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INTRODUCTION: The objective of this study was to compare the clinical efficacy of two similar tissue bulking agents, Deflux and Vurdex, used for a treatment of vesicoureteral reflux (VUR) in our institution. MATERIAL AND METHODS: The case records of 104 children, treated endoscopically for primary VUR from January 2010 to January 2015, were retrospectively reviewed. Most of the patients were treated with Deflux until 2012, when use of Vurdex was started. Exclusion criteria were patients with secondary reflux due to neurogenic bladder, duplicated refluxing ureters, primarily operated patients and patients operated after first or second injection. RESULTS: Endoscopic treatment of vesicoureteral reflux using Deflux was performed in 65 children (106 ureters). There were 24 patients with unilateral and 41 patients with bilateral VUR. After first injection of Deflux success was achieved in 74 ureters (69.8%), after second injection in 91 ureters (85.8%) and after third injection in 99 ureters (93.3%). The same procedure using Vurdex was performed in 39 children (58 ureters). There were 20 patients with unilateral and 19 patients with bilateral reflux. After first injection of Vurdex success was achieved in 43 ureters (74.1%), after second injection in 52 ureters (89.6%) and after third injection in 55 ureters (94.8%). CONCLUSIONS: Overall success rate for patients treated with Deflux was 93.3% and for patients treated with Vurdex 94.8%. No significant difference in success rates between two groups was found (p = 0.714). However, Vurdex has an advantage because of the significantly lower price, but with same treatment results as Deflux.

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New Medicare rules that set forth a revised reimbursement scheme for dialysis services will introduce significant changes for providers. The new rules will abandon the current system of separate reimbursement for drugs associated with the hemodialysis services, including erythropoiesis-stimulating agents (ESAs) and intravenous (i.v.) iron. These rules will "bundle" these agents and related laboratory tests into a single, case-mix adjusted composite rate. These bundling rules will be gradually phased-in, beginning in 2011. One of the primary effects of the new reimbursement policy will be to discourage over-utilization of ESAs that comprise nearly one-quarter of hemodialysis-related Medicare expenditures. As a result, hemodialysis providers will be challenged to make hemodialysis services more cost-effective, while ensuring that Medicare clinical performance measures are met and patient care is not compromised. i.v. iron has an integral role in making anemia care more cost-effective in the hemodialysis setting by improving measures of iron-deficiency anemia, maintaining necessary iron balance, and reducing the utilization of ESAs. This review discusses the potential benefits of i.v. iron in the management of hemodialysis patients with iron-deficiency anemia. It also focuses on the available i.v. iron options, particularly the established efficacy and safety profile of i.v. iron dextran compared with other i.v. iron formulations as well as cost considerations.

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PURPOSE: Extravesical ureteral reimplantation and subureteral Deflux injection are used to correct vesicoureteral reflux with success rates of 94% to 99% and up to 89%, respectively. It was reported that unilateral extravesical reimplantation may be performed safely in an outpatient setting. Given that, we analyzed total system reimbursement to compare planned outpatient unilateral extravesical reimplantation to subureteral Deflux injection in patients with unilateral vesicoureteral reflux. MATERIALS AND METHODS: Data were collected on consecutive patients undergoing outpatient procedures for unilateral vesicoureteral reflux. Assessment of total system reimbursement was made using a payer mix adjusted calculation of surgery plus anesthesia plus hospital reimbursement. This was compared per procedure and in terms of total system reimbursement for each approach to obtain a similar resolution rate. RESULTS: A total of 209 consecutive patients were identified, of whom 26 underwent subureteral Deflux injection and 183 underwent unilateral extravesical reimplantation. Mean operative time was 93 minutes for reimplantation and 45 minutes for injection. The mean volume of dextranomer-hyaluronic acid was 1.2 ml. Total initial system reimbursement per patient was $3,813 for reimplantation and $4,259 for injection. A 3% hospital admission rate for reimplantation increased the total to $3,945. Higher reimbursement for injection depended largely on the material expense for dextranomer-hyaluronic acid. CONCLUSIONS: In terms of total system reimbursement it is less expensive in our system to treat unilateral vesicoureteral reflux with unilateral extravesical reimplantation than with subureteral Deflux injection using dextranomer-hyaluronic acid. The ability to perform unilateral reimplantation as an outpatient procedure has shifted this relationship.

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BACKGROUND: The Zuidex system is a treatment for stress urinary incontinence comprising four prefilled syringes of non-animal stabilised hyaluronic acid/dextranomer (NASHA/Dx) gel and the Implacer device. This study aimed to investigate utility (patients' preferences for given health states) with NASHA/Dx gel therapy and to compare resource utilisation of NASHA/Dx gel treatment with tension-free vaginal tape (TVT). METHODS: Utility was measured using EuroQol (EQ-5D), a generic utility instrument. For the cost of NASHA/Dx gel treatment, data were collected prospectively from participants in a 12-month efficacy study (n = 82). Retrospective analysis of a comparable group of patients (n = 77; 3-6 months' follow-up) was used to obtain equivalent costs for TVT. Costs were analysed for both Sweden and France. RESULTS: NASHA/Dx gel produced a utility gain of 0.048 at 3 months and 0.014 at 12 months. The estimated mean total 3-month cost per patient with NASHA/Dx gel was euro 2412 in Sweden and euro 2005 in France. The corresponding values for 12 months, including 14% of patients undergoing TVT, were euro 3370-euro 3417 and euro 2935-euro 2976 for Sweden and France, respectively. In comparison, the total costs of treatment with TVT over 3-6 months were euro 3169-euro 3504 and euro 5181-euro 5471 for Sweden and France, respectively. CONCLUSIONS: NASHA/Dx gel provides utility benefits that are similar to those previously reported for TVT and, depending on the country in which the treatment is performed, are associated with similar or lower overall costs in the short to medium term. From an economic perspective, NASHA/Dx gel could be considered at least as favourable as TVT, pending the availability of long-term effectiveness data.

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PURPOSE: The use of dextranomer/hyaluronic acid copolymer has become increasingly popular as an alternative to ureteral reimplantation in the treatment of vesicoureteral reflux. We compared the cost-effectiveness of performing dextranomer/hyaluronic acid injection at the time of diagnosis of reflux to that of traditional management. MATERIALS AND METHODS: A model to estimate the costs of managing vesicoureteral reflux has previously been created. We updated the model to compare the costs of managing vesicoureteral reflux by traditional methods with the costs of managing reflux if dextranomer/hyaluronic acid injection is performed at the time of diagnosis. The success rate required for dextranomer/hyaluronic acid injection at diagnosis to be as cost effective as traditional management was estimated. We used 2 models of dextranomer/hyaluronic acid injection at diagnosis-injection at diagnosis proceeding to traditional management if injection failed (scenario 1), and injection at diagnosis proceeding to ureteral reimplantation if injection failed (scenario 2). RESULTS: If reflux is stratified by grade in scenario 1, for grades III, IV and V respective success rates of 88.5%, 66.6%, and 55.6% for unilateral reflux and 97.5%, 89.7% and 91.4% for bilateral reflux must be achieved to have equal cost-effectiveness to traditional management, while grades I and II reflux can never achieve equal cost-effectiveness. Stratified by grade for scenario 2, for grades III, IV and V respective success rates of 86.9%, 70.8% and 55.8% for unilateral reflux, and 97.6%, 89.8% and 89.8% for bilateral reflux must be achieved to attain equal cost-effectiveness compared to traditional management. In scenario 2 dextranomer/hyaluronic acid injection at diagnosis for grades I and II unilateral and bilateral reflux can never achieve equal cost-effectiveness compared to traditional management. CONCLUSIONS: Based on the results of this study, in most clinical situations dextranomer/hyaluronic acid injection at the time of diagnosis is unlikely to be as cost effective as traditional management of vesicoureteral reflux.

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PURPOSE: We examined the cost-effectiveness of dextranomer/hyaluronic acid copolymer injection in patients who would otherwise undergo ureteral reimplantation. MATERIALS AND METHODS: A model for managing vesicoureteral reflux has previously been created. We now update the model to compare the costs of treating vesicoureteral reflux using standard methods (ie ureteral reimplantation after failed medical therapy) with the costs of dextranomer/hyaluronic acid injection. RESULTS: In the first scenario created dextranomer/hyaluronic acid injection is substituted for ureteral reimplantation when surgical intervention would be performed for treatment of breakthrough infection or failure of the reflux to resolve. For dextranomer/hyaluronic acid injection to have equal cost-effectiveness compared to ureteral reimplantation in this scenario success rates for dextranomer/hyaluronic acid injection would need to be 57.8% per ureter for patients with unilateral reflux and 75.3% per ureter for patients with bilateral reflux. However, if increasing grades of reflux require increasing volumes of dextranomer/hyaluronic acid, success rates would need to be 72.5% for patients with unilateral reflux and 93.8% for patients with bilateral reflux. In the second scenario created dextranomer/hyaluronic acid injection is repeated if it fails to resolve the reflux after the first injection. Success rates to obtain equal cost-effectiveness for the repeat dextranomer/hyaluronic acid injection would need to be 0%, 11.4% and 60.3% in patients with unilateral reflux if the respective success rates of the initial injection were 85%, 70% and 55%. Success rates for the second dextranomer/hyaluronic acid injection would need to be 0%, 29.1% and 76.7% per ureter in patients with bilateral reflux if the respective success rates of the initial injection were 85%, 70% and 55%. If increasing volumes of dextranomer/hyaluronic acid were required for increasing grades of reflux, a second dextranomer/hyaluronic acid injection would not be a viable option. CONCLUSIONS: Based on our results, dextranomer/hyaluronic acid injection may be more cost-effective than ureteral reimplantation for children who meet standard criteria for surgical therapy, especially for lower grades of reflux. If increasing grades of reflux require an increased volume of dextranomer/hyaluronic acid, then injection would likely be cost-effective only for grades I and II unilateral and bilateral reflux, and perhaps unilateral grade III reflux.

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Using pure components for the fermentation medium in dextran production imposes high costs on the industry. In the present study, the economic production of dextran using local and cheap sources of carbohydrate and nitrogen was investigated. Different concentrations of molasses and wheat-bran extract, after filtration, steam sterilization and pH adjustment, were inoculated with a fresh suspension of Leuconostoc mesenteroides. Cultures were incubated, and then diluted with an equal volume of ethanol. The bacteria were pelleted, and an aliquot of the supernatant was diluted with ethanol and dextran was precipitated. The supernatant was removed and the precipitate was dissolved in a minimal volume of water. Activated charcoal was added and the solution was boiled. The solution was filtered and protein impurities removed by 2-methylbutan-2-ol/chloroform extraction. Dextran was again precipitated with cold ethanol as described above, and the precipitate was dried in a desiccator. Optimum conditions and composition of culture media for dextran production using sugar-beet molasses and wheat bran were determined. The best results were obtained when 20% (w/v) molasses and 15% (w/v) wheat bran were used. The optimal initial pH for dextran production was 7.5.

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PURPOSE: Vesicoureteral reflux is a risk factor for progressive renal damage associated with urinary tract infection. Mild to moderate reflux is routinely treated with long-term antibiotic prophylaxis to prevent recurrent infections and open surgical reimplantation for breakthrough infections despite antibiotic therapy. Endoscopic subureteral injection of implant material is a therapeutic alternative to long-term prophylaxis and open surgery but its widespread use in the United States has been prevented by the lack of a stable implant material. Dextranomer/hyaluronic acid copolymer has been shown to be a safe, effective and durable implant material and was recently approved in the United States. We estimate the effect on costs and cure rates of introducing endoscopic injection with dextranomer/hyaluronic acid copolymer as a treatment alternative in the United States. MATERIALS AND METHODS: We constructed a model that mimics current clinical practice of vesicoureteral reflux treatment for 6 years, and incorporates spontaneous resolution and surgical intervention rates obtained from 2 long-term followup studies. The treatment algorithm was established using medical data from the literature, and clinical management practices from a Delphi survey of 27 pediatric urologists and nephrologists across the United States. Endoscopic injection was introduced into the model as replacement to surgery or alternative to long-term antibiotic prophylaxis. The effectiveness of dextranomer/hyaluronic acid copolymer was calculated from 140 patients (208 ureters) with grade III reflux treated in a clinical study of 221 children in Sweden. RESULTS: With current practice, the average cost per patient in 6 years was 6,640 US dollars and 23.5% of patients continued to have reflux. Replacing open surgery with endoscopic injection led to similar cure rates (22.2% failures) but costs were reduced to 5,522 US dollars. When injection was performed after 1 year of antibiotic therapy failure rates were reduced to 8.5% but costs increased to 7,644 US dollars. CONCLUSIONS: Our results show that a persistent approach to endoscopic surgery can be expected to result in overall success that equals or exceeds open surgery at a lower cost. This finding is particularly true if open reimplant is reserved for patients with high grade or persistent vesicoureteral reflux.

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OBJECTIVES: perioperative stroke reduces the clinical effectiveness of carotid endarterectomy (CEA). Postoperative thrombotic stroke may be reduced in incidence by the use of transcranial Doppler-directed Dextran-40 therapy. This programme requires the purchase of additional equipment and employment of more staff. This study examined whether this additional financial outlay was cost-effective in terms of saving expenditure by preventing postoperative thrombotic stroke. MATERIALS AND METHODS: data was collected prospectively on a series of 600 consecutive CEAs. The costs of the monitoring programme were analysed over 1- and 5-year periods. Formulae were derived allowing other units to calculate whether this technique will be cost-effective for them. RESULTS: after the introduction of TCD monitoring the postoperative thrombotic stroke rate fell from 2.7% to 0% (8 strokes prevented). Our local unit cost for the treatment of stroke was 25,702 pounds. After allowing for the additional costs of the monitoring programme, we calculate that postoperative TCD has saved 171,393 pounds. CONCLUSIONS: postoperative TCD monitoring is a clinically effective and also cost-effective method of reducing the stroke rate associated with CEA. For units performing more than 50 CEAs per year who experience occasional postoperative carotid thrombosis, its introduction should be considered.

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OBJECTIVE: To compare the tolerance and the cost of three replacement fluids in plasmapheresis: albumin 4% alone, albumin 4% + dextran 40, or albumin 4% + hydroxyethylstarch 6%. DESIGN: A one center randomized, cross-over, comparative study designed to explore the tolerance and the colloid oncotic pressure in patients undergoing plasmapheresis. PATIENTS: 225 plasmapheresis procedures were performed in 27 patients. MEASUREMENTS AND RESULTS: Hemodynamic tolerance was good in the three treatment groups. Serum protein concentration after plasmapheresis was significantly lower in the albumin + hydroxyethylstarch group, followed by albumin + dextran 40, versus albumin alone. Colloid oncotic pressure before and after exchange was similar in the three groups. CONCLUSIONS: The clinical use of 25-30% of hydroxyethylstarch 6% or dextran 40 with albumin 4% was clinically well tolerated and associated with a 12% decrease of the cost of substitution solutions.

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OBJECTIVE: To determine whether intravenous administration of 6% dextran 70 solution to young calves with severe diarrhea is cost effective. DESIGN: Randomized, prospective, clinical trial. ANIMALS: 22 calves < 2 months old that were hospitalized for diarrhea and that did not have pneumonia. PROCEDURE: All calves received antibiotics, were fed by use of an orogastic tube, were supplied with radiant heat, and were given crystalloids, i.v., as deemed appropriate by an attending veterinarian. A group of 12 calves also received 500 ml of 6% dextran 70 solution, i.v., over a 1-hour period as part of the initial treatment. Data were collected to determine whether early treatment with 6% dextran 70 solution resulted in a similar end cost for treatment because of a decrease in the volume of fluids administered i.v., a decrease in antibiotic usage, a decrease in the amount of time hospitalized, or a decrease in mortality. RESULTS: Capillary refill times, heart rates, respiratory rates, and rectal temperatures; and scores for dehydration, mucous membrane color, lung sounds, mental status, and suckling response were not different between the 2 groups of calves at admission. Differences were not detected in client charges or in hospitalized time (6% dextran 70 group, $89.68 +/- 11.05 and 36 +/- 3 hours; control group $88.02 +/- 4.93 and 36 +/- 4 hours), but those charges did not include costs for the 6% dextran 70 solution. CLINICAL IMPLICATIONS: Use of 6% dextran 70 solution as part of the resuscitation of most young calves with diarrhea requiring hospitalization is not likely to be cost effective.

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