- Email: [email protected]
Endoscopic Subureteral Injection is Not Less Expensive Than Outpatient Open Reimplantation for Unilateral Vesicoureteral Reflux
Endoscopic Subureteral Injection is Not Less Expensive Than Outpatient Open Reimplantation for Unilateral Vesicoureteral Reflux Kara Saperston,* James Smith, Scott Putman, Richard Matern, Laura Foot, Chad Wallis, Catherine deVries, Brent Snow and Patrick Cartwright From the University of Utah, Salt Lake City, Utah
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. Key Words: ureter, injections, deflux, replantation, costs and cost analysis
pen ureteral reimplantation and endoscopic subureteral injection with Deflux or Dx/HA1 are the 2 primary surgical options available to correct VUR. There are several factors to consider when determining the best approach in a given patient, including VUR grade, unilateral vs bilateral condition, anatomical variations, initial and long-term success rates of the respective procedures, risks and complications, parent and patient preference, and the expense and cost-effectiveness of the procedures. As expense to the system and to the patient becomes more important in health care, understanding this variable becomes valuable and it is the focus of this report. Our group recently reported that unilateral VUR may be successfully treated on an outpatient basis using extravesical ureteral reimplantation.2 This creates a new dimension to managing reflux and decreases the expense of this procedure. A modified Lich-Gregoir technique of extravesical ureteral reimplantation has a reported durable success rate of 94% to 99%.3,4 On the other hand, STING of bulking agents has been used as an alternative to ureteral reimplantation since 1981 with varying success rates.5–10 Kirsch et al most recently reported success rates of up to 89% for reflux grades
O
Study received institutional review board approval. * Correspondence: University Hospitals and Clinics, 50 North Medical Dr., Salt Lake City, Utah 84132 (FAX: 801-585-2891; e-mail: [email protected]).
0022-5347/08/1804-1626/0 THE JOURNAL OF UROLOGY® Copyright © 2008 by AMERICAN UROLOGICAL ASSOCIATION
I to IV at less than 1 year of followup with a modified STING.11 The modified STING with Dx/HA has increased in use in the United States in the last 5 years.12 It is commonly stated that the lower expense of the STING approach argues for its use. This likely holds true if UER requires hospitalization but what if these 2 procedures could be accomplished on an outpatient basis? To assess this we performed an expense analysis of these 2 approaches at our children’s hospital. METHODS A retrospective, institutional review board approved review of the records of all children surgically treated for VUR between March 2002 and March 2007 was performed. A total of 818 patients were identified and assessed, of whom 209 met the study inclusion criteria of primary VUR, unilateral VUR, no history of contralateral VUR, no other procedures performed at reflux treatment and no major associated medical problems. These 209 children were consecutive patients undergoing correction for primary unilateral VUR with an anticipated outpatient approach. March 2002 was chosen as a start date because this was when our group initiated outpatient extravesical reimplantation management. Our designation of outpatient management was any patient who would be discharged home after standard same day surgery discharge criteria were met without any plan for extended observation.
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Vol. 180, 1626-1630, October 2008 Printed in U.S.A. DOI:10.1016/j.juro.2008.05.124
ENDOSCOPIC SUBURETERAL INJECTION FOR UNILATERAL VESICOURETERAL REFLUX During the study period 183 patients were treated with UER and 26 were treated with STING according to physician and parent decision. All patients were operated on by 1 of 4 pediatric urologists and a urology resident. Indications for surgery were high grade reflux that was unlikely to resolve, noncompliance with prophylactic antibiotics, failure to resolve with time, parental choice or breakthrough infections. UER was performed using a modified Lich-Gregoir technique.13 A distal advancement suture was used by 1 of the 4 pediatric urologists. STING with Dx/HA was performed as previously described by Kirsch et al.11 The clinical variables assessed were operative time, the number of Dx/HA vials, reflux grade, patient age and gender, and laterality. Operative time was defined as the time that the patient entered the operating room until the time that the patient exited the room. The goal of this study was to calculate what the actual total expense (total system reimbursement or outlay) was for each approach. Essentially we sought to understand what was actually paid by all parties to accomplish each of these procedures. This cannot be accurately represented using simple charge data since only a portion of any charge is usually reimbursed and the percent of reimbursement varies among different commercial and governmental payers. Instead, the total system reimbursement (expense) in the UER and STING groups was calculated by reviewing data on the 3 components of reimbursement for the procedure, including surgeon, anesthesia and hospital. To protect confidential fiscal information a model was used to calculate total system reimbursement, that is total system reimbursement ⫽ surgeon reimbursement ⫹ anesthesia reimbursement ⫹ hospital reimbursement. We defined the reimbursement for each section as described. For anesthesia the mean room time for the 2 procedures was determined and then used to calculate the expected time based anesthesia billing units at 12 minutes per unit. This anesthesia unit count was added to the startup units that were automatically allotted to each of these procedures. The resultant total anesthesia units (time based plus start-up units) was multiplied by the actual reimbursement percent (the collection ratio, calculated as dollars collected/ dollars billed) of all anesthesia group billings during the prior 12 months. This allowed us to calculate expected total reimbursement to anesthesia (patient portion and insurance). This method was designed to consider the usual mix of commercial payers, Medicaid, self-pay, patient contribution above insurance and charity care since the mean collection ratio, which was 0.54, was calculated from the weighted sum of all of these components. Surgeon reimbursement was calculated in similar fashion. The set surgical charge for each procedure was multiplied by the actual surgeon collection ratio (dollars collected/ dollars billed) calculated from all surgeon billings during the prior 12 months. This collection ratio was 0.60. This again created an accurate estimate of what real reimbursement would be, given the usual mix of payers. For hospital reimbursement the actual total hospital charges for these patients were multiplied by the hospital collection ratio of 0.71 for the prior 12 months. Calculated dollar figures for each of the 3 components of reimbursement were then summed to calculate the expected total system reimbursement or expense of each procedure.
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The nonpaired 2 sample Student t test was used to compare expense parameters with p ⬍0.05 considered significant. RESULTS The table lists the data. In the UER group mean patient age was 5.25 years, while in the STING group it was 8.58 years. Mean reflux grade in the UER group was 3.2, while it was 2.5 in the STING group. Total system reimbursement in the UER outpatient group was $3,813 vs $4,259 for the STING group. The expense variables in the formula that were most disparate between the 2 approaches were operative time and the number of vials of Dx/HA used. Mean operative time, calculated as the time from first entry into the operative room until the time that the patient left the room, was 93 minutes in the UER group and 45 minutes in the STING group. Mean operative time impacted expense since it affected anesthesia and hospital reimbursements. As expected, the time required to perform open extravesical reimplantation was longer than that to perform STING. However, this was not enough of a difference to offset the expense of a single vial of Dx/HA. DISCUSSION Many traditionally inpatient procedures are now being performed on an outpatient basis. Ureteral reimplantation has traditionally required a 1 to 3-day hospital stay. Extravesical reimplantation is an excellent technique for correcting unilateral VUR. Investigators at our institution and others have noted that this procedure may now be safely performed on an outpatient basis with good parent satisfaction.2 Endoscopic STING has been applied as an alternative to medical management and open surgical procedures for the last 25 years. There are numerous agents, including polytetrafluoroethylene, silicone and collagen, that have various advantages and drawbacks.7,8 Historically success rates using injection therapy have been 51% to 94%.11,14 Deflux or Dx/HA, which has been approved by the Food and Drug Administration, has been used in the United States since 2002 and much longer in Europe. Puri et al evaluated 113 patients with reflux grades II to V who were followed 3 months to 1 year after Dx/HA STING.8 After 1 injection an 86% resolution rate was reported. Kirsch et al reported their results in 285 patients with reflux grades I to IV who underwent a Dx/HA STING procedure.11 In a subset of their
Patient and treatment data
No. pts Age (yrs) % Female Mean reflux grade % Lt reflux Deflux vol (ml) Operative time (mins) Total system reimbursement ($) Total system reimbursement with same reflux resolution ($)*
UER
STING
183 5.25 84 3.2 63 Not applicable 93 $3,813
26 8.58 91 2.5 50 1.2 45 $4,259
3,945
4,727
* Considering hospital readmission and repeat STING.
p Value ⬍0.0001 ⬍0.001 Not applicable ⬍0.001 ⬍0.001 ⬍0.001
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ENDOSCOPIC SUBURETERAL INJECTION FOR UNILATERAL VESICOURETERAL REFLUX
patients a modified STING approach resulted in a shortterm success rate of 89%. Kobelt et al evaluated the cost-effectiveness of the STING procedure for VUR using Dx/HA.15 In this study a model was constructed by which the cost of managing VUR medically for 6 years was compared to that of an initial STING procedure. After 6 years the cost of medical management was calculated to be $6,640 with 23.5% of patients still having VUR at the end of the study period. If annual failures were treated with STING instead of with UER, the cost was $5,522 with a failure rate of 22.2%. They concluded that the cost of immediate Dx/HA STING was less than that of medical management for 6 years, followed by UER with eventual comparable resolution rates. Others reported a model of cost-effectiveness that compared treatment for failed medical management followed by ureteral reimplantation to treatment for failed medical management with Dx/HA STING. They showed that increasing volumes of Dx/HA used to treat reflux became less cost-effective. Essentially Dx/HA has similar cost-effectiveness to treat low grades (I, II and maybe III) but not higher grades of reflux. The data in the study presented compare the procedural expense of STING to UER for unilateral reflux only. The ability in our system to accomplish UER on an outpatient basis in 97% of cases with the most recent data revealing a 3% hospital admission-readmission rate (unpublished data) has swung the expense relationship in favor of this approach over STING with Dx/HA. It is clear from these data that the expense of Dx/HA is an important driver of the total expense outcome. If Dx/HA became less expensive, the 2 approaches would become more comparable. An added increase in the expense of this approach in our study was the need to use 2 vials of Dx/HA in some patients. The other significant impact on expense came from the operative time for each procedure. As stated, these times reflect total time in the operating room and were likely lengthened to some degree by teaching residents during the case. However, it is unlikely that this altered the expense comparison of the 2 approaches since any decrease in operative time if resident teaching was not present would have affected the procedure time in the 2 groups. An additional theoretical calculation can be made to compare the 2 procedures in terms of expenditure to achieve similar anticipated resolution rates of VUR. Three assumptions are required. 1) Our most recent review of outpatient unilateral reimplantation showed an admission-readmission rate of 3%, all for less than 24 hours. The expense for this was determined and added to the expense in the UER group. 2) As stated, extravesical reimplantation has a resolution rate of 94% to 99%. We chose 97% as our expectation for this calculation. 3) In the STING group the best reported VUR resolution rate for an initial Dx/HA STING was 89% and, thus, we can expect that 11% of patients will be candidates for repeat injection. If this second injection has an 80% anticipated success rate,1 the UER and STING groups would at that point arrive at similar overall resolution rates of around 96% to 97%. If the expense of a second STING procedure in 11% of patients was added to the overall STING expenses, the expense for achieving similar resolution rates in the 2 groups would be $3,945 for UER and $4,727 for STING. This calculation is an estimation of the expense of the 2 approaches when reflux resolution is held as the desired outcome.
Our study is limited by the relatively lower number of STING procedures performed. It should be noted that this study largely reflects procedural expenses. Other factors that could determine the overall financial impact of the procedure would include the time required away from work by parents during the recovery of the child and unplanned visits for medical care that are not covered by global surgical reimbursement (emergency room or pediatrician visits). Our study does not provide data on the impact of these variables. Also, in the final theoretical calculation of overall expense to achieve similar resolution rates, as described, we realize that some STING failures may have down graded reflux and parents would choose to have their child not undergo a second procedure, but rather be observed. CONCLUSIONS This analysis demonstrates that for correcting unilateral reflux extravesical reimplantation requires less total system reimbursement per case than endoscopic STING with Dx/ HA. These data are specific to our system and hold true because of the ability to manage unilateral reimplantation on an outpatient basis in most cases. These expense data support the value of considering outpatient unilateral extravesical reimplantation in patients requiring treatment for unilateral VUR.
Abbreviations and Acronyms Dx/HA ⫽ dextranomer-hyaluronic acid STING ⫽ subureteral injection UER ⫽ outpatient open extravesical ureteral reimplantation VUR ⫽ vesicoureteral reflux
REFERENCES 1.
2.
3.
4.
5. 6.
7.
8. 9.
Perez-Brayfield M, Kirsch AJ, Hensle TW, Koyle MA, Furness P and Scherz HC: Endoscopic treatment with dextranomer/ hyaluronic acid for complex cases of vesicoureteral reflux. J Urol 2004; 172: 1614. Putman S, Wicher C, Wayment R, Harrell B, Devries C, Snow B et al: Unilateral extravesical ureteral reimplantation in children performed on an outpatient basis. J Urol 2005; 174: 1987. Duckett JW, Walker RD and Weiss R: Surgical results: International Reflux Study in Children—United States branch. J Urol 1992; 148: 1674. Heimbach D, Brül P and Mallman R: Lich-Gregoir anti-reflux procedure: indications and results with 283 vesicoureteral units. Scand J Urol Nephrol 1995; 29: 311. Matouschek E: Treatment of vesicorenal reflux by transurethral Teflon-injection. Urologe A 1981; 20: 263. Keating MA: Role of periureteral injections in children with vesicoureteral reflux. Curr Opin Urol 2005; 15: P369. Chertin B, Colhoun E, Velayudham M and Puri P: Endoscopic treatment of vesicoureteral reflux: 11 to 17 years of followup. J Urol 2002; 167: 1443. Puri P: Ten year experience with subureteric Teflon (polytetrafluoroethylene). Br J Urol 1995; 75: 126. Stenberg A and Lackgren G: A new bioimplant for the endoscopic treatment of vesicoureteral reflux: experimental and short-term clinical results J Urol 1995; 154: 800.
ENDOSCOPIC SUBURETERAL INJECTION FOR UNILATERAL VESICOURETERAL REFLUX 10.
11.
12.
13.
14.
15.
Lackgren G, Wahlin E, Skoldenberg E and Stenberg A: Longterm followup of children treated with dextranomer/hyaluronic acid copolymer for vesicoureteral reflux. J Urol 2001; 166: 1887. Kirsch AJ, Perez-Bayfield MR, Smith EA and Scherz HC: The modified sting procedure to correct vesicoureteral reflux: improved results with submucosal implantation within the intramural ureter J Urol 2004; 171: 2413. Lendvay TS, Sorensen M, Cowan, CA, Joyner BD, Mitchell MM and Grady GM: The evolution of vesicoureteral reflux management in the era of dextranomer/hyaluronic acid copolymer: a Pediatric Health Information System database study. J Urol 2006; 176: 1864. Lapoint SP, Barriera D, Leblanc B and Williot P: Modified Lich-Gregoir ureteral reimplantation: experience of a Canadian center. J Urol 1998; 159: 1662. Elder J, Diaz M, Caldamone A, Cendron M, Greenfield S, Hurwitz R et al: Endoscopic therapy for vesicoureteral reflux: a meta-analysis. I. Reflux resolution and urinary tract infection. J Urol 2006; 175: 716. Kobelt G, Canning D, Hensle T and Lackgren G: The costeffectiveness of endoscopic injection of dextranomer/hyaluronic acid copolymer for vesicoureteral reflux. J Urol 2003; 169: 1480.
EDITORIAL COMMENTS Open ureteral reimplantation is less morbid today than in the past. At many centers children undergoing unilateral, bilateral, extravesical and transvisical reimplantation leave the hospital within 24 hours. These authors focus on outpatient unilateral extravesical ureteral reimplantation. Despite these advances, open reimplantation is more morbid than endoscopic injection. Whether practitioners choose reimplantation or endoscopic injection is based on the likelihood of success, and the severity of the underlying reflux and its consequences. Using computer modeling, we demonstrated that it is unlikely for Dx/HA injection to be cost equivalent to open reimplantation for higher grades and bilateral reflux.1 These authors have shown that at their center the cost of unilateral outpatient reimplantation is lower than that of unilateral Dx/HA injection for any grade of reflux. This effect will be magnified as injection success decreases with increasing reflux grade. It would be interesting to know the cost comparison for bilateral procedures. Presumably bilateral procedures are not done on an outpatient basis but the cost of the implant is also greater. With any cost analysis the assumptions profoundly affect the results. Using average percent recovery of charges rather than a more universal cost estimate makes this more relevant locally than generally. Nonetheless, this is a progressive approach to open reflux repair and a demonstration that excellent outcomes can be achieved in a cost conscious manner. Steven G. Docimo Department of Urology Children’s Hospital of Pittsburgh Pittsburgh, Pennsylvania 1.
Benoit RM, Peele PB and Docimo SG: The cost-effectiveness of dextranomer/hyaluronic acid copolymer for the management of vesicoureteral reflux. 1: substitution for surgical management. J Urol 2006; 176: 1588.
Studies of this sort are difficult to interpret due to regional differences in hospital costs, and other variables and as-
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sumptions. The authors postulate that 11% of patients treated endoscopically for VUR will go on to have a second procedure, which will fail in 20%. Currently this is not the case and such an assumption may be flawed. In my practice 40% of failures are reduced to grade I/V and are simply observed. The same is true of open surgery. As experience is gained with endoscopic injection, repeat injections should be infrequent but when performed, the success rate has been reported to be 90%.1 Another potential error is the use of 1.2 ml as an average volume for unilateral reflux, which implies that 0.8 ml is discarded. In practice this is seldom done. Unilateral reflux is usually treated with 1.0 ml (1 syringe including the needle flush), thus potentially reducing the cost of Dx/HA injection for unilateral cases in this analysis by more than $1,000, making it less expensive than open outpatient surgery. Surgeons should choose the surgical approach most comfortable for them and families. This study reveals that cost is not significantly different between the 2 approaches and should not be the reason to choose one approach over the other. At the end of the day the only difference between open and endoscopic surgery may be the presence or absence of a scar and as a result, parents are likely to choose the least invasive approach.2,3 Desite the limitations discussed by the authors, transformation of a highly successful inpatient procedure into one performed on an outpatient basis is laudable. Efforts to make open procedures less invasive and endoscopic injection less expensive are tenable goals. Andrew J. Kirsch Children’s Healthcare of Atlanta Emory University School of Medicine Atlanta, Georgia 1.
Elmore JM, Scherz HC and Kirsch AJ: Dextranomer/hyaluronic acid copolymer for vesicoureteral reflux: success rates after initial treatment failure. J Urol 2006; 175: 712. 2. Ogan K, Pohl HG, Carlson D, Belman AB and Rushton HG: Parental preferences in the management of vesicoureteral reflux. J Urol 2001; 166: 240. 3. Capozza N, Lais A, Matarazzo E, Nappo S, Patricolo M and Caione P: Treatment of vesico-ureteric reflux: a new algorithm based on parental preference. BJU Int 2003; 92: 285.
REPLY BY AUTHORS We did struggle with the best method for assessing the financial impact of both procedures, and selected the calculation that would deal with real figures, or what is actually paid by insurance companies and families to have the procedure done. While absolute payment amounts vary regionally, we find it likely that the relative total system payment for open versus Dx/HA injection is comparable. Hopefully this makes the comparison relevant to other regions. Concern was raised about the 1.2 ml mean of Dx/HA used for unilateral injection. If one injects many orifices with higher grade reflux, several will require greater than 1.0 ml to achieve the desired post-injection configuration. If one’s practice allows a mean use less than what we report, thenthe mean cost of the Dx/HA group will decrease correspondingly. In addition, any decrease in Dx/HA purchase cost would greatly affect the comparison.
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ENDOSCOPIC SUBURETERAL INJECTION FOR UNILATERAL VESICOURETERAL REFLUX
We did include a speculative calculation of what the outlay would be to achieve similar reflux resolution rates. Elmore et al reported that only 15% of post-Dx/HA injection persistent reflux was grade I (reference 1 in comment), which would most likely be considered for observation and not second injection. Our comparison, while clearly specula-
tive and definitely requiring some estimation, makes a decent approximation of what outlay can be expected to achieve similar resolution rates with both approaches. In addition to the absence or presence of a small scar in the open reimplant group is the long-term presence of an exogenous substance within the bladder wall of the Dx/HA group.
DISCUSSION Dr. Hal Scherz. I thought this was a nice review of the financial impact but I wanted to ask if you had any idea about the weight of each factor you used for your analysis, because at many institutions like ours we can get the patient in and out of the operating room between 20 and 25 minutes, which would significantly change your cost analysis for the anesthetic component of the endoscopy case, for example. Dr. Kara Saperston. We did not look at the weight of the different variables. I think that is a good point and we will look at that. Dr. David Roth. You included an increased cost for the Deflux failures but you did not include any costs or possible complications of the surgical arm. Did you look at that and what would be the impact if you did? Doctor Saperston. In our cohort of 206 cases of which 180 were open there was only 1 rehospitalization. It was the night of surgery but at an outside hospital, and so we were unable to get that cost data.
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. Key Words: ureter, injections, deflux, replantation, costs and cost analysis
pen ureteral reimplantation and endoscopic subureteral injection with Deflux or Dx/HA1 are the 2 primary surgical options available to correct VUR. There are several factors to consider when determining the best approach in a given patient, including VUR grade, unilateral vs bilateral condition, anatomical variations, initial and long-term success rates of the respective procedures, risks and complications, parent and patient preference, and the expense and cost-effectiveness of the procedures. As expense to the system and to the patient becomes more important in health care, understanding this variable becomes valuable and it is the focus of this report. Our group recently reported that unilateral VUR may be successfully treated on an outpatient basis using extravesical ureteral reimplantation.2 This creates a new dimension to managing reflux and decreases the expense of this procedure. A modified Lich-Gregoir technique of extravesical ureteral reimplantation has a reported durable success rate of 94% to 99%.3,4 On the other hand, STING of bulking agents has been used as an alternative to ureteral reimplantation since 1981 with varying success rates.5–10 Kirsch et al most recently reported success rates of up to 89% for reflux grades
O
Study received institutional review board approval. * Correspondence: University Hospitals and Clinics, 50 North Medical Dr., Salt Lake City, Utah 84132 (FAX: 801-585-2891; e-mail: [email protected]).
0022-5347/08/1804-1626/0 THE JOURNAL OF UROLOGY® Copyright © 2008 by AMERICAN UROLOGICAL ASSOCIATION
I to IV at less than 1 year of followup with a modified STING.11 The modified STING with Dx/HA has increased in use in the United States in the last 5 years.12 It is commonly stated that the lower expense of the STING approach argues for its use. This likely holds true if UER requires hospitalization but what if these 2 procedures could be accomplished on an outpatient basis? To assess this we performed an expense analysis of these 2 approaches at our children’s hospital. METHODS A retrospective, institutional review board approved review of the records of all children surgically treated for VUR between March 2002 and March 2007 was performed. A total of 818 patients were identified and assessed, of whom 209 met the study inclusion criteria of primary VUR, unilateral VUR, no history of contralateral VUR, no other procedures performed at reflux treatment and no major associated medical problems. These 209 children were consecutive patients undergoing correction for primary unilateral VUR with an anticipated outpatient approach. March 2002 was chosen as a start date because this was when our group initiated outpatient extravesical reimplantation management. Our designation of outpatient management was any patient who would be discharged home after standard same day surgery discharge criteria were met without any plan for extended observation.
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Vol. 180, 1626-1630, October 2008 Printed in U.S.A. DOI:10.1016/j.juro.2008.05.124
ENDOSCOPIC SUBURETERAL INJECTION FOR UNILATERAL VESICOURETERAL REFLUX During the study period 183 patients were treated with UER and 26 were treated with STING according to physician and parent decision. All patients were operated on by 1 of 4 pediatric urologists and a urology resident. Indications for surgery were high grade reflux that was unlikely to resolve, noncompliance with prophylactic antibiotics, failure to resolve with time, parental choice or breakthrough infections. UER was performed using a modified Lich-Gregoir technique.13 A distal advancement suture was used by 1 of the 4 pediatric urologists. STING with Dx/HA was performed as previously described by Kirsch et al.11 The clinical variables assessed were operative time, the number of Dx/HA vials, reflux grade, patient age and gender, and laterality. Operative time was defined as the time that the patient entered the operating room until the time that the patient exited the room. The goal of this study was to calculate what the actual total expense (total system reimbursement or outlay) was for each approach. Essentially we sought to understand what was actually paid by all parties to accomplish each of these procedures. This cannot be accurately represented using simple charge data since only a portion of any charge is usually reimbursed and the percent of reimbursement varies among different commercial and governmental payers. Instead, the total system reimbursement (expense) in the UER and STING groups was calculated by reviewing data on the 3 components of reimbursement for the procedure, including surgeon, anesthesia and hospital. To protect confidential fiscal information a model was used to calculate total system reimbursement, that is total system reimbursement ⫽ surgeon reimbursement ⫹ anesthesia reimbursement ⫹ hospital reimbursement. We defined the reimbursement for each section as described. For anesthesia the mean room time for the 2 procedures was determined and then used to calculate the expected time based anesthesia billing units at 12 minutes per unit. This anesthesia unit count was added to the startup units that were automatically allotted to each of these procedures. The resultant total anesthesia units (time based plus start-up units) was multiplied by the actual reimbursement percent (the collection ratio, calculated as dollars collected/ dollars billed) of all anesthesia group billings during the prior 12 months. This allowed us to calculate expected total reimbursement to anesthesia (patient portion and insurance). This method was designed to consider the usual mix of commercial payers, Medicaid, self-pay, patient contribution above insurance and charity care since the mean collection ratio, which was 0.54, was calculated from the weighted sum of all of these components. Surgeon reimbursement was calculated in similar fashion. The set surgical charge for each procedure was multiplied by the actual surgeon collection ratio (dollars collected/ dollars billed) calculated from all surgeon billings during the prior 12 months. This collection ratio was 0.60. This again created an accurate estimate of what real reimbursement would be, given the usual mix of payers. For hospital reimbursement the actual total hospital charges for these patients were multiplied by the hospital collection ratio of 0.71 for the prior 12 months. Calculated dollar figures for each of the 3 components of reimbursement were then summed to calculate the expected total system reimbursement or expense of each procedure.
1627
The nonpaired 2 sample Student t test was used to compare expense parameters with p ⬍0.05 considered significant. RESULTS The table lists the data. In the UER group mean patient age was 5.25 years, while in the STING group it was 8.58 years. Mean reflux grade in the UER group was 3.2, while it was 2.5 in the STING group. Total system reimbursement in the UER outpatient group was $3,813 vs $4,259 for the STING group. The expense variables in the formula that were most disparate between the 2 approaches were operative time and the number of vials of Dx/HA used. Mean operative time, calculated as the time from first entry into the operative room until the time that the patient left the room, was 93 minutes in the UER group and 45 minutes in the STING group. Mean operative time impacted expense since it affected anesthesia and hospital reimbursements. As expected, the time required to perform open extravesical reimplantation was longer than that to perform STING. However, this was not enough of a difference to offset the expense of a single vial of Dx/HA. DISCUSSION Many traditionally inpatient procedures are now being performed on an outpatient basis. Ureteral reimplantation has traditionally required a 1 to 3-day hospital stay. Extravesical reimplantation is an excellent technique for correcting unilateral VUR. Investigators at our institution and others have noted that this procedure may now be safely performed on an outpatient basis with good parent satisfaction.2 Endoscopic STING has been applied as an alternative to medical management and open surgical procedures for the last 25 years. There are numerous agents, including polytetrafluoroethylene, silicone and collagen, that have various advantages and drawbacks.7,8 Historically success rates using injection therapy have been 51% to 94%.11,14 Deflux or Dx/HA, which has been approved by the Food and Drug Administration, has been used in the United States since 2002 and much longer in Europe. Puri et al evaluated 113 patients with reflux grades II to V who were followed 3 months to 1 year after Dx/HA STING.8 After 1 injection an 86% resolution rate was reported. Kirsch et al reported their results in 285 patients with reflux grades I to IV who underwent a Dx/HA STING procedure.11 In a subset of their
Patient and treatment data
No. pts Age (yrs) % Female Mean reflux grade % Lt reflux Deflux vol (ml) Operative time (mins) Total system reimbursement ($) Total system reimbursement with same reflux resolution ($)*
UER
STING
183 5.25 84 3.2 63 Not applicable 93 $3,813
26 8.58 91 2.5 50 1.2 45 $4,259
3,945
4,727
* Considering hospital readmission and repeat STING.
p Value ⬍0.0001 ⬍0.001 Not applicable ⬍0.001 ⬍0.001 ⬍0.001
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patients a modified STING approach resulted in a shortterm success rate of 89%. Kobelt et al evaluated the cost-effectiveness of the STING procedure for VUR using Dx/HA.15 In this study a model was constructed by which the cost of managing VUR medically for 6 years was compared to that of an initial STING procedure. After 6 years the cost of medical management was calculated to be $6,640 with 23.5% of patients still having VUR at the end of the study period. If annual failures were treated with STING instead of with UER, the cost was $5,522 with a failure rate of 22.2%. They concluded that the cost of immediate Dx/HA STING was less than that of medical management for 6 years, followed by UER with eventual comparable resolution rates. Others reported a model of cost-effectiveness that compared treatment for failed medical management followed by ureteral reimplantation to treatment for failed medical management with Dx/HA STING. They showed that increasing volumes of Dx/HA used to treat reflux became less cost-effective. Essentially Dx/HA has similar cost-effectiveness to treat low grades (I, II and maybe III) but not higher grades of reflux. The data in the study presented compare the procedural expense of STING to UER for unilateral reflux only. The ability in our system to accomplish UER on an outpatient basis in 97% of cases with the most recent data revealing a 3% hospital admission-readmission rate (unpublished data) has swung the expense relationship in favor of this approach over STING with Dx/HA. It is clear from these data that the expense of Dx/HA is an important driver of the total expense outcome. If Dx/HA became less expensive, the 2 approaches would become more comparable. An added increase in the expense of this approach in our study was the need to use 2 vials of Dx/HA in some patients. The other significant impact on expense came from the operative time for each procedure. As stated, these times reflect total time in the operating room and were likely lengthened to some degree by teaching residents during the case. However, it is unlikely that this altered the expense comparison of the 2 approaches since any decrease in operative time if resident teaching was not present would have affected the procedure time in the 2 groups. An additional theoretical calculation can be made to compare the 2 procedures in terms of expenditure to achieve similar anticipated resolution rates of VUR. Three assumptions are required. 1) Our most recent review of outpatient unilateral reimplantation showed an admission-readmission rate of 3%, all for less than 24 hours. The expense for this was determined and added to the expense in the UER group. 2) As stated, extravesical reimplantation has a resolution rate of 94% to 99%. We chose 97% as our expectation for this calculation. 3) In the STING group the best reported VUR resolution rate for an initial Dx/HA STING was 89% and, thus, we can expect that 11% of patients will be candidates for repeat injection. If this second injection has an 80% anticipated success rate,1 the UER and STING groups would at that point arrive at similar overall resolution rates of around 96% to 97%. If the expense of a second STING procedure in 11% of patients was added to the overall STING expenses, the expense for achieving similar resolution rates in the 2 groups would be $3,945 for UER and $4,727 for STING. This calculation is an estimation of the expense of the 2 approaches when reflux resolution is held as the desired outcome.
Our study is limited by the relatively lower number of STING procedures performed. It should be noted that this study largely reflects procedural expenses. Other factors that could determine the overall financial impact of the procedure would include the time required away from work by parents during the recovery of the child and unplanned visits for medical care that are not covered by global surgical reimbursement (emergency room or pediatrician visits). Our study does not provide data on the impact of these variables. Also, in the final theoretical calculation of overall expense to achieve similar resolution rates, as described, we realize that some STING failures may have down graded reflux and parents would choose to have their child not undergo a second procedure, but rather be observed. CONCLUSIONS This analysis demonstrates that for correcting unilateral reflux extravesical reimplantation requires less total system reimbursement per case than endoscopic STING with Dx/ HA. These data are specific to our system and hold true because of the ability to manage unilateral reimplantation on an outpatient basis in most cases. These expense data support the value of considering outpatient unilateral extravesical reimplantation in patients requiring treatment for unilateral VUR.
Abbreviations and Acronyms Dx/HA ⫽ dextranomer-hyaluronic acid STING ⫽ subureteral injection UER ⫽ outpatient open extravesical ureteral reimplantation VUR ⫽ vesicoureteral reflux
REFERENCES 1.
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Perez-Brayfield M, Kirsch AJ, Hensle TW, Koyle MA, Furness P and Scherz HC: Endoscopic treatment with dextranomer/ hyaluronic acid for complex cases of vesicoureteral reflux. J Urol 2004; 172: 1614. Putman S, Wicher C, Wayment R, Harrell B, Devries C, Snow B et al: Unilateral extravesical ureteral reimplantation in children performed on an outpatient basis. J Urol 2005; 174: 1987. Duckett JW, Walker RD and Weiss R: Surgical results: International Reflux Study in Children—United States branch. J Urol 1992; 148: 1674. Heimbach D, Brül P and Mallman R: Lich-Gregoir anti-reflux procedure: indications and results with 283 vesicoureteral units. Scand J Urol Nephrol 1995; 29: 311. Matouschek E: Treatment of vesicorenal reflux by transurethral Teflon-injection. Urologe A 1981; 20: 263. Keating MA: Role of periureteral injections in children with vesicoureteral reflux. Curr Opin Urol 2005; 15: P369. Chertin B, Colhoun E, Velayudham M and Puri P: Endoscopic treatment of vesicoureteral reflux: 11 to 17 years of followup. J Urol 2002; 167: 1443. Puri P: Ten year experience with subureteric Teflon (polytetrafluoroethylene). Br J Urol 1995; 75: 126. Stenberg A and Lackgren G: A new bioimplant for the endoscopic treatment of vesicoureteral reflux: experimental and short-term clinical results J Urol 1995; 154: 800.
ENDOSCOPIC SUBURETERAL INJECTION FOR UNILATERAL VESICOURETERAL REFLUX 10.
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Lackgren G, Wahlin E, Skoldenberg E and Stenberg A: Longterm followup of children treated with dextranomer/hyaluronic acid copolymer for vesicoureteral reflux. J Urol 2001; 166: 1887. Kirsch AJ, Perez-Bayfield MR, Smith EA and Scherz HC: The modified sting procedure to correct vesicoureteral reflux: improved results with submucosal implantation within the intramural ureter J Urol 2004; 171: 2413. Lendvay TS, Sorensen M, Cowan, CA, Joyner BD, Mitchell MM and Grady GM: The evolution of vesicoureteral reflux management in the era of dextranomer/hyaluronic acid copolymer: a Pediatric Health Information System database study. J Urol 2006; 176: 1864. Lapoint SP, Barriera D, Leblanc B and Williot P: Modified Lich-Gregoir ureteral reimplantation: experience of a Canadian center. J Urol 1998; 159: 1662. Elder J, Diaz M, Caldamone A, Cendron M, Greenfield S, Hurwitz R et al: Endoscopic therapy for vesicoureteral reflux: a meta-analysis. I. Reflux resolution and urinary tract infection. J Urol 2006; 175: 716. Kobelt G, Canning D, Hensle T and Lackgren G: The costeffectiveness of endoscopic injection of dextranomer/hyaluronic acid copolymer for vesicoureteral reflux. J Urol 2003; 169: 1480.
EDITORIAL COMMENTS Open ureteral reimplantation is less morbid today than in the past. At many centers children undergoing unilateral, bilateral, extravesical and transvisical reimplantation leave the hospital within 24 hours. These authors focus on outpatient unilateral extravesical ureteral reimplantation. Despite these advances, open reimplantation is more morbid than endoscopic injection. Whether practitioners choose reimplantation or endoscopic injection is based on the likelihood of success, and the severity of the underlying reflux and its consequences. Using computer modeling, we demonstrated that it is unlikely for Dx/HA injection to be cost equivalent to open reimplantation for higher grades and bilateral reflux.1 These authors have shown that at their center the cost of unilateral outpatient reimplantation is lower than that of unilateral Dx/HA injection for any grade of reflux. This effect will be magnified as injection success decreases with increasing reflux grade. It would be interesting to know the cost comparison for bilateral procedures. Presumably bilateral procedures are not done on an outpatient basis but the cost of the implant is also greater. With any cost analysis the assumptions profoundly affect the results. Using average percent recovery of charges rather than a more universal cost estimate makes this more relevant locally than generally. Nonetheless, this is a progressive approach to open reflux repair and a demonstration that excellent outcomes can be achieved in a cost conscious manner. Steven G. Docimo Department of Urology Children’s Hospital of Pittsburgh Pittsburgh, Pennsylvania 1.
Benoit RM, Peele PB and Docimo SG: The cost-effectiveness of dextranomer/hyaluronic acid copolymer for the management of vesicoureteral reflux. 1: substitution for surgical management. J Urol 2006; 176: 1588.
Studies of this sort are difficult to interpret due to regional differences in hospital costs, and other variables and as-
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sumptions. The authors postulate that 11% of patients treated endoscopically for VUR will go on to have a second procedure, which will fail in 20%. Currently this is not the case and such an assumption may be flawed. In my practice 40% of failures are reduced to grade I/V and are simply observed. The same is true of open surgery. As experience is gained with endoscopic injection, repeat injections should be infrequent but when performed, the success rate has been reported to be 90%.1 Another potential error is the use of 1.2 ml as an average volume for unilateral reflux, which implies that 0.8 ml is discarded. In practice this is seldom done. Unilateral reflux is usually treated with 1.0 ml (1 syringe including the needle flush), thus potentially reducing the cost of Dx/HA injection for unilateral cases in this analysis by more than $1,000, making it less expensive than open outpatient surgery. Surgeons should choose the surgical approach most comfortable for them and families. This study reveals that cost is not significantly different between the 2 approaches and should not be the reason to choose one approach over the other. At the end of the day the only difference between open and endoscopic surgery may be the presence or absence of a scar and as a result, parents are likely to choose the least invasive approach.2,3 Desite the limitations discussed by the authors, transformation of a highly successful inpatient procedure into one performed on an outpatient basis is laudable. Efforts to make open procedures less invasive and endoscopic injection less expensive are tenable goals. Andrew J. Kirsch Children’s Healthcare of Atlanta Emory University School of Medicine Atlanta, Georgia 1.
Elmore JM, Scherz HC and Kirsch AJ: Dextranomer/hyaluronic acid copolymer for vesicoureteral reflux: success rates after initial treatment failure. J Urol 2006; 175: 712. 2. Ogan K, Pohl HG, Carlson D, Belman AB and Rushton HG: Parental preferences in the management of vesicoureteral reflux. J Urol 2001; 166: 240. 3. Capozza N, Lais A, Matarazzo E, Nappo S, Patricolo M and Caione P: Treatment of vesico-ureteric reflux: a new algorithm based on parental preference. BJU Int 2003; 92: 285.
REPLY BY AUTHORS We did struggle with the best method for assessing the financial impact of both procedures, and selected the calculation that would deal with real figures, or what is actually paid by insurance companies and families to have the procedure done. While absolute payment amounts vary regionally, we find it likely that the relative total system payment for open versus Dx/HA injection is comparable. Hopefully this makes the comparison relevant to other regions. Concern was raised about the 1.2 ml mean of Dx/HA used for unilateral injection. If one injects many orifices with higher grade reflux, several will require greater than 1.0 ml to achieve the desired post-injection configuration. If one’s practice allows a mean use less than what we report, thenthe mean cost of the Dx/HA group will decrease correspondingly. In addition, any decrease in Dx/HA purchase cost would greatly affect the comparison.
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We did include a speculative calculation of what the outlay would be to achieve similar reflux resolution rates. Elmore et al reported that only 15% of post-Dx/HA injection persistent reflux was grade I (reference 1 in comment), which would most likely be considered for observation and not second injection. Our comparison, while clearly specula-
tive and definitely requiring some estimation, makes a decent approximation of what outlay can be expected to achieve similar resolution rates with both approaches. In addition to the absence or presence of a small scar in the open reimplant group is the long-term presence of an exogenous substance within the bladder wall of the Dx/HA group.
DISCUSSION Dr. Hal Scherz. I thought this was a nice review of the financial impact but I wanted to ask if you had any idea about the weight of each factor you used for your analysis, because at many institutions like ours we can get the patient in and out of the operating room between 20 and 25 minutes, which would significantly change your cost analysis for the anesthetic component of the endoscopy case, for example. Dr. Kara Saperston. We did not look at the weight of the different variables. I think that is a good point and we will look at that. Dr. David Roth. You included an increased cost for the Deflux failures but you did not include any costs or possible complications of the surgical arm. Did you look at that and what would be the impact if you did? Doctor Saperston. In our cohort of 206 cases of which 180 were open there was only 1 rehospitalization. It was the night of surgery but at an outside hospital, and so we were unable to get that cost data.