经导管三尖瓣置换装置LuX-Valve治疗重度三尖瓣反流的超声心动图评价

Echocardiographic Evaluation of the Transcatheter Tricuspid Valve Replacement With LuX-Valve Device for the Treatment of Severe Tricuspid Regurgitation

目的:评估新型经导管三尖瓣置换装置LuX-Valve治疗重度三尖瓣反流的临床和超声心动图表现。方法:入选2020年6月至2021年8月中国医学科学院阜外医院收治的NYHA心功能III~IV级外科高危重度三尖瓣反流患者。患者均经药物治疗无明显改善,使用LuX-Valve装置行经导管三尖瓣置换术。收集并分析患者手术前后及随访期临床及超声心动图资料。结果:共纳入36例患者,均成功行经导管三尖瓣置换术,无术中或术后72 h内死亡;除4例因器械位置异常行体外循环手术外,余32例(88.9%)手术成功。无住院死亡,2例病重出院。随访350(196,386)d期间,3例(8.3%)死亡。至末次随访时,66.7%(22/33)的患者NYHA心功能分级改善,72.7%(24/33)三尖瓣反流量少量及以下,右心房、室容积均较术前明显减小[分别为(115.58±67.74)ml vs.(161.08±95.50)ml,(118.76±50.45)ml vs.(136.65±55.44)ml,P均<0.05],但右心室射血分数变化无统计学意义。Cox回归分析显示,二尖瓣平均跨瓣压差是术后不良事件的独立危险因素(校正后HR=1.514,95%CI:1.009~2.273,P=0.045)。结论:应用LuX-Valve治疗重度三尖瓣反流可行且中期安全性较好,可有效减少反流,改善临床症状,减轻右心腔扩大。二尖瓣平均跨瓣压差是影响手术结果的重要指标。

Objectives:The aim of this study was to assess the echocardiographic and clinical outcome of novel transcatheter tricuspid valve replacement device LuX-Valve in treating symptomatic severe tricuspid regurgitation.Methods:Between Jun 2020 and Aug 2021,high risk patients with NYHA functional class III-IV and symptomatic severe tricuspid regurgitation were enrolled.All patients had no significant improvement with guideline-directed medical therapy and underwent transcatheter tricuspid valve replacement with LuX-Valve device.Multimodal imaging and clinical evaluation were performed at baseline,early period of the procedure and follow-up.Results:36 patients underwent successful transcatheter tricuspid valve replacement with no death during or 72 hours after the procedure.The Procedural success rate was 88.9%(32/36),and 4 cases underwent cardiopulmonary bypass operation due to the abnormal position of instruments.In-hospital mortality is 0,and 2 patients were discharged with seriously ill.During 350(196,386)days of follow-up,3 patients died of multiple systemic organ failures.All-cause mortality was 8.3%.At the end of follow-up,66.7%(22/33)of patients had improved NYHA function,72.7%(24/33)had a≤1+tricuspid regurgitation and significant reductions in the right atrial and ventricular volumes compared with the baseline([115.58±67.74]ml vs.[161.08±95.50]ml,and[118.76±50.45]ml vs.[136.65±55.44]ml,both P<0.05),but the right ventricular ejection fraction did not change significantly.The preoperative mean mitral valve pressure difference was an independent risk factor affecting the surgical outcome(adjusted HR=1.514,95%CI:1.009-2.273,P=0.045).Conclusions:Transcatheter tricuspid valve replacement with the LuX-Valve system in high-risk patients with symptomatic severe tricuspid regurgitation shows the feasibility and a med-term safety profile,which can effectively reduce tricuspid regurgitation,improve clinical symptoms,and reduce right heart chamber enlargement.