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 SS  Vol.3 No.1 , January 2012
Left Atrial Appendage Occlusion Device: Evaluation of Surgical Implant Success and in Vivo Corrosion Performance
Abstract: Objective: The purpose of this study was to compare the in vivo corrosion resistance of the implanted titanium, nitinol annular occlusion device to a control device, i.e. an implantable device containing nitinol, approved by the FDA and currently on the market. Methods: The annular occlusion device is a self-closing, implantable clip. Three canines underwent placement of devices on the left and right atrial appendages. Two Vnus U-clips were secured to either atrium. On post-operative day 95, animals underwent en-bloc cardiac resection via the previous left thoracotomy incision. The annular occlusion device and U-clips were dissected free from the atria. The polyester fabric and tissue ingrowth were removed from the devices and were sent for corrosion analysis. Results: Gross examination of resected hearts of two canines revealed no abnormalities. The compressed endocardial surfaces were completely fused and the appendages fully necrosed. All devices were located and harvested. The annular occlusion device clips and Medtronic Vnus U-clips were evaluated using scanning electron microscopy. Both low and high magnification examination of the nitinol springs and the site of insertion of the nitinol springs into the titanium tubes in the annular occlusion device showed no evidence of localized corrosion. In no case was any evidence of general or localized corrosion found in the form of metallic oxidation. Conclusion: The annular occlusion device provides safe and reliable exclusion of the left atrial ap-pendage without evidence of general or localized corrosion over the 95-day exposure period in canines and may therefore provide a reasonable therapeutic option for stroke risk reduction in patients with atrial fibrillation.
Cite this paper: J. Snyder, A. Engel, K. White, N. Budiansky and J. Smith, "Left Atrial Appendage Occlusion Device: Evaluation of Surgical Implant Success and in Vivo Corrosion Performance," Surgical Science, Vol. 3 No. 1, 2012, pp. 28-33. doi: 10.4236/ss.2012.31005.
References

[1]   P. A. Wolf, R. D. Abbott and W. B. Kannel, “Atrial Fibrillation as an Independent Risk Factor for Stroke: The Framingham Study,” Stroke, Vol. 22, No. 8, 1991, pp. 983-988. doi:10.1161/01.STR.22.8.983

[2]   J. L. Blackshear and J. A. Odell, “Appendage Obliteration to Reduce Stroke in Cardiac Surgical Patients with Atrial Fibrillation,” Annals of Thoracic Surgery, Vol. 61, No. 2, 1996, pp. 755-759. doi:10.1016/0003-4975(95)00887-X

[3]   N. M. Al-Saady, O. A. Obel and A. J. Camm, “Left Atrial Appendage: Structure, Function, and Role in Thromboembolism,” Heart, Vol. 82, No. 5, 1999, pp. 547-554.

[4]   A. M. Lee, S. G. Melby and R. J. Damiano Jr., “The Surgical Treatment of Atrial Fibrillation,” Surgery Clinics of North America, Vol. 89, No. 4, 2009, pp. 1001-1020. doi:10.1016/j.suc.2009.06.001

[5]   V. Fuster, L. E. Rydén, D. S. Cannom, H. J. Crijns, A. B. Curtis, K. A. Ellenbogen, et al., “ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation-Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Pactice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients with Atrial Fibrillation) Developed in Collaboration w

[6]   T. Nakai, M. D. Lesh, E. P. Gerstenfeld, R. Virmani, R. Jones and R. J. Lee, “Percutaneous Left Atrial Appendage Occlusion (PLAATO) for Preventing Cardiuembolism: First Experience in a Canine Model,” Circulation, Vol. 105, No. 18, 2002, pp. 2217-2222. doi:10.1161/01.CIR.0000015605.30810.51

[7]   I. R. Hanna, P. Kolm, R. Martin, M. Reisman, W. Gray and P. C. Block, “Left Atrial Structure and Function after Percutaneous Left Atrial Appendage Transcatheter Occlusion (PLAATO): Six-Month Echocardiographic Follow-Up,” Journal of the American College of Cardiology, Vol. 43, No. 10, 2004, pp. 1868-1872. doi:10.1016/j.jacc.2003.12.050

[8]   H. Sievert, M. D. Lesh, T. Trepels, H. Omran, A. Bar- torelli, P. D. Bella, et al., “Percutaneous Left Atrial Appendage Transcatheter Occlusion to Prevent Stroke in High-Risk Patients with Atrial Fibrillation: Early Clinical Experience,” Circulation, Vol. 105, 2002, pp. 1868-1872. doi:10.1161/01.CIR.0000015698.54752.6D

[9]   B. Meier, I. Palacios, S. Windecker, M. Rotter, Q. L. Cao, D. Keane, et al., “Transcatheter Left Atrial Appendage Occlusion with Amplatzer Devices to Obviate Anticoagulation in Patients with Atrial Fibrillation,” Catheterization and Cardiovascular, Vol. 60, No. 3, 2003, pp. 417-422. doi:10.1002/ccd.10660

[10]   J. A. Odell, J. L. Blackshear, E. Davies, W. J. Byrne, C. F. Kollmorgen, W. D. Edward, et al., “Thoracoscopic Obliteration of the Left Atrial Appendage: Potential for Stroke Reduction?” Annals of Thoracic Surgery, Vol. 61, No. 2, 1996, pp. 565-569. doi:10.1016/0003-4975(95)00885-3

[11]   D. R. Holmes, V. Y. Reddy, Z. G. Turi, S. K. Doshi, H. Sievert, M. Buchbinder, C. M. Mullin and P. Sick, PROJECT AF Investigators, “Percutaneous Closure of the Left Atrial Appendage versus Warfarin Therapy for Prevention of Stroke in Patients with Atrial Fibrillation: And Randomised Non-Inferiority Trial,” Lancet, Vol. 374, No. 9689, 2009, pp. 534-542. doi:10.1016/S0140-6736(09)61343-X

[12]   K. Kamohara, K. Fukamachi, Y. Ootaki, M. Akiyama, F. Zahr, M. W. Kopcak Jr., et al., “A Novel Device for Left Atrial Appendage Exclusion,” Journal of Cardiovascular Surgery, Vol. 130, No. 6, 2005, pp. 1639-1644. doi:10.1016/j.jtcvs.2005.08.019

[13]   K. Kamohara, K. Fukamachi, Y. Ootaki, M. Akiyama, F. Cingoz, C. Ootaki, et al., “Evaluation of a Novel Device for Left Atrial Appendage Exclusion: The Second-Generation Atrial Exclusion Device,” Journal of Cardiovascular Surgery, Vol. 132, No. 2, 2006, pp. 340-346. doi:10.1016/j.jtcvs.2006.04.021

[14]   S. P. Salzberg, A. Plass, M. Y. Emmert, L. Desbiolles, H. Alkadhi, J. Grünenfelder and M. Genomi, “Left Atrial Appendage Clip Occlusion: Early Clinical Results,” Journal of Cardiovascular Surgery, Vol. 139, No. 5, 2010, pp. 1269-1274. doi:10.1016/j.jtcvs.2009.06.033

[15]   H. Fumoto, A. M. Gillinov, Y. Ootaki, M. Akiyama, D. Saeed, T. Horai, C. Ootaki, et al., “A Novel Device for Left Atrial Appendage Exclusion: The Third-Generation Atrial Exclusion Device,” Journal of Thoracic and Cardiovascular Surgery, Vol. 136, No. 4, 2008, pp. 1019-1027. doi:10.1016/j.jtcvs.2008.06.002

[16]   S. P. Salzberg, A. M. Gillinov, A. Anyanwu, J. Castillo, F. Filsoufi and D. H. Adams, “Surgical Left Atrial Appendage Occlusion: Evaluation of a Novel Device with Magnetic Resonance Imaging,” European Journal of Cardio- Thoracic Surgery, Vol. 34, No. 4, 2008, pp. 766-770.

[17]   Annual Book of ASTM Standards, “ASTM F2129-06: Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices,” ASTM International, West Conshohocken, 2006.

[18]   S. H. Ostermayer, M. Reisman, P. H. Kramer, R. V. Matthews, W. A. Gray, P. C. Block, H. Omran, et al., “Percutaneous Left Atrial Appendage Transcatheter Occlusion (PLAATO System) to Prevent Stroke in High-Risk Patients with Non-Rheumatic Atrial Fibrillation: Results from the International Multi-Center Feasibility Trials,” Journal of the American College of Cardiology, Vol. 46, No. 1, 2005, pp. 9-14. doi:10.1016/j.jacc.2005.03.042

 
 
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