Xijing Cardiovascular Hospital, Fourth Military Medical University, Xi'an, China.
Eur Heart J. 2010 Sep;31(18):2238-45. doi: 10.1093/eurheartj/ehq240. Epub 2010 Aug 27.
The aim of this study was to evaluate the safety and efficacy of transcatheter closure for perimembranous ventricular septal defect (pmVSD) and its long-term results. The most common congenital heart condition is pmVSD. Transcatheter closure of pmVSD is a recently described technique with limited results for mid- to long-term follow-up.
Between June 2002 and June 2008, 848 patients with pmVSD were enrolled in our study and treated percutaneously with pmVSD occluders. All patients were followed up until December 2008, an average of 37 months. According to colour Doppler transthoracic echocardiography before the intervention and ventriculography, the average end-diastolic pmVSD size was 5.1 and 5.4 mm, respectively. Placement of the device was successful in 832 patients (98.1%) and the median device size was 8.6 mm. During follow-up, 103 adverse events (12.4%) were reported. Most adverse events were categorized as minor and there were nine major adverse events (8.7%), including two complete atrioventricular block requiring pacemaker implantation. Kaplan-Meier estimates showed >85% freedom from major or minor adverse events during a maximal follow-up of 79 months.
In experienced hands, transcatheter pmVSD closure can be performed safely and successfully with low morbidity and mortality. Long-term prognostic results are favourable, and the transcatheter approach provides a less-invasive alternative that may become the first choice in selected pmVSD patients. This trial is registered with ClinicalTrials.gov, number NCT00890799.
本研究旨在评估经导管膜周部室间隔缺损(pmVSD)封堵术的安全性和有效性及其长期结果。pmVSD 是最常见的先天性心脏病。经导管 pmVSD 封堵术是一种最近描述的技术,其中期至长期随访结果有限。
2002 年 6 月至 2008 年 6 月期间,共有 848 例 pmVSD 患者入组本研究并接受 pmVSD 封堵器经皮治疗。所有患者均随访至 2008 年 12 月,平均随访 37 个月。根据介入前和心室造影的彩色多普勒经胸超声心动图,平均舒张末期 pmVSD 大小分别为 5.1 和 5.4mm。832 例患者(98.1%)成功放置器械,器械中位数大小为 8.6mm。随访期间,报告了 103 例不良事件(12.4%)。大多数不良事件归类为轻微不良事件,有 9 例严重不良事件(8.7%),包括 2 例需要植入起搏器的完全性房室传导阻滞。Kaplan-Meier 估计在 79 个月的最大随访中,>85%的患者无重大或轻微不良事件。
在有经验的医生手中,经导管 pmVSD 封堵术可以安全、成功地进行,且发病率和死亡率较低。长期预后结果良好,经导管方法提供了一种微创替代方法,可能成为选定的 pmVSD 患者的首选方法。本试验在 ClinicalTrials.gov 注册,编号为 NCT00890799。