Carnero-Alcázar Manuel, Maroto Luis Carlos, Cobiella-Carnicer Javier, Vilacosta Isidre, Nombela-Franco Luis, Alswies Ali, Villagrán-Medinilla Enrique, Macaya Carlos
Department of Cardiac Surgery, Hospital Clínico San Carlos, Madrid, Spain.
Department of Cardiology, Hospital Clínico San Carlos, Madrid, Spain.
Eur J Cardiothorac Surg. 2017 Apr 1;51(4):644-652. doi: 10.1093/ejcts/ezw388.
The evidence of the benefits of transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for patients of high or intermediate surgical risk is not consistent. We performed a meta-analysis to compare major adverse outcomes after TAVR or SAVR.
We searched propensity score matched studies or randomized clinical trials comparing the risks of mortality, stroke, major bleeding, acute renal injury, pacemaker implantation, vascular complications and prostheses haemodynamic performance between TAVR and SAVR in patients with moderate or high risk. Combined odds ratios (ORs), relative risk or mean differences with corresponding 95% confidence intervals (CIs) were calculated using a random effects model. Analyses of sensitivity and publication bias were also conducted.
We included 5 clinical trials and 37 observational studies, enrolling 20 224 patients (TAVR, n = 9099 and SAVR, n = 11 125). The pooled analysis suggested no differences in early (OR = 1.11, 95% CI 0.9-1.39, P = 0.355) or late mortality (relative risk = 0.91, 95% CI 0.78-1.05, P = 0.194). TAVR was associated with a lower risk of major bleeding (OR = 0.42, 95% CI 0.25-0.69, P < 0.001) and acute kidney injury (OR = 0.51, 95% CI 0.34-0.71) but with an increase in the incidence of pacemaker implantation (OR = 2.31, 95% CI 1.73-3.08) and vascular complications (OR = 4.88, 95% CI 2.84-8.39). Residual aortic regurgitation was more frequent after TAVR (OR= 6.83, 95% CI 4.87-9.6). SAVR prostheses were associated with poor trans-prosthetic gradients (mean difference: -2.4 mmHg, 95% CI - 3.27 to - 1.53).
TAVR and SAVR have similar short and long-term all-cause mortality and risk of stroke among patients of moderate or high surgical risk. TAVR decreases the risk of major bleeding, acute kidney injury and improves haemodynamic performance compared with SAVR but increases the risk of vascular complications, the need for a pacemaker and residual aortic regurgitation.
经导管主动脉瓣置换术（TAVR）或外科主动脉瓣置换术（SAVR）对手术风险高或中等的患者的益处证据并不一致。我们进行了一项荟萃分析，以比较TAVR或SAVR后的主要不良结局。
我们检索了倾向评分匹配研究或随机临床试验，比较中度或高风险患者中TAVR和SAVR之间的死亡率、中风、大出血、急性肾损伤、起搏器植入、血管并发症和人工瓣膜血流动力学性能风险。使用随机效应模型计算合并比值比（OR）、相对风险或平均差异以及相应的95%置信区间（CI）。还进行了敏感性分析和发表偏倚分析。
我们纳入了5项临床试验和37项观察性研究，共纳入20224例患者（TAVR组9099例，SAVR组11125例）。汇总分析表明，早期（OR = 1.11，95% CI 0.9 - 1.39，P = 0.355）或晚期死亡率（相对风险 = 0.91，95% CI 0.78 - 1.05，P = 0.194）无差异。TAVR与大出血风险较低（OR = 0.42, 95% CI 0.25 - 0.69, P < 0.001）和急性肾损伤风险较低（OR = 0.51, 95% CI 0.34 - 0.71）相关，但起搏器植入发生率增加（OR = 2.31, 95% CI 1.73 - 3.08）和血管并发症发生率增加（OR = 4.88, 95% CI 2.84 - 8.39）。TAVR术后残余主动脉瓣反流更常见（OR = 6.83, 95% CI 4.87 - 9.6）。SAVR人工瓣膜与跨瓣压差较差相关（平均差异：-2.4 mmHg, 95% CI -3.27至-1.53）。
在手术风险中等或高的患者中，TAVR和SAVR的短期和长期全因死亡率及中风风险相似。与SAVR相比，TAVR降低了大出血、急性肾损伤的风险并改善了血流动力学性能，但增加了血管并发症、起搏器需求和残余主动脉瓣反流的风险。
