The following is a summary of “A Double-Blind, Randomized Placebo-Procedure-Controlled Trial of an Interatrial Shunt in Patients With HFrEF and HFpEF – RELIEVE-HF,” published in the April 2024 issue of Cardiology by Bavry et al.
Researchers conducted a prospective study evaluating the effects of an interatrial shunt among patients with symptomatic heart failure undergone a procedure.
They used a randomized trial design and placed the patients who had a heart failure hospitalization within the last 12 months into an interatrial shunt (n=250) vs. placebo-procedure (n=258), with the mean age of patients being 75 years and 50% patients with diabetes. Almost 35% were females, and the follow-up duration was 22 months. The interatrial shunt was performed with the V-Wave Ventura IAS device, which is an hourglass-shaped device made of nitinol and PTFE fabric that straddles the fossa ovalis half in the left atrium and half in the right atrium.
The results showed that the primary safety outcome, at 30 days, occurred in no patient from the interatrial shunt group. At the same time, the primary effectiveness outcome (all-cause death, cardiac transplantation or left ventricular assist device [LVAD] implantation, HF hospitalization, change in Kansas City Cardiomyopathy Questionnaire Overall Score [KCCQ-OS] by 5 points) was assessed by a win-ratio, 0.86 (P=0.20). Rates of adverse events in patients with LVEF≤40% were 49.0% vs. 88.6% (P<0.001) in the shunt vs. placebo group. Adverse events in the LVEF≥40% group were 60.2% vs. 35.9% (P=0.001) in the shunt vs. placebo group.
Investigators concluded that interatrial shunts were safe among patients with symptomatic heart failure; however, they did not reduce symptoms or improve prognosis. Interatrial shunts appeared beneficial among patients with HFrEF but were harmful among patients with HFpEF.
Source: acc.org/Latest-in-Cardiology/Clinical-Trials/2024/04/04/04/11/relieve-hf