xinjian occluder is a safe and effective method The Xinjian occluder could replace the imported product in the closure of PDA