clinical evidence
Selected Study Highlights of Ultrafiltration
(UF) and Aquapheresis
Click on
the study name to view its abstract. Article reprints are available
upon request.
| Study Name |
Study Type &
Inclusion Criteria |
Pts |
Conclusion(s) |
| UNLOAD
To review the full results,
go to www.unloadstudy.com |
Randomized, multicenter, multiple
substudies, aquapheresis vs. standard therapy (diuretics) |
100/100 |
At 48 hours into treatment,
the ultrafiltration group demonstrated a:
- 38 % greater weight loss over
standard care
- 28 % greater net fluid loss over
standard care
- Equal improvement in dyspnea
score (breathing)
At 90 days following hospital discharge,
the ultrafiltration group demonstrated over standard
care a:
- 43% reduction in patients requiring
re-hospitalizations for heart failure
- 50% reduction in the total number
of re-hospitalizations for heart failure
- 52% reduction in emergency or
clinic visits
- 63% total reduction in days re-hospitalized
for heart failure
|
| Emery
RW, Innovations 2007;2: 33–35 |
Retrospective, postoperative cardiac
surgery |
30 |
- Fluid extraction with ultrafiltration in the early
postoperative
period was readily accomplished without affecting
electrolyte balance, hemodynamic
stability, or renal function.
- It is a simple process that was managed by the nursing
staff without specialty training.
- This use represents an application of new technology
for improved patient care.
|
| Costanzo,
J Am Coll Cardiol 2005;46(11):2047-2051 |
Prospective, case series, Early UF
in Diuretic Resistance |
19 |
- Early treatment strategy with aquapheresis effectively
and safely decreases length of stay and readmissions.
- Clinical benefits persist at 3 months after treatment.
- 68% of patients were discharged ² 3 days.
- No patients readmitted within 30 days.
|
| Bart, J
Am Coll Cardiol 2005; 46(11):2043-2046 |
Randomized, Early UF vs. Diuretics
|
20/20 |
- Aquapheresis is effective, safe and can be applied
in a variety of community-based hospitals.
- Over 4 times reduction in CHF symptoms
- Cumulative fluid removal is nearly 2 1/2 times greater
than that achieved by aggressive use of diuretics.
- Not associated with adverse hemodynamic or lab sequelae.
|
| Sheppard,
J Card Fail. 2004 Oct;10(5):380-3 |
Retrospective, case series, FC III-IV |
19 |
- Suggests that UF is a safe, feasible therapy.
- Important option for patients with severe and refractory
CHF.
- Number of patients considered inotrope-dependent
reduced from 86.4% to 36.8%
- Number of CHF hospitalizations during follow-up
was reduced from 2.6 to 0.3.
- NYHA class improved from 4 to 3.1
|
| Raman,
Int J Artif Organs. 2003 Aug;26(8):753-7 |
Randomized, case series, cardiac
surgery |
61/57 |
- Hemofiltration during CPB attenuates postoperative
anemia, thrombocytopenia and hypoalbuminemia.
- Appears to decrease post-operative pulmonary complications.
|
| Jaski,
Journal of Cardiac Failure 2003 9(3);227-231 |
Prospective, case series, FC III |
21 |
- Rapid removal of extracellular and intravascular
fluid volume excess can be safely achieved via peripherally
inserted ultrafiltration.
- Primary fluid removal endpoint achieved in 92% of
patients.
- No major adverse events occurred.
- Could be used in any setting where patients normally
receive IV drug therapy.
- 3 patients treated as outpatients.
- Early application could obviate the need for hospitalization.
|
| Marenzi,
J Am Coll Cardiol 2001;38:4:963-968 |
Prospective, case series, FC III |
24 |
- Subtraction of plasma water by UF in rCHF is associated
with hemodynamic improvement.
- Hypotension does not occur when plasma refilling
rate is adequate to prevent hypovolemia.
|
| Agostoni,
Am J Med. 1994 Mar;96(3):191-9 |
Randomized, UF vs. IV bolus Lasix |
8/8 |
- Favorable circulatory and ventilatory adjustments.
- Improved functional capacity of these patients.
- The improvement continued 3 months after the procedure.
|
| Pepi,
Br Heart J. 1993 Aug;70(2):135-40. |
Randomized, controlled FC II-III |
12/12 |
- Variations due to UF in the ventricular filling
pattern, lung water content, and functional performance
persisted for three months in all patients.
- None of these changes was detected in the control
group.
|
| Agostoni,
J Am Coll Cardiol. 1993 Feb; 21(2):424-31 |
Randomized, controlled, FC II-III |
18/18 |
- Significant reductions in right atrial pressure,
pulmonary wedge pressure, cardiac index, extravascular
lung water.
- Significant increases in lung function, ventilation,
tidal volume
- None of these were recorded in the control group.
|
| Marenzi,,
Am J Med. 1993 Jan;94 (1):49-56 |
Prospective, class II - IV |
32 |
- Correlation between changes in these circulatory
and hormonal variables and changes in diuresis and
natriuresis.
- UF is able to interrupt the humoral-hemodynamic
vicious circle.
|
| Rimondini,
Am J Med. 1987 Jul;83(1):43-8 |
Prospective, case series, FC IV,
diuretic resistant |
11 |
- Promoted relief of dyspnea and of clinical and radiographic
evidence of lung congestion and pleural effusion
- Reduced the dependent edema and abdominal girth
|
|
Complete References
Agostoni, PG et al, Sustained Improvement in Functional Capacity after Removal of Body Fluid with Isolated Ultrafiltration in Chronic Cardiac Insufficiency: Failure of Furosemide to Provide the Same Result. American Journal of Medicine, Vol. 96; March 1994; pp. 191-99.
Agostoni, PG et. al. Isolated ultrafiltration in moderate congestive heart failure. Journal of American College of Cardiology, Vol. 21: No. 2; Feb. 1993; pp. 424-31.
Bart B et. al. Randomized Controlled Trial of Ultrafiltration Versus
Usual Care for Hospitalized Patients with Heart Failure. Journal
of the American College of Cardiology, Vol. 46: No. 11; 2005; pp.
2043-2046.
Costanzo, MR et. al. EUPHORIA Trial: Early Ultrafiltration in Patients
with Decompensated Heart Failure and Observed Resistance to Intervention
with Diuretic Agents. Journal of the American College of Cardiology,
Vol. 46: No. 11; 2005; pp. 2047-2051.
Emery RW et. al. Use of Peripheral Ultrafiltration
in the Postoperative Cardiac
Surgery Patient. Innovations, Vol. 2, No 1, 2007, pp. 33-35.
Jaski BE, Ha J, Denys BG, Lamba S, Trupp RJ,
Abraham WT. Peripherally Inserted Veno-Venous Ultrafiltration for
Rapid Treatment of Volume Overloaded Patients. Journal of Cardiac
Failure, Vol. 9, No. 3, 2003, pp. 227-231.
Marenzi, GC et. al. Circulatory Response to Fluid Overload Removal by Extracorporeal Ultrafiltration in Refractory Congestive Heart Failure Journal of ACC, 38: 4; 2001; pp. 963-68.
Marenzi, GC et. al. Interrelation of Humoral Factors, Hemodynamics, and Fluid and Salt Metabolism in Congestive Heart Failure Effects of Extracorporeal Ultrafiltration. American Journal of Medicine, 94; Jan. 1993; pp. 49-56.
Pepi, M et. al. Sustained cardiac diastolic changes elicited by ultrafiltration in patients with moderate congestive heart failure: pathophysiological correlates. British Heart Journal, 70; Aug. 1993; pp. 135-40.
Raman, J et. al. Hemofiltration during cardiopulmonary bypass for high risk adult cardiac surgery.
International Journal of Artificial Organs. 2003 Aug;26(8):753-7.
Rimondini, A et. al. Hemofiltration as Short-Term Treatment for Refractory Congestive Heart Failure, American Journal of Medicine, 83; July 1987; pp. 43-48.
Sheppard, R et. al. Intermittent outpatient ultrafiltration for
the treatment of severe refractory congestive heart failure. Journal
of Cardiac Failure 2004 Oct;10(5):380-3.
A more extensive bibliography of the clinical literature is
available upon request. |
