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Ultrafiltration Versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure - UNLOAD
Description:
The goal of the trial was to evaluate treatment with mechanical ultrafiltration compared with diuretic therapy among patients with acute decompensated heart failure.
Study Design
Study Design:
Patients Enrolled: 200
Mean Follow Up: 90 days
Mean Patient Age: Mean age 63 years
Female: 31
Patient Populations:
Acute decompensated heart failure with ≥2 signs of fluid overload, and randomization within 24 hours of hospital admission
Exclusions:
Creatinine >3.0 mg/dl, systolic blood pressure ≤90 mm Hg, no venous access, or vasoactive drug use pre-entry
Primary Endpoints:
1) Weight loss at 48 hours, and 2) dyspnea score at 48 hours
Drug/Procedures Used:
Patients hospitalized with fluid overload due to acute decompensated heart failure were randomized to mechanical ultrafiltration (n = 100) of 500 cc/hour or intravenous diuretic therapy (n = 100) at least twice per day.
Principal Findings:
At baseline, hypertension was present in 74% of patients. The average number of hospitalizations during the prior 12 months was 1.6. Ejection fraction was ≤40% in 71% of patients. Mean New York Heart Association classification was 3.4, with 45% of patients in class IV. Medications at entry included ACE inhibitors (49%), beta-blockers (66%), and loop diuretics (75%).
The primary endpoint of weight loss at 48 hours was greater in the ultrafiltration group compared with diuretics (5.0 kg vs. 3.1 kg, p = 0.001). There was no difference in the other primary endpoint of change in dyspnea score at 48 hours (6.4 for ultrafiltration vs. 6.1 for diuretic, p = 0.35). Fluid loss at 48 hours was 4.6 L in the ultrafiltration group and 3.3 L in the diuretic group (p = 0.001).
During 90-day follow-up, rehospitalization for heart failure occurred less often in the ultrafiltration group (18% vs. 32%, p = 0.037). The average number of hospitalizations for heart failure per patient was lower in the ultrafiltration group (0.22 vs. 0.46, p = 0.022), as were the mean number of hospitalization days (1.4 days vs. 3.8 days, p = 0.009). Mortality occurred in 9.6% of the ultrafiltration group and 11.6% of the diuretic group (p = NS). There was no increase in adverse events or adverse effects on renal function. B-natriuretic peptide did not differ by treatment group.
Interpretation:
Among patients hospitalized with fluid overload due to acute decompensated heart failure, mechanical ultrafiltration was associated with greater weight loss by 48 hours, but no difference in dyspnea score compared with diuretic therapy.
The improvements in weight loss with mechanical ultrafiltration over diuretic therapy occurred without increased adverse effects on renal function. Other benefits included a reduction in rehospitalization and unscheduled office visits. Given these promising findings, a cost-effectiveness analysis would be beneficial. The mechanical ultrafiltration device as well as the costs of the filters needed for each use is high, but it is unknown if the reduction in rehospitalization would offset the initial costs. Additionally, a larger confirmatory trial is needed.
References:
Costanzo MR, Guglin ME, Saltzberg MT, et al. Ultrafiltration versus intravenous diuretics for patients hospitalized for acute decompensated heart failure. J Am Coll Cardiol 2007;49:675-83.
Presented by Dr. Maria Rosa Costanzo at the March 2006 ACC Annual Scientific Session, Atlanta, GA.
Keywords: Natriuretic Peptides, Follow-Up Studies, Weight Loss, Diuretics, Heart Failure, Dyspnea, Sodium Potassium Chloride Symporter Inhibitors, Ultrafiltration, Hypertension
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