Heart failure & cardiomyopathies
Prospective multicentre single-arm study of an interatrial shunt in heart failure with reduced ejection fraction (SUSTAIN-HF): 1-year clinical and haemodynamic outcomes
Authors' conclusion
In this prospective cohort study of symptomatic HFrEF patients, treatment with the D-Shant atrial shunt device was associated with significant improvements in functional capacity, quality of life and rates of heart failure hospitalisation at 1 year. The single-arm design precludes definitive conclusions on treatment efficacy, underscoring the need for randomised, sham-controlled trials.
Study context
- Population
- Symptomatic heart failure with reduced ejection fraction (HFrEF) patients (LVEF ≤40%) on guideline-directed medical therapyenrolled between October 2017 and December 2021
- Participants
- 120 patients
- Exposure
- Changes from baseline to 1 year after implantation of the D-Shant atrial shunt device
- D-Shant atrial shunt devicen = 120
- Outcome
- Changes in 6 min walk distance (6MWD) and New York Heart Association (NYHA) functional class
- Follow-up
- Baseline to 1 year
Methodological details16 centres in China
- 16 centres in China
Main finding
As reported in the abstract
Mean 6MWD increase
54.1 m
95% CI 45.9 to 62.3p<0.0001
Proportion of patients in New York Heart Association (NYHA) class III/IV decreased
from 95.0% to 22.9%
p<0.0001
Observational data: associations, not effects.
Secondary outcomes
KCCQ overall score · 1 year
- KCCQ overall score improved
- 16.5 points (95% CI 13.9 to 19.1; p<0.0001)
Annualised rate of heart failure hospitalisation · 1 year
- Reduced
- from 3.3 to 0.3 events per patient-year (p<0.0001)
LVEF · 1 year
- LVEF increased
- 9.0% (95% CI 6.9% to 11.1%; p<0.0001)
Safety
Primary safety endpoint: composite of major adverse cardiac and device-related events · 1 year
- Occurred in patients
- 15.0%
- Driven primarily by cardiovascular death
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →