Urey Marcus A, Hibbert Benjamin, Jorde Ulrich, Eckman Peter, Simard Trevor, Labinaz Marino, Nazer Babak, Wiley Mark, Gupta Bhanu, Sauer Andrew, Shah Hirak, Sorajja Paul, Pineda Andres M, Missov Emil, Mahmud Ehtisham, Kahwash Rami, Lilly Scott, Latib Azeem, Murthy Sandhya, Fam Neil, Garcia Santiago, Chung Eugene S, Klein Liviu, Cheng Richard, Houston Brian A, Amoroso Nicholas S, Chang Lee, Gafoor Sameer, Chaudhry Sunit-Preet, Hermiller James, Schwartz Jonathan G, Aldaia Lillian, Koulogiannis Konstantinos, Gray William A, Zahr Firas
Division of Cardiovascular Medicine, University of California San Diego, La Jolla, CA, USA.
Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.
Eur J Heart Fail. 2024 Apr;26(4):1065-1077. doi: 10.1002/ejhf.3241. Epub 2024 Apr 12.
Patients with heart failure and mildly reduced or preserved ejection fraction have limited therapeutic options. The ALT-FLOW Early Feasibility Study evaluated safety, haemodynamics and outcomes for the APTURE transcatheter shunt system, a novel left atrium to coronary sinus shunt in these patients.
Safety and shunt implantation success was evaluated for all 116 enrolled patients. An analysis population of implanted patients with a left ventricular ejection fraction (LVEF) >40% (n = 95) was chosen to assess efficacy via paired comparison between baseline and follow-up haemodynamic (3 and 6 months), and echocardiographic, clinical and functional outcomes (6 months and 1 year). Health status and quality of life outcomes were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS). The primary safety endpoint, major adverse cardiac, cerebral, and renal events, and reintervention through 30 days, occurred in 3/116 patients (2.6%). All implanted shunts were patent at 1 year. In patients with LVEF >40%, the mean (95% confidence interval) reduction in exercise pulmonary capillary wedge pressure (PCWP) at 20 W was -5.7 (-8.6, -2.9) mmHg at 6 months (p < 0.001). At baseline, 8% had New York Heart Association class I-II status and improved to 68% at 1 year (p < 0.001). KCCQ-OSS at baseline was 39 (35, 43) and improved at 6 months and 1 year by 25 (20-30) and 27 (22-32) points, respectively (both p < 0.0001). No adverse changes in haemodynamic and echocardiographic indices of right heart function were observed at 1 year. Overall, the reduction in PCWP at 20 W and improvement in KCCQ-OSS in multiple subgroups were consistent with those observed for the entire population.
In patients with heart failure and LVEF >40%, the APTURE shunt demonstrated an acceptable safety profile with significant sustained improvements in haemodynamic and patient-centred outcomes, underscoring the need for further evaluation of the APTURE shunt in a randomized trial.
射血分数轻度降低或保留的心力衰竭患者的治疗选择有限。ALT-FLOW早期可行性研究评估了APTURE经导管分流系统的安全性、血流动力学和预后，该系统是一种用于这些患者的新型左心房至冠状窦分流装置。
对所有116名入组患者评估了安全性和分流植入成功率。选择左心室射血分数（LVEF）>40%的植入患者分析人群（n = 95），通过基线与随访血流动力学（3个月和6个月）、超声心动图、临床和功能结局（6个月和1年）的配对比较来评估疗效。使用堪萨斯城心肌病问卷总体汇总评分（KCCQ-OSS）评估健康状况和生活质量结局。主要安全终点、主要不良心脏、脑和肾脏事件以及30天内的再次干预发生在3/116例患者（2.6%）中。所有植入的分流装置在1年时均保持通畅。在LVEF>40%的患者中，6个月时20W运动时肺毛细血管楔压（PCWP）的平均（95%置信区间）降低为-5.7（-8.6，-2.9）mmHg（p<0.001）。基线时，8%的患者为纽约心脏协会I-II级，1年时改善至68%（p<0.001）。基线时KCCQ-OSS为39（35，43），6个月和1年时分别改善25（20 - 30）和27（22 - 32）分（均p<0.0001）。1年时未观察到右心功能的血流动力学和超声心动图指标有不良变化。总体而言，多个亚组中20W时PCWP的降低和KCCQ-OSS的改善与整个人群观察到的情况一致。
在射血分数>40%的心力衰竭患者中，APTURE分流装置显示出可接受的安全性，血流动力学和以患者为中心的结局有显著持续改善，强调需要在随机试验中进一步评估APTURE分流装置。
