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Blue Cross and Blue Shield of Montana (BCBSMT) considers the use of ultrafiltration experimental, investigational and unproven in patients with heart failure.
Note: This policy does not apply to patients with renal failure being treated using dialysis.
In evaluating ultrafiltration, the primary question is whether or not this intervention improves important health outcomes. While removal of fluid and sodium (and weight) is important, these are viewed as surrogate outcomes. Information will be needed about impact on survival, hospitalization, complications, and quality of life for this treatment compared to comparable groups receiving conventional treatment. Since this treatment does not directly affect cardiac function, the overall impact on outcomes is difficult to predict. The studies published to date are very limited, both in terms of study population and in duration of follow-up.
Bart and colleagues reported on a small randomized trial looking at safety and efficacy involving a total of 40 hospitalized patients with heart failure in which an 8-hour ultrafiltration session with usual care was compared to usual care alone. The primary endpoint was weight (fluid) loss after 24 hours. Weight loss was 2.5 kg in the experimental group and 1.86 kg in the usual care group (p=0.24); differences in fluid removal (4650 vs. 2838 ml) were statistically significant.
Costanza and colleagues reported results on use of ultrafiltration before diuretics in 20 patients with heart failure and diuretic resistance. They found both volume reduction and loss of weight. They also indicated that length of hospital stay was reduced.
Dahle and colleagues reported results in nine patients with acute decompensated heart failure. They used a “portable” machine with peripheral intravenous catheters that did not require dialysis or intensive care unit stay. The mean length of time for ultrafiltration was 33 hours with removal of a mean volume of 7.0 liters and mean weight loss of 6.2 kg.
The UNLOAD trial was a nonblinded trial that involved 200 patients hospitalized for heart failure and hypervolemia randomly assigned during the first 24 hours of hospitalization to ultrafiltration or usual care (diuretics). The study was conducted during one year at 28 U.S. centers. Primary efficacy endpoints were 48-hour weight loss and dyspnea score (1–7 Likert scale). Primary safety endpoints were changes in blood urea nitrogen, creatinine, and electrolyte levels throughout hospitalization and 90-day follow-up, and episodes of hypotension requiring therapeutic intervention at 48 hours. At least 13 secondary efficacy endpoints are also listed, including length of index hospitalization, quality of life assessments throughout follow-up, and resource utilization (re-hospitalization for heart failure, unscheduled office and emergency department visits) during follow-up. Results showed a weight loss of 5.0 versus 3.1 kg from baseline at 48 hours (p = 0.001) for the ultrafiltration and usual care groups, respectively, with no difference in dyspnea scores between treatment groups. There was no difference in the length of stay of the index hospitalization, but the ultrafiltration group had a smaller percentage of patients re-hospitalized for heart failure at 90 days (18% and 32%, p = 0.037). There were no differences between treatment groups for quality of life assessments and renal function, except that the diuretic group was more likely to have hypokalemia (p = 0.018). An additional subgroup analysis compared the outcomes of the ultrafiltration group versus standard intravenous diuretics by continuous infusion or bolus injection. Similar fluid loss was observed with ultrafiltration and continuous diuretic infusion, with similar outcomes to the original UNLOAD trial, that being fewer rehospitalizations for heart failure at 90 days only in patients who underwent ultrafiltration.
Detailed analysis of this study raises several methodological concerns that could influence study results. The publication provided insufficient detail of patient status during the study. The study reported that 20 patients died during the study (nine in the ultrafiltration group and 11 in the usual care group), but the timing of deaths was not reported. The study results, as reported, also raise concerns about dropout rates and patient follow-up for various outcome measures. For example, although 100 patients were randomized to each group, at 48 hours only 83, 80, and 69 patients in the ultrafiltration group and 84, 83, and 75 patients in the standard care group were reported in the assessment of the three primary outcomes (weight loss, dyspnea score, and change in serum creatinine, respectively). For readmission at 90 days, while the denominators are reported as 89 for the treatment group and 87 for the usual care group, information from the paper lists 45 and 41 patients at risk at 90 days. In addition, it is not clear from the methods that intention-to-treat analyses were performed; and, in spite of the many outcomes under study, there appears to be no statistical correction for multiple comparisons. Finally, neither participants nor investigators were blinded to treatment, which is a potential source of bias in outcomes such as re-hospitalizations, which are clinically based decisions. Given these concerns, the findings from this study must be viewed as preliminary and thus do not substantially contribute to our understanding of long-term clinical outcomes of ultrafiltration as a treatment for decompensated heart failure.
In a small sub-study from the UNLOAD trail, Rogers et al. evaluated the consequences of ultrafiltration and standard intravenous diuretic (furosemide) therapy on glomerular filtration rate (GFR) and renal plasma flow in patients with acute decompensated heart failure. In this study, patients hospitalized for acute decompensated heart failure with an ejection fraction less than 40% and two or more signs of hypervolemia were randomized to receive ultrafiltration or intravenous diuretics. Urine output, GFR (as measured by iothalamate), and renal plasma flow (as measured by para-aminohippurate) were assessed before fluid removal and after 48 hours. For the 19 of 25 randomized patients who completed the study (average age was 59 years, 68% were male), nine received ultrafiltration and 10 received intravenous diuretics. The change in GFR (-3.4 mL/min vs. -3.6 mL/min), renal plasma flow (26.6 mL/min vs. 16.1 mL/min), and filtration fraction (-6.9 mL/min vs. -3.9 mL/min) after treatment was not significantly different between the ultrafiltration and furosemide treatment groups, respectively, in this small sample. There was no significant difference in net 48-hour fluid removal between the groups (-3211 mL for ultrafiltration and -725 mL for furosemide, p = .682). Urine output during 48 hours was significantly greater in the furosemide group. The authors concluded that during a 48-hour period, ultrafiltration did not cause any significant differences in renal hemodynamics compared with the standard treatment of intravenous diuretics.
A study by Jaski et al. compared short- and long-term outcomes, results, and risk profiles from 100 consecutive patients with cardiovascular disorders and recognized pulmonary and systemic volume overload treated with a simplified ultrafiltration system with findings reported from the Acute Decompensated Heart Failure National Registry (ADHERE). Over a period of 43 months, 100 patients (76 men/24 women, 65 +/- 14.0 years of age, systolic dysfunction 64%) were treated with ultrafiltration at the discretion of the attending physician during 130 hospitalizations. By using ultrafiltration, 7.1 +/- 3.9 L of ultrafiltrate were removed during 2.0 +/- 1.2 treatments per hospitalization. In hospitalizations with a principal diagnosis of heart failure (n = 79), in-hospital mortality was 7.6% compared with an ADHERE estimated mortality of 7.5%. The authors concluded that this series extends the spectrum of patients previously reported to be treated with ultrafiltration. Despite marked volume overload, ultrafiltration-treated patients with a principal diagnosis of heart failure had inpatient outcomes similar to those of the ADHERE registry. However, conclusions regarding the efficacy of ultrafiltration in the volume-overloaded patients in this study are limited by comparison with database information rather than a contemporaneous control group. In addition, patient selection criterion for applying ultrafiltration was not pre- specified.
A study by Giglioli et al. from Italy compared hemodynamic parameters in 15 patients before and after slow continuous ultrafiltration (SCUF). Each patient was NYHA Class III or IV at the onset of treatment. Hemodynamic parameters were measured using a pressure recording analytical method (PRAM), described as a minimally invasive monitor in the radial artery. Also measured were reductions in weight, edema, dyspnea, response to diuretics and B-type natriuretic peptide (BNP) level. The authors were able to demonstrate a significant inverse relationship between volumes of fluid removed utilizing this SCUF method and clinical measures of weight (-7.4%, p < 0.01), edema and dyspnea, diuretic resistance, and plasma BNP levels (21,810 +/- 13,016 to 8,581 +/- 5,549, p <0.01). Secondary endpoints of hemodynamic measures utilizing PRAM monitor were observed to correlate positively in cardiac output, contractile cardiac efficiency, and reduced systemic vascular resistance. This study does not include a comparison to standard therapies. Given the small study size, the lack of a control group and the focus on the unique hemodynamic measures of PRAM, this study does not lead to a change in the policy statement.
In 2008, researchers in Italy published a case series on a wearable continuous ultrafiltration device on humans. Six subjects with volume overload were treated for six hours with this novel system. Fluid removal rate ranged from 116ml/hr to 288ml/hr, at an overall average blood flow rate at 116ml/min. Sodium removal averaged 151 mmol over the six hours. Each patient in the study maintained cardiovascular stability.
A search of peer-reviewed literature through May 2010 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy. The quality of the evidence to date remains limited. Ninety day readmission appears to be reduced in the ultrafiltration group in one study, but otherwise no studies to date address long-term mortality or morbidity, or quality of life outcomes. Clinical trials currently underway may provide information that the existing body of evidence does not possess.
Consensus statements give limited recommendations regarding the clinical value of ultrafiltration in the treatment of patients with heart failure. The European Society of Cardiology Task Force's guidelines on the diagnosis and treatment of acute heart failure stated that ultrafiltration should be considered to reduce fluid overload in selected patients and to correct hyponatremia in symptomatic patients who are refractory to diuretics. The guidelines noted, however, that the appropriate selection criteria for ultrafiltration have not been established. The 2009 American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Guidelines for the Diagnosis and Management of Heart Failure in Adults (under Recommendations for Hospitalized Patient) lists ultrafiltration as a Class IIa recommendation (benefit greater than risk, additional studies needed) and a Level of Evidence of B (conflicting evidence). The new recommendation states “Ultrafiltration is reasonable for patients with refractory congestion not responding to medical therapy.”
A search of peer reviewed literature through February 2012 identified no additional information that would change the coverage position of this medical policy.
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