Puskas John D, Halkos Michael E, Balkhy Husam, Caskey Michael, Connolly Mark, Crouch John, Diegeler Anno, Gummert Jan, Harringer Wolfgang, Subramanian Valavanur, Sutter Francis, Matschke Klaus
Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia 30308, USA.
J Thorac Cardiovasc Surg. 2009 Jul;138(1):125-32. doi: 10.1016/j.jtcvs.2009.02.017. Epub 2009 Mar 26.
During coronary surgery, proximal vein graft anastomoses have been performed by using an aortic partial occlusion clamp to allow for a hand-sewn anastomosis. The purpose of this multicenter, prospective, randomized trial was to evaluate the efficacy of the PAS-Port device (Cardica, Inc, Redwood City, Calif), which allows an automated proximal anastomosis to be performed without aortic clamping.
Between June 22, 2006, and March 22, 2007, 220 patients requiring coronary artery bypass grafting with at least 2 vein grafts were enrolled. Within each patient, 1 graft was randomly assigned to receive a PAS-Port device, and the other was assigned to receive a hand-sewn anastomosis to the ascending aorta. The primary end point was angiographic patency (<50% stenosis) 9 months after surgical intervention. Secondary end points included average time to complete each anastomosis and 9-month freedom from major adverse cardiac events.
One hundred eighty-three patients received matched grafts that were angiographically assessed at 9 months. The 9-month graft patency was 82.0% (150/183) for hand-sewn and 80.3% (147/183) for PAS-Port grafts. The patency rate of PAS-Port anastomoses was statistically noninferior to that of hand-sewn anastomoses (95% lower confidence limit for difference, -7.95%). The freedom from major adverse cardiac events at 9 months was 97.7% for PAS-Port (95% confidence interval, 94.5%-99.0%) and 98.2% for hand-sewn (95% confidence interval, 95.1%-99.3%) grafts. The PAS-port device was associated with a 4.6 +/- 3.9-minute reduction in anastomotic time compared with that seen with a hand-sewn anastomosis (P < .001).
The PAS-Port proximal anastomotic device produces an effective anastomosis with a 9-month patency rate that is comparable with that of a hand-sewn anastomosis. It allows for construction of a proximal anastomosis without aortic clamping and requires less time than a hand-sewn anastomosis.
在冠状动脉手术中，近端静脉移植物吻合术一直是通过使用主动脉部分阻断钳来实现，以进行手工缝合吻合。这项多中心、前瞻性、随机试验的目的是评估PAS-Port装置（加利福尼亚州红木城的Cardica公司）的疗效，该装置可在不阻断主动脉的情况下进行自动化近端吻合。
在2006年6月22日至2007年3月22日期间，纳入了220例需要至少进行2处静脉移植物冠状动脉旁路移植术的患者。在每位患者体内，1处移植物被随机分配接受PAS-Port装置，另一处则分配接受与升主动脉的手工缝合吻合。主要终点是手术干预9个月后的血管造影通畅率（狭窄<50%）。次要终点包括完成每次吻合的平均时间以及9个月内无主要不良心脏事件。
183例患者接受了在9个月时进行血管造影评估的匹配移植物。手工缝合的9个月移植物通畅率为82.0%（150/183），PAS-Port移植物为80.3%（147/183）。PAS-Port吻合的通畅率在统计学上不劣于手工缝合吻合（差异的95%置信下限为-7.95%）。PAS-Port组9个月时无主要不良心脏事件的发生率为97.7%（95%置信区间，94.5%-99.0%），手工缝合组为98.2%（95%置信区间，95.1%-99.3%）。与手工缝合吻合相比，PAS-Port装置使吻合时间缩短了4.6±3.9分钟（P<.001）。
PAS-Port近端吻合装置可产生有效的吻合，9个月通畅率与手工缝合吻合相当。它允许在不阻断主动脉的情况下构建近端吻合，且所需时间比手工缝合吻合少。
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