In vivo fluid dynamics of the Ventura interatrial shunt device in patients with heart failure.
Department
Cardiology
Document Type
Article
Publication Title
ESC Heart Fail
Abstract
Aims: Interatrial shunts are under evaluation as a treatment for heart failure (HF); however, their in vivo flow performance has not been quantitatively studied. We aimed to investigate the fluid dynamics properties of the 0.51 cm orifice diameter Ventura shunt and assess its lumen integrity with serial transesophageal echocardiography (TEE).
Methods and results: Computational fluid dynamics (CFD) and bench flow tests were used to establish the flow-pressure relationship of the shunt. Open-label patients from the RELIEVE-HF trial underwent TEE at shunt implant and at 6 and 12 month follow-up. Shunt effective diameter (Deff) was derived from the vena contracta, and flow was determined by the continuity equation. CFD and bench studies independently validated that the shunt's discharge coefficient was 0.88 to 0.89. The device was successfully implanted in all 97 enrolled patients; mean age was 70 ± 11 years, 97% were NYHA class III, and 51% had LVEF ≤ 40%. Patency was confirmed in all instances, except for one stenotic shunt at 6 months. Deff remained unchanged from baseline at 12 months (0.47 ± 0.01 cm, P = 0.376), as did the trans-shunt mean pressure gradient (5.1 ± 3.9 mmHg, P = 0.316) and flow (1137 ± 463 mL/min, P = 0.384). TEE measured flow versus pressure closely correlated (R2 ≥ 0.98) with a fluid dynamics model. At 12 months, the pulmonary/systemic flow Qp/Qs ratio was 1.22 ± 0.12.
Conclusions: When implanted in patients with advanced HF, this small interatrial shunt demonstrated predictable and durable patency and performance.
First Page
2499
Last Page
2509
DOI
10.1002/ehf2.14859
Volume
11
Issue
5
Publication Date
10-1-2024
Medical Subject Headings
Humans; Heart Failure; Female; Male; Aged; Hydrodynamics; Echocardiography, Transesophageal; Heart Atria; Prosthesis Design; Follow-Up Studies
PubMed ID
38773938
Recommended Citation
Pfeiffer, M., Boehmer, J., Gorcsan, J., Eguchi, S., Orihara, Y., Laufer Perl, M., Eigler, N., Abraham, W. T., Villota, J., Lee, E., Bayés-Genís, A., Moravsky, G., Kar, S., Zile, M. R., Holcomb, R., Anker, S. D., Stone, G. W., Rodés-Cabau, J., Lindenfeld, J., & Bax, J. J. (2024). In vivo fluid dynamics of the Ventura interatrial shunt device in patients with heart failure.. ESC Heart Fail, 11 (5), 2499-2509. https://doi.org/10.1002/ehf2.14859