clinical evidence
Costanzo et. al. J Am Coll Cardiol 2007;49:675–683
First randomized study to compare the safety and
efficacy of a non-drug-based option (ultrafiltration) with standard
intravenous diuretic drug therapy to treat fluid overload in acutely
decompensated heart failure patients.
Randomized, multi-center study (28 centers) on 200
patients.
Results:
• Ultrafiltration patients experienced superior
salt & water removal and weight loss at 48 hours and significantly
reduced readmissions out to 90 days.
• At 48 hours, ultrafiltration demonstrated
• 38% greater weight loss
• 28% greater net fluid loss
• Improvement in breathing
• At 90 days, reduced readmissions
• 50% reduction in re-hospitalization episodes
• 63% reduction in total re-hospitalized days
• 52% reduction in emergency department or clinic visits
Conclusion: In decompensated heart failure, ultrafiltration
safely produces greater weight and fluid loss than intravenous diuretics,
reduces 90-day resource utilization for HF, and is an effective
alternative therapy. More info is available at www.unloadstudy.com
Costanzo et. al. J Am Coll Cardiol 2005;46(11):2047-2051
Explored the benefits of early ultrafiltration in
fluid overloaded patients.
Prospective, single center study on 20 patients
Initial ultrafiltration within 12 hours of hospitalization
and before any significant administration of IV diuretics and/or
vasoactive drugs
Results:
• 60% of patients were discharged in = 3
days
• Average hospitalization was 3.7 ± 1.8 days
• Clinical benefits persist at three months.
Conclusion: In heart failure patients with volume
overload and diuretic resistance, ultrafiltration before IV diuretics
effectively and safely decreases length of stay and readmissions.
Bart et. al. J Am Coll Cardiol 2005; 46(11):2043-2046
Compared the treatment effects of ultrafiltration
to usual care for patients who are hospitalized for decompensated
heart failure at 24 and 48 hours
Randomized, multi-center study (6 centers) on 40
patients
UF was limited to a single, 8 hour UF session. Diuretics
were not.
Results:
• Fluid removal after 24 h was 4,650 ml
and 2,838 ml in the UF and usual care groups, respectively.
• Compared to usual care, UF was not associated with significant
changes in heart rate, blood pressure, or electrolytes
• Dyspnea and CHF symptoms were significantly improved in
the UF group compared to usual care at 48 h
• Weight loss after 24 h, the primary end point, trended
in favor of patients randomized to UF (2.5 kg vs 1.86 kg).
Conclusion: The early application of UF for patients
with CHF was feasible, well-tolerated, and resulted in significant
weight loss and fluid removal.
Jaski et. al. Journal of Cardiac Failure 2003
9(3);227-231
Studied the safety and efficacy of peripherally
based ultrafiltration for market clearance.
Multi-center, prospective study, 21 patients (25
treatments)
Initial UF within 12 hours of hospitalization and
before any significant administration of IV diuretics and/or vasoactive
drugs
Results:
• Primary endpoint of greater than 1 L fluid
removal in less than 8 hours was achieved in 92% of treatments
(treatment period 6:43±1:47 hrs:min).
• On average, 2611±1002 mL (maximum 3,725 mL) of
ultrafiltrate was removed per treatment
• Patient weight decreased from 91.9±17.5 to 89.3±17.3
kg (P < .0001) after ultrafiltration.
• No major adverse events occurred.
Conclusion: Rapid removal of extracellular and intravascular
fluid volume excess can be safely achieved via peripherally inserted
ultrafiltration without the need for central venous catheter placement.
References:
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