Key result
APTURE shunt linked to ~8-point higher 1-year survival than MAGGIC-predicted risk in HF.
Why the study?
It remained unknown whether hemodynamic and symptomatic benefits of the APTURE left atrial-to-coronary sinus shunt translate into clinical outcome benefit in heart failure with left ventricular ejection fraction >40%.
Does implantation of the APTURE left atrial-to-coronary sinus shunt improve survival compared to MAGGIC-predicted mortality and reduce HF hospitalizations compared to pre-implantation rates in patients with heart failure and LVEF >40%?
Observational (n=95)
Yes
Does implantation of the APTURE left atrial-to-coronary sinus shunt improve survival compared to MAGGIC-predicted mortality and reduce HF hospitalizations compared to pre-implantation rates in patients with heart failure and LVEF >40%?
Implantation of the APTURE left atrial-to-coronary sinus shunt in HFpEF/HFmrEF patients was associated with lower-than-predicted 1-year mortality and a reduction in heart failure hospitalizations compared to baseline, providing hypothesis-generating evidence for future randomized trials.
APTURE shunt was associated with better-than-predicted survival in HFpEF/HFmrEF; hypothesis-generating and requires randomized trials before any practice change.
BACKGROUND AND AIMS: Whether hemodynamic and symptomatic benefits of the APTURE left atrial-to-coronary sinus shunt translate into clinical outcome benefit in heart failure with left ventricular ejection fraction >40% remains unknown. METHODS: In this post hoc analysis of ALT-FLOW EFS patients undergoing APTURE implantation, Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) score-predicted 1-year all-cause mortality was compared with observed mortality by Kaplan-Meier analysis of adjudicated events. Heart failure hospitalization (HFH) rates were compared for the 12 months before vs after implantation. Additional analyses included stratification by baseline sodium-glucose cotransporter 2 inhibitor (SGLT2i) use and N-terminal pro-B-type natriuretic peptide (NT-proBNP), recurrent HFH cumulative hazard estimation (Nelson-Aalen), and H2FPEF score calculation. RESULTS: Among 95 patients (mean age 70.9 ± 8.5 years; 50% women; 93% New York Heart Association Class III; 85.9% with H2FPEF score >3), MAGGIC-predicted 1-year mortality was 13.0%. Observed 1-year survival was significantly higher than predicted (94.7% vs 87.0%; P=0.04), consistent across SGLT2i subgroups (log-rank P=0.59). The proportion of patients with HFH declined from 37.9% pre implantation to 9.6% post implantation (P<0.0001), with event rates falling from 0.61 to 0.21 per patient-year (P<0.001) and a 1-year cumulative hazard of recurrent HFH of 0.19 (95% confidence interval, 0.12-0.31). HFHs were evenly distributed across NT-proBNP strata. CONCLUSIONS: 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.
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Fioretti et al. (2026) conducted an observational in Heart failure with LVEF >40% (n=95). APTURE left atrial-to-coronary sinus shunt vs. MAGGIC score-predicted outcomes (model control) was evaluated on 1-year survival (p=0.04). Implantation of the APTURE shunt in patients with heart failure and LVEF >40% was associated with a significantly higher observed 1-year survival than predicted by the MAGGIC score (94.7% vs 87.0%, P=0.04).
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