Long term safety and outcomes after atrial shunting for heart failure with preserved or mildly reduced ejection fraction: 5-year and 3-year follow-up in the REDUCE LAP-HF I and II trials

作者：Sheldon E. Litwin, Jan Komtebedde, Barry A. Borlaug, David M. Kaye, Gerd Hasenfuβ, Rami Kawash, Elke S. Hoendermis, Scott L. Hummel, Maja Čikeš, Finn Gustafsson, Eugene S. Chung, Rajeev Mohan, Aaron L. Sverdlov, Vijendra Swarup, Sebastian Winkler, Christopher S. Hayward, Martin Bergmann, Heiko Bugger, S. McKenzie, Ajith Nair, Andreas Rieth, Daniel Burkhoff, Donald E. Cutlip, Scott D. Solomon, Dirk J. van Veldhuisen, Martin B. Leon, Sanjiv J. Shah · 发表于：American Heart Journal · 年份：2024 · DOI：10.1016/j.ahj.2024.08.014 · 被引用次数：8 · 研究领域：Atrial Fibrillation Management and Outcomes、Cardiovascular and Diving-Related Complications、Cardiovascular Function and Risk Factors

BACKGROUND: There is a little evidence regarding long-term safety and efficacy for atrial shunt devices in heart failure (HF). METHODS: 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. RESULTS: 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). CONCLUSIONS: With ...