Gu X, Han Y M, Titus J L, Amin Z, Berry J M, Kong H, Rickers C, Urness M, Bass J L
AGA Medical Corporation, Golden Valley, Minneapolis, USA.
Catheter Cardiovasc Interv. 2000 Aug;50(4):502-9. doi: 10.1002/1522-726x(200008)50:4<502::aid-ccd29>3.0.co;2-8.
Transcatheter closure of a membranous ventricular septal defect (MVSD) is much more difficult than closure of other intracardiac defects because of the proximity to the aortic and tricuspid valves and their relatively large size in small children. In this report, transcatheter closure of naturally occurring membranous VSDs was attempted in 12 Yucatan minipigs. The prosthesis is constructed from fine Nitinol wires in the shape of two buttons and a connecting waist filled with polyester fiber. Two kinds of prosthesis were used in this study: concentric and eccentric left-sided retention disks. A 6 or 7 Fr delivery sheath was advanced across the membranous VSD over a wire from femoral vein. The prosthesis was inserted through the sheath by pushing the delivery cable to deploy a button into left ventricle and the second button was then deployed into right ventricle by withdrawing the sheath. Successful implantation of the device was achieved in all animals except one. Complete closure rate was 58.3% immediately after placement, 100% at 1 week, 90.9% at 1 month and 3 months, and 100% at 6 months. An associated aneurysm of the membranous septum increased significantly in size in two of three animals using the concentric device, and in none of the animals using the eccentric device. A trace to mild aortic regurgitation was present in two of the three animals using the concentric device, and only in one of the eight animals using the eccentric device. Five animals developed a trace to mild tricuspid regurgitation. Pathologic examination showed all devices to be covered by smooth neoendothelium at 3 months. This report presents the first experimental study where closure of membranous ventricular septal defects in a swine model was attempted by specially constructed devices. Procedural success and occlusion rates are very encouraging but overall results cannot equal surgery. Further experimentation is needed with devices that are redesigned according to the experience gained from this study.
经导管闭合膜周部室间隔缺损（MVSD）比闭合其他心内缺损困难得多，这是因为其靠近主动脉瓣和三尖瓣，且在小儿患者中尺寸相对较大。在本报告中，对12只尤卡坦小型猪尝试进行经导管闭合自然发生的膜周部室间隔缺损。该封堵器由细镍钛诺丝制成，呈两个纽扣形状以及一个填充聚酯纤维的连接腰部。本研究使用了两种封堵器：同心和偏心左侧固定盘。通过股静脉将一根导丝穿过膜周部室间隔缺损，然后推进一个6或7F的输送鞘管。通过推送输送电缆将封堵器经鞘管插入，将一个纽扣状部件部署到左心室，然后通过回撤鞘管将第二个纽扣状部件部署到右心室。除一只动物外，所有动物均成功植入该装置。放置后立即完全闭合率为58.3%，1周时为100%，1个月和3个月时为90.9%，6个月时为100%。在使用同心装置的三只动物中的两只以及使用偏心装置的动物中均未出现膜周部间隔相关动脉瘤大小显著增加的情况。使用同心装置的三只动物中的两只出现微量至轻度主动脉瓣反流，而使用偏心装置的八只动物中只有一只出现。五只动物出现微量至轻度三尖瓣反流。病理检查显示，3个月时所有装置均被光滑的新生内膜覆盖。本报告展示了首次在猪模型中尝试使用特制装置闭合膜周部室间隔缺损的实验研究。手术成功率和封堵率非常令人鼓舞，但总体结果仍无法与手术相媲美。需要根据本研究获得的经验对装置进行重新设计并进一步试验。
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