Rao P S, Chandar J S, Sideris E B
Department of Pediatrics, St. Louis University School of Medicine/Cardinal Glennon Children's Hospital, Missouri 63104, USA.
Am J Cardiol. 1997 Oct 1;80(7):914-21. doi: 10.1016/s0002-9149(97)00545-6.
Feasibility, safety, and effectiveness of transcatheter occlusion of atrial septal defect (ASD) with the buttoned device has been demonstrated. Despite its effectiveness in occluding secundum ASD with left-to-right shunt and patent foramina ovalia, presumably responsible for paradoxic embolism, it has limitations in effectively occluding ASD with evident right-to-left shunts. Therefore, the device was modified so that the square-shaped occluder component of the device is on the right atrial side, the inverted buttoned device. This study determines the feasibility, safety, and effectiveness of inverted buttoned device occlusion of atrial defects with right-to-left shunts. During a 17-month period ending August 1996, 12 patients, aged 1.6 to 39.0 years, underwent occlusion of residual ASD after repair of pulmonary atresia/stenosis with intact ventricular septum (n = 5), modified or fenestrated Fontan for tricuspid or pulmonary atresia (n = 5), and double-inlet left ventricle (n = 2). The systemic arterial oxygen saturation increased (p <0.001) from 82 +/- 7% (range 72% to 90%) to 94 +/- 3% (range 88% to 98%). There was no change in heart rate or cardiac index measured by Fick. Right atrial pressure increased by 1 to 4 mm in 5 of 12 patients (42%). There was trivial (n = 5) or no (n = 7) residual shunt by color Doppler study. Six- to 18-month (median 12) follow-up in all 12 patients revealed stable oxygen saturations (92 +/- 3%) by pulse oximetry. Color Doppler studies revealed small (n = 1), trivial (n = 1), or no (n = 10) residual shunt at follow-up. Based on these data, it is concluded that transcatheter occlusion of ASD with right-to-left shunts with inverted buttoned device is feasible in relieving arterial hypoxemia. Further clinical trials in a larger number of patients and careful evaluation of follow-up results are indicated to examine its safety and longer term effectiveness.
纽扣式装置经导管封堵房间隔缺损（ASD）的可行性、安全性及有效性已得到证实。尽管其在封堵继发孔型ASD伴左向右分流及卵圆孔未闭（推测为反常栓塞的原因）方面有效，但在有效封堵伴有明显右向左分流的ASD方面存在局限性。因此，对该装置进行了改良，使装置的方形封堵器组件位于右心房侧，即倒置纽扣式装置。本研究确定了倒置纽扣式装置封堵伴有右向左分流的房缺的可行性、安全性及有效性。在截至1996年8月的17个月期间，12例年龄在1.6至39.0岁的患者，接受了在室间隔完整的肺动脉闭锁/狭窄修复术后残余ASD的封堵（n = 5）、三尖瓣或肺动脉闭锁的改良或开窗Fontan手术（n = 5）以及双入口左心室手术（n = 2）。体循环动脉血氧饱和度从82±7%（范围72%至90%）升至94±3%（范围88%至98%）（p <0.001）。通过Fick法测得的心率或心指数无变化。12例患者中有5例（42%）右心房压力升高1至4 mmHg。彩色多普勒检查显示微量残余分流（n = 5）或无残余分流（n = 7）。对所有12例患者进行6至18个月（中位数12个月）的随访，经脉搏血氧饱和度测定显示血氧饱和度稳定（92±3%）。彩色多普勒检查显示随访时有少量残余分流（n = 1）、微量残余分流（n = 1）或无残余分流（n = 10）。基于这些数据，得出结论：采用倒置纽扣式装置经导管封堵伴有右向左分流的ASD在缓解动脉低氧血症方面是可行的。需要在更多患者中进行进一步的临床试验并仔细评估随访结果，以检验其安全性和长期有效性。
