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Ultrafiltration Versus Usual Care for Hospitalized Patients With Heart Failure

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 . RAPID-CHF Study. Multi-center, randomized, controlled study

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Ultrafiltration Versus Usual Care for Hospitalized Patients With Heart Failure

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  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 2005;46:2043-2046 (n=40)

  3. RAPID-CHF Study • Inclusion • hospitalized with primary diagnosis of CHF • EF <40% • Significant volume expansion manifested by at least 2+ edema and one of the following • Elevated JVD >10cm • 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 <90 mmHg • Hematocrit >40 • 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 2005;46:2043-2046 (n=40)

  4. Patient Baseline Characteristics Bart et. al. JACC 2005;46:2043-2046 (n=40)

  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 2005;46:2043-2046 (n=40)

  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 2005;46:2043-2046 (n=40)

  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 2005;46:2043-2046 (n=40)

  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 2005;46:2043-2046 (n=40)

  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 2005;46:2043-2046 (n=40)

  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 2005;46:2047-2051 (n=20)

  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 > 80 mg, torsemide > 40 mg, or bumetamide > 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 < 85 mm Hg • Requirement for intravenous inotropes • Participation in another research study or previously in this trial Costanzo et. al. JACC 2005;46:2047-2051 (n=20)

  13. Clinical Signs and Symptoms Costanzo et. al. JACC 2005;46:2047-2051 (n=20)

  14. Clinical and Laboratory Outcomes Costanzo et. al. JACC 2005;46:2047-2051 (n=20)

  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 (80±18 kg); p = 0.006 Costanzo et. al. JACC 2005;46:2047-2051 (n=20)

  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 2005;46:2047-2051 (n=20)

  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 2005;46:2047-2051 (n=20)

  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 2005;46:2047-2051 (n=20)

  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 2005;46:2047-2051 (n=20)

  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 2005;46:2047-2051 (n=20)

  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 2005;46:2047-2051 (n=20)

  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 2005;46:2047-2051 (n=20)

  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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