Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Experimental Surgery Services, Robinson College of Veterinary Medicine, University of Minnesota, Minneapolis, MN, USA.
Eur J Cardiothorac Surg. 2017 Dec 1;52(6):1098-1103. doi: 10.1093/ejcts/ezx188.
Exclusion of the left atrial appendage has been proposed to reduce the risk of stroke in patients with atrial fibrillation. The aim of this study was to evaluate the feasibility and efficacy of the AtriClip PRO·V device (AOD2), now in development, for left atrial appendage exclusion in a canine model.
The newest AtriClip design comprises a dual-spring mechanism that allows the clip to open into a 'V' shape while still providing equivalent force along the length of the beam. The AOD2's hallmark is a distal tip closure to help retain the appendage during clip closure. Six dogs were implanted via thoracotomy with the clinically available AtriClip device (AOD1) on the right atrial appendage and the AOD2 on the left. At 90 days after implantation, all devices were evaluated by epicardial echocardiography, computed tomography, gross pathology and histology. System performance at the initial surgery was evaluated as well.
The ease of use of the clinically available AtriClip device (AOD1) and AOD2 was deemed comparable in all cases. All animals survived for the planned 90-day duration without complications. The atrial appendages were fully occluded in all cases without device migration. On histology, all AtriClip devices demonstrated an acceptable biocompatibility response.
The AOD2 achieved easy, reliable and safe exclusion of the left atrial appendage, with favourable histologic findings. Once approved for clinical application, the AOD2 could provide a new therapeutic option to lower the risks of stroke in patients with atrial fibrillation.
已提出排除左心耳以降低房颤患者中风风险。本研究旨在评估目前正在开发的 AtriClip PRO·V 装置（AOD2）用于犬模型左心耳排除的可行性和疗效。
最新的 AtriClip 设计包括双弹簧机构，允许夹子在打开成“V”形的同时仍然沿梁的长度提供等效的力。AOD2 的特点是远端尖端闭合，有助于在夹子关闭时保留心耳。6 只狗通过开胸术植入了临床上可用的 AtriClip 装置（AOD1）在右心耳和 AOD2 在左心耳。植入后 90 天，通过心外膜超声心动图、计算机断层扫描、大体病理学和组织学评估所有装置。还评估了初始手术时的系统性能。
在所有情况下，临床上可用的 AtriClip 装置（AOD1）和 AOD2 的易用性都被认为是相当的。所有动物均在无并发症的情况下按计划存活 90 天。所有情况下心耳均完全闭塞，无器械移位。组织学上，所有 AtriClip 装置均显示出可接受的生物相容性反应。
AOD2 可轻松、可靠且安全地排除左心耳，具有良好的组织学发现。一旦获得临床应用批准，AOD2 可能为降低房颤患者中风风险提供新的治疗选择。
