Medical Policy

 

Subject: Ultrafiltration in Decompensated Heart Failure
Document #: MED.00102 Publish Date:    06/06/2018
Status: Reviewed Last Review Date:    05/03/2018

Description/Scope

This document addresses ultrafiltration, (also referred to as aquapheresis), which describes a treatment of refractory congestive heart failure (CHF, also referred to as heart failure [HF]) that involves the removal of excess fluid. The technique utilizes pressure differentials during treatment with a dialysis machine or similar filtration device. Proponents suggest that this treatment may offer the potential for greater and more expeditious volume and sodium removal compared with conventional therapies for hospitalized individuals. Ultrafiltration is generally used for decompensated HF where fluid overload is unresponsive to conventional medical management with use of diuretics.

Position Statement

Investigational and Not Medically Necessary:

The use of ultrafiltration is considered investigational and not medically necessary for the treatment of heart failure.

Rationale

Ultrafiltration (UF) differs from dialysis in that it acts via convection rather than diffusion, which lowers the risk for induced metabolic abnormalities. Conventional UF devices required central venous access with a double lumen catheter, monitoring by a dialysis technician, and specialized hospital units. More recently, devices have been developed that allow UF to be carried out via large peripheral venous catheters (California Technology Assessment Forum, 2007) that potentially allow for continuous UF in ambulatory individuals. At the present time, UF techniques are performed primarily in hospitalized individuals or in facility-based ambulatory settings, such as specialized dialysis clinics.

Clinical studies of UF techniques on human subjects have been limited regarding the impact of this technology on survival, hospitalization, complication rates, and quality of life, compared to conventional treatment options. Studies of UF include small randomized trials (Bart, 2005; Bart, 2012; Costanzo, 2007; Costanzo, 2016; Rogers, 2008), case series (Costanzo, 2005; Dahle, 2006) and a retrospective case series (Jaski, 2008). Results of the UNLOAD trial (Ultrafiltration vs. Intravenous Loop Diuretics for Patients Hospitalized for Acute Decompensated Congestive Heart Failure) were published in 2007. A total of 200 individuals hospitalized for CHF at 28 sites were randomized to receive either UF or standard care. The primary endpoints included weight loss and dyspnea measured at 48 hours on a 7point Likert scale. While the UF group reported a 30-40% greater fluid and weight loss, there was no difference in dyspnea between the two groups at 48 hours. Among the secondary outcomes, quality of life and other functional assessments were also similar between the two groups. However, the rehospitalization rates were lower in the UF group (18% vs. 32%). Study design and methodologic concerns have been raised and call into question the validity of the results from the UNLOAD trial. There were discrepancies between the improvement in intermediate outcomes, such as weight loss, and the key reported outcomes, such as dyspnea scores and walking distance, which did not differ between the two groups. The reduction in hospital admissions in the UF group was unexpected and is not explained by the intermediate measures of HF severity. Additional limitations included lack of blinding for subjects, investigators, and staff. In addition, there was inadequate reporting of recruitment and follow-up. Only 83 of 100 individuals randomized to the UF group and 84 of 100 individuals randomized to the standard care group were included in measures of the primary outcomes. This high rate of incomplete data at 48 hours after randomization of inpatient cohorts was unexplained. In addition, only 72 of the 100 individuals receiving UF had failed prior diuretic therapies, which is the U.S. Food and Drug Administration (FDA) labeled indication for peripheral UF in CHF (Costanzo, 2007).

Post-hoc analysis of the UNLOAD trial results investigated the primary outcomes of individuals randomized to UF (n=100), which were compared with those treated with continuous (n=32) or bolus (n=68) IV diuretics. In this analysis, the two primary outcome measures (dyspnea scores and weight loss at 48 hours) were compared across the three groups. Dyspnea scores at 48 hours did not differ between the three groups (p=0.608). Pair-wise comparisons showed the weight loss to be similar in the UF and IV continuous diuretic infusion groups (5 ± 3.1 vs. 3.6 ± 3.5 kg; p=0.145) but greater in the UF than in the IV bolus diuretic group (5 ± 3.1 vs. 2.9 ± 3.5 kg; p=0.001), although similar between the continuous IV diuretic infusion and bolus IV diuretic groups (3.6 ± 3.5 kg vs. 2.9 ± 3.5 kg; p=0.358). At 90 days, a secondary outcome measure of “rehospitalization equivalents” (rehospitalization plus unscheduled visits for HF) were fewer in the UF group (0.65 vs. 2.29; p=0.016) than in the continuous diuretic infusion group and the bolus diuretic group (0.65 vs. 1.31; p=0.05) (Costanzo, 2010).

In 2010, an assessment of UF for HF was conducted by the Veterans Health Administration Technology Assessment Program in the United Kingdom (UK), which found no recently published evidence to materially change conclusions from a previous report by the Centre for Evidence-based Purchasing (CEP) of the UK National Health Services, that noted, “CEP finds that ultrafiltration has significant potential to become a routine therapy for excess fluid removal in patients with congestive heart failure. However, further work is needed to establish the patient groups who would benefit most” (Flynn, 2010).

Results of the Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure (ADHF) and Cardiorenal Syndrome (CARRESS-HF) trial were published in 2012, which was a large, multi-center study sponsored by the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) and Duke University, in collaboration with CHF Solutions®, Inc. The primary purpose of this trial was to investigate the safety and effectiveness of UF versus standard medical drug therapy in improving renal function and relieving fluid buildup in people hospitalized with ADHF and cardiorenal syndrome. Subjects with ADHF, worsening renal function, and persistent congestion were randomized to a strategy of stepped pharmacologic therapy (n=94) or UF (n=94). The primary endpoint was the bivariate change from baseline in the serum creatinine level and body weight, as assessed 96 hours after random assignment. Study subjects were followed for 60 days. The results showed that UF was inferior to pharmacologic therapy with respect to the bivariate endpoint of the change in the serum creatinine level and body weight at 96 hours after enrollment (p=0.003), owing primarily to an increase in the creatinine level in the UF group. At 96 hours, the mean change in the creatinine level was -0.04 ± 0.53 mg per deciliter (-3.5 ± 46.9 μmol per liter) in the pharmacologic-therapy group, as compared with +0.23 ± 0.70 mg per deciliter (20.3 ± 61.9 μmol per liter) in the UF group (p=0.003). There was no significant difference in weight loss at 96 hours after enrollment between subjects in the pharmacologic-therapy group and those in the UF group (a loss of 5.5 ± 5.1 kg [12.1 ± 11.3 lb] and 5.7 ± 3.9 kg [12.6 ± 8.5 lb], respectively; p=0.58). A higher percentage of subjects in the UF group than in the pharmacologic-therapy group had a serious adverse event (72% vs. 57%, p=0.03). The investigators concluded that the use of a stepped pharmacologic-therapy algorithm was superior to UF for the preservation of renal function at 96 hours, with similar amounts of weight loss for both approaches. UF was associated with a higher rate of adverse events (Bart, 2012; NCT00608491).

Results of a retrospective, single center review included 63 consecutive adult subjects with ADHF who were admitted to the Heart Failure Intensive Care Unit at the Cleveland Clinic from 2004 through 2009 and who required slow continuous ultrafiltration (SCUF) because of congestion that had been refractory to hemodynamically guided intensive medical therapy. The mean creatinine level was 1.9 ± 0.8 mg/dl on admission and 2.2 ± 0.9 mg/dl at SCUF initiation. After 48 hours of SCUF, there were significant improvements in hemodynamic variables (mean pulmonary arterial pressure: 40 ± 12 mm Hg vs. 33 ± 8 mm Hg, p=0.002; central venous pressure: 20 ± 6 mm Hg vs. 16 ± 8 mm Hg, p=0.007; mean pulmonary wedge pressure: 27 ± 8 mm Hg vs. 20 ± 7 mm Hg, p=0.02; Fick cardiac index: 2.2 l/min/m2 [interquartile range: 1.87 to 2.77 l/min/m2] vs. 2.6 l/min/m2 [interquartile range: 2.2 to 2.9 l/min/m2], p=0.0008); and weight loss (102 ± 25 kg vs. 99 ± 23 kg, p=0.0001). However, there were no significant improvements in serum creatinine levels (2.2 ± 0.9 mg/dl vs. 2.4 ± 1 mg/dl, p=0.12) and blood urea nitrogen (60 ± 30 mg/dl vs. 60 ± 28 mg/dl, p=0.97). Fifty-nine percent of study participants receiving SCUF required conversion to continuous hemodialysis during their hospital course and 14% were dependent on dialysis at hospital discharge. Thirty percent died during hospitalization, and 6 individuals were discharged to hospice care. The authors concluded that SCUF after admission for ADHF refractory to standard medical therapy was associated with high incidence of subsequent transition to renal replacement therapy and high in-hospital mortality, despite significant improvement in hemodynamics (Patarroyo, 2012).

Cheng and colleagues (2015) published a systematic review and meta-analysis of seven randomized controlled trials (RCTs) (total n=569 participants) that evaluated UF in decompensated HF with renal insufficiency. A pooled analysis of five of these trials did not find a significant difference between groups in all-cause mortality (odds ratio [OR] 0.95; 95% confidence interval [CI], 0.58 to 1.55; p=0.83). There was significantly more 48-hour weight loss (WMD 1.59, 95% CI, 0.32 to 2.86; p=0.01; I2=68%) and 48-hour fluid removal (WMD 1.23, 95% CI, 0.63 to 1.82; p<0.0001; I2=43%) in the UF group. Serum creatinine and serum creatinine changes were similar between the UF and control groups. All-cause mortality (OR 0.95, 95% CI, 0.58 to 1.55; p=0.83; I2=0.0%) and all-cause rehospitalization (OR 0.97, 95% CI, 0.49 to 1.92; p=0.94; I2=52%) were also similar between the UF and control groups. Adverse events, such as anemia, infection, hemorrhage, worsening HF, and other cardiac disorders did not differ significantly between the UF and control groups.

Siddiqui and colleagues (2017) performed a systematic review and meta-analysis to determine the role of ultrafiltration for individuals with ADHF. The authors analyzed nine RCTs (n=820) that compared UF (n=403) to conventional diuretics (n=417). The primary endpoints were cumulative heart failure readmissions, cumulative heart failure readmissions at 90 days, and cumulative all-cause admissions. Cumulative hospital readmissions secondary to heart failure were less in the UF group than the diuretic group (77 vs.111, risk ratio [RR] 0.71; 95% CI, 0.49 to 1.02; p=0.07). Likewise, at 90 days there were less readmissions in the UF group than the diuretic group (43 vs. 67, RR 0.65; 95% CI, 0.47 to 0.90; p=0.01). However, there were no differences between the UF group and the diuretic group for all-cause readmissions (56 vs. 58, RR 0.65; 95% CI, 0.18 to 2.38; p=0.52). Hypotension was more common in the UF group than the diuretic group (24 vs. 13, OR 2.06; 95% CI, 0.98 to 4.32; p=0.06). The cumulative mortality, length of hospital stay, and renal function between the two groups was similar. The study was limited by the heterogeneity of the RCTs. The authors concluded that ultrafiltration “remains a plausible treatment option” for ADHF and larger RCTs with extended follow-up are needed.

Kabach and colleagues (2017) performed a meta-analysis to compare UF to conventional diuretic therapy for ADHF. They used pooled data from nine RCTs (n=605) and compared UF to diuretics in a 1:1 ratio. They found that UF was associated with a reduced risk of clinical worsening (OR 0.57; 95% CI, 0.38 to 0.86; p=0.007) and better clinical decongestion (OR 2.32; 95% CI, 1.09 to 4.91; p=0.03). However, they did not find that UF improved the risk of re-hospitalization (OR 0.92; 95% CI, 0.62 to 1.38; p=0.70) or mortality (OR 0.99; 95% CI, 0.60 to 1.62; p=0.97). The authors noted that the study was limited by the heterogeneity of the RCTs. They concluded that although UF improves symptoms, “many questions concerning the indications of UF, as a unique decision-making tool in ADHF are still unanswered.”

A 2009 focused update from the American College of Cardiology Foundation (ACCF), American Heart Association (AHA) Task Force on Practice Guidelines has been incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults (Hunt, 2005). Within this focused update, the following recommendation was given a Class IIa, Level of Evidence: B – “Ultrafiltration is reasonable for patients with refractory congestion not responding to medical therapy” (Jessup, 2009). This recommendation was repeated in another 2009 update to the ACC/AHA Guidelines for the Diagnosis and Management of Heart Failure in Adults (Hunt, 2009). Additional excerpted comments from these documents are as follows:

If all diuretic strategies are unsuccessful, ultrafiltration or another renal replacement strategy may be reasonable. Ultrafiltration moves water and small- to medium-weight solutes across a semipermeable membrane to reduce volume overload. Because the electrolyte concentration is similar to plasma, relatively more sodium can be removed than by diuretics…Consultation with a kidney specialist may be appropriate before opting for any mechanical strategy to affect diuresis. (Hunt, 2009; Jessup, 2009).

An updated 2013 ACCF/AHA Guideline for the Management of Heart Failure downgraded its recommendations to Class IIb for UF as renal replacement therapy in hospitalized individuals based on the limited evidence demonstrating safety/efficacy as follows:

The European Society of Cardiology (ESC) Task Force guidelines developed with contribution from the Heart Failure Association (HFA) (Ponilowski, 2016) on the diagnosis and treatment of acute and chronic heart failure state the following:

There is no evidence favouring ultrafiltration over loop diuretics as first-line therapy in patients with AHF. At the present time, routine use of ultrafiltration is not recommended and should be confined to patients who fail to respond to diuretic-based strategies.

The Heart Failure Society of America's 2010 Comprehensive Heart Failure Practice Guideline states, “When individuals have acute decompensated HF and evidence of fluid overload, they should initially be treated with loop diuretics but that UF may be considered in lieu of diuretics” (strength of evidence 5 B [derived from cohort studies or smaller clinical trials, diverse in design and prospective or retrospective in nature]) (Lindenfeld, 2010).

At the present time, the published evidence is insufficient to support the safety and efficacy of UF (aquapheresis) techniques for the treatment of refractory ADHF, as compared to conventional treatment modalities. Although recent reviews and meta-analyses have shown favorable clinical results from use of UF in ADHF, most investigators concur that additional large, well-designed trials are needed to establish the role of UF in refractory ADHF (DeVecchis, 2014; Ebrahim, 2015; Kwong, 2014; Wen, 2013; Zhi, 2013).

Background/Overview

In June 2002, the Aquadex FlexFlow® System (CHF Solutions, Inc., Eden Prairie, MN) received clearance from the FDA through the 510(k) clearance process, as substantially equivalent to prior predicate devices that perform UF/aquapheresis techniques. The current FDA approved indications for use are as follows:

“All treatments must be administered by a health care provider, under physician prescription, both of whom having received training in extracorporeal therapies” (FDA, 2007). Newer models of the Aquadex FlexFlow System have also obtained 510(k) clearance from the FDA.

Definitions

Aquapheresis: The trademarked term for removal of salt and water with the Aquadex FlexFlow System which was classified by the FDA as a high permeability dialysis system.

Heart failure (HF; [also referred to as congestive heart failure {CHF}]): The term used for a clinical syndrome characterized by systemic perfusion that is inadequate to meet the body’s metabolic demands as a result of impaired cardiac pump function. The heart is unable to pump sufficient oxygenated blood to vital organs and there is congestion/pooling of blood in the extremities and lungs with resultant symptoms, such as dyspnea (shortness of breath).

New York Heart Association (NYHA) Definitions:
The NYHA classification of heart failure is a 4-tier system that categorizes based on subjective impression of the degree of functional compromise. The four NYHA functional classes are as follows:

Ultrafiltration (UF): A term for a technique that moves water and small-to-medium weight solutes across a semi-permeable membrane to reduce volume overload.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:

CPT

 

37799

Unlisted procedure, vascular surgery [when specified as ultrafiltration, aquapheresis]

 

 

ICD-10 Procedure

 

6A550Z3

Pheresis of plasma, single [when specified as ultrafiltration, aquapheresis]

 

 

ICD-10 Diagnosis

 

I09.81

Rheumatic heart failure

I11.0

Hypertensive heart disease with heart failure

I13.0

Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease

I13.2

Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease

I50.1-I50.9

Heart failure

I97.130-I97.131

Postprocedural heart failure

References

Peer Reviewed Publications:

  1. Badawy SS, Fahmy A. Efficacy and cardiovascular tolerability of continuous veno-venous hemodiafiltration in acute decompensated heart failure: a randomized comparative study. J Crit Care. 2012; 27(1):106 e7-13.
  2. Bart BA, Boyle A, Bank AJ, et al. Ultrafiltration vs. usual care for hospitalized patients with heart failure: the Relief for Acutely Fluid-Overloaded Patients with Decompensated Congestive Heart Failure (RAPID-CHF) trial. J Am Coll Cardiol. 2005; 46(11):2043-2046.
  3. Bart BA, Goldsmith SR, Lee KL, et al.; Heart Failure Clinical Research Network. Ultrafiltration in decompensated heart failure with cardiorenal syndrome. N Engl J Med. 2012; 367(24):2296-2304.
  4. Cheng Z, Wang L, Gu Y, et al. Efficacy and safety of ultrafiltration in decompensated heart failure patients with renal insufficiency. Int Heart J. 2015; 56(3):319-323.
  5. Costanzo MR, Guglin ME, Saltzberg MT, et al. Ultrafiltration versus intravenous diuretics for patients hospitalized for acute decompensated heart failure (UNLOAD). J Am Coll Cardiol. 2007; 49(6):675-683.
  6. Costanzo MR, Jessup M. Treatment of congestion in heart failure with diuretics and extracorporeal therapies: effects on symptoms, renal function, and prognosis. Heart Fail Rev. 2012; 17(2):313-324.
  7. Costanzo MR, Negoianu D, Jaski BE, et al. Aquapheresis versus intravenous diuretics and hospitalizations for heart failure. JACC Heart Fail. 2016; 4(2):95-105.
  8. Costanzo MR, Saltzberg MT, Jessup M, et al. Ultrafiltration is associated with fewer rehospitalizations than continuous diuretic infusion in patients with decompensated heart failure: results from UNLOAD. J Card Fail. 2010; 16(4):277-284.
  9. Costanzo MR, Saltzberg M, O’Sullivan, et al. Early ultrafiltration in patients with decompensated heart failure and diuretic resistance. J Am Coll Cardiol. 2005; 46(11):2047-2051.
  10. Dahle TG, Bladke D, Ali SS, et al. Large volume ultrafiltration for acute decompensated heart failure using standard peripheral intravenous catheters. J Card Fail. 2006; 12(5):349-352.
  11. Dahle TG, Sobotka PA, Boyle AJ. A practical guide for ultrafiltration in acute decompensated heart failure. Congest Heart Fail. 2008; 14(2):83-88.
  12. De Maria E, Pignatti F, Patrizi G, et al. Ultrafiltration for the treatment of diuretic-resistant, recurrent, acute decompensated heart failure: experience in a single center. J Cardiovasc Med (Hagerstown). 2010; 11(8):599-604.
  13. De Vecchis R, Esposito C, Ariano C. Efficacy and safety assessment of isolated ultrafiltration compared to intravenous diuretics for acutely decompensated heart failure: a systematic review with meta-analysis. Minerva Cardioangiol. 2014; 62(2):131-146.
  14. Ebrahim B, Sindhura K, Okoroh J, et al. Meta-analysis of ultrafiltration versus diuretics treatment option for overload volume reduction in patients with acute decompensated heart failure. Arq Bras Cardiol. 2015; 104(5):417-425.
  15. Giglioli C, Landi D, Cecchi E, et al. Effects of ULTRAfiltration vs. DIureticS on clinical, biohumoral and hemodynamic variables in patients with deCOmpensated heart failure: the ULTRADISCO study. Eur J Heart Fail. 2011; 13(3):337-346.
  16. Hanna MA, Tang WH, Teo BW, et al. Extracorporeal ultrafiltration vs. conventional diuretic therapy in advanced decompensated heart failure. Congest Heart Fail. 2012; 18(1):54-63.
  17. Jaski BE, Romeo A, Ortiz B, et al. Outcomes of volume-overloaded cardiovascular patients treated with ultrafiltration. J Card Fail. 2008; 14(6):515-520.
  18. Kabach M, Alkhawam H, Shah S, et al. Ultrafiltration versus intravenous loop diuretics in patients with acute decompensated heart failure: a meta-analysis of clinical trials. Acta Cardiol. 2017; 72(2):132-141.
  19. Kazory A, Ross EA. Ultrafiltration for decompensated heart failure: renal implications. Heart. 2009; 95(13):1047-1051.
  20. Kitai T, Grodin JL, Kim YH, Tang WH. Impact of ultrafiltration on serum sodium homeostasis and its clinical implication in patients with acute heart failure, congestion, and worsening renal function. Circ Heart Fail. 2017 Feb; 10(2):e003603.
  21. Kwong JS, Yu CM. Ultrafiltration for acute decompensated heart failure: a systematic review and meta-analysis of randomized controlled trials. Int J Cardiol. 2014; 172(2):395-402.
  22. Liang KV, Williams AW, Greene EL, Redfield MM. Acute decompensated heart failure and the cardiorenal syndrome. Crit Care Med. 2008; 36(1 Suppl):S75-88.
  23. Marenzi G, Muratori M, Cosentino ER et al. Continuous ultrafiltration for congestive heart failure: the CUORE trial. J Card Fail. 2014; 20(1):9-17.
  24. Mentz RJ, Stevens SR, DeVore AD, et al. Decongestion strategies and renin-angiotensin-aldosterone system activation in acute heart failure. JACC Heart Fail. 2015; 3(2):97-107.
  25. Patarroyo M, Wehbe E, Hanna M, et al. Cardiorenal outcomes after slow continuous ultrafiltration therapy in refractory patients with advanced decompensated heart failure. J Am Coll Cardiol. 2012; 60(19):1906-1912.
  26. Rogers HL, Marshall J, Bock J, et al. A randomized, controlled trial of the renal effects of ultrafiltration as compared to furosemide in patients with acute decompensated heart failure. J Card Fail. 2008; 14(1):1-5.
  27. Siddiqui WJ, Kohut AR, Hasni SF, et al. Readmission rate after ultrafiltration in acute decompensated heart failure: a systematic review and meta-analysis. Heart Fail Rev. 2017; (6):685-698.
  28. Wen H, Zhang Y, Zhu J, et al. Ultrafiltration versus intravenous diuretic therapy to treat acute heart failure: a systematic review. Am J Cardiovasc Drugs. 2013; 13(5):365-373.
  29. Wertman BM, Gura V, Schwarz ER. Ultrafiltration for the management of acute decompensated heart failure. J Card Fail. 2008; 14(9):754-759.
  30. Yancy CW. Climbing the mountain of acute decompensated heart failure: the EVEREST trials. JAMA. 2007; 297(12):1374-1376.
  31. Zhi Q, Liang JC. Diuretics and ultrafiltration in acute heart failure syndrome. Int Heart J. 2013; 54(6):390-394.

Government Agency, Medical Society, and other Authoritative Publications:

  1. Canadian Agency for Drugs and Technologies in Health (CADHT). Aquadex Flexflow for Patients with Congestive Heart Failure: Clinical and Cost-Effectiveness. March 31, 2011. Available at:  https://www.cadth.ca/aquadex-flexflow-patients-congestive-heart-failure-clinical-and-cost-effectiveness.  Accessed on March 26, 2018.
  2. Dickstein K, Cohen-Solal A, Filippatos G, et al; Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology (ESC). 2010 Focused update of ESC Guidelines on device therapy in heart failure. 2010. Eur J Heart Fail. 2010; 31:2677-2687.
  3. Flynn K. Brief overview: Ultrafiltration for decompensated heart failure. Boston, MA: Technology Assessment Program (VATAP), Office of Patient Care Services, Veterans Health Administration; January 2011.
  4. Hunt SA, Abraham WT, Chin MH, et al. 2009 Focused update incorporated into the ACC/AHA 2005 guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2009; 119:e391- e479. Available at: http://circ.ahajournals.org/content/119/14/e391.full.pdf. Accessed on March 26, 2018.
  5. Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Heart failure in adults. 13th edition. July 2013. Available at: https://www.icsi.org/guidelines__more/catalog_guidelines_and_more/catalog_guidelines/catalog_cardiovascular_guidelines/heart_failure/. Accessed on March 26, 2018.
  6. Jessup M, Abraham WT, Casey DE, et al. writing on behalf of the 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult Writing Committee. 2009 Focused update: ACCF/AHA guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2009; 119(14):1977-2016. Available at: http://content.onlinejacc.org/article.aspx?articleid=1139600. Accessed on March 26, 2018.
  7. Lindenfeld J, Albert NM, Boehmer JP, et al. Heart Failure Society of America (HFSA). 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail. 2010; 16:475-539.
  8. McMurray JJ, Adamopoulos S, Anker SD, et al. European Society of Cardiology (ESC). Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the ESC. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012; 33(14):1787-1847. Available at: http://www.escardio.org/static_file/Escardio/Guidelines/publications/HFGuidelines-Heart-Failure-Web-Tables.pdf. Accessed on March 26, 2018.
  9. National Heart Lung and Blood Institute (NHLBI) and Duke University. Effectiveness of ultrafiltration in treating people with acute decompensated heart failure and cardiorenal syndrome (The CARRESS Study). NLM Identifier: NCT00608491. Last updated on May 15, 2013. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00608491?term=NCT00608491&rank=1. Accessed on March 26, 2018.
  10. NxStage Medical Inc. Extracorporeal ultrafiltration (UF) vs. usual and customary care for patients with severe heart failure (HF). NLM Identifier: NCT00288587. Last updated on May 16, 2012. Available at: http://clinicaltrials.gov/show/NCT00288587. Accessed on March 26, 2018.
  11. Pan I, McGregor M. Efficacy, safety and cost of ultrafiltration for the management of acute decompensated heart failure. Report No 47. Montreal, QC: Technology Assessment Unit of the McGill University Health Centre (MUHC); May 31, 2010. Available at:  http://www.crd.york.ac.uk/CRDWeb/ShowRecord.asp?AccessionNumber=32010001378. Accessed on March 26, 2018.
  12. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC): Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016; 18(8):891-975.
  13. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Aquadex FlexFlow System Summary of Safety and Effectiveness. No. K062922. Rockville, MD: FDA. December 13, 2006. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062922.pdf. Accessed on March 26, 2018.
  14. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Aquadex FlexFlow System Summary of Safety and Effectiveness. No. K070512. Rockville, MD: FDA. April 27, 2007. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070512.pdf. Accessed on March 26, 2018.
  15. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circ. 2013;128:e240–e327.
Websites for Additional Information
  1. Clinical information about heart failure from the Cleveland Clinic Journal of Med. Available at: http://my.clevelandclinic.org/health/articles/heart-failure. Accessed on March 26, 2018.
Index

Aquadex FlexFlow System
Aquapheresis
Heart Failure
PRISMA Continuous Fluid Management System
Ultrafiltration

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed

05/03/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” The Rationale, References, and Websites sections updated.

Reviewed

05/04/2017

MPTAC review. The Rationale and References sections were updated.

Reviewed

05/05/2016

MPTAC review. The Rationale and References were updated. Removed ICD-9 codes from Coding section.

Reviewed

05/07/2015

MPTAC review. The Rationale and References were updated.

Reviewed

05/15/2014

MPTAC review. The Rationale, Definitions and References were updated.

Reviewed

05/09/2013

MPTAC review. The Rationale and References were updated.

Reviewed

05/10/2012

MPTAC review. The Rationale and References were updated.

Reviewed

05/19/2011

MPTAC review. Rationale, Background/Overview, References and Index updated.

Reviewed

05/13/2010

MPTAC review. The Rationale and References were updated.

New

05/21/2009

MPTAC review. Initial document development.