Heart failure & cardiomyopathiesSecondary analysis

Predicted versus observed outcomes in the ALT-FLOW early feasibility study

ESC Heart FailPublished

  • post hoc analysis
  • early feasibility study

Authors' conclusion

In ALT-FLOW EFS, observed 1-year mortality was lower than MAGGIC-predicted mortality, and post implantation HFH rates were lower than pre implantation rates. These hypothesis-generating findings will require confirmation in the randomized, sham-controlled ALT-FLOW II trial.

Study context

Population
Patients with heart failure with left ventricular ejection fraction >40% undergoing APTURE left atrial-to-coronary sinus shunt implantation in ALT-FLOW EFSpatients undergoing APTURE implantation
Participants
95 patients
Comparison
Observed vs MAGGIC-predicted

Primary result

As reported in the abstract

1-year survival, observed vs MAGGIC-predicted · 1 year

P = 0.04

MAGGIC-predicted 1-year mortality
13.0%

Further findings

OutcomeValuesP value
Proportion of patients with HFH · 12 months before vs after implantation · declined post implantationPre implantation 37.9% · Post implantation 9.6%P < 0.0001
HFH event rate · falling post implantationPre implantation 0.61 per patient-year · Post implantation 0.21 per patient-yearP < 0.001

Cumulative hazard of recurrent heart failure hospitalization (HFH) · 1 year

1-year cumulative hazard of recurrent HFH
0.19 (95% confidence interval, 0.12-0.31)

Baseline characteristics

mean age
70.9 ± 8.5 years
women
50%
New York Heart Association Class III
93%
H2FPEF score >3
85.9%

HFH by NT-proBNP strata

HFHs were evenly distributed across NT-proBNP strata

Original publication

Predicted versus observed outcomes in the ALT-FLOW early feasibility study. ESC Heart Fail. Published 8 June 2026. doi:10.1093/eschf/xvag101

Summarised from the published abstract; every number is checked against it