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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.

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Presentation on theme: "Ultrafiltration as a Therapy Option for Diuretic Resistance: Inpatient & Outpatient Case Studies Beth Davidson DNP, ACNP, CCRN Kristi Hayes MSN, FNP St."— Presentation transcript:

1 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

2 Objectives Review the epidemiology and pathophysiology of diuretic-resistant, acute heart failure Review the epidemiology and pathophysiology of diuretic-resistant, acute heart failure Identify volume overload treatment options Identify volume overload treatment options Review/discuss case studies of diuretic- resistance and use of ultrafiltration for volume removal Review/discuss case studies of diuretic- resistance and use of ultrafiltration for volume removal

3 Epidemiology of Heart Failure (HF) Heart failure is a major public health problem resulting in substantial morbidity and mortality Heart failure is a major public health problem resulting in substantial morbidity and mortality Major cost-driver of HF is high incidence of hospitalizations Major cost-driver of HF is high incidence of hospitalizations JCAHO has initiated quality care indicators for hospitalized HF patients JCAHO has initiated quality care indicators for hospitalized HF patients CMS reimbursement for readmission < 30 days = $ 0 CMS reimbursement for readmission < 30 days = $ 0 Population GroupPrevalenceIncidenceMortality Hospital DischargesCost Total population 5,000,000550,00057,2181,093,000 $29.6 billion

4 Insult Cardiac Dysfunction LV Remodeling Hemodynamic Decompensation  Preload  Afterload ↓ Cardiac Output Renal Vasoconstriction/ Fluid Retention Neurohormonal Activation  RAAS/SNS  Catecholamine  Endothelin Fluid Overload Symptoms Morbidity Death Decompensated Heart Failure

5 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 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 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

6 Diuretics Current “Standard of Care” Diuretics… More diuretics... Still more diuretics…

7 7% 6% 13% 26% 27% 16% 3% 2% 0 5 10 15 20 25 30 Enrolled Discharges (%) (<-20)(–20 to –15)(-15 to –10)(–10 to –5)(–5 to 0)(0 to 5)(5 to 10)(>10) Change in Weight (lbs) Nearly 50% of ADHF patients discharged with weight gain or losing less than 5 lbs Evidence of Incomplete Relief From Congestion Change in Weight During Hospitalization Outcomes with Standard Care

8 20% 50% 30 Days 3 Months Hospital Readmissions 12% 50% 30 Days 12 Months Mortality 33% 5 Years 6 Months 37% Patients have persistently high event rates despite use of evidence-based therapies… Outcomes with Standard Care

9 Loop Diuretic Inhibition of Macula Densa Increased Renin- Angiotensin Increased Aldosterone Cardiac Remodeling and Fibrosis Left Ventricular Dysfunction CARDIAC FAILURE Effect of Loop Diuretics on RAAS in Cardiac Failure

10  Favorable aspects of diuretic therapy  Increases urine output; reduces total body volume  Adverse aspects of diuretic therapy Direct activation of renin-angiotensin-aldosterone system Direct activation of renin-angiotensin-aldosterone system Enhanced myocardial aldosterone uptake Enhanced myocardial aldosterone uptake Loss of K, Mg, Ca, secondary myocyte Ca loading Loss of K, Mg, Ca, secondary myocyte Ca loading Indirect reduction of cardiac output Indirect reduction of cardiac output Increased total systemic vascular resistance Increased total systemic vascular resistance Reduced natriuresis and GFR Reduced natriuresis and GFR Associated with increased morbidity and mortality Associated with increased morbidity and mortality Current Options May Have Undesirable Clinical Impacts

11 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.

12 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 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 Affects 20% – 30% of patients with HF

13 Diuretic Resistance: Two Types “Braking” phenomenon “Braking” phenomenon A decrease in response to a diuretic after the first dose has been administered A decrease in response to a diuretic after the first dose has been administered Long-term tolerance Long-term tolerance Tubular hypertrophy to compensate for salt loss Tubular hypertrophy to compensate for salt loss

14 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 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 Fluid removal by ultrafiltration may be recommended in this clinical setting

15  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 * What is Aquapheresis?

16  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 Fluid Removal by Ultrafiltration Vascular Space UF Vascular Space Interstitial Space (edema) Na K P H2OH2O K P PR

17 The EUPHORIA Study Single center, prospective study, 20 patients 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 Initial UF within 12 hours of hospitalization and before any significant administration of IV diuretics and/or vasoactive drugs Results Results  Removed an average of 8.6 liters of fluid  60% of patients were discharged in ≤ 3 days  Average hospitalization was 3.7 days

18 The EUPHORIA Study  Rehospitalization  In the three months preceding ultrafiltration: 10 hospitalizations in 9 patients 10 hospitalizations in 9 patients  After ultrafiltration: 1 readmission for ADHF within 30 days

19 The UNLOAD Study 200 patients (100 each arm) randomized, multi- center study comparing ultrafiltration versus standard care for acutely decompensated patients 200 patients (100 each arm) randomized, multi- center study comparing ultrafiltration versus standard care for acutely decompensated patients Superior salt & water removal/weight loss Superior salt & water removal/weight loss At 48 hours, ultrafiltration demonstrated At 48 hours, ultrafiltration demonstrated 38% greater weight loss 38% greater weight loss 28% greater net fluid loss 28% greater net fluid loss At 90 days, reduced readmissions At 90 days, reduced readmissions 50% reduction in re-hospitalization episodes 50% reduction in re-hospitalization episodes 63% reduction in total re-hospitalized days 63% reduction in total re-hospitalized days 52% reduction in emergency department or clinic visits 52% reduction in emergency department or clinic visits

20 Ultrafiltration is reasonable for patients with refractory congestion not responding to medical therapy ACC/AHA Guidelines: Class IIa, Level of Evidence B I IIa IIb III 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

21 Case Study 68 yo WM Diastolic heart failure Ischemic heart disease CAB 4/06 HTN Afibrillation/flutter Anemia Hospitalized every 6 months for exacerbation

22 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

23 Case Study: Outpatient Therapy 1 st 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

24 Case Study: Outpatient Therapy 2 nd treatment – 3/26/10 ELC catheter and 18 g peripheral IV Access issues! 2130 ultrafiltrate over 6.5 hrs 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

25 Saint Thomas Hospital: Inpatient Outcomes 54 UF treatments from 5/1/08 – 6/1/10 54 UF treatments from 5/1/08 – 6/1/10 Average treatment time = 37 hours, 28 minutes Average treatment time = 37 hours, 28 minutes Average fluid removal = 6.15 liters/circuit Average fluid removal = 6.15 liters/circuit Minimal adverse events Minimal adverse events 9 episodes of worsening renal insufficiency 9 episodes of worsening renal insufficiency No significant electrolyte disturbances No significant electrolyte disturbances No significant hypotension No significant hypotension 1 asymptomatic, small apical pneumothorax 1 asymptomatic, small apical pneumothorax 6 minor bleeding episodes – epistaxis, line insertion site, generalized “oozing” 6 minor bleeding episodes – epistaxis, line insertion site, generalized “oozing”

26 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!

27 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!

28 Advanced Heart Failure Clinic Saint Thomas Hospital

29 Another satisfied customer…

30 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

31 Any questions?

32 Contact Information Beth Davidson DNP, ACNP bethdavidsondnp@comcast.net Kristi Hayes MSN, FNP khayes@stthomas.org


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