Tam Derrick Y, Vo Thin Xuan, Wijeysundera Harindra C, Ko Dennis T, Rocha Rodolfo Vigil, Friedrich Jan, Fremes Stephen E
Division of Cardiac Surgery, Department of Surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
School of Medicine, Queen's University, Kingston, Ontario, Canada.
Can J Cardiol. 2017 Sep;33(9):1171-1179. doi: 10.1016/j.cjca.2017.06.005. Epub 2017 Jun 15.
Transcatheter aortic valve replacement (TAVR) has emerged as the treatment of choice for patients with severe aortic stenosis at high surgical risk; the role of TAVR compared with surgical aortic valve replacement (SAVR) in the low-intermediate surgical risk population remains uncertain. Our primary objective was to determine differences in 30-day and late mortality in patients treated with TAVR compared with SAVR at low-intermediate risk (Society of Thoracic Surgeons Predicted Risk of Mortality < 10%).
Medline and Embase were searched from 2010 to March 2017 for studies that compared TAVR with SAVR in the low-intermediate surgical risk population, restricted to randomized clinical trials and matched observational studies. Two investigators independently abstracted the data and a random effects meta-analysis was performed.
Four randomized clinical trials (n = 4042) and 9 propensity score-matched observational studies (n = 4192) were included in the meta-analysis (n = 8234). There was no difference in 30-day mortality between TAVR and SAVR (3.2% vs 3.1%, pooled risk ratio: 1.02; 95% confidence interval, 0.80-1.30; P = 0.89; I = 0%) or mortality at a median of 1.5-year follow-up (incident rate ratio: 1.01; 95% confidence interval, 0.90-1.15; P = 0.83; I = 0%). There was a higher risk of pacemaker implantation and greater than trace aortic insufficiency in the TAVR group whereas the risk of early stroke, atrial fibrillation, acute kidney injury, cardiogenic shock, and major bleeding was higher in the SAVR group.
Although there was no difference in 30-day and late mortality, the rate of complications differed between TAVR and SAVR in the low-intermediate surgical risk population.
经导管主动脉瓣置换术（TAVR）已成为手术风险高的严重主动脉瓣狭窄患者的首选治疗方法；在低-中度手术风险人群中，与外科主动脉瓣置换术（SAVR）相比，TAVR的作用仍不确定。我们的主要目标是确定低-中度风险（胸外科医师协会预测死亡率<10%）患者接受TAVR与SAVR治疗后30天及晚期死亡率的差异。
检索2010年至2017年3月期间的Medline和Embase数据库，查找在低-中度手术风险人群中比较TAVR与SAVR的研究，仅限于随机临床试验和匹配的观察性研究。两名研究人员独立提取数据并进行随机效应荟萃分析。
荟萃分析纳入了四项随机临床试验（n = 4042）和九项倾向评分匹配的观察性研究（n = 4192）（n = 8234）。TAVR与SAVR之间30天死亡率无差异（3.2%对3.1%，合并风险比：1.02；95%置信区间，0.80 - 1.30；P = 0.89；I² = 0%），或在中位1.5年随访时的死亡率（发生率比：1.01；95%置信区间，0.90 - 1.15；P = 0.83；I² = 0%）。TAVR组起搏器植入风险较高且主动脉瓣反流大于微量，而SAVR组早期卒中、心房颤动、急性肾损伤、心源性休克和大出血风险较高。
虽然30天和晚期死亡率无差异，但在低-中度手术风险人群中，TAVR与SAVR的并发症发生率不同。
