Zhao Peng-Ying, Wang Yong-Hong, Liu Rui-Sheng, Zhu Ji-Hai, Wu Jian-Ying, Song Bing
Department of Cardiovascular Surgery, Lanzhou University First Affiliated Hospital, Lanzhou, China.
Department of Cardiovascular Surgery, Qinghai University Affiliated Hospital, Xi'ning, China.
Medicine (Baltimore). 2021 Jul 16;100(28):e26556. doi: 10.1097/MD.0000000000026556.
Currently, transcatheter aortic valve implantation (TAVI) as an effective and convenient intervention has been adopted extensively for patients with severe aortic disease. However, the efficacy and safety of TAVI have not yet been well evaluated and its noninferiority compared with traditional surgical aortic valve replacement (sAVR) still lack sufficient evidence. This meta-analysis was designed to comprehensively compare the noninferiority of TAVI with sAVR for patients with severe aortic disease.
A systematic search of PubMed, Embase, Cochrane Library, and Web of Science up to October 1, 2020 was conducted for relevant studies that comparing TAVI and sAVR in the treatment of severe aortic disease. The primary outcomes were early, midterm and long term mortality. The secondary outcomes included early complications and other late outcomes. Two reviewers assessed trial quality and extracted the data independently. All statistical analyzes were performed using the standard statistical procedures provided in Review Manager 5.2.
A total of 16 studies including 14394 patients were identified. There was no difference in 30-day, 1-year, 2-year, and 5-year all-cause or cardiovascular mortality as well as stroke between TAVI and sAVR. Regarding to the 30-day outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of myocardial infarction (risk ratio [RR] 0.62; 95% confidence interval [CI] 0.40-0.97; 5441 pts), cardiogenic shock (RR 0.34; 95% CI 0.19-0.59; 1936 pts), acute kidney injury (AKI) > stage 2 (RR 0.37; 95% CI 0.25-0.54; 5371 pts), and new-onset atrial fibrillation (NOAF) (RR 0.29; 95% CI 0.24-0.35; 5371 pts) respectively, but higher incidence of permanent pacemaker implantation (RR 3.16; 95% CI 1.61-6.21; 5441 pts) and major vascular complications (RR 2.22; 95% CI 1.14-4.32; 5371 pts). Regarding to the 1- and 2-year outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of NOAF, but higher incidence of neurological events, transient ischemic attacks (TIA), permanent pacemaker and major vascular complications respectively. Regarding to the 5-year outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of NOAF, but higher incidence of TIA and reintervention respectively.
Our analysis shows that TAVI was equal to sAVR in early, midterm and long term mortality for patients with severe aortic disease. In addition, TAVI may be favorable in reducing the incidence of both early, midterm and long term NOAF. However, pooled results showed superiority of sAVR in reducing permanent pacemaker implantation, neurological events, TIA, major vascular complications and reintervention.
目前，经导管主动脉瓣植入术（TAVI）作为一种有效且便捷的干预措施，已被广泛应用于严重主动脉疾病患者。然而，TAVI的疗效和安全性尚未得到充分评估，其与传统外科主动脉瓣置换术（sAVR）相比的非劣效性仍缺乏足够证据。本荟萃分析旨在全面比较TAVI与sAVR治疗严重主动脉疾病患者的非劣效性。
截至2020年10月1日，对PubMed、Embase、Cochrane图书馆和科学网进行系统检索，以查找比较TAVI和sAVR治疗严重主动脉疾病的相关研究。主要结局为早期、中期和长期死亡率。次要结局包括早期并发症和其他晚期结局。两名研究者独立评估试验质量并提取数据。所有统计分析均使用Review Manager 5.2中提供的标准统计程序进行。
共纳入16项研究，包括14394例患者。TAVI与sAVR在30天、1年、2年和5年的全因死亡率、心血管死亡率以及卒中方面无差异。关于30天结局，与sAVR相比，TAVI的心肌梗死发生率显著较低（风险比[RR]0.62；95%置信区间[CI]0.40 - 0.97；5441例患者）、心源性休克发生率较低（RR 0.34；95% CI 0.19 - 0.59；1936例患者）、急性肾损伤（AKI）>2期发生率较低（RR 0.37；95% CI 0.25 - 0.54；5371例患者）以及新发房颤（NOAF）发生率较低（RR 0.29；95% CI 0.24 - 0.35；5371例患者），但永久性起搏器植入发生率较高（RR 3.16；95% CI 1.61 - 6.21；5441例患者）和主要血管并发症发生率较高（RR 2.22；95% CI 1.14 - 4.32；5371例患者）。关于1年和2年结局，与sAVR相比，TAVI的NOAF发生率显著较低，但神经事件、短暂性脑缺血发作（TIA）、永久性起搏器和主要血管并发症发生率较高。关于5年结局，与sAVR相比，TAVI的NOAF发生率显著较低，但TIA和再次干预发生率较高。
我们的分析表明，对于严重主动脉疾病患者，TAVI在早期、中期和长期死亡率方面与sAVR相当。此外，TAVI可能有利于降低早期、中期和长期NOAF的发生率。然而，汇总结果显示sAVR在减少永久性起搏器植入、神经事件、TIA、主要血管并发症和再次干预方面具有优势。
