Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure

• Published in: JACC. Heart failure Vol. 4; no. 2; pp. 95 - 105
• Main Authors: Costanzo, Maria Rosa, MD, Negoianu, Daniel, MD, Jaski, Brian E., MD, Bart, Bradley A., MD, Heywood, James T., MD, Anand, Inder S., MD, DPhil (Oxon), Smelser, James M., MD, Kaneshige, Alan M., MD, Chomsky, Don B., MD, Adler, Eric D., MD, Haas, Garrie J., MD, Watts, James A., MD, Nabut, Jose L., MS, Schollmeyer, Michael P., DVM, Fonarow, Gregg C., MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-02-2016
• Subjects: Aged; aquapheresis; Cardiovascular; congestion; Dose-Response Relationship, Drug; Female; fluid overload; Follow-Up Studies; heart failure; Heart Failure - physiopathology; Heart Failure - therapy; Hospitalization - trends; hospitalizations; Humans; Infusions, Intravenous; loop diuretics; Male; Prospective Studies; Sodium Potassium Chloride Symporter Inhibitors - administration & dosage; Time Factors; Treatment Outcome; Ultrafiltration - methods; worsening renal function; Study Endpoint Committee; heart failure; aquapheresis; fluid overload; BNP; adjustable loop diuretics; cardiovascular; loop diuretics; IV; ultrafiltration; SEC; UF; AUF; B-type natriuretic peptide; CV; intravenous; adjustable ultrafiltration; LD; ALD; worsening renal function; congestion; hospitalizations; HF
• ISSN: 2213-1779; 2213-1787
• DOI: 10.1016/j.jchf.2015.08.005

Abstract Objectives The AVOID-HF (Aquapheresis versus Intravenous Diuretics and Hospitalization for Heart Failure) trial tested the hypothesis that patients hospitalized for HF treated with adjustable ultrafiltration (AUF) would have a longer time to first HF event within 90 days after hospital discharge than those receiving adjustable intravenous loop diuretics (ALD). Background Congestion in hospitalized heart failure (HF) patients portends unfavorable outcomes. Methods The AVOID-HF trial, designed as a multicenter, 1-to-1 randomized study of 810 hospitalized HF patients, was terminated unilaterally and prematurely by the sponsor (Baxter Healthcare, Deerfield, Illinois) after enrollment of 224 patients (27.5%). Aquadex FlexFlow System (Baxter Healthcare) was used for AUF. A Clinical Events Committee, blinded to the randomized treatment, adjudicated whether 90-day events were due to HF. Results A total of 110 patients were randomized to AUF and 114 to ALD. Baseline characteristics were similar. Estimated days to first HF event for the AUF and ALD group were, respectively, 62 and 34 (p = 0.106). At 30 days, compared with the ALD group, the AUF group had fewer HF and cardiovascular events. Renal function changes were similar. More AUF patients experienced an adverse effect of special interest (p = 0.018) and a serious study product-related adverse event (p = 0.026). The 90-day mortality was similar. Conclusions Compared with the ALD group, the AUF group trended toward a longer time to first HF event within 90 days and fewer HF and cardiovascular events. More patients in the AUF group experienced special interest or serious product-related adverse event. Due to the trial’s untimely termination, additional AUF investigation is warranted.