D-shant心房分流器用于射血分数降低的心力衰竭患者短期结果

One-year outcomes of D-shant atrial shunt device for patients with heart failure with reduced ejection fraction

目的评估单中心射血分数降低的心力衰竭(HFrEF)患者植入D-shant心房分流器的短期临床结果。方法回顾性分析2022年1月至2023年1月入住中国人民解放军空军军医大学第一附属医院心血管外科的12例接受经皮植入D-shant的HFrEF患者。使用超声心动图评估心腔大小和心室功能,同时收集右心导管测量的数据和患者临床指标,并将术后12个月的随访数据与D-shant植入前所搜集的数据进行比较。研究的主要终点为随访期间发生的重大心脏、神经或肾不良事件。次要终点为功能状态的提升,包括心功能、生活质量和运动能力。结果对12例患者都成功使用D-shant实施了经皮心房分流术。术后即刻透视和超声心动图证实所有患者的D-shant定位准确、血流通畅。术后血流动力学评估显示,平均肺毛细血管楔压显著下降[(29.8±3.4)mmHg比(17.8±0.8)mmHg,P<0.001],差异有统计学意义。12个月随访时,累计不良事件发生率为8.3%(因1例患者接受心脏移植),左心房内径从(65.8±6.5)mm显著缩小至(48.0±4.5)mm(P<0.001),差异有统计学意义。此外,临床心功能指标、患者的生活质量以及运动能力均有显著改善。结论这项单中心研究发现,使用D-shant心房分流器对HFrEF患者实施经皮心房分流术是安全有效的。短期随访表明,分流管持续通畅,并且干预措施与改善功能状态相关。

Objective To assess the clinical short-term outcomes of implanting D-shant atrial shunt device(aSD)in a single center for patients with heart failure with reduced ejection fraction(HFrEF).Methods From January 2022 to January 2023,a retrospective analysis was conducted on 12 patients with HFrEF who underwent percutaneous implantation of a D-shant aSD.We assessed cardiac chamber size and ventricular function using echocardiography,right heart catheterization measurements and patient clinical indicators were collected,follow up data of 12 months postoperative and pre-implantation D-shant were compared.The primary endpoint of the study was the cumulative occurrence of adverse 8cardiac,neurologic,or renal events during the follow-up period.Secondary endpoints were improvements in functional status included cardiac function,quality of life,and exercise capacity.Results All 12 patients underwent successful percutaneous inter-atrial shunting procedures using the D-shant.Postoperative immediately fluoroscopy and echocardiography confirmed accurate localization and patency of the atrial shunt devices in all cases.Postoperative hemodynamic assessment revealed a significant decrease in pulmonary capillary wedge pressure[(29.8±3.4)mmHg vs.(17.8±0.8)mmHg,P<0.001].During 12 months follow-up,the cumulative adverse event rate was 8.3%(one patient received a heart transplant),a significant reduction in left atrial diameter from(65.8±6.5)mm to(48.0±4.5)mm(P<0.001)was observed.Furthermore,there was notable improvement in clinical cardiac function indices quality of life,and exercise capacity of the patients.Conclusions This single-center retrospective study found that the use of a D-shant aSD to perform percutaneous interatrial shunting in patients with HFrEF is safe and effective.Short-term follow-up demonstrated sustained patency of the shunt and that the intervention was associated with improved functional status.