Dr Maria Rosa Costanzo

The randomized Ultrafiltration vs IV Diuretics for Patients Hospitalized for Acute Decompensated CHF (UNLOAD) trial was noteworthy for excluding patients from analysis if they ultimately needed adjunctive vasoactive medications to stabilize, principal investigator Dr Maria Rosa Costanzo (Edward Hospital Center, Naperville, IL) told heartwire. That, she said, allowed a pure comparison of the two strategies for the first time.

In patients with acute decompensated HF, "ultrafiltration is more effective than diuretics for removal of excess salt and water, and this strategy is associated with sustained clinical benefits," said Costanzo when presenting the UNLOAD results yesterday at a press conference. "Furthermore, we identified no safety issues associated with ultrafiltration. We believe that the results are immediately applicable to a large proportion of patients who are admitted with decompensated heart failure." The UNLOAD trial will be formally presented to ACC attendees on the morning of Tuesday, March 14.

We believe that the results are immediately applicable to a large proportion of patients that are admitted with decompensated heart failure.

In the trial, 200 patients with acute decompensated HF were equally randomized at 28 institutions to peripheral ultrafiltration using a commercially available system (CHF Solutions, Brooklyn Park, MN) or standard IV diuretic therapy and were evaluated at 48 hours and out to 90 days. "If a patient required additional medications in this trial," Costanzo told heartwire, "we considered that patient a treatment failure."

As it turned out, she said, fewer patients in the ultrafiltration group than those who were treated with diuretics required rescue therapy with vasoactive drugs. Nor was ultrafiltration associated with hypokalemia or adverse changes in serum creatinine. As an added benefit, Costanzo observed, ultrafiltration allowed patients to take lower dosages of oral diuretics after discharge compared with those treated acutely with diuretics.

Costanzo told heartwire that little or no relationship was observed between changing symptom status and the volume of fluid removed from patients with either therapy. "Despite similar improvement in symptoms, the outcomes were very different." That challenges the current practice of using symptomatic responses to guide treatment of acute decompensated HF, she said, and suggests a need for different therapeutic targets for the syndrome. She recommends fluid and weight loss as alternatives. Those measures, according to Costanzo, correlated significantly with readmission rates in the trial.

The device used in UNLOAD differs from older ultrafiltration equipment incarnations by receiving blood from one of the patient's peripheral veins and holding only about 33 mL outside the body at a given time, according to Costanzo. Earlier systems required central venous access and removed "large volumes" of blood for extracorporeal treatment, she said, so the strategy was not often used.

CHF Solutions told heartwire that the Aquadex FlexFlow ultrafiltration device used in UNLOAD costs about $19 000 per unit and that the filters—one is used at each ultrafiltration session—are sold for $900 each. Costanzo said the device is capable of removing up to four liters per eight-hour session and that patients with acute decompensated HF historically have required up to two sessions for successful volume reduction.