经导管主动脉瓣植入术后并发症的发生率和预测因素——依据VARC-3标准：一项系统评价与Meta分析。
完整摘要 · 中文译文
背景：尽管器械和技术不断进步，经导管主动脉瓣植入术仍伴有影响预后的并发症。2021年，瓣膜学术研究联盟（VARC）引入了VARC-3标准，以更好地对手术并发症进行分类。 方法：我们对2021年至2025年间采用VARC-3定义报告经导管主动脉瓣植入术相关并发症的研究进行了系统评价和荟萃分析。主要终点为末次随访时的全因死亡率。次要终点包括主要VARC-3并发症及不良事件的预测因素。 结果：共纳入57项研究，涉及73 588例患者。该队列平均年龄为81.7岁，51.7%为女性，大多数患者射血分数保留（55.5%），手术风险为低至中度（胸外科医师学会[STS]预测死亡风险[PROM] 4.1%）。技术成功率和30天器械成功率分别为95%和90%；30天早期安全率为66%。在平均12个月随访时，全因死亡率为10.2%。最常见的并发症是永久性起搏器植入（13%），其次为2级或以上出血（9.7%）、3-4期急性肾损伤（4.7%）、主要血管事件（4.3%）和卒中（3.0%）。中重度瓣周反流和患者-人工瓣膜不匹配分别发生于4%和8%的患者中。研究层面的合并预测因素分析显示，急性肾损伤、2级或以上出血、瓣周反流、非结构性瓣膜功能障碍及较 r STS评分与更高的死亡率相关，而偏心性/重度主动脉瓣钙化与显著的瓣周反流相关。 结论：经导管主动脉瓣植入术在VARC-3标准下显示出较高的手术成功率，但并发症发生率不可忽视。急性肾损伤、2级或以上出血、NSVD、围手术期卒中以及经导管主动脉瓣植入术后的心肌梗死与更高的死亡率相关。
完整摘要 · 英文原文
BACKGROUND: Despite continuous advancements in devices and techniques, transcatheter aortic valve implantation remains associated with complications impacting outcomes. In 2021, the Valve Academic Research Consortium (VARC) introduced the VARC-3 criteria to better classify procedural complications. METHODS: We conducted a systematic review and meta-analysis of studies reporting transcatheter aortic valve implantation-related complications using VARC-3 definitions between 2021 and 2025. The primary end point was all-cause mortality at latest follow-up. Secondary end points included major VARC-3 complications and predictors of adverse events. RESULTS: A total of 57 studies with 73 588 patients were included. The cohort had a mean age of 81.7 years, 51.7% were women, and most had preserved ejection fraction (55.5%) and low-to-moderate surgical risk (Society of Thoracic Surgeons [STS] predicted risk of mortality [PROM] 4.1%). Technical and 30-day device success rates were 95% and 90%, respectively; early safety rate at 30 days was 66%. At average 12 months follow-up, all-cause mortality was 10.2%. The most common complication was permanent pacemaker implantation (13%), followed by type 2 or greater bleeding (9.7%), acute kidney injury stage 3-4 (4.7%), major vascular events (4.3%), and stroke (3.0%). Moderate/severe paravalvular regurgitation and patient-prosthesis mismatch occurred in 4% and 8%, respectively. Study-level pooled predictor analyses showed that acute kidney injury, type 2 or greater bleeding, paravalvular regurgitation, non-structural valve dysfunction, and higher STS score were associated with higher mortality, while eccentric/severe aortic valve calcification was associated with significant paravalvular regurgitation. CONCLUSIONS: Transcatheter aortic valve implantation shows high procedural success but non-negligible complication rates under VARC-3 criteria. acute kidney injury, type 2 or greater bleeding, NSVD, periprocedural stroke and myocardial infarction after transcatheter aortic valve implantation were associated with higher mortality.