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英国使用戈尔间隔封堵器(GSO™)闭合儿童和成人房间隔缺损的多中心经验。

UK multicenter experience using the Gore septal occluder (GSO(TM) ) for atrial septal defect closure in children and adults.

作者信息

Smith Ben, Thomson John, Crossland David, Spence Mark S, Morgan Gareth J

机构信息

Yorkhill Hospital, Glasgow, United Kingdom.

出版信息

Catheter Cardiovasc Interv. 2014 Mar 1;83(4):581-6. doi: 10.1002/ccd.25216. Epub 2013 Nov 13.

DOI:10.1002/ccd.25216
PMID:24115686
Abstract

BACKGROUND

Percutaneous closure of atrial defects (ASD) has evolved as the treatment of choice for the majority of defects and patent oval foramens. The Gore Septal Occluder (GSO) is an innovative device consisting mostly of a folded thin GoreTex tube for use in the closure of septal defects.

METHODS

Reviewed is the multicenter UK experience of the first 22 ASD occlusions with the GSO(TM) device. All implantations were performed by consultant operators experienced in ASD device closure. The inclusion criterion was the presence of a hemodynamically significant secundum ASD with a diameter of <18 mm. Procedural data and acute and mid-term closure rates were retrospectively matched to a cohort of patients having defect closure using the Amplatzer Septal Occluder(TM) (ASO(TM) ).

RESULTS

Acute and 3-month follow-up closure rates for the GSO(TM) were 100% and 100% vs. 100% and 100% closure with the ASO(TM) implants. The difference in paired procedure times was not statistically significant (56 min: GSO(TM) ; 42 min: ASO(TM) device P = ns), nor was the paired difference in fluoroscopic screening times (12 min: GSO(TM) vs. 8.4 min: ASO(TM) , P = ns). One GSO device embolized immediately after deployment and was successfully retrieved at the same procedure. There were no other significant complications in either group.

CONCLUSIONS

The GSO(TM) implant can achieve comparable closure rates to the ASO(TM) in small to moderate atrial septal defects after 3 months. Longer fluoroscopy and procedure times are a drawback; however these should improve with familiarity with the implant and deployment system. The larger sheath size was not associated with increased complications in our cohort.

摘要

背景

经皮闭合房间隔缺损(ASD)已成为大多数缺损和卵圆孔未闭的首选治疗方法。戈尔间隔封堵器(GSO)是一种创新装置,主要由一根折叠的薄戈尔特斯管组成,用于闭合间隔缺损。

方法

回顾了英国多中心使用GSO(TM)装置进行的前22例ASD封堵的经验。所有植入手术均由有ASD装置闭合经验的顾问医生进行。纳入标准为存在直径<18 mm的血流动力学显著的继发孔型ASD。将手术数据以及急性和中期闭合率与一组使用Amplatzer间隔封堵器(ASO(TM))进行缺损闭合的患者进行回顾性匹配。

结果

GSO(TM)的急性和3个月随访闭合率均为100%,ASO(TM)植入物的闭合率也为100%和100%。配对手术时间的差异无统计学意义(GSO(TM)为56分钟;ASO(TM)装置为42分钟,P =无显著性差异),荧光透视筛查时间的配对差异也无统计学意义(GSO(TM)为12分钟,ASO(TM)为8.4分钟,P =无显著性差异)。一个GSO装置在释放后立即发生栓塞,并在同一手术中成功取出。两组均无其他严重并发症。

结论

3个月后,GSO(TM)植入物在中小房间隔缺损中的闭合率与ASO(TM)相当。荧光透视时间和手术时间较长是一个缺点;然而,随着对植入物和释放系统的熟悉,这些情况应该会有所改善。在我们的队列中,较大的鞘管尺寸与并发症增加无关。

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