Safety and Performance of the Aortix Device in Acute Decompensated Heart Failure and Cardiorenal Syndrome

作者：Jennifer Cowger, Mir B. Basir, David A. Baran, Chris Hayward, Janani Rangaswami, Antony Walton, Cristina Tita, Steven Minear, Emad Hakemi, Liviu Klein, Richard K. Cheng, Robby Wu, Bibhu D. Mohanty, J.J. Heuring, Elisabeth Neely, Palak Shah · 发表于：JACC Heart Failure · 年份：2023 · DOI：10.1016/j.jchf.2023.06.018 · 被引用次数：22 · 研究领域：Mechanical Circulatory Support Devices、Aortic Disease and Treatment Approaches、Heart Failure Treatment and Management

Cardiorenal syndrome (CRS) complicates 33% of acute decompensated heart failure (ADHF) admissions, and patients with persistent congestion at discharge have high 30-day event rates. The purpose of this study was to evaluate a novel catheter-deployed intra-aortic entrainment pump (IAEP) in patients with ADHF with CRS and persistent congestion. A multicenter (n = 14), nonrandomized, single-arm, safety and feasibility study of IAEP therapy was conducted. Within patient changes (post–pre IAEP therapy) in fluid loss, hemodynamics, patient-reported dyspnea, and serum biomarkers were assessed using Wilcoxon signed-rank testing. Of 21 enrolled patients, 18 received Aortix therapy. Mean ± SD patient age was 60.3 ± 7.9 years. The median left ventricular ejection fraction was 22.5% (25th-75th percentile: 10.0%-53.5%); 27.8% had a left ventricular ejection fraction ≥50%. Pre-therapy, patients received 8.7 ± 4.1 days of loop diuretic agents and 44% were on inotropes. Pump therapy averaged 4.6 ± 1.6 days, yielding net fluid losses of 10.7 ± 6.5 L (P < 0.001) and significant (P < 0.01) reductions in central venous pressure (change from baseline: −8.5 mm Hg [25th-75th percentile: −3.5 to −10.0 mm Hg]), pulmonary capillary wedge pressure (−11.0 mm Hg [25th-75th percentile: −5.0 to −14.0 mm Hg]), and serum creatinine (−0.2 mg/dL [25th-75th percentile: −0.1 to −0.5 mg/dL]) with improved estimated glomerular filtration rate (+5.0 mL/min/1.73 m2 [25th-75th percentile: 2.0-9.0 mL/min/1.73 m2]) and...