Translating ethical and quality principles for the effective, safe and fair development, deployment and use of artificial intelligence technologies in healthcare.

OBJECTIVE: The complexity and rapid pace of development of algorithmic technologies pose challenges for their regulation and oversight in healthcare settings. We sought to improve our institution's approach to evaluation and governance of algorithmic technologies used in clinical care and operations by creating an Implementation Guide that standardizes evaluation criteria so that local oversight is performed in an objective fashion. MATERIALS AND METHODS: Building on a framework that applies key ethical and quality principles (clinical value and safety, fairness and equity, usability and adoption, transparency and accountability, and regulatory compliance), we created concrete guidelines for evaluating algorithmic technologies at our institution. RESULTS: An Implementation Guide articulates evaluation criteria used during review of algorithmic technologies and details what evidence supports the implementation of ethical and quality principles for trustworthy health AI. Application of the processes described in the Implementation Guide can lead to algorithms that are safer as well as more effective, fair, and equitable upon implementation, as illustrated through 4 examples of technologies at different phases of the algorithmic lifecycle that underwent evaluation at our academic medical center. DISCUSSION: By providing clear descriptions/definitions of evaluation criteria and embedding them within standardized processes, we streamlined oversight processes and educated communities using and developing algorithmic technologies within our institution. CONCLUSIONS: We developed a scalable, adaptable framework for translating principles into evaluation criteria and specific requirements that support trustworthy implementation of algorithmic technologies in patient care and healthcare operations.

Rural For-Profit Hospitals Are Associated With Higher Commercial Prices for 3 Common Urological Procedures.

INTRODUCTION: Rural patients lack access to urological services, and high local prices may dissuade underinsured patients from surgery. We sought to describe commercially insured prices for 3 urological procedures at rural vs metropolitan and for-profit vs nonprofit hospitals. METHODS: A cross-sectional analysis of commercially insured prices from the Turquoise Health Transparency data set was performed for ureteroscopy with laser lithotripsy, transurethral resection of bladder tumor, and transurethral resection of prostate. Hospital characteristics were linked using the Centers for Medicare and Medicaid Services Healthcare Cost Reporting Information System. Linear modeling analyzed median hospital price and its association with hospital characteristics. RESULTS: Overall, 1,532 hospitals reported urological prices in Turquoise. Median prices for each procedure were higher at rural for-profits (ureteroscopy $16,522, transurethral resection of bladder tumor $5,393, transurethral resection of prostate $9,999) vs rural nonprofits (ureteroscopy $4,512, transurethral resection of bladder tumor $2,788, transurethral resection of prostate $3,881) and metropolitan for-profits (ureteroscopy $5,411, transurethral resection of bladder tumor $3,420, transurethral resection of prostate $4,874). Rural for-profit status was independently associated with 160% higher price for ureteroscopy (relative cost ratio 2.60, P < .001), 50% higher for transurethral resection of bladder tumor (relative cost ratio 1.50, P = .002), and 113% higher for transurethral resection of prostate (relative cost ratio 2.13, P < .001). CONCLUSIONS: Prices are higher for 3 common urological surgeries at rural for-profit hospitals. Differential pricing may contribute to disparities for underinsured rural residents who lack access to nonprofit facilities. Interventions that facilitate transportation and price shopping may improve access to affordable urological care.

In Pursuit of the Optimal Dusting Settings with the Thulium Fiber Laser: An In Vitro Assessment.

Objective: Low energy and high frequency settings are used in stone dusting for holmium lasers. Such settings may not be optimal for thulium fiber laser (TFL). With the seemingly endless combination of settings, we aim to provide guidance to the practicing urologists and assess the efficiency of the TFL platform in an automated in vitro "dusting model." Materials/Methods: Three experimental setups were designed to investigate stone dusting produced by an IPG Photonics TLR-50 W TFL system using 200 µm fiber and soft BegoStone phantoms. The most popular 10 and 20 W dusting settings among endourologist familiar with TFL were evaluated. We directly compared short pulse (SP) vs long pulse (LP) mode using various combinations of pulse energy (Ep) and pulse frequency (F). Thereafter, we tested the 10 and 20 W settings and compared them among each other to elucidate the most efficient settings at each power. Treatments were performed under the same total laser energy delivered to the stone at four different standoff distances (SDs) with a clinically relevant scanning speed of either 1 or 2 mm/sec. Ablation volumes were quantified by optical coherence tomography to assess stone dusting efficiency. Fragment size after ablation at different pulse energies was evaluated by sieving and evaluating under a microscope after treatment. Results: Overall, SP provided greater ablation volume when compared with LP. Our dusting efficiency model demonstrated that the maximum stone ablation was achieved at the combination of high energy/low frequency settings (p < 0.005) and at a SD of 0.2 mm. At all tested pulse energies, no stone phantoms were broken into fragments >1 mm. Conclusions: During stone dusting with TFL, SP offers superior ablation to LP settings. Optimal dusting at clinically relevant scanning speeds of 1 and 2 mm/sec occurs at high energy/low frequency settings. Thulium lithotripsy with high Ep does not result in increased fragment size.

Association of Rural Hospital for-Profit Status With Higher Publicly Reported Prices for the Components of Inpatient Hematuria Evaluation Among Commercially Insured Patients.

INTRODUCTION: Rural patients have limited access to urological care and are vulnerable to high local prices. Little is known about price variation for urological conditions. We aimed to compare reported commercial prices for the components of inpatient hematuria evaluation between for-profit vs not-for-profit and rural vs metropolitan hospitals. METHODS: We abstracted commercial prices for the components of intermediate- and high-risk hematuria evaluation from a price transparency data set. We compared hospital characteristics between those that do and do not report prices for a hematuria evaluation using the Centers for Medicare and Medicaid Services Healthcare Cost Reporting Information System. Generalized linear modelling evaluated the association between hospital ownership and rural/metropolitan status with prices of intermediate- and high-risk evaluations. RESULTS: Of all hospitals, 17% of for-profits and 22% of not-for-profits report prices for hematuria evaluation. For intermediate-risk, median price at rural for-profit hospitals was $6,393 (interquartile range [IQR] $2,357-$9,295) compared to $1,482 (IQR $906-$2,348) at rural not-for-profits and $2,645 (IQR $1,491-$4,863) at metropolitan for-profits. For high-risk, rural for-profit hospitals' median price was $11,151 (IQR $5,826-$14,366) vs $3,431 (IQR $2,474-$5,156) at rural not-for-profits and $4,188 (IQR $1,973-$8,663) at metropolitan for-profits. Rural for-profit status was associated with an additional higher price for intermediate- (relative cost ratio 1.62, 95% CI 1.16-2.28, P = .005) and high-risk evaluations (relative cost ratio 1.50, 95% CI 1.15-1.97, P = .003). CONCLUSIONS: Rural for-profit hospitals report high prices for components of inpatient hematuria evaluation. Patients should be aware of prices at these facilities. These differences may dissuade patients from undergoing evaluation and lead to disparities.

Evolution of Single-Use Urologic Endoscopy: Benchtop and Initial Clinical Assessment of a New Single-Use Flexible Cystoscope.

Introduction: Office cystoscopy is one of the most frequently performed procedures by a urologist. However, single-use cystoscopes remain quite undeveloped. Ambu® has developed single-use broncoscopes, rhinolaryngoscopes, and duodenoscopes. Recently, they released a single-use cystoscope. In this study, we performed a benchtop and an initial clinical assessment of the Ambu aScope™ (4) Cysto (aS4C) single-use cystoscope. Materials and Methods: Ten new, never-used aS4C single-use cystoscopes were assessed for optical performance, maximal tip flexion, and irrigation flow rate with empty working channel, 365 µm laser fiber, 0.035 in hydrophilic-tipped wire, 1.9F nitinol basket, and a 1.8 mm flexible stent grasper. All cystoscopes were then fully flexed 25 times in each direction, and maximal flexion angles were remeasured with and without instruments. Optical resolution, distortion, and depth of field were measured and compared with our reusable digital flexible cystoscopes. Assessment of clinical use was performed for inpatient bedside procedures using a Likert feedback survey and the NASA Task Load Index. Results: Maximal upward flexion exceeded 200° and 160° for all working instruments in upward and downward flexion. Downward flexion demonstrated different flexion between instrument groups in pre- and postcycling (p < 0.001). There was no clinical difference between the pre- and postcycling flexion. Flow rate decreased with increasing working instrument size (p < 0.001). The Olympus HD cystoscope resolution was superior at 3 and 5 mm distance, but not at other distances. The Ambu scope was superior to the Olympus SD scope at all distances except 3 mm. The aS4C had higher Likert scale survey scores for clinical use. Conclusions: The new Ambu single-use cystoscope demonstrates good flexion across instruments and comparable optics with reusable cystoscopes. In addition, initial inpatient bedside use of the aS4C and Monitor system compares favorably with the Olympus reusable cystoscope. Further testing in clinical scenarios such as hematuria, urothelial carcinoma, and operative endoscopy is warranted.

Benchtop Assessment of a New Single-Use Flexible Ureteroscope.

Introduction: Single-use flexible ureteroscopes are an increasingly popular alternative to reusable ureteroscopes. In this study, we performed a benchtop examination of the physical and optical properties of the new Dornier Axis™ (Webling, Germany) single-use ureteroscope. Methods: Ten new, never-used Dornier Axis ureteroscopes were assessed for optical performance, maximal tip deflection, and irrigation flow rate with an empty working channel and with insertion of 200 and 365 µm laser fibers, and a 1.9F nitinol basket. All ureteroscopes were then fully deflected 100 times in each direction, and maximal deflection angles were re-measured with and without instruments in the working channel. All measurements were performed in duplicate. In vitro optical testing for resolution, image distortion, and depth of field was performed and compared vs the LithoVue™ (Boston Scientific, Marlborough, MA) single-use ureteroscope. Statistical analyses using paired Wilcoxon rank-sum tests and Kruskal-Wallis multiple-group comparison tests were performed in R. Results: Median maximal deflection angles exceeded 300° in both directions before and after 100 full deflection cycles for all groups except the 365 µm laser fiber group. After 100 deflection cycles, there was no change in the majority of working instruments, except a decrease in upward flexion with an empty channel and 200 µm Moses™ laser fiber, and downward flexion with 200 µm Flexiva™ laser fiber (all <10°). After excluding the 365 µm fiber, there was no difference in multi-group comparison for upward and downward flexion pre- and post-cycling. Median flow rate through an empty channel was 48.0 mL/min, and it decreased significantly with all used instruments (p < 0.001). Compared with the LithoVue, the Axis demonstrated superior resolution at all tested distances and less distortion. Conclusions: The new Dornier Axis single-use ureteroscope demonstrates excellent tip deflection, which remains unchanged after 100 manual flexions in each direction. The Axis also demonstrates superior optical performance compared with the LithoVue in benchtop testing.

Assessment of conservative dietary management as a method for normalization of 24-h urine pH in stone formers.

Low urine pH is a metabolic risk factor for stone formation. While medical therapy is typically prescribed (as urinary alkalinization), patients typically prefer dietary modifications. We aimed to assess capacity to alter urine pH with dietary management alone. We analyzed a retrospective cohort of stone formers seen between 2000 and 2015 with multiple 24-h urine collections (24hUC). Patients ≥ 18 years old with low urine pH (< 6.0) were included; those prescribed alkalinizing agents or thiazides were excluded. Demographic data, 24hUC parameters, and medications were abstracted. 24hUC was utilized to calculate gastrointestinal alkali absorption (GIAA). The primary outcome was urine pH ≥ 6.0 on second 24hUC. Predictors were selected utilizing multivariable logistic regression. The database consisted of 2197 stone formers; 224 of these met inclusion criteria. On second 24hUC, 124 (55.4%) achieved a favorable pH ≥ 6.0. On univariable analysis, a second pH ≥ 6.0 was associated with high initial pH, low initial sulfate, younger age, increase in citrate/GIAA/urine volume, and decrease in ammonium (P < 0.02). On multivariable analysis, high initial pH (OR = 23.64, P < 0.001), high initial GIAA (OR = 1.03, P = 0.001), lower initial sulfate (OR = 0.95, P < 0.001), increase in urine volume (OR = 2.19, P = 0.001), increase in GIAA (OR = 8.6, P < 0.001), increase in citrate (OR = 2.7, P = 0.014), decrease in ammonium (OR = 0.18, P < 0.001), and younger age (OR = 0.97, P = 0.025) were associated with a second pH ≥ 6.0. The analysis demonstrated a corrected AUC of 0.853. These data suggest that certain dietary recommendations (increases in urine volume, citrate, GIAA, and decreased acid load) may normalize urine pH in a select group of patients. This may allow urologists to counsel patients with low urine pH on possibility of success with dietary modification alone.

No-Shows in Adult Urology Outpatient Clinics: Economic and Operational Implications.

INTRODUCTION: We analyzed trends and explored implications of no-show rates in adult urology from provider related characteristics at an academic program. METHODS: No-show rates were determined from electronic health records of appointments in adult urology at Duke University Medical Center and affiliated clinics between January 2014 and December 2016. t-Test, Wilcoxon rank sum and ANOVA were employed. RESULTS: Of 72,571 total appointments 13,219 (18.2%) were no-shows. The no-show rates per provider related characteristic were provider type (physician 22.1% vs advanced primary provider 34.0%), visit category (new 26.9% vs return 25.6% vs procedure 17.5%), faculty status (assistant 22.9% vs associate 21.9% vs professor 21.4%) and specialty (oncology 26.7% vs reconstructive 22.9% vs stones 25.4%). Average lead times of advanced primary practitioners and physicians were 47 and 62 days, respectively. There was a statistically significant difference in mean no-show rates by provider type (p <0.01) and new patient by provider type (p <0.01). However, there was no statistical difference in mean rates by specialty, faculty status, provider bump history, provider based visit types and average lead time. The potential loss in revenue from outpatient no-shows is at least $429,810 annually. CONCLUSIONS: Provider type and new patient visits by provider type have statistically different no-show rates. Missed appointments are costly and affect clinical efficiency, access to care and potentially patient outcomes. Given the shift toward value based care and future workforce changes, further investigations are needed to determine interventions to help reduce no-show rates. Models to predict and adjust clinics should be developed and deployed.

Avoiding a Lemon: Performance Consistency of Single-Use Ureteroscopes.

INTRODUCTION AND OBJECTIVES: Single-use flexible ureteroscopes are increasingly popular because of high repair costs of reusable ureteroscopes. As new single-use ureteroscopes enter the market, the consistency of performance of these devices has been questioned. Our objective was to compare two single-use ureteroscopes: the Pusen PU3022a (Zhuhai Pusen) and the LithoVue (Boston Scientific) with emphasis on physical and optical performance consistency. METHODS: Ten LithoVue and 10 Pusen ureteroscopes were evaluated in never-used condition. The following parameters were recorded: maximal tip deflection with an empty working channel, 200 µm laser fiber, and 1.9F basket; image resolution at 10, 20, and 50 mm; and irrigation flow rate; all ureteroscopes were then fully deflected for 200 cycles. Maximum deflection was remeasured. Mean values for each parameter were compared. To examine within-manufacturer consistency, the variance was calculated and an F-test performed to evaluate for equivalence. RESULTS: Both ureteroscopes provided max deflection over 270°. The Pusen flexed to a greater degree than LithoVue. The Pusen lost more deflection with a laser fiber in the working channel. LithoVue had higher resolution at 10 mm, but the ureteroscopes were similar at 20 and 50 mm. Although the working channel diameter is identical, irrigation flow was higher with the Pusen. However, its working channel was 7 cm shorter than LithoVue. After 200 cycles of deflections, LithoVue had less deflection loss, although one ureteroscope was excluded from analysis because of mechanical failure. Variability was minimal and not significant between manufacturers at all measured parameters. CONCLUSIONS: LithoVue and the newer PU3022a have similar "out-of-the-box" performance characteristics and seem durable. These two single-use flexible ureteroscopes performed consistently regardless of the manufacturer.

A Decision Analysis of Observation vs Immediate Reintervention for Asymptomatic Residual Fragments Less than 4 mm Following Ureteroscopic Lithotripsy.

INTRODUCTION: We performed a decision analysis model of the cost-effectiveness of observation vs intervention for asymptomatic residual fragments less than 4 mm in diameter following ureteroscopic holmium laser lithotripsy. METHODS: Outcomes data from a retrospective analysis evaluating the natural history, complications and reintervention rates of asymptomatic residual stone fragments performed by the EDGE (Endourology Disease Group for Excellence) Research Consortium were used. A decision analysis model was constructed to compare the cost-effectiveness of initial observation of residual fragments to immediate intervention. Cost of observation included emergency room visits, hospitalizations and reinterventions. The cost analysis model extended to 3 years to account for delayed reintervention rates for fragments less than 4 mm. Costs of emergency department visits, readmissions and reinterventions were calculated based on published figures from the literature. RESULTS: Decision analysis modeling demonstrated that when comparing initial observation to immediate reintervention, the cost was $2,183 vs $4,424. The difference in cost was largely driven by the fact that over 3 years, approximately 55% of all patients remained asymptomatic and did not incur additional costs. This represents an approximate annual per patient savings of $747, and $2,241 over 3 years when observation is selected over immediate reintervention. CONCLUSIONS: Our decision analysis model demonstrates superior cost-effectiveness for observation over immediate reintervention for asymptomatic residual stones less than 4 mm following ureteroscopic lithotripsy. Based on these findings careful stratification and selection of patients may enable surgeons to improve cost-effectiveness of managing small, asymptomatic residual fragments following ureteroscopic lithotripsy.

Dusting Efficiency of the Moses Holmium Laser: An Automated In Vitro Assessment.

INTRODUCTION: Moses technology is a novel Holmium:YAG laser system designed to minimize stone retropulsion and improve stone ablation when the laser is not in direct contact with the stone. Our aim was to assess the efficiency of Moses technology relative to short- and long-pulse lithotripsy using an automated in vitro "dusting model" of stone comminution. METHODS: All tests were conducted using a Lumenis Pulse 120H Holmium:YAG laser with a 365 µm Moses D/F/L fiber. "Hard" (15:3) and "soft" (15:6) Begostones mimicking calcium oxalate monohydrate and uric acid stones, respectively, were used. To assess ablation efficiency and fiber tip degradation, a dusting model was employed: the laser was moved by a three-dimensional positioning system in a spiral motion across a flat Begostone surface submerged in water. Ablation efficiency was measured as stone mass loss after 4 kJ of energy delivery. Fiber tip degradation was measured at 1 kJ intervals. Comparative trials with short pulse, long pulse, Moses contact, and Moses distance settings were completed with the laser tip positioned at 0, 1, and 2 mm distances from the stone at energy settings of 0.4 J delivered at 70 Hz. RESULTS: In our dusting model, stone ablation was significantly greater the closer the laser was to the stone. On hard stones, pulse type did not have a significant impact on ablation at any distance. On soft stones at 0 mm, Moses contact produced the greatest ablation, significantly greater than long pulse (p < 0.05). At 1 mm, Moses distance produced significantly greater ablation than all other settings (p = 0.025) and was as effective as long or short pulse at 0 mm. At 2 mm distance, no pulse type demonstrated significantly different ablation. Fiber tip degradation was minimal and not significant between settings. CONCLUSIONS: Moses technology delivers greater ablation of soft stones when in contact and 1mm from the stone surface.

Disproportionate Use of Inpatient Care by Older Adults With Kidney Stones.

OBJECTIVE: To describe variation in utilization and costs of inpatient care for patients with kidney stones, examining associations with older age. MATERIALS AND METHODS: Using the Nationwide Inpatient Sample we examined inpatient discharges with stone diagnoses from 2007 to 2011. We examined length of stay, hospitalization cost, and postdischarge care utilization using multivariable regression to identify associations between patient/hospital characteristics and resource. RESULTS: An estimated 1.7 million hospital discharges for stone disease occurred during the study period. Median length of stay was 2.1 days with a median cost of $6300. Hospital use was substantially higher among persons ≥65 years old (older adults) as compared to those aged 18-64 (younger adults): median length of stay was 3.1 days, with 25% staying more than 5.9 days. Older adults were significantly more likely to utilize home health (odds ratio [OR] 3.6) or skilled nursing (OR 5.0) after discharge. Older adults accounted for 1 in 3 hospital discharges, 40% of costs, and half of postdischarge care utilization. They were more likely to be septic during hospitalization (OR 1.8) which doubled costs per episode, but less likely to receive surgery (OR 0.93). CONCLUSION: While historically at lower risk for kidney stones compared to younger adults, older adults utilizing inpatient care account for a disproportionate share of the economic burden of disease. Utilization is higher for older adults across multiple dimensions, including hospital costs, length of stay, and postdischarge care. These findings suggest that efforts to understand and mitigate the impact of kidney stones on this vulnerable population are required.

The economics of stone disease.

The rising prevalence of kidney stone disease is associated with significant costs to healthcare systems worldwide. This is in part due to direct procedural and medical management costs, as well as indirect costs to health systems, patients, and families. A number of manuscripts evaulating the economics of stone disease have been published since the 2008s International Consultation on Stone Disease. These highlight costs associated with stone disease, including acute management, surgical management, and medical management. This work hopes to highlight optimization in care by reducing inefficient treatments and maximizing cost-efficient preventative strategies.

Digital Tomosynthesis: A Viable Alternative to Noncontrast Computed Tomography for the Follow-Up of Nephrolithiasis?

OBJECTIVE: Digital tomosynthesis (DT) is a new X-ray-based imaging technique that allows image enhancement with minimal increase in radiation exposure. The purpose of this study was to compare DT with noncontrast computed tomography (NCCT) and to evaluate its potential role for the follow-up of patients with nephrolithiasis in a nonemergent setting. METHODS: A retrospective review of patients with nephrolithiasis at our institution that underwent NCCT and DT from July 2012 to September 2013 was performed. Renal units (RUs) that did not undergo treatment or stone passage were randomly assigned to two blinded readers, who recorded stone count, size area (mm(2)), maximum stone length (mm), and location, for both DT and NCCT. Mean differences per RU were compared. Potential variables affecting stone detection rate, including stone size and body mass index (BMI), were evaluated. Interobserver agreement was determined using the intraclass correlation coefficient to measure the consistency of measurements made by the readers. RESULTS: DT and NCCT demonstrated similar stone detection rates in terms of stone counts and stone area mm(2). Of the 79 RUs assessed, 41 RUs showed exact stone counts on DT and NCCT. The mean difference in stone area was 16.5 mm(2) (-4.6 to 38.5), p = 0.121. The mean size of the largest stone on NCCT and DT was 9.27 and 8.87 mm, respectively. Stone size and BMI did not cause a significant difference in stone detection rates. Interobserver agreement showed a strong correlation between readers and adequate reproducibility. CONCLUSION: We found DT to be a comparable imaging modality to NCCT for the detection of intrarenal stones, without a significant effect from stone size and BMI and adequate reproducibility between multiple readers. DT appears to be an ideal alternative for following patients with nephrolithiasis due to its acceptable stone detection rates, low radiation exposure, and decreased cost compared to NCCT.

Estimating the nationwide, hospital based economic impact of pediatric urolithiasis.

PURPOSE: The incidence of urolithiasis is increasing in children and adolescents but the economic impact of this problem is unclear. We examined 2 large databases to estimate the nationwide economic impact of pediatric urolithiasis. MATERIALS AND METHODS: We analyzed the 2009 NEDS and KID, used ICD-9-CM codes to identify children 18 years or younger diagnosed with urolithiasis and abstracted demographic and charge data from each database. RESULTS: We identified 7,348 weighted inpatient discharges in KID and 33,038 emergency department weighted encounters in NEDS. Of the patients 32% and 36% were male, respectively. Inpatients were younger than those who presented to the ED (mean age 13.9 vs 15.7 years). Most patients had private insurance (52.9% to 57.2%) and the South was the most common geographic region (39.5% to 44.4%). The most common procedures were ureteral stent placement in 20.4% to 24.1% of cases, followed by ureteroscopy in 3.8% to 4.4%. Median charges per admission were $13,922 for a weighted total of $229 million per year. Median emergency department charges were $3,991 per encounter for a weighted total of $146 million per year. CONCLUSIONS: Each day in 2009 in the United States an estimated 20 children were hospitalized and 91 were treated in the emergency department for upper tract stones. A conservative estimate of 2009 annual charges related to pediatric urolithiasis in the United States is at least $375 million. This is likely a significant underestimate of the true economic burden of pediatric urolithiasis because it accounts for neither outpatient management nor indirect costs such as caregiver time away from work.

Disposable devices for RIRS: where do we stand in 2013? What do we need in the future?

PURPOSE: Disposable devices for retrograde intrarenal surgery (RIRS) form a significant part of the urologist's armamentarium for the endoscopic management of urologic diseases. Herein, we provide an overview of the literature regarding the advances and controversies of these devices. METHODS: A PubMed search was used to identify the literature discussing the subject of disposable devices for RIRS. Articles published between 2012 and 2013 were considered. RESULTS: Ureteral access implements including access sheaths, wires, and dilators are an area of both improvement and controversy regarding their proper use. The safety, effectiveness, and limitations of lithotrites continue to be refined. Stone retrieval devices are undergoing persistent miniaturization, and their use may prove to be cost effective. The debate over perioperative stenting remains, while symptom management is explored. A cost-effective option for disposable flexible ureteroscopy shows promise. CONCLUSIONS: While rapid advances in technology and knowledge continue, continual improvements are necessary. Disposable equipment needs persistent refinement and possible miniaturization. More efficient fragment retrieval devices are needed. Durability of laser fibers and safety within ureteroscopes needs to be improved. Reducing stent morbidity remains an ongoing challenge. Lastly, costs need to be reduced by the further development of disposable flexible ureteroscopes and in the recyclability of disposable devices to improve availability worldwide.

Antiretropulsion devices.

PURPOSE OF REVIEW: Stone migration during the treatment of ureteral stones can prove frustrating and increases both healthcare cost and patient morbidity. Antiretropulsion devices have been engineered to prevent stone migration. RECENT FINDINGS: Improvements in antiretropulsion devices allow for efficient prevention of stone migration during ureteroscopic lithotripsy with minimal adverse effects or complications. Multiple devices are now available each with advantages and disadvantages. New devices are currently engineered to prevent stone migration and maintain ureteral access. Antiretropulsion devices appear to be cost-effective to prevent stone migration during intracorporeal lithotripsy. SUMMARY: Antiretropulsion devices have been safely and effectively used during ureteroscopic procedures. These tools increase stone-free rates, decrease morbidity and new studies have demonstrated their cost-effectiveness.

Accuracy of endoscopic intraoperative assessment of urologic stone size.

INTRODUCTION: Endoscopic treatment of renal calculi relies on surgeon assessment of residual stone fragment size for either basket removal or for the passage of fragments postoperatively. We therefore sought to determine the accuracy of endoscopic assessment of renal calculi size. MATERIALS AND METHODS: Between January and May 2013, five board-certified endourologists participated in an ex vivo artificial endoscopic simulation. A total of 10 stones (pebbles) were measured (mm) by nonparticipating urologist (N.D.P.) with electronic calibers and placed into separate labeled opaque test tubes to prevent visualization of the stones through the side of the tube. Endourologists were blinded to the actual size of the stones. A flexible digital ureteroscope with a 200-µm core sized laser fiber in the working channel as a size reference was placed through the ureteroscope into the test tube to estimate the stone size (mm). Accuracy was determined by obtaining the correlation coefficient (r) and constructing an Altman-Bland plot. RESULTS: Endourologists tended to overestimate actual stone size by a margin of 0.05 mm. The Pearson correlation coefficient was r=0.924, with a p-value<0.01. The estimation of small stones (<4 mm) had a greater accuracy than large stones (≥4 mm), r=0.911 vs r=0.666. Altman-bland plot analysis suggests that surgeons are able to accurately estimate stone size within a range of -1.8 to +1.9 mm. CONCLUSIONS: This ex vivo simulation study demonstrates that endoscopic assessment is reliable when assessing stone size. On average, there was a slight tendency to overestimate stone size by 0.05 mm. Most endourologists could visually estimate stone size within 2 mm of the actual size. These findings could be generalized to state that endourologists are accurately able to intraoperatively assess residual stone fragment size to guide decision making.

Assessment of a modified acoustic lens for electromagnetic shock wave lithotripters in a swine model.

PURPOSE: The acoustic lens of the Modularis electromagnetic shock wave lithotripter (Siemens, Malvern, Pennsylvania) was modified to produce a pressure waveform and focal zone more closely resembling that of the original HM3 device (Dornier Medtech, Wessling, Germany). We assessed the newly designed acoustic lens in vivo in an animal model. MATERIALS AND METHODS: Stone fragmentation and tissue injury produced by the original and modified lenses of the Modularis lithotripter were evaluated in a swine model under equivalent acoustic pulse energy (about 45 mJ) at 1 Hz pulse repetition frequency. Stone fragmentation was determined by the weight percent of stone fragments less than 2 mm. To assess tissue injury, shock wave treated kidneys were perfused, dehydrated, cast in paraffin wax and sectioned. Digital images were captured every 120 µm and processed to determine functional renal volume damage. RESULTS: After 500 shocks, the mean ± SD stone fragmentation efficiency produced by the original and modified lenses was 48% ± 12% and 52% ± 17%, respectively (p = 0.60). However, after 2,000 shocks, the modified lens showed significantly improved stone fragmentation compared to the original lens (mean 86% ± 10% vs 72% ± 12%, p = 0.02). Tissue injury caused by the original and modified lenses was minimal at a mean of 0.57% ± 0.44% and 0.25% ± 0.25%, respectively (p = 0.27). CONCLUSIONS: With lens modification the Modularis lithotripter demonstrates significantly improved stone fragmentation with minimal tissue injury at a clinically relevant acoustic pulse energy. This new lens design could potentially be retrofitted to existing lithotripters, improving the effectiveness of electromagnetic lithotripters.

In-vitro assessment of a new portable ballistic lithotripter with percutaneous and ureteroscopic models.

BACKGROUND AND PURPOSE: The EMS Swiss LithoBreaker is a new, portable, electrokinetic lithotripter. We compared its tip velocity and displacement characteristics with a handheld, pneumatic lithotripter LMA StoneBreaker.™ We also evaluated fragmentation efficiency using in vitro models of percutaneous and ureteroscopic stone fragmentation. MATERIALS AND METHODS: Displacement and velocity profiles were measured for 1-mm and 2-mm probes using a laser beam aimed at a photo detector. For the percutaneous model, 2-mm probes fragmented 10-mm spherical BegoStone phantoms until the fragments passed through a 4-mm mesh sieve. The ureteroscopic model used 1-mm probes and compared the pneumatic and electrokinetic devices to a 200-µm holmium laser fiber. Cylindrical (4-mm diameter, 4-mm length) BegoStone phantoms were placed into silicone tubing to simulate the ureter; fragmented stones passed through a narrowing in the tubing. RESULTS: For both 1-mm and 2-mm probes, the electrokinetic device had significantly higher tip displacement and slower tip velocity, P<0.01. In the percutaneous model, the electrokinetic device needed an average of 484 impulses over 430 seconds to fragment one BegoStone, while the pneumatic device needed 29 impulses over 122 seconds to fragment one stone. Both clearance times and number of impulses needed for percutaneous stone clearance were significantly different at P<0.01. Ureteroscopically, the mean clearance time was 97 seconds for the electrokinetic lithotripter, 145 seconds for the pneumatic lithotripter, and 304 seconds for the laser. Comparing the pneumatic device with the electrokinetic device ureteroscopically, there was no significant difference in clearance time, P=0.55. Both the pneumatic and electrokinetic lithotripters, however, demonstrated decreased clearance times compared with the laser, P=0.027. CONCLUSIONS: The portable electrokinetic lithotripter may be better suited for ureteroscopy instead of percutaneous nephrolithotomy. It appears to be comparable to the portable pneumatic device in the ureter. Further clinical studies are needed to confirm these findings in vivo.