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Echocardiographic Evaluation of Atrial Communications before Transcatheter Closure
Published on: February 8, 2022
Left Atrial to Coronary Sinus Shunting for Treatment of Symptomatic Heart Failure
Benjamin Hibbert1, Firas Zahr2, Trevor Simard3
1CAPITAL Research, Department of Medicine, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
Insights
The APTURE Transcatheter Shunt System shows promise for heart failure (HF) patients, improving health status and reducing pulmonary capillary wedge pressure safely. This novel interatrial shunting therapy offers a new option for symptomatic HF management.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Heart failure (HF) significantly impacts mortality and patient health status.
- Interatrial shunting is an emerging therapeutic strategy for HF management.
Purpose of the Study:
- To evaluate the safety and efficacy of the Edwards APTURE Transcatheter Shunt System in patients with symptomatic HF.
- Assessed the impact of the shunt on pulmonary capillary wedge pressure, HF symptoms, and quality of life.
Main Methods:
- The ALT FLOW Early Feasibility Study enrolled 87 patients with symptomatic HF across 18 centers.
- Patients had elevated pulmonary capillary wedge pressure (>15 mmHg rest or >25 mmHg exercise).
- The APTURE shunt was implanted, and safety and clinical outcomes were assessed up to 6 months.
Main Results:
- Device success was achieved in 90% of patients, with a low primary safety event rate (2.3% at 30 days).
- At 6 months, 67% of patients improved to NYHA functional class I-II, with a 23-point increase in quality of life scores.
- Pulmonary capillary wedge pressure decreased by 7 mmHg during exercise, with no adverse effects on right heart function.
Conclusions:
- The APTURE Transcatheter Shunt System demonstrated safety in symptomatic HF patients.
- The system effectively reduced pulmonary capillary wedge pressure.
- Clinically meaningful improvements in HF symptoms and quality of life were observed.
Background:
Heart failure (HF) is associated with both mortality and a significant decline in health status. Interatrial shunting is increasingly being investigated as a novel therapeutic option.
Objectives:
The ALT FLOW Early Feasibility Study was designed to evaluate the safety of the Edwards left atrial to coronary sinus APTURE Transcatheter Shunt System in patients with symptomatic HF.
Methods:
A total of 18 centers enrolled patients with symptomatic HF with a pulmonary capillary wedge pressure >15 mm Hg at rest or 25 mm Hg during exercise.
Results:
Between May 2018 and September 2022, 87 patients underwent attempted APTURE shunt implantation. Mean age was 71 years, and 53% were male. At baseline, mean left ventricular ejection fraction was 59% with 90% of the patients being in NYHA functional class III. Device success was achieved in 78 patients (90%), with no device occlusions or associated adverse events identified after implantation. The primary safety outcome occurred in only 2 patients (2.3%) at 30 days. At 6 months, health status improved: 67% of participants achieved NYHA functional class I to II status, with a 23-point improvement (P < 0.0001; 95% CI: 17-29 points) in the Kansas City Cardiomyopathy Questionnaire overall summary score. Also at 6 months, 20-W exercise pulmonary capillary wedge pressure was 7 mm Hg lower (P < 0.0001; 95% CI: -11 to -4 mm Hg) without change in right atrial pressure or other right heart function indices.
Conclusions:
In this single-arm experience, the APTURE Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in pulmonary capillary wedge pressure and clinically meaningful improvements in HF symptoms and quality of life indices.
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