Abstract：
OBJECTIVE: 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).
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.
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.
摘要：
目的：正在评估心房分流作为心力衰竭（HF）的治疗方法；然而，它们在体内的流动性能还没有定量研究。我们旨在研究0.51cm孔口直径Ventura分流的流体动力学特性，并通过连续经食管超声心动图（TEE）评估其管腔完整性。
结果：使用计算流体动力学（CFD）和台架流量测试来建立分流器的流量-压力关系。来自RELIEVE-HF试验的开放标签患者在分流植入以及6和12个月随访时接受了TEE。分流有效直径(Deff)来自静脉收缩，流量由连续性方程决定。CFD和台架研究独立验证了分流器的放电系数为0.88至0.89。该装置成功植入所有97名患者，平均年龄为70±11岁，97%是NYHA三级，51%的LVEF≤40%。在所有情况下都确认了通畅，除了6个月时的一个狭窄分流。Deff在12个月时与基线相比保持不变（0.47±0.01cm，P=0.376),跨流平均压力梯度(5.1±3.9mmHg，P=0.316）和流量（1137±463mL/min，P=0.384）。TEE测量的流量与压力的关系与流体动力学模型密切相关（R2≥0.98）。12个月时,肺流/体流Qp/Qs比值为1.22±0.12。
结论：当植入晚期HF患者时，这种小的房间分流显示出可预测且持久的通畅性和性能.
结果：使用计算流体动力学（CFD）和台架流量测试来建立分流器的流量-压力关系。来自RELIEVE-HF试验的开放标签患者在分流植入以及6和12个月随访时接受了TEE。分流有效直径(Deff)来自静脉收缩，流量由连续性方程决定。CFD和台架研究独立验证了分流器的放电系数为0.88至0.89。该装置成功植入所有97名患者，平均年龄为70±11岁，97%是NYHA三级，51%的LVEF≤40%。在所有情况下都确认了通畅，除了6个月时的一个狭窄分流。Deff在12个月时与基线相比保持不变（0.47±0.01cm，P=0.376),跨流平均压力梯度(5.1±3.9mmHg，P=0.316）和流量（1137±463mL/min，P=0.384）。TEE测量的流量与压力的关系与流体动力学模型密切相关（R2≥0.98）。12个月时,肺流/体流Qp/Qs比值为1.22±0.12。
结论：当植入晚期HF患者时，这种小的房间分流显示出可预测且持久的通畅性和性能.
