Kheiri Babikir, Osman Mohammed, Abubakar Hossam, Subahi Ahmed, Chahine Adam, Ahmed Sahar, Bachuwa Ghassan, Alkotob Mohammad L, Hassan Mustafa, Bhatt Deepak L
Department of Internal Medicine, Hurley Medical Center, Michigan State University, Flint, MI, USA.
Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.
Cardiovasc Revasc Med. 2019 Oct;20(10):838-842. doi: 10.1016/j.carrev.2018.12.023. Epub 2019 Jan 4.
Transcatheter aortic valve replacement (TAVR) is a valid option for patients with high or intermediate surgical risk. However, clinical outcomes of TAVR in low-risk patients are lacking. Our aim was to evaluate the efficacy and safety of TAVR versus surgical aortic valve replacement (SAVR) in low-surgical-risk patients.
Electronic database review was conducted for all randomized clinical trials (RCTs) that compared TAVR versus SAVR in low-risk patients. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) using a random-effects model.
We included 3 RCTs totaling 604 patients (310 TAVR and 294 SAVR). Our results showed no significant difference in mortality between TAVR compared with SAVR (RR = 0.71; 95% CI = 0.22-2.30; P = 0.56), however, there was a significantly increased risk of pacemaker implantation (RR = 7.28; 95% CI = 3.94-13.42; P < 0.01) and moderate/severe paravalvular leakage (PVL) (RR = 6.74; 95% CI = 1.31-34.65; P = 0.02) with TAVR. Nevertheless, TAVR demonstrated a significantly reduced risk of post-procedural bleeding (RR = 0.40; 95% CI = 0.30-0.54; P < 0.01) and new-onset atrial fibrillation (RR = 0.36; 95% CI = 0.27-0.47; P < 0.01). Other clinical outcomes were not significantly different between the groups and included cardiovascular mortality, stroke, transient ischemic attack, and myocardial infarction.
Among low-risk patients, TAVR offered comparable efficacy outcomes and fewer bleeding events compared with SAVR. There were increased risks of pacemaker implantation and PVL associated with TAVR, though lower atrial fibrillation risks.
经导管主动脉瓣置换术（TAVR）是手术风险高或中等的患者的一种有效选择。然而，缺乏低风险患者TAVR的临床结果。我们的目的是评估低手术风险患者中TAVR与外科主动脉瓣置换术（SAVR）相比的疗效和安全性。
对所有比较低风险患者中TAVR与SAVR的随机临床试验（RCT）进行电子数据库检索。我们使用随机效应模型计算风险比（RR）和95%置信区间（CI）。
我们纳入了3项RCT，共604例患者（310例TAVR和294例SAVR）。我们的结果显示，TAVR与SAVR相比，死亡率无显著差异（RR = 0.71；95%CI = 0.22 - 2.30；P = 0.56），然而，TAVR导致起搏器植入风险显著增加（RR = 7.28；95%CI = 3.94 - 13.42；P < 0.01）以及中/重度瓣周漏（PVL）风险显著增加（RR = 6.74；95%CI = 1.31 - 34.65；P = 0.02）。尽管如此，TAVR显示术后出血风险显著降低（RR = 0.40；95%CI = 0.30 - 0.54；P < 0.01）以及新发房颤风险显著降低（RR = 0.36；95%CI = 0.27 - 0.47；P < 0.01）。两组之间的其他临床结果无显著差异，包括心血管死亡率、中风、短暂性脑缺血发作和心肌梗死。
在低风险患者中，与SAVR相比，TAVR具有相当的疗效结果且出血事件更少。TAVR与起搏器植入和PVL风险增加相关，不过房颤风险较低。
