Efficacy and safety of interatrial shunt treatment for heart failure: A systematic review and meta-analysis

BACKGROUND Heart failure (HF), especially in patients with preserved ejection fraction and mid-range ejection fraction, remains a significant global health burden. Interatrial shunt devices (IASDs), which allow blood flow from the left to the right atrium, offer a novel treatment approach by reducing left atrial pressure and alleviating symptoms. AIM To evaluate the efficacy and safety of IASDs in patients with HF through a systematic review and meta-analysis. METHODS We performed a systematic review and meta-analysis following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines, analyzing studies up to April 2025. Randomized controlled trials and observational studies comparing interatrial shunt therapy with control groups were included. Data on clinical outcomes were analyzed using Review Manager software. RESULTS Nine studies involving 1689 patients were included. IASDs significantly improved cardiac output [mean difference (MD): 0.72, 95%CI: 0.13-1.32, P = 0.02], right atrial pressure (RAP) (MD: 0.70, 95%CI: 0.14-1.26, P = 0.01), and 6-minute walk distance (MD: 71.63, 95%CI: 24.13-119.13, P = 0.003). There were no significant differences in major adverse cardiac events, myocardial infarction, ischemic stroke, or new-onset atrial fibrillation. However, all-cause mortality [risk ratio (RR): 1.49, 95%CI: 1.02-2.18, P = 0.04] and cardiovascular death (RR: 1.66, 95%CI: 1.01-2.74, P = 0.05) were significantly higher in the shunt group. CONCLUSION IASDs offer significant short-term improvements in cardiac output, RAP, and exercise capacity in HF patients. However, long-term safety concerns, particularly regarding mortality, necessitate further research and careful patient selection.