managing fluid overload in heart failure patients … · risk of hypokalemia (low potassium levels)...

1 ©2020 CHF Solutions, Inc.

MANAGING FLUID OVERLOADIN HEART FAILURE PATIENTS

USING ULTRAFILTRATION

START-UP GUIDE

HEART FAILURE

› Company Letter 03 › Managing Fluid Overload

in Heart Failure Patients 04

› Product Information 13

› Standing Orders Template 20

› Vendor Information 23

› Patient Care Pathway 18

› Additional Reading on Role of Ultrafiltration in the Treatment of Heart Failure Patients 17

Table of Contents

13 Aquadex SmartFlow System Overview

16 Product Resourcesn Therapy Guide Card

n Quick Reference Guide

n Console and Blood Set Brochure

n Dual Lumen Extended Length Catheter

n Venous Access Considerations


Company Letter

Dear Physicians and Caregivers:

Every day, physicians and caregivers face the challenge of managing fluid balance in patients with Heart Failure (HF). HF is the leading cause of hospitalizations in patients >65 years of age in the US.1 Over 1 million HF related hospitalizations occur in the US and 90% of these hospitalizations are due to signs and symptoms of fluid overload.2 The average length of stay for these patients is nearly 5 days and this puts a tremendous strain on already scarce hospital resources.3

Diuretics play a critical role in the management of fluid overload in HF patients. However, they are associated with mixed outcomes and adverse clinical events.

The Aquadex SmartFlow™ System is a simplified form of ultrafiltration that provides safe and predictable removal of isotonic fluid in HF patients with fluid overload. It has been clinically shown to:

nHave no significant changes to electrolytes4

nReduce neurohormonal stimulation (RAAS)5

nStabilize or improve cardiac hemodynamics6

nRestore diuretic effectiveness in patients allowing for improved response to diuretic agents7,8

nDecrease the risk of rehospitalization for HF compared to diuretics by 53%9

nRe-establish euvolemia and decrease hospital length of stay when initiated early10

Additional benefits include:nEasy setup and management allows for 4:1 patient to nurse ratio

nIntegrated diagnostics, including Hematocrit and SV02 monitoring

nLow 35 ml of extracorporeal blood volume in the circuit may help promote hemodynamic stability

I understand that you are busy, but a brief discussion may lead to a solution to your needs.Do you have a short window of time to talk this week or next?

Kind Regards,CHF Solutions

Sources:[1] Desai AS, et al. Circulation. 2012;126:501-506 [2] Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445 [3] Chen J, et al. J Am Coll Cardiol. 2013 Mar 12; 61(10): 1078-1088 [4] De Vecchis R, et al. Minerva Cardioangiol. 2014; 62:131-146 [5] Kabach M, et al. Acta Cardiol. 2017 Apr; 72(2):132-141 [6] Hanna MA, et al. Congest Heart Fail. 2012 Jan-Feb;18(1):54-63 [7] Siddiqui WJ, et al. Heart Fail Rev. 2017; 22:685-698 [8] Marenzi G, et al. J Card Fail. 2014 Jan; 20(1):9-17 [9] Costanzo MR, et al. J Am Coll Cardiol. 2007;49(6):675-683 [10] Costanzo MR, et al. J of Am Coll Cardiol. 2005;46(11):2047-2051


MANAGING FLUID OVERLOAD IN HEART FAILURE PATIENTS USING ULTRAFILTRATION


Managing Fluid Overload in Heart Failure Patients Using Ultrafiltration

Fluid Overload in Heart Failure Patients

90%of heart failure

hospitalizations due to signs and symptoms

fluid overload2

Average length of stay for HF hospitalization is

~5 days³

24%of HF patients will be readmitted within

30 daysand

50%of HF patients will be readmitted within

6 months2

nHeart failure is the leading cause of hospitalizations among adults >65 years of age in the United States1

• >1 million HF hospitalizations occur annually in the US, and hypervolemia (fluid overload) is the predominant cause2

nAverage length of stay for HF hospitalization is ~5 days3

• HF hospitalizations are a strong predictor of mortality4

n24% of HF patients will be readmitted within 30 days and 50% of HF patients will be readmitted within 6 months2

• Since 2012, Medicare has levied penalties for hospitals with 30-day readmission rates above expected5

• Penalty: Hospitals can lose ≤3% of Medicare reimbursement for all admissions

Sources: [1]Desai AS, et al. Circulation. 2012;126:501-506. [2]Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445. [3]Chen J, et al. J Am Coll Cardiol. 2013 Mar 12; 61(10): 1078-1088. [4]Setoguchi S, et al. Am Heart J. 2007; 154:260-266 [5]Readmissions Reduction Program (HRRP). Centers for Medicare & Medicaid Services website: https://www.cms.gov/medicare/medicare-fee-for-service-payment/acuteinpatientpps/readmissions-reduction-program.html.


Sources: [1] Felker MG and Mentz RJ. J Am Coll Cardiol. 2012;59(24):2145-53. [2] Doering A, et al. Int J Emerg Med. 2017;10(17). [3]Testani JM, et al. Circ Heart Failure. 2016;9(1):e002370. [4]Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19)2428-2445. [5]Al‐Naher et al. Br J Clin Pharmacol. 2018 Jan; 84(1): 5–17. [6]Butler J et al. Am Heart J. 2004 Feb;147(2):331-8. [7]Mullen W et al. Eur J Heart Fail, 2019; 21:137-155. [8]Knauf H and Mutschler E. J Cardiovasc Pharmacol 1997;29:367–372. [9]Arampatzi S et al. BMC Medicine 2013,11:83. [10]McMurray JJ et al. Eur Heart J 2012; 33:1787-847. [11]Cooper H.A et al, Circulation 1999, 00(12);1311-1315. [12]Valente MAE et al. European Heart Journal 2014, 35;1284-1293. [13]Hassleblad V et al. Eur J Heart Fail. 2007;Oct 9 (10):1064-1069. [14]Damman K. Eur J Heart Fail. 2016 Mar;18(3):328-336. [15]ter Maat¬en et al. Nat Rev Cardiol 2015; 12:184-192. [16]Testani JM et al. Circ Heart Fail. 2014 March 1; 7(2): 261–270. [17]Brisco-Bacik M, et al, JAHA 2018;7(18): e009149.


Diuretics VS. Ultrafiltration in Heart Failure Patients

ULTRAFILTRATION4

to remove isotonic plasma water

Predictable removal of sodium and fluids

Restoration of diuretic responsiveness

No change in electrolytes, particularly potassium and magnesium

More effective decongestion and fewer heart failure events compared to loop diuretics

Improved glomerular filtration rate

Efficacy, and improved outcomes

LOOP DIURETICS4

to eliminate hypotonic urine

Unpredictable elimination of sodium and water Development of diuretic resistance

Risk of hypokalemia (low potassium levels) and hypomagnesemia (low magnesium levels)

Insufficient symptom relief:Persistent congestion, failure to lowersodium levels

Worsening heart failure, increased mortality after discharge, increase in re-hospitalization rates

Use of Diuretics in Heart Failure Patients

Diuretics play a central role in the management of fluid overload in HF patients; however diuretics are associated with:

MIXED OUTCOMES ADVERSE CLINICAL EVENTS

• The longer a patient is on diuretics, the less effective they become1,2

• Increased risk of worsening renal failure/ accelerated kidney function decline1,4,5,6

• High incidence of poor diuretic response: among HF patients, 40% showed poor diuretic response and 68% showed suboptimal response3

• Electrolyte imbalances and symptomatic hypotension4,7,8,9,10

• High risk of re-hospitalization (24% of HF patients readmitted within 30 days and 50% within 6 months)4

• Higher risk of mortality11-17


ADHERE Registry1 (Acute Decompensated Heart Failure National Registry)

nOut of > 50,000 pts nearly half of hospitalized HF patients are discharged with residual fluid excess after receiving diuretics.

DOSE Trial2 (Diuretic Optimization Strategies Evaluation)

nRegardless of diuretic strategy, 42% of acutely decompensated HF pts reached the composite endpoint of death, rehospitalization, or ER visit at 60 days.


Clinical Evidence on Diuretics

49%of patients discharged

with weight loss of less than 5 pounds

16%of patients discharged

with weight gain

Sources:[1]Gheorghiade M, et al. Eur Heart J Suppl 2005;7:B13-9.[2]Felker MG, et al. N Engl J Med 2011; 36:797-80

2

Clinical Evidence on Ultratiltration in Heart Failure Patients


[1] Level of Evidence Grading Scale as Adapted from the Oxford Centre for Evidence-based Medicine (2009)

STUDY NAME STUDY DESIGN # OF PATIENTS RATIONALE SUMMARY OF FINDINGS PUBLICATION DATE

SAFE Multi-center, prospective, single-arm

21 IDE for 510k Safety. Intravascular excess fluid can be safely achieved via peripherally inserted ultrafiltration

2003JCF

EUPHORIA Single-center, prospective, single-arm

20

Early Ultrafiltration (UF) in diuretic resistance

Efficacy. UF before IV diuretics effectively and safely decreases length of stay and readmissions

2005JACC

RAPID-HF Multi-center, prospective, RCT

40 20 UF/20 SC

Early UF vs Diuretics

Small, short study, positive. Early application of UF for patients with CHF was feasible, well-tolerated, and resulted in significant weight loss and fluid removal

2005JACC

UNLOAD Multi-center, prospective, RCT

200100 UF/100 SC UF vs SC

Viewed as more positive • UF safely produces greater weight and fluid loss

than IV diuretics

• UF significantly decreased HF rehospitalizations

2007JACC

CARRESS-HF Multi-center, prospective, RCT

18894 UF/94 SC

UF vs SC patients with cardiorenal syndrome

Not viewed as a positive study • UF group had a higher SCr

• No difference in weight loss

• No significant difference in death or rehospitalization

2012NEJM

AVOID-HF Multi-center, prospective, RCT

224110 UF/114 SC(810 planned)

UF vs SC to evaluate readmissions

Results trended positive study stopped prematurely. • Fewer patients rehospitalized at 30 days

• Fewer days in the hospital due to HF readmissions at 30 days

2016JACC:HF

HIGHEST LEVEL OF EVIDENCE: LEVEL 1 (RANDOMIZED CLINICAL TRIAL)1




10-Year Experience With Ultrafiltration For The Management Of Acute Decompensated Heart Failure: Real World Experience AT ABINGTON HOSPITAL – JEFFERSON HEALTH

Retrospective, single center analysis of 335 consecutive acutely decompensated heart failure patients treated with adjustable rate UF using the CHF Solutions

Aquadex FlexFlow® System from 7/28/2009 to 6/30/2019.

RESULTS:

Source: [1]Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445

HF HOSPITALIZATIONS

n Average 2.14 hospitalizations the year before ultrafiltration with Aquadex

n Average .4 hospitalizations per year after ultrafiltration with Aquadex

RENAL FUNCTION BIOMARKERS Before Initiation of Ultrafiltration with Aquadex

n Mean BUN 49 mg/dln Mean creatinine 1.78 mg/dl

n GFR 39 m/min/1.73 m2

FLUID REMOVED AND WEIGHT LOSS

Mean Weight Loss(sustained 1-2 weeks)15.63 lbs

Mean FluidRemoved14.58 L

RE-HOSPITALIZATION RATE

12.4% at 30 days (National Avg. at 30 days = 24%) 1

14.9% at 90 days

27.3% at 1 year

KEY TAKEAWAYS:

n All patients had stable renal function at follow up

n Compared with previous UF trials (UNLOAD, CARRESS & AVOID), real-world experience demonstrates that UF compares favorably for HF re-hospitalizations, renal function response, and weight/volume loss

n Real world experience allowed for the adjustment of UF rate during therapy, which contributed to favorable outcomes

n UF is a safe and effective strategy for decongestion

Rehospitalizations for patients after receiving ultrafiltration with Aquadex

was 48% less than the National Average at 30 days

Hospitalizations per patient per year decreased, on average, by 81%

from twice a year to once every two and a half years



Source: [1] Costanzo MR, et al. J of Am Coll Cardiol. 2005;46(11):2047-2051

STUDY DESIGNnSingle center, prospective, single-arm: 20 patients

RESULTSAdministration of early UF in acute decompensated HF patients with diuretic resistancenRemoved an average of 8.6 liters of fluid

nHospitalizations:• When initiated early, average Length of Stay was 3.7 days

• In the 3 months preceding ultrafiltration, 10 hospitalizations in 9 patients

• After ultrafiltration, 1 patient was readmitted for ADHF within 30 days

nImprovement of volume overload after ultrafiltration persisted at 30 and 90 days

CONCLUSIONnHF 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.

EUPHORIA (Early Ultrafiltration with Decompensated Heart Failure and Diuretic Resistance)1


Ultrafiltration in Heart Failure Patients

nShown to have no significant changes to electrolytes1

nReduces neurohormonal stimulation (RAAS)2

nStabilizes or improves cardiac hemodynamics3

nRestored diuretic effectiveness in patients allowing for improved response to diuretic agents4,5

n53% reduction in the risk of rehospitalization for HF compared to diuretics6

nEarly initiation of UF in ADHF patients shown to re-establish euvolemia and may decrease hospital length of stay.7


Sources:[1]De Vecchis R, et al. Minerva Cardioangiol. 2014; 62:131-146. [2]Kabach M, et al. Acta Cardiol.2017 Apr; 72(2):132-141. [3]Hanna MA, et al. Congest Heart Fail. 2012 Jan-Feb;18(1):54-63. [4]Siddiqui WJ, et al. Heart Fail Rev. 2017; 22:685-698. [5]Marenzi G, et al. J Card Fail. 2014 Jan; 20(1):9-17. [6]Costanzo MR,et al. J Am Coll Cardiol. 2007;49(6):675-683. [7]Costanzo MR, et al. J of Am Coll Cardiol. 2005;46(11):2047-2051

Sources: [1]Bart BA, et al. NEJM. 2012 Dec; 367(24):2296-2304. [2] Grodin JL, et al. Eur J of Heart Fail. 2018 Mar. [3]Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445. [4] Bart BA, et. al., Am Coll Cardiol., 2005;46(11):2043– 6. [5] Costanzo MR et al. J Am Coll Cardiol 2007;49:675–83. [6] Rao VS, et al. Circ Heart Fail. 2019 June; 12(6):e005552.

CARRESS-HF Per-protocol StudyConclusions2 and Counter Points3 (N=163)

Better understand the direct effects of UF in comparison to an aggressive, urine output-guided pharmacological protocol for decongestion in heart failure patients

n UF had higher serial cumulative fluid loss (p=0.003)*n UF had higher net fluid loss (p=0.001)*n UF had a greater relative reduction in weight

over time (p=0.02)*

n 39% in the UF group received only diuretic agents or were given diuretic agents before the assessment of the primary endpoint at 96 h, which impairs adjudication of adverse events to one or the other therapy1

n All patients’ fluid removal rates were fixed at 200 ml/h and vasodilators or inotropic drugs were prohibited unless necessary for rescue therapyThese results are consistent with data from other randomized, controlled studies for volume removal (RAPID-CHF 4 and UNLOAD 5)

* Statistically significant

CARRESS-HF Study Results1 (N=200)

Compare ultrafiltration (UF) and stepped pharmacological therapy (SPT) in the treatment of patients with acute decompensated heart failure (ADHF)

n No significant difference between UF vs. SPT for weight loss at 96 h

n UF group had a higher increase in serum creatinine (SCr) vs. SPT group

n SAEs: 72% (UF) vs. 57% (SPT) at 60-days

ADDITIONAL ANALYSES ON CARRESS DATA (N=105) Urine Biomarker Sub-Study on CARRESS-HF Patients6

n Although intensive volume removal resulted in a further worsening of creatinine levels approximately half of the time in CARRESS-HF patients, decongestion and renal function recovery at 60 days were superior in patients with increased tubular injury markers

n The authors concluded “these data suggest that the benefits of decongestion may outweigh any modest or transient increases in serum creatinine or tubular injury markers that occur during intensive volume removal”

n Increase in renal tubular injury biomarker score was associated with a greater incidence of hemoconcentration and trends toward other metrics of superior decongestion

n Change in creatinine (i.e. transient increase creatinine) should not be the major factor to dissuade the use of UF where a therapeutic advantage may exist

2012 2018 2019

OBJE

CTIV

ESAN

D FI

NDI

NGS

Understand the impact of intensive volume removal in ADHF patients with preexisting worsening renal function and renal tubular injury

n Although SCr levels increased in the UF arm, there was no significant difference in long-term outcomes

What We’ve Learned Since CARESS-HF



Aquadex’s Healthcare Economic Benefits

Analysis published in February 2019 Journal of Medical Economics1:

nCompared costs at the hospital level for treating fluid overload in HF patients when using ultrafiltration versus IV diuretics (DIUR-T) over a 90 day period

nModel in analysis used clinical data from published literature (i.e., UNLOAD) and hospital data from the Healthcare Cost and Utilization Project (HCUP) database

nThe analysis demonstrated that despite higher up-front costs, ultrafiltration reduces hospital readmission rates and readmission duration of stay

nData showed a cost savings of $3,975 per patient when using ultrafiltration versus diuretic therapy over 90 days

ORIGINAL RESEARCH

Ultrafiltration versus diuretics for the treatment of fluid overload in patientswith heart failure: a hospital cost analysis

Maria R. Costanzoa, Gregg C. Fonarowb and John A. Rizzoc

aAdvocate Heart Institute, Naperville, IL, USA; bUniversity of California Los Angeles, Los Angeles, CA, USA; cStony Brook University, StonyBrook, NY, USA

ABSTRACTBackground: Heart failure (HF) is a common, serious disease in the US and Europe. Patients with HFoften require treatment for fluid overload, resulting in costly inpatient visits; however, limited evidenceexists on the costs of alternative treatments. This study performed a cost-analysis of ultrafiltration (UF)vs diuretic therapy (DIUR-T) for patients with HF from the hospital perspective.Methods: The model used clinical data from the literature and hospital data from the Healthcare Costand Utilization Project to follow a decision-analytic framework reflecting treatment decisions, probabilis-tic outcomes, and associated costs for treating patients with HF and hypervolemia with veno-venous UFor intravenous DIUR-T. A 90-day timeframe was considered to account for hospital readmissions beyond30days. Sensitivity and scenario analyses were performed to gauge the robustness of the results.Results: Although initial hospitalization costs were higher, fluid removal by UF reduced hospitalreadmission days, leading to cost savings of $3,975 (14.4%) at the 90-day follow-up (UF costs, $23,633;DIUR-T costs, $27,608).Conclusions: UF is a viable alternative to DIUR-T when treating fluid overload in HF patients becauseit reduces hospital readmission rates and durations, which substantially lowers costs over a 90-dayperiod compared to DIUR-T.

ARTICLE HISTORYReceived 21 December 2018Revised 3 February 2019Accepted 12 February 2019

KEYWORDSHeart failure; ultrafiltration;fluid overload; cost-analysis

JEL CLASSIFICATION CODESA10; A30

Introduction

Heart failure (HF) is a common and serious disease in the USand in Europe. Approximately 6.5 million adults in the UShave HF, and one in eight deaths included HF as a contribu-ting cause of mortality1. Approximately 40–45% of patientswho develop HF die within 5 years of diagnosis1.

The risk of HF increases with age (the annual incidence ofHF is 10 per 1,000 for patients aged over 65 years2) and HF isa leading cause or among the leading causes of hospitaliza-tions2, with over 1 million hospitalizations annually in the USand in Europe3 and fluid overload accounting for more than90% of those hospital admissions2–4. The average hospital stayfor HF treatment is 5 days; however, rehospitalization is com-mon in these patients, with almost 25% readmitted within30days and up to 50% readmitted within 6months of theindex hospitalization5–7. Because HF is so common andrequires inpatient treatment, it carries a huge economic bur-den in the US, costing the nation an estimated $60.2 billioneach year, with hospital costs accounting for 62% of the eco-nomic burden8. As the population ages, healthcare expendi-tures are expected to increase substantially9.

Fluid overload is common in patients with HF and cancause dyspnea, the symptom that most commonly leadsthese patients to seek medical attention in the emergency

department (ED). Once in the ED, more than 80% of patientswith HF are admitted to the hospital10.

The Aquadex FlexFlow System (CHF Solutions,Minneapolis, MN) is indicated for temporary (up to 8 hours)ultrafiltration (UF) treatment of patients with fluid overloadin whom diuretic therapy (DIUR-T) has failed and extended(longer than 8 hours) UF treatment of patients with fluidoverload in whom DIUR-T has failed and hospitalization isnow required.

Some clinical trials have found UF to be an effective treat-ment, resulting in greater weight and fluid loss than DIUR-T11–13. Veno-venous UF treatment offers a number of poten-tial advantages compared to DIUR-T, which may include thefollowing: (1) reduction in renal venous-congestion andimprovement in renal hemodynamics; (2) rapid and adjust-able fluid-removal and improvement in symptoms of conges-tion; (3) higher mass-clearance of sodium; (4) decreased riskof electrolyte abnormalities (e.g. hypokalemia); (5) decreasedrate of HF-related rehospitalization; and (6) decreased dur-ation of rehospitalizations14. Moreover, decreasing rehospital-ization rates and durations will not only help control hospitalcosts, but may also improve patients quality-of-life14.

To date, there has not been a prospective evaluation ofthe cost-effectiveness of UF therapy and the only published

CONTACT John A. Rizzo [email protected] Stony Brook University, 403 Myrtle Ave, Port Jefferson, NY 11777, USA� 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis GroupThis is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/),which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in anyway.www.tandfonline.com/ijme

JOURNAL OF MEDICAL ECONOMICS2019, VOL. 22, NO. 6, 577–583https://doi.org/10.1080/13696998.2019.1584109Article 0234-FT.R1/1584109

Ultrafiltration vs. Diuretics for the Treatment of Fluid Overload in Patients with Heart Failure: A Hospital Cost Analysis

Costanzo MR1, Fonarow GC2, Rizzo JA3

1Advocate Heart Institute, Naperville, IL, USA, 2University of California Los Angeles, Los Angeles, CA, USA, 3Stony Brook University, Stony Brook, NY, USA

Background• Heart failure is a common, serious disease in the United States and Europe.• Patients with heart failure often require treatment for fluid overload resulting in costly inpatient visits.• The first line of treatment for fluid overload is diuretic therapy (DIUR-T), but if DIUR-T fails alternative treatment options should be considered.• Limited data exists on the costs (or cost savings) associated with the use of alternative therapies to treat patients with fluid overload.

ObjectiveThe purpose of this study was to perform a cost-analysis from the hospital perspective on ultrafiltration versus DIUR-T in the treatment of patients with heart failure related fluid overload.

Methods• The cost-analysis model used a decision-analytic framework to reflect treatment decisions, probabilistic outcomes, and associated costs for treating patients with heart failure and fluid overload with veno-venous ultrafiltration or intravenous DIUR-T (Figure 1).• The model was informed by clinical data obtained from published literature and the Healthcare Cost and Utilization Project (HCUP) for the calendar year 2014.• A 90-day timeframe was considered to account for hospital readmissions beyond 30 days. • Sensitivity and scenario analyses were performed to gauge the robustness of the results.

Figure 1: Decision Analytic Framework*

Cong

estiv

e He

art F

ailu

re

Hosp

italiz

atio

n

Ultrafiltration

Central Line Catheter

Heparin-Induced Thrombocytopenia

Major Bleed

Infection

Rehospitalization

Mid Line Catheter

Heparin-Induced Thrombocytopenia

Major Bleed

Infection

Rehospitalization

IV Diuretics

Heparin-InducedThrombocytopenia

Major Bleed

Infection

Rehospitalization

Results• Initial hospitalization costs were higher in the ultrafiltration arm due to the cost of the ultrafiltration system itself.• Fluid removal by ultrafiltration lead to reduced hospital readmission days which resulted in a cost savings of $6,148 per patient.• UF treatment showed a total cost savings of $3,975 or 14.4% ($23,633 for UF vs. $27,608 for DIUR-T).• A one-way sensitivity analysis was performed that incorporated varied model input values that showed a greater cost savings for the ultrafiltration arm compared to DIUR-T (Figure 3).

Figure 2: Hospital Readmission Costs per Patient at 90 Days Following Discharge

Figure 3: Tornado Diagram for One-way Sensitivity Analysis

2000 3000 4000 5000 6000

Amortized UF machineHeparin infusion

CRBSI with midline catheterMidline catheter

Major bleed with IV diureticsAdditional nursing costs per shift

CVLPhysician fees

HIT with IV diureticsHIT

Major bleedUF via midline catheter

Major bleed with UFHIT with UF

CRBSICRBSI with CVL

UF filterUF via CVL

Baseline CHF hospitalization…

Cost Difference: Diuretic Minus UF Therapy

Cate

gory

Upper Limit of Range Lower Limit of Range

Abbreviations: CHF, congestive heart failure; UF, ultrafiltration; CVL, central venous line; CRBSI, catheter-related bloodstream infection; HIT, heparin-induced thrombocytopenia; IV, intravenous.

ConclusionUltrafiltration is a viable alternative to DIUR-T when treating fluid overload in heart failure patients. Despite higher upfront costs, ultrafiltration substantially reduced hospital cost via readmission rates and durations, over a 90-day period compared to DIUR-T.

Poster presented at ISPOR 23rd Annual International Meeting, May 19-23, 2018, Baltimore, MD, USA.

*Adapted from Bradley SM, Levy WC, Veenstra DL. Cost-consequences of ultrafiltration for acute heart failure: a decision model analysis. Circ Cardiovasc Qual Outcomes. 2009;2(6):566-573.)

18-2018-A

$0

$5,000

$10,000

$15,000

$20,000

$25,000

$30,000

Ultrafiltration Diuretic Therapy

Total Costs (Initial Treatment and Rehospitalization)Rehospitalization Costs

$3,975 or 14.4%

$6,148 or 57%

Source: [1]Costanzo MR, et al. J Med Econ. 2019, VOL. 22, NO. 6, 577–583.


Product Information

Aquadex SmartFlow™ System

The Aquadex SmartFlow System uses a simplified approach to ultrafiltration for the removal of salt and water in patients with hypervolemia, or fluid overload. Compared to renal replacement devices used for ultrafiltration, the Aquadex SmartFlow System is smaller and more portable.Physicians can specify and adjust the exact amount and rate of fluid to be removed from each patient, resulting in a gradual reduction that has been shown to have no significant clinical impact on blood pressure, heart rate, or the balance of electrolytes (e.g. sodium, potassium, etc.) in the body.1

Up to 500 mL per hour of excess fluid can be removed with no clinically significant impact on electrolyte balance.1,2

Sources:[1] RAPID Trial: Bart BA, et al. J Am Coll Cardiol. 2005 Dec 6; 46(11): 2043-2046.[2] SAFE Trial: Jaski BE, et al. J Card Fail. 2003 Jun; 9(3): 227-231.

Features & Benefits

SIMPLE

nEasy set-up and monitoring allows for up to 4:1 patient to nurse rationHighly automated with only one setting required to beginnSmart alarms/alerts prompt action when necessary

FLEXIBLE

nPerform therapy through peripheral or central venous accessnPortable system with small 35 ml extracorporeal volume meets patient needs in a multitude of clinical settingsnCustomizable HCT monitor can be tailored to individual patient needs

SMART

nHCT sensor provides real time measurement of % blood volume changenSvO2 monitoring provides insights into tissue oxygen deliverynFilter Alert prompts action to extend filter life and reduce therapy time


Easy to Operate, Safe to Use nControllable fluid reduction and individualized patient fluid removal

nPerform therapy through peripheral or central venous access

nHighly automated with only one setting required to begin

nHematocrit sensor provides real time measurement of % blood volume change

nUser defined hematocrit limit

nSvO2 monitoring provides insights into tissue oxygen delivery

Blood Leak Detector

Hemofilter

Display Screen

Ultrafiltrate Pressure Sensor & Infusion Pressure Sensor

Air Detector

Touch Pad

Withdrawal PressureSensor

Data Key

Hematocrit Monitoring

Simplified approach to ultrafiltration for the removal of isotonic fluid.

Product Information


Infusion Pressure Sensor

Filter

Ultrafiltrate Pressure Sensor

Blood Leak Detector

Ultrafiltrate Weight Scale

Infusion Priming Adaptor

Clip Clamp

Withdrawal Priming Adaptor

Drain Valve

Withdrawal Lumen

Blood Pump

Access Port

Infusion Lumen

Withdrawal Pressure Sensor

Sensor Clip & Blood

Chamber

Air

Dete

ctor

Clip Clamp

Ultrafiltrate Collection Bag

Ultrafiltrate Pump

Clip Clamp

Access Port

Aquadex System Fluid Path

Fully Integrated Blood Circuit Set

n Patented filter designed to reduce clotting

n Air and blood leak detectors to ensure correct operation

n Needleless access ports for aspiration or infusion of fluids

n Filter Resistance Alert prompts action to help extend circuit life

Blood Circuit SetUniquely designed for the removal of isotonic fluid with a low extracorporeal blood volume of approximately 35 ml.

Product Information


CHFS Resources

Venous Access Considerations

Click on the links below to access the complete product resource.

Therapy Guidelines Card

Dual Lumen Extended Length Catheter

Console and Blood Set Brochure

Quick Reference Guide

Product Information

https://www.chf-solutions.com/wp-content/uploads/2020/05/19-1928-B_Venous-Access-Considerations.pdf

https://www.chf-solutions.com/wp-content/uploads/2020/03/18-2052-B_Therapy-Guide-Card.pdf

https://www.chf-solutions.com/wp-content/uploads/2020/03/18-2019-C_Catheter-Brochure.pdf

https://www.chf-solutions.com/wp-content/uploads/2020/03/18-2019-C_Catheter-Brochure.pdf

https://www.chf-solutions.com/wp-content/uploads/2020/05/DIGITAL_18-2020-D_Console-and-Blood-set_Brochure.pdf

https://www.chf-solutions.com/wp-content/uploads/2020/05/DIGITAL_16-05629-G_SmartFlow-Quick-Reference-Guide_MAY20.pdf


Clinical References

Additional Reading on Role of Ultrafiltration in the Treatment of Heart Failure Patients

https://pubmed.ncbi.nlm.nih.gov/28494980/


https://academic.oup.com/eurheartjsupp/article/7/suppl_B/B13/603537


https://pubmed.ncbi.nlm.nih.gov/17291932/ https://pubmed.ncbi.nlm.nih.gov/30775944/

https://www.nejm.org/doi/full/10.1056/NEJMoa1005419




https://academic.oup.com/eurheartjsupp/article/7/suppl_B/B13/603537




https://www.nejm.org/doi/full/10.1056/NEJMoa1005419



Patient Care Pathway

Fluid Overload Patient Care Pathway with Aquadex SmartFlowTM System

INITIATE AQUADEX THERAPY

GOALClinical Euvolema: JVP < 8 mmHg,

absence of dyspnea,trace or no peripheral edema3,

reduction in NT proBNP by 30%7

or BNP by 45%8

Evaluate transition to oral diuretics.If oral diuretics indicated, consider lower home dose.Follow GWTG or ACC transitional care guidelines 9-10

• Optional second dose of diuretics double previous dose or repeat FST

MONITOR

Continue todose diuretics

PATIENT IDENTIFICATION

GENERAL SYMPTOMSOF FLUID OVERLOAD

• Outpatient diuretics uptritrated without adequate response

• Frequently present with fluid overload

Expedited fluid removal path

HEART FAILURE

Fluid overload as indicated by at least2 of the following:1-4

• Patient weight 10 lbs. > dry weight or > 5 lbs. for pt weighing < 50 kg

• Patient admitted with fluid overload who are taking ≥ 80 mg furosemide (or equivalent) per day

• Low urine output (<100 cc/hr)

• JVD > 8 cm H2O

• Peripheral or sacral edema ≥ 2+

• Pulmonary rales

• Pulmonary edema or pleural effusions on CXR

• PND or orthopnea

• Respiratory rate ≥ 20 per minute

• Hypoxemia requiring supplemental oxygen

• LVEDP or PCWP > 20 mmHg

Stop diuretics*

<200 ml in 2 hrsurine output

>200 ml in 2 hrsurine output

CURRENTLY ON DIURETICS?

• IV diuretics at double the baseline oral dose or• Furosemide Stress Test (FST) 1.5 mg/kg IV bolus

• Lasix 40 mg IV or• FST: 1 mg/kg IV bolus

YES NO

Customize monitoringbased on data

• Heart rate• Blood pressure

• SCr level• Urine output

Choose initial UF rate6

SBP 100-120 mm HgSBP <100 mm Hg SBP >120 mm Hg

200 cc/h150 cc/h 250 cc/h

Decrease initial UF rate by 50 ml/hr if any of the following

• RV>LV dysfunction

• sCR increase 0 .3 mg/dl above baseline

• Baseline sCR > 2.0 mg/dl

• Hx of instability with diuresis or UF in the past

Start anticoagulationunless contraindicated

Obtain vascular access

*Consider stopping electrolyte replacement

MONITORFST: 200 ml/hr urine output over 2 hours and/or spot urine sodium <50 mEq/L5

[1]CHF Solutions Medical advisory board meeting 2020 recommendations. [2]Costanzo MR, Guglin ME et al. JACC.2007; 49(6):675-83.[3]Costanzo MR, Negoianu D et al. JACC. 2016; 4(2):95-105. [4]Bart BA et al. JACC. 2005;46(11):204306. [5]Brinkley DM, Burpee L, ChaudhryP et al. Spot urine for triage effective diuretic infusion in ambulatory heart failure unit. J Card Fail. 2018:24(16); 346-354.[6]Adjustable UF guideines used by the AVOID-HF Study Investigators, Constanzo MR et al. J ACC. 2017.16;69(19):2428-2445.[7]Bhardwaj A & Januzzi J Crit Pathway in Cardiol. 2009;8:146-150. [8]DiSomma S et al. Critical Care. 2010.14(3):2-8.[9]www.heart.org. [10]www.cvquality.acc.org.

© 2020 CHF Solutions, Inc. All Rights Reserved. 20-2057-B

CHFS Medical Advisory Board consultation was sought on the pathway.

FST: 200 ml/hr urine output over 2 hoursand/or spot urine sodium <50 mEq/L5

OR


Patient Care Pathway

Fluid Overload Patient Care Pathway with Aquadex SmartFlowTM System

INITIATE AQUADEX THERAPY

GOALClinical Euvolema: JVP < 8 mmHg,

absence of dyspnea,trace or no peripheral edema3,

reduction in NT proBNP by 30%7

or BNP by 45%8

Evaluate transition to oral diuretics.If oral diuretics indicated, consider lower home dose.Follow GWTG or ACC transitional care guidelines 9-10

• Optional second dose of diuretics double previous dose or repeat FST

MONITOR

Continue todose diuretics

PATIENT IDENTIFICATION

GENERAL SYMPTOMSOF FLUID OVERLOAD

• Outpatient diuretics uptritrated without adequate response

• Frequently present with fluid overload

Expedited fluid removal path

HEART FAILURE

Fluid overload as indicated by at least2 of the following:1-4

• Patient weight 10 lbs. > dry weight or > 5 lbs. for pt weighing < 50 kg

• Patient admitted with fluid overload who are taking ≥ 80 mg furosemide (or equivalent) per day

• Low urine output (<100 cc/hr)

• JVD > 8 cm H2O

• Peripheral or sacral edema ≥ 2+

• Pulmonary rales

• Pulmonary edema or pleural effusions on CXR

• PND or orthopnea

• Respiratory rate ≥ 20 per minute

• Hypoxemia requiring supplemental oxygen

• LVEDP or PCWP > 20 mmHg

Stop diuretics*

<200 ml in 2 hrsurine output

>200 ml in 2 hrsurine output

CURRENTLY ON DIURETICS?

• IV diuretics at double the baseline oral dose or• Furosemide Stress Test (FST) 1.5 mg/kg IV bolus

• Lasix 40 mg IV or• FST: 1 mg/kg IV bolus

YES NO

Customize monitoringbased on data

• Heart rate• Blood pressure

• SCr level• Urine output

Choose initial UF rate6

SBP 100-120 mm HgSBP <100 mm Hg SBP >120 mm Hg

200 cc/h150 cc/h 250 cc/h

Decrease initial UF rate by 50 ml/hr if any of the following

• RV>LV dysfunction

• sCR increase 0 .3 mg/dl above baseline

• Baseline sCR > 2.0 mg/dl

• Hx of instability with diuresis or UF in the past

Start anticoagulationunless contraindicated

Obtain vascular access

*Consider stopping electrolyte replacement

MONITORFST: 200 ml/hr urine output over 2 hours and/or spot urine sodium <50 mEq/L5

[1]CHF Solutions Medical advisory board meeting 2020 recommendations. [2]Costanzo MR, Guglin ME et al. JACC.2007; 49(6):675-83.[3]Costanzo MR, Negoianu D et al. JACC. 2016; 4(2):95-105. [4]Bart BA et al. JACC. 2005;46(11):204306. [5]Brinkley DM, Burpee L, ChaudhryP et al. Spot urine for triage effective diuretic infusion in ambulatory heart failure unit. J Card Fail. 2018:24(16); 346-354.[6]Adjustable UF guideines used by the AVOID-HF Study Investigators, Constanzo MR et al. J ACC. 2017.16;69(19):2428-2445.[7]Bhardwaj A & Januzzi J Crit Pathway in Cardiol. 2009;8:146-150. [8]DiSomma S et al. Critical Care. 2010.14(3):2-8.[9]www.heart.org. [10]www.cvquality.acc.org.


CHFS Medical Advisory Board consultation was sought on the pathway.

FST: 200 ml/hr urine output over 2 hoursand/or spot urine sodium <50 mEq/L5

OR


1. Indication: The Aquadex SmartFlow System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) orextended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilogramsor more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administeredby a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, bothof whom having received training in extracorporeal therapies.

2. Patient selection:

a. Fluid overload and two of the following

i. ____ lbs/kg over dry weight (estimated)

II. IV Diuretic Dose ≥ ____ mg furosemide or equivalent (1 mg bumetanide or 20 mg torsemide=40 mg furosemide)

iii. Diuresis < _____ cc/hr, and/or ≥ _____ mg/dl sCr rise

iv. ___ hospitalizations in ______ days

v. readmission

3. Labs:

a. CBC prior to treatment and every_____hour_____days during treatment

b. BMP prior to treatment and every_____hour_____days during treatment

c. CMP prior to treatment and every_____hour_____days during treatment

e. Other Labs:_______________________________________________________________

4. Anticoagulation therapy (e.g. aPTT, PTT, INR, etc):

a. Keep the patient is contraindicated

b. Labs: obtain anticoagulation level prior to treatment

i. ___PT/INR, PTT now and every ____ hrs. Every ____ day

ii. ___ACT now and every _____ hrs

iii. ___AntiXa level and every ____ day(s)

iv. follow PTT based on heparin protocol

c. Therapy

i. Heparin with DVT protocol dosing or

ii. Alternative therapy

____ Continuous slow infusion of heparin (e.g. 500 units/hr)1

____ ECMO Heparin protocols, narrower range of PTT (for example 40-60 sec general range)2

____ Heparinized saline to prime/reprime the circuit (for example 5000 units in 500 ml normal saline or 5000 units in 1L normal saline)3-4

Bolus of Heparin prior to initiation of therapy:____ Priming circuit with Heparin in saline 5000 Units/L in saline (9 mg/ml)4

____ Weight based option: patient on Heparin gtt, with subtherapeutic PTT, bolus units/kg per Heparin protocol5

ULTRAFILTRATION ORDERS USING THE AQUADEX SMARTFLOW™

CHF Solutions is providing this template in association with the delivery of Ultrafiltration therapy with the Aquadex SmartFlow (Rx Only) to patients with fluid overload who have failed diuretic therapy. This template is intended to be customized for standardization& compliance with an institution’s standard operating procedures and does not take the place of the Aquadex SmartFlow User’s Guide. Physician & hospital staff judgment should be exercised at all times in the care of the patient. For HCP use only.

Patient #:_________________________ Date: _________________ Time: ______________

Standing Orders Template


ULTRAFILTRATION ORDERS USING THE AQUADEX SMARTFLOW

5. Venous access:

a.____ CHF 6Fr. dual, triple or quad lumen (with at least 2 lines 16ga or larger) Peripheral Extended Length Catheter (dELC),

-- OR --

b.____ 7-8Fr. dual lumen central line (dual 14ga or dual 16ga). -- OR --

c.___________________________________________________

d. Remove all extensions and needle-less systems from the lines when connecting blood circuit (e.g. hub to hub)

6. Before starting treatment:

a. Diuretic and electrolyte replacement therapies may be discontinued for duration of Aquapheresis treatment.

b. Ensure venous access is patent and can deliver required blood flow.

c. Ensure blood circuit set is loaded properly (press the PRIME then HELP keys on device).

d. Prime blood circuit with a minimum of 250 ml NS and ensure prime is successfully completed.

7. Treatment:

a. Connect blood circuit to venous access.

b. NET Fluid removal at a rate of _____ ml/hr (0-500 ml/hr) for ____ hours OR until _____ liters of fluid removed.

i. Monitor patient for clinical signs of hypovolemia and hypotension as appropriate.

c. Vital signs Q___ minutes or first ____ hour(s), then Q____ hour for duration of treatment and PRN patient status.

d. Strict INTAKE & OUTPUT during treatment.

e. IV drug therapy can be administered through the access ports on the blood circuit.

f. For laboratory testing, blood can be removed through the access port on the withdrawal side of the blood circuit.

8. Monitoring

a. Vital signs every _____ minutes for the first hour(s), then every _____ hr(s)

i. Aline monitoring every _____ hr(s)

b. Hemodynamic Monitoring

i. CVP monitor every ___ hr(s)

ii. PA monitoring every _____ hr(s)

iii. CO/CI every ______ hr(s)

c. SVO2 Monitoring

i. Keep the SVO2 monitor every ___ hr(s)

ii. add contact provider for ______%

iii. if SVO2 < ____% contact provider

iv. if SVO2 < ___% set UF rate to 0 and contact provider

d. Hematocrit Monitoring (if prescribed/available):

i. To enable, place sensor clip on the blood set chamber and follow the onscreen instructions.

ii. After baselining is complete, accept the default or set the prescribed Hct Limit:

Accept the default Hct limit, or

Set Hct limit to (%) _______

e. Strict I& O record every _____ hr(s)

f. Daily weight ________

g. Fluid restriction ______ ml/24 hours

Standing Orders Template



9. Call the physician or provider if:

a. SBP < ______ mm HG

b. Heart rate > ____and decreased UF rate by ______ ml/hr, or place at 0 ml/hr until stabilized.

Once stable, Resume UF at lower rate ( i.e 50-100 ml/hr less that last rate)

c. If the Hct Limit is consistently exceeded (e.g. at least ____ “Extended UF Pump Stoppage” alerts have occurred) and the patient is otherwise stable and obviously fluid overloaded, consider the following:

i. Returning the patient to the baseline position.

ii. Reducing the UF Rate by _______ (e.g. 100 ml/hr)

iii. Increasing Hct Limit to ________ (e.g. 34.5 to 35.5)

iv. 50-100 ml/hr by reducing UF rate add increasing Hct limit by ____%

10. Post therapy:

a. Maintain IV access per unit protocol ________________________________________________

b. Discontinue anticoagulation as appropriate.

c. Resume diuretics as appropriate.

Additional Orders

Physician signature � Sent to pharmacy ______ (initials)

Printed physician name RN Name

Date/Time

Sources: [1] Beckles D. 2019. CHF Solutions’ Sponsored AATS Theatre Session, “Personalized Medicine: Improving Clinical Outcomes with Novel Fluid Management Strategies. www.chf-solutions.com. [2]Raffini L. Anticoagulation with VADs and ECMO: walking the tightrope. Am Soc Hematology. 2017. 674-681.[3]Ziyaeifard M, Alizadehas A et al Heparinized and saline solutions in the maintenance of arterial and central venous catheters after cardiac surgery. Anesth Pain Med.2015.5(4);e28056. [4]Skagerlind MS & Stegmayr BG. An evaluation of four modes of low-dose anticoagulation during intermittent hemodialysis. Europ J of Clinical Pharm. 2018:74(3):267-274. [5]Peterangelo M. Incorporating Aquapheresis into the hospital setting: A practical approach. Prog Cardiovasc Nurs. 2008;23:168-172.

ULTRAFILTRATION ORDERS USING THE AQUADEX SMARTFLOW


9. Call the physician or provider if:

a. SBP < ______ mm HG

b. Heart rate > ____and decreased UF rate by ______ ml/hr, or place at 0 ml/hr until stabilized.

Once stable, Resume UF at lower rate ( i.e 50-100 ml/hr less that last rate)

c. If the Hct Limit is consistently exceeded (e.g. at least ____ “Extended UF Pump Stoppage” alerts have occurred) and the patient is otherwise stable and obviously fluid overloaded, consider the following:

i. Returning the patient to the baseline position.

ii. Reducing the UF Rate by _______ (e.g. 100 ml/hr)

iii. Increasing Hct Limit to ________ (e.g. 34.5 to 35.5)

iv. 50-100 ml/hr by reducing UF rate add increasing Hct limit by ____%

10. Post therapy:

a. Maintain IV access per unit protocol ________________________________________________

b. Discontinue anticoagulation as appropriate.

c. Resume diuretics as appropriate.

Additional Orders

Physician signature � Sent to pharmacy ______ (initials)

Printed physician name RN Name

Date/Time

Sources: [1] Beckles D. 2019. CHF Solutions’ Sponsored AATS Theatre Session, “Personalized Medicine: Improving Clinical Outcomes with Novel Fluid Management Strategies. www.chf-solutions.com. [2]Raffini L. Anticoagulation with VADs and ECMO: walking the tightrope. Am Soc Hematology. 2017. 674-681.[3]Ziyaeifard M, Alizadehas A et al Heparinized and saline solutions in the maintenance of arterial and central venous catheters after cardiac surgery. Anesth Pain Med.2015.5(4);e28056. [4]Skagerlind MS & Stegmayr BG. An evaluation of four modes of low-dose anticoagulation during intermittent hemodialysis. Europ J of Clinical Pharm. 2018:74(3):267-274. [5]Peterangelo M. Incorporating Aquapheresis into the hospital setting: A practical approach. Prog Cardiovasc Nurs. 2008;23:168-172.

ULTRAFILTRATION ORDERS USING THE AQUADEX SMARTFLOWStanding Orders Template


Vendor Information

Legal Name: CHF Solutions, Inc

Address: 12988 Valley View Rd,

Eden Prairie, MN 55344

Tax ID: 68-0533453

Customer Service: 1-855-786-2778

To place an order:

• Email orders to: [email protected]

• Fax orders to: 952-500-8731

Remittance: Same as above

Payment method: Check/Credit Card/ACH

Electronic Funds Transfer:

Bank: JP Morgan Chase Bank, N.A.

Account: 878351183

ABA: 075000019

Terms: Net 30

Accounts Receivable Contact:

Chris Paulson

[email protected]

952-563-7039

Product Family: The Aquadex SmartFlow™ Product Line

Vendor Information

Aquadex FlexFlow® and Aquadex SmartFlow™ are trademarks of CHF Solutions, Inc.

20-2105-B

managing fluid overload in heart failure patients … · risk of hypokalemia (low potassium levels)...

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