Preclinical Assessment of a Modified Occlutech Left Atrial Appendage Closure Device in a Canine Model

• Published in: International journal of cardiology Vol. 221; pp. 413 - 418
• Main Authors: Kim, Jung-Sun, Lee, Seul-Gee, Bong, Sung-Kyung, Park, Se-Il, Hong, Sung-Yu, Shin, Sanghoon, Shim, Chi Young, Hong, Geu-Ru, Choi, Donghoon, Jang, Yangsoo, Park, Jai-Wun
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ireland Ltd 15-10-2016
• Subjects: Animals; Atrial Appendage - surgery; Atrial Fibrillation - surgery; Canine model; Cardiovascular; Device study; Disease Models, Animal; Dogs; Left atrial appendage; Prosthesis Implantation - instrumentation; Prosthesis Implantation - methods; Septal Occluder Device; Stroke - prevention & control; device study; canine model; left atrial appendage; Canine model; Left atrial appendage; Device study
• ISSN: 0167-5273; 1874-1754
• DOI: 10.1016/j.ijcard.2016.07.048

Abstract Background LAA occlusion has a similar stroke prevention efficacy compared to anticoagulation treatment for non-valvular atrial fibrillation. Objective The objective of this study was to assess the feasibility and safety of a modified Occlutech® left atrial appendage (LAA) closure device in a canine model. Methods The device was implanted in 10 dogs (33 ± 1 kg) using fluoroscopy and transesophageal echocardiography (TEE) guidance. The modified Occlutech® LAA occlusion device was compared with the current version, the Watchman device, and the Amplazter cardiac plug (ACP). LAA occlusion and anchoring to the LAA were evaluated. All dogs were assessed using angiography, TEE, and a gross anatomy examination. Results The 10 LAA occlusion devices were to be implanted into 10 dogs (5 new Occlutech devices, 3 current Occlutech devices, 1 Watchman, and 1 ACP). LAA implantation was not performed in one dog due to transeptal puncture failure. The three current Occlutech devices were embolized immediate after implantation, so three modified devices of the same size were implanted securely without embolization. The mean implant size was 20.1 ± 2.0 mm. The devices chosen were a mean of 23.3 ± 10.6% larger than the measured landing zone diameters. Post-implant angiography and TEE revealed well-positioned devices without pericardial effusion or impingement on surrounding structures. Conclusions The results of this acute animal study suggested that a modified Occlutech® LAA occlusion device was feasible and had greater anchoring performance in canines. Additional large clinical studies are needed to evaluate safety and efficacy.