三尖瓣重建治疗重度三尖瓣反流患者的 6 个月结果。
6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation.
机构信息
Department of Cardiology, University Hospital Bonn, Bonn, Germany.
Department of Cardiology, University Hospital Bonn, Bonn, Germany.
出版信息
J Am Coll Cardiol. 2019 Apr 23;73(15):1905-1915. doi: 10.1016/j.jacc.2019.01.062.
BACKGROUND
Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options.
OBJECTIVES
The authors report the 6-month safety and performance of a transcatheter tricuspid valve reconstruction system in the treatment of moderate to severe functional TR in 30 patients enrolled in the TRI-REPAIR (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System) study.
METHODS
Between October 2016 and July 2017, 30 patients were enrolled in this single-arm, multicenter, prospective trial. Patients were diagnosed with moderate to severe, symptomatic TR in the absence of untreated left-heart disease and deemed inoperable because of unacceptable risk for open-heart surgery by the local heart team. Clinical, functional, and echocardiographic data were prospectively collected before and up to 6 months post-procedure. An independent core lab assessed all echocardiographic data, and an independent clinical event committee adjudicated the safety events.
RESULTS
Mean patient age was 75 years, 73% were female, and 23% had ischemic heart disease. At baseline, 83% were in New York Heart Association (NYHA) functional class III to IV, and mean left ventricular ejection fraction was 58%. Technical success was 100%. Through 6 months, 3 patients died. Between 6 months and baseline, echocardiography showed average reductions of annular septolateral diameter of 9% (42 mm vs. 38 mm; p < 0.01), proximal isovelocity surface area effective regurgitant orifice area of 50% (0.8 cm vs. 0.4 cm; p < 0.01), and mean vena contracta width of 28% (1.2 cm vs. 0.9 cm; p < 0.01). Clinical assessment showed that 76% of patients improved by at least 1 NYHA functional class with 88% in NYHA functional class I or II. Six-minute walk distance improved by 60 m (p < 0.01), and Kansas City Cardiomyopathy Questionnaire score improved by 24 points (p < 0.01).
CONCLUSIONS
Six-month outcomes show that the system performs as intended and appears to be safe in patients with symptomatic and moderate to severe functional TR. Significant reduction of TR through decrease of annular dimensions, improvements in heart failure symptoms, quality of life, and exercise capacity were observed. Further studies are warranted to validate these initial promising results. (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System [TRI-REPAIR]; NCT02981953).
背景
严重三尖瓣反流（TR）与高发病率和死亡率相关，治疗选择有限。
目的
作者报告了在 30 例接受经导管三尖瓣瓣膜重建系统治疗的中度至重度功能性 TR 患者中，该系统在 6 个月时的安全性和疗效，这些患者来自 TRI-REPAIR（经导管三尖瓣反流修复与 Cardioband 系统）研究。
方法
在 2016 年 10 月至 2017 年 7 月期间，这项单臂、多中心、前瞻性试验共纳入 30 例患者。这些患者被诊断为中度至重度、有症状的 TR，且左心疾病未经治疗，且由于当地心脏团队认为开胸手术风险不可接受，被认为不适合手术。在术前和术后 6 个月内，前瞻性地收集了临床、功能和超声心动图数据。一个独立的核心实验室评估了所有超声心动图数据，一个独立的临床事件委员会对安全性事件进行了裁决。
结果
患者的平均年龄为 75 岁，73%为女性，23%有缺血性心脏病。基线时，83%为纽约心脏协会（NYHA）心功能 III 级至 IV 级，平均左心室射血分数为 58%。技术成功率为 100%。在 6 个月时，有 3 例患者死亡。在 6 个月和基线之间，超声心动图显示瓣环间隔侧直径平均减少 9%（42mm 比 38mm；p<0.01），近等速表面积有效反流口面积减少 50%（0.8cm 比 0.4cm；p<0.01），平均收缩期瓣环宽度减少 28%（1.2cm 比 0.9cm；p<0.01）。临床评估显示，76%的患者 NYHA 心功能至少改善 1 级，88%的患者 NYHA 心功能为 I 级或 II 级。6 分钟步行距离增加了 60m（p<0.01），堪萨斯城心肌病问卷评分增加了 24 分（p<0.01）。
结论
6 个月的结果表明，该系统的性能符合预期，在有症状和中度至重度功能性 TR 的患者中似乎是安全的。通过瓣环尺寸的减小、心力衰竭症状、生活质量和运动能力的改善，观察到 TR 显著减少。需要进一步的研究来验证这些初步的有希望的结果。（经导管三尖瓣反流修复与 Cardioband 系统[TRI-REPAIR]；NCT02981953）。
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