D-Shant心房分流器治疗慢性心力衰竭的超声心动图评价

Echocardiographic evaluation of the domestic D-Shant device for treatment of patients with chronic heart failure

目的应用超声心动图评估国产D-Shant心房分流器治疗慢性心力衰竭(CHF)的有效性。方法连续入组2020年9月至2021年12月在华中科技大学同济医学院附属协和医院植入国产D-Shant心房分流器的CHF患者24例。植入术前及术后即刻,右心导管测量肺毛细血管楔压(PCWP)/左房压(LAP)、右房压(RAP)、肺动脉压、跨房间隔梯度压差、心脏指数及肺/体循环血流量比(Qp/Qs);术前、术后1个月和术后3个月,超声心动图测量左房舒张末面积指数(LAEDAI)、左房舒张末容积指数(LAEDVI)、左室舒张末容积指数(LVEDVI)、左室收缩末容积指数(LVESVI)、左室射血分数(LVEF)、右室舒张末横径、三尖瓣环收缩期位移(TAPSE)、右室面积变化率(RVFAC)、心房分流器分流孔径、分流速度和分流压差;评估二尖瓣及三尖瓣反流程度;记录美国纽约心脏病协会(NYHA)分级、6 min步行测试(6MWT)等,行堪萨斯城心肌病问卷(KCCQ)调查;采用Spearman相关分析评估植入术前、术后PCWP/LAP及超声心动图参数变化与术后3个月患者NYHA分级的相关性,二分类Logistic回归分析确定术后3个月NYHA分级改善的独立预测因素。结果①所有患者均成功植入D-Shant心房分流器。②与术前相比,术后即刻PCWP/LAP收缩压、舒张压及平均压显著下降(均P<0.001),跨房间隔梯度压差显著下降(P<0.001),肺动脉收缩压、舒张压及平均压减低(均P<0.001),Qp/Qs显著升高(P<0.001)。③与术前相比,术后1个月TAPSE、RVFAC及肺动脉血流速度显著增加(均P<0.05);术后3个月LVEF及肺动脉血流速度显著增加(均P<0.05),二尖瓣反流程度显著减轻(P=0.001),三尖瓣反流程度未见显著改善(P>0.05)。LAEDAI、LAEDVI、LVEDVI、LVESVI、舒张早期二尖瓣口峰值流速(E)/舒张晚期二尖瓣口峰值流速(A)、室间隔侧二尖瓣环收缩期峰值(S′)、E/舒张早期二尖瓣环运动速度(e′)、肺动脉内径、右房舒张末横径、右室舒张末横径和下腔静脉内径三组间差异无统计学意义(均P>0.05)。术后1个月与术后3个月心房分流器分流孔径、分流速度及分流压差差异无统计学意义(均P>0.05)。④与术前相比,术后1个月及3个月患者NYHA分级改善、KCCQ评分增高、6MWT显著增加(均P<0.01)。⑤LVEF_(术前-术后)、PCWP/LAP_(术前-术后)、TAPSE_(术前-术后)、RVFAC_(术前-术后)与术后3个月患者NYHA分级存在显著相关(r_(s)=0.738、-0.730、0.738、0.723,均P<0.001)。二分类Logistic回归分析显示LVEF_(术前-术后)是术后3个月患者NYHA分级改善的独立预测因素(OR=0.687,95%CI=0.475~0.992,P=0.045)。结论国产D-Shant心房分流器植入后可有效改善CHF患者心功能与临床症状。超声心动图是评价CHF患者D-Shant心房分流器植入疗效可行、有效的影像学方法。

Objective To evaluate the efficacy of the domestic D-Shant device for the treatment of patients with chronic heart failure(CHF)using echocardiography.Methods Twenty-four CHF patients who were treated with domestic D-Shant device in Union Hospital,Tongji Medical College,Huazhong University of Science and Technology from September 2020 to December 2021 were enrolled in the study.Pulmonary capillary wedge pressure(PCWP)/left atrial pressure(LAP),right atrial pressure(RAP),pulmonary artery pressure,interatrial septal gradient pressure,cardiac index and pulmonary/systemic blood flow ratio(Qp/Qs)were measured before and after implantation using right heart catheterization.Left atrial end-diastolic area index(LAEDAI),left atrial end-diastolic volume index(LAEDVI),left ventricular end-diastolic volume index(LVEDVI),left ventricular end-systolic volume index(LVESVI),left ventricular ejection fraction(LVEF),right atrial end-diastolic diameter,right ventricular end-diastolic diameter,tricuspid annular plane systolic excursion(TAPSE),right ventricular tractional area change(RVFAC),device shunt aperture,velocity and pressure,together with mitral and tricuspid regurgitation severity were measured using echocardiography before,and 1 month as well as 3 months after D-Shant device implantation.Clinical data were collected and analyzed including 6-minute walking test(6MWT),New York Heart Association(NYHA)classification and the Kansas City Cardiomyopathy Questionnaire(KCCQ).Spearman correlation analysis was used to determine the relation between the changes in PCWP/LAP as well as echocardiographic parameters before and 3 months after implantation and NYHA classification.Binary Logistic regression analysis was performed to determine the predictive factors of NYHA classification improvement at 3-month follow-up after D-Shant device implantation.Results①D-Shant devices were successfully implanted in all patients.②Compared with preoperative values,invasive PCWP/LAP systolic,diastolic and mean pressures,transatrial septal gradient,and pulmonary systolic,diastolic and mean pressures decreased significantly after implantation(all P<0.001);Qp/Qs increased significantly after implantation(P<0.001).③Compared with preoperative values,TAPSE,RVFAC and pulmonary artery flow velocity increased at 1 month after implantation(all P<0.05),whereas a significant reduction in mitral regurgitation grade,and an increase in LVEF and pulmonary artery flow velocity at 3 months after implantation(all P<0.05).Right atrial end-diastolic diameter,right ventricular end-diastolic diameter,LAEDAI,LAEDVI,LVEDVI,LVESVI,ratio of early to late diastolic peak velocities of mitral inflow(E/A),systolic peak velocity of mitral annulus at septal site(S′),ratio of early diastolic peak velocity of mitral inflow to diastolic peak velocity of mitral annulus(E/e′),pulmonary artery diameter,inferior vena cava diameter and degree of tricuspid regurgitation did not change among before,and 1 month as well as 3 months after implantation.There were no significant changes in the device shunt aperture,velocity and pressure between 1 month and 3 months after implantation(all P>0.05).④The significant improvements in NYHA classification,KCCQ scores and 6MWT were observed at 1 and 3 months after implantation compared with preoperative values(all P<0.01).⑤NYHA classification at 3 months after implantation was correlated with LVEF_(pre-post),PCWP/LAP_(pre-post),TAPSE_(pre-post) and RVFAC_(pre-post)(r_(s)=0.738,-0.730,0.738,0.723;all P<0.001).Logistic regression analysis showed that LVEF _(pre-post) was an independent predictor for NYHA classification improvement at 3 months after implantation(OR=0.687,95%CI=0.475-0.992,P=0.045).Conclusions Domestic D-Shant device can effectively improve the cardiac function and clinical symptoms in patients with CHF.Echocardiography is a feasible and effective method to evaluate the benefits of domestic D-Shant device for the treatment of CHF.