RELIEVE-ing HFrEF with interatrial shunting

In the RELIEVE-HF trial, interatrial shunting was associated with improved clinical outcomes in patients with heart failure with reduced ejection fraction (HFrEF). Favourable effects were observed for the composite of all-cause death, insertion of a left ventricular assist device or heart transplantation, heart failure (HF) hospitalisations, and outpatient worsening heart failure events, in addition to all-cause and HF hospitalisation. A general improvement in health status with interatrial shunting may mediate the favourable effect on non-HF hospitalisations. Opposite effects were observed in patients with HF and preserved EF (HFpEF), with increased risk of all-cause death, all-cause hospitalisation, and both HF and non-HF hospitalisations.

Prof. Stefan Anker (Charité - University Hospital Berlin, Germany) presented the results of the RELIEVE-HF trial (NCT03499236), which evaluated the efficacy of interatrial shunting using the Ventura® shunt in patients with HF with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) with an EF cut-off of 40% [1]. This global, placebo-controlled study randomised 508 participants to receive either the shunt (n=250) or a sham procedure (n=258), alongside optimal medical therapy.

The study's primary endpoint, a composite of mortality, heart transplant or device implantation, HF hospitalisations, outpatient worsening heart failure events, and change in the Kansas City Cardiomyopathy Questionnaire, showed no significant difference between the shunt and placebo groups at 22 months follow-up. However, the safety performance goal of 11% was met (P<0.0001), with no participants in the shunt group experiencing any procedure- or device-related major adverse cardiovascular or neurological event.

The results of a pre-specified subgroup analysis revealed that implantation of the shunt was associated with benefits among participants with HFrEF, particularly in HF hospitalisations (HR 0.46; 95% CI 0.29–0.69), whereas participants with HFpEF experienced all-cause death (HR 3.37; 95% CI 1.47–13.00) and hospitalisations (HR 1.71; 95% CI 1.41–2.10). The risk of cumulative HF events (i.e. composite all-cause death, heart transplant, or left ventricular assist device implantation) was half that of the control group (HR 0.49; see Figure). The risk of all-cause events was also significantly lower in the shunt group (HR 0.59).

These findings are exploratory, and further larger scale studies are needed to confirm whether patients with HFrEF derive benefit from interatrial shunting.

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   1. Anker S, et al. REducing Lung congestIon symptoms using the v-wavE shunt in adVancEd Heart Failure. Late breaking clinical trials: devices, Heart Failure 2024, 11–14 May, Lisbon, Portugal.

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Posted on 16 July 202416 July 2024