Circulation, Vol 88, 1754-1764, Copyright © 1993 by American Heart Association
GS Das, G Voss, G Jarvis, K Wyche, R Gunther and RF Wilson
BACKGROUND. 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. METHODS AND RESULTS. 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. CONCLUSIONS. 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.
ARTICLES
Experimental atrial septal defect closure with a new, transcatheter, self-centering device
Department of Medicine, University of Minnesota Medical School, Minneapolis 55455.
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|
|
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|
|
|
|
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