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Stentless Versus Stented Bioprosthetic Aortic Valves A Systematic Review and Meta-Analysis of Controlled Trials

机译:无支架与带支架的生物人工主动脉瓣系统对照试验的系统评价和荟萃分析

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Objective: This meta-analysis sought to determine whether stentless bioprosthetic valves improve clinical and resource outcomes compared with stented valves in patients undergoing aortic valve replacement.Methods: A comprehensive search was undertaken to identify all randomized and nonrandomized controlled trials comparing stentless to stented bioprosthetic valves in patients undergoing aortic valve replacement available up to March 2008. The primary outcomes were clinical and resource outcomes in randomized controlled trial (RCT). Secondary outcomes clinical and resource outcomes in nonrandomized controlled trial (non-RCT). Odds ratios (OR), weighted mean differences (WMD), or standardized mean differences and their 95% confidence intervals (CI) were analyzed as appropriate.Results: Seventeen RCTs published in 23 articles involving 1317 patients, and 14 non-RCTs published in 18 articles involving 2485 patients were included in the meta-analysis. For the primary analysis of randomized trials, mortality for stentless versus stented valve groups did not differ at 30 days (OR 1.36, 95% CI 0.68-2.72), 1 year (OR 1.01, 95% CI 0.55-1.85), or 2 to 10 years follow-up (OR 0.82, 95% CI 0.50-1.33). Aggregate event rates for all-cause mortality at 30 days were 3.7% versus 2.9%, at 1 year were 5.5% versus 5.9% and at 2 to 10 years were 17% versus 19% for stentless versus stented valve groups, respectively. Stroke or neurologic complications did not differ between stentless (3.6%) and stented (4.0%) valve groups. Risk of prosthesis-patient mismatch was numerically lower in the stentless group (11.0% vs. 31.3%, OR 0.30, 95% CI 0.05-1.66), but this parameter was reported in few trials and did not reach statistical significance. Effective orifice area index was significantly greater for stentless aortic valve compared with stented valves at 30 days (WMD 0.12 cm2/m2), at 2 to 6 months (WMD 0.15 cm2/m2), and at 1 year (WMD 0.26 cm2/m2). Mean gradient at 1 month was significantly lower
机译:目的:这项荟萃分析旨在确定与无支架瓣膜置换术相比,无支架生物瓣膜与主动脉瓣膜置换术相比是否能改善临床和资源结果。方法:进行全面搜索,以比较所有无支架与无支架生物瓣膜比较的随机和非随机对照试验。截止至2008年3月可进行主动脉瓣置换术的患者。主要结局是随机对照试验(RCT)的临床和资源结局。次要结局非随机对照试验(non-RCT)中的临床和资源结局。结果:在23篇文章中发表了17篇随机对照研究,涉及1317例患者,在14篇非RCT中发表了17篇随机对照研究荟萃分析包括18篇涉及2485例患者的文章。对于随机试验的主要分析,无支架组和带支架瓣膜组的死亡率在30天(OR 1.36,95%CI 0.68-2.72),1年(OR 1.01,95%CI 0.55-1.85)或2至2天时无差异。十年随访(OR 0.82,95%CI 0.50-1.33)。对于无支架瓣膜组和带支架瓣膜组,在30天时全因死亡率的总事件发生率分别为3.7%和2.9%,在1年时分别为5.5%和5.9%,在2至10年时分别为17%和19%。无支架(3.6%)和带支架(4.0%)瓣膜组的卒中或神经系统并发症无差异。无支架组的假体与患者不匹配的风险在数值上更低(11.0%比31.3%,或0.30,95%CI 0.05-1.66),但是该参数在少数试验中已有报道,但未达到统计学意义。与无支架主动脉瓣相比,在30天(WMD 0.12 cm2 / m2),2至6个月(WMD 0.15 cm2 / m2)和1年(WMD 0.26 cm2 / m2)时,无支架主动脉瓣的有效孔面积指数显着更大。 。 1个月时的平均梯度明显降低

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