Experimental atrial septal defect closure with a new, transcatheter, self-centering device

Gladwin S Das, Greg Voss, Gary Jarvis, Keith Wyche, Roland Gunther, Robert F Wilson

Research output: Contribution to journalArticlepeer-review

192 Scopus citations

Abstract

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±13 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.

Original languageEnglish (US)
Pages (from-to)1754-1764
Number of pages11
JournalCirculation
Volume88
Issue number4
DOIs
StatePublished - Oct 1993

Keywords

  • Atrial septal defect
  • Implants, artificial
  • Transcatheter closure

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