IJCA-13553; No of Pages 4

International Journal of Cardiology xxx (2011) xxx–xxx

Contents lists available at ScienceDirect

International Journal of Cardiology
j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / i j c a r d

Review

Ultrafiltration for acute decompensated heart failure: Financial implications ☆
Amir Kazory a,⁎, Frank B. Bellamy b, Edward A. Ross a
a b

Division of Nephrology, Hypertension, and Renal Transplantation, University of Florida, Gainesville, FL, USA Department of Utilization Management, Shands at the University of Florida, Gainesville, FL, USA

a r t i c l e

i n f o

a b s t r a c t
Heart failure is the leading cause of hospitalization in older patients and is considered a public health problem with a significant financial burden on the health care system. Ultrafiltration represents an emerging therapy for patients with heart failure with a number of advantages over the conventional therapy. In this article, a summary of the relevant pathophysiological mechanisms such as removal of inflammatory cytokines are provided that might indeed be associated with a number of financial implications for ultrafiltration. Then practical points such as training of physicians and staff that need to be considered by physicians and medical centers with regards to financial implications of this therapy are reviewed. © 2011 Published by Elsevier Ireland Ltd.

Article history: Received 12 November 2010 Received in revised form 1 April 2011 Accepted 13 May 2011 Available online xxxx Keywords: Ultrafiltration Heart failure LOS DRG Financial

1. Background Heart failure (HF) is the leading cause of hospitalization in patients older than 65 years and is considered a significant financial burden on health care system [1]. Unfortunately, the current therapeutic options for acute decompensated heart failure (ADHF) remain limited with high-dose intravenous diuretics still being the most commonly used medications in this setting. These agents portend a number of serious complications such as worsening renal function, which in turn is known to significantly increase the mortality. Moreover, the efficiency of the current therapeutic strategies is questionable: one third of the patients leave the hospital with unresolved symptoms, and 16–20% of the patients even gain weight during the course of hospitalization [2]. In the absence of an ideal efficient therapeutic modality, extracorporeal ultrafiltration (UF) therapy using the novel portable devices has recently gained much attention as a promising option mainly in an attempt to avoid deleterious effects of diuretics. It has been suggested that early use of UF in this setting might also have additional beneficial effects such as lower rate of re-hospitalization as well as shorter length of stay (LOS). From a financial standpoint, UF represents by far one of the most expensive therapies currently available for refractory HF. While it has been hypothesized that lower rate of re-hospitalization could offset its costs at long term, there are

currently no studies to indicate a cost-saving impact for UF in patients with HF. Moreover, it is conceivable that the beneficial impact of UF therapy might in part depend on variables that are not yet identified such as the etiology of HF or the degree of right ventricular dysfunction and venous congestion. Here we present a number of financially relevant pathophysiological and practical characteristics of UF and discuss their potential implications. 2. Persistence of beneficial effects Several studies have consistently shown that the beneficial effects of UF could extend beyond the period of therapy. Agostoni et al. found that the respiratory parameters (e.g. tidal volume and pulse oxygen) were still improving up to 6 months after UF therapy [3]. In another study by Libetta et al., the anti-inflammatory cytokines decreased after therapy and remained low until one month later [4]. Although the exact mechanisms underlying this phenomenon are not well understood, a number of factors have been proposed. First, it has been shown that UF is more efficient in removal of fluid compared with diuretics [5]. Therefore, patients are more likely to leave the hospital with improved volume status (see later discussion). Moreover, the fluid produced by ultrafiltration (ultrafiltrate) is iso-osmolar and therefore it is capable of removing sodium more efficiently than the hypo-osmolar urine produced by diuretics. Since sodium is the main determinant of extracellular volume, it is then conceivable that relatively lower total body sodium content achieved by UF can help the decongested state persist for a longer period of time. Removal of anti-inflammatory cytokines and myocardial depressant factors by UF are among hypotheses proposed to explain persistence of its beneficial clinical effects on cardiac function. It is noteworthy as well

☆ No specific financial support was obtained for the preparation of this article. The authors have no potential conflicts of interest to declare with respect to this paper. ⁎ Corresponding author at: Division of Nephrology, Hypertension and Renal Transplantation, University of Florida, 1600 SW Archer Road, Gainesville, FL 32610–0224, USA. Tel.: +1 352 392 4007; fax: +1 352 392 3581. E-mail address: amir.kazory@medicine.ufl.edu (A. Kazory). 0167-5273/$ – see front matter © 2011 Published by Elsevier Ireland Ltd. doi:10.1016/j.ijcard.2011.05.073

Please cite this article as: Kazory A, et al, Ultrafiltration for acute decompensated heart failure: Financial implications , Int J Cardiol (2011), doi:10.1016/j.ijcard.2011.05.073

the subjective part is not as clear. Rate of re-hospitalization Interestingly. These studies have used new portable devices with a maximum UF rate of 500 ml/h. Moreover.g. trained physicians.ijcard. 6. The portable UF devices are intended for use by any physician who has received training in extracorporeal therapies.073 .g. the great majority of patients with ADHF are admitted because of congestion and fluid retention [2]. electrolyte abnormalities). the larger studies such as UNLOAD failed to report the number of patients that actually needed placement of a central venous access. the advances in the manufacture of the hemofilters and tubings over the past decades have made them more efficient.022) [9]. Currently this cost is surprisingly very high (up to 90 times more expensive compared to equivalent material used in renal replacement therapies). Patients with HF. similar to other wasting syndromes and chronic diseases. p = 0. will potentially help HF patients stay controlled and stable on their outpatient diuretic regimen after termination of UF therapy. in the UNLOAD trial. symptoms could be related to re-distribution of fluid rather than its accumulation [10].g. It is of note that in these studies. Nevertheless.9 days for nesiritide and usual care groups respectively). Therefore. Length of stay LOS in patients admitted for ADHF is directly related to disease course and “decongestion” which can be determined by two distinct groups of factors: objective relief of congestion (e. The expenses to achieve and maintain competency in performing these procedures would be expected to vary between countries. can result in impairment in plasma refill rate and susceptibility to complications related to acute contraction of intravascular volume. the UF group showed a trend towards an increase in the LOS compared to the other two groups (mean LOS 7. Besides. This phenomenon. and less costly. LOS remains higher in this group. and fluid overload. Moreover. as compared to diuretics. 6.8 days. UF-related complications) might also play a role. In a recent study by Bartone. Int J Cardiol (2011). UF was shown to be capable of reducing the number and length of subsequent hospitalizations over the 3 months following a single session of UF by more than 50% [9]. While the objective component of factors influencing the LOS (e. thus pointing to other not-well-known potential factors. It is important to note that in the UNLOAD trial the LOS for the first hospitalization was similar for patients receiving standard care and those who underwent UF therapy (5.e. poor cardiac output. Kazory et al. air embolus or hemolysis). the discrepancy between the subjective and objective findings in patients with ADHF who undergo UF is reflected in the reported LOS in these patients. which are similar to those associated with other extracorporeal therapies [12].1016/j. Not surprisingly.9. at 90 days.4 vs. It should be noted that in other studies the renal function was not reported to significantly deteriorate with the use of UF. 5. Training of physicians and staff Training of physicians and staff represents an overlooked financial aspect of UF in the field of cardiology. and material). Some studies could show overall improvement in patients' symptoms. / International Journal of Cardiology xxx (2011) xxx–xxx that a number of studies have reported on restoration of responsiveness to diuretics in patients undergoing UF [6]. the studies have so far failed to show this. the role of disposable materials in determining the cost of this therapy is more prominent. Patients in UF group showed a statistically significant increase in serum creatinine while the changes in the other two groups were not significant. standard care. Not surprisingly.979).g. and subjective feeling of improvement reported by the patients. a number of studies have consistently shown that UF. However. although these expenses are hard to quantify on a global basis due to variations in available technologies. potential catheter-related complications are not only associated with increased morbidity and mortality in these patients.g. while it was hoped that more rapid removal of fluid with UF would result in a faster improvement in patients' symptoms leading to a shorter LOS. more biocompatible.9]. the weight loss has been higher in UF group compared with patients who received intravenous diuretics. In contrast. Therefore. is capable of faster fluid removal and decreasing patient's weight without increasing the potential complications [8. This will mandate courses and workshops that will lead to additional costs associated with these therapies. improvement in pulmonary congestion or pedal edema) would therefore act favorably for UF. 3. Although these new sophisticated technologies are very simple to use.2011. This might indeed be related to the well-known effect of diuretics on pulmonary vasculature and venous return resulting in improvement in respiratory symptoms unrelated to diuresis and decongestion. Yet. equipment for placement. Surprisingly. but they can also significantly impact the Please cite this article as: Kazory A. The frequency for needing indwelling vascular access is of important because of their related cost (e. it has been suggested that in ADHF. 3. The authors hypothesized that lack of sufficient familiarity with this novel modality might have been a reason for the delay in discharging the patients.3 days. Therefore.g. UF. Ultrafiltration for acute decompensated heart failure: Financial implications . This. the LOS was similar in the standard care group and UF group on the first admission where UF was performed.2 A. These complications as well as their management strategies should ideally be incorporated in the training of the staff and physicians who intend to deliver such therapies. Therefore. the relief in symptoms after UF can conceivably be disproportionate to the amount of fluid removed. doi:10.2 and 4. deionizers) and sophisticated computerized dialysis devices comprise a more significant portion of the cost of extracorporeal strategies in this field. patients in the UF group were shown to have significantly fewer re-hospitalization days (1. other aspects of the therapy such as water treatment technology (i.11]. Interestingly. et al. 4. p = 0. and nesiritide were compared in patients with ADHF [11]. Disposable material Filters and tubing are another financial aspect of UF therapy in patients with HF that can significantly contribute to the increase in cost of this therapy. Other factors (e.8 vs. decrease in pulmonary rales) in the absence of potential complications (e. It is then expected that a therapeutic strategy with higher rate of fluid removal could potentially result in a faster improvement in signs and symptoms related to congestion and subsequently a shorter length of stay.2 days for UF compared with 6. In the field of renal replacement therapy. which in turn might be related to reduction in the inflammatory cytokines. brands and contracts. the devices used for isolated UF in HF would not need water treatment technology and are not yet available in various models and brands. there are problems that can arise from overzealous fluid removal as well as those associated with any blood-pumped extracorporeal therapy (e. We have previously discussed several serious potential complications of UF. HF patients generally tend to have compromised peripheral blood vessels due to their advanced age. their efficacy and safety would be optimized by a fully-trained staff. Only a few studies on the use of UF in ADHF have so far evaluated the impact of ultrafiltration on LOS [8.9]. In particular. as mentioned earlier. whereas others did not find any significant difference between diuretics and UF regarding their impact on patients' subjective feeling of improvement [8.05. frequently present with malnutrition–inflammation complex syndrome [7]. It is also possible that the more frequent and chronic use of this modality in the future could increase the need for more durable blood access with its related costs. and does not require the presence of trained nephrologists or dialysis nurses for its operation. while some studies with a limited number of patients have exclusively used peripheral venous catheters. in turn.

e. The practitioner needs to be acutely aware of complete and thorough documentation. Heart Fail Rev 2007. from Medicare and hospital payer perspectives. and relatively few pay per diem or by percent of charges. Bunte MC. However.g. These investigators found that there was a discordance in cost between payer perspective. Ali SS. Reduction in the length of stay as well as Need for extracorporeal machines and complications related to hospitalization disposable material (e.05. heparin-induced thrombocytopenia) fewer medications Need for training of physicians and staff Please cite this article as: Kazory A. UF had a high probability of being cost-saving (total cost estimates at 90 days: US $2820 for diuretics vs.12:91–5. in a study by Perencevich et al. The wide variation between countries and policies makes this difficult to quantify. It is imperative that financial analyses and literature reviews incorporate these wide ranges of expenses and scrutinize how long patients stay at any given level of care. Kazory et al. Int J Cardiol (2011).96:183–9. Facilities will have all their reimbursements (regardless of DRG) decreased by up to 3% if the 30-day HF readmission rate is higher than predicted [16].12:349–52. / International Journal of Cardiology xxx (2011) xxx–xxx 3 health care cost.e. Eur Heart J 2005.1016/j. The financial impact of care on different types of nursing units will be facility-specific and can vary widely. catheter-related bloodstream infection could increase the healthcare cost by more than US $18.000 in 2005 with an average excess LOS of 12 days per episode [13]. Management in different levels of care Contrary to traditional renal replacement therapy devices (i. and hospital payer perspectives. [4] Libetta C. Zucchi M. adopting conventional hemodialysis machines for UF allows use of inexpensive supplies but necessitates higher expenses for dialysis nurses and possibly a higher acuity bed [14]. Advantages Disadvantages The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology [17]. it is noteworthy that these calculations have been based on the use of a recently developed UF device as well as proprietary supplies. This is likely to significantly reduce the costs associated with this therapy. Reassessing treatment of acute heart failure syndromes: the ADHERE Registry. This study suggested that the payer perspective might be very important in formulating strategies and reimbursement structures to reduce HF hospitalizations. et al. The potential advantages and disadvantages of UF therapy for ADHF from a financial standpoint have been summarized in Table 1.2011.469). the cost of treatment will dramatically decrease (total cost estimates at 90 days for UF: US $11. and ICUs three to four times higher. Cardiology 2001. published the findings of their study on the cost-consequences of UF therapy for patients with ADHF [15]. since these dramatically affect the diagnosis coding and the ultimate reimbursement. If conventional devices and hemofilters routinely used by nephrologists for extracorporeal therapies are considered for UF therapy in patients with ADHF. Bradley et al. Epidemiology of acute heart failure syndromes. However. it is believed that the LOS savings will exceed the high price of those machine's disposable supplies. the broad “congestive heart failure” terminology as opposed to “acute systolic heart failure”). Nephrol Dial Transplant 2007. Olinger CC. Apart from the fixed (“indirect”) costs for administering and operating the hospital. The ability of newer portable UF devices to be performed outside the ICU presents a major advantage and cost savings. there are a number of considerations with regards to its financial aspects. They developed a decision model analysis to evaluate the clinical outcomes and associated costs of UF compared to diuretic therapy from societal. complications and co-morbidities can be fully captured for billing purposes.A. $13469 for UF). UF was very unlikely to result in cost savings from a societal perspective (total cost estimates at 90 days: US $11. The magnitude of those costs and the number of days a patient spends at different levels of care can determine whether UF programs are financially viable in a particular medical center. Physicians and medical centers interested in development of UF programs need to be fully aware of these implications to overcome the associated financial constraints. Intermittent haemodiafiltration in refractory congestive heart failure: BNP and balance of inflammatory cytokines. 7.610 for diuretics vs. Boyle AJ. bloodstream infections) Restoration of diuretic responsiveness Anticoagulation-related complications and better control of symptoms with (e. Ultrafiltration for acute decompensated heart failure: Financial implications . there is not even any need for an intermediate care setting. Reimbursement The overall costs of the HF patient's care.7(suppl B):B13–9. [3] Agostoni PG. Compared to a low-acuity medical ward. Similarly. 8. Each facility thus needs to assess the payor mix for this patient population in order to determine the financial implications of strategies that could reduce LOS or increase costs from services rendered. References [1] Alla F.g. Acknowledgement Table 1 Evaluation of ultrafiltration therapy for acute decompensated heart failure from a financial standpoint. Zannad F. Conclusion While UF has certainly the potential for tremendously changing the current care provided for patients with ADHF. however. $6157 for UF). For instance. Sepe V.22:2013–9. nosocomial infections) Reduction in the rate of re-hospitalization Complications related to extracorporeal therapies (e. continuous veno-venous hemofiltration and hemodialysis) that are mainly used in specialized settings such as intensive care unit or hemodialysis center. need to be put in the perspective of the reimbursement by the insurance company or governmental agency. and it would be likely for this modality to become financially comparable or even advantageous in this setting [14]. In 2009. Medicare. Marenzi GC. Sustained benefit from ultrafiltration in moderate congestive heart failure. [5] Dahle TG. whether traditional diuretics and inotropes or new UF techniques.ijcard. the facility must invest in mechanisms to meticulously extract from the chart documentation all the appropriate co-morbidities and severity of the HF (i. J Card Fail 2006. [2] Gheorghiade M. as we have previously discussed. which can be over US $900/day. 9. Large volume ultrafiltration for acute decompensated heart failure using standard peripheral intravenous catheters. Reportedly.g. especially in the background of longer LOS reported in some of the previous studies. air embolus) Reduction in the rate of unscheduled Need for placement of central venous clinic visits or emergency department catheter and possibility of catheteradmissions related complications (e. financial payment to the hospital can vary two to three-folds depending on whether the heart failure is associated with severe concurrent disorders. Filippatos G.. many nations have a reimbursement structure based on a single diagnosis-driven global payment (i.073 .e. intermediate care units can have twice the cost. the novel UF devices can be used on the normal hospital floor.g. Filippatos G. et al. despite a reduction in re-hospitalization rates. Further complicating financial analyses are new Medicare regulations that will be phased in between 2013 and 2015. the prospective diagnosis-related group [DRG] approach utilized in the US). so that the subtleties in clinical conditions. For example. Alternatively. Blake D. doi:10. the “direct” costs will depend on the actual expenses incurred by the services rendered.293 instead of 13.

Fonarow GC. Metra M. Saltzberg M. UNLOAD Trial Investigators. Am J Cardiol 2010.14: 298–301. Saghir S. Infect Control Hosp Epidemiol 2007. Saltzberg MT. Hemofiltration in heart failure. Wright SB. J Am Coll Cardiol 2005. Fluid overload in acute heart failure—re-distribution and other mechanisms beyond fluid accumulation. Raising standards while watching the bottom line: making a business case for infection control. Dittrich HC. Milo-Cotter O.2011. [10] Cotter G. Please cite this article as: Kazory A. Ross EA. [8] Costanzo MR. [16] Ross EA. [15] Bradley SM. doi:10. Horwich T.117:975–83.144:1–2. Reverse epidemiology of conventional cardiovascular risk factors in patients with chronic heart failure.43:1439–44.05. Sobotka P.ijcard.1016/j. Int J Cardiol 2010. and usual care in acute decompensated heart failure. Levy WC. Stone PW.46:2047–51. Carmeli Y. [14] Ross EA. reimbursement & financial impact. Kazory A. Int J Cardiol (2011).49:675–83. Cost-consequences of ultrafiltration for acute heart failure: a decision model analysis.10:165–9. [11] Bartone C. Circ Cardiovasc Qual Outcomes 2009. Eur J Heart Fail 2008. Block G.34:273–7. [6] Marenzi G. Guglin ME. J Am Coll Cardiol 2007.27: 1070–6. [9] Costanzo MR. [7] Kalantar-Zadeh K. et al. J Am Coll Cardiol 2004. Bellamy FB. Overcoming financial constraints of ultrafiltration for heart failure. nesiritide. Circulation 2008. Int J Artif Organs 2004. [13] Perencevich EN. Congest Heart Fail 2008. Early ultrafiltration in patients with decompensated heart failure and diuretic resistance. et al. Contemporary trends in the pharmacologic and extracorporeal management of heart failure: a nephrologic perspective. Kazory A. [17] Shewan LG. Ethics in the authorship and publishing of scientific articles.4 A. Gheorghiade M. Menon SG. Comparison of ultrafiltration. Ultrafiltration for acute decompensated heart failure: Cost. Clin Cardiol 2011. Veenstra DL. Ultrafiltration for acute decompensated heart failure: Financial implications .073 . Ultrafiltration versus intravenous diuretics for patients hospitalized for acute decompensated heart failure.2:566–73.105:1504–5. Society for Healthcare Epidemiology of America. Kazory et al. Fisman DN. Hawig S. / International Journal of Cardiology xxx (2011) xxx–xxx [12] Kazory A. Agostoni P. O'Sullivan J. et al. Coats AJ.28:1121–33.