经导管国产封堵器与外科手术治疗心室间隔缺损对比研究

Comparison of surgery versus domestic-made VSD occluder device implantation.in the closure of ventricular septal defects

目的比较经导管封堵与心脏直视手术治疗室间隔缺损(VSD)的疗效和并发症。方法采用相同的入选标准,从2002年在我院接受治疗的VSD患者,选择符合条件的患者共458人。外科手术组患者215(男81,女134)例。介入治疗组243(男96,女147)例。外科手术组和介入治疗组年龄分别为9±10岁和8±11岁(P>0.05);VSD大小分别为8.5±5.0mm和8.4±6.1mm(P>0.05)。结果全组无死亡。介入治疗组和外科手术组的成功率分别为99.2%和100%(P>0.05)。介入治疗组术后即刻左心室造影示44例(18.1%)存在微～少量残余分流,199例(81.9%)封堵完全无残余分流。术后24～48h超声心动图示分流完全消失223例(91.8%)、微～少量残余分流20例(8.2%)。1例封堵术后24h发生溶血,经过7d内科保守治疗治愈。5例封堵术后3d发生一过性Ⅲ度房室传导阻滞,经过4～10d内科保守治疗治愈。1个月超声心动图发现2例残余分流(0.8%),均为少量。外科手术组1个月超声心动图发现2例残余分流(0.9%),5例封堵术后3d发生一过性Ⅲ度房室传导阻滞,5例经过4～10d内科保守治疗治愈,1例需安装心脏永久起搏器治疗。.介入治疗组中无一例患者需要输血,外科手术组中86例患者需要输血,平均输血量为547±171ml。瓣膜关闭不全介入治疗组显著低于外科手术组.

AIM: To compare effectiveness, complications, and cost of domestic-made VSD occluder with surgical in ventricular septal defect (VSD) closure. METHODS: We prospectively compared closure rates, complication rates, cost, inpatient stay, and home convalescent time in 458 patients with ventricular septal defects: 215 cases (9±10 years) were treated surgically and 243 cases(8±11 years) were treated by percutaneous domestic-made VSD septal occluder. RESULTS: domestic-made VSD occluder closure was successful in 241 of 243 (99.1%) patients. Surgical closure was successful in all 215 cases. In domestic-made VSD septal occluder group, the left ventricular graphies(LVG) showed that 199(81.9%)patients had complete immediate closure, 44(18.1%)had a trace to small shunt immediately after the procedures;Within 24~48 h, color Doppler revealed complete closure in 223(91.8%) patients and a trace to small shunt in 20 patients (8.2%); 5 cases suffered with temporary Ⅲ° atrial ventricular block and returned to normal 4~10 days after medicines treatment;One patient developed hemolysis 24h after the procedure and recovered 7 days after medicines treatment; Doppler revealed that a trace to small shunt in 2 patients 1mo after the procedure. In surgical group, doppler revealed that a trace to small shunt in 2 patients 1mo after the procedure; 5 cases suffered with temporary Ⅲ°atrial ventricular block and returned to normal 4~10 days after medicines treatment;One patient developed hemolysis 24h after the procedure and recovered 7 days after medicines treatment.Blood products were administered to 86 patients in the surgical group and no patient in the device group (P<0.01). Both hospital stay and home convalescent times were significantly shorter after domestic-made VSD occluder closure (median hospital stay: domestic-made VSD occluder 5 day, surgery 14 days; median convalescent time: domestic-made VSD occluder two weeks, surgery 6 weeks). Median cost was slightly higher in surgical groups (domestic-made VSD occluder RMB 2956±542, surgical RMB 2536±742, P<0.05). CONSLUSION: Transcatheter closure of ventricular septal defects with the domestic-made VSD occluder device has the advantage of fewer complications, shorter hospitalization, and reduced need of blood products. Nonetheless, the surgeon's ability to close any ventricular septal defect regardless of its size or location remains an important advantage of surgery.