https://doi.org/10.55788/84a29c51
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.
- 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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Table of Contents: HFA 2024
Featured articles
Meet the Trialist: Innovating cardiac monitoring with MONITOR-HF
Trials: Pharmacology
Effects of semaglutide on MACE irrespective of HF status
SEQUOIA-HCM: Aficamten demonstrates clinical efficacy in obstructive HCM
ARIES-HM3 trial: Subgroup analysis in patients with prior need for aspirin
Three diuretic regimens compared in the DEA-HF study
Adding a mineralocorticoid receptor modulator in heart failure with CKD
SGLT2 Inhibitors
Empagliflozin did not reduce mortality for HF after MI regardless of T2D status
SGLT2 inhibitors decrease atrial fibrillation risk in patients with HFrEF
SGLT2 inhibition: Major and early impact on heart failure hospitalisation risk
Trials: Other
Individualised diuretic titration in acute HF without a physician
Intravenous iron deficiency treatment improves exercise capacity in patients with HFpEF
CD34+ stem cells promote reverse cardiac remodelling after acute MI
Registries
Sex-specific outcomes and resource utilisation after HF hospitalisation
Application of guideline-directed medical therapy in patients with HFrEF in the Netherlands
Devices
PAP-guided management system appears safe in patients with HF
Delivery of CRT guided by non-invasive anatomy assessment
RELIEVE-ing HFrEF with interatrial shunting
Miscellaneous
Algorithm-based remote patient monitoring was associated with lower mortality in a retrospective cohort study
High mortality and morbidity in suspected de novo HF in outpatient care
Bio-ADM as a marker for congestion in patients hospitalised for acute HF
Hypertonic saline not effective in ambulatory patients with heart failure?
No effect of low-dose carperitide on mortality or hospitalisation in acute HF
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