Cowger Jennifer A, Basir Mir B, Baran David A, Hayward Christopher S, Rangaswami Janani, Walton Antony, Tita Cristina, Minear Steven, Hakemi Emad, Klein Liviu, Cheng Richard, Wu Robby, Mohanty Bibhu D, Heuring Jason J, Neely Elisabeth, Shah Palak
Henry Ford Health Heart and Vascular Institute, Detroit, Michigan, USA.
Cleveland Clinic Florida, Weston, Florida, USA.
JACC Heart Fail. 2023 Nov;11(11):1565-1575. doi: 10.1016/j.jchf.2023.06.018. Epub 2023 Oct 4.
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 m [25th-75th percentile: 2.0-9.0 mL/min/1.73 m]) and patient-reported dyspnea score (+16 [25th-75th percentile: 3-37]). Dyspnea scores, natriuretic peptides, and renal function improvements persisted through 30 days.
This pilot study of patients with ADHF, persistent congestion, and worsening renal function due to CRS supports the potential for safely achieving decongestion using IAEP therapy. These initial promising results provide the basis for future randomized clinical trials of this novel pump. (An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome [The Aortix CRS Pilot Study]; NCT04145635).
心肾综合征（CRS）使33%的急性失代偿性心力衰竭（ADHF）住院患者病情复杂化，出院时仍存在持续性充血的患者30天事件发生率很高。
本研究旨在评估一种新型的经导管置入的主动脉内夹带泵（IAEP）在合并CRS和持续性充血的ADHF患者中的应用效果。
进行了一项多中心（n = 14）、非随机、单臂的IAEP治疗安全性和可行性研究。采用Wilcoxon符号秩检验评估IAEP治疗前后患者在液体丢失、血流动力学、患者报告的呼吸困难及血清生物标志物方面的变化。
21例入组患者中，18例接受了Aortix治疗。患者平均年龄为60.3±7.9岁。左心室射血分数中位数为22.5%（第25至75百分位数：10.0% - 53.5%）；27.8%的患者左心室射血分数≥50%。治疗前，患者接受袢利尿剂治疗的平均天数为8.7±4.1天，44%的患者使用了正性肌力药物。泵治疗平均持续4.6±1.6天，净液体丢失量为10.7±6.5升（P < 0.001），中心静脉压显著降低（较基线变化：-8.5 mmHg [第25至75百分位数：-3.5至-10.0 mmHg]）、肺毛细血管楔压降低（-11.0 mmHg [第25至75百分位数：-5.0至-14.0 mmHg]）、血清肌酐降低（-0.2 mg/dL [第25至75百分位数：-0.1至-0.5 mg/dL]），同时估算肾小球滤过率提高（+5.0 mL/min/1.73 m² [第25至75百分位数：2.0 - 9.0 mL/min/1.73 m²]），患者报告的呼吸困难评分提高（+16 [第25至75百分位数：3 - 37]）。呼吸困难评分、利钠肽及肾功能改善持续至30天。
这项针对ADHF、持续性充血且因CRS导致肾功能恶化患者的初步研究支持了使用IAEP治疗安全实现去充血的可能性。这些初步的阳性结果为该新型泵未来的随机临床试验提供了依据。（心肾综合征患者主动脉内机械循环支持的Aortix系统安全性和性能评估[The Aortix CRS初步研究]；NCT04145635）
