国产室间隔缺损封堵器的安全性和疗效评价

The Safety and Efficacy of Transcatheter Closure of Home-Made Nitinol Occluder for Perimembranous Ventricular Septal Defects

目的:评价国产室间隔缺损(VSD)封堵器的安全性和疗效。 方法:312例先天性心脏病(先心病)膜周部VSD患者,男144例,女168例,年龄2-65岁,平均(16.44±9.09)岁。超声测量VSD直径2-15 mm,平均(5.08±2.79)mm。应用7F-10F输送鞘管从右心系统送入封堵器。在超声和X线指导下放置封堵器。术后连续心电监护5天。出院前,术后1个月、6个月和1年定期做心电图、超声心动图检查。 结果:312例中302例患者封堵成功,成功率96.79％。左心室造影测量的VSD直径2-20 mm,平均(4.96±2.67)mm。封堵器直径为4-20 mm,平均(7.09±3.60)mm。X线透视时间5-60 min,平均(14.92±8.09)min,操作时间30-160 min,平均(55.67±7.25)min。随访1个月至3年期间,未发生心律失常、感染性心内膜炎、血栓栓塞等并发症。 结论:国产VSD封堵器经导管封堵膜部VSD使用安全,操作简便,疗效可靠。

Objective:To evaluate the safety and efficacy of home-made nitinol occluder for transcatheter perimembranous ventricular septal defects (VSD) occlusion.Methods:Transcatheter closure was attempted in 312 patients (144 men and 168 women, aged 2 to 65 years, mean age 16. 44±9. 09 years) with perimembranous VSD. The diameter of VSD measured by echocardiography was 2 to 15 mm, mean 5. 08±2. 79 mm. A 7F-10F delivery sheath was advanced across the membranous VSD over a wire from femoral vein to deploy the oecluder with the guidance of echocardiography and fluoroscopy. Continuous electrocardiogram monitoring lasted for 5 days after procedure in all patients. The echocardiography and electrocardiogram examinations were scheduled before and at 1 , 6 and 12 months after discharge.Results:The occluders were successfully deployed in 302 patients. The VSD diameter measured by left ventriculography was 2 to 20 mm,mean 4. 96±2. 67 mm. The device diameter selected was from 4 to 20 mm, mean 7. 09±3. 60 mm. There were 10 procedural failures, with device-related aortic insufficiency in 4 patients, inability to pass through VSD in 3 patients, hypotension in 1 patient, severe tricuspid regurgitation in 1 patient,and the dislocation of device in 1 patient. After deployment of the devices, there was no residual shunt in 286 of 302 patients. Trivial residual shunt occurring in 16 patients disappeared in 13 at one-month follow up. Three patients developed mild tricuspid insufficiency. Sixteen patients developed transient complete right bundle branch block, 10 transient complete left bundle branch block. , and 4 transient complete atrioventricular block. Repetitive nonparoxysmal ventricular tachycardia occurred in 4 patients 1 week after procedure. Of the 2 patients with perimembranous VSD, one had a device embolized into the left pulmonary artery and the other in the abdominal aorta with successful catheter retrieval by snare and finished transcatheter closure. The devices were similarly applied in 3 patients with VSD and patent Ductus Arteriosus, and 8 patient with VSD and atrial septal defects. The fluoroscopy time for the procedure was 14. 92±8. 09 min (range, 5-60 min). The procedure time was 55. 67±1. 25 min (range, 30-160 min). On follow-up evaluation at 1 month to 3years, there were no episodes of endocarditis, thromboembolism, or hemolysis.Conclusion: Transcatheter closure of membranous ventricular septal defects with home-made nitinol occluder is safe, easy and effective.