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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
3 ©2020 CHF Solutions, Inc.
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
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MANAGING FLUID OVERLOAD IN HEART FAILURE PATIENTS USING ULTRAFILTRATION
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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.
6 ©2020 CHF Solutions, Inc.
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.
Managing Fluid Overload in Heart Failure Patients Using Ultrafiltration
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
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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.
Managing Fluid Overload in Heart Failure Patients Using Ultrafiltration
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
Managing Fluid Overload in Heart Failure Patients Using Ultrafiltration
[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
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9 ©2020 CHF Solutions, Inc.
Managing Fluid Overload in Heart Failure Patients Using Ultrafiltration
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
10 ©2020 CHF Solutions, Inc.
Managing Fluid Overload in Heart Failure Patients Using Ultrafiltration
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
11 ©2020 CHF Solutions, Inc.
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
Managing Fluid Overload in Heart Failure Patients Using Ultrafiltration
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
12 ©2020 CHF Solutions, Inc.
Managing Fluid Overload in Heart Failure Patients Using Ultrafiltration
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.
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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
14 ©2020 CHF Solutions, Inc.
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
15 ©2020 CHF Solutions, Inc.
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
16 ©2020 CHF Solutions, Inc.
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
17 ©2020 CHF Solutions, Inc.
Clinical References
Additional Reading on Role of Ultrafiltration in the Treatment of Heart Failure Patients
https://pubmed.ncbi.nlm.nih.gov/28494980/
https://pubmed.ncbi.nlm.nih.gov/16325040/
https://academic.oup.com/eurheartjsupp/article/7/suppl_B/B13/603537
https://pubmed.ncbi.nlm.nih.gov/29493059/
https://pubmed.ncbi.nlm.nih.gov/17291932/ https://pubmed.ncbi.nlm.nih.gov/30775944/
https://www.nejm.org/doi/full/10.1056/NEJMoa1005419
https://pubmed.ncbi.nlm.nih.gov/31163974/
18 ©2020 CHF Solutions, Inc.
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
19 ©2020 CHF Solutions, Inc.
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
20 ©2020 CHF Solutions, Inc.
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
21 ©2020 CHF Solutions, Inc.
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
22 ©2020 CHF Solutions, Inc.
© 2020 CHF Solutions, Inc. All Rights Reserved. 17-1019-B
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
© 2020 CHF Solutions, Inc. All Rights Reserved. 17-1019-B
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
23 ©2020 CHF Solutions, Inc.
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
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