UNLOAD Supports at Least a Limited Role for Ultrafiltration as Diuresis Alternative in Acute HF

February 2, 2007 (Washington, DC) - The technique is used today on the strength of smaller studies, but peripheral ultrafiltration's capable showing in a 200-patient controlled trial, now published after its previous release at a scientific meeting, lends more authority to its role as at least an alternative to IV diuretics in patients with acute decompensated heart failure (ADHF) [1]. Compared with standard management, peripheral ultrafiltration (UF) was seen to remove more fluid and reduce subsequent risk of HF hospitalizations.

The results of the Ultrafiltration vs Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Congestive Heart Failure (UNLOAD) study "suggest that UF is a safe and effective therapeutic modality for correction of volume overload in hospitalized patients with decompensated heart failure due to LV systolic dysfunction," write Dr Uri Elkayam (University of Southern California, Los Angeles) and associates in an editorial accompanying the trial's formal publication [2]. "The use of this therapy should be considered early in patients not responding to intravenous diuretics and vasoactive medications and in patients in whom such therapy is discontinued or reduced because of worsening renal function or other drug-induced complications."

Both the editorial and the UNLOAD report from Dr Maria Rosa Costanzo (Midwest Heart Foundation, Lombard, IL) and colleagues are published in the February 13, 2007 issue of the Journal of the American College of Cardiology. The study's main outcomes had been presented at the American College of Cardiology 2006 Scientific Sessions and reported then by heartwire .

The trial's 200 patients hospitalized with HF and clinical signs of hypervolemia were randomized equally to peripheral ultrafiltration or standard IV diuretic therapy. The UF group could not receive diuretics for at least the first 48 hours. Also during that time, any patient needing IV vasodilators or inotropic agents due to worsening symptoms or low urine output was judged a treatment failure.

The patients had been enrolled at 28 centers in the US that were experienced with the peripheral UF device used exclusively in the study (Aquadex System 100, CHF Solutions, Minneapolis, MN), write Costanzo et al.

Outcomes in the UNLOAD trial

End point	Ultrafiltration, n=100	Standard care, n=100	p
Dyspnea scores at 8 hours	5.4	5.2	NS
Net fluid loss at 48 hours (L)	4.6	3.3	0.001
HF rehospitalization rate at 90 days (%)	18	32	0.037
HF rehospitalization days within 90 days (d/patient)	1.4	3.8	0.022

Significantly fewer UF-treated patients required IV diuretics or inotropes at 48 hours (3.1% vs 12%, p=0.015). Serum creatinine changes were similar in the two groups, as were the proportions of patients with rises >0.3 mg/dL.

The UNLOAD results, write Elkayam et al, "clearly demonstrate a great potential for the use of UF in patients with decompensated heart failure either resistant to diuretics or [who] demonstrate unfavorable side effects. An early application of this technology in such patients should allow effective therapy, prevention of adverse events, and improvement of after-discharge outcome." But, they add, whether UF should replace standard IV diuretic therapy as a broadly applicable first-line therapy in ADHF remains to be shown in larger safety, efficacy, and cost-effectiveness studies.

"Costanzo is a member of the Medical Advisory Board of CHF Solutions, has CHF Solutions stock options as compensation for Medical Advisory Board membership, and receives speaker’s honoraria from CHF Solutions," the report states. Coauthor Dr Mitchell T Saltzberg (Midwest Heart Foundation) is a consultant for and received honoraria for speaking from CHF Solutions. Of the other coauthors, Dr Paul A Sobotka is chief medical officer and Dr Michael P Schollmeyer is director of clinical affairs for CHF Solutions.

1. 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; 49:675–683.

2. Elkayam U, Hatamizadeh P, Janmohamed M. The challenge of correcting volume overload in hospitalized patients with decompensated heart failure. J Am Coll Cardiol 2007; 49:684-686.

The complete contents of Heartwire , a professional news service of WebMD, can be found at www.theheart.org , a Web site for cardiovascular healthcare professionals.

Heartwire from Medscape © 2007  Medscape

Cite this: Steve Stiles . UNLOAD Supports at Least a Limited Role for Ultrafiltration as Diuresis Alternative in Acute HF - Medscape - Feb 02, 2007.