Aquapheresis vs. Intravenous Diuretics and Hospitalization for Heart Failure - AVOID-HF

Sep 27, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Baxter Healthcare
Date Published:
09/27/2015
Original Posted Date:
09/27/2015
References

Description:

The goal of the trial was to evaluate ultrafiltration compared with intravenous diuretics among patients hospitalized with acute decompensated heart failure.

Contribution to the Literature: The AVOID-HF trial failed to show that ultrafiltration prolonged the time to first heart failure event within 90 days of hospital discharge.

Study Design

  • Randomized
  • Parallel

Subjects admitted with acute decompensated heart failure were randomized to ultrafiltration (n = 110) versus intravenous (IV) diuretics (n = 114).

In the ultrafiltration group, diuretic therapy was not allowed. Ultrafiltration required anticoagulation and was performed with the Aquadex FlexFlow System.

In both groups, the daily fluid and sodium restriction was 1,500 cc and 1.5 g, respectively. Vasoactive drugs were prohibited.

  • Total number of enrollees: 221
  • Duration of follow-up: 90 days
  • Mean patient age: 67 years
  • Percentage female: 29%
  • Percentage diabetics: 37%

Inclusion criteria:

  • Patients ≥18 years of age admitted with acute decompensated heart failure
  • On regularly scheduled daily oral loop diuretics
  • Received ≤2 doses of IV loop diuretics before randomization
  • Able to be enrolled within 24 hours of hospital admission

Exclusion criteria:

  • Acute coronary syndrome
  • Serum creatinine ≥3.0 mg/dl
  • Systolic blood pressure <90 mm Hg
  • Pulmonary artery hypertension not due to left heart disease
  • Contraindication to anticoagulation
  • Hematocrit >45%
  • Inability to obtain venous access
  • Hemodynamic instability
  • Severe concomitant disease expected to prolong hospitalization or result in death within 90 days
  • Sepsis
  • Severe valvular heart disease
  • Active myocarditis
  • Hypertrophic obstructive cardiomyopathy
  • Constrictive pericarditis or restrictive cardiomyopathy
  • Liver cirrhosis
  • Prior organ transplant
  • Ventilatory support
  • Mechanical support device
  • Active drug or alcohol abuse

Principal Findings:

In April 2014, the trial was terminated prematurely due to slow enrollment (27.5% of originally planned sample size).

The primary outcome, time to first heart failure event after hospital discharge was 62 days in the ultrafiltration group versus 34 days in the diuretic group (p = 0.11).

Secondary outcomes:

  • Total fluid removal: 18.7 L with ultrafiltration vs. 14.0 L with diuretics (p = 0.015)
  • Adverse event of special interest: 31% with ultrafiltration vs. 17% with diuretics (p = 0.018)
  • Serious adverse event related to study therapy: 15% with ultrafiltration vs. 5% with diuretics (p = 0.026)

Interpretation:

Among individuals hospitalized with acute decompensated heart failure, ultrafiltration was not associated with a prolonged time to first heart failure event within 90 days compared with IV diuretics. However, there was a numerical trend toward benefit in the primary outcome with ultrafiltration, and this therapy resulted in more removal of fluid. Ultrafiltration was associated with more adverse and serious adverse events related to study therapy.

It is important to note that this study was severely underpowered due to early termination; therefore, any interpretation on clinical outcomes with this therapy is speculative.

References:

Costanzo MR, Negoianu D, Jaski BE, et al. Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure. JACC Heart Fail 2015;Sep 27:[Epub ahead of print].

Keywords: Acute Disease, Anticoagulants, Diuretics, Heart Failure, Hospitalization, Primary Prevention, Sodium, Sodium Potassium Chloride Symporter Inhibitors, Ultrafiltration


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