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内镜下采集静脉移植物可安全用于CABG

Endo Vein Harvesting Found Safe for Bypass
来源:EGMN 2012-08-02 09:56点击次数:246发表评论

《美国医学会杂志》8月1日发表的一项数据库分析显示,内镜下采集静脉移植物不会增加冠状动脉旁路移植术(CABG)患者的死亡、心肌梗死(MI)和再次血运重建发生率(JAMA 2012;308:475-84)。


2009年,一项对3,000例CABG患者的观察性研究显示,内镜下采集静脉移植物导致的死亡和移植失败风险高于切开法采集静脉移植物。此外,世界各地的其他研究在比较这两种技术时得出了不同的结果。因此,美国食品药品管理局(FDA)要求杜克临床研究所的Judson B. Williams博士及其同事采用胸外科医师协会的成人心脏手术数据库进一步研究这一问题。


研究者将该数据库的数据与来自医疗保险和医疗补助服务中心数据库的长期预后数据进行了关联,对5年内在934个中心进行初次单纯CABG的235,394例患者的预后进行跟踪。中位随访时间为3年。


分析结果显示,这两种静脉移植物采集方法在总死亡率方面无显著差异。内镜下采集静脉移植物组(n=122,899)和切开法采集静脉移植物组(n=112,495)的累计死亡率分别为13.2%和13.4%。此外,两组的死亡、MI或再次血运重建复合终点事件发生率也无显著差异:内镜组19.5%,切开组19.7%。不出意料,内镜组采集部位的切口并发症显著少于切开组(3.0% vs. 3.6%)。


该研究的大样本量使研究者能够对重要CABG亚组作进一步分析。分析结果表明,在42,000例胰岛素依赖型糖尿病患者中,内镜法与切开法的结果也无差异;根据患者体重指数或采集的静脉移植物数量进行分析也得出相同结果。


敏感性分析结果与主要结果一致。内镜组CABG患者的死亡率与切开组相同,死亡、MI和血运重建复合终点事件发生率也与切开组相同,但切口并发症发生率显著低于切开组。


与其他同类研究一样,该分析的局限性在于不能说明内镜组与切开组的导管管径差异。在这两种技术的比较中,导管管径是潜在的关键混杂因素。另一个重要局限性是随访时间仅为3年,这是因为胸外科医师协会数据库无2008年以前的内镜采集病例。另外,与既往研究一样,该观察研究也未能评价技术的各个方面,如二氧化碳吹入、电灼术的使用或内镜采集者的经验等。


随刊述评:明确且极其重要的结果


达特茅斯-希契科克医疗中心心胸外科的Lawrence J. Dacey博士表示,上述研究表明,内镜下采集静脉移植物不会增加患者发生重要不良长期预后的风险。该研究纳入了许多在治疗实践风格方面存在巨大差异的不同中心,并采用多种复杂统计方法来证实这些“极其重要”结果的鲁棒性(robustness)。


由于患者对内镜采集法的满意度高于切开法,目前大部分CABG手术均采用内镜采集法。内镜下静脉移植物采集主要由医师助手进行,而这些人往往缺乏切开采集静脉移植物的经验。因此,这可能是最后一项探讨此课题的研究,未来将没有足够的切开采集病例样本可供比较。在此情况下,Dacey博士认为能得到上述决定性研究结果是个意外的惊喜。(JAMA 2012;308:512-3)。


该研究获FDA等机构资助。Williams博士声明无经济利益冲突。其他研究者声明与多家药企存在诸多关联。Dacey博士声明无经济利益冲突。


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By: MARY ANN MOON, Cardiology News Digital Network


Endoscopic vein-graft harvesting was not associated with increased rates of death, myocardial infarction, or repeat revascularization in patients undergoing coronary artery bypass grafting, according to a database analysis of more than 200,000 patients. The study was requested and funded by the Food and Drug Administration and reported in the Aug. 1 issue of JAMA.


In 2009, an observational study of 3,000 CABG patients showed that endoscopic vein-graft harvesting carried a higher risk of mortality and graft failure than did open vein-graft harvesting. It was suggested that the endoscopic technique might cause more harm because it involved added vessel manipulation, venous stasis from the pressurized subcutaneous tunnel, and larger caliber vein-graft segments. In addition, other studies throughout the world showed conflicting results when comparing the two techniques.


In response, the FDA asked that the issue be further investigated using the massive Society of Thoracic Surgeons’ adult cardiac surgery database. By linking this information with data on long-term outcomes from the Centers for Medicare and Medicaid Services database, investigators were able to track outcomes in 235,394 patients who underwent primary isolated CABG at 934 sites during a 5-year period. They were followed for a median of 3 years.


Dr. Judson B. Williams of Duke Clinical Research Institute, Durham, N.C., and his associates found no significant difference between the two techniques of vein-graft harvesting in overall mortality. The cumulative rates of death were 13.2% in the 122,899 patients who had endoscopic vein-graft harvesting and 13.4% in the 112,495 who had open vein-graft harvesting.


In addition, the composite rate of death, MI, or repeat revascularization also was not significantly different between the two groups: 19.5% with endoscopic and 19.7% with open vein-graft harvesting, the investigators said (JAMA 2012;308:475-84).


The endoscopic technique carried a significantly lower rate of harvest site wound complications, as expected (3.0% vs. 3.6%).


The large study population allowed for further assessment of important subgroups of CABG patients. Again, there were no differences in outcomes between endoscopic and open techniques in the nearly 42,000 subjects with insulin-dependent diabetes, and no differences according to subjects’ body mass index. There also were no differences in outcomes according to the number of vein-grafts harvested.


The results of sensitivity analyses paralleled the main finding of the study. CABG patients undergoing endoscopic vein-graft harvesting showed the same long-term mortality and the same composite rate of death, MI, and revascularization as did those undergoing open vein-graft harvesting, but significantly lower rates of wound complications.


As with other studies of this controversial issue, this analysis was limited in that it "was unable to account for differences in conduit caliber between the endoscopic and open vein-graft harvesting groups, a potentially critical confounding variable" in comparing the two techniques, Dr. Williams and his associates said.


Another important limitation was the length of follow-up – only 3-years, since the STS database did not identify endoscopic harvesting before 2008.


In addition, "our observational study, as with previous studies, is unable to assess for particulars of technique such as carbon dioxide insufflations, use of electrocautery, or the experience of the endoscopic harvester," they added.


This study was funded by the Food and Drug Administration, the National Institutes of Health, and the National Heart, Lung, and Blood Institute. Dr. Williams reported no financial conflicts of interest, and his associates reported numerous ties to industry sources.


Definitive and Vitally Important Results


The "elegant and definitive" study by Williams and colleagues allows clinicians "to say with certainty that the benefits of endoscopic vein-graft harvesting ... are not associated with an increased risk of important adverse long-term outcomes," said Dr. Lawrence J. Dacey.


The analysis included many diverse sites with widely varying practice styles and used multiple sophisticated statistical techniques to confirm the robustness of these "vitally important" findings, he said.


Such results are fortuitous because of patient satisfaction with endoscopic harvesting over open, and because "today, the majority of CABG surgeries use endoscopic vein harvest." Endoscopic vein harvesting is mostly performed by physician assistants, many of whom have no experience with open harvesting. Thus "It is likely that this will be the last study of its kind on the subject. In the future there will simply not be enough patients with vein grafts obtained by open harvesting to provide a meaningful comparison," he concluded.


DR. DACEY is in the department of cardiothoracic surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H. He reported no financial conflicts of interest. These remarks were taken from his editorial accompanying Dr. Williams’ report (JAMA 2012;308:512-3).


学科代码:心血管病学 外科学   关键词:内镜下采集静脉移植物 冠状动脉旁路移植术
来源: EGMN
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