Low-Tech Device Beats Out IV Diuretics for Heart Failure
For patients with acute decompensated heart failure, mechanical ultrafiltration of blood to flush out excess water and salt significantly reduced the number of patients requiring rehospitalization for heart failure at 90 days compared with intravenous diuretics, according to results of the first study of its kind.
"Up to now, diuretics have been the mainstay of therapy [for such patients], but amazingly they have never been tested in a randomized controlled trial," said principal investigator Maria Rosa Costanzo, MD, from the Midwest Heart Foundation in Lombard, Illinois.
Dr. Costanzo presented the findings of the Ultrafiltration versus IV Diuretics for Patients Hospitalized for Acute Decompensated Congestive Heart Failure (UNLOAD) trial here at a late-breaking session of the American College of Cardiology 55th Annual Scientific Session.
She reported that the ultrafiltration treatment resulted in a 53% reduction in the total number of hospitalizations, a 64% decrease in total hospital days, and a 53% decrease in emergency room and unscheduled office visits during the first 90 days after treatment compared with diuretics.
Ultrafiltration's benefits became evident early on, with the technique associated with 44% more weight loss and 30% more fluid loss than the medical therapy at 48 hours, she said.
Dr. Costanzo said, "We believe these results are immediately applicable to a large number of patients admitted with decompensated heart failure," especially because about 90% of the 1 million heart failure patients hospitalized annually in the United States are due to volume overload, she said.
"Ultrafiltration treatment can relieve fluid overload quickly, safely, and predictably, and leads to sustained clinical benefits," she told Medscape.
With the ultrafiltration treatment, blood is withdrawn from one vein, passed through the filter, and, with the aid of a pump, salt and water are removed. The excess fluid remains in a bag, and the rest of the blood goes back into the patient. Up to 500 cc of fluid can be removed an hour. The device can remove up to a pound per hour of excess salt and water from the bloodstream; typically the procedure takes 8 hours, Dr. Costanzo said.
For the study, 200 patients at 28 medical sites were randomized to either ultrafiltration or intravenous diuretic therapy.
At 48 hours, median weight loss was 5.0 kg in the ultrafiltration group vs 3.1 kg in the standard-care group (P = .001). Median fluid loss was 4.6 L in the ultrafiltration group vs 3.3 L in the standard-care group (P = .001).
By 90 days, 18% of patients in the ultrafiltration group had to be rehospitalized compared with 32% patients in the diuretic group (P = .022). Also, there were a total of 123 rehospitalization days in the ultrafiltration group vs 330 days in the standard-care group (P = .022).
In addition, at 90 days, 21% of patients in the ultrafiltration group had unscheduled office and emergency department visits compared with 44% of patients in the diuretic group (P = .009).
There was no difference in renal function between the groups.
According to the study, the benefits were evident in all subgroups, regardless of age, sex, race, presence of diabetes or coronary artery disease, or New York Heart Association heart failure class.
These results are also important when considering the adverse effects associated with diuretic use. Dr. Costanzo noted that 20% to 30% of heart failure patients develop diuretic resistance, and the drugs are also associated with renal dysfunction. In addition, once admitted to the hospital for heart failure, a patient has a 30% chance of being readmitted within the next 3 months.
Previous ultrafiltration devices required central venous access and large amounts of blood to be filtered, Dr. Costanzo pointed out. In contrast, the newer Aquadex FlexFlow system allows peripheral venous access and requires that only 33 mL of blood are extracorporeal at any given time.
Clyde Yancy, MD, professor of medicine at the University of Texas Southwestern Medical Center in Dallas and a spokesperson for the American Heart Association, told Medscape that new treatments for acute decompensated heart failure are desperately needed.
"This is an exciting technology that deserves further study in a larger population," Dr. Yancy said. "And it didn't harm kidney function, which is very important."
Mike Gebauer, vice president of marketing at CHF Solutions Inc, in Brooklyn Park, Minnesota, which makes the device and sponsored the trial, said that even though the initial cost is more, there is the potential for real cost savings due to the reduction in rehospitalizations.
The cost of the device is about $10,000, and each filter runs about $800, according to Dr. Costanzo. Heart failure is associated with $28 billion in healthcare costs annually in the United States.
"Up to now, diuretics have been the mainstay of therapy [for such patients], but amazingly they have never been tested in a randomized controlled trial," said principal investigator Maria Rosa Costanzo, MD, from the Midwest Heart Foundation in Lombard, Illinois.
Dr. Costanzo presented the findings of the Ultrafiltration versus IV Diuretics for Patients Hospitalized for Acute Decompensated Congestive Heart Failure (UNLOAD) trial here at a late-breaking session of the American College of Cardiology 55th Annual Scientific Session.
She reported that the ultrafiltration treatment resulted in a 53% reduction in the total number of hospitalizations, a 64% decrease in total hospital days, and a 53% decrease in emergency room and unscheduled office visits during the first 90 days after treatment compared with diuretics.
Ultrafiltration's benefits became evident early on, with the technique associated with 44% more weight loss and 30% more fluid loss than the medical therapy at 48 hours, she said.
Dr. Costanzo said, "We believe these results are immediately applicable to a large number of patients admitted with decompensated heart failure," especially because about 90% of the 1 million heart failure patients hospitalized annually in the United States are due to volume overload, she said.
"Ultrafiltration treatment can relieve fluid overload quickly, safely, and predictably, and leads to sustained clinical benefits," she told Medscape.
With the ultrafiltration treatment, blood is withdrawn from one vein, passed through the filter, and, with the aid of a pump, salt and water are removed. The excess fluid remains in a bag, and the rest of the blood goes back into the patient. Up to 500 cc of fluid can be removed an hour. The device can remove up to a pound per hour of excess salt and water from the bloodstream; typically the procedure takes 8 hours, Dr. Costanzo said.
For the study, 200 patients at 28 medical sites were randomized to either ultrafiltration or intravenous diuretic therapy.
At 48 hours, median weight loss was 5.0 kg in the ultrafiltration group vs 3.1 kg in the standard-care group (P = .001). Median fluid loss was 4.6 L in the ultrafiltration group vs 3.3 L in the standard-care group (P = .001).
By 90 days, 18% of patients in the ultrafiltration group had to be rehospitalized compared with 32% patients in the diuretic group (P = .022). Also, there were a total of 123 rehospitalization days in the ultrafiltration group vs 330 days in the standard-care group (P = .022).
In addition, at 90 days, 21% of patients in the ultrafiltration group had unscheduled office and emergency department visits compared with 44% of patients in the diuretic group (P = .009).
There was no difference in renal function between the groups.
According to the study, the benefits were evident in all subgroups, regardless of age, sex, race, presence of diabetes or coronary artery disease, or New York Heart Association heart failure class.
These results are also important when considering the adverse effects associated with diuretic use. Dr. Costanzo noted that 20% to 30% of heart failure patients develop diuretic resistance, and the drugs are also associated with renal dysfunction. In addition, once admitted to the hospital for heart failure, a patient has a 30% chance of being readmitted within the next 3 months.
Previous ultrafiltration devices required central venous access and large amounts of blood to be filtered, Dr. Costanzo pointed out. In contrast, the newer Aquadex FlexFlow system allows peripheral venous access and requires that only 33 mL of blood are extracorporeal at any given time.
Clyde Yancy, MD, professor of medicine at the University of Texas Southwestern Medical Center in Dallas and a spokesperson for the American Heart Association, told Medscape that new treatments for acute decompensated heart failure are desperately needed.
"This is an exciting technology that deserves further study in a larger population," Dr. Yancy said. "And it didn't harm kidney function, which is very important."
Mike Gebauer, vice president of marketing at CHF Solutions Inc, in Brooklyn Park, Minnesota, which makes the device and sponsored the trial, said that even though the initial cost is more, there is the potential for real cost savings due to the reduction in rehospitalizations.
The cost of the device is about $10,000, and each filter runs about $800, according to Dr. Costanzo. Heart failure is associated with $28 billion in healthcare costs annually in the United States.
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