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J Thorac Cardiovasc Surg 2005;130:1639-1644
© 2005 The American Association for Thoracic Surgery

Evolving Technology

A novel device for left atrial appendage exclusion

Keiji Kamohara, MD ^a , Kiyotaka Fukamachi, MD, PhD ^{a , _*} , Yoshio Ootaki, MD, PhD ^a , Masatoshi Akiyama, MD, PhD ^a , Firas Zahr, MD ^a , Michael W. Kopcak, Jr, BA ^a , Raymond Dessoffy, AA ^a , Zoran B. Popovi, MD ^b , Masao Daimon, MD ^b , Delos M. Cosgrove, MD ^c , A. Marc Gillinov, MD ^c

^a Biomedical Engineering
^b Lerner Research Institute; Cardiovascular Medicine
^c Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio

Received for publication May 18, 2005; revisions received August 11, 2005; accepted for publication August 15, 2005.

^_* Address for reprints: Kiyotaka Fukamachi, MD, PhD, Department of Biomedical Engineering/ND20, The Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195 (Email: fukamak{at}ccf.org).

OBJECTIVE: The left atrial appendage is a frequent source of thromboemboli in patients with atrial fibrillation. Exclusion or excision of the left atrial appendage may reduce the risk of stroke in patients with atrial fibrillation. We evaluated the ability of a novel device to exclude the left atrial appendage during early and intermediate follow-up periods in a canine model.

METHODS: Eight mongrel dogs (mean weight 29.1 ± 4.0 kg) were used in this study. The occlusion device, constructed from 2 stainless steel strips covered with a knit braided polyester fabric, was implanted at the base of the left atrial appendage through a left thoracotomy on a beating heart. Dogs were evaluated at 7 days (n = 2), 30 days (n = 2), and 90 days (n = 4) by epicardial echocardiography, left atrial angiography, histologic inspection, and gross pathology.

RESULTS: Device implantation was performed without complications in all animals. Complete exclusion of the left atrial appendage from the circulation was confirmed acutely and chronically by echocardiographic and angiographic evaluations. There was no device migration or damage to adjacent structures.

CONCLUSION: This novel device enables rapid, reliable, and safe exclusion of the left atrial appendage. The device provides a new therapeutic option for reducing the risk of stroke in patients with atrial fibrillation.

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