Department of Cardiology, German Centre for Cardiovascular Research partner site Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research, partner site Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany.
Kaufman Center for Heart Failure, Cleveland Clinic, Cleveland, Ohio, USA; Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio, USA.
JACC Heart Fail. 2021 Jun;9(6):453-462. doi: 10.1016/j.jchf.2021.03.002. Epub 2021 May 12.
This study sought to determine the effect of percutaneous mitral valve annuloplasty with the Carillon device versus guideline-directed medical therapy (GDMT) alone in patients with secondary mitral regurgitation (MR) and severe left ventricular (LV) enlargement.
The clinical impact of the Carillon device in patients with severe LV dilation is not well established.
This is a pooled analysis involving 3 prospective trials (TITAN [Transcatheter Implantation of Carillon Mitral Annuloplasty Device], TITAN II, and REDUCE FMR [CARILLON Mitral Contour System for Reducing Functional Mitral Regurgitation] trials) in which patients with functional MR and severe LV enlargement (LV end-diastolic diameter >65 mm) were treated with GDMT and the Carillon device versus GDMT alone. Key outcomes of this analysis were changes over 1 year of follow-up in mitral valve and LV echocardiographic parameters, functional outcome, quality of life, mortality, and heart failure hospitalization (HFH).
A total of 95 patients (67 in the Carillon group, 28 in the GDMT group) with severe LV enlargement were included. In the Carillon group, all mitral valve and LV morphology parameters were significantly improved at 1 year. Regurgitant volume decreased by 12 ml (p < 0.001), MR grade decreased by 0.6 U (p < 0.001), LV end-diastolic volume decreased by 25 cm (p = 0.005), and LV end-systolic volume decreased by 21 cm (p = 0.01). Significant functional improvement differences were also noted between the Carillon group and the GDMT group including an improvement of Kansas City Cardiomyopathy Questionnaire score (15 ± 4 vs. 6 ± 6; p = 0.03). The incidence of HFH was 29.9% versus 50.0% and the cumulative rate of HFH was 0.43 versus 0.75 (p < 0.001).
In patients with functional MR and severe LV enlargement, the Carillon device improved mitral valve function, LV morphology, and functional outcome compared with patients receiving GDMT only. Preoperative LV dimension should not be a limiting factor when evaluating patient eligibility or anticipated response to therapy with the Carillon device.
本研究旨在评估 Carillon 装置行经皮二尖瓣环成形术与单纯指南指导的药物治疗（GDMT）在继发二尖瓣反流（MR）和严重左心室（LV）扩张患者中的疗效。
Carillon 装置在严重 LV 扩张患者中的临床效果尚未明确。
这是一项包含 3 项前瞻性试验（TITAN [经导管植入 Carillon 二尖瓣环成形装置]、TITAN II 和 REDUCE FMR [Carillon 二尖瓣轮廓系统减少功能性二尖瓣反流]试验）的汇总分析，其中功能性 MR 且严重 LV 扩张（LV 舒张末期直径>65mm）的患者接受 GDMT 和 Carillon 装置治疗与单纯 GDMT 治疗。该分析的主要结局是在 1 年随访期间二尖瓣和 LV 超声心动图参数、功能结局、生活质量、死亡率和心力衰竭住院（HFH）的变化。
共纳入 95 例严重 LV 扩张患者（Carillon 组 67 例，GDMT 组 28 例）。在 Carillon 组，所有二尖瓣和 LV 形态参数在 1 年均显著改善。反流容积减少 12ml（p<0.001），MR 分级降低 0.6U（p<0.001），LV 舒张末期容积减少 25cm（p=0.005），LV 收缩末期容积减少 21cm（p=0.01）。Carillon 组与 GDMT 组之间也观察到显著的功能改善差异，包括堪萨斯城心肌病问卷评分改善（15±4 分比 6±6 分；p=0.03）。HFH 的发生率分别为 29.9%和 50.0%，HFH 的累积发生率分别为 0.43 和 0.75（p<0.001）。
在功能性 MR 和严重 LV 扩张患者中，Carillon 装置与单纯 GDMT 治疗相比，改善了二尖瓣功能、LV 形态和功能结局。术前 LV 尺寸不应成为评估患者接受 Carillon 装置治疗的资格或预期反应的限制因素。
