Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany; German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.
Department of Cardiovascular Surgery, University Hospital of Zürich, University of Zürich, Zürich, Switzerland.
JACC Cardiovasc Interv. 2019 Aug 12;12(15):1451-1461. doi: 10.1016/j.jcin.2019.04.019.
The purpose of this study was to evaluate procedural and 1-year clinical and echocardiographic outcomes of patients treated with tricuspid edge-to-edge repair.
Transcatheter edge-to-edge repair has been successfully performed in selected patients with symptomatic tricuspid regurgitation (TR) and high risk for surgery, but outcome data are sparse.
This analysis of the multicenter international TriValve (Transcatheter Tricuspid Valve Therapies) registry included 249 patients with severe TR treated with edge-to-edge repair in compassionate and/or off-label use. Clinical and echocardiographic outcomes were prospectively collected and retrospectively analyzed.
In 249 patients (mean age 77 ± 9 years; European System for Cardiac Operative Risk Evaluation II score 6.4% [interquartile range: 3.9% to 13.9%]), a successful procedure with TR reduction to grade ≤2+ was achieved in 77% by placement of 2 ± 1 tricuspid clips. Concomitant treatment of severe TR and mitral regurgitation was performed in 52% of patients. At 1-year follow-up, significant and durable improvements in TR severity (TR ≤2+ in 72% of patients) and New York Heart Association functional class (≤II in 69% of patients) were observed. All-cause mortality was 20%, and the combined rate of mortality and unplanned hospitalization for heart failure was 35%. Predictors of procedural failure included effective regurgitant orifice area, tricuspid coaptation gap, tricuspid tenting area, and absence of central or anteroseptal TR jet location. Predictors of 1-year mortality were procedural failure, worsening kidney function, and absence of sinus rhythm.
Transcatheter tricuspid edge-to-edge repair can achieve TR reduction at 1 year, resulting in significant clinical improvement. Predictors of procedural failure and 1-year mortality identified here may help select patients who will benefit most from this therapy.
本研究旨在评估经皮缘对缘修复术治疗三尖瓣缘对缘修复术患者的手术过程和 1 年临床及超声心动图结果。
经导管缘对缘修复术已成功应用于有症状的三尖瓣反流（TR）和手术风险高的患者，但结果数据较少。
这项多中心国际 TriValve（经导管三尖瓣瓣膜治疗）注册研究分析了 249 例因严重 TR 而接受边缘对边缘修复术治疗的患者，这些患者接受的是同情性和/或超适应证治疗。前瞻性收集并回顾性分析临床和超声心动图结果。
在 249 例患者（平均年龄 77 ± 9 岁；欧洲心脏手术风险评估系统 II 评分 6.4%[四分位距：3.9%~13.9%]）中，通过放置 2 ± 1 个三尖瓣夹，77%的患者手术成功，TR 减少至≤2+。52%的患者同时治疗严重的 TR 和二尖瓣反流。在 1 年随访时，TR 严重程度（72%的患者 TR≤2+）和纽约心脏协会功能分级（69%的患者≤Ⅱ级）均显著且持久改善。全因死亡率为 20%，死亡率和心力衰竭计划外住院的综合发生率为 35%。手术失败的预测因素包括有效反流口面积、三尖瓣对合间隙、三尖瓣膨出面积和无中心或前间隔 TR 射流部位。1 年死亡率的预测因素包括手术失败、肾功能恶化和无窦性节律。
经皮三尖瓣缘对缘修复术可在 1 年内降低 TR 程度，显著改善临床症状。此处确定的手术失败和 1 年死亡率的预测因素可能有助于选择最受益于这种治疗的患者。
