Atrial septal defect occlusion with the buttoned device (a multi-institutional U.S. trial).
Atrial septal defect occlusion with the buttoned device (a multi-institutional U.S. trial).
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DOI：
10.1016/0002-9149(94)90235-6
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发表时间：
1994-02
期刊：
影响因子：
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通讯作者：
T. Lloyd;P. S. Rao;R. Beekman;Alan M. Mendelsohn;E. Sideris
中科院分区：
文献类型：
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作者：
T. Lloyd;P. S. Rao;R. Beekman;Alan M. Mendelsohn;E. Sideris
对经导管应用带扣式封堵器治疗继发性房间隔缺损开口部进行了临床研究。在57例年龄为1至62岁（中位数5岁）的患者中尝试了闭塞。7例患者在1次或多次尝试失败后放弃手术，50例患者释放器械。4例患者因器械位置不稳定而需要紧急手术回收：3件器械"未扣"，反封堵器移位至肺动脉或下腔静脉，1件完整器械栓塞至主肺动脉。所有患者病情稳定，手术成功。因此，46名患者成功植入器械，Qp Qs从1.8 ± 0.6立即降低至1.1 ± 0.2（平均值± SD，p <0.0001）。在最近的随访（1 - 20个月）中，46例患者中有45例（98%）没有分流或轻微的残余分流。残余分流的发生率从闭塞手术后1个月的65%下降到12个月的19%（p <0.0001）。并发症包括第四件器械的纽扣解开、2例患者的一过性三尖瓣返流和2例患者的一过性二尖瓣返流。在一名46岁患者中观察到无症状性房扑发作，可能与器械植入有关，但未复发。在350个患者月的随访中，没有心内膜炎或血栓栓塞病例。在尝试植入的57例患者中，有45例（79%）使用带纽扣器械有效闭合了房间隔缺损，在成功完成器械植入的46例患者中，有45例（98%）使用带纽扣器械有效闭合了房间隔缺损。解开纽扣仍然是手术的主要并发症;增加术者经验和对器械的设计修改可能会降低未来该问题的发生频率。
A clinical trial was conducted of the buttoned device for transcatheter closure of ostium secundum atrial septal defect. Occlusion was attempted in 57 patients aged 1 to 62 years (median 5). The procedure was abandoned in 7 patients after 1 or more unsuccessful attempts, and devices were released in 50 patients. Urgent surgical retrieval was necessary in 4 patients because of unstable device position: 3 devices “unbuttoned,” with migration of the counteroccluder to the pulmonary artery or inferior vena cava, and 1 intact device embolized to the main pulmonary artery. All patients remained stable and underwent successful operation. Successful device implantation was therefore achieved in 46 patients, with immediate reduction in Qp Qs from 1.8±0.6 to 1.1±0.2 (mean±SD, p< 0.0001). At most recent follow-up (1 to 20 months), 45 of 46 patients (98%) have no shunt or a trivial residual shunt. The prevalence of residual shunts declined from 65% at 1 month to 19% at 12 months after the occlusion procedure (p< 0.0001). Complications included unbuttoning of a fourth device, transient tricuspid regurgitation in 2 patients, and transient mitral regurgitation in 2 patients. An episode of asymptomatic atrial flutter was noted in a 46-year-old patient which may have been related to device implantation, but which has not recurred. There have been no cases of endocarditis or thromboembolism in 350 patient-months of follow-up. The buttoned device provided effective closure of the atrial septal defect in 45 of 57 patients (79%) in whom implantation was attempted and in 45 of 46 patients (98%) in whom device implantation was successfully accomplished. Unbuttoning remains the major complication of the procedure; increased operator experience and design modifications to the device may reduce the frequency of this problem in the future.