Holzer Ralf, de Giovanni Jo, Walsh Kevin P, Tometzki Andrew, Goh Th, Hakim Fakhri, Zabal Carlos, de Lezo Jose Suarez, Cao Qi-Ling, Hijazi Ziyad M
Section of Cardiology, Department of Pediatrics, University of Chicago Comer Children's Hospital, Pritzker School of Medicine, Chicago, Illinois, USA.
Catheter Cardiovasc Interv. 2006 Oct;68(4):620-8. doi: 10.1002/ccd.20659.
To report the immediate and midterm results of transcatheter closure of perimembranous ventricular septal defect (PmVSD) using the Amplatzer membranous VSD occluder (AMVSD).
Between April 2002 and August 2004, 100 patients underwent an attempt of percutaneous device closure of PmVSD using the AMVSD in 24 international centers. The median age was 9.0 years (0.7-58 years) and the median weight was 27.5 kg (7-121 kg).
A device was successfully deployed in 93/100 (93%) patients. Reasons for procedural failure were an increased gradient across the left ventricle outflow tract in one patient, aortic regurgitation in 2 patients, and inability to securely position the device in 4 patients. The median VSD size by TEE was 7.0 mm (1.5-13 mm), median device size 10 mm (4-16 mm) and median fluoroscopy time 22.1 min (8.9-96.0 min). Weight below 10 kg (P = 0.0392), inlet extension of the VSD (P = 0.0139) and aortic cusp prolapse into the VSD (P = 0.0084) were significantly associated with a lower procedural success. Patients have been followed up for a median of 182 days (1-763 days). There were no procedure-related deaths. Complications were encountered in 29/100 (29%) patients, including rhythm or conduction anomalies in 13 patients (two with complete heart block requiring permanent pacemaker implantation), new or increased aortic (9 patients) or tricuspid (9 patients) regurgitation, most of which were classified as trivial or mild. Patients with a weight below 10 kg had a significantly higher incidence of adverse events than patients with a weight above 10 kg (58.3% versus 25.0%, P = 0.0285). Immediately after device release complete closure of the defect was present in 54/93 (58.1%) patients, increasing to 46/55 (83.6%) patients at 6-months follow-up (P = 0.0012). Left ventricle end-diastolic diameter decreased from a median of 44 mm prior to device closure to a median of 39 mm at 6-months postprocedure (P = 0.0015).
Closure of PmVSDs using the AMVSD occluder is safe and effective. However, longer follow-up period is warranted prior to the wide spread use of this device.
报告使用Amplatzer膜周部室间隔缺损封堵器（AMVSD）经导管封堵膜周部室间隔缺损（PmVSD）的近期及中期结果。
2002年4月至2004年8月期间，24个国际中心的100例患者尝试使用AMVSD经皮封堵PmVSD。年龄中位数为9.0岁（0.7 - 58岁），体重中位数为27.5 kg（7 - 121 kg）。
93/100（93%）例患者成功植入封堵器。手术失败的原因包括：1例患者左心室流出道压差增加，2例患者出现主动脉瓣反流，4例患者无法牢固放置封堵器。经食管超声心动图（TEE）测得的室间隔缺损（VSD）大小中位数为7.0 mm（1.5 - 13 mm），封堵器大小中位数为10 mm（4 - 16 mm），透视时间中位数为22.1分钟（8.9 - 96.0分钟）。体重低于10 kg（P = 0.0392）、VSD入口延伸（P = 0.0139）和主动脉瓣叶脱垂入VSD（P = 0.0084）与手术成功率较低显著相关。患者随访时间中位数为182天（1 - 763天）。无手术相关死亡。100/29（29%）例患者出现并发症，包括13例患者出现节律或传导异常（2例完全性心脏传导阻滞需植入永久性起搏器），9例患者出现新的或加重的主动脉瓣反流，9例患者出现新的或加重的三尖瓣反流，大多数为轻度或微量反流。体重低于10 kg的患者不良事件发生率显著高于体重高于10 kg的患者（58.3%对25.0%，P = 0.0285）。封堵器释放后即刻，54/93（58.1%）例患者缺损完全关闭，随访6个月时增至46/55（83.6%）例患者（P = 0.0012）。左心室舒张末期内径从封堵术前的中位数44 mm降至术后6个月的中位数39 mm（P = 0.0015）。
使用AMVSD封堵器封堵PmVSD安全有效。然而，在广泛应用该装置之前，需要更长时间的随访。
