mp-435 - Medical Policies - Alabama
Ultrafiltration in Decompensated Heart Failure
Policy Number: MP-435
This policy does not apply to patients with renal failure being treated using dialysis.
Latest Review Date: Effective July 1, 2021: Active policy but no longer scheduled for regular literature reviews or updates
Policy Grade: A
The use of ultrafiltration is considered investigational in patients with heart failure.
**Note - This policy does not apply to patients with renal failure being treated using dialysis.
DESCRIPTION OF PROCEDURE OR SERVICE:
Ultrafiltration is used to remove excess fluid from patients with volume overload and heart failure. It removes fluid from the blood by using pressure differentials with dialysis equipment or similar filtration devices.
Heart failure is a relatively common condition that frequently results in hospitalizations and readmissions.
Various treatment approaches are being explored, especially when the condition is refractory to conventional therapy. Ultrafiltration, also referred to as aquapheresis, is a technique being investigated for a possible role in hospitalized patients with marked volume overload from heart failure.
It has been suggested that ultrafiltration may offer greater and more expeditious volume and sodium removal than conventional therapies, particularly in patients with decompensated heart failure whose fluid overload is unresponsive to medical management.
Newer devices that allow continuous ultrafiltration in ambulatory patients are under investigation to reduce volume overload.
Heart failure is a condition with a variable natural history and multiple confounders of outcome. Clinical outcomes of interest in the treatment of heart failure include survival, hospitalization, complications, and quality of life; although removal of fluid and sodium, and weight loss, are important, they are surrogate outcomes that do not necessarily translate into clinical outcomes. Because ultrafiltration does not directly affect ventricular function, its effect on clinical outcomes is difficult to evaluate.
The most recent literature review is through February 11, 2021.
Summary of Evidence
For individuals who have decompensated heart failure who receive ultrafiltration, the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are overall survival, quality of life, hospitalizations, and treatment-related morbidity. A number of RCTs and meta-analyses of RCTs have been published. Meta-analyses did not find significant differences in all-cause mortality in patients receiving ultrafiltration or diuretics, and nearly all meta-analyses did not find significant between-group differences in rehospitalization rates. RCTs and meta-analysis found that patients undergoing ultrafiltration had significantly greater weight loss and more fluid removal than diuretic therapy. Although pooled analyses of RCTs did not find significant differences in adverse events in groups receiving ultrafiltration or diuretics, some RCTs (e.g., CARESS and, AVOID-HR) have reported higher rates of adverse events after ultrafiltration including significant worsening of renal function and treatment-related serious adverse events. The available trials have several methodologic limitations (e.g., unblinded outcome assessment, incomplete information on patient status). Moreover, long-term outcomes (i.e., >1 year) have not been reported. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.
Practice Guidelines and Position Statements
American College of Cardiology Foundation and American Heart Association
In 2013, the American College of Cardiology Foundation and American Heart Association published joint guidelines on the diagnosis and management of heart failure in adults (under Recommendations for Hospitalized Patient) lists ultrafiltration as a Class IIb recommendation (benefit greater than or equal to risk, additional studies needed). The recommendations stated ultrafiltration “may be considered for patients with obvious volume overload to alleviate congestive symptoms and fluid weight” (level of evidence B: conflicting evidence) and “for patients with refractory congestion not responding to medical therapy” (level of evidence C: recommendation less well established).
A 2017 update from the American College of Cardiology, the American heart Association Task Force on Clinical Practice Guidelines, and the Heart Failure Society of America did not mention ultrafiltration.
European Society of Cardiology and Heart Failure Association
In 2012, the European Society of Cardiology Heart Failure Association released joint guidelines on the diagnosis and treatment of acute heart failure stated that “ultrafiltration is sometimes used to remove fluid in patients with HF [heart failure], although is usually reserved for those unresponsive or resistant to diuretics.” In 2016, an update noted that "ultrafiltration is not recommended and should be confined to patients who fail to respond to diuretic-based strategies” was added.
Heart Failure Society of America
In 2010, the Heart Failure Society of America’s (HFSA) comprehensive heart failure practice Guidelines indicate ultrafiltration may be considered for the treatment of acute decompensated heart failure fluid overload in lieu of diuretics. (Level B evidence- cohort or smaller studies) The HFSA guidelines also indicate ultrafiltration may be considered when congestion continues despite diuretic therapy. (Level C evidence - opinion)
U.S. Preventive Services Task Force
Ultrafiltration, Aquapheresis, Aquadex, FlexFlow, CHF Solutions, Congestive Heart Failure, CHF
APPROVED BY GOVERNING BODIES:
In June 2002, the Aquadex FlexFlow™ System (Baxter, acquired by CHF Solutions in 2016) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. An amended 510(k) approval (classified as a high permeability dialysis system) was given in September 2007 following modifications. The FDA determined that this device was substantially equivalent to existing devices for use in temporary (≤8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and for extended (> 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
In 2020, the FDA approved the Aquadex FlexFlow® System 2.0 for a slightly modified use: “Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.”
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
There are no specific CPT codes for this procedure
- 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.
- 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):2043-6.
- Bart BA, Goldsmith SR, Lee KL et al. Ultrafiltration in decompensated heart failure with cardiorenal syndrome. N Engl J Med 2012; 367(24): 2296-304.
- Cheng Z, Wang L, Gu Y, et al. Efficacy and safety of ultrafiltration in decompensated heart failure patients with renal insufficiency. Int Heart J. May 13 2015; 56(3):319-323.
- Costanzo MR, Guglin ME, Saltzberg MT et al. Ultrafiltration versus intravenous diuretics for patients hospitalized for acute decompensated heart failure. J Am Coll Cardiol 2007; 49(6):675-683.
- Costanzo MR, Negoianu D, Jaski BE, et al. Aquapheresis versus intravenous diuretics and hospitalizations for heart failure. JACC Heart Fail. Feb 2016;4(2):95-105.
- Costanzo MR, Saltzberg J, O’Sullivan J et al. Early ultrafiltration in patients with decompensated heart failure and diuretic resistance. J Am Coll Cardiol 2005; 46(11):2052-3.
- 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. Apr 2010;16(4):277-284.
- Costanzo MR, Saltzberg MT, Jessup M et al. Ultrafiltration versus intravenous diuretics for patients hospitalized for acute decompensated heart failure (UNLOAD) investigators. 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.
- Dahle TG, Blake D, Ali SS et al. Large volume ultrafiltration for acute decompensated heart failure using standard peripheral intravenous catheters. J Card Fail 2006; 12(5):349-52.
- 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):131-46.
- Dev S, Shirolkar SC, Stevens SR et al. Reduction in body weight but worsening renal function with late ultrafiltration for treatment of acute decompensated heart failure. Cardiology 2012; 123(3):145-53.
- 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 Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008. Eur J Heart Fail 2008; 10(10):933-89.
- 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. Jan 27 2015; 0.
- 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. May 2015; 104(5):417-425.
- Giglioli C, Landi D, Cecchi E, et al. Effects of ULTRAfiltration vs. DIureticS on clinical, biohumoral and haemodynamic variables in patients with deCOmpensated heart failure: the ULTRADISCO study. Eur J Heart Fail. Mar 2011; 13(3):337-346.
- Giglioli C, Landi D, Gensini GF et al. Cardiac efficiency improvement after slow continuous ultrafiltration is assessed by beat-to-beat minimally invasive monitoring in congestive heart failure patients: a preliminary report. Blood Purif 2010; 29(1):44-51.
- Grodin JL, Carter S, Bart BA, et al. Direct comparison of ultrafiltration to pharmacological decongestion in heart failure: a per-protocol analysis of CARRESS-HF. Eur J Heart Fail. 2018 Jul;20(7):1148-1156.
- Gura V, Beizai M, EzonC, et al. Continuous renal replacement therapy for congestive heart failure: the wearable continuous ultrafiltration system. ASAIO J 2006; 52(1):59-61.
- Gura V, Ronco C, Nalesso F, et al. A wearable hemofilter for continuous ambulatory ultrafiltration. Kidney Int. Feb 2008; 73(4):497-502.
- 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.
- Heart Failure Society of America, Lindenfeld J, Albert NM et al. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail 2010; 16(6):e1-194.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- Jain A, Agrawal N, Kazory A. Defining the role of ultrafiltration therapy in acute heart failure: a systematic review and meta-analysis. Heart Fail Rev. Sep 2016;21(5):611-619.
- Jaski BE, Romeo A, Ortiz B et al. Outcomes of volume-overloaded cardiovascular patients treated with ultrafiltration. J Card Fail 2008; 14(6):515-20.
- Jessup M, Abraham W, Casey D et al. 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: developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation 2009; 119(14):1977-2016.
- Kwok CS, Wong CW, Rushton CA, et al. Ultrafiltration for acute decompensated cardiac failure: a systematic review and meta-analysis. Int J Cardiol. Feb 01 2017;228:122-128.
- 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.
- Lindenfeld J, Albert NM, Boehmer JP, et al. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail. Jun 2010; 16(6): e1-194.
- 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.
- McMurray JJ, Adamopoulos S, Anker SD et al. 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 European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J 2012; 33(14):1787-1847.
- Nakayama M. Nonuremic indication for peritoneal dialysis for refractory heart failure in cardiorenal syndrome type II: review and perspective. Peritoneal Dialysis International 2012; 33: 8-14.
- 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):1906-12.
- 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 Heart J. 2016 Jul 14;37(27):2129-2200.
- Rao VS, Ahmad T, Brisco-Bacik MA, et al. Renal effects of intensive volume removal in heart failure patients with preexisting worsening renal failure. Circ Heart Fail. 2019 Jun;12(6):e005552.
- 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.
- Ronco C, Nalesso F, Brendolan A et al. A wearable hemofilter for continuous ambulatory ultrafiltration. Kidney Int 2008; 73(4):497-502.
- U.S. Food and Drug Administration. Aquadex FlexFlow System 2.0 510(k) Summary. 2020. https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192756.pdf. Accessed April 25, 2021.
- Wankowicz Z, Prochnicka A et al. Extracorporeal versus peritoneal ultrafiltration in diuretic-resistant congestive heart failure – a review. Med Sci Monit 2011; 17(12): RA271-281.
- 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):365-73.
- Wobbe B, Wagner J, Szabo DK, et al. Ultrafiltration is better than diuretic therapy for volume overloaded acute heart failure patients: a meta-analysis. Heart Fail Rev. 2021 May; 26(3):577-585.
- Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2017 Aug 8;136(6):e137-e161.
- 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. J Am Coll Cardiol 2013; 62(16):e147-239.
- Zhi Q, Liang JC. Diuretics and ultrafiltration in acute heart failure syndrome. Int Heart J 2013; 54(6):390-4
Medical Policy Group, December 2006 (2)
Medical Policy Panel, June 2008
Medical Policy Panel, June 2010
Medical Policy Group, June 2010 (2)
Medical Policy Administration Committee, June 2010
Available for comment June 18-August 2, 2010
Medical Policy Group, January 2012 (3): Updated Key Points and References-added
Medical Policy Panel, June 2012
Medical Policy Group, July 2012 (4): Updated Key Points and References
Medical Policy Group, September 2013 (4): 2013 Update to Key Points and References
Medical Policy Group, October 2013 (4): Removed ICD-9 Procedure codes; no change to policy statement.
Medical Policy Panel, June 2014
Medical Policy Group, June 2014 (4): Updated Key Points and References. No change to the policy statement.
Medical Policy Group, January 2015 (3): Ad hoc request for literature review; References updated. No change in policy statement.
Medical Policy Panel, June 2015
Medical Policy Group, June 2015 (4): Updates to Key Points and References. No change in policy statement.
Medical Policy Group, May 2016 (4): Updates to Description, Key Points, Key Words and References. No change in policy statement.
Medical Policy Panel, May 2017
Medical Policy Group, May 2017 (4): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change in policy statement.
Medical Policy Panel, May 2018
Medical Policy Group, May 2018 (4): Updates to Description and Key Points. No change to policy statement.
Medical Policy Panel, May 2019
Medical Policy Group, May 2019 (4): Updates to Key Points and References. No change to policy statement.
Medical Policy Panel, May 2020
Medical Policy Group, May 2020 (4): Updates to Key Points, Practice Guidelines, Governing Bodies and References. No change to policy intent.
Medical Policy Panel, May 2021
Medical Policy Group, May 2021 (4): Updates to Key Points, Approved by Governing Bodies, and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.
Medical Policy Panel, June 2021
Medical Policy Group, July 2021 (4): Policy retired.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.