Villablanca Pedro A, Mathew Verghese, Thourani Vinod H, Rodés-Cabau Josep, Bangalore Sripal, Makkiya Mohammed, Vlismas Peter, Briceno David F, Slovut David P, Taub Cynthia C, McCarthy Patrick M, Augoustides John G, Ramakrishna Harish
Division of Cardiovascular Diseases, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.
Division of Cardiology, Loyola University Stritch School of Medicine, Maywood, IL, USA.
Int J Cardiol. 2016 Dec 15;225:234-243. doi: 10.1016/j.ijcard.2016.10.003. Epub 2016 Oct 6.
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to surgical aortic-valve replacement (SAVR) for patients with severe symptomatic aortic stenosis (AS) who are at high operative risk. We sought to determine the long-term (≥1year follow-up) safety and efficacy TAVR compared with SAVR in patients with severe AS. METHODS: A comprehensive search of PubMed, EMBASE, Cochrane Central Register of Controlled Trials, conference proceedings, and relevant Web sites from inception through 10 April 2016. RESULTS: Fifty studies enrolling 44,247 patients met the inclusion criteria. The mean duration follow-up was 21.4months. No difference was found in long-term all-cause mortality (risk ratios (RR), 1.06; 95% confidence interval (CI) 0.91-1.22). There was a significant difference favoring TAVR in the incidence of stroke (RR, 0.82; 95% CI 0.71-0.94), atrial fibrillation (RR, 0.43; 95% CI 0.33-0.54), acute kidney injury (RR, 0.70; 95% CI 0.53-0.92), and major bleeding (RR, 0.57; 95% CI 0.40-0.81). TAVR had significant higher incidence of vascular complications (RR, 2.90; 95% CI 1.87-4.49), aortic regurgitation (RR, 7.00; 95% CI 5.27-9.30), and pacemaker implantation (PPM) (RR, 2.02; 95% CI 1.51-2.68). TAVR demonstrated significantly lower stroke risk compared to SAVR in high-risk patients (RR, 1.49; 95% CI 1.06-2.10); no differences in PPM implantation were observed in intermediate-risk patients (RR, 1.68; 95% CI 0.94-3.00). In a meta-regression analysis, the effect of TAVR baseline clinical features did not affect the long-term all-cause mortality outcome. CONCLUSION: TAVR and SAVR showed similar long-term survival in patients with severe AS; with important differences in treatment-associated morbidity.
背景:对于手术风险高的重度症状性主动脉瓣狭窄(AS)患者,经导管主动脉瓣置换术(TAVR)已成为外科主动脉瓣置换术(SAVR)的替代方案。我们试图确定重度AS患者中,TAVR与SAVR相比的长期(≥1年随访)安全性和疗效。 方法:全面检索PubMed、EMBASE、Cochrane对照试验中央注册库、会议论文集及相关网站,检索时间从数据库建立至2016年4月10日。 结果:50项纳入44247例患者的研究符合纳入标准。平均随访时间为21.4个月。长期全因死亡率无差异(风险比(RR)为1.06;95%置信区间(CI)为0.91 - 1.22)。在卒中发生率(RR为0.82;95%CI为0.71 - 0.94)、心房颤动(RR为0.43;95%CI为0.33 - 0.54)、急性肾损伤(RR为0.70;95%CI为0.53 - 0.92)和大出血(RR为0.57;95%CI为0.40 - 0.81)方面,TAVR有显著优势。TAVR的血管并发症(RR为2.90;95%CI为1.87 - 4.49)、主动脉瓣反流(RR为7.00;95%CI为5.27 - 9.30)和起搏器植入(PPM)发生率(RR为2.02;95%CI为1.51 - 2.68)显著更高。与SAVR相比,TAVR在高危患者中显示出显著更低的卒中风险(RR为1.49;95%CI为1.06 - 2.10);在中危患者中,PPM植入率无差异(RR为1.68;95%CI为0.94 - 3.0)。在一项Meta回归分析中,TAVR的基线临床特征对长期全因死亡率结果无影响。 结论:在重度AS患者中,TAVR和SAVR显示出相似的长期生存率;在与治疗相关的发病率方面存在重要差异。
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