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• W3083177761 abstract "Open AccessUrology PracticeBusiness of Urology1 Mar 2021Initial Experience with Novel Single-Use Disposable Ureteroscopy: A Prospective, Single Arm 90-Day Trial of the Axis UreteroscopeThis article is commented on by the following:Editorial Commentary Tim Large, Marcelino Rivera, Charles Nottingham, Deepak Agarwal, Matthew Mellon, and Amy Krambeck Tim LargeTim Large Department of Urology, Indiana University, Indianapolis, Indiana Financial interest and/or other relationship with Boston Scientific Corporation. More articles by this author , Marcelino RiveraMarcelino Rivera Department of Urology, Indiana University, Indianapolis, Indiana Financial interest and/or other relationship with Boston Scientific Corporation. More articles by this author , Charles NottinghamCharles Nottingham Department of Urology, Indiana University, Indianapolis, Indiana More articles by this author , Deepak AgarwalDeepak Agarwal Department of Urology, Indiana University, Indianapolis, Indiana More articles by this author , Matthew MellonMatthew Mellon Department of Urology, Indiana University, Indianapolis, Indiana More articles by this author , and Amy KrambeckAmy Krambeck ‡Correspondence: Department of Urology, Indiana University/IU Health Physicians, 1801 Senate Blvd., Suite 220, Indianapolis, Indiana 46202 telephone: 317-962-3700; E-mail Address: [email protected] Department of Urology, Indiana University, Indianapolis, Indiana Financial interest and/or other relationship with Boston Scientific Corporation. Financial interest and/or other relationship with Lumenis. More articles by this author View All Author Informationhttps://doi.org/10.1097/UPJ.0000000000000194AboutAbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Abstract Introduction: Novel digital disposable ureteroscopes are becoming more commonplace in endourological practices. We trialed the Axis™ single-use ureteroscope, which is distributed within the United States by Dornier MedTech. Our goal was to demonstrate clinical equivalence to our reusable platform and to evaluate the cost-effectiveness of a single-use digital ureteroscope. Methods: We conducted a prospective 90-day trial where all flexible ureteroscopic procedures were completed using the single-use ureteroscope. The cases were monitored for scope failure, scope deficiencies and surgeon satisfaction scores via an immediate postoperative REDCap® survey. We also performed a cost analysis between reusable scopes and the single-use ureteroscope. The cost of the reusable platform included the amortized initial purchase, maintenance and clean processing. Results: Over a 90-day period, we performed 93 flexible ureteroscopy procedures with a single-use ureteroscope, of which 74 were completed using Axis. After controlling for operating room time and disposable items used, the utilization of Axis was associated with an average reduction of $140.31 per case. Extrapolating the per-case savings over an annual case volume, we estimate a total savings of $56,127.15. There were no disposable scope malfunctions. There were 4 (4.3%) cases converted to reusable scopes due to image quality (1), inadequate secondary deflection (2) and a tight ureter (1). Mean±SD score for image quality, mobility and ergonomics was 9.1±1.1, 8.9±1.1, 9.3±1.1, respectively. The 90-day complication rates were equal to our controls. Conclusions: We demonstrated that the Axis single-use digital ureteroscope is equivalent in function to our digital reusable scope and reduced the cost of flexible ureteroscopy. Abbreviations and Acronyms f-URS flexible ureteroscopy PCNL percutaneous nephrolithotomy ru-scope reusable ureteroscope SFR stone-free rate su-scope single-use ureteroscope The adoption of flexible ureteroscopy continues to increase worldwide.1 Flexible ureteroscopy is predominantly performed with a reusable fiber optic and digital ureteroscope with a fraction of the total flexible ureteroscopy being performed with single-use disposable ureteroscopes.2 Despite representing the smallest portion of total ureteroscopy procedures, increasing adoption of disposable scopes is likely to occur as the visual acuity and scope agility improve while the cost per unit decreases. The original disposable ureteroscope, LithoVue™, was developed by Boston Scientific Corporation in 2015 and has been extensively evaluated against commercially available reusable ureteroscopes.3–7 Clarion Medical Technologies followed with the Pusen Uscope,8 and now there are multiple devices, including ZebraScope™ (Happiness Workshop),9 Cook Medical,10 WiScope™ (Bard)11 and Axis.12 Despite the major advances in endoscopic technology, there remain benchmark metrics that are required for all endoscopes, including: visual acuity, tip diameter and agility, scope safety, durability and cost. The importance placed on each metric may vary amongst urologists. Improvements in the technology and manufacturing of su-scopes, especially with complementary metal oxide semiconductor camera chips, is improving su-scope image quality and cost control compared to ru-scopes.13 Additionally, concerns over the environmental impact of a wider utilization of su-scopes have largely been mitigated by a comparative analysis showing that the carbon footprint is equivalent for both su-scopes and ru-scopes.14 Nevertheless, the historical sentiment that ru-scopes provide a better image quality, smaller environmental impact and cost savings still persists today.15 Therefore, we sought to evaluate and identify if any of the novel su-scopes could challenge commercially available ru-scopes. After evaluating all available digital disposable ureteroscopes in the U.S. (as of August 30, 2019), we believed the Axis su-scopes provided the best image quality while maintaining excellent agility along with a comparative scope tip size.12 Additionally, the price per unit for the Axis su-scope was competitive. Our study evaluates the Axis su-scope during a 90-day period with an institutional conversion to 100% su-scope f-URS during the study period. Methods This is an IRB approved, single-site, prospective 90-day study of all consecutive f-URS performed (IRB No. 2008196320). All cases were performed with a su-scope during the study period. Cases were performed by 4 surgeons (AK, MM, MR, TL). Prior to this trial, our institution performed all f-URS with a digital reusable platform. In 2016, 11 new flexible reusable ureteroscopes were purchased. Our institution is a tertiary teaching facility with 2 endourology/stone fellows and 2 urology residents (1 first year and 1 third year) performing all f-URS in tandem with one of the above mentioned surgeons. The identity of the digital, reusable platform is purposely excluded as repair and replacement pricing is variable and at our institution, we use a hybrid repair/replace maintenance plan with the vendor to maximally reduce repair costs. Patients were excluded if f-URS was aborted because of stone impaction, infected urine, or the stone location did not require f-URS. Combination cases with PCNL or other genitourinary procedures such as holmium laser enucleation of the prostate were permitted. The designation of scope failure was assigned to any su-scope that did not work upon unpackaging prior to insertion into the patient. Scope inadequacy was assigned to cases where the primary surgeon did not believe the standard of care could be provided using the su-scope and a ru-scope was substituted in the su-scope’s place. Lastly, malfunction was assigned to cases where the Axis could perform the case if it was in its normal function, but because of a mechanical issue, the su-scope was designated non-functioning and a ru-scope was used in its place. All su-scopes were purchased and the price of the su-scope is reflected in the cost analysis. Clinical Outcomes Analysis All f-URS was completed as outlined in previous publications.16 Prior to f-URS all patients underwent clinical evaluation, including computerized tomography, to evaluate their appropriateness for f-URS. Patient demographics, stone characteristics, and perioperative data were captured using the electronic health records and stored in an encrypted REDCap database. To verify that the trial cohort was similar to our standard practice cohort, we tracked pertinent disposable equipment utilization, operating room times, and postoperative outcomes including complications (table 1). During the trial, intraoperative surveys were sent to the surgeon evaluating su-scope agility, reliability, and image quality using a 10-point Likert scale. We noted if any su-scopes did not function before use, exchanging it for our ru-scope if broken. A second su-scope was never opened on the same case during this trial. Our standard practice for followup includes a 6-week renal bladder ultrasound and an abdominal x-ray to assesses for hydronephrosis and residual stone after f-URS (table 1). Table 1. Demographic and stone characteristics Reusable Ureteroscope Single-Use Ureteroscope p Value No. 194 74 Mean±SD yrs age (IQR) 54±20 (43–66) 48±26 (37–65) 0.08 No. gender: 0.41 Female 108 45 Male 86 29 No. ASA® class: 0.52 0 3 2 1 11 3 2 60 26 3 111 38 4 9 5 No. laterality: 0.40 Bilat 89 32 Rt 42 18 Lt 63 24 Mean±SD body mass index (IQR) 32±9.1 (24–36) 31±10 (24–35) 0.64 No. pre-stented: 0.15 Yes 32 21 No 91 45 No. first stone event: 0.38 Yes 56 19 No 80 38 No. procedure (%): 0.15 f-URS 166 (85.5) 56 (75.67) f-URS+PCNL 18 (9.3) 11 (14.8) f-URS+other 10 (5.2) 7 (9.5) Mean±SD mins operating room time (IQR) 61±36 (38–75) 58±32 (38–69) 0.29 No. renal ultrasound+x-ray of kidney, ureter & bladder without evidence of stone (%): 0.31 Unknown 3 (2) 1(1.3) Yes 160 (82) 64 (86.5) No 31 (16) 9 (12.2) No. laser lithotripsy used: 0.43 Unknown 14 0 Yes 120 47 No 60 27 No. ureteral stent used: 0.55 Rt 122 45 Lt 135 52 No. ureteral sheath used: 0.13 Yes 118 71 No 18 3 No. UroSeal/Tuohy-Borst/UroLok: 0.0001 Yes 194 0 No 0 74 No. stone basket extractor used: 0.92 Yes 188 72 No 6 2 Mean±SD procedure cost without scope ,$2016.80±$584.11 $2,020.15±$470.85 0.19 Cost Analysis The cost per su-scope varies based on regional contracts, supply volume as well as institutional demand. Prior to the trial period, the cost per su-scope was established for all cases to be performed during the 90-day trial. The Axis platform requires an external image processor and power source which is approximately $3,000/unit but can be offset with the original order and therefore was not included in the cost analysis. To evaluate the cost-effectiveness of the su-scope, we compared costing for all f-URS completed with the Axis ureteroscope to cost data from the 6 months immediately preceding the trial period. During the 6 months immediately preceding the trial period our institution used ru-scopes in all f-URS cases. In combination cases, the f-URS cost component was separated from the combination cases including operating room time and disposable equipment used specifically for f-URS. Statistical significance was established through t-test and chi-square analysis with any associated p value of 0.05. Results from the cost analysis are reported in table 2. Table 2. Perioperative outcomes Reusable Ureteroscope Single-Use Ureteroscope p Value No. 194 74 Image quality 10 Mean±SD 9.1±1.1 — Flexibility/tip deflection 10 Mean±SD 8.9±1.1 — Ergonomics 10 Mean±SD 9.3±1.1 — No. disposable scope replacement (%): Vision 1 (1.1) — Flexibility 2 (2.2) — Caliber/diameter 1 (1.1) — Malfunction 0 (0) — No. complications (%): Overall 3 (1.5)—Intensive care unit-sepsis, sepsis, respiratory insufficiency 2 (3.2)—Intensive care unit -sepsis, hematuria/pseudo-aneurysm 0.08 f-URS 0 (0) 0 (0) Results During the 90-day trial, 93 f-URS procedures were performed, all with a su-scope. Of these procedures 74 were completed with the Axis. All cases were completed as part of surgical intervention for nephrolithiasis. All su-cases were compared to our ru-scope platform. Intraoperative case details and disposable items used between the su-scope and ru-scope cases are outlined in table 1. There was no difference between the su-scope and the ru-scope cohorts with regards to case specifics; however, the ru-scopes had a higher disposable cost due to the need for ancillary working channel and water sealing devices (UroSeal™/Tuohy-Borst/UroLok™ category). The cost of delivering the care including operating room cost and disposables cost (excluding the cost of the su-scope) was similar between the groups (table 1, p=0.19). We then added the cost of the ru-scope per case, calculated by amortized cost of the ru-scopes, added to the cost to maintain, repair, replace scopes per case: and finally, the cost on average of $17.50 for the working channel water sealing device. The average total cost per case when using a ru-scope was $3,260.46, compared to $3,120.15 for the su-scope. This provides an average $140.31 cost savings per case advantage, favoring the su-scope. Extrapolated out for the number of f-URS performed per year this would save on average $56,127.15 at our center. The su-scope did not result in any direct patient complications. However, there were 4 cases (5%) where the Axis was inadequate to complete the case resulting in a conversion to our institutional ru-scope to complete the case (table 2). Two cases were for inadequate secondary deflection to get into the lower pole, and 1 case required an Olympus URF-P6 ru-scope (which is not our standard ru-scope) because the caliber of the ureter was too small to accommodate the su-scope. The last case where the Axis was unable to complete the case was a secondary f-URS after PCNL for a residual stone fragment. In this case the image quality of the su-scope was inadequate to identify stone in a bloody field requiring conversion to the ru-scope, where visualization remained challenging. Immediate postoperative surveys were sent to the surgeons asking about image quality, flexibility, and ergonomics of the su-scope compared to our ru-scope. A score of 10 was established for all 3 categories as the level of our current ru-scopes (table 2). Overall, satisfaction with the su-scope was high, with mean±SD ratings of 9.1±1.1, 8.9±1.1 and 9.3±1.1 for image quality, flexibility and ergonomics, respectively. There were 5 complications over the course of the control period and the 90-day trial.2,3 All 5 complications occurred during combination cases and were related to the PCNL component of the case. Therefore, we report no complications resulting directly from the su-scopes or from f-URS. Stone-free rates at 6 to 12-week followup were comparable for su-scopes compared to ru-scopes (85% vs 82%, p=0.31). Discussion Flexible ureteroscopy continues to grow as the preferred surgical intervention for the treatment of kidney stones.1 F-URS is increasing in prevalence,16 and with new frontiers in opioid-free surgery and cost containment.17,18 A significant amount of resources are directed toward sterile processing,19 maintaining, repairing and replacing flexible endoscopes.20 In the last 5 years, numerous publications have evaluated the safety, quality, environmental impact and cost of disposable ureteroscopes.13,14,21 Recently, environmental concerns regarding su-scope use have been placated by Davis et al.14 Therefore, the decision to adopt su-scopes hinges largely on the cost relative to a practice’s reusable platform and the quality of the disposable scope measured by flexion/deflection ability, ergonomics, durability and image quality. Scope deflection is a vital part of f-URS in order to visualize the entire collecting system to maximize stone clearance and improve stone-free rates.5 In our experience, the mean±SD surgeon rating for su-scope tip deflection was 8.9±1.1. There was only 1 instance of inadequate deflection which occurred when treating stones in a lower pole location. Treating stones in a lower pole location occurred in 18 cases (24%). This aligns with findings reported by Ozimek et al on the use of su-scopes compared to fiber optic ru-scopes for lower pole stones.6 They found that mean±SD operative times were shorter and SFRs were higher after 31 su-scope cases (56.1±34.8 vs 77.0±37.4 minutes, p=0.01; 95% vs 88.2%, p=0.1). The superior results with the su-scope were attributed to better vision with digital su-scope and a more aggressive approach to stone treatment with laser lithotripsy in the lower pole as su-scope breakage is an acceptable outcome. We had similar findings with an overall SFR of 85% and 79% SFR when looking specifically at patients with lower pole stones. However, we must acknowledge that SFR was determined by x-ray of the kidney, ureter and bladder, and ultrasound which is less sensitive compared to computerized tomography. The most perceivable improvement with the Axis scope is with respect to the image quality (see figure). Advancements in the complementary metal oxide semiconductor digital imager has led to improved visual quality without increasing cost per unit. Additionally, cost reduction was achieved by externalizing all the hardware responsible for illumination and image processing from the su-scope. In contrast to prior publications,22,23 our center believes that a historical limitation of su-scopes was their image quality, which has been resolved with this novel Axis su-scope (table 2). Of the 93 f-URSs completed 19 were performed with the LithoVue. However, due in part to the image quality difference, LithoVue use was discontinued. Increase in digital quality comes at a price as the larger chip required contributes to the larger distal tip size of the Axis when compared to the LithoVue (8.5Fr vs 7.7Fr). For some surgeons, this size difference may be more important than image quality. Figure. Left panel, f-URS with matched papilla for disposable Axis and reusable ureteroscopes. Right panel, compound upper pole papilla through Axis. The cost-effectiveness of transitioning from an established ru-scope to a su-scope platform can be challenging to evaluate, largely due to the high variability of ru-scope costs. Variability in ru-scope costs is determined by the initial purchase price, the number of cases until a ru-scope fails requiring repair and the cost associated with sterile reprocessing of ru-scopes.10 Two studies attempting to evaluate the cost associated with a ru-scope compared to a su-scope estimated that after 99 and somewhere between 61 and 118 f-URS procedures (depending on the initial purchase price per ru-scope), ru-scopes became more cost-effective than su-scope f-URS.5,7 One of the studies also demonstrated that ru-scopes cost more to maintain as they age.5 In our study, we found that maintaining our ru-scope system cost on average $140 dollars more per case compared to purchasing an Axis su-scope. Our ru-scopes are only 3 years old, which would suggest as the ru-platform ages, this cost difference may increase. Also, our institution has struggled with the variability in repair costs from month to month. Despite multiple internal quality improvement projects that removed trainee usage, required surgeon re-housing, and improving sterilization, we failed to increase the longevity of the ru-scopes. During our 90-day trial there were no su-scope failures or malfunctions. There were 4 (5%) cases in which the su-scope was unable to accomplish the procedure, which prompted the conversion to our ru-scope (table 2). In 1 instance the ureter would not accommodate the 8.5Fr su-scope despite ureteral dilation and therefore the case was completed using the Olympus URF-P6 (4.9Fr) ru-scope. Of the 3 remaining events there were 2 cases where the secondary deflection of the Axis, which has a stiff shaft, was inadequate to treat the target stone. There was also a secondary ureteroscopy after PCNL where the vision quality was insufficient with the su-scope and the residual fragment was removed with our ru-scope. Interestingly, 6.8% of patients were anticoagulated at the time of a primary single-use f-URS, none of which converted to our ru-scope. This suggests that su-scope vision quality is preserved in cases of turbid irrigation from hematuria. We did note that old clotted blood within the collecting system would have a yellow discoloration when the Axis scope was in very close proximity to the clot. This yellow discoloration could have prompted the exchange for a ru-scope in post-PCNL cases, looking for residual fragments imbedded within a clot. This study is not without limitations. First, it is prospective in nature but was structured as a quality improvement project. The external validity of our study may be limited because we have significant trainee involvement at our center. Second, our ru-scopes are premium digital flexible ureteroscopes, which can be associated with higher repair costs and potentially fewer cases before scope breakage. Additionally, the cost to repair or refurbish ru-scopes is not universally priced the same which affects the external validity of this cost analysis. We chose a 6-month control because tracking ru-scope usage is very challenging as ru-scopes can register usage during cleaning, repairs or even anticipated use without actually being used in a case. A third limitation is that this study only primarily represents 1 of the novel su-scopes. Although we trialed all the current available su-scopes, we chose to study the Axis scope due to unanimous preference among the group. Despite these limitations, this study provides high quality real-world data on the true costs associated with a novel su-flexible ureteroscope. Conclusions Single-use ureteroscopes are becoming more commonplace. The adoption of su-scopes has led to concerns over the ballooning disposable costs. Our study demonstrates that over a 90-day trial period a high volume tertiary stone center could successfully convert to 100% su-scope f-URS and significantly reduce cost. References 1. : Contemporary trends in the ambulatory surgical treatment of urolithiasis: population-based analysis. J Endourol 2015; 29: 1189. Google Scholar 2. : A comprehensive literature-based equation to compare cost-effectiveness of a flexible ureteroscopy program with single-use versus reusable devices. Int Braz J Urol 2019; 45: 658. Google Scholar 3. : Micro-costing analysis demonstrates comparable costs for lithovue compared to reusable flexible fiberoptic ureteroscopes. J Endourol 2018; 32: 267. Google Scholar 4. : A prospective case–control study comparing LithoVue, a single-use, flexible disposable ureteroscope, with flexible, reusable fiber-optic ureteroscopes. J Endourol 2017; 31: 468. Google Scholar 5. : Clinical outcomes and costs of reusable and single-use flexible ureterorenoscopes: a prospective cohort study. Urolithiasis 2018; 46: 587. Google Scholar 6. : Retrospective cost analysis of a single-center reusable flexible ureterorenoscopy program: a comparative cost simulation of disposable fURS as an alternative. J Endourol 2017; 31: 1226. Google Scholar 7. : The economic implications of a reusable flexible digital ureteroscope: a cost-benefit analysis. J Urol 2017; 197: 730. Link, Google Scholar 8. : Endoscopic treatment of lower pole stones: is a disposable ureteroscope preferable? Results of a prospective case-control study. Cent Eur J Urol 2019; 72: 280. Google Scholar 9. : Single-use versus reusable digital flexible ureteroscopes for the treatment of renal calculi: a prospective multicenter randomized controlled trial. J Endourol 2020; 34: 18. Google Scholar 10. : Single-use flexible ureteroscopes: how do they compare with reusable ureteroscopes?J Endourol 2019; 33: 71. Google Scholar 11. : Single use and disposable flexible ureteroscopes. Curr Opin Urol 2017; 27: 176. Google Scholar 12. : Flexible ureteroscopy: reuse? Or is single use the new direction?Curr Opin Urol 2020; 30: 113. Google Scholar 13. : Single-use ureteroscopes. Urol Clin N Am 2019; 46: 165. Google Scholar 14. : Carbon footprint in flexible ureteroscopy: a comparative study on the environmental impact of reusable and single-use ureteroscopes. J Endourol 2018; 32: 214. Google Scholar 15. : Next-generation fiberoptic and digital ureteroscopes. Urol Clin 2019; 46: 147. Google Scholar 16. : A prospective, multi-institutional study of flexible ureteroscopy for proximal ureteral stones smaller than 2 cm. J Urol 2015; 193: 165. Link, Google Scholar 17. : Burden of urolithiasis: trends in prevalence, treatments, and costs. Eur Urol Focus 2017; 3: 18. Google Scholar 18. : Initial experience with narcotic-free ureteroscopy: a feasibility analysis. J Endourol 2018; 32: 907. Google Scholar 19. : Patient-reported outcomes in nephrolithiasis: can we do better?J Endourol 2018; 32: 10. Google Scholar 20. : Comparative medico-economic study of reusable vs. single-use flexible ureteroscopes. Int Urol Nephrol 2019; 51: 1735. Google Scholar 21. : Avoiding a lemon: performance consistency of single-use ureteroscopes. J Endourol 2019; 33: 127. Google Scholar 22. : Comparison of new single-use digital flexible ureteroscope versus nondisposable fiber optic and digital ureteroscope in a cadaveric model. J Endourol 2016; 30: 655. Google Scholar 23. : Evaluation of a novel single-use flexible ureteroscope. J Endourol 2017; doi: 10.1089/end.2016.0237. Google Scholar This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.© 2021 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc.FiguresReferencesRelatedDetailsRelated articlesUrology PracticeJan 12, 2021, 12:00:00 AMEditorial Commentary Volume 8Issue 2March 2021Page: 196-202 Advertisement Copyright & Permissions© 2021 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc.Keywordspercutaneousnephrolithotomystaghorn calculinephrolithiasisMetricsAuthor Information Tim Large Department of Urology, Indiana University, Indianapolis, Indiana Financial interest and/or other relationship with Boston Scientific Corporation. More articles by this author Marcelino Rivera Department of Urology, Indiana University, Indianapolis, Indiana Financial interest and/or other relationship with Boston Scientific Corporation. More articles by this author Charles Nottingham Department of Urology, Indiana University, Indianapolis, Indiana More articles by this author Deepak Agarwal Department of Urology, Indiana University, Indianapolis, Indiana More articles by this author Matthew Mellon Department of Urology, Indiana University, Indianapolis, Indiana More articles by this author Amy Krambeck Department of Urology, Indiana University, Indianapolis, Indiana ‡Correspondence: Department of Urology, Indiana University/IU Health Physicians, 1801 Senate Blvd., Suite 220, Indianapolis, Indiana 46202 telephone: 317-962-3700; E-mail Address: [email protected] Financial interest and/or other relationship with Boston Scientific Corporation. Financial interest and/or other relationship with Lumenis. 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• W3083177761 title "Initial Experience with Novel Single-Use Disposable Ureteroscopy: A Prospective, Single Arm 90-Day Trial of the Axis Ureteroscope" @default.
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