Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas, USA.
Catheter Cardiovasc Interv. 2023 Sep;102(3):521-527. doi: 10.1002/ccd.30772. Epub 2023 Jul 26.
There is a paucity of data regarding the comparative efficacy and safety of Mitral valve transcatheter edge-to-edge repair (MTEER) using the PASCAL or MitraClip systems for patients with mitral regurgitation (MR).
An electronic search was conducted for MEDLINE, COCHRANE, and EMBASE, through February 2023, for studies comparing the clinical outcomes of MTEER using PASCAL versus MitraClip systems among patients with severe MR. The primary study outcome was residual MR ≤ 2 at discharge. Data were pooled using a random-effects model.
The final analysis included six studies with a total of 1581 patients, with a weighted follow-up period of 3.5 months. Two studies only included patients with degenerative MR, while the remaining studies included both degenerative and functional MR. There was no significant difference in procedure duration between MTEER with the PASCAL or MitraClip systems. There was no difference in residual MR ≤ 2 at discharge (94.7% vs. 91.9%; odds ratio [OR]: 1.44; 95% confidence interval [CI]: 0.92-2.27) or residual MR ≤ 2 at the mid-term follow-up (94.6% vs. 91.0%, p = 0.05) among the PASCAL versus MitraClip systems. There was no difference between both groups in residual MR ≤ 1 at discharge (73.1% vs. 63.8%, p = 0.12), while there was greater incidence of residual MR ≤ 1 at midterm follow-up with the PASCAL system (71.3% vs. 56.2%, p < 0.001). There was no difference between the PASCAL and MitraClip MTEER systems in technical success (97.0% vs. 97.9%, p = 0.15), procedural success (89.1% vs. 87.1%, p = 0.78), single leaflet detachment (1.8% vs. 1.4%, p = 0.55), or all-cause mortality (3.6% vs. 4.6%, p = 0.71).
In this meta-analysis, we demonstrated comparable efficacy and safety between the PASCAL and MitraClip MTEER systems at short- and mid-term assessments. Randomized trials are warranted to evaluate the comparative long-term outcomes between both MTEER systems.
关于二尖瓣经导管缘对缘修复术（MTEER）使用 PASCAL 或 MitraClip 系统治疗二尖瓣反流（MR）患者的疗效和安全性比较，数据有限。
通过电子检索 MEDLINE、COCHRANE 和 EMBASE，检索时间截至 2023 年 2 月，比较 MTEER 使用 PASCAL 与 MitraClip 系统治疗重度 MR 患者的临床结局的研究。主要研究结局为出院时残余 MR≤2。采用随机效应模型进行数据合并。
最终分析纳入了 6 项研究，共 1581 例患者，加权随访时间为 3.5 个月。有 2 项研究仅纳入退行性 MR 患者，其余研究均纳入退行性和功能性 MR 患者。PASCAL 与 MitraClip 系统行 MTEER 的手术时间无显著差异。出院时残余 MR≤2 的比例（94.7% vs. 91.9%；比值比[OR]：1.44；95%置信区间[CI]：0.92-2.27）或中期随访时残余 MR≤2 的比例（94.6% vs. 91.0%，p=0.05）在 PASCAL 与 MitraClip 系统之间无差异。两组出院时残余 MR≤1 的比例（73.1% vs. 63.8%，p=0.12）无差异，而 PASCAL 系统在中期随访时残余 MR≤1 的发生率更高（71.3% vs. 56.2%，p<0.001）。PASCAL 和 MitraClip MTEER 系统在技术成功率（97.0% vs. 97.9%，p=0.15）、手术成功率（89.1% vs. 87.1%，p=0.78）、单叶瓣脱（1.8% vs. 1.4%，p=0.55）或全因死亡率（3.6% vs. 4.6%，p=0.71）方面无差异。
在这项荟萃分析中，我们在短期和中期评估中证明了 PASCAL 和 MitraClip MTEER 系统的疗效和安全性相当。需要进行随机试验来评估这两种 MTEER 系统的长期比较结局。
