AimsPatients 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.Methods and resultsSafety 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.ConclusionsIn 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.

中文翻译：

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左心房至冠状窦分流治疗射血分数轻度降低或保留的心力衰竭：ALT FLOW 早期可行性研究 1 年结果

目标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、血流动力学和结果，这是一种新型左心房至冠状窦分流术。方法和结果对所有 116 名入组患者的安全性和分流器植入成功率进行了评估。左心室射血分数 (LVEF) >40% 的植入患者的分析群体（n= 95）通过基线和随访血流动力学（3个月和6个月）以及超声心动图、临床和功能结果（6个月和1年）之间的配对比较来评估疗效。使用堪萨斯城心肌病问卷总体评分（KCCQ-OSS）评估健康状况和生活质量结果。 3/116 名患者 (2.6%) 发生了主要安全终点、主要不良心脏、大脑和肾脏事件以及 30 天的重新干预。所有植入分流器均在一年内获得专利。在 LVEF > 40% 的患者中，6 个月时 20 W 时运动肺毛细血管楔压 (PCWP) 的平均降低（95% 置信区间）为 -5.7 (-8.6, -2.9) mmHg（p< 0.001）。在基线时，8% 的人具有纽约心脏协会 I-II 级状态，并在 1 年时改善至 68%（p< 0.001）。基线时的 KCCQ-OSS 为 39 (35, 43)，6 个月和 1 年时分别提高了 25 (20–30) 和 27 (22–32) 分（均为p< 0.0001)。 1 年时未观察到血流动力学和右心功能超声心动图指数的不良变化。总体而言，多个亚组中 20 W 时 PCWP 的降低和 KCCQ-OSS 的改善与在整个人群中观察到的结果一致。 结论 在心力衰竭且 LVEF > 40% 的患者中，APTURE 分流术表现出可接受的安全性，并且具有显着的持续性血流动力学和以患者为中心的结果的改善，强调需要在随机试验中进一步评估 APTURE 分流器。