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Clinical Evidence 

Aquadex FlexFlow Clinical Studies

 

Study Name Study Design # of Patients Study Patient Group Date Key Findings
SAFE Multi-center, prospective, single arm 21 IDE for 510k 2003 JCF Extracellular and intravascular  fluid volume excess can be safely achieved via peripherally inserted UF

Fluid removal endpoint achieved in 92% of patients

RAPID-HF Multi-center, prospective, RCT 40
20 UF/20 SC
Early UF vs Diuretics 2005 JACC Early use of UF in CHF patients resulted in weight loss and significant fluid removal

Dyspnea and CHF symptoms were significantly improved in the UF group at 48 hours

EUPHORIA Single-center, prospective, single-arm 20 Early UF in diuretic resistance 2005 JACC Early UF before IV diuretics may decrease length of stay and readmission

Average length of stay was 3.7 days

60% of patients were discharged in ≤ 3 days

UNLOAD Multi-center, prospective, RCT 200
100 UF/100 SC
UF vs SC 2007 JACC At 48 hours, weight and net fluid loss were greater in the UF group than IV diuretics

At 90-days, UF group had fewer patients rehospitalized for heart failure, heart failure rehospitalization days per patient, and unscheduled visits than IV diuretics

CARRESS-HF Multi-center, prospective, RCT 188
94 UF/94 SC
UF vs SC patients with cardiorenal syndrome 2012 NEJM Stepped pharmacological therapy algorithm was superior to a strategy of ultrafiltration for the preservation of renal function at 96 hours, with a similar amount of weight loss with the two approaches
AVOID-HF Multi-center, prospective, RCT 224
110 UF/114 SC (810 planned)
UF vs SC to evaluate readmissions 2016 JACC-HF Ultrafiltration group trended towards a longer time to first HF event within 90 days and fewer HF and cardiovascular events

UF = Ultrafiltration

Publications on Ultrafiltration

Readmission Rate After Ultrafiltration in Acute Decompensated Heart Failure: A Systematic Review and Meta-Analysis

2017 | Siddiqui et al. | Heart Failure Reviews

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Defining The Role of Ultrafiltration Therapy in Acute Heart Failure: A Systematic Review and Meta-Analysis

2016 | Jain et al. | Heart Failure Reviews

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Ultrafiltration in patients with decompensated heart failure and diuretic resistance: an Asian center's experience

2016 | Teo et al. | Singapore Medical Journal

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Efficacy and safety assessment of isolated ultrafiltration compared to intravenous diuretics for acutely decompensated heart failure: a systematic review with meta-analysis

2014 | De Vecchis et al. | Minerva Cardioangiol

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Peripheral Ultrafiltration for Patients with Volume Overload: A Center's 4-year Experience

2007 | Walsh et al. | Critical Care Nursing Quarterly

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Sustained Cardiac Diastolic Changes Elicited by Ultrafiltration in Patients with Moderate Congestive Heart Failure: Pathophysiological Correlates

1993 | Pepi et al. | British Heart Journal

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Extracorporeal Ultrafiltration for Fluid Overload in Heart Failure: Current Status and Prospects for Further Research

2017 | Costanzo et al. | Journal of the American College of Cardiology

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Professional Society Guidelines

American College of Cardiology Foundation and American Heart Association | ACCF/AHA

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Heart Failure Society of America | HFSA

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The Canadian Cardiovascular Society | CCS

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European Society of Cardiology | ESC

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CHF Solutions