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J Thorac Cardiovasc Surg 2008;136:1019-1027
© 2008 The American Association for Thoracic Surgery

Evolving Technology

A novel device for left atrial appendage exclusion: The third-generation atrial exclusion device

Hideyuki Fumoto, MD^a, A. Marc Gillinov, MD^b, Yoshio Ootaki, MD, PhD^a, Masatoshi Akiyama, MD, PhD^a, Diyar Saeed, MD^a, Tetsuya Horai, MD^a, Chiyo Ootaki, MD^a, D. Geoffrey Vince, PhD^a, Zoran B. Popovi, MD^c, Raymond Dessoffy, AA^a, Alex Massiello, MEBME^a, Jacquelyn Catanese, MA^a, Kiyotaka Fukamachi, MD, PhD^a,_*

^a Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio
^b Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio
^c Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio

Received for publication March 18, 2008; revisions received May 6, 2008; accepted for publication June 1, 2008.

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

Objective: Occlusion of the left atrial appendage is proposed to reduce the risk of stroke in patients with atrial fibrillation. The third-generation atrial exclusion device, modified to provide uniform distribution of pressure at appendage exclusion, was assessed for safety and effectiveness in a canine model and compared with a surgical stapler.

Methods: The atrial exclusion device consists of 2 parallel, straight, rigid titanium tubes and 2 nitinol springs with a knit-braided polyester fabric. Fourteen mongrel dogs were implanted with the device at the base of the left atrial appendage via a median sternotomy. In each dog, the right atrial appendage was stapled with a commercial apparatus for comparison. The animals were evaluated at 7 days (n = 3), 30 days (n = 5), and 90 days (n = 6) after implantation by epicardial echocardiography, left atrial and coronary angiography, gross pathology, and histology.

Results: Left atrial appendage exclusion was complete and achieved without hemodynamic instability, and coronary angiography revealed that the left circumflex artery was patent in all cases. A new endothelial tissue layer developed on the occluded orifice of the left atrium 90 days after implantation. This endothelial layer was not evident on the stapled right atrial appendage.

Conclusion: In dogs, the third-generation atrial exclusion device achieved easy, reliable, and safe exclusion of the left atrial appendage with favorable histologic results. Clinical application could provide a new therapeutic option for reducing the risk of stroke in patients with atrial fibrillation.