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CARRESS HF: Pharmacologic care superior to ultrafiltration for acute decompensated HF
LOS ANGELES — Hospitalized patients with acute decompensated HF had better outcomes with use of a stepped pharmacologic-therapy algorithm as compared with a strategy of venovenous ultrafiltration for the preservation of renal function at 96 hours, with similar weight loss between the two groups, according to results from the CARRESS-HF study.
Bradley A. Bart, MD, of the Mayo Clinic in Rochester, Minn., presented the findings on behalf of the NHLBI Heart Failure Clinical Research Network. Bart noted that patients receiving intensified loop diuretics for acute decompensated HF are prone to worsening renal function despite persistent congestion. There is uncertainty as to whether loop diuretic therapy contributes to the renal complications.
CARESS HF examined whether venovenous ultrafiltration is a viable treatment modality to improve renal function and relieve congestion in this patient population. The primary outcome measure was change in serum creatinine and change in weight between randomization and 96 hours, considered as a bivariate response. An intention-to-treat analysis was conducted in addition to a multivariate analysis adjusting for baseline values of weight and creatinine. Changes in weight and renal function at discharge, rates of clinical decongestion, changes in symptoms, rates of death and HF hospitalizations and serious adverse events served as secondary endpoints.
There were 94 patients with worsening renal function on loop diuretic therapy for acute decompensated HF in each group. Patients were randomly assigned one of two regimens in a 1:1 ratio: a stepped pharmacologic-care algorithm based on intensified loop diuretic therapy or venovenous ultrafiltration at a nominal rate of 200 cc/hr.
Mean change in creatinine level at 96 hours was –0.04 mg/dL in the pharmacologic therapy group and 0.23 mg/dL in the ultrafiltration group (P=.003).
Mean weight loss at 96 hours was 5.5 kg (12.1 lb) in the pharmacologic group and 5.7 kg (12.6 lb) in the ultrafiltration group, which Bart noted was not statistically different (P=.58).
Serious adverse events occurred in more patients in the ultrafiltration group than in the pharmacologic therapy group (72% vs. 57%; P=.03).
“Ultrafiltration, as administered in this study, had higher rates of adverse events, and therefore offers no advantage to stepped pharmacologic care in patients with acute decompensated HF, worsened renal function and persistent congestion,” Bart said at a press conference. “Treatment of these patients remains a challenging clinical problem in need of better therapy.” – by Samantha Costa and Rob Volansky
For more information:
Bart BA. Late-breaking clinical trials: Management of LV dysfunction: Devices and drugs. Presented at: the American Heart Association Scientific Sessions; Nov. 3-7, 2012; Los Angeles.
Bart BA. NEJM. 2012; doi: 10.1056/NEJMoa1210357.
Perspective
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There has been the concept that performing ultrafiltration to mechanically remove the fluid could be beneficial in patients hospitalized with HF. In the past, that was highly inconvenient. It essentially required dialysis and venous catheters, and the real advance was developing a peripheral system that could be done at the bedside rather than an intensive care unit. The UNLOAD trial showed greater reductions in fluid and similar relief in symptoms, but less rehospitalizations for HF.
The CARRESS-HF trial was designed to evaluated peripheral ultrafiltration in patients who had started to be treated for HF but had a rise in creatinine. Researchers randomized them to an arm with diuretics but where additional therapeutics could be added compared with ultrafiltration. What the trial showed is actually a similar amount of fluid and weight loss between the two groups. However, this trial also showed a rise in creatinine with ultrafiltration and more adverse events.
That said, this was a small trial. Clearly, larger trials are needed. These new findings raise a little more concern regarding ultrafiltration and clearly necessitate additional trials to be completed.