Abstract Body (Do not enter title and authors here): Background: The potential benefit of an iatrogenic interatrial shunt in heart failure (HF) is based on observations wherein decompression of the pressure-overloaded left atrium appears beneficial. Consequently, devices designed to mimic this effect have been developed. However, their effectiveness remains controversial.
Methods: We searched PubMed, Cochrane, and Embase for randomized controlled trials (RCTs) comparing the use of atrial shunt devices (ASD) versus standard therapy in patients with heart failure with preserved ejection fraction (HFpEF). The outcomes of interest were: (1) quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and (2) HF events after ASD intervention. Heterogeneity was examined with I2 statistics. Statistical analysis was performed using R Studio 4.3.2.
Results: A total of 3 RCTs were included, encompassing 966 patients, of whom 479 (49.5%) were in the ASD group. Most of the participants were female (53%), had a three or higher NYHA class(92%), with a mean age of 72.5 years and a mean follow-up of 1.2 years. In the pooled analysis, there was no difference between groups in improvement of KCCQ (MD 0.65; 95% CI −2.22,3.52; p=0.66;I2=0%; Fig 1) and HF events (RR 1.06; 95% CI 0.81,1.39; p=0.68;I2=0%; Fig 2).
Conclusion: In this meta-analysis of patients with HFpEF, ASD therapy was not associated with improvements in quality of life and HF events.