IJCA-13553; No of Pages 4

International Journal of Cardiology xxx (2011) xxxxxx

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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

Ultraltration 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 signicant nancial burden on the health care system. Ultraltration 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 inammatory cytokines are provided that might indeed be associated with a number of nancial implications for ultraltration. Then practical points such as training of physicians and staff that need to be considered by physicians and medical centers with regards to nancial 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: Ultraltration 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 signicant nancial 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 signicantly increase the mortality. Moreover, the efciency of the current therapeutic strategies is questionable: one third of the patients leave the hospital with unresolved symptoms, and 1620% of the patients even gain weight during the course of hospitalization [2]. In the absence of an ideal efcient therapeutic modality, extracorporeal ultraltration (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 benecial effects such as lower rate of re-hospitalization as well as shorter length of stay (LOS). From a nancial 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 benecial impact of UF therapy might in part depend on variables that are not yet identied such as the etiology of HF or the degree of right ventricular dysfunction and venous congestion. Here we present a number of nancially relevant pathophysiological and practical characteristics of UF and discuss their potential implications. 2. Persistence of benecial effects Several studies have consistently shown that the benecial 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-inammatory 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 efcient in removal of uid compared with diuretics [5]. Therefore, patients are more likely to leave the hospital with improved volume status (see later discussion). Moreover, the uid produced by ultraltration (ultraltrate) is iso-osmolar and therefore it is capable of removing sodium more efciently 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-inammatory cytokines and myocardial depressant factors by UF are among hypotheses proposed to explain persistence of its benecial clinical effects on cardiac function. It is noteworthy as well

No specic nancial support was obtained for the preparation of this article. The authors have no potential conicts 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 326100224, USA. Tel.: +1 352 392 4007; fax: +1 352 392 3581. E-mail address: amir.kazory@medicine.u.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, Ultraltration for acute decompensated heart failure: Financial implications , Int J Cardiol (2011), doi:10.1016/j.ijcard.2011.05.073

A. Kazory et al. / International Journal of Cardiology xxx (2011) xxxxxx

that a number of studies have reported on restoration of responsiveness to diuretics in patients undergoing UF [6]. This phenomenon, which in turn might be related to reduction in the inammatory cytokines, will potentially help HF patients stay controlled and stable on their outpatient diuretic regimen after termination of UF therapy. 3. 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.g. decrease in pulmonary rales) in the absence of potential complications (e.g. electrolyte abnormalities), and subjective feeling of improvement reported by the patients. Not surprisingly, the great majority of patients with ADHF are admitted because of congestion and uid retention [2]. It is then expected that a therapeutic strategy with higher rate of uid removal could potentially result in a faster improvement in signs and symptoms related to congestion and subsequently a shorter length of stay. Patients with HF, similar to other wasting syndromes and chronic diseases, frequently present with malnutritioninammation complex syndrome [7]. This, in turn, can result in impairment in plasma rell rate and susceptibility to complications related to acute contraction of intravascular volume. Nevertheless, a number of studies have consistently shown that UF, as compared to diuretics, is capable of faster uid removal and decreasing patient's weight without increasing the potential complications [8,9]. While the objective component of factors inuencing the LOS (e.g. improvement in pulmonary congestion or pedal edema) would therefore act favorably for UF, the subjective part is not as clear. Some studies could show overall improvement in patients' symptoms, whereas others did not nd any signicant difference between diuretics and UF regarding their impact on patients' subjective feeling of improvement [8,9]. 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. Moreover, it has been suggested that in ADHF, symptoms could be related to re-distribution of uid rather than its accumulation [10]. Therefore, the relief in symptoms after UF can conceivably be disproportionate to the amount of uid removed. Not surprisingly, the discrepancy between the subjective and objective ndings in patients with ADHF who undergo UF is reected in the reported LOS in these patients. Only a few studies on the use of UF in ADHF have so far evaluated the impact of ultraltration on LOS [8,9,11]. These studies have used new portable devices with a maximum UF rate of 500 ml/h. It is of note that in these studies, the weight loss has been higher in UF group compared with patients who received intravenous diuretics. Yet, LOS remains higher in this group. Therefore, while it was hoped that more rapid removal of uid with UF would result in a faster improvement in patients' symptoms leading to a shorter LOS, the studies have so far failed to show this. It is important to note that in the UNLOAD trial the LOS for the rst hospitalization was similar for patients receiving standard care and those who underwent UF therapy (5.8 vs. 6.3 days, p = 0.979). However, at 90 days, patients in the UF group were shown to have signicantly fewer re-hospitalization days (1.4 vs. 3.8 days, p = 0.022) [9]. 4. Rate of re-hospitalization Interestingly, in the UNLOAD trial, 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]. Surprisingly, as mentioned earlier, the LOS was similar in the standard care group and UF group on the rst admission where UF was performed. The authors hypothesized that lack of sufcient familiarity with this novel modality might have been a reason for the delay in

discharging the patients. Other factors (e.g. UF-related complications) might also play a role. In a recent study by Bartone, UF, standard care, and nesiritide were compared in patients with ADHF [11]. Patients in UF group showed a statistically signicant increase in serum creatinine while the changes in the other two groups were not signicant. Interestingly, the UF group showed a trend towards an increase in the LOS compared to the other two groups (mean LOS 7.2 days for UF compared with 6.2 and 4.9 days for nesiritide and usual care groups respectively). It should be noted that in other studies the renal function was not reported to signicantly deteriorate with the use of UF, thus pointing to other not-well-known potential factors. 5. Disposable material Filters and tubing are another nancial aspect of UF therapy in patients with HF that can signicantly contribute to the increase in cost of this therapy. In the eld of renal replacement therapy, the advances in the manufacture of the hemolters and tubings over the past decades have made them more efcient, more biocompatible, and less costly. Therefore, other aspects of the therapy such as water treatment technology (i.e. deionizers) and sophisticated computerized dialysis devices comprise a more signicant portion of the cost of extracorporeal strategies in this eld. In contrast, the devices used for isolated UF in HF would not need water treatment technology and are not yet available in various models and brands. Therefore, the role of disposable materials in determining the cost of this therapy is more prominent. Currently this cost is surprisingly very high (up to 90 times more expensive compared to equivalent material used in renal replacement therapies), although these expenses are hard to quantify on a global basis due to variations in available technologies, brands and contracts. 6. Training of physicians and staff Training of physicians and staff represents an overlooked nancial aspect of UF in the eld of cardiology. The portable UF devices are intended for use by any physician who has received training in extracorporeal therapies, and does not require the presence of trained nephrologists or dialysis nurses for its operation. Although these new sophisticated technologies are very simple to use, their efcacy and safety would be optimized by a fully-trained staff. We have previously discussed several serious potential complications of UF, which are similar to those associated with other extracorporeal therapies [12]. In particular, there are problems that can arise from overzealous uid removal as well as those associated with any blood-pumped extracorporeal therapy (e.g. air embolus or hemolysis). 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. This will mandate courses and workshops that will lead to additional costs associated with these therapies. The expenses to achieve and maintain competency in performing these procedures would be expected to vary between countries. Moreover, while some studies with a limited number of patients have exclusively used peripheral venous catheters, the larger studies such as UNLOAD failed to report the number of patients that actually needed placement of a central venous access. HF patients generally tend to have compromised peripheral blood vessels due to their advanced age, poor cardiac output, and uid overload. The frequency for needing indwelling vascular access is of important because of their related cost (e.g. trained physicians, equipment for placement, and material). 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. Besides, potential catheter-related complications are not only associated with increased morbidity and mortality in these patients, but they can also signicantly impact the

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

A. Kazory et al. / International Journal of Cardiology xxx (2011) xxxxxx

health care cost. For instance, in a study by Perencevich et al., 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]. The potential advantages and disadvantages of UF therapy for ADHF from a nancial standpoint have been summarized in Table 1. 7. Management in different levels of care Contrary to traditional renal replacement therapy devices (i.e. continuous veno-venous hemoltration and hemodialysis) that are mainly used in specialized settings such as intensive care unit or hemodialysis center, the novel UF devices can be used on the normal hospital oor. Reportedly, there is not even any need for an intermediate care setting. This is likely to signicantly reduce the costs associated with this therapy, especially in the background of longer LOS reported in some of the previous studies. The nancial impact of care on different types of nursing units will be facility-specic and can vary widely. Apart from the xed (indirect) costs for administering and operating the hospital, the direct costs will depend on the actual expenses incurred by the services rendered. The magnitude of those costs and the number of days a patient spends at different levels of care can determine whether UF programs are nancially viable in a particular medical center. Compared to a low-acuity medical ward, intermediate care units can have twice the cost, and ICUs three to four times higher. It is imperative that nancial analyses and literature reviews incorporate these wide ranges of expenses and scrutinize how long patients stay at any given level of care. The ability of newer portable UF devices to be performed outside the ICU presents a major advantage and cost savings; it is believed that the LOS savings will exceed the high price of those machine's disposable supplies, which can be over US $900/day. Alternatively, as we have previously discussed, 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]. 8. Reimbursement The overall costs of the HF patient's care, whether traditional diuretics and inotropes or new UF techniques, need to be put in the perspective of the reimbursement by the insurance company or governmental agency. The wide variation between countries and policies makes this difcult to quantify; however, many nations have a reimbursement structure based on a single diagnosis-driven global payment (i.e. the prospective diagnosis-related group [DRG] approach utilized in the US), and relatively few pay per diem or by percent of charges. Each facility thus needs to assess the payor mix for this patient population in order to determine the nancial implications of

strategies that could reduce LOS or increase costs from services rendered. The practitioner needs to be acutely aware of complete and thorough documentation, so that the subtleties in clinical conditions, complications and co-morbidities can be fully captured for billing purposes. For example, nancial payment to the hospital can vary two to three-folds depending on whether the heart failure is associated with severe concurrent disorders. Similarly, the facility must invest in mechanisms to meticulously extract from the chart documentation all the appropriate co-morbidities and severity of the HF (i.e. the broad congestive heart failure terminology as opposed to acute systolic heart failure), since these dramatically affect the diagnosis coding and the ultimate reimbursement. In 2009, Bradley et al. published the ndings of their study on the cost-consequences of UF therapy for patients with ADHF [15]. They developed a decision model analysis to evaluate the clinical outcomes and associated costs of UF compared to diuretic therapy from societal, Medicare, and hospital payer perspectives. These investigators found that there was a discordance in cost between payer perspective; from Medicare and hospital payer perspectives, UF had a high probability of being cost-saving (total cost estimates at 90 days: US $2820 for diuretics vs. $6157 for UF). However, despite a reduction in re-hospitalization rates, UF was very unlikely to result in cost savings from a societal perspective (total cost estimates at 90 days: US $11,610 for diuretics vs. $13469 for UF). This study suggested that the payer perspective might be very important in formulating strategies and reimbursement structures to reduce HF hospitalizations. However, it is noteworthy that these calculations have been based on the use of a recently developed UF device as well as proprietary supplies. If conventional devices and hemolters routinely used by nephrologists for extracorporeal therapies are considered for UF therapy in patients with ADHF, the cost of treatment will dramatically decrease (total cost estimates at 90 days for UF: US $11,293 instead of 13,469), and it would be likely for this modality to become nancially comparable or even advantageous in this setting [14]. Further complicating nancial analyses are new Medicare regulations that will be phased in between 2013 and 2015. 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]. 9. Conclusion While UF has certainly the potential for tremendously changing the current care provided for patients with ADHF, there are a number of considerations with regards to its nancial aspects. Physicians and medical centers interested in development of UF programs need to be fully aware of these implications to overcome the associated nancial constraints. Acknowledgement

Table 1 Evaluation of ultraltration therapy for acute decompensated heart failure from a nancial standpoint. Advantages Disadvantages

The authors of this manuscript have certied that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology [17]. References
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Reduction in the length of stay as well as Need for extracorporeal machines and complications related to hospitalization disposable material (e.g. nosocomial infections) Reduction in the rate of re-hospitalization Complications related to extracorporeal therapies (e.g. 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.g. bloodstream infections) Restoration of diuretic responsiveness Anticoagulation-related complications and better control of symptoms with (e.g. heparin-induced thrombocytopenia) fewer medications Need for training of physicians and staff

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A. Kazory et al. / International Journal of Cardiology xxx (2011) xxxxxx [12] Kazory A, Ross EA. Contemporary trends in the pharmacologic and extracorporeal management of heart failure: a nephrologic perspective. Circulation 2008;117:97583. [13] Perencevich EN, Stone PW, Wright SB, Carmeli Y, Fisman DN. Society for Healthcare Epidemiology of America. Raising standards while watching the bottom line: making a business case for infection control. Infect Control Hosp Epidemiol 2007;28:112133. [14] Ross EA, Kazory A. Overcoming nancial constraints of ultraltration for heart failure. Am J Cardiol 2010;105:15045. [15] Bradley SM, Levy WC, Veenstra DL. Cost-consequences of ultraltration for acute heart failure: a decision model analysis. Circ Cardiovasc Qual Outcomes 2009;2:56673. [16] Ross EA, Bellamy FB, Hawig S, Kazory A. Ultraltration for acute decompensated heart failure: Cost, reimbursement & nancial impact. Clin Cardiol 2011;34:2737. [17] Shewan LG, Coats AJ. Ethics in the authorship and publishing of scientic articles. Int J Cardiol 2010;144:12.

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