Although ultrafiltration (UF) in recent years has become increasingly popular as an alternative to intravenous diuretics for patients with acute decompensated heart failure with acute cardiorenal system (type 1), the first clinical trial to test its value shows that it is inferior to standard drug therapy.
The results of CARRESS-HF (Cardiorenal Rescue Study in Acute Decompensated Heart Failure) were presented at the AHA scientific session in Los Angeles by Bradley Bart and published simultaneously in the New England Journal of Medicine. The study compared UF with standard drug care in 188 patients with acute decompensated heart failure, worsening renal function, and persistent congestion.
UF was inferior to standard pharmacologic therapy as assessed by the primary endpoint of the trial, which was the bivariate change in serum cretinine and weight measured at 96 hours. Weight loss was similar between the groups (5.5 kg in the drug treatment group and 5.7 kg in the UF group ((p=0.58) but creatinine was significantly higher in the UF group:
- -0.04 mg/dl in the drug group versus +0.23 mg/dl in the UF group (p=0.003)
At 60 days there was no difference in the rate of death or rehospitalization between the groups, but a serious safety signal emerged as more UF patients had a serious adverse event (57% versus 72%, p=0.03).
The authors concluded:
Given the high cost and complexity of ultrafiltration, the use of this technique as performed in the current study does not seem justified for patients hospitalized for acute decompensated heart failure, worsened renal function, and persistent congestion.
In an accompanying editorial. W.H. Wilson Tang writes that “it is difficult to argue that ultrafiltration provides ‘diuretic sparing’ benefits in patients with acute cardiorenal syndrome when a well-managed pharmacologic approach provided equivalent clinical outcomes with fewer serious adverse effects.” He left hope that “a slower but steady ultrafiltration rate” might yet prove beneficial. Further, it is possible that aggressive therapy in order to reduce length of stay “may actually result in an increased incidence of the acute cardiorenal syndrome and cause unwanted consequences. Perhaps slow and steady may ultimately win the race after all.”
Here is the press release from the AHA:
Ultrafiltration may not be best approach for heart failure patients
LOS ANGELES, Nov. 6, 2012 — Ultrafiltration was no more effective in removing excess fluid from the heart than using standard treatment including diuretics to reduce congestion in heart failure patients, according to late-breaking clinical trial research presented at the American Heart Association Scientific Sessions 2012.
The full manuscript for Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARRESS-HF) is published in the New England Journal of Medicine.
Excess fluid build-up in the body can occur in many heart failure patients and lead to a need to hospitalize these patients. For decades, physicians have used intravenous drugs known as diuretics to remove excess fluid. Many heart failure patients may have some degree of abnormality in kidney function and diuretics can lead to further worsening of kidney function.
“We need better treatments for managing hospitalized heart failure patients, but our findings indicate that ultrafiltration may not be the answer,” said Bradley Bart, M.D., lead author of the study and chief of cardiology at Hennepin County Medical Center in Minneapolis, Minn.
In the prospective randomized comparison of the treatments, researchers randomly assigned ultrafiltration or a diuretic-based approach to 188 hospitalized patients (average age 68, mostly male) with persistent excess fluid and worsening kidney function. Eighty-four percent had high blood pressure; 66 percent had diabetes; and 75 percent had at least one recent admission to the hospital for heart failure.
Researchers measured the patients’ weight change (as a measure of improved congestion and fluid loss) and kidney function four days after starting treatment, and followed patients for 60 days to see if they remained stable and out of the hospital.
Both groups lost about 12 pounds during the first four days of treatment. Kidney function worsened in ultrafiltration patients and they also had more side effects. After 60 days, there were no differences between the two groups in either heart failure hospitalizations or death.
“Ultrafiltration is more expensive, more complex and doesn’t offer any advantage as administered in this study,” Bart said.
“The overall disappointing results of this trial indicate that more research is needed to find better ways to treat these seriously ill patients,” said Eugene Braunwald, co-author and chair of the Heart Failure Network that conducted the study.
Other co-authors are Steven R. Goldsmith, M.D.; Kerry L. Lee, Ph.D.; Michael M. Givertz, M.D.; Christopher M. O’Connor, M.D.; David A. Bull, M.D.;Margaret M. Redfield, M.D.; Anita Deswal, M.D., M.P.H.; Jean L. Rouleau, M.D.; Martin M. LeWinter, M.D.; Elizabeth O. Ofili, M.D., M.P.H.; Lynne W. Stevenson, M.D.; Marc J. Semigran, M.D.; G. Michael Felker, M.D.; Horng H. Chen, M.D.; Adrian F. Hernandez, M.D.; Kevin J. Anstrom, Ph.D.; Steven E. McNulty, M.S.; Eric J. Velazquez, M.D.; Jenny C. Ibarra, R.N., M.S.N.; and Alice M. Mascette, M.D.
Disclosures are here http://newsroom.heart.org/pr/aha/document/DISCLOSURES.pdf
The National Heart, Lung, and Blood Institute funded the study.
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