常三帅,刘新民,姜正明,科雨彤,张骞,吕强,杜昕,董建增,宋光远

• 1:首都医科大学附属北京安贞医院心脏瓣膜病介入中心国家心血管病临床医学研究中心
• 2:首都医科大学附属北京安贞医院心力衰竭中心国家心血管病临床医学研究中心

摘要(Abstract)：

目的 初步评估基于射频切割的新型无植入心房分流导管用于治疗慢性心力衰竭（心衰）的安全性和有效性。方法 本研究为前瞻性单组研究。2023年1—12月于首都医科大学附属北京安贞医院连续入选5例符合标准的心衰患者，采用深圳佰特威心房分流导管行心房分流术。术前及术后即刻行右心导管测量肺毛细血管楔压（PCWP）、右心房压（RAP）、肺动脉压（PAP）、全肺阻力（TPR）、肺血管阻力（PVR）及肺/体循环血流量比（Qp/Qs）；术后对患者进行90 d随访，完善超声心动图、右心导管检查及心脏功能学评价指标。研究主要终点为手术成功；次要终点包括术后90 d临床成功、超声心动图变化、6min步行距离（6MWD）变化、纽约心脏病协会（NYHA）心功能分级变化、堪萨斯城心肌病问卷调查（KCCQ）评分变化及N末端B型脑钠肽前体（NT-proBNP）水平变化。安全性终点为术后90 d主要不良心脑血管事件及器械相关不良事件。结果 5例患者均成功实现左心房向右心房分流。与术前相比，5例患者术后即刻PCWP均明显下降，手术成功率100%，术前和术后即刻RAP、PAP、TPR和PVR无明显变化。随访90 d后，4例患者存在持续的左心房向右心房分流，且PCWP较基线明显减低，临床成功率80%。与术前相比，5例患者术后90 d左心室射血分数均有所升高，左心室舒张末期容积均有所降低，三尖瓣瓣环收缩期位移、右心室面积变化分数无明显受损；KCCQ评分、6MWD均有所提高，NT-proBNP水平均有所下降，NYHA心功能分级无明显变化。随访期内无死亡，无心衰再住院，无脑卒中相关不良事件，无器械相关不良事件。结论 新型无植入心房分流导管可安全有效地改善心衰患者血流动力学、超声心动图及心脏功能学评价指标，未来仍需更大规模的临床研究验证其临床长期有效性。

关键词(KeyWords)： 心力衰竭;心房分流术;无植入;肺毛细血管楔压;左心室射血分数

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 常三帅,刘新民,姜正明,科雨彤,张骞,吕强,杜昕,董建增,宋光远

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