Department of Cardiothoracic Surgery, Heart and Vessel Center, Bad Bevensen, Germany.
Ann Thorac Surg. 2011 Dec;92(6):2177-83. doi: 10.1016/j.athoracsur.2011.07.003.
During off-pump coronary artery bypass graft (OPCABG) surgery, a bloodless surgical field is mandatory for visualization and construction of optimal coronary anastomoses. Presently used temporary vascular occluders are known to cause endothelial dysfunction and vessel injury. The present prospective multicenter randomized clinical trial evaluates safety and efficacy of a novel thermosensitive polymer (LeGoo) as an atraumatic temporary vascular occluder.
Between July 2008 and February 2010, 110 patients undergoing OPCABG were randomized between LeGoo (LG) and conventional vessel loops (VL) for coronary artery occlusion during construction of the distal anastomosis. A semiquantitative 4-point scale was used to evaluate the degree of bloodless surgical field and surgical comfort. Duration of coronary artery occlusion was also recorded. Safety during the operation and ensuing 30 days was evaluated by a composite endpoint of major adverse cardiac events that consisted of death from all causes, graft occlusion, myocardial infarction, and low cardiac output.
Fifty-six patients (117 distal anastomoses) were randomly assigned to LG and 54 patients (122 anastomoses) to VL. There were 2 anastomoses crossed over from LG to the control arm, and 3 from control to LG. Five anastomoses in LG patients were treated with an alternative device (shunts). Satisfactory hemostasis was achieved in 88.0% of LG anastomoses (103 of 117) compared with 60.7% of VL anastomoses (74 of 122; p < 0.001). Mean total anastomotic time was 12.8 minutes in the LG group and 15.1 minutes in the VL group (p < 0.001). This difference was more pronounced for arteries on the posterior and lateral than on the anterior walls of the heart. Composite adverse events were similar in the two groups: 3 of 48 LG patients and 3 of 46 VL patients. There was 1 death in the LG group. One patient in the LG group and 1 in the VL arm had a myocardial infarction. No operation was converted from OPCABG to CABG with cardiopulmonary bypass.
LeGoo is a safe and effective temporary coronary occluder during OPCABG. It provided a dry surgical field for visualization of the anastomotic field and surgical comfort more frequently than conventional vessel loops. In addition, anastomotic times were shorter with LG. Major cardiac adverse events were similar in the LG and VL arms.
在非体外循环冠状动脉旁路移植术（OPCABG）中，为了可视化和构建最佳的冠状动脉吻合口，需要保持无血的手术视野。目前使用的临时血管夹已知会引起内皮功能障碍和血管损伤。本前瞻性多中心随机临床试验评估了新型热敏聚合物（LeGoo）作为一种无创伤性临时血管夹的安全性和有效性。
2008 年 7 月至 2010 年 2 月，110 例行 OPCABG 的患者被随机分为 LeGoo（LG）组和常规血管环（VL）组，在构建远端吻合口时使用 LG 或 VL 夹闭冠状动脉。使用半定量的 4 分制评分来评估无血手术视野和手术舒适度的程度。还记录了冠状动脉夹闭的持续时间。通过主要不良心脏事件的复合终点评估手术期间和术后 30 天的安全性，该终点包括所有原因引起的死亡、移植物闭塞、心肌梗死和低心输出量。
56 例患者（117 个远端吻合口）被随机分配至 LG 组，54 例患者（122 个吻合口）被分配至 VL 组。LG 组有 2 个吻合口交叉至对照组，对照组有 3 个吻合口交叉至 LG 组。LG 组的 5 个吻合口使用了替代装置（分流器）。LG 组 117 个吻合口中有 88.0%（103 个）达到了满意的止血效果，而 VL 组 122 个吻合口中只有 60.7%（74 个）（p < 0.001）。LG 组的总吻合时间平均为 12.8 分钟，VL 组为 15.1 分钟（p < 0.001）。这种差异在心脏后、外侧壁的动脉上比在前壁上更为明显。两组的复合不良事件相似：LG 组有 3 例，VL 组有 3 例。LG 组有 1 例死亡。LG 组和 VL 组各有 1 例心肌梗死。没有一例手术从 OPCABG 转为体外循环下的 CABG。
LeGoo 是 OPCABG 中一种安全有效的临时冠状动脉夹。与常规血管环相比，它能更频繁地提供干燥的手术视野，便于观察吻合口，并提高手术舒适度。此外，LG 组的吻合时间更短。LG 组和 VL 组的主要心脏不良事件相似。
