Atrial shunt treatment significantly improved left ventricular global longitudinal strain compared to sham control at 1 month (placebo-adjusted difference +3.7 %-units; 95% CI 0.5-6.9; P=0.027).
RCT (n=44)
Blinded
1:1
Does an atrial shunt device improve indices of cardiac mechanics in patients with heart failure with preserved or mildly reduced ejection fraction?
In patients with HFpEF/HFmrEF, an atrial shunt device improved left ventricular global longitudinal strain at 1 month compared to sham control.
Mean Difference: 3.7 (95% CI 0.5–6.9)
p-value: p=0.027
Abstract Background The effects of atrial shunt devices on cardiac mechanics in heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF) are not well understood. Methods Patients with HF and LVEF ≥40% randomized in REDUCE LAP-HF I underwent both echocardiography and invasive exercise hemodynamics at baseline and during the 1-month follow-up visit. Left ventricle (LV) global longitudinal strain (GLS), RV free wall strain (RVFWS), left atrial reservoir strain (LARS), and right atrial reservoir strain (RARS) were measured on the baseline and 1-month echocardiograms blinded to treatment assignment and invasive hemodynamics. We examined the correlation of indices of cardiac mechanics and resting and exercise invasive hemodynamics at baseline; compared differences of changes in indices of cardiac mecahnics between treatment groups; and evaluated correlations of 1-month changes in indices of cardiac mechanics with changes in invasive hemodynamics. Results A total of 44 patients (mean age 70±9 years, 50% female) were randomized 1:1 to atrial shunt (n=22) or sham control (n=22). Baseline GLS (absolute values) and LARS were inversely correlated with resting PCWP (R=-0.43, P=0.007; and R=-0.41, P=0.01, respectively). One month after randomization, atrial shunt treatment led to significant improvement in GLS (placebo-adjusted +3.7 %-units 95% CI +0.5, +6.9; P=0.027). LARS showed a trend to improvement (placebo-adjusted +5.6 %-units 95% CI -1.3, +12.6; (P=0.11). Within-group change in LARS was significant in the atrial shunt group (+5.4 %-unit 95% CI +0.2, +10.6; p=0.041) but not in the sham group (-1.0 %-units 95% CI -6.7, +4.7; P=0.72). No between-group differences were observed in delta RVFWS (P=0.70) or delta RARS (P=0.10). Among the rest, legs up, and exercise invasive hemodynamic measures, 1-month change in LARS correlated best with 1-month change in legs up PCWP (R=-0.60, P=0.0006). Conclusions Compared to sham, atrial shunt treatment improved LV and LA mechanics, without differences in RV or RA mechanics after 1 month of follow-up. Improvement in LA strain may reflect a reduction in LA pressure over time and may be a novel indicator of change in LA pressure in response to HFpEF/HFmrEF treatment.
Kim et al. (2026) conducted an RCT in Heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF) (n=44). Atrial shunt device vs. Sham control was evaluated on Change in left ventricle global longitudinal strain (GLS) at 1 month (MD 3.7 %-units, 95% CI 0.5 to 6.9, p=0.027). Atrial shunt treatment significantly improved left ventricular global longitudinal strain compared to sham control at 1 month (placebo-adjusted difference +3.7 %-units; 95% CI 0.5-6.9; P=0.027).