Aims: To assess the efficacy and safety, primarily in relation to the haemodynamic effects, of interatrial shunting devices (ISD) for the treatment of heart failure (HF), we conducted a systematic review and a meta-analysis.
Methods and results: We used the MEDLINE, Cochrane Library, Embase, and PubMed databases to identify clinical studies (published to 4 August 2021) that evaluated the effect of ISD on HF. The primary endpoint was defined as changes in pulmonary capillary wedge pressure (PCWP). Secondary endpoints included (i) other haemodynamic indexes, including cardiac output (CO), right atrial pressure (RAP), and mean pulmonary artery pressure (mPAP) by right heart catheterization, and (ii) change from baseline in 6 min walk distance (6MWD). After a literature search and detailed evaluation, six trials enrolling a total of 203 individuals were included in the quantitative analysis. Pooled analyses showed that after ISD implantation, PCWP decreased by a mean 3.10 mmHg [95% confidence interval (CI) -4.56 to -1.64; I2 = 0%; P < 0.0001]. Overall, CO increased by 0.77 L/min (95% CI 0.02 to 1.52; P = 0.04; I2 = 82%), but there were no significant changes in RAP or mPAP. The mean 6MWD increased by 32.33 m (95% CI 10.74 to 53.92; P = 0.003; I2 = 0) after ISD implantation.
Conclusions: Interatrial shunting device can effectively reduce PCWP, increase CO and 6MWD, and has no obvious adverse effects on the right heart and pulmonary pressure. Studies with larger sample size and longer follow-up time are needed for further verification.
Keywords: Haemodynamic changes; Heart failure; Interatrial shunting devices; Meta-analysis; Pulmonary capillary wedge pressure.
© 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.