Exclusion of the left atrial appendage with a novel device: Early results of a multicenter trial
Exclusion of the left atrial appendage with a novel device: Early results of a multicenter trial
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DOI：
10.1016/j.jtcvs.2011.07.052
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发表时间：
2011-11-01
影响因子：
6
通讯作者：
Mack, Michael J.
中科院分区：
文献类型：
--
作者：
Ailawadi, Gorav;Gerdisch, Marc W.;Mack, Michael J.
目的：房颤患者发生的栓塞性卒中中，高达90%起源于左心耳。在心脏手术中排除左心耳可能会降低未来中风的风险，特别是在房颤患者或房颤高危患者中。我们报告了美国食品和药物管理局多中心试验的初步结果，以评估一种新型左心耳封堵夹的安全性和有效性。通过正中胸骨切开术接受择期心脏手术的房颤或充血性心力衰竭、高血压、年龄> 75岁、糖尿病、卒中评分大于2的患者有资格合并使用AtriClip（Atricure Inc，韦斯特切斯特，俄亥俄州）器械插入。在胸骨切开术后的任何时间点进行器械插入（35、40、45和50 mm），无论是否进行心肺转流。安全性进行了评估，在30天，左心耳封堵术的疗效进行了评估，在操作（经食管超声心动图）和3个月的后续行动（通过计算机断层扫描血管造影或经食管超声心动图）。1例患者的左心耳过小，不符合合格标准;其余70例患者成功置入AtriClip器械。70例患者中有67例（95.7%）证实了术中成功的左心耳封堵术。尽管70例患者中有34例（48.6%）发生了严重不良事件，但没有与器械相关的不良事件，也没有围手术期死亡。3个月随访时，1例患者死亡，70例患者中有65例（92.9%）可用于评估。在接受成像的患者中，61例患者中有60例通过计算机断层扫描血管造影或经食管超声心动图成像，98.4%的患者成功进行了左心耳封堵术。在这项小型研究中，在开放性心脏手术期间，使用AtriClip器械可以安全无创地隔绝左心耳，成功，并且通过成像显示在短期内是持久的。需要长期研究来评估预防中风的有效性。（《胸血管外科杂志》2011;142：1002-9）
Objective: Up to 90% of embolic strokes that occur in patients with atrial fibrillation originate from the left atrial appendage. Exclusion of the left atrial appendage during cardiac surgery may decrease the future risk of stroke, especially in patients with atrial fibrillation or at high risk for developing atrial fibrillation. We report the initial results of a multicenter Food and Drug Administration trial to assess the safety and efficacy of a novel left atrial appendage exclusion clip.Methods: Patients undergoing elective cardiac surgery via median sternotomy with atrial fibrillation or a Congestive Heart Failure, Hypertension, Age > 75 Years, Diabetes Mellitus, Stroke score greater than 2 were eligible for concomitant AtriClip (Atricure Inc, Westchester, Ohio) device insertion. Device insertion (35, 40, 45, and 50 mm) was performed at any point after sternotomy on or off cardiopulmonary bypass. Safety was assessed at 30 days, and efficacy of left atrial appendage exclusion was assessed at operation (by transesophageal echocardiography) and 3-month follow-up (by computed tomography angiography or transesophageal echocardiography).Results: A total of 71 patients (mean age, 73 years) undergoing open cardiac surgery at 7 US centers were enrolled in the study. The left atrial appendage in 1 patient was too small and did not meet eligibility criteria; the remaining 70 patients had successful placement of an AtriClip device. Intraprocedural successful left atrial appendage exclusion was confirmed in 67 of 70 patients (95.7%). Although significant adverse events occurred in 34 of 70 patients (48.6%), there were no adverse events related to the device and no perioperative mortality. At 3-month follow-up, 1 patient died and 65 of 70 patients (92.9%) were available for assessment. Of the patients who underwent imaging, 60 of 61 patients (98.4%) had successful left atrial appendage exclusion by computed tomography angiography or transesophageal echocardiography imaging.Conclusions: In this small study, safe and atraumatic exclusion of the left atrial appendage can be performed during open cardiac surgery with the AtriClip device with greater than 95% success and appears to be durable in the short term by imaging. Long-term studies are needed to evaluate the efficacy in the prevention of stroke. (J Thorac Cardiovasc Surg 2011;142:1002-9)