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Ultrafiltration Versus Usual Care for Hospitalized Patients With Heart Failure

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Title: Ultrafiltration Versus Usual Care for Hospitalized Patients With Heart Failure


1
Ultrafiltration Versus Usual Care for
Hospitalized Patients With Heart Failure The
Relief for Acutely Fluid-Overloaded Patients With
Decompensated Congestive Heart Failure
(RAPID-CHF) Trial
2
RAPID-CHF Study
  • Multi-center, randomized, controlled study
  • Compared the treatment effects of
    ultrafiltration to usual care for patients who
    are hospitalized for decompensated heart failure
    at 24 and 48 hours
  • Forty patients enrolled (20 in ultrafiltration
    arm, 20 in standard care arm)
  • UF was limited to a single, 8 hour UF session

Bart et. al. JACC 2005462043-2046 (n40)
3
RAPID-CHF Study
  • Inclusion
  • hospitalized with primary diagnosis of CHF
  • EF lt40
  • Significant volume expansion manifested by at
    least 2 edema and one of the following
  • Elevated JVD gt10cm
  • Pulmonary edema or pleural effusion on chest
    x-ray
  • Pulmonary rales
  • PCWP .20 mmHG
  • Ascites
  • Presacral edema
  • Exclusion
  • Severe stenotic valvular disease
  • ACS
  • Systolic BP lt90 mmHg
  • Hematocrit gt40
  • Poor venous access
  • Clinical instability
  • Use of iodinated radiocontrast material in the
    last 72 Hrs or planned use
  • Severe concomitant disease expected to prolong
    hospitalization

Bart et. al. JACC 2005462043-2046 (n40)
4
Patient Baseline Characteristics
Bart et. al. JACC 2005462043-2046 (n40)
5
Early application of UF resulted in significant
fluid removal
Median cumulative fluid removal at 24 and 48 h in
patients assigned to ultrafiltration (solid line)
and usual care (dashed line). p 0.001 p
0.012.
Bart et. al. JACC 2005462043-2046 (n40)
6
Early application of UF resulted in significant
weight loss
Median weight loss at 24 and 48 h in patients
assigned to ultrafiltration (solid line) and
usual care (dashed line).
Bart et. al. JACC 2005462043-2046 (n40)
7
Results
  • Fluid removal after 24 h was 4,650 ml and 2,838
    ml in the UF and usual care groups, respectively
    (p 0.001)
  • Compared to usual care, UF was not associated
    with significant changes in heart rate, blood
    pressure, or electrolytes
  • Dyspnea and CHF symptoms were significantly
    improved in the UF group compared to usual care
    at 48 h

Bart et. al. JACC 2005462043-2046 (n40)
8
Results
  • Weight loss after 24 h, the primary end point,
    was 2.5 kg and 1.86 kg in the UF and usual care
    groups, respectively (p 0.240)
  • The primary end point of this trial, weight loss
    at 24 h, trended in favor of patients randomized
    to UF.
  • In addition to small sample sizes, one of the
    reasons the primary end point did not reach
    statistical significance is the effective and
    aggressive use of diuretics in the usual care
    group. These patients produced nearly 3 L of
    urine in the first 24 h and lost 1.86 kg at 24 h
    and 3.9 kg at 48 h. This degree of diuresis and
    weight loss substantially exceeds usual practices
    as described in Acute Decompensated Heart Failure
    National Registry (ADHERE) and a recent acute CHF
    clinical trial with similar end points.

Bart et. al. JACC 2005462043-2046 (n40)
9
Conclusion
  • The early application of UF for patients with CHF
    was feasible, well-tolerated, and resulted in
    significant weight loss and fluid removal.

Bart et. al. JACC 2005462043-2046 (n40)
10
Early Ultrafiltration in Patients with
Decompensated Heart Failure and Observed
Resistance to Intervention with Diuretic
Agents The EUPHORIA Trial
11
EUPHORIA Study
  • Single center, prospective study, 20 patients
  • Compared the feasibility and safety of reducing
    the length of hospitalization by instituting
    ultrafiltration (UF) with the CHF Solutions
    Aquadex FlexFlow as an initial primary therapy
    for decompensated CHF patients demonstrating
    diuretic resistance on admission
  • Initial UF within 12 hours of hospitalization
    and before any significant administration of IV
    diuretics and/or vasoactive drugs
  • Follow-up one and three months after discharge

Costanzo et. al. JACC 2005462047-2051 (n20)
12
EUPHORIA Study
  • Inclusion
  • The subjects were consenting adult ADHF patients
    hospitalized for 12 h and given no vasoactive
    drugs and 1 dose of intravenous diuretic and
    with the following
  • Renal insufficiency or diuretic resistance (serum
    creatinine sCr 1.5 mg/dl, high daily oral
    diuretic doses furosemide gt 80 mg, torsemide gt
    40 mg, or bumetamide gt 2 mg, or both)
  • Fluid overload, defined as 2 of the following
  • a. Peripheral or sacral edema ( 2)
  • b. Enlarged liver or ascites
  • c. Pulmonary rales, paroxysmal nocturnal dyspnea
    (PND), or orthopnea
  • d. Jugular venous distention 7 cm
  • Exclusion
  • Hematocrit 40
  • End-stage renal disease requiring dialysis
  • Hypercoagulability
  • SBP lt 85 mm Hg
  • Requirement for intravenous inotropes
  • Participation in another research study or
    previously in this trial

Costanzo et. al. JACC 2005462047-2051 (n20)
13
Clinical Signs and Symptoms
Costanzo et. al. JACC 2005462047-2051 (n20)
14
Clinical and Laboratory Outcomes
Costanzo et. al. JACC 2005462047-2051 (n20)
15
Average Weights
Weights decreased from 87 23 kg to 81 22 kg
and remained lower than pretreatment weights at
30 (84 21 kg) and 90 days (8018 kg) p 0.006
Costanzo et. al. JACC 2005462047-2051 (n20)
16
Average Calculated Creatinine Clearance
Pre-ultrafiltration sCr was 2.12 0.60 mg/dl
(range 1.0 to 3.6 mg/dl) and remained unchanged.
Calculated CrCl was 37.9 13.4 ml/min and
remained unchanged unchanged p 0.161
Costanzo et. al. JACC 2005462047-2051 (n20)
17
Average Serum Sodium
Average serum sodium (Na) for all 20 patients and
for the seven patients presenting with Na 135
mg/dl. Pre-ultrafiltration (UF) to discharge
pre-UF to 90 days
Costanzo et. al. JACC 2005462047-2051 (n20)
18
Average Minnesota Living With Heart Failure
Questionnaire Scores
Pretreatment MLWHFQ score of 70 18 declined at
discharge and 30 and 90 days to 65 21, 60
23.0, and 51 27, respectively p 0.003
Costanzo et. al. JACC 2005462047-2051 (n20)
19
Average Global Clinical Assessment Scores
Global assessment improved after ultrafiltration
(from 5.7 1.3 to 1.8 0.8) and remained
improved at 30 (2.7 1.6) and 90 days (2.5
1.5) p 0.00003
Costanzo et. al. JACC 2005462047-2051 (n20)
20
Results
  • 60 of patients were discharged in 3 days
  • - four (20) at day four, three (15) at day
    five, and
  • one (5) at day 10.
  • Ultrafiltration, initiated within 4.7 3.5 h of
    hospitalization
  • Average hospitalization was 3.7 1.8 days
  • Average fluid removal of 8.6 4.21 liters
  • There were no failed venous cannulations, line
    malfunctions, phlebitis, or thromboembolism
  • Blood pressure, renal function, and medications
    were unchanged

Costanzo et. al. JACC 2005462047-2051 (n20)
21
Results
  • Clinical signs and symptoms and laboratory
    indices of hypervolemia improved by discharge
  • Mean decrease in weight of approximately 6 kg at
    discharge
  • Weight, Minnesota Living with Heart Failure
    scores, and Global Assessment improved after
    ultrafiltration and at 30 and 90 days
  • In the three months preceding ultrafiltration,
    ten hospitalizations occurred in nine patients.
  • After ultrafiltration, one patient was
    readmitted for ADHF within 30 days. Two patients
    were readmitted between 30 and 90 days for
    unrelated causes.

Costanzo et. al. JACC 2005462047-2051 (n20)
22
Conclusion
  • In heart failure patients with volume overload
    and diuretic resistance, UF before IV diuretics
    effectively and safely decreases length of stay
    and readmissions.
  • Clinical benefits persist at three months.
  • A treatment strategy of early UF may decrease
    length of stay and rehospitalizations in
    high-risk heart failure patients.
  • Early UF may be an alternative to reserving UF
    for patients refractory to all other
    pharmacologic strategies.
  • A prospective randomized study comparing UF with
    standard
  • therapy for ADHF to identify effects
    specifically attributable
  • to UF (UNLOAD) is complete and awaiting
    publication 2006.

Costanzo et. al. JACC 2005462047-2051 (n20)
23
Indication
The Aquadex System is indicated for
    Temporary (up to 8 hours) ultrafiltration
treatment of patients with fluid overload who
have failed diuretic therapy, and
   Extended (longer than 8 hours)
ultrafiltration treatment of patients with fluid
overload who have failed diuretic therapy and
require hospitalization. All treatments must
be administered by a healthcare provider, under
physician prescription, both of whom having
received training in extracorporeal therapies.
L5100 Rev. A 01/06
Rx only
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