Safety, Feasibility of Controllable Decrease of Vena Cava Pressure by Doraya Catheter in Heart Failure

Shielding the Heart

“…The Doraya pilot clinical trial which is published in this issue of JACC: Basic to Translational Science , 4 is a nonrandomized, open-label, single-arm, prospective study that sought to evaluate the safety, feasibility, and hemodynamic and renal effects of a temporary (<12 hours) Doraya catheter procedure as an add-on to the usual diuretic therapy in patients with AHF. 3 , 4 The patients were required to have a primary diagnosis of congestive AHF, a poor response to diuretic therapy, and evidence of fluid overload. Patients with a history of deep venous thrombosis or pulmonary embolism, systolic blood pressure <90 mm Hg, and severe renal dysfunction (estimated glomerular filtration rate <18 mL/min/1.73 m 2 ) were excluded.…”

“…Zymliński et al 4 are to be congratulated on conducting a novel study which supports the safety of Doraya catheter in patients with AHF and provides the groundwork for further study of clinical efficacy. However, some limitations, which are in keeping with first-in-human studies, should be appreciated.…”