- Question
- Can a transcatheter interatrial shunt, by decompressing the left atrium, improve symptoms and prognosis in patients with symptomatic heart failure regardless of ejection fraction?
- Design
- Randomized 1:1 trial with a sham (placebo) procedure as control, stratified by reduced (≤40%) or preserved (>40%) LVEF. A total of 508 patients were randomized at 94 sites in 11 countries between October 2018 and October 2022, with a maximum follow-up of 2 years.
- Population
- Patients with symptomatic heart failure of any LVEF; median age 73.0 years, 37.2% women. LVEF was reduced in 206 patients (40.6%) and preserved in 302 (59.4%).
- Intervention
- Transcatheter implantation of an interatrial shunt.
- Control
- A placebo procedure without device implantation.
- Primary outcome
- Safety: composite of device- or procedure-related major adverse cardiovascular or neurological events at 30 days, compared with a performance goal of 11%. Effectiveness: hierarchical composite of all-cause death, cardiac transplantation or LVAD implantation, HF hospitalization, outpatient worsening HF events, and change in KCCQ overall summary score, expressed as a win ratio.
- Results
- There was no difference in the 2-year primary effectiveness outcome (win ratio 0.86 [95% CI 0.61-1.22]; P=0.20). In the exploratory analysis, patients with reduced LVEF had fewer cardiovascular events with the shunt (annualized rate 49.0% vs 88.6%; RR 0.55 [95% CI 0.42-0.73]), whereas those with preserved LVEF had more (60.2% vs 35.9%; RR 1.68 [95% CI 1.29-2.19]; P interaction <0.0001).
- Safety
- No primary safety events occurred after shunt implantation (upper 97.5% confidence limit 1.5%; P<0.0001).
- Conclusion
- The interatrial shunt was safe but did not improve outcomes in the overall heart failure population; exploratory analysis suggests benefit with reduced LVEF and harm with preserved LVEF.
- Why it matters
- It showed that atrial decompression with a shunt is not a broadly useful strategy across heart failure and that its effect may differ by LVEF, generating hypotheses for trials targeting reduced LVEF and raising concern about possible harm with preserved LVEF.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026