University of Erlangen-Nuremberg, Erlangen, Germany.
University of Bonn, Bonn, Germany.
BMC Cardiovasc Disord. 2024 Oct 14;24(1):557. doi: 10.1186/s12872-024-04201-6.
The edge-to-edge transcatheter tricuspid valve repair (TTVR) has emerged as a promising technique for the treatment of tricuspid regurgitation (TR). Despite its potential, comparative data on the performance of the novel edge-to-edge devices-MitraClip, PASCAL, and TriClip-remain controversial. In this study, we aim to evaluate the safety and efficacy of these devices in treating TR.
Five databases were systematically searched up to May 2023, with an updated search conducted in May 2024. Only original studies were included in the analysis and were critically evaluated using an adapted version of the Newcastle-Ottawa Scale (NOS) for observational cohort studies and the Cochrane Risk of Bias (ROB) tool for randomized controlled trials.
The database search yielded 2239 studies, out of which 21 studies were included in the final analysis. These studies encompassed a total of 2178 patients who underwent TTVR using either the MitraClip, TriClip, or PASCAL devices. The risk of bias across these studies ranged from moderate to high. No significant differences were found among the three devices in terms of effective regurgitant orifice area (EROA) and tricuspid regurgitant volume. However, TriClip demonstrated statistically superior efficacy in reducing vena contracta compared to both MitraClip and PASCAL (P < 0.01) [TriClip: (MD = -7.4; 95% CI: -9.24, -5.56), MitraClip: (MD = -4.04; 95% CI: -5.03, -3.05), and PASCAL: (MD = -6.56; 95% CI: -7.76, -5.35)]. The procedural success rates and incidence of single leaflet device attachment (SLDA) were similar across all devices. Furthermore, there were no significant differences in mortality, stroke rates, or major bleeding events among the three devices.
The TriClip outperforms the MitraClip and PASCAL in reducing vena contracta width, indicating greater effectiveness for severe tricuspid regurgitation. All devices show similar safety profiles and procedural success rates. Further research is needed to confirm these results.
经导管三尖瓣缘对缘修复术（TTVR）已成为治疗三尖瓣反流（TR）的一种很有前途的技术。尽管有这种潜力，但新型缘对缘装置（MitraClip、PASCAL 和 TriClip）的性能比较数据仍存在争议。本研究旨在评估这些器械治疗 TR 的安全性和有效性。
系统检索了五个数据库，截至 2023 年 5 月，并于 2024 年 5 月进行了更新检索。仅纳入分析原始研究，并使用改良的纽卡斯尔-渥太华量表（NOS）对观察性队列研究和 Cochrane 偏倚风险（ROB）工具对随机对照试验进行严格评估。
数据库检索产生了 2239 项研究，其中 21 项研究纳入最终分析。这些研究共纳入 2178 例接受 MitraClip、TriClip 或 PASCAL 器械进行 TTVR 的患者。这些研究的偏倚风险从中度到高度不等。在有效反流口面积（EROA）和三尖瓣反流容积方面，三种器械之间没有显著差异。然而，TriClip 在减小收缩期瓣环宽度方面显示出优于 MitraClip 和 PASCAL 的统计学优势（P<0.01）[TriClip：（MD=-7.4；95%CI：-9.24，-5.56），MitraClip：（MD=-4.04；95%CI：-5.03，-3.05）和 PASCAL：（MD=-6.56；95%CI：-7.76，-5.35）]。所有器械的手术成功率和单叶瓣装置附着发生率相似。此外，三种器械的死亡率、卒中和大出血事件发生率也无显著差异。
TriClip 在减小收缩期瓣环宽度方面优于 MitraClip 和 PASCAL，表明对严重 TR 更有效。所有器械的安全性和手术成功率相似。需要进一步研究来证实这些结果。
