Double BioDisk: a new bioprosthetic device for transcatheter closure of atrial septal defects - a feasibility study in adult sheep.
Double BioDisk: a new bioprosthetic device for transcatheter closure of atrial septal defects - a feasibility study in adult sheep.
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DOI：
10.2478/v10019-012-0029-8
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发表时间：
2012-06
影响因子：
2.4
通讯作者：
Rösch J
中科院分区：
文献类型：
--
作者：
Pavcnik D;Tekulve K;Uchida BT;Luo ZH;Jeromel M;Van Alstine WG;Keller FS;Rösch J
评价一种新型双生物盘（DBD）治疗房间隔缺损（ASD）的长期疗效和安全性。采用经鼻中隔针（TS）和球囊扩张法对12只体重40.1 ~ 64 kg（平均55.2±7.1）的绵羊进行ASD治疗。在创建后和DBD植入前两周测量ASD直径。dbd由两个直径18 - 28mm的镍钛诺环组成，与小套管连接，并覆盖猪小肠粘膜下层（SIS）。它们通过10 Fr鞘植入。通过心血管造影和多普勒超声心动图（ICE）评估DBD的有效性。急性期2只，随访6周2只，随访3个月3只，随访6个月3只，随访12个月2只。TS穿刺在10只羊身上成功。在两只绵羊中，ASD是由现有的PFO扩张引起的。2周后ASD大小从9-13 mm（平均10.06±1.37 mm）到13-15 mm（平均14.1±0.73 mm）不等。在所有动物中，没有一个成功植入的dbd在释放或随访时自发栓塞。在随访期间，ICE显示dbd周围没有分流。6周、12周、24周和52周大鼠的宏观和组织学评估显示，dbd在房间隔内整合良好，分流器完全闭合。SIS表现出与宿主细胞的进行性重塑，包括DBD装置的内皮化。双生物盘封闭ASD对成年羊安全有效。
To evaluate the long-term effectiveness and safety of a new Double BioDisk (DBD) device for closure of atrial septal defect (ASD). ASD was created with transeptal needle (TS) followed by balloon dilatation in 12 sheep weighing 40.1 to 64 kg (mean 55.2 ± 7.1). The ASD diameters were measured after creation and two weeks later before DBD implantation. The DBDs consists of two nitinol rings 18 to 28 mm in diameter connected with small cannulas and covered with a porcine small intestinal submucosa (SIS). They were implanted via a 10 Fr sheath. DBD effectiveness was evaluated by angiocardiography and by intra-cardiac echogram (ICE) with Doppler studies. Two animals were acute, two were followed for 6 weeks, three for 3 months, three for 6 months and two for 12 months. TS punctures were successful in 10 sheep. In two sheep ASD was created by existing PFO dilation. The ASD size ranged from 13–15 mm (mean 14.1± 0.73 mm) after initial balloon dilation and from 9–13 mm (mean 10.06 ± 1.37 mm) after two weeks. In all animals none of the successfully implanted DBDs spontaneously embolized on release or on follow up. ICE demonstrated no shunting around the DBDs during follows ups. Macroscopic and histologic evaluation of the 6, 12, 24 and 52 weeks animals showed that DBDs were well incorporated in the atrial septum with complete shunt closure. The SIS showed progressive remodeling with the host cells, including endothelization of the DBD devices. ASD closure with the Double BioDisk is safe and effective in adult sheep.
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影响因子：
2.1
作者：
Majunke, Nicolas;Sievert, Horst
通讯作者：
Sievert, Horst
影响因子：
14
作者：
Badylak, Stephen F.
通讯作者：
Badylak, Stephen F.
影响因子：
2.3
作者：
Hoehn, Rene;Hesse, Carola;Peuster, Matthias
通讯作者：
Peuster, Matthias
影响因子：
2.3
作者：
Morgan, Gareth;Lee, Kyong-Jin;Benson, Lee
通讯作者：
Benson, Lee
影响因子：
2.4
作者：
Kranokpiraksa, Pawanrat;Pavcnik, Dusan;Roesch, Josef
通讯作者：
Roesch, Josef