Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, United Kingdom.
Clinique Pôle Sanioyté République, Clermont Ferrand, France.
JACC Heart Fail. 2019 Nov;7(11):945-955. doi: 10.1016/j.jchf.2019.06.011. Epub 2019 Sep 11.
This study sought to evaluate the effects of the Carillon device on mitral regurgitation severity and left ventricular remodeling.
Functional mitral regurgitation (FMR) complicates heart failure with reduced ejection fraction and is associated with a poor prognosis.
In this blinded, randomized, proof-of-concept, sham-controlled trial, 120 patients receiving optimal heart failure medical therapy were assigned to a coronary sinus-based mitral annular reduction approach for FMR or sham. The pre-specified primary endpoint was change in mitral regurgitant volume at 12 months, measured by quantitative echocardiography according to an intention-to-treat analysis.
Patients (69.8 ± 9.5 years of age) were randomized to either the treatment (n = 87) or the sham-controlled (n = 33) arm. There were no significant differences in baseline characteristics between the groups. In the treatment group, 73 of 87 (84%) had the device implanted. The primary endpoint was met, with a statistically significant reduction in mitral regurgitant volume in the treatment group compared to the control group (decrease of 7.1 ml/beat [95% confidence interval [CI]: -11.7 to -2.5] vs. an increase of 3.3 ml/beat [95% CI: -6.0 to 12.6], respectively; p = 0.049). Additionally, there was a significant reduction in left ventricular volumes in patients receiving the device versus those in the control group (left ventricular end-diastolic volume decrease of 10.4 ml [95% CI: -18.5 to -2.4] vs. an increase of 6.5 ml [95% CI: -5.1 to 18.2]; p = 0.03 and left ventricular end-systolic volume decrease of 6.2 ml [95% CI: -12.8 to 0.4] vs. an increase of 6.1 ml [95% CI: -1.42 to 13.6]; p = 0.04).
The Carillon device significantly reduced mitral regurgitant volume and left ventricular volumes in symptomatic patients with functional mitral regurgitation receiving optimal medical therapy. (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation [REDUCE FMR]; NCT02325830).
本研究旨在评估 Carillon 装置对二尖瓣反流严重程度和左心室重构的影响。
功能性二尖瓣反流（FMR）合并射血分数降低的心力衰竭，并与预后不良相关。
在这项盲法、随机、概念验证、假对照试验中，120 名接受最佳心力衰竭药物治疗的患者被分配至接受基于冠状窦的二尖瓣环减少术治疗 FMR 或假手术。主要终点是根据意向治疗分析，通过定量超声心动图测量 12 个月时二尖瓣反流容积的变化。
患者（69.8±9.5 岁）被随机分为治疗组（n=87）或假手术对照组（n=33）。两组之间的基线特征无显著差异。在治疗组中，87 例中有 73 例（84%）植入了该设备。主要终点得到满足，与对照组相比，治疗组的二尖瓣反流容积有统计学显著减少（减少 7.1ml/搏[95%置信区间（CI）：-11.7 至-2.5]与增加 3.3ml/搏[95%CI：-6.0 至 12.6]；p=0.049）。此外，与对照组相比，接受该设备治疗的患者的左心室容积有显著减少（左心室舒张末期容积减少 10.4ml[95%CI：-18.5 至-2.4]与增加 6.5ml[95%CI：-5.1 至 18.2]；p=0.03 和左心室收缩末期容积减少 6.2ml[95%CI：-12.8 至 0.4]与增加 6.1ml[95%CI：-1.42 至 13.6]；p=0.04）。
在接受最佳药物治疗的有症状的功能性二尖瓣反流患者中，Carillon 装置显著降低了二尖瓣反流容积和左心室容积。（Carillon 二尖瓣轮廓系统减少功能性二尖瓣反流[REDUCE FMR]；NCT02325830）。
