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Biological response to Bard Clamshell Septal Occluders in the canine heart.

BACKGROUND
The Clamshell Septal Occluder has been used to close various congenital heart defects. The purpose of this study was to evaluate the long-term biological response to this device after placement in the canine heart. Previous in vivo studies with device placement were limited to 60 days.


METHODS AND RESULTS
An atrial septal defect was created in dogs by blade septostomy followed by balloon dilation. Both old and new (redesigned) devices were placed. Angiographic follow-up was performed at 1, 3, and 6 months and 1 and 2 years after device placement with groups of dogs euthanitized at the same intervals. Gross and microscopic assessment was done on the explanted devices. The implants were covered at least 50% by neointima at 1 month and covered completely by 3 months. There was no thrombus formation. Areas of focal hemorrhage were evident at 1 month and were not present at 3 months. The fibrous capsule that covered the device became more densely organized and neovascularized by 2 years. A focal foreign body reaction at the device-tissue interface persisted for 2 years. There were no arm fractures with either the old or new devices in these dogs.


CONCLUSIONS
The Bard Clamshell Septal Occluder is well tolerated in the canine heart for at least 2 years and elicits a normal healing process.