Acute cardiac care & resuscitation

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

JACC Heart FailPublished Single-arm safety and feasibility study

Authors' conclusion

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.

Study context

Population
Patients with acute decompensated heart failure (ADHF) with cardiorenal syndrome and persistent congestion18 received Aortix therapy
Participants
21 patients
Comparison
Within-patient changes post vs pre intra-aortic entrainment pump (IAEP) therapy
  • Aortixn = 18
Outcome
Within-patient changes with IAEP therapy (post-pre): net fluid loss, CVP, PCWP, serum creatinine, eGFR, dyspnea score
Follow-up
Pump therapy 4.6 ± 1.6 days
Methodological detailsmulticentre (n = 14), nonrandomised, pilot
  • Multicentre (n = 14)
  • Nonrandomised
  • Pilot

Main finding

As reported in the abstract

Net fluid loss
10.7 ± 6.5 L (P < 0.001)
Central venous pressure, change from baseline (median [25th-75th percentile])
−8.5 mm Hg [−3.5 to −10.0 mm Hg] (P < 0.01)
Pulmonary capillary wedge pressure, change
−11.0 mm Hg [−5.0 to −14.0 mm Hg] (P < 0.01)
Serum creatinine, change
−0.2 mg/dL [−0.1 to −0.5 mg/dL] (P < 0.01)
eGFR, change
+5.0 mL/min/1.73 m² [2.0-9.0 mL/min/1.73 m²]
Patient-reported dyspnea score, change
+16 [3-37]

Further findings

Dyspnea scores, natriuretic peptides, renal function · 30 days

Improvements persisted through 30 days

Original publication

Safety and Performance of the Aortix Device in Acute Decompensated Heart Failure and Cardiorenal Syndrome. JACC Heart Fail. Published 4 October 2023. doi:10.1016/j.jchf.2023.06.018

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