Department of Medicine, University of Mississippi, Jackson, MS, USA.
Department of Medical Statistics, University Medical Center Göttingen, and German Centre for Cardiovascular Research (DZHK), partner site Göttingen, Göttingen, Germany.
ESC Heart Fail. 2021 Jun;8(3):1885-1891. doi: 10.1002/ehf2.13301. Epub 2021 Mar 30.
The Carillon Mitral Contour System has been shown to reduce mitral regurgitation and left ventricular volumes in symptomatic heart failure patients with functional mitral regurgitation. We sought to evaluate the effects of the Carillon device on quality of life and functional capacity in these patients.
An individual participant data meta-analysis was conducted utilizing data from REDUCE-FMR, TITAN, and TITAN II studies. The main outcomes assessed were changes from baseline in Kansas City Cardiomyopathy Questionnaire overall summary scores (KCCQ-OSS), 6 min walk test (6MWT) distance, and New York Heart Association (NYHA) classification at Months 1 and 12 after device implantation. Subgroup analyses were conducted for patients with severe functional mitral regurgitation (Grade 3 or 4). Pooled estimates were calculated using a random-effects model and are presented as weighted proportions or weighted mean differences along with 95% confidence intervals (CIs). Among 139 patients included in the analysis, Carillon device significantly improved the 6MWT distance (63.0 m; 95% CI 18.8-107.2, P = 0.0056) and KCCQ-OSS score (15.1; 95% CI 5.6-24.7, P = 0.0022) at 1 month from baseline. These benefits were sustained at 12 months (64.1 m; 95% CI 13.2-115.0, P = 0.0141, for 6MWT distance, and 12.3; 95% CI 4.7-19.8, P = 0.0019, for KCCQ-OSS score). More than 50% of the patients had improvements in KCCQ-OSS by ≥5 (60.4%; 95% CI 47.4-72.1) and 10 points (50.5%; 95% CI 34.9-66.0) at 12 months. Almost half of the patients experienced a ≥1 class improvement in NYHA class after implantation of the device at 1 month (67.9%; 95% CI 37.3-88.3) and at 12 months (48.8%; 95% CI 31.8-66.2). Results remained similar for KCCQ-OSS, 6MWT distance, and NYHA classification when only patients with Grade 3 or 4 mitral regurgitation were analysed. The pooled estimates of 30 day and 1 year all-cause mortality were 2.2% (95% CI 0.7-6.5) and 17.3% (95% CI 11.8-24.5), respectively.
The Carillon Mitral Contour System significantly improved patient-reported quality-of-life outcomes in heart failure patients with functional mitral regurgitation.
卡利永二尖瓣轮廓系统已被证明可减少功能性二尖瓣反流的心力衰竭症状患者的二尖瓣反流和左心室容积。我们旨在评估卡利永装置对这些患者生活质量和功能能力的影响。
利用 REDUCE-FMR、TITAN 和 TITAN II 研究的数据进行了个体参与者数据荟萃分析。主要评估指标为基线时堪萨斯城心肌病问卷总评分（KCCQ-OSS）、6 分钟步行试验（6MWT）距离和纽约心脏协会（NYHA）分级的变化，分别为植入设备后 1 个月和 12 个月。对二尖瓣反流严重（3 或 4 级）的患者进行了亚组分析。使用随机效应模型计算汇总估计值，并以加权比例或加权平均差异以及 95%置信区间（CI）表示，同时给出 95%置信区间（CI）。在纳入分析的 139 例患者中，卡利永装置在 1 个月时显著改善了 6MWT 距离（63.0m；95%CI 18.8-107.2，P=0.0056）和 KCCQ-OSS 评分（15.1；95%CI 5.6-24.7，P=0.0022）。这些益处在 12 个月时仍保持稳定（64.1m；95%CI 13.2-115.0，P=0.0141，用于 6MWT 距离，和 12.3；95%CI 4.7-19.8，P=0.0019，用于 KCCQ-OSS 评分）。超过 50%的患者在 12 个月时 KCCQ-OSS 评分至少改善了 5 分（60.4%；95%CI 47.4-72.1）和 10 分（50.5%；95%CI 34.9-66.0）。植入设备后 1 个月时（67.9%；95%CI 37.3-88.3）和 12 个月时（48.8%；95%CI 31.8-66.2），近一半的患者 NYHA 分级至少改善了 1 级。当仅分析二尖瓣反流 3 或 4 级的患者时，KCCQ-OSS、6MWT 距离和 NYHA 分级的汇总估计值仍然相似。30 天和 1 年全因死亡率的汇总估计值分别为 2.2%（95%CI 0.7-6.5）和 17.3%（95%CI 11.8-24.5）。
卡利永二尖瓣轮廓系统显著改善了心力衰竭伴功能性二尖瓣反流患者的患者报告生活质量结局。
