Interatrial Shunt Device for Heart Failure and Preserved EF

Study Questions:

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)?

Methods:

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.

Results:

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).

Conclusions:

The IASD demonstrated favorable safety and efficacy in this observational study.

Perspective:

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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