Evaluation of the New American Urological Association Guidelines Risk Classification for Hematuria.

PURPOSE: Microhematuria is a prevalent condition and the American Urological Association has developed a new risk-stratified approach for the evaluation of patients with microhematuria. Our objective was to provide the first evaluation of this important guideline. MATERIALS AND METHODS: This multinational cohort study combines contemporary patients from 5 clinical trials and 2 prospective registries who underwent urological evaluation for hematuria. Patients were stratified into American Urological Association risk strata (low, intermediate or high risk) based on sex, age, degree of hematuria, and smoking history. The primary end point was the incidence of bladder cancer within each risk stratum. RESULTS: A total of 15,779 patients were included in the analysis. Overall, 727 patients (4.6%) were classified as low risk, 1,863 patients (11.8%) were classified as intermediate risk, and 13,189 patients (83.6%) were classified as high risk. The predominance of high risk patients was consistent across all cohorts. A total of 857 bladder cancers were diagnosed with a bladder cancer incidence of 5.4%. Bladder cancer was more prevalent in men, smokers, older patients and patients with gross hematuria. The cancer incidence for low, intermediate and high risk groups was 0.4% (3 patients), 1.0% (18 patients) and 6.3% (836 patients), respectively. CONCLUSIONS: The new risk stratification system separates hematuria patients into clinically meaningful categories with differing likelihoods of bladder cancer that would justify evaluating the low, intermediate and high risk groups with incremental intensity. Furthermore, it provides the relative incidence of bladder cancer in each risk group which should facilitate patient counseling regarding the risks and benefits of evaluation for bladder cancer.

Microhematuria: AUA/SUFU Guideline.

PURPOSE: Patients presenting with microhematuria represent a heterogeneous population with a broad spectrum of risk for genitourinary malignancy. Recognizing that patient-specific characteristics modify the risk of underlying malignant etiologies, this guideline sought to provide a personalized diagnostic testing strategy. MATERIALS AND METHODS: The systematic review incorporated evidence published from January 2010 through February 2019, with an updated literature search to include studies published up to December 2019. Evidence-based statements were developed by the expert Panel, with statement type linked to evidence strength, level of certainty, and the Panel's judgment regarding the balance between benefits and risks/burdens. RESULTS: Microhematuria should be defined as ≥ 3 red blood cells per high power field on microscopic evaluation of a single specimen. In patients diagnosed with gynecologic or non-malignant genitourinary sources of microhematuria, clinicians should repeat urinalysis following resolution of the gynecologic or non-malignant genitourinary cause. The Panel created a risk classification system for patients with microhematuria, stratified as low-, intermediate-, or high-risk for genitourinary malignancy. Risk groups were based on factors including age, sex, smoking and other urothelial cancer risk factors, degree and persistence of microhematuria, as well as prior gross hematuria. Diagnostic evaluation with cystoscopy and upper tract imaging was recommended according to patient risk and involving shared decision-making. Statements also inform follow-up after a negative microhematuria evaluation. CONCLUSIONS: Patients with microhematuria should be classified based on their risk of genitourinary malignancy and evaluated with a risk-based strategy. Future high-quality studies are required to improve the care of these patients.

Comparison of the Harms, Advantages, and Costs Associated With Alternative Guidelines for the Evaluation of Hematuria.

IMPORTANCE: Existing recommendations for the diagnostic testing of hematuria range from uniform evaluation of varying intensity to patient-level risk stratification. Concerns have been raised about not only the costs and advantages of computed tomography (CT) scans but also the potential harms of CT radiation exposure. OBJECTIVE: To compare the advantages, harms, and costs associated with 5 guidelines for hematuria evaluation. DESIGN, SETTING, AND PARTICIPANTS: A microsimulation model was developed to assess each of the following guidelines (listed in order of increasing intensity) for initial evaluation of hematuria: Dutch, Canadian Urological Association (CUA), Kaiser Permanente (KP), Hematuria Risk Index (HRI), and American Urological Association (AUA). Participants comprised a hypothetical cohort of patients (n = 100 000) with hematuria aged 35 years or older. This study was conducted from August 2017 through November 2018. EXPOSURES: Under the Dutch and CUA guidelines, patients received cystoscopy and ultrasonography if they were 50 years or older (Dutch) or 40 years or older (CUA). Under the KP and HRI guidelines, patients received different combinations of cystoscopy, ultrasonography, and CT urography or no evaluation on the basis of risk factors. Under the AUA guidelines, all patients 35 years or older received cystoscopy and CT urography. MAIN OUTCOMES AND MEASURES: Urinary tract cancer detection rates, radiation-induced secondary cancers (from CT radiation exposure), procedural complications, false-positive rates per 100 000 patients, and incremental cost per additional urinary tract cancer detected. RESULTS: The simulated cohort included 100 000 patients with hematuria, aged 35 years or older. A total of 3514 patients had urinary tract cancers (estimated prevalence, 3.5%; 95% CI, 3.0%-4.0%). The AUA guidelines missed detection for the fewest number of cancers (82 [2.3%]) compared with the detection rate of the HRI (116 [3.3%]) and KP (130 [3.7%]) guidelines. However, the simulation model projected 108 (95% CI, 34-201) radiation-induced cancers under the KP guidelines, 136 (95% CI, 62-229) under the HRI guidelines, and 575 (95% CI, 184-1069) under the AUA guidelines per 100 000 patients. The CUA and Dutch guidelines missed detection for a larger number of cancers (172 [4.9%] and 251 [7.1%]) but had 0 radiation-induced secondary cancers. The AUA guidelines cost approximately double the other 4 guidelines ($939/person vs $443/person for Dutch guidelines), with an incremental cost of $1 034 374 per urinary tract cancer detected compared with that of the HRI guidelines. CONCLUSIONS AND RELEVANCE: In this simulation study, uniform CT imaging for patients with hematuria was associated with increased costs and harms of secondary cancers, procedural complications, and false positives, with only a marginal increase in cancer detection. Risk stratification may optimize the balance of advantages, harms, and costs of CT.

Evaluation of microscopic hematuria and risk of urologic cancer in female patients.

BACKGROUND: Urologic cancer has a lower prevalence in women compared with men; however, there are no differences in the recommended evaluation for women and men with microscopic hematuria. OBJECTIVES: The purpose of this study was to identify risk factors that are associated with urologic cancer in women with microscopic hematuria and to determine the applicability of a hematuria risk score for women. STUDY DESIGN: We conducted a retrospective cohort study within an integrated healthcare system in Southern California. All urinalyses with microscopic hematuria (>3 red blood cells per high-power field) that were performed from 2009-2015 were identified. Women who were referred for urologic evaluation were entered into a prospective database. Clinical and demographic variables that included the presence of gross hematuria in the preceding 6 months were recorded. The cause of the hematuria, benign or malignant, was entered into the database. Cancer rates were compared with the use of chi-square and logistic regression models. Adjusted risk ratios of urologic cancer were estimated with the use of multivariate regression analysis. We also explored the applicability of a previously developed, gender nonspecific, hematuria risk score in this female cohort. RESULTS: A total of 2,705,696 urinalyses were performed in women during the study period, of which 552,119 revealed microscopic hematuria. Of these, 14,539 women were referred for urologic evaluation; clinical data for 3573 women were entered into the database. The overall rate of urologic cancer was 1.3% (47/3573). In women <60 years old, the rate of urologic cancer was 0.6% (13/2053) compared with 2.2% (34/1520) in women ≥60 years old (P<.01). In women who reported a history of gross hematuria, the rate of urologic cancer was 5.8% (20/346) compared with a 0.8% (27/3227) in women with no history of gross hematuria (P<.01). In multivariate analysis, > 60 years old (odds ratio, 3.1; 95% confidence interval, 1.6-5.9), a history of smoking (odds ratio, 3.2; 95% confidence interval, 1.8-5.9), and a history of gross hematuria in the previous 6 months (odds ratio, 6.2; 95% confidence interval, 3.4-11.5) were associated with urologic cancers. A higher microscopic hematuria risk score was associated with an increased risk of cancer in this test cohort (P<.01). Women in the highest risk group had a urologic cancer rate of 10.8% compared with a rate of 0.5% in the lowest risk group. CONCLUSIONS: In this female population, >60 years old and a history of smoking and/or gross hematuria were the strongest predictors of urologic cancer. Absent these risk factors, the rate of urologic cancer did not exceed 0.6%. A higher hematuria risk score correlated significantly with the risk of urologic cancer in this female test cohort.

Multi-institutional validation of the ability of preoperative hydronephrosis to predict advanced pathologic tumor stage in upper-tract urothelial carcinoma.

OBJECTIVE: The presence of hydronephrosis (HN) has been implicated as a predictor of poor outcomes for patients diagnosed with bladder cancer. Small, single institution preliminary reports suggest a similar negative relationship may exist for upper-tract urothelial carcinoma (UTUC). Herein, we attempt to validate the prognostic value of preoperative HN in a large, multi-institutional cohort of UTUC patients. MATERIALS AND METHODS: Data on 469 patients with localized UTUC from 5 tertiary referral centers who underwent a radical nephroureterectomy (91%) or distal ureterectomy (9%) without neoadjuvant chemotherapy were integrated into a relational database. Preoperative HN data, including presence vs. absence and high vs. low grade, were available in 408 patients. The association of HN with pathologic features was evaluated. RESULTS: A total of 254 men and 154 women with a median age of 69 years (IQR 15) were analyzed. Overall, 192 patients (47%) had ≥pT2 disease, 145 (36%) had non-organ-confined (NOC) cancers (≥pT3 and/or positive lymph nodes), and 298 (73%) had high grade UTUC on final pathology. Forty-six percent of patients had tumors in the renal pelvis, 27% in the ureter, and 27% in both locations. Preoperatively, 223 patients (55%) were noted to have ipsilateral HN (39% low grade and 61% high grade). Hydronephrosis was associated with ≥pT2 stage (P < 0.001), NOC disease (P < 0.001), and high grade cancers (P = 0.04). On multivariate analysis adjusting for gender, age, and tumor location, HN was an independent predictor of muscle invasive (HR 7.4, P < 0.001), NOC (HR 5.5, P < 0.001), and high pathologic grade (HR 1.6, P = 0.03) UTUC disease. CONCLUSION: The presence of preoperative HN was associated with advanced stage UTUC. This readily available imaging modality may improve preoperative risk stratification for UTUC patients thereby guiding use of endoscopic versus extirpative surgery as well as the need for neoadjuvant chemotherapy regimens.

Preoperative radiographic parameters predict long-term renal impairment following partial nephrectomy.

PURPOSE: We analyzed radiographic parameters describing anatomic features of renal tumors to identify preoperative characteristics that could help predict long-term decline in renal function following partial nephrectomy. METHODS: We retrospectively reviewed the records of 194 consecutive patients who underwent partial nephrectomy from January 2006 to March 2009 and analyzed a cohort of 53 patients for whom complete clinical, radiographic, and operative information was available. Computed tomography images were reviewed by a single radiologist. Radiographic criteria for describing renal tumor size and location included diameter, volume, endophytic properties, proximity to collecting system, anterior/posterior location, location relative to polar lines, and R.E.N.A.L. nephrometry score. Postoperative estimated glomerular filtration rate was calculated using the MDRD study group equation with serum creatinine at last follow-up. RESULTS: The median preoperative and postoperative GFR values were 75 (IQR 65-97) and 66 (IQR 55-84) mL/min/1.73 m(2), respectively. At a median follow-up of 38 months, the median percentage decrease in GFR was 12%. On univariate analyses, tumor diameter (P = 0.002), tumor volume (P < 0.0001), nearness of tumor to collecting system (P = 0.017), and location relative to polar lines (P = 0.017) were associated with percentage decrease in GFR. Furthermore, higher R.E.N.A.L. nephrometry score was also associated with poorer renal functional outcomes following partial nephrectomy (P = 0.019). CONCLUSIONS: Anatomic features of renal tumors defined by preoperative radiographic characteristics correlate with the degree of renal functional decline after partial nephrectomy. Identification of these parameters may assist in patient counseling and clinical decision making following partial nephrectomy. Validation in larger prospective studies is necessary.

Laparoscopic and open partial nephrectomy: complication comparison using the Clavien system.

BACKGROUND AND OBJECTIVES: To compare postoperative complications in patients undergoing laparoscopic and open partial nephrectomy using a standardized complication-reporting system and a standardized tumor-scoring system. METHODS: We conducted a retrospective analysis of 189 consecutive patients with nephrometry scores available who underwent elective partial nephrectomy for renal masses. Demographic, perioperative, and complication data were recorded. By using the modified Clavien scale, we graded 30- and 90-day complication rates. RESULTS: 107 patients underwent laparoscopic partial nephrectomy and 82 underwent open partial nephrectomy (N=189). Open partial nephrectomy patients had higher nephrometry scores than laparoscopic patients had (7.1±2.4 vs. 5.6±1.8, P<.001). Surgical and hospitalization times were shorter, and estimated blood loss was lower in the laparoscopic group (P<.001). At 30 days, there were more overall complications in the open group, but more major complications in the laparoscopic group (P>.05). After multivariable logistic regression analysis, only higher body mass index and higher estimated blood loss were predictors of more overall complications. CONCLUSIONS: Laparoscopic partial nephrectomy has the advantages of decreased operative time, lower blood loss, and shorter hospital stay. The complication rate in the laparoscopic group is similar to that in the open group, despite favorable tumor characteristics in the laparoscopic group.

Impact of histological variants on clinical outcomes of patients with upper urinary tract urothelial carcinoma.

PURPOSE: We investigated the clinical and prognostic impact of variant histologies on upper tract urothelial carcinoma outcomes after radical nephroureterectomy. MATERIALS AND METHODS: Data on 1,648 patients with upper tract urothelial carcinoma treated with radical nephroureterectomy without preoperative chemotherapy or radiotherapy were reviewed for histological differentiation and variants. We analyzed differences between pure upper tract urothelial carcinoma and upper tract urothelial carcinoma with variant histology, and differences in the histological variants using different stratifications. RESULTS: A total of 398 patients (24.2%) had histological upper tract urothelial carcinoma variants. The most common variants were squamous cell and glandular differentiation in 9.9% and 4.4% of cases, respectively. Histological variants were associated with advanced tumor stage, tumor multifocality, sessile tumor architecture, tumor necrosis, lymphovascular invasion and lymph node metastasis compared to pure upper tract urothelial carcinoma (p ≤0.031). On univariable analysis variant histology was associated with disease recurrence (p = 0.002) and cancer specific mortality (p = 0.003). In 174 patients treated with adjuvant chemotherapy there was no difference in disease recurrence or survival between variant histology and pure upper tract urothelial carcinoma (p = 0.42 and 0.59, respectively). On multivariable analysis adjusted for the effects of standard clinicopathological characteristics variant histology was not associated with either end point. CONCLUSIONS: Almost 25% of patients with upper tract urothelial carcinoma treated with radical nephroureterectomy harbored histological variants. Variant histology was associated with features of biologically aggressive upper tract urothelial carcinoma. While variant histology is associated with worse outcomes on univariable analysis but this effect did not remain significant on multivariable analysis.

Validation of a novel robotic-assisted partial nephrectomy surgical training model.

UNLABELLED: What's known on the subject? and What does the study add? One area of particular growth for robotic surgery has been partial nephrectomy. Despite a perceived notion that robotic-assisted partial nephrectomy is more easily adaptable compared to laparoscopic partial nephrectomy, there is nonetheless an associated learning curve. Validated training models with a corresponding assessment method for robotic-assisted partial nephrectomy were previously unavailable. We have designed and validated a RAPN surgical model appropriate for resident and fellow training. OBJECTIVE: To evaluate the face, content and construct validities of a novel ex vivo surgical training model for robotic-assisted partial nephrectomy (RAPN). METHODS: We prospectively identified participants as novice (not completed any robotic console cases), intermediate (at least one robotic console case but <100 cases), and expert (≥100 robotic console cases). Each participant performed a partial nephrectomy using the da Vinci Si Surgical System on an ex vivo porcine kidney with an embedded Styrofoam ball that mimics a renal tumour. Subjects completed a post-study questionnaire assessing training model realism and utility. Participants were anonymously judged by three expert reviewers using a validated laparoscopic assessment tool. Performance between groups was compared using the tukey-kramer test. RESULTS: The 46 participants recruited for this study included 24 novices, nine intermediates, and 13 experts. Overall, expert surgeons rated the training model as 'very realistic' (median visual analogue score 7/10) (face validity). Experts also rated the model as an 'extremely useful' training tool for residents (median 9/10) and fellows (9/10) (content validity), although less so for experienced robotic surgeons (5/10). Experts outscored novices on overall performance (P = 0.0002) as well as individual metrics, including 'depth perception,''bimanual dexterity,''efficiency,''tissue handling,''autonomy,''precision,' and 'instrument and camera awareness' (P < 0.05) (construct validity). Experts similarly outperformed intermediates in most metrics (P < 0.05). CONCLUSION: Our novel ex vivo RAPN surgical model has demonstrated face, content and construct validity. Future development of this model should include simulation of haemostasis management and renal reconstruction.

Predicting clinical outcomes after radical nephroureterectomy for upper tract urothelial carcinoma.

BACKGROUND: Novel prognostic factors for patients after radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC) have recently been described. OBJECTIVE: We tested the prognostic value of pathologic characteristics and developed models to predict the individual probabilities of recurrence-free survival (RFS) and cancer-specific survival (CSS) after RNU. DESIGN, SETTING, AND PARTICIPANTS: Our study included 2244 patients treated with RNU without neoadjuvant or adjuvant therapy at 23 international institutions. Tumor characteristics included T classification, grade, lymph node status, lymphovascular invasion, tumor architecture, location, and concomitant carcinoma in situ (CIS). The cohort was randomly split for development (12 centers, n=1273) and external validation (11 centers, n=971). INTERVENTIONS: All patients underwent RNU. MEASUREMENTS: Univariable and multivariable models addressed RFS, CSS, and comparison of discrimination and calibration with American Joint Committee on Cancer (AJCC) stage grouping. RESULTS AND LIMITATIONS: At a median follow-up of 45 mo, 501 patients (22.3%) experienced disease recurrence and 418 patients (18.6%) died of UTUC. On multivariable analysis, T classification (p for trend <0.001), lymph node metastasis (hazard ratio [HR]: 1.98; p=0.002), lymphovascular invasion (HR: 1.66; p<0.001), sessile tumor architecture (HR: 1.76; p<0.001), and concomitant CIS (HR: 1.33; p=0.035) were associated with disease recurrence. Similarly, T classification (p for trend<0.001), lymph node metastasis (HR: 2.23; p=0.001), lymphovascular invasion (HR: 1.81; p<0.001), and sessile tumor architecture (HR: 1.72; p=0.001) were independently associated with cancer-specific mortality. Our models achieved 76.8% and 81.5% accuracy for predicting RFS and CSS, respectively. In contrast to these well-calibrated models, stratification based upon AJCC stage grouping resulted in a large degree of heterogeneity and did not improve discrimination. CONCLUSIONS: Using standard pathologic features, we developed highly accurate prognostic models for the prediction of RFS and CSS after RNU for UTUC. These models offer improvements in calibration over AJCC stage grouping and can be used for individualized patient counseling, follow-up scheduling, risk stratification for adjuvant therapies, and inclusion criteria for clinical trials.

Zero ischemia anatomical partial nephrectomy: a novel approach.

PURPOSE: We present a novel concept of zero ischemia anatomical robotic and laparoscopic partial nephrectomy. MATERIALS AND METHODS: Our technique primarily involves anatomical vascular microdissection and preemptive control of tumor specific, tertiary or higher order renal arterial branch(es) using neurosurgical aneurysm micro-bulldog clamps. In 58 consecutive patients the majority (70%) had anatomically complex tumors including central (67%), hilar (26%), completely intrarenal (23%), pT1b (18%) and solitary kidney (7%). Data were prospectively collected and analyzed from an institutional review board approved database. RESULTS: Of 58 cases undergoing zero ischemia robotic (15) or laparoscopic (43) partial nephrectomy, 57 (98%) were completed without hilar clamping. Mean tumor size was 3.2 cm, mean ± SD R.E.N.A.L. score 7.0 ± 1.9, C-index 2.9 ± 2.4, operative time 4.4 hours, blood loss 206 cc and hospital stay 3.9 days. There were no intraoperative complications. Postoperative complications (22.8%) were low grade (Clavien grade 1 to 2) in 19.3% and high grade (Clavien grade 3 to 5) in 3.5%. All patients had negative cancer surgical margins (100%). Mean absolute and percent change in preoperative vs 4-month postoperative serum creatinine (0.2 mg/dl, 18%), estimated glomerular filtration rate (-11.4 ml/minute/1.73 m(2), 13%), and ipsilateral kidney function on radionuclide scanning at 6 months (-10%) correlated with mean percent kidney excised intraoperatively (18%). Although 21% of patients received a perioperative blood transfusion, no patient had acute or delayed renal hemorrhage, or lost a kidney. CONCLUSIONS: The concept of zero ischemia robotic and laparoscopic partial nephrectomy is presented. This anatomical vascular microdissection of the artery first and then tumor allows even complex tumors to be excised without hilar clamping. Global surgical renal ischemia is unnecessary for the majority of patients undergoing robotic and laparoscopic partial nephrectomy at our institution.

Subclassification of pT3 urothelial carcinoma of the renal pelvicalyceal system is associated with recurrence-free and cancer-specific survival: proposal for a revision of the current TNM classification.

BACKGROUND: The clinical course of pT3 upper tract urothelial carcinoma (UTUC) is highly variable. OBJECTIVES: The aim of the current study was to validate the clinical and prognostic importance of pT3 subclassification in the renal pelvicalyceal system in a large international cohort of patients. DESIGN, SETTING, AND PARTICIPANTS: From a multi-institutional international database, 858 renal pelvicalyceal tumors treated with radical nephroureterectomy (RNU) were systematically reevaluated by genitourinary pathologists. Category pT3 pelvic tumors were categorized as pT3a (infiltration of the renal parenchyma on a microscopic level only) versus pT3b (macroscopic infiltration of the renal parenchyma and/or infiltration of peripelvic adipose tissue). INTERVENTION: RNU. MEASUREMENTS: Associations of pT3 subclassifications with clinicopathologic features were assessed with the chi-square test. Prognostic impact was assessed with the log-rank test and multivariable Cox regression analyses. RESULTS AND LIMITATIONS: Of 858 patients with renal pelvicalyceal tumors, 266 (31%) had pT3 disease. Of these, 146 (54.9%) were classified as pT3a and 120 (45.1%) as pT3b. Compared with pT3a, pT3b cancers were associated with higher tumor grade, nodal disease, and tumor necrosis. Ten-year recurrence-free (pT3a 58% vs pT3b 38%; p<0.001) and cancer-specific (pT3a 60% vs pT3b 39%; p=0.002) survival rates were lower for patients with pT3b disease. In multivariable analyses, classification pT3b was an independent predictor of both disease recurrence (hazard ratio [HR]: 1.8, p=0.003) and cancer-specific mortality (HR: 1.7; p=0.02). The major limitation is the retrospective character of the study. CONCLUSIONS: Subclassification of pT3 renal pelvicalyceal UTUC helps identify patients who are at increased risk of disease progression and cancer-related death. Further research may help assess the value of subclassification and its inclusion in future editions of the American Joint Committee on Cancer-International Union Against Cancer TNM classification system.

Anatomic renal artery branch microdissection to facilitate zero-ischemia partial nephrectomy.

BACKGROUND: Robot-assisted and laparoscopic partial nephrectomies (PNs) for medial tumors are technically challenging even with the hilum clamped and, until now, were impossible to perform with the hilum unclamped. OBJECTIVE: Evaluate whether targeted vascular microdissection (VMD) of renal artery branches allows zero-ischemia PN to be performed even for challenging medial tumors. DESIGN, SETTING, AND PARTICIPANTS: A prospective cohort evaluation of 44 patients with renal masses who underwent robot-assisted or laparoscopic zero-ischemia PN either with anatomic VMD (group 1; n=22) or without anatomic VMD (group 2; n=22) performed by a single surgeon from April 2010 to January 2011. INTERVENTION: Zero-ischemia PN with VMD incorporates four maneuvers: (1) preoperative computed tomographic reconstruction of renal arterial branch anatomy, (2) anatomic dissection of targeted, tumor-specific tertiary or higher-order renal arterial branches, (3) neurosurgical aneurysm microsurgical bulldog clamp(s) for superselective tumor devascularization, and (4) transient, controlled reduction of blood pressure, if necessary. MEASUREMENTS: Baseline, perioperative, and postoperative data were collected prospectively. RESULTS AND LIMITATIONS: Group 1 tumors were larger (4.3 vs 2.6 cm; p=0.011), were more often hilar (41% vs 9%; p=0.09), were medial (59% and 23%; p=0.017), were closer to the hilum (1.46 vs 3.26 cm; p=0.0002), and had a lower C index score (2.1 vs 3.9; p=0.004) and higher RENAL nephrometry scores (7.7 vs 6.2; p=0.013). Despite greater complexity, no group 1 tumor required hilar clamping, and perioperative outcomes were similar to those of group 2: operating room time (4.7 and 4.1h), median blood loss (200 and 100ml), surgical margins for cancer (all negative), major complications (0% and 9%), and minor complications (18% and 14%). The median serum creatinine level was similar 2 mo postoperatively (1.2 and 1.3mg/dl). The study was limited by the relatively small sample size. CONCLUSIONS: Anatomic targeted dissection and superselective control of tumor-specific renal arterial branches facilitate zero-ischemia PN. Even challenging medial and hilar tumors can be excised without hilar clamping. Global surgical renal ischemia has been eliminated for most patients undergoing PN at our institution.

Concurrent and predictive validation of a novel robotic surgery simulator: a prospective, randomized study.

PURPOSE: We evaluated the concurrent and predictive validity of a novel robotic surgery simulator in a prospective, randomized study. MATERIALS AND METHODS: A total of 24 robotic surgery trainees performed virtual reality exercises on the da Vinci® Skills Simulator using the da Vinci Si™ surgeon console. Baseline simulator performance was captured. Baseline live robotic performance on ex vivo animal tissue exercises was evaluated by 3 expert robotic surgeons using validated laparoscopic assessment metrics. Trainees were then randomized to group 1-simulator training and group 2-no training while matched for baseline tissue scores. Group 1 trainees underwent a 10-week simulator curriculum. Repeat tissue exercises were done at study conclusion to assess performance improvement. Spearman's analysis was used to correlate baseline simulator performance with baseline ex vivo tissue performance (concurrent validity) and final tissue performance (predictive validity). The Kruskal-Wallis test was used to compare group performance. RESULTS: Groups 1 and 2 were comparable in pre-study surgical experience and had similar baseline scores on simulator and tissue exercises (p >0.05). Overall baseline simulator performance significantly correlated with baseline and final tissue performance (concurrent and predictive validity each r = 0.7, p <0.0001). Simulator training significantly improved tissue performance on key metrics for group 1 subjects with lower baseline tissue scores (below the 50th percentile) than their group 2 counterparts (p <0.05). Group 1 tended to outperform group 2 on final tissue performance, although the difference was not significant (p >0.05). CONCLUSIONS: Our study documents the concurrent and predictive validity of the Skills Simulator. The benefit of simulator training appears to be most substantial for trainees with low baseline robotic skills.

High-grade ureteroscopic biopsy is associated with advanced pathology of upper-tract urothelial carcinoma tumors at definitive surgical resection.

BACKGROUND AND PURPOSE: Accurate assessment of upper-tract urothelial carcinoma (UTUC) pathology may guide use of endoscopic vs extirpative therapy. We present a multi-institutional cohort of patients with UTUC who underwent surgical resection to characterize the association of ureteroscopic (URS) biopsy features with final pathology results. PATIENTS AND METHODS: URS biopsy data were available in 238 patients who underwent surgical resection of UTUC. Biopsies were performed using a brush biopsy kit, mechanical biopsy device, or basket. Stage was classified as a positive brush, nonmuscle-invasive (

Face, content and construct validity of a novel robotic surgery simulator.

PURPOSE: We evaluated the face, content and construct validity of the novel da Vinci® Skills Simulator™ using the da Vinci Si™ Surgeon Console as the surgeon interface. MATERIALS AND METHODS: We evaluated a novel robotic surgical simulator for robotic surgery using the da Vinci Si Surgeon Console and Mimic™ virtual reality. Subjects were categorized as novice-no surgical training, intermediate-surgical training with fewer than 100 robotic cases or expert-100 or more primary surgeon robotic cases. Each participant completed 10 virtual reality exercises with 3 repetitions and a questionnaire with a 1 to 10 visual analog scale to assess simulator realism (face validity) and training usefulness (content validity). The simulator recorded performance based on specific metrics. The performance of experts, intermediates and novices was compared (construct validity) using the Kruskal-Wallis test. RESULTS: We studied 16 novices, 32 intermediates with a median surgical experience of 6 years (range 1 to 37) and a median of 0 robotic cases (range 0 to 50), and 15 experts with a median of 315 robotic cases (range 100 to 800). Participants rated the virtual reality and console experience as very realistic (median visual analog scale score 8/10) while expert surgeons rated the simulator as a very useful training tool for residents (10/10) and fellows (9/10). Experts outperformed intermediates and novices in almost all metrics (median overall score 88.3% vs 75.6% and 62.1%, respectively, between group p<0.001). CONCLUSIONS: We confirmed the face, content and construct validity of a novel robotic skill simulator that uses the da Vinci Si Surgeon Console. Although it is currently limited to basic skill training, this device is likely to influence robotic surgical training across specialties.

Obesity adversely impacts disease specific outcomes in patients with upper tract urothelial carcinoma.

PURPOSE: The relationship between body mass index and urothelial carcinoma is poorly understood. We investigated the association between body mass index and oncological outcomes in patients with upper tract urothelial carcinoma. MATERIALS AND METHODS: We retrospectively reviewed the records of 520 patients treated with radical nephroureterectomy for upper tract urothelial carcinoma. Univariate Cox regression analysis was done to evaluate estimated recurrence-free, cancer specific and overall survival. We created a multivariate model based on preoperative and postoperative characteristics. RESULTS: Median patient body mass index was 27.9 kg/m(2) (IQR 6.7). Patients with a higher body mass index were more likely to have infiltrative architecture (p <0.001) and lymphovascular invasion (p = 0.012). In the preoperative model body mass index 25 to 29 (HR 2.25, 95% CI 1.3-3.8, p = 0.003) and 30 kg/m(2) or greater (HR 3.72, 95% CI 2.2-6.3, p <0.001) was associated with disease recurrence. Body mass index 30 kg/m(2) or greater (HR 4.24, 95% CI 2.4-7.5, p <0.001) was associated with cancer specific death. In the postoperative model tumor stage (p <0.001), positive lymph nodes (HR 2.52, 95% CI 1.59-4.0, p <0.001), and body mass index 25 to 29 (HR 2.18, 95% CI 1.27-3.73, p = 0.005) and 30 kg/m(2) or greater (HR 3.52, 95% CI 2.08-5.95, p <0.001) were associated with disease recurrence. Tumor stage (p <0.001), positive lymph nodes (HR 3.1, 95% CI 1.84-5.21, p <0.001) and body mass index 30 kg/m(2) or greater (HR 4.13, 95% CI 2.32-7.36, p <0.001) were associated with worse cancer specific and overall survival. CONCLUSIONS: Higher body mass index is associated with worse recurrence-free, cancer specific and overall survival in patients treated with radical nephroureterectomy for upper tract urothelial carcinoma. Improving oncological outcomes by also focusing on patient modifiable factors such as body mass index has significant individual and public health implications in patients with upper tract urothelial carcinoma.

Racial differences in the outcome of patients with urothelial carcinoma of the upper urinary tract: an international study.

OBJECTIVE: •To assess the impact of differences in ethnicity on clinico-pathological characteristics and outcomes of patients with upper urinary tract urothelial carcinoma (UTUC) in a large multi-center series of patients treated with radical nephroureterectomy (RNU). MATERIALS AND METHODS: •We retrospectively collected the data of 2163 patients treated with RNU at 20 academic centres in America, Asia, and Europe. •Univariable and multivariable Cox regression models addressed recurrence-free survival (RFS) and cancer-specific survival (CSS). RESULTS: •In all, 1794 (83%) patients were Caucasian and 369 (17%) were Japanese. All the main clinical and pathological features were significantly different between the two ethnicities. •The median follow-up of the whole cohort was 36 months. At last follow-up, 554 patients (26%) developed disease recurrence and 461 (21%) were dead from UTUC. •The 5-year RFS and CSS estimates were 71.5% and 74.2%, respectively, for Caucasian patients compared with 68.8% and 75.4%, respectively, for Japanese patients. •On univariable Cox regression analyses, ethnicity was not significantly associated with either RFS (P= 0.231) or CSS (P= 0.752). •On multivariable Cox regression analyses that adjusted for the effects of age, gender, surgical type, T stage, grade, tumour architecture, presence of concomitant carcinoma in situ, lymphovascular invasion, tumour necrosis, and lymph node status, ethnicity was not associated with either RFS (hazard ratio [HR] 1.1; P= 0.447) or CSS (HR 1.0; P= 0.908). CONCLUSIONS: •There were major differences in the clinico-pathological characteristics of Caucasian and Japanese patients. •However, RFS and CSS probabilities were not affected by ethnicity and race was not an independent predictor of either recurrence or cancer-related death.

Chronological age is not an independent predictor of clinical outcomes after radical nephroureterectomy.

PURPOSE: Higher chronological age has been suggested to confer worse prognosis in patients with upper tract urothelial carcinoma (UTUC). The aim of the current study was to test this hypothesis in a large multicenter external validation cohort of patients treated with radical nephroureterectomy (RNU) while controlling for patient performance status. MATERIALS AND METHODS: We retrospectively reviewed the data from 1,169 patients treated with RNU for UTUC. Age at RNU was analyzed both as a continuous and categorical variable (<50 years, n = 66; 50-59.9 years, n = 185; 60-69.9 years, n = 367; 70-79.9 years, n = 419; ≥80 years, n = 132). Median follow-up was 37 months. RESULTS: Actuarial recurrence-free, cancer-specific, and all-cause survival estimates at 5 years after RNU were 69, 73, and 61%, respectively. Advanced age was associated with female gender, higher ECOG status, higher ASA score, and a lower probability of receiving adjuvant chemotherapy (all P values ≤ 0.02). In multivariable analyses, advanced age was associated with decreased recurrence-free (P = 0.021), cancer-specific (P = 0.002), and all-cause survival (P < 0.001) after controlling for the effects of gender, tumor location, number of lymph nodes removed, tumor grade, stage, architecture, necrosis, and lymphovascular invasion. After addition of ECOG status, age remained an independent predictor of only all-cause mortality (P > 0.001). CONCLUSIONS: We confirmed that advanced patient age at the time of RNU is associated with worse clinical outcomes after surgery. However, ECOG performance status abrogated the association. Furthermore, a large proportion of elderly patients were cured with RNU. This suggests that chronological age alone is an inadequate indicator criterion to predict response of older UTUC patients to RNU.