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使用市售活检钳取出大型Occlutech Figula Flex房间隔缺损封堵器:概念验证

Retrieval of large Occlutech Figula Flex septal defect occluders using a commercially available bioptome: proof of concept.

作者信息

Georgiev Stanimir, Tanase Daniel, Genz Thomas, Ewert Peter, Naumann Susanne, Pozza Robert Dalla, Eicken Andreas

机构信息

1Department of Pediatric Cardiology and Congenital Heart Disease,German Heart Center Munich at the TU Munich,Munich,Germany.

2Experimental and Molecular Pediatric Cardiology,German Heart Center Munich at the TU Munich,Munich,Germany.

出版信息

Cardiol Young. 2018 Jul;28(7):955-960. doi: 10.1017/S1047951118000586. Epub 2018 May 21.

DOI:10.1017/S1047951118000586
PMID:29779498
Abstract

OBJECTIVES

This study aimed to develop a method for retrieval of the new meshed nitinol atrial septal defect occluders - Ceraflex and Occlutech.

BACKGROUND

The newly developed atrial septal defect occluders have potential benefits considering implantation, but concerns regarding their removal in case of embolisation have been raised.

METHODS

Over 21 years, 1449 patients underwent interventional atrial septal defect occlusion in our institution. We reviewed the cases of embolisation of the device, developed a strategy for device removal, and tested it on the benchside and in animal tests.

RESULTS

In 11 patients (0.8%), the intended atrial septal defect occlusion was complicated by an embolisation of the device. In contrast to the Amplatzer septal occluders, retrieval of Occlutech devices larger than 16 mm with snare techniques was impossible. In benchside tests, this was confirmed and a new method for removal of large meshed devices was developed. This involved the commercially available Maslanka® biopsy forceps. The feasibility of this technique in vivo was tested in a pig model. During animal tests, using the Maslanka biopsy forceps it was possible to interventionally retrieve embolised Ceraflex and Occlutech devices of different sizes - 10, 16, 30, and 40 mm - into a 12-F sheath.

CONCLUSION

It was impossible to retrieve Occlutech and Ceraflex devices larger than 16 mm into a large sheath in vivo and during benchside tests. However, this was feasible on the bench and in vivo using the Maslanka biopsy forceps even with the largest available devices.

摘要

目的

本研究旨在开发一种用于取出新型网状镍钛合金房间隔缺损封堵器——Ceraflex和Occlutech的方法。

背景

新开发的房间隔缺损封堵器在植入方面具有潜在优势,但对于栓塞情况下如何取出这些封堵器引发了担忧。

方法

在21年的时间里,我们机构有1449例患者接受了房间隔缺损介入封堵术。我们回顾了封堵器栓塞的病例,制定了取出封堵器的策略,并在实验台和动物实验中进行了测试。

结果

11例患者(0.8%)的房间隔缺损封堵术中出现了封堵器栓塞并发症。与Amplatzer房间隔封堵器不同,使用圈套技术无法取出直径大于16mm的Occlutech封堵器。在实验台测试中,这一点得到了证实,并开发了一种取出大型网状封堵器的新方法。该方法使用市售的Maslanka®活检钳。在猪模型中测试了该技术在体内的可行性。在动物实验中,使用Maslanka活检钳能够将不同尺寸(10mm、16mm、30mm和40mm)的栓塞Ceraflex和Occlutech封堵器经介入方式取出并放入12F鞘管中。

结论

在体内和实验台测试中,无法将直径大于16mm的Occlutech和Ceraflex封堵器放入大鞘管中。然而,即使是最大尺寸的可用封堵器,在实验台和体内使用Maslanka活检钳也能实现取出。

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