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低中手术风险人群中经导管主动脉瓣置换术(TAVR)与外科主动脉瓣置换术(SAVR)治疗重度主动脉瓣狭窄的比较:一项更新的荟萃分析、荟萃回归分析和试验序贯分析

TAVR vs. SAVR for severe aortic stenosis in the low and intermediate surgical risk population: An updated meta-analysis, meta-regression, and trial sequential analysis.

作者信息

Krishna Mrinal Murali, Joseph Meghna, Ezenna Chidubem, Pereira Vinicius, Rossi Raiza, Akman Zafer, Rubens Muni, Mahadevan Vaikom S, Nanna Michael G, Goldsweig Andrew M

机构信息

Department of Medicine, Medical College Thiruvananthapuram, India. Electronic address: https://twitter.com/MrinalMkrishna.

Department of Medicine, Medical College Thiruvananthapuram, India. Electronic address: https://twitter.com/meg_joe_.

出版信息

Cardiovasc Revasc Med. 2025 May 20. doi: 10.1016/j.carrev.2025.05.021.

Abstract

BACKGROUND

Guidelines recommend transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for patients of age > 65 years. The relative risks and benefits of TAVR vs. SAVR in low and intermediate surgical risk remain incompletely described.

METHODS

A systematic search of PubMed, Scopus, and Cochrane Central databases identified randomized controlled trials (RCTs) comparing clinical outcomes of TAVR vs. SAVR in low and intermediate surgical risk.

RESULTS

Ten RCTs (9239 patients, TAVR 50.8 %) were included. TAVR was associated with lower rates of all-cause death or stroke at 30-day (rate ratio [RR] 0.70; 95%CI 0.55-0.89; p = 0.003; I = 26 %) and 1-year (RR 0.77; 95%CI 0.60-0.98; p = 0.033; I = 54 %) follow-up. Bleeding complications, new-onset atrial fibrillation (AF), acute kidney injury (AKI), and severe patient-prosthesis mismatch (PPM) were lower with TAVR at 30 days and 1-year. Permanent pacemaker implantation, aortic valve reintervention, major vascular complications, and paravalvular leak (PVL) were significantly higher with TAVR at 30-day and 1-year follow-ups. Rates of all-cause death, stroke, MI, endocarditis, and rehospitalization were comparable between the groups at 30-day and 1-year follow-up.

CONCLUSION

In patients with severe AS and low to intermediate surgical risk, TAVR is associated with reduced rates of all-cause death or stroke, bleeding, new-onset AF, AKI, and severe PPM compared to SAVR. However, despite these short-term benefits, higher rates of permanent pacemaker implantation, PVL, and reintervention raise significant concerns about the long-term safety of TAVR, particularly for younger, lower-risk patients.

摘要

背景

指南推荐对年龄>65岁的患者进行经导管主动脉瓣置换术(TAVR)或外科主动脉瓣置换术(SAVR)。TAVR与SAVR在低手术风险和中等手术风险患者中的相对风险和获益仍未完全阐明。

方法

对PubMed、Scopus和Cochrane Central数据库进行系统检索,以确定比较TAVR与SAVR在低手术风险和中等手术风险患者中临床结局的随机对照试验(RCT)。

结果

纳入了10项RCT(9239例患者,TAVR组占50.8%)。在30天(率比[RR]0.70;95%置信区间[CI]0.55 - 0.89;p = 0.003;I² = 26%)和1年(RR 0.77;95%CI 0.60 - 0.98;p = 0.033;I² = 54%)随访时,TAVR与全因死亡或卒中发生率较低相关。在30天和1年时,TAVR的出血并发症、新发心房颤动(AF)、急性肾损伤(AKI)和严重患者-人工瓣膜不匹配(PPM)发生率较低。在30天和1年随访时,TAVR的永久起搏器植入、主动脉瓣再次干预、主要血管并发症和瓣周漏(PVL)发生率显著较高。在30天和1年随访时,两组间的全因死亡、卒中、心肌梗死、心内膜炎和再住院率相当。

结论

在重度主动脉瓣狭窄且手术风险低至中等的患者中,与SAVR相比,TAVR与全因死亡或卒中、出血、新发AF、AKI和严重PPM发生率降低相关。然而,尽管有这些短期获益,但永久起搏器植入、PVL和再次干预的较高发生率引发了对TAVR长期安全性的重大担忧,尤其是对于年轻、低风险患者。

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