Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): A randomized, multicenter, blinded, sham-controlled trial
The Lancet Feb 03, 2022
In the overall population of patients with heart failure and ejection fraction of greater than or equal to 40%, placement of an atrial shunt device neither decreased the total rate of heart failure events nor improved health status.
This randomized, international, blinded, sham-controlled trial included patients (aged ≥40 years) with symptomatic heart failure, an ejection fraction of at least 40%, and pulmonary capillary wedge pressure during exercise of at least 25 mm Hg while exceeding right atrial pressure by at least 5 mm Hg.
A total of 626 patients were randomized to receive either the atrial shunt device (n=314) or sham procedure (n=312).
Primary endpoint was defined as a hierarchical composite of cardiovascular death or non-fatal ischemic stroke at 12 months, rate of total heart failure events up to 24 months, and alteration in Kansas City Cardiomyopathy Questionnaire overall summary score at 12 months.
With regard to the primary composite endpoint or the individual components of the primary endpoint, no differences were found between groups.
A differential impact of atrial shunt device treatment on heart failure events was evident in the following prespecified subgroups: pulmonary artery systolic pressure at 20W of exercise (>70 mm Hg linked with worse outcomes), right atrial volume index (≥29·7 mL/m <sup>2</sup> , worse outcomes]), and gender (men, worse outcomes]).
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