Interatrial shunt devices in heart failure with preserved ejection fraction: A meta-analysis of randomized trials

The clinical effect of an iatrogenic interatrial shunt in heart failure with preserved ejection fraction (HFpEF) was based on observational data, wherein decompression of the pressure-overloaded left atrium improved symptoms and hemodynamics. However, the identification of a specific patient population that may benefit remains unclear.

We searched for randomized controlled trials (RCTs) that compared the creation of interatrial shunts versus a sham procedure in patients with HFpEF. The primary outcomes of interest were HF events and Cardiovascular (CV) mortality.

Three RCTs were included, encompassing 966 patients, of which 479 (49.5%) were in the interatrial shunt group. The mean age of the participants was 73.2 years, with an average LVEF of 58.7%. Of the 479 patients undergoing interatrial shunt placement, 69% had exercise hemodynamics to assist in selection for therapy. Interatrial shunt therapy in the selected patients showed a trend towards an increased risk of HF events (RR:1.29;95%CI:0.98-1.70;p=0.069) and CV death (RR:2.30;95%CI:0.94-5.59;p=0.067), compared with the sham procedure.

In this meta-analysis of patients with HFpEF, interatrial shunt therapy showed a trend towards an increased risk of HF events and CV mortality compared with the sham procedure, with no significant improvement in MACE, quality of life, or rates of MI and stroke/TIA. These findings raise concerns about interatrial shunt therapy for the broader HFpEF population and highlight the need for better patient selection.