Division of Cardiology, Medical University of South Carolina and the Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC.
Corvia Medical, Tewksbury, MA.
Am Heart J. 2024 Dec;278:106-116. doi: 10.1016/j.ahj.2024.08.014. Epub 2024 Sep 3.
There is a little evidence regarding long-term safety and efficacy for atrial shunt devices in heart failure (HF).
The REDUCE LAP-HF I (n = 44) and II (n = 621) trials (RCT-I and -II) were multicenter, randomized, sham-controlled trials of patients with HF and ejection fraction >40%. Outcome data were analyzed from RCT-I, a mechanistic trial with 5-year follow-up, and RCT-II, a pivotal trial identifying a responder group (n = 313) defined by exercise PVR <1.74 WU and no cardiac rhythm management device with 3-year follow-up.
At 5 years in RCT I, there were no differences in cardiovascular (CV) mortality, HF events, embolic stroke, or new-onset atrial fibrillation between groups. After 3 years in RCT II, there was no difference in the primary outcome (hierarchical composite of CV mortality, stroke, HF events, and KCCQ) between shunt and sham in the overall trial. Compared to sham, those with responder characteristics in RCT-II had a better outcome with shunt (win ratio 1.6 [95% CI 1.2-2.2], P = .006; 44% reduction in HF events [shunt 9 vs. control 16 per 100 patient-years], P = .005; and greater improvement in KCCQ overall summary score [+17.9 ± 20.0 vs. +7.6 ± 20.4], P < .001), while nonresponders had significantly more HF events. Shunt treatment at 3 years was associated with a higher rate of ischemic stroke (3.2% vs. 0%, 95% CI 2%-6.1%, P = .032) and lower incidence of worsening kidney dysfunction (10.7% vs. 19.3%, P = .041).
With up to 5 years of follow up, adverse events were low in patients receiving atrial shunts. In the responder group, atrial shunt treatment was associated with a significantly lower HF event rate and improved KCCQ compared to sham through 3 years of follow-up.
NCT02600234, NCT03088033.
关于心力衰竭（HF）患者使用房分流装置的长期安全性和疗效，目前证据有限。
REDUCE LAP-HF I（n=44）和 II 期（n=621）试验（RCT-I 和 -II）是多中心、随机、假对照试验，纳入 HF 且射血分数>40%的患者。对来自 RCT-I（一项有 5 年随访的机制试验）和 RCT-II（一项确定应答者组（n=313）的关键试验，应答者定义为运动肺动脉楔压（PVR）<1.74 伍德单位且未使用心脏节律管理装置，随访 3 年）的 RCT-I 进行了结局数据分析。
在 RCT-I 的 5 年随访中，各组间心血管（CV）死亡率、HF 事件、栓塞性卒中或新发心房颤动无差异。在 RCT-II 的 3 年随访中，整个试验中分流与假分流组之间的主要结局（CV 死亡率、卒中、HF 事件和 KCCQ 的分层复合结局）无差异。与假分流相比，RCT-II 中具有应答特征的患者分流治疗的结局更好（胜率 1.6[95%CI 1.2-2.2]，P=0.006；HF 事件减少 44%[分流组每 100 患者年 9 例，对照组 16 例]，P=0.005；KCCQ 总体评分改善更大[+17.9±20.0 比 +7.6±20.4]，P<0.001），而非应答者 HF 事件显著更多。分流治疗 3 年后，缺血性卒中发生率更高（3.2%比 0%，95%CI 2%-6.1%，P=0.032），肾功能恶化发生率更低（10.7%比 19.3%，P=0.041）。
在接受房分流治疗的患者中，5 年随访期间不良事件发生率较低。在应答者组中，与假分流相比，房分流治疗 3 年随访时 HF 事件发生率显著降低，KCCQ 显著改善。
NCT02600234，NCT03088033。
