冠状动脉手术新方法的安全引入与质量控制。
Safe introduction and quality control of new methods in coronary surgery.
作者信息
Bergsland Jacob
机构信息
The Interventional Centre, Oslo University Hospital, Oslo, Norway ; BH Heart Centre, Tuzla, Bosnia and Herzegovina.
出版信息
Acta Inform Med. 2011 Dec;19(4):203-15. doi: 10.5455/aim.2011.19.203-215.
INTRODUCTION
The first part of the paper analyses off pump coronary bypass surgery (OPCAB), which is compared with traditional on-pump procedures (ONCAB). Furthermore ,the paper evaluates the use of a new automatic device for performance of the proximal anastomosis and finally the effect of intracoronary shunt on myocardial ischemia during OPCAB. The main goal of the paper is to demonstrate the importance of careful clinical studies during introduction of the new techniques in cardiac surgery.
METHODS
Statistical analysis was performed on a large clinical database from Buffalo, NY, USA comparing OPCAB and ONCAB. Subsequently, a sequential controlled clinical study compared patients operated with a new automatic connector device to patients operated with classic suture technique. Finally a randomized study was performed to evaluate the effect of the use of an intracoronary shunt during construction of distal anastomosis.
RESULTS
The studies from Buffalo demonstrated reduced complications rates in high risk patients when OPCAB techniques were used. The use of connector devices in saphenous venous anastomosis was clearly inferior to standard technique. Intracoronary shunt was found to be beneficial by preventing ischemia.
DISCUSSION
Numerous studies have studied the results of OPCAB vs ONCAB and although results are variable it seems that OPCAB is advantageous in high risk patients, while in low risk patients there are much less if any benefit. The results of the studies of connector devices caused the product to be taken off the market. The value of shunt in OPCAB was clearly demonstrated by the randomized studies.
CONCLUSION
The investigations presented in this paper clearly demonstrates the importance of well-designed studies when new surgical methods are introduced. In the present period of rapid technological development, carefully controlled, un-biased clinical trials are crucial to preserve patient safety and avoid unjustified societal cost.
引言
本文第一部分分析了非体外循环冠状动脉搭桥手术（OPCAB），并将其与传统体外循环手术（ONCAB）进行比较。此外，本文评估了一种用于近端吻合的新型自动装置的使用情况，最后评估了冠状动脉分流在非体外循环冠状动脉搭桥手术期间对心肌缺血的影响。本文的主要目的是证明在心脏手术中引入新技术时进行仔细临床研究的重要性。
方法
对来自美国纽约州布法罗的一个大型临床数据库进行统计分析，比较非体外循环冠状动脉搭桥手术和体外循环冠状动脉搭桥手术。随后，进行了一项序贯对照临床研究，将使用新型自动连接装置进行手术的患者与使用经典缝合技术进行手术的患者进行比较。最后进行了一项随机研究，以评估在远端吻合构建过程中使用冠状动脉分流的效果。
结果
布法罗的研究表明，使用非体外循环冠状动脉搭桥手术技术时，高危患者的并发症发生率降低。在大隐静脉吻合中使用连接装置明显不如标准技术。发现冠状动脉分流通过预防缺血有益。
讨论
许多研究对非体外循环冠状动脉搭桥手术与体外循环冠状动脉搭桥手术的结果进行了研究，尽管结果各不相同，但似乎非体外循环冠状动脉搭桥手术在高危患者中具有优势，而在低危患者中即使有任何益处也少得多。连接装置的研究结果导致该产品退出市场。随机研究清楚地证明了分流在非体外循环冠状动脉搭桥手术中的价值。
结论
本文提出的研究清楚地证明了在引入新手术方法时进行精心设计研究的重要性。在当前技术快速发展的时期，精心控制、无偏倚的临床试验对于保障患者安全和避免不合理的社会成本至关重要。
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