Forty patients were catheterized for closure of atrial septal defects with the Rashkind patent ductus arteriosus umbrella device, a modified Rashkind umbrella device, and the newly designed Lock Clamshell Occluder. Patients weighed 8 kg or more (a requirement for transvenous access with the 11F delivery sheath) and had defects suitable for closure based on two-dimensional echocardiography. The new device was at least 1.6 times the diameter of the atrial septal defect as determined by balloon sizing at catheterization. Patients were followed up by telephone, clinical examination, and echocardiography at 6 months. We attempted closure in 34 patients, with atrial septal defects ranging in diameter from 3 to 22 mm; device sizes ranged from 17 to 33 mm. Initial device position immediately after release was correct in all patients. A cerebral embolus occurred in one elderly patient before device placement--the patient died 1 week later. Two instances of early device embolization occurred, and devices were retrieved by catheter without complication. Follow-up of 31 patients discharged with devices in place, for a total of 31 patient-years, has yielded no umbrella-related complications. Adequate imaging studies in 19 patients 6.5 months after device placement revealed no atrial shunt in 12; residual flow through separate, previously unrecognized atrial septal defects occurred in two; and small residual leaks (less than 3 mm) around devices were present in five patients. This initial success indicates that double-umbrella closure of atrial septal defects will aid in the treatment of intracardiac defects.

译文

用Rashkind动脉导管未闭伞装置,改良的Rashkind伞装置和新设计的锁翻盖封堵器对40例患者进行了房间隔缺损的导管插入术。患者体重8千克或更多 (需要通过11F递送鞘的静脉通路),并且具有适合基于二维超声心动图闭合的缺陷。根据导管插入时的球囊大小确定,新装置的直径至少是房间隔缺损直径的1.6倍。6个月时,对患者进行电话、临床检查和超声心动图随访。我们尝试对34例房间隔缺损的患者进行封堵,其直径范围为3至22毫米; 设备尺寸范围为17至33毫米。在所有患者中,释放后立即的初始设备位置正确。一名老年患者在设备放置前发生了脑栓塞-该患者在1周后死亡。发生了两次早期器械栓塞,并且通过导管取回了器械,没有并发症。对31例使用设备出院的患者进行了随访,共31个患者年,没有产生与伞相关的并发症。设备放置后6.5个月对19名患者进行了充分的影像学研究,发现12名患者没有心房分流; 两名患者发生了通过单独的,以前未识别的房间隔缺损的残留血流; 五名患者存在设备周围的小残留泄漏 (小于3毫米)。最初的成功表明,房间隔缺损的双伞闭合将有助于治疗心内缺损。

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