Das G S, Voss G, Jarvis G, Wyche K, Gunther R, Wilson R F
Department of Medicine, University of Minnesota Medical School, Minneapolis 55455.
Circulation. 1993 Oct;88(4 Pt 1):1754-64. doi: 10.1161/01.cir.88.4.1754.
Despite two decades of research, a transcatheter atrial septal defect closure device is not available for clinical use. We have designed a new superelastic Nitinol-Dacron, double-disk, self-centering, atrial septal defect closure device and studied its efficacy in a canine model of atrial septal defects.
Atrial septal defects were created surgically in 20 adult dogs using either a 7.5-mm or 10-mm punch. Percutaneous transcatheter closures were attempted using a new device. The device sizes used were 20 mm in 6 dogs, 22 mm in 9, and 25 mm in 5 (22.1 +/- 1.9 mm, mean +/- SD). The stretched atrial septal defect diameter was 10.5 +/- 1.3 mm, and the device to stretched atrial septal defect diameter ratio was 2.1 +/- 0.3. Closures were successful in 19 studies and unsuccessful in 1. Angiography showed a left-to-right shunt in all 20 dogs before closure. Immediately after closure (n = 19), there were no shunts in 17 and trivial shunts in 2. Six dogs were followed for a period of 4.7 +/- 3.0 months (range, 2 to 8 months). The trivial shunt present in 1 animal immediately after closure had closed by the time of the repeat study. Spontaneous embolization of the device was not seen during follow-up. A solitary wire fracture was found 8 months after closure in 1 device. Light microscopy at 8 weeks in 3 dogs showed the devices to be covered by smooth endocardium, enmeshed in mature collagen tissue, with a minimal mononuclear cell infiltration. Retrievability was assessed by deliberately embolizing 4 devices in 2 dogs into the right atrium (n = 1) and pulmonary artery (n = 3). All devices were successfully retrieved with a snare.
This feasibility study demonstrates that this new self-centering atrial septal defect closure device has a number of design features that permit effective and safe closures in a canine model. These results support the investigation of this device in human clinical trials.
尽管经过了二十年的研究，但经导管房间隔缺损封堵装置仍未投入临床使用。我们设计了一种新型的超弹性镍钛诺-涤纶双盘自定心房间隔缺损封堵装置，并在犬房间隔缺损模型中研究了其疗效。
使用7.5毫米或10毫米打孔器对20只成年犬进行手术制造房间隔缺损。尝试使用新装置进行经皮经导管封堵。使用的装置尺寸在6只犬中为20毫米，9只中为22毫米，5只中为25毫米（平均±标准差为22.1±1.9毫米）。拉伸后的房间隔缺损直径为10.5±1.3毫米，装置与拉伸后房间隔缺损直径的比值为2.1±0.3。19项研究封堵成功，1项失败。血管造影显示所有20只犬在封堵前均有左向右分流。封堵后立即（n = 19），17只犬无分流，2只犬有微量分流。6只犬随访了4.7±3.0个月（范围为2至8个月）。封堵后立即出现微量分流的1只动物在重复研究时分流已消失。随访期间未发现装置自发栓塞。1个装置在封堵8个月后发现1根导线断裂。3只犬在8周时的光镜检查显示装置被光滑的心内膜覆盖，嵌入成熟的胶原组织中，单核细胞浸润极少。通过将2只犬中的4个装置故意栓塞到右心房（n = 1）和肺动脉（n = 3）来评估可回收性。所有装置均用圈套器成功回收。
这项可行性研究表明，这种新型自定心房间隔缺损封堵装置具有许多设计特点，可在犬模型中实现有效和安全的封堵。这些结果支持在人体临床试验中对该装置进行研究。
