Heart failure & cardiomyopathies
In Vivo Fluid Dynamics of the Ventura Interatrial Shunt Device in Patients with Heart Failure
Authors' conclusion
When implanted in patients with advanced HF, this small interatrial shunt demonstrated predictable and durable patency and performance.
Study context
- Population
- Open-label patients with heart failure (HF) from the RELIEVE-HF trial
- Participants
- 97 patients
- Outcome
- In vivo fluid dynamics (effective diameter, trans-shunt gradient, flow) and lumen integrity of the shunt
- Follow-up
- Implant, 6 and 12 months
Methodological detailsopen-label, serial transesophageal echocardiography (TEE), computational fluid dynamics (CFD) and bench flow tests
- Open-label
- Serial TEE
- CFD and bench flow tests
Main finding
As reported in the abstract
- Discharge coefficient (CFD and bench)
- 0.88 to 0.89
- Patency confirmed in all instances except one stenotic shunt at 6 months
- 1
- Deff at 12 months, unchanged from baseline (cm)
- 0.47 ± 0.01, P = 0.376
- Trans-shunt mean pressure gradient at 12 months, unchanged (mmHg)
- 5.1 ± 3.9, P = 0.316
- Shunt flow at 12 months, unchanged (mL/min)
- 1137 ± 463, P = 0.384
- TEE flow vs pressure correlation with fluid dynamics model
- R2 ≥ 0.98
- Qp/Qs ratio at 12 months
- 1.22 ± 0.12
Further findings
Implant success
- Successfully implanted in all enrolled patients
- 97
- Mean age 70 ± 11 years; 97% NYHA III; 51% LVEF ≤40%
Original publication
In Vivo Fluid Dynamics of the Ventura Interatrial Shunt Device in Patients with Heart Failure. ESC Heart Fail. Published 22 May 2024. doi:10.
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