Kałmucki Piotr, Lipiecki Janusz, Witte Klaus K, Goldberg Steven L, Baszko Artur, Siminiak Tomasz
Poznan University of Medical Sciences, HCP Medical Center, Poznan, Poland.
Clinique Pôle Santé République, Clermont Ferrand, France.
Am Heart J. 2023 Nov;265:137-142. doi: 10.1016/j.ahj.2023.07.010. Epub 2023 Jul 27.
It has been suggested that the disparity of outcomes between the studies of transcutaneous edge-to-edge repair (TEER) for functional mitral regurgitation (FMR) in heart failure with reduced ejection fraction (HFrEF) could be due to systematic differences in the populations studied. One proposal is that there are 2 broad groups: those with proportional FMR who respond less favorably, and those in whom the FMR is greater than expected (disproportionate) FMR where edge-to-edge TEER seems to be more effective. Whether this grouping is relevant for other percutaneous interventions for FMR is unknown.
We sought to compare clinical and echocardiographic outcomes of patients with HFrEF and proportionate and disproportionate FMR treated with indirect annuloplasty using the Carillon device.
This is a pooled analysis from 3 trials of patients with FMR. Key patient eligibility in these trials specified persistent grade 2+ to 4+ FMR with >5.5 cm left ventricular (LV) end-diastolic diameter (LVEDD) and reduced ejection fraction. Patients with an effective regurgitant orifice area/LV end-diastolic volume (EROA/LVEDV) ratio under 0.15 were assigned to the proportionate FMR group (n = 74;65%) and those with a ratio above 0.15 were classed as having disproportionate FMR (n = 39;35%).
At 12 months following treatment, both groups showed improvements in all MR variables including regurgitation volume, EROA and vena contracta. Moreover, in patients with proportionate MR there were clinically relevant and statistically significant improvements in LV volumes and diameters. There was no independent relationship between the degree of proportionality as a continuous variable and the remodeling response to Carillon therapy (change in LVEDV r = 0.17; change in LVESV r = 0.14).
Percutaneous mitral annuloplasty with the Carillon device reduces MR in patients with both proportionate and disproportionate FMR, and also results in LV reverse remodeling in those with proportionate FMR. The effect on remodeling remains to be verified in a large-scale trial.
有研究表明，射血分数降低的心力衰竭（HFrEF）患者中，经皮边缘对边缘修复术（TEER）治疗功能性二尖瓣反流（FMR）的研究结果存在差异，这可能是由于所研究人群的系统差异所致。一种观点认为存在两大类人群：一类是比例性FMR患者，其反应较差；另一类是FMR大于预期（不成比例）的FMR患者，边缘对边缘TEER似乎更有效。这种分组对于FMR的其他经皮干预是否相关尚不清楚。
我们试图比较使用Carillon装置进行间接瓣环成形术治疗的HFrEF患者以及比例性和非比例性FMR患者的临床和超声心动图结果。
这是一项对3项FMR患者试验的汇总分析。这些试验的关键患者入选标准为持续性2+至4+级FMR、左心室（LV）舒张末期直径（LVEDD）>5.5 cm且射血分数降低。有效反流口面积/左心室舒张末期容积（EROA/LVEDV）比值低于0.15的患者被分配到比例性FMR组（n = 74；65%），比值高于0.15的患者被归类为非比例性FMR（n = 39；35%）。
治疗后12个月，两组的所有二尖瓣反流变量均有改善，包括反流容积、EROA和反流束宽度。此外，比例性二尖瓣反流患者的左心室容积和直径有临床相关且具有统计学意义的改善。作为连续变量的比例程度与对Carillon治疗的重塑反应之间没有独立关系（LVEDV变化r = 0.17；LVESV变化r = 0.14）。
使用Carillon装置进行经皮二尖瓣瓣环成形术可降低比例性和非比例性FMR患者的二尖瓣反流，并且在比例性FMR患者中还可导致左心室逆向重塑。对重塑的影响仍有待大规模试验验证。
