Interatrial Shunt Device for Heart Failure and Preserved EF
What is the long-term efficacy and safety of an interatrial septal shunt device (IASD), which allows shunting to reduce left atrial pressure in patients with heart failure and preserved ejection fraction (HFPEF)?
The REDUCE LAP-HF study authors report the 1-year outcome of 64 patients with left ventricular ejection fraction (LVEF) ≥40%, New York Heart Association (NYHA) class II-IV, and elevated pulmonary capillary wedge pressure (PCWP ≥15 mm Hg at rest or ≥25 mm Hg during supine bicycle exercise), who participated in the open-label study of the IASD.
Survival at 1 year was 95% with three deaths between 6 months and 1 year. One patient had a stroke, but this was deemed to be not related to the device and there was no other device-related complication. One year after IASD implantation, there were sustained improvements in NYHA class (p < 0.001), quality of life (Minnesota Living with Heart Failure score, p < 0.001), and 6-minute walk distance (363 ± 93 vs. 331 ± 90 m, p = 0.001). There was a small, stable reduction in LV end-diastolic volume index (p < 0.001), with a small increase in right ventricular end-diastolic volume index (p < 0.001). The Qp:Qs ratio in patients undergoing cardiac catheterization at 12 months was 1.25 ± 0.25, and there was a sustained reduction in the workload corrected exercise PCWP (p < 0.01).
The IASD demonstrated favorable safety and efficacy in this observational study.
Iatrogenic left-to-right shunting to relieve symptoms in patients with HFPEF is a novel therapeutic approach that has demonstrated remarkable benefits in two studies (Del Trigo M, et al., Lancet 2016;387:1290-7 and Hasenfuss G, et al., Lancet 2016;387:1298-304). This study suggests that the benefits of this approach are sustained at 1 year, and provides a strong argument for a randomized controlled trial.
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