Author + information
- Received August 3, 2015
- Revision received August 25, 2015
- Accepted August 25, 2015
- Published online February 1, 2016.
- Maria Rosa Costanzo, MDa,∗ (, )
- Daniel Negoianu, MDb,
- Brian E. Jaski, MDc,
- Bradley A. Bart, MDd,
- James T. Heywood, MDe,
- Inder S. Anand, MD, DPhil (Oxon)f,
- James M. Smelser, MDg,
- Alan M. Kaneshige, MDh,
- Don B. Chomsky, MDi,
- Eric D. Adler, MDj,
- Garrie J. Haas, MDk,
- James A. Watts, MDl,
- Jose L. Nabut, MSm,
- Michael P. Schollmeyer, DVMm and
- Gregg C. Fonarow, MDn
- aAdvocate Heart Institute, Edward Heart Hospital, Naperville, Illinois
- bDivision of Nephrology, University of Pennsylvania Medical Center, Philadelphia, Pennsylvania
- cSan Diego Cardiac Center, Sharp Memorial Hospital, San Diego, California
- dDivision of Cardiology, Department of Medicine, Hennepin County Medical Center, Minneapolis, Minnesota
- eHeart Failure Recovery & Research Program, Scripps Clinic, San Diego, California
- fUniversity of Minnesota VA Medical Center, Minneapolis, Minnesota
- gHuntsville Renal Clinic, Huntsville, Alabama
- hOklahoma Heart Institute, Tulsa, Oklahoma
- iSaint Thomas Heart Hospital, Nashville, Tennessee
- jDivision of Cardiology, University of California, San Diego, California
- kDivision of Cardiology, Ohio State University, Columbus, Ohio
- lBrooke Army Medical Center, San Antonio, Texas
- mBaxter Healthcare Corporation, Deerfield, Illinois
- nDivision of Cardiology, University of California, Los Angeles, California
- ↵∗Reprint requests and correspondence:
Dr. Maria Rosa Costanzo, Advocate Heart Institute, Edward Heart Hospital, 4th Floor, 801 South Washington Street, Naperville, Illinois 60566.
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.
- fluid overload
- heart failure
- loop diuretics
- worsening renal function
Drs. Costanzo, Negoianu, Jaski, Heywood, and Fonarow have received compensation for their work for the AVOID-HF Trial Steering Committee. Dr. Costanzo was the principal investigator of the AVOID-HF trial sponsored by Baxter Healthcare; and has received research grant support from Baxter Healthcare to the Advocate Heart Institute. Dr. Negoianu has served on the Speakers Bureau of Fresenius, DaVita, and Gambro. Dr. Nabut previously was employed by Baxter Healthcare. Dr. Fonarow has served as a consultant for Baxter Healthcare, Gambro, Novartis, Medtronic, Amgen, Bayer, and Janssen. Mr. Nabut is a former employee of Baxter Healthcare. Dr. Schollmeyer is a former consultant for Baxter Healthcare. The institutions of all authors have received a research grant initially from Gambro and subsequently from Baxter for the conduct of the AVOID-HF trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 3, 2015.
- Revision received August 25, 2015.
- Accepted August 25, 2015.
- 2016 American College of Cardiology Foundation