Volume 139, Issue 5 , Pages 1269-1274, May 2010
Left atrial appendage clip occlusion: Early clinical results
Objective
Atrial fibrillation puts patients at significant risk for embolic stroke originating from the left atrial appendage. Few means are available for safe, effective, and durable left atrial appendage occlusion. A new clip device was evaluated with regard to safety and effectiveness for epicardial left atrial appendage occlusion.
Methods
Patients with atrial fibrillation undergoing elective cardiac surgery through a median sternotomy were enrolled for concomitant epicardial clip placement. Early postoperative and 3-month follow-up computed tomography studies were used to assess clip stability and left atrial appendage perfusion.
Results
From September 2007 to December 2008, 34 patients underwent successful clip placement. No device-related complications occurred. Operative mortality was 8.8% and not study or device related. Deployment was rapid, and left atrial appendage occlusion was confirmed by intraoperative transesophageal echocardiography in all patients. In addition to excellent clinical outcomes (no stroke/transient ischemic attack), serial computed tomography demonstrated stable clip location and appendage perfusion at 3 months in all patients.
Conclusion
Safe, effective, and durable left atrial appendage occlusion can easily be achieved with this new clip. Further trials are necessary to evaluate the role of the left atrial appendage occlusion in stroke prevention.
CTSNet classification: 18, 19, 24, 28
Abbreviations and Acronyms: AF, atrial fibrillation, CT, computed tomography, LAA, left atrial appendage, TEE, transesophageal echocardiography
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Disclosures: S.P.S. reports consulting fees and grant support from Atricure. This study was supported by a grant from Atricure, the manufacturer of the LAA clip. All ablation technology was purchased as part of standard clinical care. The authors had full control of the design of the study, methods used, outcomes parameters, analysis of data, and production of this article. This research was funded with an unrestricted research grant from Atricure Inc. H.A. and L.D. have been supported by the National Center of Competence in Research, Computer Aided and Image Guided Medical Interventions of the Swiss National Science Foundation. The trial is registered at www.ClinicalTrials.gov, Reference: NCT00567515.
PII: S0022-5223(09)01134-9
doi:10.1016/j.jtcvs.2009.06.033
© 2010 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
Volume 139, Issue 5 , Pages 1269-1274, May 2010
