Division of Thoracic and Cardiovascular Surgery, University of Louisville, Louisville, Kentucky 40202, USA.
Ann Thorac Surg. 2012 Jun;93(6):2035-8; discussion 2038-40. doi: 10.1016/j.athoracsur.2011.12.077.
This Food and Drug Administration-approved investigational device exempt trial assessed the safety and efficacy of a novel device for external left atrial appendage (LAA) exclusion.
Delivery tool and implant consisting of connectors imbedded in a compliant, soft silicone applied to the base of the LAA flush with the external wall was assessed.
Patients in this prospective, multicenter trial were undergoing elective, nonendoscopic cardiac operations. A core laboratory independently assessed all intraprocedural and 90-day transesophageal echocardiograms. Sixty patients (37 men), aged 33 to 86 years, enrolled. The mean LAA application time was 27 seconds. Transesophageal echocardiograms at 90 days were available in 54 patients, and no leaks were detected. The residual LAA cavity exceeded 6 mm in 5 patients. One delivery device failed to close, and an adjunctive suture was required to complete LAA exclusion. One patient required adjunct sutures at a small tear site related to manual manipulation after fastener application.
The study demonstrated safety and efficacy of this LAA exclusion device, offering an alternative to manual suturing or staples with or without reinforcement.
这项食品和药物管理局批准的研究性器械豁免试验评估了一种新型外部左心耳（LAA）封堵装置的安全性和有效性。
评估了一种输送工具和植入物，由嵌入在与 LAA 基底齐平的柔软硅酮中的连接器组成，该连接器贴合 LAA 的外壁。
这项前瞻性、多中心试验纳入了正在接受选择性、非内镜心脏手术的患者。一个核心实验室独立评估了所有术中及 90 天经食管超声心动图。共纳入 60 名年龄 33 至 86 岁的患者（男性 37 名）。LAA 应用时间的平均时间为 27 秒。54 名患者的 90 天经食管超声心动图检查显示无泄漏。5 名患者的 LAA 残腔超过 6 毫米。1 个输送装置未能关闭，需要附加缝线以完成 LAA 封堵。1 名患者在应用固定器后手动操作时出现小撕裂部位，需要附加缝线。
该研究表明这种 LAA 封堵装置具有安全性和有效性，为手动缝合或缝合钉提供了一种替代方法，无论是否需要加固。
