CAPITAL Research, Department of Medicine, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
Knight Cardiovascular Institute, Oregon Health and Science University, Portland, Oregon, USA.
JACC Cardiovasc Interv. 2023 Jun 12;16(11):1369-1380. doi: 10.1016/j.jcin.2023.03.012. Epub 2023 Mar 21.
Heart failure (HF) is associated with both mortality and a significant decline in health status. Interatrial shunting is increasingly being investigated as a novel therapeutic option.
The ALT FLOW Early Feasibility Study was designed to evaluate the safety of the Edwards left atrial to coronary sinus APTURE Transcatheter Shunt System in patients with symptomatic HF.
A total of 18 centers enrolled patients with symptomatic HF with a pulmonary capillary wedge pressure >15 mm Hg at rest or 25 mm Hg during exercise.
Between May 2018 and September 2022, 87 patients underwent attempted APTURE shunt implantation. Mean age was 71 years, and 53% were male. At baseline, mean left ventricular ejection fraction was 59% with 90% of the patients being in NYHA functional class III. Device success was achieved in 78 patients (90%), with no device occlusions or associated adverse events identified after implantation. The primary safety outcome occurred in only 2 patients (2.3%) at 30 days. At 6 months, health status improved: 67% of participants achieved NYHA functional class I to II status, with a 23-point improvement (P < 0.0001; 95% CI: 17-29 points) in the Kansas City Cardiomyopathy Questionnaire overall summary score. Also at 6 months, 20-W exercise pulmonary capillary wedge pressure was 7 mm Hg lower (P < 0.0001; 95% CI: -11 to -4 mm Hg) without change in right atrial pressure or other right heart function indices.
In this single-arm experience, the APTURE Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in pulmonary capillary wedge pressure and clinically meaningful improvements in HF symptoms and quality of life indices.
心力衰竭（HF）与死亡率和健康状况显著下降有关。房间隔分流术作为一种新的治疗选择，越来越受到关注。
ALT FLOW 早期可行性研究旨在评估有症状心力衰竭患者使用 Edwards 左心房至冠状窦 APTURE 经导管分流系统的安全性。
共有 18 个中心招募了有症状心力衰竭患者，静息时肺毛细血管楔压>15mmHg 或运动时 25mmHg。
2018 年 5 月至 2022 年 9 月，87 例患者尝试植入 APTURE 分流器。平均年龄为 71 岁，53%为男性。基线时，左心室射血分数为 59%，90%的患者处于 NYHA 功能 III 级。78 例（90%）患者成功植入了该设备，植入后未发现设备阻塞或相关不良事件。主要安全性结果仅在 30 天时发生在 2 例患者（2.3%）。6 个月时，健康状况得到改善：67%的患者达到 NYHA 功能 I 至 II 级，堪萨斯城心肌病问卷整体综合评分提高 23 分（P<0.0001；95%CI：17-29 分）。同样在 6 个月时，20-W 运动时肺毛细血管楔压降低了 7mmHg（P<0.0001；95%CI：-11 至-4mmHg），右心房压力或其他右心功能指数没有变化。
在这项单臂经验中，有症状心力衰竭患者使用 APTURE 经导管分流系统观察到安全，可降低肺毛细血管楔压，并在心力衰竭症状和生活质量指标方面带来有临床意义的改善。
