Heart failure & cardiomyopathies
Left Atrial-to-Coronary Sinus Shunting in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: The ALT-FLOW Trial (Early Feasibility Study) 2-Year Results
Authors' conclusion
In patients with HF and LVEF >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.
Study context
- Population
- Patients with HF and LVEF >40% (mildly reduced or preserved EF)
- Participants
- 95 patients
- Outcome
- KCCQ CSS, TSS and OSS (change from baseline)
- Follow-up
- 2 years
Methodological detailssingle-arm, 2-year follow-up of the ALT-FLOW EFS
- Single-arm, 2-year follow-up of the ALT-FLOW EFS
Main finding
As reported in the abstract
NYHA functional class improvement at 2 years
51 of 62
82.3%
Mean PCWL, baseline to 6 months (mm Hg/W/kg)
131 ± 74 to 76 ± 57
P < 0.0001
Further findings
Shunt patency · up to 5 years
- All implanted shunts patent
PCWL, NYHA, Kansas City Cardiomyopathy Questionnaire (KCCQ) by pulmonary vascular disease (subgroup)
- Consistent in patients with or without pulmonary vascular disease
Safety
Major adverse cardiac, cerebral and renal events and reintervention · 30 days
- Major adverse cardiac, cerebral and renal events and reintervention through 30 days
- 2.8%
Shunt patency · up to 5 years
- All implanted shunts patent
RV and LV function
- No detrimental changes in right or left ventricular function
Original publication
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