Predicted Impact of Atrial Flow Regulator on Survival in Heart Failure with Reduced and Preserved Ejection Fraction
Authors' conclusion
In patients with HFpEF, the mortality rate following AFR implantation was lower than the predicted mortality rate.
Study context
- Population
- Symptomatic HF (heart failure with reduced ejection fraction (HFrEF) or heart failure with preserved ejection fraction (HFpEF)) with elevated PCWP (≥15 mmHg at rest or ≥25 mmHg during exercise) after successful Occlutech atrial flow regulator (AFR) implantation60 with complete 12-month follow-up
- Participants
- 87 participants
- Comparison
- Observed vs MAGGIC-predicted 1-year mortality after AFR implantation
- Primary endpoint
- Observed mortality rate vs median predicted probability for 1-year mortality (MAGGIC model)
- Follow-up
- 12 months
Methodological detailsprospective, multicentre, open-label
- Prospective
- Multicentre
- Open-label
Primary result
As reported in the abstract
Observed vs median predicted (MAGGIC) one-year mortality
Difference, deaths per 100 patient-years (95% CI)
HFpEF observed vs HFpEF predictedobserved 0vs predicted 9.3 (95% CI 8.4 to 11.1); significantly lower
−9.3(−11.1 to −8.4)
HFrEF observedvs HFrEF predicted
−3.6(−9.5 to 3.0)
- Observed mortality, overall (6 [7%] deaths, all HFrEF)
- 8.6 deaths per 100 patient-years; 95% CI 2.7 to 15.5
- Median predicted mortality, overall
- 12.2 deaths per 100 patient-years; 95% CI 10.2 to 14.7
Further findings
- HF-related deaths — HFrEF
- 10.8 (95% CI 2.5–23.1) HF-related deaths per 100 patient-years
- HF-related deaths — Overall: 4 HF-related deaths
- 5.7 HF-related deaths per 100 patient-years; 95% CI 1.4 to 11.9
Original publication
Predicted Impact of Atrial Flow Regulator on Survival in Heart Failure with Reduced and Preserved Ejection Fraction. ESC Heart Fail. Published 13 June 2023. doi:10.
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