使用SAPIEN瓣膜进行瓣中瓣和环中瓣经导管二尖瓣置换术的汇总分析。
完整摘要 · 中文译文
背景：使用Sapien（Edwards Lifesciences，Irvine，CA）经导管心脏瓣膜进行的经导管二尖瓣置换术（TMVR）已成为合并人工二尖瓣生物瓣衰败或既往外科二尖瓣修复术的高危患者的首选治疗。瓣中瓣TMVR（ViV-TMVR）与瓣环中瓣TMVR（ViR-TMVR）在解剖结构和手术复杂性上的差异可能影响临床结局。 方法：我们系统检索了OVID Medline、Embase、SCOPUS、Web of Science和Cochrane数据库中2015年至2022年间发表的比较ViV-TMVR与ViR-TMVR的研究。主要终点为30天全因死亡率。次要结局包括院内死亡率、卒中、急性肾损伤、大出血、再次干预、左心室流出道梗阻和器械栓塞。采用随机效应模型合并结局。 结果：共分析了8项研究，包括1947例患者（瓣中瓣经导管二尖瓣置换术（ViV-TMVR）：1435例；瓣环中瓣经导管二尖瓣置换术（ViR-TMVR）：512例）。接受ViV-TMVR的患者年龄更大，基线合并症负担更重。两组在30天死亡率（比值比[OR]：0.70 [95% CI: 0.47-1.05]；I2=0%）和院内死亡率（OR：1.05 [95% CI: 0.34-3.21]；I2=3%）方面未观察到显著差异。同样，卒中、大出血和装置栓塞在两组间也无显著差异。然而，ViV-TMVR与较低的左心室流出道梗阻（OR：0.30 [95% CI: 0.18-0.51]）、再次干预（OR：0.19 [95% CI: 0.13-0.30]）和急性肾损伤（OR：0.51 [95% CI: 0.29-0.90]）发生率相关，且无异质性。 结论：与ViR-TMVR相比，ViV-TMVR与较低的左心室流出道梗阻、再次干预和急性肾损伤发生率相关，而死亡率和其他主要并发症相当。这些发现可为经导管二尖瓣介入治疗的患者选择和手术规划提供参考。
完整摘要 · 英文原文
BACKGROUND: Transcatheter mitral valve replacement (TMVR) using the Sapien (Edwards Lifesciences, Irvine, CA) transcatheter heart valve has become the preferred treatment for high-risk patients with failed mitral bioprosthetic valves or prior surgical mitral valve repairs. Differences in anatomy and procedural complexity between valve-in-valve TMVR (ViV-TMVR) and valve-in-ring TMVR (ViR-TMVR) may influence clinical outcomes. METHODS: We systematically searched OVID Medline, Embase, SCOPUS, Web of Science, and Cochrane for studies published between 2015 and 2022 comparing ViV-TMVR and ViR-TMVR. The primary end point was 30-day all-cause mortality. Secondary outcomes included in-hospital mortality, stroke, acute kidney injury, major bleeding, reintervention, left ventricular outflow tract obstruction, and device embolization. Random-effects models were used to pool outcomes. RESULTS: Eight studies including 1947 patients (ViV-TMVR: 1435; ViR-TMVR: 512) were analyzed. Patients undergoing ViV-TMVR were older and had a greater baseline comorbidity burden. No significant differences were observed in 30-day mortality (odds ratio [OR]: 0.70 [95% CI: 0.47-1.05]; I2=0%) or in-hospital mortality (OR: 1.05 [95% CI: 0.34-3.21]; I2=3%). Similarly, stroke, major bleeding, and device embolization did not differ significantly between groups. However, ViV-TMVR was associated with lower rates of left ventricular outflow tract obstruction (OR: 0.30 [95% CI: 0.18-0.51]), reintervention (OR: 0.19 [95% CI: 0.13-0.30]), and acute kidney injury (OR: 0.51 [95% CI: 0.29-0.90]), with no significant heterogeneity. CONCLUSIONS: Compared with ViR-TMVR, ViV-TMVR was associated with lower rates of left ventricular outflow tract obstruction, reintervention, and acute kidney injury, whereas mortality and other major complications were comparable. These findings may inform patient selection and procedural planning for transcatheter mitral valve interventions.