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经桡动脉冠状动脉介入治疗中5法国与6法国鞘管的临床及操作结果

Clinical and Procedural Outcomes of 5-French versus 6-French Sheaths in Transradial Coronary Interventions.

作者信息

Polimeni Alberto, Passafaro Francesco, De Rosa Salvatore, Sorrentino Sabato, Torella Daniele, Spaccarotella Carmen, Mongiardo Annalisa, Indolfi Ciro

机构信息

From the Division of Cardiology, Department of Medical and Surgical Sciences, "Magna Graecia" University (AP, FP, SDR, SS, DT, CS, AM, CI); and URT-CNR, Department of Medicine, Consiglio Nazionale delle Ricerche, Catanzaro, Italy (CI).

出版信息

Medicine (Baltimore). 2015 Dec;94(52):e2170. doi: 10.1097/MD.0000000000002170.

Abstract

The radial artery has been increasingly used for its favorable safety profile. However, no conclusive data are available on the optimal sheath size. In particular, it is seemingly difficult to weight both advantages and disadvantages of narrower versus larger sheaths size. Despite several studies were performed to compare the use of 6-Fr to the smaller 5-Fr sheaths, these were mostly small, single center-studies, yielding various results.We performed a comprehensive meta-analysis of all available studies comparing the use of 5-Fr versus 6-Fr sheaths in coronary procedures through the TRA.Studies comparing a 5-Fr versus a 6-Fr sheaths were searched for in PubMed, the Cochrane Library, and ISI Web of Knowledge databases.Studies were deemed eligible if they only included patients undergoing transradial cardiac catheterization with 5-Fr or 6-Fr system and reported at least one of these parameters: contrast dye volume, procedural success, procedural time, access complications, radial artery occlusion, and bleedings.Odds ratio (OR) and the mean difference (MD) were respectively used for dichotomous and continuous variables as summary measures. Both the random-effects model and the fixed effect models were used for computation of meta-analyses. Heterogeneity was assessed by means of the Cochrane Q test. Metaregression was calculated using the unrestricted maximal likelihood random effects model.The use of a 5-Fr system is associated with a significant lower contrast medium administration (MD = -22.20 [-36.43 to -7.96], P < 0.01) and significantly reduces bleedings (OR = 0.58 [0.38-0.90], P = 0.02), without compromising procedural success (OR = 0.95 [0.53-1.69], P = 0.86) or procedure length (OR = 0.55 [-2.58 to 3.69], P = 0.73), compared to the 6-Fr system. Despite no significant difference was observed between the groups (OR = 0.88 [0.50-1.56], P = 0.67), at metaregression RAO incidence in the 5-Fr group was increasingly lower as the percentage of women included into the study increased (P = 0.02).Some potentially interesting technical details, such as sheath length, hydrophilic coating, or periprocedural anticoagulation, were not homogeneously reported in individual studies.Results of the present meta-analysis confirm the excellent safety profile of transradial procedures both with 5-Fr and 6-Fr system. A 5-Fr system could be preferred in patients with a higher bleeding propensity or kidney injury.

摘要

桡动脉因其良好的安全性而越来越多地被使用。然而,关于最佳鞘管尺寸尚无确凿数据。特别是,权衡较窄与较大鞘管尺寸的利弊似乎很困难。尽管进行了多项研究来比较6F鞘管与较小的5F鞘管的使用情况,但这些大多是小型单中心研究,结果各异。我们对所有比较经桡动脉途径冠状动脉介入手术中5F与6F鞘管使用情况的现有研究进行了全面的荟萃分析。在PubMed、Cochrane图书馆和ISI Web of Knowledge数据库中检索比较5F与6F鞘管的研究。如果研究仅纳入接受5F或6F系统经桡动脉心脏导管插入术的患者,并报告以下至少一项参数:造影剂用量、手术成功率、手术时间、穿刺部位并发症、桡动脉闭塞和出血,则该研究被视为合格。比值比(OR)和平均差(MD)分别用于二分类变量和连续变量作为汇总指标。随机效应模型和固定效应模型均用于荟萃分析的计算。异质性通过Cochrane Q检验进行评估。使用无限制最大似然随机效应模型计算Meta回归。与6F系统相比,使用5F系统可显著降低造影剂用量(MD=-22.20[-36.43至-7.96],P<0.01),并显著减少出血(OR=0.58[0.38-0.90],P=0.02),且不影响手术成功率(OR=0.95[0.53-1.69],P=0.86)或手术时长(OR=0.55[-2.58至3.69],P=0.73)。尽管两组之间未观察到显著差异(OR=0.88[0.50-1.56],P=0.67),但在Meta回归中,随着纳入研究的女性比例增加,5F组的桡动脉闭塞发生率越来越低(P=0.02)。一些潜在有趣的技术细节,如鞘管长度、亲水涂层或围手术期抗凝,在个别研究中报告并不一致。本荟萃分析的结果证实了5F和6F系统经桡动脉手术均具有出色的安全性。对于出血倾向较高或有肾损伤的患者,可能更倾向于使用5F系统。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6c6d/5291601/447ec4172616/medi-94-e2170-g002.jpg

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