Zymliński Robert, Biegus Jan, Vanderheyden Marc, Gajewski Piotr, Dierckx Riet, Bartunek Jozef, Ponikowski Piotr
Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.
Institute of Heart Diseases, University Hospital, Wroclaw, Poland.
JACC Basic Transl Sci. 2023 Apr 24;8(4):394-402. doi: 10.1016/j.jacbts.2023.02.010. eCollection 2023 Apr.
Lowering elevated central venous pressure may reduce renal dysfunction in acute heart failure (AHF) patients. The Doraya catheter lowers renal venous pressure by creating a gradient in the inferior vena cava below the renal veins. Here, we present a first-in-human feasibility study of the Doraya catheter performed on 9 AHF patients. We assessed the safety, feasibility, and acute clinical (hemodynamic and renal) effects of transient Doraya catheter deployment when added to the standard diuretic-based regimen in AHF patients with a poor diuretic response. The procedures decreased central venous pressure from 18.4 ± 3.8 mm Hg to 12.4 ± 4.7 mm Hg ( < 0.001) and improved mean diuresis and clinical signs of congestion. No device-related serious adverse events were observed. Thus, Doraya catheter deployment was safe and feasible in AHF patients. (First In Human Study of the Doraya Catheter for the Treatment of AHF Patients; NCT03234647).
降低升高的中心静脉压可能会减轻急性心力衰竭（AHF）患者的肾功能不全。多拉亚导管通过在肾静脉下方的下腔静脉中形成梯度来降低肾静脉压力。在此，我们展示了一项针对9例AHF患者进行的多拉亚导管人体首次可行性研究。我们评估了在利尿剂反应不佳的AHF患者中，将多拉亚导管短暂置入添加到基于利尿剂的标准治疗方案时的安全性、可行性以及急性临床（血流动力学和肾脏）效果。这些操作使中心静脉压从18.4±3.8毫米汞柱降至12.4±4.7毫米汞柱（P<0.001），并改善了平均尿量和充血的临床体征。未观察到与器械相关的严重不良事件。因此，在AHF患者中置入多拉亚导管是安全可行的。（多拉亚导管治疗AHF患者的人体首次研究；NCT03234647）
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