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Ultrafiltration as a Therapy Option for Diuretic Resistance: Inpatient & Outpatient Case Studies Beth Davidson DNP, ACNP, CCRN Kristi Hayes MSN, FNP St. Thomas Hospital Nashville, TN Objectives  Review the epidemiology and pathophysiology of diuretic-resistant, acute heart failure  Identify volume overload treatment options  Review/discuss case studies of diureticresistance and use of ultrafiltration for volume removal Epidemiology of Heart Failure (HF) Population Group Total population Prevalence Incidence Mortality Hospital Discharges 5,000,000 550,000 57,218 1,093,000 Cost $29.6 billion  Heart failure is a major public health problem resulting in substantial morbidity and mortality  Major cost-driver of HF is high incidence of hospitalizations  JCAHO has initiated quality care indicators for hospitalized HF patients  CMS reimbursement for readmission < 30 days = $ 0 Insult Cardiac Dysfunction Neurohormonal Activation Decompensated Heart Failure LV Remodeling Hemodynamic Decompensation  RAAS/SNS  Catecholamine  Preload  Endothelin  Afterload Renal Vasoconstriction/ Fluid Retention Fluid Overload Symptoms Morbidity Death ↓ Cardiac Output ACC/AHA Guidelines: Management of Fluid Status  Patients should not be discharged from the hospital until a stable and effective diuretic regimen is established, and ideally, not until euvolemia is achieved  Patients who are sent home before these goals are reached are at high risk of recurrence of fluid retention and early readmission because unresolved edema may itself attenuate the response to diuretics Diuretics Current “Standard of Care” Diuretics… More diuretics... Still more diuretics… Change in Weight During Hospitalization Outcomes with Standard Care Enrolled Discharges (%) Evidence of Incomplete Relief From Congestion Nearly 50% of ADHF 27% patients discharged with weight gain or losing 26% less than 5 lbs 30 25 20 13% 15 10 7% 16% 6% 3% 5 0 (<-20) (–20 to –15) (-15 to –10) (–10 to –5) (–5 to 0) (0 to 5) Change in Weight (lbs) (5 to 10) 2% (>10) Outcomes with Standard Care Hospital Readmissions Mortality 50% 50% 33% 37% 20% 30 Days 12% 3 6 Months Months 30 12 Days Months 5 Years Patients have persistently high event rates despite use of evidence-based therapies… Effect of Loop Diuretics on RAAS in Cardiac Failure CARDIAC FAILURE Left Ventricular Dysfunction Loop Diuretic Inhibition of Macula Densa Cardiac Remodeling and Fibrosis Increased ReninAngiotensin Increased Aldosterone Current Options May Have Undesirable Clinical Impacts  Favorable aspects of diuretic therapy   Increases urine output; reduces total body volume Adverse aspects of diuretic therapy • Direct activation of renin-angiotensin-aldosterone system • Enhanced myocardial aldosterone uptake • Loss of K, Mg, Ca, secondary myocyte Ca loading • Indirect reduction of cardiac output • Increased total systemic vascular resistance • Reduced natriuresis and GFR • Associated with increased morbidity and mortality Diuretics and ADHF  No consensus dosing guidelines  No common definition of diuretic resistant  No long-term studies of diuretic therapy for the treatment of heart failure  No outcomes data regarding morbidity and mortality 14):39-42. Diuretic Resistance  Can be described as a clinical state in which the diuretic response is diminished or lost before the therapeutic goal of relief from edema has been reached  Affects 20%–30% of patients with HF Diuretic Resistance: Two Types  “Braking” phenomenon   A decrease in response to a diuretic after the first dose has been administered Long-term tolerance  Tubular hypertrophy to compensate for salt loss Diuretic Therapeutic Dilemma  Diminished renal function and concurrent sodium and water retention in ADHF presents a therapeutic dilemma with regard to sub-maximal diuretic therapy  Fluid removal by ultrafiltration may be recommended in this clinical setting What is Aquapheresis?  Method to safely achieve euvolemia  Simplified form of ultrafiltration  Inpatient or outpatient settings  ICU, CCU, MICU, telemetry, step-down, observation, ED, outpatient clinics  Peripheral or central venous access  Flexible access sites and catheters  Diverse physician prescription  Highly automated operation  No clinically significant impact on electrolyte balance, blood pressure, or heart rateor heart rate* Fluid Removal by Ultrafiltration  Ultrafiltration can remove fluid from the blood at the same rate that fluid can be naturally recruited from the tissue  The transient removal of blood illicits compensatory mechanisms, termed plasma or intravascular refill (PR), aimed at minimizing this reduction Interstitial Space (edema) Na P H2O Na UF K K PR P Na Vascular Space Vascular Space Na The EUPHORIA Study    Single center, prospective study, 20 patients Initial UF within 12 hours of hospitalization and before any significant administration of IV diuretics and/or vasoactive drugs Results    Removed an average of 8.6 liters of fluid 60% of patients were discharged in ≤ 3 days Average hospitalization was 3.7 days The EUPHORIA Study  Rehospitalization  In the three months preceding ultrafiltration: 10 hospitalizations in 9 patients  After ultrafiltration: 1 readmission for ADHF within 30 days The UNLOAD Study    200 patients (100 each arm) randomized, multicenter study comparing ultrafiltration versus standard care for acutely decompensated patients Superior salt & water removal/weight loss At 48 hours, ultrafiltration demonstrated 38% greater weight loss  28% greater net fluid loss   At 90 days, reduced readmissions 50% reduction in re-hospitalization episodes  63% reduction in total re-hospitalized days  52% reduction in emergency department or clinic visits  ACC/AHA Guidelines: Class IIa, Level of Evidence B I IIa IIb III Ultrafiltration is reasonable for patients with refractory congestion not responding to medical therapy Aquapheresis is now ranked HIGHER in the Level of Evidence than: - salt restriction - strict I/Os - higher doses of loop diuretics - addition of a second diuretic - continuous infusion of a loop diuretic - vasodilators – IV nitroglycerin, nesiritide - IV inotropes All of these are Level of Evidence: C Case Study        68 yo WM Diastolic heart failure Ischemic heart disease  CAB 4/06 HTN Afibrillation/flutter Anemia Hospitalized every 6 months for exacerbation Case Study: Inpatient Therapy  Inpatient ultrafiltration – January 2010 Access issues – extended length catheter (ELC)  Creatinine 1.5 2.9 after 48 hrs of treatment   Creatinine 1.6 at discharge Therapy/ACEI discontinued  Diuresed with IV lasix continuous infusion  LOS = 5 days  Net volume loss = 7 kgs  Case Study: Outpatient Therapy  1st treatment- 2/22/10 ELC catheter  1850 cc ultrafiltrate over 7 hrs  Wt loss = 2 lbs  Serum Cre = 1.8 pre and at termination of therapy  Hct 29 – sent home with hemoccult cards   Positive x 3- referred to PCP – no follow-up Case Study: Outpatient Therapy   2nd treatment – 3/26/10 ELC catheter and 18 g peripheral IV   2130 ultrafiltrate over 6.5 hrs    Access issues! Also treated with Lasix 240mg IV due to loss of time waiting for access Serum Cre = 1.7 pre and post termination of therapy Hct 26 - referred to Hematology Saint Thomas Hospital: Inpatient Outcomes     54 UF treatments from 5/1/08 – 6/1/10 Average treatment time = 37 hours, 28 minutes Average fluid removal = 6.15 liters/circuit Minimal adverse events 9 episodes of worsening renal insufficiency  No significant electrolyte disturbances  No significant hypotension  1 asymptomatic, small apical pneumothorax  6 minor bleeding episodes – epistaxis, line insertion site, generalized “oozing”  Saint Thomas Hospital: Inpatient Outcomes  Readmissions < 30 days      1 re-admitted with LOC changes 2 discharged to hospice  ultrafiltration for palliation 1 patient, 5 re-admissions  now on dialysis for volume control  no readmits since dialysis except for recent hip fracture 1 expired within 90 days of readmission 1 patient, 2 re-admissions  suspect non-compliance – eating Whopper at discharge! Saint Thomas Hospital: Outpatient Outcomes   1st outpatient treatment – January 19, 2010 13 treatments – 7 pts     avg treatment time 5.79 hrs avg volume removal 1.49 L 1 repeated hospitalization  now on peritoneal dialysis 1 deceased  1 ARF     patient did not follow medication discharge instructions Effective in keeping pts out of hospital > 30 days Need more data Pt satisfaction and QOL are most important! Advanced Heart Failure Clinic Saint Thomas Hospital Another satisfied customer… Challenges and Opportunities for Improvement     Early identification of patients that could benefit from outpatient therapy to decrease readmission within 30 days Process improvement – timely, efficient IV access to allow faster initiation of therapy Patient education – medications, line care, follow-up appointments, etc… Anticoagulation – preserve integrity of circuit Any questions? Contact Information Beth Davidson DNP, ACNP bethdavidsondnp@comcast.net Kristi Hayes MSN, FNP khayes@stthomas.org