Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure

Maria Rosa Costanzo; Daniel Negoianu; Brian E. Jaski; Bradley A. Bart; James T. Heywood; Inder S. Anand; James M. Smelser; Alan M. Kaneshige; Don B. Chomsky; Eric D. Adler; Garrie J. Haas; James A. Watts; Jose L. Nabut; Michael P. Schollmeyer; Gregg C. Fonarow

doi:10.1016/j.jchf.2015.08.005

Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure

Maria Rosa Costanzo, Daniel Negoianu, Brian E. Jaski, Bradley A. Bart, James T. Heywood, Inder S. Anand, James M. Smelser, Alan M. Kaneshige, Don B. Chomsky, Eric D. Adler, Garrie J. Haas, James A. Watts, Jose L. Nabut, Michael P. Schollmeyer, Gregg C. Fonarow

Research output: Contribution to journal › Article › peer-review

149 Scopus citations

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.

Original language	English (US)
Pages (from-to)	95-105
Number of pages	11
Journal	JACC: Heart Failure
Volume	4
Issue number	2
DOIs	https://doi.org/10.1016/j.jchf.2015.08.005
State	Published - Feb 1 2016

Bibliographical note

Funding Information:
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.

Publisher Copyright:
© 2016 American College of Cardiology Foundation.

Keywords

Aquapheresis
Congestion
Fluid overload
Heart failure
Hospitalizations
Loop diuretics
Worsening renal function

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access

10.1016/j.jchf.2015.08.005

OpenUrl availability

Full text

Cite this

Costanzo, M. R., Negoianu, D., Jaski, B. E., Bart, B. A., Heywood, J. T., Anand, I. S., Smelser, J. M., Kaneshige, A. M., Chomsky, D. B., Adler, E. D., Haas, G. J., Watts, J. A., Nabut, J. L., Schollmeyer, M. P., & Fonarow, G. C. (2016). Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure. JACC: Heart Failure, 4(2), 95-105. https://doi.org/10.1016/j.jchf.2015.08.005

@article{0aeb61e63d424fed8b240eec533e4f16,

title = "Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure",

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.",

keywords = "Aquapheresis, Congestion, Fluid overload, Heart failure, Hospitalizations, Loop diuretics, Worsening renal function",

author = "Costanzo, {Maria Rosa} and Daniel Negoianu and Jaski, {Brian E.} and Bart, {Bradley A.} and Heywood, {James T.} and Anand, {Inder S.} and Smelser, {James M.} and Kaneshige, {Alan M.} and Chomsky, {Don B.} and Adler, {Eric D.} and Haas, {Garrie J.} and Watts, {James A.} and Nabut, {Jose L.} and Schollmeyer, {Michael P.} and Fonarow, {Gregg C.}",

note = "Funding Information: 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. Publisher Copyright: {\textcopyright} 2016 American College of Cardiology Foundation.",

year = "2016",

month = feb,

day = "1",

doi = "10.1016/j.jchf.2015.08.005",

language = "English (US)",

volume = "4",

pages = "95--105",

journal = "JACC: Heart Failure",

issn = "2213-1779",

publisher = "Elsevier BV",

number = "2",

}

TY - JOUR

T1 - Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure

AU - Costanzo, Maria Rosa

AU - Negoianu, Daniel

AU - Jaski, Brian E.

AU - Bart, Bradley A.

AU - Heywood, James T.

AU - Anand, Inder S.

AU - Smelser, James M.

AU - Kaneshige, Alan M.

AU - Chomsky, Don B.

AU - Adler, Eric D.

AU - Haas, Garrie J.

AU - Watts, James A.

AU - Nabut, Jose L.

AU - Schollmeyer, Michael P.

AU - Fonarow, Gregg C.

N1 - Funding Information: 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. Publisher Copyright: © 2016 American College of Cardiology Foundation.

PY - 2016/2/1

Y1 - 2016/2/1

N2 - 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.

AB - 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.

KW - Aquapheresis

KW - Congestion

KW - Fluid overload

KW - Heart failure

KW - Hospitalizations

KW - Loop diuretics

KW - Worsening renal function

UR - http://www.scopus.com/inward/record.url?scp=84959162739&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84959162739&partnerID=8YFLogxK

U2 - 10.1016/j.jchf.2015.08.005

DO - 10.1016/j.jchf.2015.08.005

M3 - Article

C2 - 26519995

AN - SCOPUS:84959162739

SN - 2213-1779

VL - 4

SP - 95

EP - 105

JO - JACC: Heart Failure

JF - JACC: Heart Failure

IS - 2

ER -

Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure

Abstract

Bibliographical note

Keywords

UN SDGs

Access

OpenUrl availability

Other files and links

Fingerprint

Cite this