ACC 24 Late-Breaker Discussion: The RELIEVE-HF Trial 

ACC 2024 - Late-breaker host Dr Harriette Van Spall (McMaster University, CA) welcomes Principal Investigator Dr Gregg Stone (Icahn School of Medicine at Mount Sinai, New York, NY, US) to discuss the REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure (RELIEVE-HF trial, clinicaltrials.gov/study/NCT0...) (V-Wave Ltd).
The RELIEVE-HF trial aims to assess the safety and efficacy of a new device, the V-Wave Interatrial Shunt System, in improving clinical outcomes for heart failure patients regardless of their ejection fraction. This is a prospective, multi-center, 1:1 randomized trial that enrolled 605 participants with both HFrEF and HFpEF. Patients must have NYHA Class II, Class III, or ambulatory Class IV heart failure (HF).
The primary outcome measure is device related adverse events and effectiveness of hierarchical composite of death, heart transplant or LVAD implantation, HF hospitalisations, worsening HF events treated as an outpatient and change in KCCQ. Findings presented at ACC.24 demonstrated that transcatheter implantation of the V-Wave inter-atrial shunt was safe but did not reduce symptoms or improve heart failure patient's prognosis across 2 years across the full range of LVEF. Results from a pre-specified stratified analysis suggested that inter-atrial shunt implantation is beneficial in patients with reduced LVEF, and harmful in patients with preserved LVEF.
Recorded remotely from New York and Hamilton, 2024.
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