Heart failure & cardiomyopathies
Left Atrial to Coronary Sinus Shunting for Treatment of Heart Failure with Mildly Reduced or Preserved Ejection Fraction: The ALT FLOW Early Feasibility Study 1-Year Results
Authors' conclusion
In patients with heart failure and LVEF >40%, the APTURE shunt demonstrated an acceptable safety profile with significant sustained improvements in haemodynamic and patient-centred outcomes
Study context
- Population
- Patients with HF and mildly reduced or preserved EF95 implanted with left ventricular ejection fraction (LVEF) >40% analysed
- Participants
- 116 patients
- Outcome
- Primary safety endpoint: major adverse cardiac, cerebral and renal events, and reintervention
- Follow-up
- 30 days
Methodological detailssingle-group, paired comparison baseline vs follow-up
- Single-group
- Paired comparison baseline vs follow-up
Main finding
As reported in the abstract
Patients with primary safety endpoint event
3 of 116
2.6%
Further findings
Shunt patency · 1 year
- All implanted shunts patent
Reduction in exercise pulmonary capillary wedge pressure (PCWP) at 20 W (LVEF >40%) · 6 months
- Mean reduction vs baseline, mmHg
- −5.7 (−8.6, −2.9) (95% CI)
- P
- P < 0.001
- Paired comparison vs baseline
- n = 95
NYHA class I-II (LVEF >40%) · 1 year
- Baseline
- 8%
- 1 year
- 68%
- P
- P < 0.001
Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS) (LVEF >40%) · 6 months and 1 year
- Baseline
- 39 (35, 43) (95% CI)
- Improvement at 6 months, points
- 25 (20-30) (95% CI)
- Improvement at 1 year, points
- 27 (22-32) (95% CI)
- P
- both p < 0.0001
PCWP at 20 W and KCCQ-OSS by subgroup
- Results in multiple subgroups consistent with the entire population
Safety
Major adverse cardiac, cerebral and renal events and reintervention (primary safety endpoint) · 30 days
- Patients with event
- 3/116 (2.6%)
Right heart function (haemodynamic and echocardiographic indices) · 1 year
- No adverse changes observed
Original publication
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