Development and validation of a multicenter Cox regression model to predict all-cause mortality in patients with renal masses suspicious for renal cancer.

OBJECTIVE: Life expectancy models are useful tools to support clinical decision-making. Prior models have not been used widely in clinical practice for patients with renal masses. We sought to develop and validate a model to predict life expectancy following the detection of a localized renal mass suspicious for renal cell carcinoma. MATERIALS AND METHODS: Using retrospective data from 2 large centers, we identified patients diagnosed with clinically localized renal parenchymal masses from 1998 to 2018. After 2:1 random sampling into a derivation and validation cohort stratified by site, we used age, sex, log-transformed tumor size, simplified cardiovascular index and planned treatment to fit a Cox regression model to predict all-cause mortality from the time of diagnosis. The model's discrimination was evaluated using a C-statistic, and calibration was evaluated visually at 1, 5, and 10 years. RESULTS: We identified 2,667 patients (1,386 at Corewell Health and 1,281 at Johns Hopkins) with renal masses. Of these, 420 (16%) died with a median follow-up of 5.2 years (interquartile range 2.2-8.3). Statistically significant predictors in the multivariable Cox regression model were age (hazard ratio [HR] 1.04; 95% confidence interval [CI] 1.03-1.05); male sex (HR 1.40; 95% CI 1.08-1.81); log-transformed tumor size (HR 1.71; 95% CI 1.30-2.24); cardiovascular index (HR 1.48; 95% CI 1.32-1.67), and planned treatment (HR: 0.10, 95% CI: 0.06-0.18 for kidney-sparing intervention and HR: 0.20, 95% CI: 0.11-0.35 for radical nephrectomy vs. no intervention). The model achieved a C-statistic of 0.74 in the derivation cohort and 0.73 in the validation cohort. The model was well-calibrated at 1, 5, and 10 years of follow-up. CONCLUSIONS: For patients with localized renal masses, accurate determination of life expectancy is essential for decision-making regarding intervention vs. active surveillance as a primary treatment modality. We have made available a simple tool for this purpose.

Daily Ecological Momentary Assessments of Pain and Ability to Work After Ureteroscopy and Stenting.

Introduction: Ureteral stents can cause significant patient discomfort, yet the temporal dynamics and impact on activities remain poorly characterized. We employed an automated tool to collect daily ecological momentary assessments (EMAs) regarding pain and the ability to work following ureteroscopy with stenting. Our aims were to assess feasibility and better characterize the postoperative patient experience. Materials and Methods: As an exploratory endpoint within an ongoing clinical trial, patients undergoing ureteroscopy with stenting were asked to complete daily EMAs for 10 days postoperatively or until the stent was removed. Questionnaires were distributed through text messages and included a pain scale (0-10) and a single item from the validated Patient-Reported Outcomes Measurement Information System Ability to Participate in Social Roles and Activities instrument, as well as days missed from work or school. Results: Among the first 65 trial participants, 59 completed at least 1 EMA (overall response rate 91%). Response rates were >85% for each time point through postoperative day (POD)10. Median respondent age was 58 years (interquartile range [IQR] 50-67), and 56% were female. Stones were 54% renal and 46% ureteral, with a median diameter of 9 mm (IQR 7-10). Median stent dwell time was 7 days (IQR 6-8). Pain scores were highest on POD1 (median score 4) and declined on each subsequent day, reaching a median score of 2 on POD5. Sixty-three percent of patients on POD1 reported that they had trouble performing their usual work at least sometimes, but by POD5, this was <50% of patients. Patients who work or attend school reported a median of 1 day missed (IQR 0-2). Conclusions: An automated daily EMA system for capturing patient-reported outcomes was demonstrated to be feasible with sustained excellent engagement. Patients with stents reported the worst pain and interference with work on POD1, with steady improvements thereafter, and by POD5, the majority of patients had minimal pain or trouble performing their usual work. This work is associated with a registered clinical trial [NCT05026710].

Assessing renal tissue temperature changes and perfusion effects during laser activation in an in vivo porcine model.

INTRODUCTION: High fluid temperatures have been seen in both in vitro and in vivo studies with laser lithotripsy, yet the thermal distribution within the renal parenchyma has not been well characterized. Additionally, the heat-sink effect of vascular perfusion remains uncertain. Our objectives were twofold: first, to measure renal tissue temperatures in response to laser activation in a calyx, and second, to assess the effect of vascular perfusion on renal tissue temperatures. METHODS: Ureteroscopy was performed in three porcine subjects with a prototype ureteroscope containing a temperature sensor at its tip. A needle with four thermocouples was introduced percutaneously into a kidney with ultrasound guidance to allow temperature measurement in the renal medulla and cortex. Three trials of laser activation (40W) for 60 s were conducted with an irrigation rate of 8 ml/min at room temperature in each subject. After euthanasia, three trials were repeated without vascular perfusion in each subject. RESULTS: Substantial temperature elevation was observed in the renal medulla with thermal dose in two of nine trials exceeding threshold for tissue injury. The temperature decay time (t½) of the non-perfused trials was longer than in the perfused trials. The ratio of t½ between them was greater in the cortex than the medulla. CONCLUSION: High-power laser settings (40W) can induce potentially injurious temperatures in the in vivo porcine kidney, particularly in the medullary region adjacent to the collecting system. Additionally, the influence of vascular perfusion in mitigating thermal risk in this susceptible area appears to be limited.

Does Urologist-level Utilization of Active Surveillance for Low-risk Prostate Cancer Correspond with Utilization of Active Surveillance for Small Renal Masses?

Active surveillance (AS) for prostate cancer (CaP) or small renal masses (SRMs) helps in limiting the overtreatment of indolent malignancies. Implementation of AS for these conditions varies substantially across individual urologists. We examined the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry to assess for correlation of AS between patients with low-risk CaP and patients with SRM managed by individual urologists. We identified 27 urologists who treated at least ten patients with National Comprehensive Cancer Network low-risk CaP and ten patients with SRMs between 2017 and 2021. For surgeons in the lowest quartile of AS use for low-risk CaP (<74%), 21% of their patients with SRMs were managed with AS, in comparison to 74% of patients of surgeons in the highest quartile (>90%). There was a modest positive correlation between the surgeon-level risk-adjusted proportions of patients managed with AS for low-risk CaP and for SRMs (Pearson correlation coefficient 0.48). A surgeon's tendency to use AS to manage one low-risk malignancy corresponds to their use of AS for a second low-risk condition. By identifying and correcting structural issues associated with underutilization of AS, interventions aimed at increasing AS use may have effects that influence clinical tendencies across a variety of urologic conditions. PATIENT SUMMARY: The use of active surveillance (AS) for patients with low-risk prostate cancer or small kidney masses varies greatly among individual urologists. Urologists who use AS for low-risk prostate cancer were more likely to use AS for patients with small kidney masses, but there is room to improve the use of AS for both of these conditions.

Performance of brushite plaster as kidney stone phantoms for laser lithotripsy.

Artificial phantoms used in photothermal near-infrared laser lithotripsy research generally fail to mimic both the chemical and the physical properties of human stones. Though high-energy, 1 J pulses are capable of fracturing hard human stones into several large fragments along natural boundaries, similar behavior has not been observed in commonly used gypsum plasters like BegoStone. We developed a new brushite-based plaster formulation composed of ≈90% brushite that undergoes rapid fracture in the manner of human stones under fragmentation pulse regimes. Single-pulse (1 J) ablation crater volumes for phantoms were not significantly different from those of pure brushite stones. Control over crater volumes was demonstrated by varying phosphorous acid concentration in the plaster formulation. Fragmentation of cylindrical brushite phantoms was filmed using a high-speed camera which demonstrated rapid fragmentation in < 100 µs during the bubble expansion phase of a short pulse from a high-powered Ho:YAG laser (Lumenis Pulse 120 H). The rapid nature of observed fracture suggests increasing laser pulse energy by increasing laser pulse duration will not improve fragmentation performance of laser lithotripters. Brushite plaster phantoms are a superior alternative to gypsum plasters for laser lithotripsy research due to their better mimicry of stone composition, controllable single-pulse crater volumes, and fragmentation behavior.

Laser Ablation Efficiency, Laser Ablation Speed, and Laser Energy Consumption During Lithotripsy: What Are They and How Are They Defined? A Systematic Review and Proposal for a Standardized Terminology.

CONTEXT: Laser performance for lithotripsy is currently reported using units of measurement such as J/mm3, mm3/J, mm3/s, s/mm3, and mm3/min. However, there are no current standardized definitions or terminology for these metrics. This may lead to confusion when assessing and comparing different laser systems. OBJECTIVE: The primary objective was to summarize outcome values and corresponding terminology from studies on laser lithotripsy performance using stone volume in relation to time or energy. The secondary objective was to propose a standardized terminology for reporting laser performance metrics. EVIDENCE ACQUISITION: A systematic review of the literature was conducted using the search string ("j*/mm3" OR "mm3/j*" OR "mm3/s*" OR "s*/mm3" OR "mm3/min*" OR "min*/mm3" AND "lithotripsy") on Scopus, Web of Science, Embase, and PubMed databases. Study selection, data extraction, and quality assessment were performed independently by two authors. EVIDENCE SYNTHESIS: A total of 28 studies were included, covering holmium:yttrium-aluminum-garnet (Ho:YAG), MOSES, and thulium fiber laser (TFL) technologies. Laser energy consumption values reported for the studies ranged from 2.0 - 43.5 J/mm3in vitro and from 2.7 - 47.8 J/mm3in vivo, translating to laser ablation efficiency of 0.023 - 0.500 mm3/J and 0.021 - 0.370 mm3/J, respectively. Laser ablation speeds ranged from 0.3 - 8.5 mm3/s in vivo, translating to lasing time consumption of 0.12 - 3.33 s/mm3. Laser efficacy ranged from 4.35 - 51.7 mm3/min in vivo. There was high heterogeneity for the terminology used to describe laser performance for the same metrics. CONCLUSIONS: The range of laser performance metric values relating stone volume to energy or time is wide, with corresponding differing terminology. We propose a standardized terminology for future studies on laser lithotripsy, including laser ablation efficiency (mm3/J), laser ablation speed (mm3/s), and laser energy consumption (J/mm3). Laser efficacy (mm3/min) is proposed as a broader term that is based on the total operative time, encompassing the whole technique using the laser. PATIENT SUMMARY: We reviewed studies to identify the units and terms used for laser performance when treating urinary stones. The review revealed a wide range of differing units, outcomes, and terms. Therefore, we propose a standardized terminology for future studies on laser stone treatment.

Change in renal blood flow in response to intrarenal pressure alterations induced by ureteroscopy in an in-vivo porcine model.

INTRODUCTION: High irrigation rates are commonly used during ureteroscopy and can increase intrarenal pressure (IRP) substantially. Concerns have been raised that elevated IRP may diminish renal blood flow (RBF) and perfusion of the kidney. Our objective was to investigate the real-time changes in RBF while increasing IRP during Ureteroscopy (URS) in an in-vivo porcine model. METHODS: Four renal units in two porcine subjects were used in this study, three experimental units and one control. For the experimental units, RBF was measured by placing an ultrasonic flow cuff around the renal artery, while performing ureteroscopy in the same kidney using a prototype ureteroscope with a pressure sensor at its tip. Irrigation was cycled between two rates to achieve targeted IRPs of 30 mmHg and 100 mmHg. A control data set was obtained by placing the ultrasonic flow cuff on the contralateral renal artery while performing ipsilateral URS. RESULTS: At high IRP, RBF was reduced in all three experimental trials by 10-20% but not in the control trial. The percentage change in RBF due to alteration in IRP was internally consistent in each porcine renal unit and independent of slower systemic variation in RBF encountered in both the experimental and control units. CONCLUSION: RBF decreased 10-20% when IRP was increased from 30 to 100 mmHg during ureteroscopy in an in-vivo porcine model. While this reduction in RBF is unlikely to have an appreciable effect on tissue oxygenation, it may impact heat-sink capacity in vulnerable regions of the kidney.

Effect of outflow resistance on intrarenal pressure at different irrigation rates during ureteroscopy: in vivo evaluation.

To maintain visualization and control temperature elevation during ureteroscopy, higher irrigation rates are necessary, but this can increase intrarenal pressure (IRP) and lead to adverse effects like sepsis. The IRP is also dependent on outflow resistance but this has not been quantitatively evaluated in a biological system. In this study, we sought to characterize the IRP as a function of irrigation rate in an in vivo porcine model at different outflow resistances. Ureteroscopy was performed in a porcine model with a 9.5 Fr prototype ureteroscope containing a pressure sensor. A modified ureteral access sheath (UAS) (11/13 Fr, 36 cm) was configured to adjust outflow resistance. IRP-irrigation rate curves were generated at four different outlet resistances representing different outflow scenarios. At lower irrigation rates, the pressure change in response to increased irrigation was gradual and non-linear, likely reflecting a "compliant" phase of the renal collecting system. Once IRP reached the range of 35-50 cm H2O, the pressure increased in a linear fashion with irrigation rate, suggesting that the distensibility of the collecting system had become saturated. The relationship between IRP and irrigation rate becomes linear during in vivo porcine studies once the initial compliance of the system is saturated. IRP is more sensitive to changes in irrigation rate in systems with higher outflow resistance. The modified UAS is a novel research tool which allows variance of outflow resistance to mimic different clinical scenarios. Knowledge of outflow resistance may simplify the decision to use an UAS.

Thermal Safety Boundaries for Laser Power and Irrigation Rate During Ureteroscopy: In Vivo Porcine Assessment With a Ho:YAG Laser.

OBJECTIVE: To map thermal safety boundaries during ureteroscopy (URS) with laser activation in two in vivo porcine subjects to better understand the interplay between laser power, irrigation rate, and fluid temperature in the collecting system. METHODS: URS was performed in two in vivo porcine subjects with a prototype ureteroscope containing a thermocouple at its tip. Up to 6 trials of 60 seconds laser activation were carried out at each selected power setting and irrigation rate. Thermal dose was calculated for each trial, and laser power-irrigation rate parameter pairs were categorized based on number of trials that exceeded a thermal dose of 120 equivalent minutes. RESULTS: The collecting fluid temperature was increased with greater laser power and slower irrigation rate. In the first porcine subject, 25 W of laser power could safely be applied if irrigation was at least 15 mL/min, and 48 W with at least 30 mL/min. Intermediate values followed a linear curve between these bounds. For the second subject, where the calyx appeared larger, 15 W laser power required 9 mL/min irrigation, 48 W required 24 mL/min, and intermediate points also followed a near-linear curve. CONCLUSION: This study validates previous bench research and provides a conceptual framework for selection of safe laser lithotripsy settings and irrigation rates during URS with laser lithotripsy. Additionally, it provides insight and guidance for future development of thermal mitigation strategies and devices.

How I Do It: Ureteroscopy and high-power holmium laser lithotripsy to treat renal stones.

In North America, ureteroscopy has become the most popular treatment modality for upper urinary tract urinary calculi. Herein we describe our technique for the treatment of renal stones with flexible ureteroscopy and high-power holmium laser lithotripsy. We discuss preoperative planning, intraoperative strategies, and laser settings for a high-frequency dusting technique with the goal to provide optimal patient outcomes.

What Is the Optimal Stenting Duration After Ureteroscopy and Stone Intervention? Impact of Dwell Time on Postoperative Emergency Department Visits.

PURPOSE: AUA stone management guidelines recommend stenting duration following ureteroscopy be minimized to reduce morbidity; stents with extraction strings may be used for this purpose. However, an animal study demonstrated that short dwell time results in suboptimal ureteral dilation, and a pilot clinical study showed this increases postprocedure events. Using real-world practice data we examined stent dwell time after ureteroscopy and its association with postoperative emergency department visits. MATERIALS AND METHODS: We used the Michigan Urological Surgery Improvement Collaborative registry to identify ureteroscopy and stenting procedures (2016-2019). Pre-stented cases were excluded. Stenting cohorts with and without strings were analyzed. Using multivariable logistic regression we evaluated the risk of an emergency department visit occurring on the day of, or day after, stent removal based on dwell time and string status. RESULTS: We identified 4,437 procedures; 1,690 (38%) had a string. Median dwell time was lower in patients with a string (5 vs 9 days). Ureteroscopy in younger patients, smaller stones, or renal stone location had a higher frequency of string use. The predicted probability of an emergency department visit was significantly greater in procedures with string, compared to without string, when dwell times were less than 5 days (P < .01) but were not statistically significant after. CONCLUSIONS: Patients who had ureteroscopy and stenting with a string have short dwell times. Patients are at increased risk of a postoperative emergency department visit around the time of stent removal if dwell time is ≤4 days. We recommended stenting duration of at least 5 days in nonpre-stented patients.

Under pressure: irrigation practice patterns during flexible ureteroscopy.

Introduction: Irrigation parameters during flexible ureteroscopy (fURS) may impact patient outcomes, yet there are limited data on current practice patterns of irrigation methods and parameter selection. We assessed the common irrigation methods, pressure settings, and situations that present the most problems with irrigation among worldwide endourologists. Methods: A questionnaire on fURS practice patterns was sent to Endourology Society members in January 2021. Responses were collected through QualtricsXM over a 1-month period. The study was reported according to the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). Surgeons were from North America (the United States and Canada), Latin America, Europe, Asia, Africa, and Oceania. Results: Questionnaires were answered by 208 surgeons (response rate 14%). North American surgeons accounted for 36% of respondents; 29% Europe, 18% Asia, and 14% Latin America. In North America, the most common irrigation method was the pressurized saline bag using a manual inflatable cuff (55%). Saline bag (gravity) with a bulb or syringe injection system was the most common method in Europe (45%). Automated systems were the most common method in Asia (30%). For pressures used during fURS, the majority of respondents used 75-150 mmHg. The clinical scenario which had the greatest issue with adequate irrigation was during biopsy of urothelial tumor. Conclusion: There is variation in irrigation practices and parameter selection during fURS. North American surgeons primarily used a pressurized saline bag, in contrast to European surgeons who preferred a gravity bag with a bulb/syringe system. Overall, automated irrigation systems were not commonly used.

Improving the Quality of Upper Urinary Tract Stone Surgery: External Validation of a Statewide Collaborative's Efforts to Reduce Emergency Department Visits After Ureteroscopy.

PURPOSE: The ROCKS (Reducing Operative Complications from Kidney Stones) program in MUSIC (Michigan Urological Surgery Improvement Collaborative) was created to optimize ureteroscopy outcomes. Through data collection, distribution of reports, patient education, and standardization of medication, post-ureteroscopy emergency department visits in Michigan have declined. It is unclear whether this is because of statewide quality efforts or due to national trends. We therefore sought to understand emergency department visit rates in Michigan compared to a national data set. MATERIALS AND METHODS: We compared the MUSIC ROCKS clinical registry in Michigan against a national cohort, Optum's de-identified Clinformatics Data Mart, from 2016-2021 (excluding Michigan). We identified patients who underwent ureteroscopy and the proportion who had a postoperative emergency department visit within 30 days. Emergency department rates were modeled over time, adjusting for age, gender, comorbidity, and ureteral stenting. RESULTS: We identified 24,688 patients in MUSIC ROCKS and 99,340 in the Clinformatics Data Mart database who underwent ureteroscopy. The risk-adjusted emergency department visit rate in MUSIC ROCKS significantly declined over the study period (10.5% in 2016 to 6.9% in 2021, P < 0.001) while the mean emergency department visit rate in the Clinformatics Data Mart cohort was 9.9% and did not change over time (9.6% in 2016 to 10% in 2021). Comparing emergency department visits between the cohorts, the MUSIC ROCKS rate significantly declined relative to the Clinformatics Data Mart (P < 0.001) over the study period. CONCLUSIONS: Postoperative emergency department visit rates in Michigan have declined significantly after ureteroscopy since the establishment of MUSIC ROCKS. This decline outpaced national rates, providing evidence that systematic quality initiatives can improve urological care.

Development and Validation of a Model to Predict Ureteral Stent Placement Following Ureteroscopy: Results From a Statewide Collaborative.

OBJECTIVE: To develop and validate a model to predict whether patients undergoing ureteroscopy (URS) will receive a stent. METHODS: Using registry data obtained from the Michigan Urological Surgery Improvement Collaborative Reducing Operative Complications from Kidney Stones initiative, we identified patients undergoing URS from 2016 to 2020. We used patients' age, sex, body mass index, size and location of the largest stone, current stent in place, history of any kidney stone procedure, procedure type, and acuity to fit a multivariable logistic regression model to a derivation cohort consisting of a random two-thirds of episodes. Model discrimination and calibration were evaluated in the validation cohort. A sensitivity analysis examined urologist variation using generalized mixed-effect models. RESULTS: We identified 15,048 URS procedures, of which 11,471 (76%) had ureteral stents placed. Older age, male sex, larger stone size, the largest stone being in the ureteropelvic junction, no prior stone surgery, no stent in place, a planned procedure type of laser lithotripsy, and urgent procedure were associated with a higher risk of stent placement. The model achieved an area under the receiver operating characteristic curve of 0.69 (95% CI 0.67, 0.71). Incorporating urologist-level variation improved the area under the receiver operating characteristic curve to 0.83 (95% CI 0.82, 0.84). CONCLUSION: Using a large clinical registry, we developed a multivariable regression model to predict ureteral stent placement following URS. Though well-calibrated, the model had modest discrimination due to heterogeneity in practice patterns in stent placement across urologists.