国产封堵器治疗先天性膜周部室间隔缺损的疗效评估

Outcome of transcatheter closure of perimembranous ventricular septal defect with modified doubledisk occluder device

目的评价应用国产封堵器治疗先天性膜周部室间隔缺损（pmVSD）的近期疗效和安全性。方法选择2001年12月至2008年12月在上海长海医院心内科使用国产封堵器治疗的pmVSD患者604例。所有患者术后1周每天观察临床症状并行12导联心电图检查，术后3—7d复查经胸超声心动图（TTE）和X线胸片。结果604例患者中封堵成功576例，共置入封堵器583枚，放弃封堵28例，手术成功率95．4％。无感染性心内膜炎、血栓栓塞、猝死等并发症发生。81例患者术后出现不同类型的传导阻滞，其中右束支传导阻滞56例，左束支传导阻滞14例。31例患者在术后出现一过性的加速性室性自主心律。完全性房室传导阻滞（cAVB）11例，9例在3周内恢复，2例安置永久性心脏起搏器，其中1例术前有一过性cAVB，另1例为同时封堵房间隔缺损并室间隔缺损的患者。术后即刻，69例（12．0％）有微量-少量残余分流，术后7d，31例分流完全消失，仍有38例（6．6％）存在微量-少量残余分流。术后主动脉瓣反流加重5例，2例由术前的微量加重到术后少量反流，3例由少量加重到中量；术后出现三尖瓣微-少量反流32例，中量反流3例。5例机械性溶血，其中1例持续5d无好转，经导管取出封堵器，其余4例均在术后3～14d恢复正常。1例术后出现股动脉假性动脉瘤，经加压包扎后消失。封堵器脱落1例，经导管取出，并成功行封堵治疗。封堵器移位1例，在原位置入另一封堵器。结论使用国产封堵器治疗室间隔缺损成功率高，并发症少，是一种安全有效的治疗方法。

Objective To evaluate the efficacy and adverse effects of transcatheter closure of perimembranous ventricular septal defect （pmVSD） with modified double-disk occluder device （MDVO）. Methods Clinical data including clinical examination, electrocardiography daily after the procedure for a week, chest-X-rays and TIE before discharge and at 3-5 days after the procedure were analyzed from 604 patients underwent percutaneous closure of a pmVSD with MDVO at our department between December 2001 and December 2008. Results Procedure was successful in 576 out of 604 patients （95.4%） and 583 VSD occluders were placed. Endocarditis, thromboembolism, or deaths were not observed after procedure. Conduction block occurred in 81 patients （56 RBBB, 14 LBBB） and transient nonparoxysmal ventricular tachycardia in 31 patients after the procedure. Complete heart block occurred in 11 patients, 9 of them recovered in 3 weeks, permanent pacemaker was implanted in 2 patients （one had transient Ⅲ°AVB before the procedure, the other underwent simultaneous closure of ventricular septal defect and atrial septal defect）. Trivial/small residual shunts were found in 69 patients（ 12. 0% ）. The residual shunts disappeared in 31 patients and remained unchanged in 38 patients （6. 6% ） 7 days after procedures. Aortic regurgitation developed in 5 patients （2 trivial/small, 3 small/moderate）, and tricuspid regurgitation was present in 35 patients （32 trivial/small, 3 moderate）. Five patients developed haemolysis （device retrieved via catheter in 1 patient due to persistent haemolysis, the other 4 patients recovered 3-14 days post procedure）.Pseudoaneurysm of femoral artery occurred in 1 patient, and disappeared by pressure dressing. Device was successfully replaced in 2 patients with either device embolization （ n = 1 ） or device misplacement （ n = 1 ） after device retrieval by catheter. Conclusion It is safe and effective to close congenital perimembranous ventricular septal defect with domestic-made occluder device.