February 11, 2025Open Access
View Full PaperLeft Atrial-to-Coronary Sinus Shunting in Heart Failure With Mildly Reduced or Preserved Ejection Fraction
Key Result
The APTURE transcatheter shunt system in patients with HF and LVEF >40% had a 2.8% 30-day major adverse event rate and reduced mean PCWL from 131 to 76 mm Hg/W/kg at 6 months (P<0.0001).
Structured PICO
Does the APTURE transcatheter shunt system improve health status, functional capacity, and hemodynamics in patients with heart failure and LVEF >40%?
P
Population
95 patients with heart failure and mildly reduced or preserved ejection fraction (LVEF >40%)
I
Intervention
APTURE transcatheter shunt system (left atrial-to-coronary sinus shunting)
O
Outcome
2-year health status, functional capacity, and outcomes (including device safety, performance, patency, hemodynamics, echocardiographic parameters, NYHA functional class, KCCQ scores, 6-minute walk distance, and PCWL)patient reported
The APTURE left atrial-to-coronary sinus shunt demonstrates an acceptable safety profile and is associated with significant improvements in hemodynamics, symptoms, and quality of life at 2 years in patients with HFmrEF and HFpEF.
Abstract
BACKGROUND: The ALT-FLOW trial EFS (Early Feasibility Study) evaluated safety, hemodynamics and outcomes for the APTURE system in patients with HF and mildly reduced or preserved ejection fraction. OBJECTIVES: In this study, the authors sought to examine the 2-year health status, functional capacity, and outcomes of ALT-FLOW EFS. METHODS: Device safety, performance, patency, hemodynamics, echocardiographic parameters, and outcomes were assessed in patients with LVEF >40% (n = 95); NYHA functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS), Total Symptom Score (TSS), and Overall Summary Score (OSS), 6-minute walk distance, and the ratio of pulmonary capillary wedge pressure at peak exercise to workload normalized to body weight (PCWL) were evaluated. RESULTS: Major adverse cardiac, cerebral, and renal events and reintervention through 30 days occurred in 2.8% of patients. All implanted shunts were patent for up to 5 years. The mean PCWL decreased from 131 ± 74 mm Hg/W/kg at baseline to 76 ± 57 mm Hg/W/kg after 6 months (P 40%, the APTURE shunt confirmed an acceptable safety profile with improvements in HF symptoms, quality of life, and functional capacity without negatively affecting right and left heart function after 2 years, regardless of pulmonary vascular disease. (Exploratory Study of the Edwards APTURE Transcatheter Shunt System ALT-FLOW Canada; NCT04000607; Early Feasibility Study-Edwards APTURE Transcatheter Shunt System ALT-FLOW US; NCT03523416).