Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.
Catheter Cardiovasc Interv. 2012 Mar 1;79(4):666-74. doi: 10.1002/ccd.23344. Epub 2011 Dec 8.
The objective of this study was to evaluate the safety and efficacy of transcatheter closure of perimembranous ventricular septal defect (pmVSD) and intracristal VSD (icVSD) using the Shanghai Shape Memory Alloy (SHSMA) pmVSD occluder.
There is still limited experience with transcatheter closure of pmVSD and icVSD.
Between January 2003 and September 2010, 348 patients with pmVSD and 47 patients with icVSD underwent transcatheter closure using a SHSMA pmVSD occluder.
The total successful closure rate in pmVSD and icVSD subjects was 97.4 and 78.7%, respectively. During the perioperative period, no death, major bleeding or hemolysis occurred in both groups. In pmVSD group, one case of occluder dislodgement, one case of pericardial tamponade, and two cases of thromboembolism occurred. None in icVSD group had these complications. During a median of 3.2 years of follow-up, there was no evidence of significant residual shunt and device-related valve regurgitation. None in icVSD group and 10 patients (2.9%) in pmVSD group had a persistent arrhythmia. Overall, only one patient (0.3%) with pmVSD acquired complete atrioventricular block requiring implantation of a permanent pacemaker. The rim from the tricuspid valve to the defect < 4 mm was the only predictor of arrhythmic complications after procedure (OR = 4.24; P = 0.021).
Transcatheter closure of pmVSD in selected patients using the SHSMA occluder is effective and safe. Transcatheter closure of icVSD in experienced hands using this device is also feasible and safe.
本研究旨在评估使用上海形状记忆合金(SHSMA)膜周部室间隔缺损(pmVSD)封堵器经导管闭合膜周部室间隔缺损(pmVSD)和嵴内型室间隔缺损(icVSD)的安全性和有效性。
经导管闭合 pmVSD 和 icVSD 的经验仍然有限。
2003 年 1 月至 2010 年 9 月,348 例 pmVSD 患者和 47 例 icVSD 患者接受了 SHSMA pmVSD 封堵器经导管闭合治疗。
pmVSD 和 icVSD 患者的总闭合成功率分别为 97.4%和 78.7%。在围手术期,两组均未发生死亡、大出血或溶血。pmVSD 组中,1 例封堵器移位,1 例心包填塞,2 例血栓栓塞。icVSD 组均无这些并发症。在中位随访 3.2 年期间,均无明显残余分流和器械相关瓣膜反流的证据。icVSD 组和 pmVSD 组各有 10 例(2.9%)患者持续存在心律失常。pmVSD 组中有 1 例(0.3%)患者出现完全性房室传导阻滞,需要植入永久性起搏器。三尖瓣瓣环至缺损<4mm 是术后发生心律失常并发症的唯一预测因素(OR=4.24;P=0.021)。
在选择的患者中使用 SHSMA 封堵器经导管闭合 pmVSD 是有效和安全的。在有经验的医生手中,使用该器械经导管闭合 icVSD 也是可行和安全的。