TY - JOUR
T1 - Evaluation of a novel device for left atrial appendage exclusion
T2 - The second-generation atrial exclusion device
AU - Kamohara, Keiji
AU - Fukamachi, Kiyotaka
AU - Ootaki, Yoshio
AU - Akiyama, Masatoshi
AU - Cingoz, Faruk
AU - Ootaki, Chiyo
AU - Vince, D. Geoffrey
AU - Popović, Zoran B.
AU - Kopcak, Michael W.
AU - Dessoffy, Raymond
AU - Liu, Jenny
AU - Gillinov, A. Marc
N1 - Funding Information:
This study was supported financially by the Atrial Fibrillation Innovation Center, an Ohio Wright Center of Innovation, and by AtriCure, Inc. A. Marc Gillinov reports consulting fees from Atricure. Faruk Cingoz and Kiyotaka Fukamachi report grant support from Atricure. The Cleveland Clinic holds equity interests in Atricure.
PY - 2006/8
Y1 - 2006/8
N2 - Background: The left atrial appendage is a frequent source of thromboemboli in patients with atrial fibrillation. Exclusion of the left atrial appendage may reduce the risk of stroke in patients with atrial fibrillation. The atrial exclusion device, previously developed to perform left atrial appendage exclusion on a beating heart, was modified to accommodate different anatomic patterns of the human left atrial appendage and to ensure uniform pressure and occlusion. The purpose of this study was to evaluate this second-generation atrial exclusion device during a midterm period in a canine model. Methods: Ten mongrel dogs (mean weight 28.9 ± 4.6 kg) were used in this study. The atrial exclusion device, constructed from two parallel and rigid titanium tubes and two nitinol springs with a knit-braided polyester fabric, was implanted at the base of the left atrial appendage through a left thoracotomy on a beating heart using a specially designed delivery tool. Dogs were evaluated at 30 days (n = 4) and 90 days (n = 6) by epicardial echocardiography, left atrial and coronary angiography, gross pathology, and histologic inspection. Results: Device implantation was performed without complications in all dogs. Complete left atrial appendage exclusion without device migration or hemodynamic instability was confirmed, and there was no damage to the left circumflex artery or pulmonary artery. Macroscopic and microscopic assessments revealed favorable biocompatibility during midterm follow-up. Conclusion: The atrial exclusion device enabled rapid, reliable, and safe exclusion of the left atrial appendage. Clinical application may provide a new therapeutic option for reducing the risk of stroke in patients with atrial fibrillation.
AB - Background: The left atrial appendage is a frequent source of thromboemboli in patients with atrial fibrillation. Exclusion of the left atrial appendage may reduce the risk of stroke in patients with atrial fibrillation. The atrial exclusion device, previously developed to perform left atrial appendage exclusion on a beating heart, was modified to accommodate different anatomic patterns of the human left atrial appendage and to ensure uniform pressure and occlusion. The purpose of this study was to evaluate this second-generation atrial exclusion device during a midterm period in a canine model. Methods: Ten mongrel dogs (mean weight 28.9 ± 4.6 kg) were used in this study. The atrial exclusion device, constructed from two parallel and rigid titanium tubes and two nitinol springs with a knit-braided polyester fabric, was implanted at the base of the left atrial appendage through a left thoracotomy on a beating heart using a specially designed delivery tool. Dogs were evaluated at 30 days (n = 4) and 90 days (n = 6) by epicardial echocardiography, left atrial and coronary angiography, gross pathology, and histologic inspection. Results: Device implantation was performed without complications in all dogs. Complete left atrial appendage exclusion without device migration or hemodynamic instability was confirmed, and there was no damage to the left circumflex artery or pulmonary artery. Macroscopic and microscopic assessments revealed favorable biocompatibility during midterm follow-up. Conclusion: The atrial exclusion device enabled rapid, reliable, and safe exclusion of the left atrial appendage. Clinical application may provide a new therapeutic option for reducing the risk of stroke in patients with atrial fibrillation.
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U2 - 10.1016/j.jtcvs.2006.04.021
DO - 10.1016/j.jtcvs.2006.04.021
M3 - Article
C2 - 16872960
AN - SCOPUS:33746209045
SN - 0022-5223
VL - 132
SP - 340
EP - 346
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 2
ER -