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Evolving Patterns Of Use Of Aldosterone Inhibition In Chronic Heart Failure; A Report From Get With The Guidelines HF . Nancy M. Albert, Clyde W. Yancy, Li Liang, Adrian Hernandez, Gregg C. Fonarow, and the Get with the Guidelines Steering Committee and Hospitals.

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Evolving Patterns Of Use OfAldosterone Inhibition In Chronic Heart Failure;A Report From Get With The Guidelines HF

Nancy M. Albert,

Clyde W. Yancy,

Li Liang,

Adrian Hernandez,

Gregg C. Fonarow,

and the Get with the Guidelines Steering Committee and Hospitals

presenter disclosure information aha scientific sessions
Presenter Disclosure InformationAHA Scientific Sessions

Evolving Patterns Of Use OfAldosterone Inhibition In Chronic Heart Failure;A Report From Get With The Guidelines HF

I willnotdiscuss off label or investigational use of drugs or devices in my presentation.

I have financial relationships to disclose:

Consultant and Speakers Bureau: GlaxoSmithKline

Consultant: Medtronic

GWTG-HF was sponsored in part by funding from GlaxoSmithKline to the American Heart Association

background level b evidence
Background: Level B Evidence

Aldosterone inhibition recommendations:

Moderately severe-severe HF symptoms (i.e. hospitalized for HF) and

Reduced LVEF

Careful monitoring to preserve renal function and normal K+

Serum creatinine

≤ 2.5 mg/dL- men

≤ 2.0 mg/dL – women

Serum potassium < 5.0 mEq/L

Hunt SA, et al. ACC/AHA 2005 Practice Guidelines. Available at http://www.acc.org.

background utilization of aldosterone inhibitors
Background: Utilization Of Aldosterone Inhibitors

OPTIMIZE-HF: Hospital Discharge

83

83

65.4

52.3

Eligible Patients Treated (%)

39.2

18

ACEI/ARB at Discharge (11,976/14,493)

-Blocker at Discharge (13,032/15,675)

Evidence-Based -Blocker (10,248/15,675)

Aldosterone Antagonist (3,621/20,118)

Statin (14,904/38,066)

Warfarin (6,571/12,560)

ACEI/ARB, -blocker, and aldosterone antagonist use in eligible patients with LVSD; statin in HF patients with a history of CAD, PVD, CVD and/or diabetes; and warfarin use in patients with HF and atrial fibrillation.

Fonarow et al. JAMA 2007;297:61-70.

background utilization of aldosterone inhibitors1
Background: Utilization Of Aldosterone Inhibitors

IMPROVE-HF: Cardiology Outpatient Practices at Baseline

Patients (%)

(N = 11,271 / 14,167)

(N = 12,039 / 14,058)

(N = 3630 / 7169)

(N = 9459 / 15,381)

(N = 905 / 2505)

(N = 528 / 1361)

(N = 2450 / 3533)

Fonarow GC, et al. Circ Heart Fail. 2008;1:98–106.

background potential for harm
Background: Potential for Harm
  • Usage  since RALES1
    • > 7 fold : 3% to 21.3%1
    • > 4 fold : 34/1000 pts. (94) to 149/1000 pts (01)
  • 30.9% did not meet enrollment criteria1
      • 22.8%, hyperkalemia; 14.1% Sr. Creatinine ≥ 2.5 mg/dL; 17.3%, eGFR < 30 ml/min
  • Discontinued in 7.2% (67/926 cases)3
    • 49%, hyperkalemia; 51%, renal failure
  • Hospitalization for hyperkalemia2
    • 2.4/1000 (1994) to 11.0/1000 (2001)
  • Mortality for hyperkalemia2
    • 0.3/1000 (1994) to 2.0/1000 (2001)

1Masoudi FA, et al. Circulation 2005;112:39-47.

2 Juurlink DN, et al. NEJM 2004;351:543-551.

3Tamirisa KP et al. Am Heart J 2004;148:971-978.

purpose
Problem:

It is unknown if HF patients in a quality of care hospital program receive aldosterone inhibitors more often and receive this therapy per recommendations

Research Question:

Has the appropriateness of aldosterone inhibitor usage among patients hospitalized for heart failure improved since 2005?

PURPOSE
methods sample
METHODS: Sample

Get With the Guidelines-Heart Failure (GWTG-HF)

National initiative of the AHA to improve guidelines adherence in patients hospitalized with HF

Study Cohort

242 participating hospitals

45,322 patients hospitalized for HF

Discharged home

Without contraindications to aldosterone inh.

January 1, 2005 – December 26, 2007

patient management tool
Patient Management Tool
  • Data was recorded using the Patient Management Tool™ (Outcome, Cambridge, MA), a Web-based interactive assessment and reporting system that tracks treatment and facilitates evidence- based medicine
methods definitions analysis
METHODS: Definitions & Analysis

Definitions

  • LV systolic dysfunction: EF ≤ 35%
  • Normal K+ level: ≤ 5.5 mmol/L
  • Normal serum creatinine: < 2.5 mg/dL
  • Opt Medical Tx: BB, ACEi/ARB or diuretic if indicated

Analysis

  • Cochran-Mantel Haenzel general association statistics: Aldosterone in patient groups
  • Cochran-Mantel Haenzel- Row Mean scores: Aldosterone and time
    • Within hospital clustering was considered
  • Multivariable logistic regression analysis using Generalized Estimating Equations to account for pt & hosp characteristics and clustering within hospitals
results aldosterone inh use over time
RESULTS: Aldosterone Inh. Use Over Time

*, adjusted for within-hospital clustering

results trends in compliance of aldosterone inhibitor use over time
RESULTS: Trends in Compliance of Aldosterone Inhibitor Use Over Time

*, adjusted for within-hospital clustering

multivariable modeling
Multivariable Modeling

Logistic regression with GEE approach

  • Excluded cases with missing data. N=13,289 (67% of LVSD population)
  • Aldosterone use = 30.7%
limitations
LIMITATIONS
  • Data presented are dependent upon the accuracy and completeness of data abstraction from medical chart review
  • GWTG-HF hospitals are self selected
  • Rationale for decisions regarding therapy utilization may not be captured
  • These findings may not apply to practices that differ in patient characteristics or care patterns from GWTG-HF hospitals
conclusions
CONCLUSIONS
  • These data are among the first to assess aldosterone inhibitor use in hospitalized patients and appropriateness since ~ 2005.
  • Within pts enrolled in GWTG HF, they demonstrate:
    • Appropriate use of aldosterone inhibitors increased modestly from 2005-2007
    • Non-indicated use was low
    • Overall use of aldosterone inhibitors remains lower than expected
    • Users are more likely to have higher compliance on other performance and quality measures
  • Additional research is required to identify ongoing impediments to aldosterone inhibitorsuse.