Ahmed Mushood, Ahsan Areeba, Shafiq Aimen, Nadeem Zain A, Arif Fariha, Zulfiqar Eeshal, Kazmi Muhammad H, Yadav Rukesh, Jain Hritvik, Ahmed Raheel, Alam Mahboob, Shahid Farhan
Rawalpindi Medical University, Rawalpindi, Pakistan.
Foundation University School of Health Sciences, Islamabad, Pakistan.
Int J Surg. 2024 Dec 1;110(12):8097-8106. doi: 10.1097/JS9.0000000000002158.
Surgical aortic valve replacement (SAVR) is the commonly used approach for aortic valve replacement (AVR) in patients with aortic stenosis at low or intermediate surgical risk. However, transcatheter aortic valve replacement (TAVR) has emerged as an alternative to SAVR for AVR. This meta-analysis aims to assess the comparative efficacy and safety of TAVR versus SAVR in low-to-intermediate surgical risk patients by analyzing temporal trends in the outcomes of TAVR and SAVR at various follow-up intervals, providing a more detailed understanding.
A thorough literature search was performed across PubMed/MEDLINE, Embase, and the Cochrane Library from their inception up to May 2024 to identify eligible randomized controlled trials (RCTs). Clinical outcomes were evaluated using a random-effects model to pool risk ratios (RRs) with 95% CIs.
A total of 17 studies reporting data at different follow-ups for nine trials were included (n=9092). No statistically significant difference was observed between TAVR and SAVR for reducing all-cause death at 30 days, 1 year, and 2 years but significantly increased risk with TAVR at 5 years or longer follow-up (RR=1.13, 95% CI: 1.03-1.23). However, TAVR was associated with a significantly decreased risk for cardiac death at 1-year follow-up (RR=0.79, 95% CI: 0.64-0.96) and comparable risk for cardiac death at 30 days, 2 years, and 5 years or longer follow-up when compared with SAVR. No statistically significant difference was observed between TAVR and SAVR for reducing the risk of myocardial infarction (MI) at 30 days, 1 year, 2 years, and 5 years or longer follow-up.TAVR was associated with a significantly lower risk of major bleeding events at 30 days (RR=0.38, 95% CI: 0.21-0.67); lower risk of acute kidney injury (AKI) at 30 days (RR=0.38, 95% CI: 0.26-0.54) and 1 year (RR=0.58, 95% CI: 0.41-0.82) and lower risk of new onset or worsening atrial fibrillation (AF) at 30 days (RR=0.25, 95% CI: 0.18-0.34), 1 year (RR=0.26, 95% CI: 0.16-0.41) and 2 years (RR=0.32, 95% CI: 0.20-0.49) when compared with SAVR. However, TAVR was associated with a significantly increased risk of permanent pacemaker implantation (PPI) at 30 days (RR: 2.62, 95% CI: 1.40-4.91), at 1 year (RR: 2.19, 95% CI: 1.24-3.87), at 2 years (RR: 2.74, 95% CI: 1.31-5.71), and beyond 5 years (RR: 1.95, 95% CI: 1.20-3.15). TAVR was also associated with a significantly increased risk of prosthetic valve thrombosis at 2 years (RR=2.70, 95% CI: 1.08-6.71), though no significant association was observed at 30 days, 1 year, or 5 years. Similarly, no significant differences were observed in aortic-valve reintervention rates at 30 days, 2 years, or 5 years, but TAVR showed a significantly increased risk at 1 year (RR=1.98, 95% CI: 1.21-3.24). TAVR was associated with a significantly increased risk of major vascular complications at 30 days (RR=2.37, 95% CI: 1.38-4.04) and a significantly increased risk of TIA at 2 years (RR: 1.43, 95% CI: 1.02-2.00, I2=0%). The risk of hospitalizations was comparable between the groups.
TAVR and SAVR demonstrated comparable rates of all-cause death up to 2 years of follow-up. However, at 5 years or longer follow-up, TAVR was associated with a higher risk of all-cause death. While TAVR showed certain procedural advantages, such as a lower risk of major bleeding, AKI, and new-onset or worsening AF, the choice between TAVR and SAVR in patients with low or intermediate surgical risk should consider long-term outcomes, with SAVR potentially being more favorable due to better survival observed on longer follow-up durations.
对于手术风险较低或中等的主动脉瓣狭窄患者,外科主动脉瓣置换术(SAVR)是常用的主动脉瓣置换(AVR)方法。然而,经导管主动脉瓣置换术(TAVR)已成为AVR替代SAVR的一种选择。本荟萃分析旨在通过分析TAVR和SAVR在不同随访间隔的结局时间趋势,评估TAVR与SAVR在低至中等手术风险患者中的相对疗效和安全性,以提供更详细的了解。
从创刊至2024年5月,在PubMed/MEDLINE、Embase和Cochrane图书馆进行了全面的文献检索,以确定符合条件的随机对照试验(RCT)。使用随机效应模型评估临床结局,汇总风险比(RR)及95%置信区间(CI)。
共纳入17项研究,这些研究报告了9项试验在不同随访时间的数据(n=9092)。在30天、1年和2年时,TAVR和SAVR在降低全因死亡方面无统计学显著差异,但在5年或更长时间的随访中,TAVR的风险显著增加(RR=1.13,95%CI:1.03-1.23)。然而,与SAVR相比,TAVR在1年随访时心脏死亡风险显著降低(RR=0.79,95%CI:0.64-0.96),在30天、2年和5年或更长时间的随访中,心脏死亡风险相当。在30天、1年、2年和5年或更长时间的随访中,TAVR和SAVR在降低心肌梗死(MI)风险方面无统计学显著差异。TAVR在30天时主要出血事件风险显著较低(RR=0.38,95%CI:0.21-0.67);在30天(RR=0.38,95%CI:0.26-0.54)和1年(RR=0.58,95%CI:0.41-0.82)时急性肾损伤(AKI)风险较低,在30天(RR=0.25,95%CI:0.18-0.34)、1年(RR=0.26,95%CI:0.16-0.41)和2年(RR=0.32,95%CI:0.20-0.49)时新发或恶化心房颤动(AF)风险较低,与SAVR相比。然而,TAVR在30天(RR:2.62,95%CI:1.40-4.91)、1年(RR:2.19,95%CI:1.24-3.87)、2年(RR:2.74,95%CI:1.31-5.71)和5年以上(RR:1.95,95%CI:1.20-3.15)时永久起搏器植入(PPI)风险显著增加。TAVR在2年时人工瓣膜血栓形成风险也显著增加(RR=2.70,95%CI:1.08-6.71),尽管在30天、1年或5年时未观察到显著关联。同样,在30天、2年或5年时主动脉瓣再次干预率无显著差异,但TAVR在1年时风险显著增加(RR=1.98,95%CI:1.21-3.24)。TAVR在30天时主要血管并发症风险显著增加(RR=2.37,95%CI:1.38-4.04),在2年时短暂性脑缺血发作(TIA)风险显著增加(RR:1.43,95%CI:1.02-2.00,I2=0%)。两组住院风险相当。
在长达2年的随访中,TAVR和SAVR的全因死亡率相当。然而,在5年或更长时间的随访中,TAVR的全因死亡风险更高。虽然TAVR显示出某些手术优势,如主要出血、AKI和新发或恶化AF风险较低,但对于低或中等手术风险患者,TAVR和SAVR的选择应考虑长期结局,由于在更长随访期观察到更好的生存率,SAVR可能更有利。