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A Double-Blind, Randomized Placebo-Procedure-Controlled Trial of an Interatrial Shunt in Patients With HFrEF and HFpEF - RELIEVE-HF
Contribution To Literature:
The RELIEVE-HF trial failed to show that an interatrial shunt device reduces symptoms or improves prognosis among heart failure patients.
Description:
The goal of the trial was to evaluate an interatrial shunt compared with placebo-procedure among patients with symptomatic heart failure.
Study Design
- Randomized
- Parallel
- Blinded
- Placebo
- Stratified
Patients with symptomatic heart failure were randomized to an interatrial shunt (n = 250) vs. placebo-procedure (n = 258). The interatrial shunt was performed with the V-Wave Ventura IAS device. The device is an hourglass shaped device made of nitinol and PTFE fabric that straddles the fossa ovalis so that half is in the left atrium and half is in the right atrium.
- Total number of enrollees: 605
- Total number randomized: 508
- Duration of follow-up: 22 months
- Mean patient age: 74 years
- Percentage female: 35%
- Percentage with diabetes: 50%
Inclusion criteria:
- Heart failure with any left ventricular ejection fraction (LVEF)
- Symptoms (New York Heart Association [NYHA] class II-IV) despite guideline-directed medical therapy
- Heart failure hospitalization within the last 12 months and/or an elevated cardiac biomarker (B-type natriuretic peptide [BNP]/NT-proBNP)
- Six-minute walk distance between 100 and 450 m
Exclusion criteria:
- Resting systolic blood pressure <90 or >160 mm Hg
- Intractable heart failure
- Severe pulmonary hypertension (pulmonary artery systolic pressure >70 mm Hg or pulmonary vascular resistance >4.0 Wood units)
- Right ventricular systolic dysfunction
- LV end-diastolic diameter >8 cm
- Atrial septal defect, patent foramen ovale, anomalous pulmonary venous return, corrected congenital heart disease, severe valve lesions
- Transseptal procedure planned within 6 months
- Atrial septal aneurysm
- Intracardiac thrombus
- Hemodynamic, rhythm, or respiratory instability
Other salient features/characteristics:
- LVEF ≤40%: 40%
- LVEF >40%: 60%
- Mean pulmonary capillary wedge pressure: 16 mm Hg
Principal Findings:
The primary safety outcome (all-cause death, stroke, systemic embolism, or need for open cardiac surgery or major endovascular surgical repair) at 30 days, occurred in 0% of the interatrial shunt group.
The primary effectiveness outcome (all-cause death, cardiac transplantation or left ventricular assist device [LVAD] implantation, heart failure hospitalization, outpatient worsening of heart failure events, change in Kansas City Cardiomyopathy Questionnaire Overall Summary score [KCCQ-OS] by 5 points) was assessed by a win-ratio: 0.86 (p = 0.20).
Secondary outcomes:
Stratification by LVEF:
- Among those with LVEF ≤40%, all-cause death, cardiac transplantation or LVAD implantation, heart failure hospitalization, outpatient worsening of heart failure events: 49.0% in the shunt group vs. 88.6% in the placebo group (p < 0.001)
- Among those with LVEF >40%, all-cause death, cardiac transplantation or LVAD implantation, heart failure hospitalization, outpatient worsening of heart failure events: 60.2% in the shunt group vs. 35.9% in the placebo group (p = 0.001)
Interpretation:
Among patients with symptomatic heart failure, an interatrial shunt was safe; however, it did not reduce symptoms or improve prognosis. The interatrial shunt appeared to be beneficial among those with reduced EF; however, it was harmful among those with preserved EF. The reason for this unexpected effect modification is currently unknown.
References:
Presented by Dr. Gregg W. Stone at the American College of Cardiology Annual Scientific Session (ACC.24), Atlanta, GA, April 6, 2024.
Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure
Keywords: ACC24, ACC Annual Scientific Session, Heart Failure, Implantable Devices
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