Heart failure & cardiomyopathies
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
An erratum to this article was published (Am Heart J, Mar 2026 ↗)
Authors' conclusion
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.
Study context
- Population
- Patients with heart failure (HF) and EF >40%RCT-I n = 44
- Comparison
- Atrial shunt vs sham
- Primary endpoint
- Hierarchical composite of:
- CV mortality
- Stroke
- HF events
- KCCQ (RCT-II)
- Follow-up
- 3 years
Methodological detailsmulticentre, sham-controlled
- Multicentre
- Sham-controlled
Primary result
As reported in the abstract
- No difference between shunt and sham in the overall trial
Further findings
| Outcome | Win ratio (95% CI) | P value | |
|---|---|---|---|
| Hierarchical composite, responders (exercise PVR <1.74 WU, no cardiac rhythm management device; subgroup, n = 313) · 3 years | 1.6 (1.2–2.2) | P = 0.006 | |
| 0.512Win ratio (log scale) |
HF events, responders (subgroup) · 3 years
reduction 44% · P = 0.005
| Outcome | Shunt | Sham | P value |
|---|---|---|---|
| Improvement in KCCQ overall summary score, responders (subgroup) · 3 years | +17.9 ± 20.0 | +7.6 ± 20.4 | P < 0.001 |
Cardiovascular (CV) mortality, HF events, embolic stroke, new-onset AF (RCT-I) · up to 5 years
- No differences between groups
HF events, nonresponders (subgroup) · 3 years
- Significantly more HF events with shunt
Safety
Ischemic stroke · 3 years
(95% CI 2%–6.1%) · P = 0.032
Worsening kidney dysfunction · 3 years
P = 0.041
Original publication
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