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1 Aquapheresis and the Aquadex FlexFlow L0058 Rev. B 11/05.

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1 1 Aquapheresis and the Aquadex FlexFlow L0058 Rev. B 11/05

2 2 Contents Key Points What is Aquapheresis? How does it work? What is the Aquadex FlexFlow? Who are candidates for aquapheresis? Why use aquapheresis and the Aquadex FlexFlow? How to use aquapheresis and the Aquadex FlexFlow? Ultrafiltration/Aquapheresis clinical evidence and background

3 3 Key Points The Aquadex System is indicated for: Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. All treatments must be administered by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.

4 4 Key Points Aquapheresis is the trademarked name of CHF Solutions advanced and simplified form of ultrafiltration (UF) performed by the Aquadex FlexFlow and designed for fluid removal. Aquapheresis is used to describe the clinical treatment that offers safe, convenient, and predictable salt and water removal for patients with fluid overload. The Aquadex FlexFlow is the system that enables the delivery of that treatment. To minimize the chances of hypovolemic and hypotensive complications, the rate of fluid removal should not exceed the rate of a patients intravascular fluid refilling. Periodic monitoring of a patients systolic blood pressure can be used to determine how well these rates are currently matched.

5 5 Key Points In clinical trials, aquapheresis using the Aquadex FlexFlow: allowed rapid removal of extracellular and intravascular fluid volume excess, can be safely achieved via peripherally inserted ultrafiltration without the need for central venous catheter placement 1 And is associated with: no clinically significant impact on electrolyte balance, heart rate, blood pressure 1 greater fluid removal, weight loss and symptom relief compared to medical therapy alone 2 reductions in patient hospital length of stay and hospital readmissions 3 significant and sustainable reductions in patient weight, cardiac filling pressures and left atrial volume index as well as marked improvements in stroke volume and mitral regurgitant severity 4 1. Jaski, Journal of Cardiac Failure (3); Costanzo, J Am Coll Cardiol 2005;46: Bart, J Am Coll Cardiol 2005;46: Saltzberg, J Heart Lung Transpl, Feb 2005, Vol. 24, Issue 2 (Suppl.) S

6 6 Key Points The best sources of the latest information on aquapheresis and the Aquadex FlexFlow can be found in the following: Product label and instructions for use documents (e.g. Aquadex FlexFlow Users Guide, UF-500 blood set) Applicable and specific hospital Policy & Procedures and Standing Orders Aquadex FlexFlow onscreen help and alarm/alert information CHF Solutions website,

7 7 What is Aquapheresis? Aquapheresis safe, convenient, and predictable salt and water removal from patients with fluid overload as delivered by the Aquadex FlexFlow system.

8 8 How does Aquapheresis work? Aquapheresis with the Aquadex FlexFlow works by pulling a small amount of venous blood from the body (10-40 mL/min in increments of 5 mL/min), filtering out the excess salt and water ( mL/hour in increments of 10 mL/hour), and returning the filtered blood back to the patient.

9 9 What is the Aquadex FlexFlow?

10 10 Aquapheresis with the Aquadex FlexFlow Advanced form of ultrafiltration Inpatient or outpatient settings ICU, CCU, MICU, telemetry, stepdown, observation, ED, outpatient clinics Peripheral or central venous access Flexible access sites and catheters 1 to 1 monitoring not required No clinically significant impact on electrolyte balance, blood pressure or heart rate

11 11 What is the Aquadex FlexFlow? Aquadex FlexFlow console UF 500 blood circuit set Console cart

12 12 What is the Aquadex FlexFlow? Low blood flow: mL/min Low blood volume:33 mL Precise fluid removal rates: mL/hour Quick and easy device setup (less than 10 minutes) Highly automated operation, nursing oversight is minimized

13 13 What is the Aquadex FlexFlow? On/Off key Power lights Alarm Mute key Alarm/Alert lights RUN key Accept key Clear key Help key UF Rate key Blood Flow key Contrast key MANUAL key STOP key Menu key mmHg key Screen Arrow Up/Down key Datakey receptacle

14 14 What is the Aquadex FlexFlow? Blood pump cartridge UF pump cartridge UF collection bag UF bag drain Data key Withdrawal line Access ports Infusion line Pressure sensors Blood filter Priming adaptor

15 15 Who are candidates for Aquapheresis? Volume Overloaded: As evidenced by two or more of the following - Peripheral edema (e.g.>2+) 1,2,3 - Ascites 2,3 - Pulmonary rales, paroxysmal nocturnal dyspnea PND), or orthopnea 2,3 - Jugular venous distention (e.g.>7 cm ) 2,3 - Significantly above dry weight (e.g. 10+ lbs ) 8 AND

16 16 Inadequate Diuretic and/or Natriuretic Response (as a subset of patients with volume overload): As evidenced by two or more of the following: - High daily diuretic doses (e.g. furosemide > 80 mg, torsemide > 40 mg, and bumetamide > 2 mg ) 2 - Low urine volume (e.g. < 1,000 ml in 24 hours ) 4 - Elevated serum creatinine 2,5 - Increasing serum creatinine on standard therapy 6,7 AND Who are candidates for Aquapheresis?

17 17 Special Considerations Should Be Given If Any Of The Following Are Present: - Need for renal replacement therapy 2 - Unstable hemodynamic condition 1,2,3 - Documented hypercoagulable state 2 - Hemoconcentrated (e.g. Hct > 53% ) 1,2,3 Who are candidates for Aquapheresis? 1.Jaski, Journal of Cardiac Failure (3); Costanzo, J Am Coll Cardiol 2005;46: Bart, J Am Coll Cardiol 2005;46: Gottlieb, JACC 2000;35(1): Gottlieb, JCF 2002;8 (3): Butler, Am Heart J 2004; 147: Akhter, Am J Cardiol 2004; 94: % of admitted patients lose less than 10 lbs over course of standard therapy, Q ADHERE Registry National Benchmark Report, Scios Inc

18 18 Who are candidates for Aquapheresis?

19 19 Why should Aquapheresis be used? Current options not performing as they NEED to Current options not performing as they NEED to Current options are not achieving the standard of care Current options are not achieving the standard of care Current options have undesirable clinical impacts Current options have undesirable clinical impacts

20 20 89% of patients present with difficulty breathing (dypsnea, i.e. fluid in lungs) Average duration of IV loop diuretic treatment = 2.9 days IV heart failure medications include … ADHERE Registry Quarter Benchmark Report (AD001444) Not performing as they NEED to

21 21 ADHERE: Inpatient IV Medications Acute Heart Failure All Enrolled Discharges over 12 months n=52,047 Not performing as they NEED to

22 22 Not performing as they NEED to 43% of patients are improved but still symptomatic at time of discharge This number has been increasing each quarter by 1% since Q ADHERE Registry Quarter Benchmark Report (AD001444)

23 23 Not performing as they NEED to 75% of patients are discharged with 10 lbs or less change in weight from admission. This number is unchanged for over 2 years. ADHERE Registry Quarter Benchmark Report (AD001444)

24 24 Current options are not achieving the standard of care In general, patients should not be discharged from the hospital until a stable and effective diuretic regimen is established, and ideally, not until euvolemia is achieved. Patients who are sent home before these goals are reached are at high risk of recurrence of fluid retention and early readmission because unresolved edema may itself attenuate the response to diuretics. In general, patients should not be discharged from the hospital until a stable and effective diuretic regimen is established, and ideally, not until euvolemia is achieved. Patients who are sent home before these goals are reached are at high risk of recurrence of fluid retention and early readmission because unresolved edema may itself attenuate the response to diuretics. -- Hunt et. al. Management of Fluid Status, ACC/AHA Guidelines for the Evaluation and Management of Chronic Heart Failure in the Adult, © 2001 by the American College of Cardiology and the American Heart Association, Inc. (http://www.acc.org/clinical/guidelines/failure/hf_index.htm,

25 25 Current options are not achieving the standard of care Appropriate use of diuretics is a key element in the success of other drugs used for the treatment of HF. The use of inappropriately low doses of diuretics will cause fluid retention, which can diminish the response to ACE inhibitors and increase the risk of treatment with beta-blockers. Conversely, the use of inappropriately high doses of diuretics will lead to volume contraction, which can increase the risk of hypotension with ACE inhibitors and vasodilators and the risk of renal insufficiency with ACE inhibitors and angiotensin II receptor antagonists. Optimal use of diuretics is the cornerstone of any successful approach to the treatment of HF. Appropriate use of diuretics is a key element in the success of other drugs used for the treatment of HF. The use of inappropriately low doses of diuretics will cause fluid retention, which can diminish the response to ACE inhibitors and increase the risk of treatment with beta-blockers. Conversely, the use of inappropriately high doses of diuretics will lead to volume contraction, which can increase the risk of hypotension with ACE inhibitors and vasodilators and the risk of renal insufficiency with ACE inhibitors and angiotensin II receptor antagonists. Optimal use of diuretics is the cornerstone of any successful approach to the treatment of HF. -- Hunt et. al. Management of Fluid Status, ACC/AHA Guidelines for the Evaluation and Management of Chronic Heart Failure in the Adult, © 2001 by the American College of Cardiology and the American Heart Association, Inc. (http://www.acc.org/clinical/guidelines/failure/hf_index.htm,

26 26 Current options are not achieving the standard of care … ultrafiltration or hemofiltration may be needed to achieve adequate control of fluid retention. The use of such mechanical methods of fluid removal can produce meaningful clinical benefits in patients with diuretic-resistant HF and may restore responsiveness to conventional doses of loop diuretics. … ultrafiltration or hemofiltration may be needed to achieve adequate control of fluid retention. The use of such mechanical methods of fluid removal can produce meaningful clinical benefits in patients with diuretic-resistant HF and may restore responsiveness to conventional doses of loop diuretics. -- Hunt et. al. Management of Fluid Status, ACC/AHA Guidelines for the Evaluation and Management of Chronic Heart Failure in the Adult, © 2001 by the American College of Cardiology and the American Heart Association, Inc. (http://www.acc.org/clinical/guidelines/failure/hf_index.htm,

27 27 The Good about diuretics – –Induce hypotonic urine, reduce total body volume in majority of patients 8 The Bad about diuretics – –Direct Activation of renin-aldosterone (RAA) system 7,14 – –Enhanced Myocardial Aldosterone uptake 16 – –Loss of K, Mg, Ca, secondary myocyte Ca loading 16 – –Indirect Reduction of Cardiac Output 14,15 – –Increased Total Systemic Vascular Resistance 15 – –Reduced Natriuresis 12 – –Reduction of GFR 11,13 The Ugly about diuretics – –Associated with enhanced morbidity 6 – –Associated with increased mortality 6,9,10 Diuretics are inefficient in reduction of edema and effective in reduction of symptomatic congestion 5 5. Q National Benchmark Report, Scios Inc.6. Emerman, JCF 2004;10(4):S116: Bayliss, Br Heart J 1987;57: Faris, Int J Cardiol. 2002;82(2): Mehta, JAMA 2002;288(20): Butler, Am Heart J 2004; 147: Gottlieb, JACC, 2000;35(1): Brater DC. N Engl J Med. 1998;339: Firth et al Lancet 5/7/ Francis AIM 1985;103: Ribboli Am J Physiol Sep;267(3 Pt 2):H McCurley, JACC 2004;44(6): Current options have undesirable clinical impacts

28 28 Braking PhenomenonBraking Phenomenon – –A decrease in response to a diuretic after the first dose has been administered Long-term ToleranceLong-term Tolerance – –Tubular hypertrophy to compensate for salt loss Brater DC. N Engl J Med. 1998;339:387 Current options have undesirable clinical impacts

29 29 Diuretics Worsen CHF by Reducing GFR and Activating Neurohormones Gottlieb SS et al. Circulation. 2002;105:1348–1353 (n=63) Gottlieb showed that loop diuretics diminish GFR In patients with heart failure Bayliss showed that the significant increase in renin and aldosterone occurred as a response to diuretic treatment rather than as a result of the disease process itself

30 30 The High Morbidity and Mortality in CHF Is Strongly Related to Renal Function Total of 1906 patients NYHA Class III (n = 1138) III/IV (n = 607) IV (n =161) GFRc = Uses Cockroft- Gault Eqn Impaired renal function is a strong predictor of mortality Relationship of GFRc with Mortality in 1,906 Pts. With CHF Hillege HL et al. Circulation 2000; 102:

31 31 Diuretic Dose Predicts Mortality in Pts. With Advanced HF Neuberg did sub-analysis of PRAISE study (n=1153) High diuretic, low ACE-I dose High mortality Philbin studied 1,150 patients with decompensated CHF treated in community setting High mortality in patient having less rapid clearance of volume excess despite greater use of IV diuretics. Philbin, et al. AJC 1997; 80: Neuberg GW et al. AHJ 2002; 144: 31-8.

32 32 Why Aquapheresis instead of CVVH? CVVH devices designed to offer several modes of Continuous Renal Replacement Therapy (CRRT) in ICU settings to patients with acute renal failure. Aquadex FlexFlow device designed to offer solely fluid removal by aquapheresis in many settings to patients with fluid overload.

33 33 CRRT (Continuous Renal Replacement Therapy) is an umbrella term that incorporates several common modes of therapy. All modes remove plasma water, but most remove other solutes as well. All modes use the technique of convection, diffusion or a combination of both. Why Aquapheresis instead of CVVH?

34 34 Convection - can be thought of as water as it passes over a waterfall. A slow gentle waterfall will not pull many solutes with it as compared to a rushing waterfall that will drag large amounts of solutes as it flows over the waterfall Diffusion - solutes move from an area of high concentration to an area of low solute concentration Why Aquapheresis instead of CVVH?

35 35 Common modes of CRRT Slow Continuous Ultrafiltration (SCUF) Used to remove fluid: not able to remove many solutes and/or urea. Utilizes convection Continuous Venovenous Hemofiltration (CVVH) Removes fluids, small to medium solutes and some urea Utilizes convection Continuous Venovenous Hemodialysis (CVVHD) Continuous slow dialysis, medium and large solutes removed Utilizes diffusion Continuous Venovenous Hemodiafiltration (CVVHDF) Removes small and medium solutes, clears urea Utilizes both convection and diffusion

36 36 Why Aquapheresis instead of CVVH? AquapheresisCVVH Patient Fluid overload Renal complications Primary Physician Cardiologist, Nephrologist, Surgeon, etc. Nephrologist Treatment Venue Inpatient/OutpatientICU Blood Withdrawal Rates 10 – 40 mL/min. 100 – 300 mL/min. Extracorporeal Volumes 33 mL 100 – 300 mL Access Peripheral or Central Central only

37 37 We do a lot of CVVH. But if we just need to take some fluid off, aquapheresis with the Aquadex FlexFlow is simply easier and cheaper. Thats why we prefer it in those patients with fluid overload. -- Todd Y., MS, CNS, CNP, Clinical Nurse Specialist, Cardiology Why Aquapheresis instead of CVVH?

38 38 How to Use Aquapheresis and the Aquadex FlexFlow

39 39 Responsibilities Physician Identifies appropriate patient(s) according to accepted criteria (refer to Patient Selection / Identification) Completes Standing Orders for Ultrafiltration / Aquapheresis Establishes / coordinates venous access site, catheter, and insertion (refer to Choosing Venous Access) Defines quantity of total fluid to be removed (in liters) and/or total duration of treatment (in hours) Defines initial fluid removal rate Defines / details / clarifies criteria for adjusting fluid removal rate and/or blood flow Prescribes and communicates anticoagulation plan Establishes fluid restriction

40 40 Responsibilities Nurse Treatment Set Up Begin per physicians orders Basic Monitoring Enforce and record intake and output (I & Os). Monitor patient as appropriate. If necessary, adjust the fluid removal rate as prescribed. Listen for possible alarms and respond as necessary. Perform basic troubleshooting to assure proper functioning. Assess venous access sites periodically. If required, titrate anticoagulation as ordered. Confirm patient at physician prescribed amount of fluid removed or duration of therapy. Disconnect patient from the device. Care or dispose of blood set and catheters according to institutional policy. Routine console cleaning.

41 41 Loading and setup Prior to use, the UF-500 blood set must be properly installed and connected to the Aquadex FlexFlow console. This can be achieved by the several different methods listed below: Aquadex FlexFlow Users Guide instructions (Chapter 2) One page Aquadex FlexFlow Instructions for Setup and Priming document Interactive, step by step onscreen instructions (e.g. press PRIME then Help key) Graphic step by step instructions on UF-500 blood set label

42 42 Priming Before starting PRIME, ensure that… both of the UF-500 blood set pump cartridges are fully and properly inserted all three of the pressure sensors are inserted tubing is properly inserted into the air and blood leak sensors new datakey provided with the new UF-500 blood set is inserted withdrawal line is spiked into priming solution bag and is hanging from the cart hook clear infusion line is connected to the collection bag and its hanging from the weight scale hook all clamps are open Press PRIME then ACCEPT key to begin.

43 43 Displaying the pressures The pressures in the Aquadex FlexFlow blood circuit set (UF-500 blood set) may be displayed on the Aquadex FlexFlow screen by pressing the Graph or mmHg keys. The numbers displayed are in units of millimeters of mercury (mmHg) and represent the 3 individual pressures that are monitoring during treatment – withdrawal (Pw), infusion, (Pi) and ultrafiltrate (Pu).

44 44 Displaying the pressures Pw: measures the withdrawal pressure and is typically negative (-) and depending upon the chosen access, usually between -50 to -200 mmHg. Obtaining the lowest pressure is best (i.e. the smallest negative number), but Pw should also be below 0 mmHg to prevent a withdrawal disconnect alarm from occurring. Below -300 mmHg, the pumps may slow and a withdrawal occlusion alert may occur. Pi: the infusion pressure range is of the same order as the withdrawal pressure but positive (+), that is, usually between +50 to +200 mmHg. Below 0 mmHg, an infusion disconnect alarm may occur. Above +300 mmHg, the pumps may slow and an infusion occlusion alert may occur. Pu: can range from nearly Pis current value to -300 mmHg. Pu is limited to -300 mmHg by the Aquadex FlexFlow. A more negative Pu indicates that the resistance of the filter is higher than expected (e.g. if the filter is clotted/fouled).

45 45 Expected pressure ranges The pressures generated during operation is a function of blood flow rate, blood viscosity, and patient and catheter resistance. The Aquadex FlexFlow blood flow rate is adjustable by the user, but always between mL/min. Blood viscosity is a function of blood temperature and hematocrit (Hct). Patient resistance is a function of where the catheter is placed, a patients venous vasculature, and the patients body positioning. Catheter resistance is a function of the diameter and length of the selected catheter.

46 46 Understanding the pressures One way to think of this is using a straw in a milkshake analogy. How much milkshake you actually get out (blood flow rate) is dependent upon how thick the milkshake is (viscosity), where exactly is the straw in the glass (patient resistance), and what kind of straw youre using (catheter resistance). The thicker the milkshake or the longer and thinner the straw is, the more you will have to suck on the straw (withdrawal) to get the same amount of milkshake out, the higher the resistance is, the more negative the pressure will be in the straw. If you were blowing into the same straw to make bubbles (infusion), the higher resistance will make the pressure more positive.

47 47 How much? How fast? As with any mechanical method of extracorporeal fluid removal, the rate of fluid removed per hour from the intravascular space must not exceed the rate of fluid entering the intravascular space from the interstitial and intracellular spaces. Setting the appropriate fluid removal rate to not exceed this intravascular refilling is crucial to minimizing risk of hypovolemia, hypotension, transient renal malperfusion, increases in creatinine, arrhythmias

48 48 How much? How fast? rate of fluid removed from the intravascular space = UF rate (UFR) rate of fluid entering the intravascular space = Plasma Refill Rate (PRR) Therefore, UFR < PRR

49 49 How much? How fast? This can be most easily achieved with a periodic monitoring of the systolic blood pressure and setting specific limits that would warrant a reduction in the fluid removal rate (refer to the hospitals Aquapheresis Standing Orders) For example, Vital signs Q 15 minutes x 1 hour, Q for the remainder of treatment. If SBP 130 bpm after 2 consecutive 5 minute observation periods, decrease the fluid removal rate (UF Rate) by 100 mL/hr or place at 0 mL/hr for 30 minutes or until patient is stable. Then, resume UF rate 100 mL/hr lower than the level at which the patient became unstable.

50 50 Setting the Fluid Removal Rate (UF Rate) Using the UF Rate key,, users can set the fluid removal rate from 10 to 500 mL/hour in increments of 10 mL/hour. Default is 0 mL/min. Press the UF RATE key Press Arrow UP or DOWN keys to set a desired value. Press ACCEPT. With this feature, our users can set the fluid removal rate that is best for the chosen patient. F

51 51 How long? Most physicians prescribe a treatment length based on any of the following: Indication For Use Desired fluid goal being achieved Desired weight reduction goal being achieved Desired symptom relief goal being achieved Desired time goal being achieved Filter clotting Shifts in BP, sCr, etc.

52 52 Anticoagulation For maximal UF-500 blood set life, it is recommended that during treatment the patient have a therapeutic range of anticoagulation, that is, twice normal (e.g. an ACT of seconds). Refer to the appropriate institutional policy (i.e. weight based protocol) for recommended bolus and drip requirements and make sure that all parties involved understand what is expected and required.

53 53 Anticoagulation Common anticoagulants used with the Aquadex FlexFlow are heparin, lovenox, argatroban and coumadin. Many hospitals periodically take a blood sample and test what level of anticoagulation is being achieved in the patient during treatment (e.g. every 4 hours). Intravenous anticoagulation can be administered through either the withdrawal or infusion access ports on the UF-500 blood circuit set, but the withdrawal line access port is most common.

54 54 Anticoagulation If the withdrawal line access port is used with an infusion pump, occlusion alarms may occur if the infusion pumps occlusion pressure limits are not set appropriately. It is recommended that the occlusion limit for the infusion pump be set to at least 400 mmHg. Refer to the infusion pumps operators manual for instructions on setting its occlusion pressure limits.

55 55 Choosing Venous Access For optimal performance and minimal inconvenience, the Aquadex FlexFlow requires adequately sized catheter lumens and a steady flow of venous blood. If the required blood flow cannot be achieved without causing higher than normal pressures, the Aquadex FlexFlow may alert and interrupt treatment more often than desired.

56 56 Antecubital Vein Basilic Vein External Jugular VeinInternal Jugular Vein Femoral Vein Subclavian Vein Hand Vein Lower Arm Vein Possible Aquapheresis Venous Access Sites Central Peripheral

57 57 Choosing Venous Access It is imperative that the required blood flow set on the machine matches that which can be delivered using the chosen catheter / catheter lumen (i.e. catheter flow rating). For more information on choosing a catheter and setting the blood flow, press HELP from STOP mode and select the appropriate menu item. For a complete view of the most appropriate catheter and blood flow selection, refer to the latest version of the Aquadex Catheter Compatibility Guide.

58 58 Setting the Blood Flow Using the BLOOD FLOW key,, users can set the blood flow from 10 to 40 mL/min in increments of 5 mL/min. Default is 40 mL/min. Therefore, if users do not set blood flow to something, the console will operate just as it did before. Thats why its considered optional. Pressing the BLOOD FLOW key Press Arrow UP or DOWN key to set a desired value Press ACCEPT With this feature, our users can set the blood flow that is best for the chosen patient and the chosen venous access catheter.

59 59 Setting the Blood Flow Getting good venous access FIRST is still ESSENTIAL to successful therapy but, users can adjust blood flow to possibly reduce blood flow alarms and possibly use venous access sites and catheters not available before.

60 60 Troubleshooting The Aquadex FlexFlow displays helpful information and suggests remedies to correct alarms/alerts that it may experience during treatment. The usual troubleshooting procedure is: 1.Press the alarm mute key (mutes for 2 minutes). 2.Read and follow the instructions displayed. 3.When corrected, press the Clear key to clear screen and alarm to continue. 4.If further information is needed, refer to the Aquadex FlexFlow Users Guide and/or call customer service ( )

61 61 Ultrafiltration/Aquapheresis Clinical Evidence and Background

62 62 Clinical trials of Ultrafiltration in HF Study Name Study Type & Inclusion Criteria PtsConclusion(s) UNLOAD UNLOAD Randomized, multicenter, multiple substudies, aquapheresis vs. standard therapy (diuretics) 100 / 100 Enrollment complete, publications expected early 2006 Costanzo, J Am Coll Cardiol 2005;46: Prospective, case series, Early UF in Diuretic Resistant + CRS 19 Early treatment strategy with aquapheresis effectively and safely decreases length of stay and readmissions. Clinical benefits persist at 3 months after treatment. Bart, J Am Coll Cardiol 2005;46: Randomized, Early UF vs. Diuretics 40 Aquapheresis is effective, safe and can be applied in a variety of community-based hospitals. Cumulative fluid removal after is greater than that achieved by aggressive use of diuretics and is not associated with adverse hemodynamic or laboratory sequelae. Jaski B Current Heart Failure Reports 2005, 2:148–154. Review, summary of recent clinical work. -- Compared with diuretics, ultrafiltration provides a more predictable and safer way to achieve euvolemia with minimal electrolyte abnormalities and neurohormonal activation. The emerging familiarity and ease of use of ultrafiltration suggests that in the future this will be an important therapy for the treatment of acute and chronic volume overload associated with decompensated heart failure. Saltzberg, J Heart Lung Transpl, 2005, Vol. 24, Issue 2 Suppl S Prospective, case series, Early UF in Diuretic Resistant + CRS 10 Aquapheresis in acutely decompensated HF pts mediates significant and sustainable reductions in pt weight, cardiac filling pressures and LAVI as well as marked improvements in SV and MR severity. Sheppard, J Card Fail Oct;10(5):380-3 Retrospective, case series, FC III-IV, Intermittent outpatient UF 19 Our study suggests that UF is a safe, feasible therapy and has the potential for offering another important therapeutic option for patients with severe and refractory CHF

63 63 Clinical trials of Ultrafiltration in HF Study Name Study Type & Inclusion Criteria PtsConclusion(s) Saltzberg, J Card Failure Vol. 9 No. 5 Suppl S Prospective, case series, FC III-IV, Diuretic Resistant 25 1) Safely and effectively removes large volumes of excess fluid 2) Produces significant symptomatic and functional improvement 3) Reduces neurohormonal activation and 4) Reduces LOS by almost 2 days compared to that observed nationally in DHF patients receiving conventional heart failure treatment. Raman, Int J Artif Organs Aug;26(8):753-7 Randomized, case series, CV Surg 61/57 Hemofiltration during CPB attenuates postoperative anemia, thrombocytopenia and hypoalbuminemia, may reduce post-operative bleeding and appears to decrease post-operative pulmonary complications. Jaski, Journal of Cardiac Failure (3); Prospective, case series, FC III 21 Rapid removal of extracellular and intravascular fluid volume excess can be safely achieved via peripherally inserted ultrafiltration without the need for central venous catheter placement. Marenzi, J Am Coll Cardiol 2001;38:4: Prospective, case series, FC III 24 In patients with rCHF, subtraction of plasma water by UF is associated with hemodynamic improvement. Hypotension does not occur when plasma refilling rate is adequate to prevent hypovolemia Canaud, Nephrol Dial Transplant [Suppl 4]:51-55 [Suppl 4]:51-55 Prospective, Severe CHF, class IV 52 Veno-venous ultrafiltration has the potential to block the deleterious effects of the cardiac and renal interactions secondary to severe CHF. In a significant proportion of patients, it improves cardiac performance and a number of clinical parameters. Blake, Adv Ren Replace Ther Apr;3(2): Referenced summary of clinical work to date. -- UF relieves pulmonary edema, reduces ascites and peripheral edema, enhances the response to subsequent diuretic therapy, improves overall volume status, normalizes filling pressures, and reduces clinical symptoms, and offers an improvement in overall quality of life. Agostoni, Am J Med Mar;96(3):191-9 Randomized, UF vs. IV bolus Lasix 8/8 After ultrafiltration, the favorable circulatory and ventilatory adjustments consequent to the reabsorption of lung water improved the functional capacity of these patients. The improvement continued 3 months after the procedure

64 64 Clinical trials of Ultrafiltration in HF Study Name Study Type & Inclusion Criteria PtsConclusion(s) Pepi, Br Heart J Aug;70(2): Randomized, controlled FC II-III 12/12 In the ultrafiltration group, variations in the ventricular filling pattern, lung water content, and functional performance persisted for three months in all cases. None of these changes was detected in the control group. Agostoni, J Am Coll Cardiol Feb; 21(2): Randomized, controlled, FC II-III 18/18 In patients with moderate congestive heart failure, ultrafiltration reduces the severity of the syndrome. Marenzi,, Am J Med Jan;94 (1):49-56 Prospective, class II - IV 32 Refractory CHF requires the interruption of the humoral-hemodynamic vicious circle, and ultrafiltration is able to accomplish that. Susuni, Crit Care Med 1990; 18:14-18 Prospective, FC IV, diuretic resistant 20 UF may be considered an effective tool for the treatment of acute pulmonary edema refractory to drug therapy, as an alternative to mechanical ventilation, and as a remedy for excessive extravascular lung water. Rimondini, Am J Med Jul;83(1):43-8 Prospective, case series, FC IV, diuretic resistant 11 Hemofiltration promoted relief of dyspnea and of clinical and radiographic evidence of lung congestion and pleural effusion, and substantially reduced the dependent edema and abdominal girth Fauchald, Acta Med Scand. 1986;219(1):47-52 Prospective, case series, FC III-IV, diuretic resistant 6 Ultrafiltration is a safe method of fluid removal in patients with therapy-resistant cardiac edema and can be used as preparation for cardiac catheterization or surgery.

65 65 Clear, Beneficial Hemodynamic Effects of UF In CHF Marenzi et.al. 2001

66 66 Changes in Plasma Volume and Refilling Rate During UF Marenzi GC et al. JACC 2001; 38:

67 67 Aquapheresis and Aquadex FlexFlow Certification Program

68 Certificate of Completion is hereby granted to: for completing the Aquapheresis and Aquadex FlexFlow Certification Program CHF Solutions, Inc. Date Paul A. Sobotka, MD, Chief Medical Officer CHF Solutions, Inc.


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