房间隔分流器治疗射血分数降低心衰的SUSTAIN-HF研究一年结果
SUSTAIN-HF是一项前瞻性多中心单臂研究，纳入120例接受指南导向药物治疗的症状性HFrEF患者（LVEF≤40%），植入D-Shant房间隔分流器。1年随访时6分钟步行距离平均增加54.1米，KCCQ评分改善16.5分，NYHA III/IV级比例从95.0%降至22.9%，心衰住院年化率从3.3降至0.3次/患者年，LVEF增加9.0%。主要安全终点发生率为15.0%，主要由心血管死亡驱动。单臂设计限制疗效结论，需随机假手术对照试验验证。
要点
- D-Shant房间隔分流器植入后1年，HFrEF患者6分钟步行距离平均增加54.1米。
- KCCQ总分改善16.5分，NYHA III/IV级比例从95.0%降至22.9%。
- 心衰住院年化率从3.3降至0.3次/患者年，主要安全终点发生率15.0%。
核心结论
- 在症状性HFrEF患者中，D-Shant房间隔分流器治疗与1年时功能能力、生活质量和心衰住院率的显著改善相关。
- 单臂设计无法得出确切的疗效结论，需随机假手术对照试验进一步验证。
研究设计与样本
- 前瞻性、多中心、单臂队列研究（SUSTAIN-HF），在中国16个中心纳入120例接受指南导向药物治疗的症状性HFrEF患者（LVEF≤40%）。
- 干预为植入D-Shant房间隔分流器，预设主要结局为基线至1年6分钟步行距离和NYHA功能分级的改变。
主要发现
- 1年随访时6分钟步行距离平均增加54.1米（95% CI 45.9至62.3；p<0.0001）。
- KCCQ总体评分改善16.5分（95% CI 13.9至19.1；p<0.0001）。
- NYHA III/IV级患者比例从95.0%降至22.9%（p<0.0001）。
- 心衰住院年化率从3.3降至0.3次/患者年（p<0.0001）。
- LVEF增加9.0%（95% CI 6.9%至11.1%；p<0.0001），主要安全终点（主要不良心脏和器械相关事件复合终点）1年发生率为15.0%，主要由心血管死亡驱动。
临床怎么用
- 对于接受指南导向药物治疗仍有症状的HFrEF患者，房间隔分流器可能作为改善功能能力和生活质量的辅助手段。
- 需注意主要安全终点事件率较高（15.0%），主要由心血管死亡驱动，应严格评估患者风险。
- 单臂研究结果不足以支持常规临床推荐，需等待随机假手术对照试验证据。
局限性
- 单臂设计缺乏对照组，无法排除安慰剂效应或自然病程影响，不能得出确切疗效结论。
- 研究仅纳入中国16个中心，结果外推性需谨慎。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
BACKGROUND: Evidence for atrial shunt devices in heart failure with reduced ejection fraction (HFrEF) is limited. This study aimed to evaluate the 1-year clinical and haemodynamic outcomes associated with an atrial shunt device in this population. METHODS: In this prospective, multicentre, single-arm cohort study of an interatrial shunt in heart failure with reduced ejection fraction (SUSTAIN-HF), 120 symptomatic HFrEF patients (left ventricular ejection fraction; LVEF ≤40%) on guideline-directed medical therapy were enrolled across 16 centres in China. The intervention was implantation of the D-Shant atrial shunt device. Prespecified primary outcomes were the changes from baseline to 1 year in 6 min walk distance (6MWD) and New York Heart Association (NYHA) functional class. Secondary outcomes included quality of life (Kansas City Cardiomyopathy Questionnaire; KCCQ), echocardiographic parameters and adjudicated adverse events. RESULTS: Between October 2017 and December 2021, 120 patients were enrolled. At 1-year follow-up, implantation of the shunt device was associated with significant improvements in clinical outcomes. The mean 6MWD increased by 54.1 m (95% CI 45.9 to 62.3; p<0.0001), and the KCCQ overall score was improved by 16.5 points (95% CI 13.9 to 19.1; p<0.0001). The proportion of patients in NYHA class III/IV decreased from 95.0% to 22.9% (p<0.0001). The annualised rate of heart failure hospitalisation was reduced from 3.3 to 0.3 events per patient-year (p<0.0001). LVEF increased by 9.0% (95% CI 6.9% to 11.1%; p<0.0001). The primary safety endpoint, a composite of major adverse cardiac and device-related events at 1 year, occurred in 15.0% of patients, driven primarily by cardiovascular death. CONCLUSIONS: In this prospective cohort study of symptomatic HFrEF patients, treatment with the D-Shant atrial shunt device was associated with significant improvements in functional capacity, quality of life and rates of heart failure hospitalisation at 1 year. The single-arm design precludes definitive conclusions on treatment efficacy, underscoring the need for randomised, sham-controlled trials.
引用
- Zhang, Zhong, Li, et al. Prospective multicentre single-arm study of an interatrial shunt in heart failure with reduced ejection fraction (SUSTAIN-HF): 1-year clinical and haemodynamic outcomes. Heart. 2026. PMID: 41107031. doi:10.1136/heartjnl-2025-326319
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。