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

BACKGROUND

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.

OBJECTIVES

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.

METHODS

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.

RESULTS

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

CONCLUSIONS

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).

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures The study was funded by the sponsor Procyrion Inc (Houston, Texas, USA). Dr Cowger has served as a consultant for Abbott, Medtronic, Nuwellis, Corwave, Bioventrix, Endotronix, Procyrion; speaker for Zoll, Bioventrix, and Abbott; Data and Safety Monitoring Board for Berlin Excor and BiVacor; and has stock options with Procyrion. Dr Basir has served as a consultant for Abiomed, Boston Scientific, Cardiovascular Systems, Chiesi, Saranas, and Zoll. Dr Baran has served as a consultant for Abiomed, Abbott, Getinge, Teleflex, Livanova; on the steering committee of Procyrion, Natera, and CareDx; and as a speaker for Pfizer. Dr Hayward has received research support from Procyrion, Abbott, and Medtronic; and has served on the Scientific Advisory Board for Abbott, Medtronic, and VenstraMedical. Dr Rangaswami has served as a consultant for Boehringer-Ingelheim, AstraZeneca, Edwards Lifesciences, and Procyrion. Dr Walton has served as a consultant for Abbott Vascular and Medtronic. Dr Minear has served on the medical advisory board of Vyaire Medical. Dr Klein has received research support from Procyrion; and served on the scientific advisory board of Abbott and Medtronic. Dr Cheng has served as a consultant for Adona Medical. Dr Wu has served on the Speakers Bureau for Abbott; and the eligibility committee of Endotronix. Dr Mohanty has served on the Speakers Bureau for Abbott Structural Heart, as a consultant for W.L. Gore and Associates and Medtronic, and on the medical advisory board of Boston Scientific and Biotel; and has received grant support from W.L. Gore and Associates, Medtronic, and Edwards Lifesciences. Dr Heuring and Ms Neely are Procyrion employees. Dr Shah has received unrelated grant support paid to institution from the National Institutes of Health, Merck, Bayer, Roche, and Abbott; and served as a consultant for Natera, Merck, and Procyrion. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.