Postradical prostatectomy prostate-specific antigen outcomes after 6 versus 18 months of perioperative androgen-deprivation therapy in men with localized, unfavorable intermediate-risk or high-risk prostate cancer: Results of part 2 of a randomized phase 2 trial.

BACKGROUND: Patients with localized, unfavorable intermediate-risk and high-risk prostate cancer have an increased risk of relapse after radical prostatectomy (RP). The authors previously reported on part 1 of this phase 2 trial testing neoadjuvant apalutamide, abiraterone, prednisone, plus leuprolide (AAPL) or abiraterone, prednisone, and leuprolide (APL) for 6 months followed by RP. The results demonstrated favorable pathologic responses (tumor <5 mm) in 20.3% of patients (n = 24 of 118). Herein, the authors report the results of part 2. METHODS: For part 2, patients were randomized 1:1 to receive either AAPL for 12 months (arm 2A) or observation (arm 2B), stratified by neoadjuvant therapy and pathologic tumor classification. The primary end point was 3-year biochemical progression-free survival. Secondary end points included safety and testosterone recovery (>200 ng/dL). RESULTS: Overall, 82 of 118 patients (69%) enrolled in part 1 were randomized to part 2. A higher proportion of patients who were not randomized to adjuvant therapy had a favorable prostatectomy pathologic response (32.3% in nonrandomized patients compared with 17.1% in randomized patients). In the intent-to-treat analysis, the 3-year biochemical progression-free survival rate was 81% for arm 2A and 72% for arm 2B (hazard ratio, 0.81; 90% confidence interval, 0.43-1.49). Of the randomized patients, 81% had testosterone recovery in the AAPL group compared with 95% in the observation group, with a median time to recovery of <12 months in both arms. CONCLUSIONS: In this study, because 30% of patients declined adjuvant treatment, part B was underpowered to detect differences between arms. Future perioperative studies should be biomarker-directed and include strategies for investigator and patient engagement to ensure compliance with protocol procedures.

Reliability and Management Outcomes Following a Percutaneous Biopsy Diagnosis of Oncocytoma: A 15-year Retrospective Analysis.

Background There is uncertainty in the management of renal masses diagnosed as oncocytomas with image-guided percutaneous biopsy. Purpose To assess the reliability of a diagnosis of oncocytoma based on image-guided percutaneous renal mass biopsy and evaluate patient outcomes following different management strategies. Materials and Methods In this retrospective study, image-guided percutaneous biopsy pathology reports from April 2004 to April 2019 were searched for keywords "oncocytoma" and "oncocytic neoplasm" and compared with surgical pathology or repeat biopsy results. Patients with at least 12 months of clinical follow-up and known cause of death were grouped according to management strategies, and disease-specific survival and metastatic renal cell carcinoma (RCC)-free survival were compared. Mass growth rates were calculated with use of a normal linear mixed model. Results The database yielded 160 biopsy reports of 149 renal masses in 139 patients; 149 masses were categorized as oncocytoma (n = 107), likely oncocytoma (n = 12), oncocytic neoplasm (n = 28), and indeterminate with oncocytoma in differential (n = 2). Biopsied masses categorized as oncocytoma or likely oncocytoma were oncocytomas in 16 of 17 masses (94%) based on surgical pathology or repeat biopsy; four of eight masses (50%) categorized as oncocytic neoplasms were low-grade RCCs. Outcome analysis included 121 patients (mean age ± SD, 68 years ± 9.1; 82 men); 80 patients initially underwent active surveillance (11 were later treated), 33 underwent ablation, and eight underwent surgery. Disease-specific survival and metastatic-free survival were 100% after each management strategy (median follow-up, 86.6 months; range, 14.2-207.9 months). Mass growth rate (mean, 1.7 mm per year) showed no evidence of a significant difference among biopsy result categories (P = .37) or initial (P = .84) or final management strategies (P = .11). Conclusion Image-guided percutaneous biopsy diagnosis of renal oncocytoma was reliable. Although some masses diagnosed as oncocytic neoplasms were low-grade renal cell carcinomas (RCCs) at final diagnosis, no patients died of RCC, including those managed with active surveillance. © RSNA, 2023 See also the editorial by Lockhart in this issue.

Promoting the use of the PI-QUAL score for prostate MRI quality: results from the ESOR Nicholas Gourtsoyiannis teaching fellowship.

OBJECTIVES: The Prostate Imaging Quality (PI-QUAL) score is a new metric to evaluate the diagnostic quality of multiparametric magnetic resonance imaging (MRI) of the prostate. This study assesses the impact of an intervention, namely a prostate MRI quality training lecture, on the participant's ability to apply PI-QUAL. METHODS: Sixteen participants (radiologists, urologists, physicists, and computer scientists) of varying experience in reviewing diagnostic prostate MRI all assessed the image quality of ten examinations from different vendors and machines. Then, they attended a dedicated lecture followed by a hands-on workshop on MRI quality assessment using the PI-QUAL score. Five scans assessed by the participants were evaluated in the workshop using the PI-QUAL score for teaching purposes. After the course, the same participants evaluated the image quality of a new set of ten scans applying the PI-QUAL score. Results were assessed using receiver operating characteristic analysis. The reference standard was the PI-QUAL score assessed by one of the developers of PI-QUAL. RESULTS: There was a significant improvement in average area under the curve for the evaluation of image quality from baseline (0.59 [95 % confidence intervals: 0.50-0.66]) to post-teaching (0.96 [0.92-0.98]), an improvement of 0.37 [0.21-0.41] (p < 0.001). CONCLUSIONS: A teaching course (dedicated lecture + hands-on workshop) on PI-QUAL significantly improved the application of this scoring system to assess the quality of prostate MRI examinations. KEY POINTS: • A significant improvement in the application of PI-QUAL for the assessment of prostate MR image quality was observed after an educational intervention. • Appropriate training on image quality can be delivered to those involved in the acquisition and interpretation of prostate MRI. • Further investigation will be needed to understand the impact on improving the acquisition of high-quality diagnostic prostate MR examinations.

The impact of smoking on radical cystectomy complications increases in elderly patients.

BACKGROUND: Smoking, the most common risk factor for bladder cancer (BC), is associated with increased complications after radical cystectomy (RC), poorer oncologic outcomes, and higher mortality. The authors hypothesized that the effect of smoking on the probability of major complications increases with increasing age among patients who undergo RC. METHODS: The authors analyzed the American College of Surgeons National Surgical Quality Improvement Program database (2011-2017), identified all patients undergoing RC using Current Procedural Terminology codes, and formed two groups according to smoking status (active smoker and nonsmoker [included former and never-smokers]). Patient characteristics and 30-day postoperative complications using the Clavien-Dindo Classification (CDC) were assessed. A multivariable logistic regression model was constructed that included age, sex, race, body mass index, operative time, comorbidities, chemotherapy status, and type of diversion with major complications (CDC ≥III) as the outcome variable, and explored the interaction between age and smoking status. RESULTS: A total of 10,528 patients underwent RC, including 22.8% who were active smokers. The authors identified an interaction between age and smoking status (P = .045). Older patients were found to experience a stronger smoking effect than younger patients with regard to the probability of major complications. The risk of a major complication was the same for 50-year-old nonsmokers and smokers, but it increased from 17.8% to 21.7% for 70-year-old nonsmokers and smokers, respectively (P < .001). CONCLUSIONS: Up to 20% of patients who undergo RC are active smokers, and these individuals have an increased risk of major complications. The effect of smoking is stronger with increasing age; the difference with regard to complications for smokers versus nonsmokers was found to increase substantially, wherein older smokers are at an especially high risk of complications.

miR-218 Expressed in Endothelial Progenitor Cells Contributes to the Development and Repair of the Kidney Microvasculature.

Ischemia due to hypoperfusion is one of the most common forms of acute kidney injury. We hypothesized that kidney hypoxia initiates the up-regulation of miR-218 expression in endothelial progenitor cells (EPCs) to guide endocapillary repair. Murine renal artery-derived EPCs (CD34+/CD105-) showed down-regulation of mmu-Mir218-5p/U6 RNA ratio after ischemic injury, while in human renal arteries, MIR218-5p expression was up-regulated after ischemic injury. MIR218 expression was clarified in cell culture experiments in which increases in both SLIT3 and MIR218-2-5p expressions were observed after 5 minutes of hypoxia. ROBO1 transcript, a downstream target of MIR218-2-5p, showed inverse expression to MIR218-2-5p. EPCs transfected with a MIR218-5p inhibitor in three-dimensional normoxic culture showed premature capillary formation. Organized progenitor cell movement was reconstituted when cells were co-transfected with Dicer siRNA and low-dose Mir218-5p mimic. A Mir218-2 knockout was generated to assess the significance of miR-218-2 in a mammalian model. Mir218-2-5p expression was decreased in Mir218-2-/- embryos at E16.5. Mir218-2-/- decreased CD34+ angioblasts in the ureteric bud at E16.5 and were nonviable. Mir218-2+/- decreased peritubular capillary density at postnatal day 14 and increased serum creatinine after ischemia in adult mice. Systemic injection of miR-218-5p decreased serum creatinine after injury. These experiments demonstrate that miR-218 expression can be triggered by hypoxia and modulates EPC migration in the kidney.

Results of a Randomized Phase II Trial of Intense Androgen Deprivation Therapy prior to Radical Prostatectomy in Men with High-Risk Localized Prostate Cancer.

PURPOSE: This multicenter randomized phase 2 trial investigates the impact of intense androgen deprivation on radical prostatectomy pathologic response and radiographic and tissue biomarkers in localized prostate cancer (NCT02903368). MATERIALS AND METHODS: Eligible patients had a Gleason score ≥4+3=7, prostate specific antigen >20 ng/mL or T3 disease and lymph nodes <20 mm. In Part 1, patients were randomized 1:1 to apalutamide, abiraterone acetate, prednisone and leuprolide (AAPL) or abiraterone, prednisone, leuprolide (APL) for 6 cycles (1 cycle=28 days) followed by radical prostatectomy. Surgical specimens underwent central review. The primary end point was the rate of pathologic complete response or minimum residual disease (minimum residual disease, tumor ≤5 mm). Secondary end points included prostate specific antigen response, positive margin rate and safety. Magnetic resonance imaging and tissue biomarkers of pathologic outcomes were explored. RESULTS: The study enrolled 118 patients at 4 sites. Median age was 61 years and 94% of patients had high-risk disease. The combined pathologic complete response or minimum residual disease rate was 22% in the AAPL arm and 20% in the APL arm (difference: 1.5%; 1-sided 95% CI -11%, 14%; 1-sided p=0.4). No new safety signals were observed. There was low concordance and correlation between posttherapy magnetic resonance imaging assessed and pathologically assessed tumor volume. PTEN-loss, ERG positivity and presence of intraductal carcinoma were associated with extensive residual tumor. CONCLUSIONS: Intense neoadjuvant hormone therapy in high-risk prostate cancer resulted in favorable pathologic responses (tumor <5 mm) in 21% of patients. Pathologic responses were similar between treatment arms. Part 2 of this study will investigate the impact of adjuvant hormone therapy on biochemical recurrence.

Patient factors predict complications after partial nephrectomy: validation and calibration of the Preoperative Risk Evaluation for Partial Nephrectomy (PREP) score.

OBJECTIVES: To develop and validate the Preoperative Risk Evaluation for Partial Nephrectomy (PREP) score to predict the probability of major postoperative complications after partial nephrectomy (PN) based on patient comorbidities. PATIENTS AND METHODS: The Premier Healthcare Database was used to identify patients who had undergone elective PN. Through review of International Classification of Diseases ninth revision codes, we identified patient comorbidities and major surgical complications (Clavien-Dindo Grade III-V). Multivariable logistic regression was used to identify predictors of major complications. We used half of the set as the training cohort to develop our risk score and the other half as a validation cohort. RESULTS: From 2003 to 2015, 25 451 PNs were performed. The overall rate of major complications was 4.9%. The final risk score consisted of 10 predictors: age, sex, congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, chronic kidney disease, diabetes, hypertension, obesity, and smoking. In the training cohort, the area under the receiver operating characteristic curve (AUC) was 0.75 (95% confidence interval [CI] 0.73-0.78), while the AUC for the validation cohort was 0.73 (95% CI 0.70-0.75). The predicted probabilities of major complication in the low- (≤10 points), intermediate- (11-20 points), high- (21-30 points), and very high-risk (>30 points) categories were 3% (95% CI 2.6-3.2), 8% (95% CI 7.2-9.2), 24% (95% CI 20.5-27.8), and 41% (95% CI 34.5-47.8), respectively. CONCLUSIONS: We developed and validated the PREP score to predict the risk of complications after PN based on patient characteristics. Calculation of the PREP score can help providers select treatment options for patients with a cT1a renal mass and enhance the informed consent process for patients planning to undergo PN.

Percutaneous CT- and MRI-guided Cryoablation of cT1 Renal Cell Carcinoma: Intermediate- to Long-term Outcomes in 307 Patients.

Background Percutaneous ablation for cT1 renal cell carcinoma (RCC) remains underused, partially because of heterogeneous and limited long-term outcomes data assessing recent cryoablation methods. Purpose To report intermediate- to long-term outcomes of image-guided percutaneous cryoablation of cT1 RCC and to compare outcomes for CT versus MRI guidance. Materials and Methods This HIPAA-compliant retrospective single-institution study assessed patients who underwent percutaneous cryoablation for solitary pathology-proven cT1 RCC between August 2000 and July 2017. Tumors (cT1a, n = 282; cT1b, n = 25; size range, 0.6-6.5 cm; median size, 2.5 cm) underwent cryoablation with CT (n = 155) or MRI (n = 152) guidance. Primary end points of overall survival (OS), disease-specific survival (DSS), imaging-confirmed disease-free survival (DFS), and local progression-free survival (LPFS) were calculated by using Kaplan-Meier analysis. Secondary end points of technique efficacy and adverse event rate were also calculated. Primary and secondary end points for CT and MRI guidance were compared by using univariable regression analysis. Results A total of 307 patients (mean age, 68 years ± 11 [standard deviation]; 192 men) were evaluated. Median clinical follow-up lasted 95 months (range, 8-219 months), and median imaging follow-up lasted 41 months (range, 0-189 months). Survival metrics at 3, 5, 10, and 15 years, respectively, included OS of 91% (95% confidence interval [CI]: 88%, 94%), 86% (95% CI: 82%, 90%), 78% (95% CI: 73%, 84%), and 76% (95% CI: 69%, 83%); DSS of 99.6% (95% CI: 99%, 100%), 99% (95% CI: 98%, 100%), 99% (95% CI: 98%, 100%), and 99% (95% CI: 98%, 100%); DFS of 94% (95% CI: 92%, 97%), 91% (95% CI: 88%, 96%), 88% (95% CI: 83%, 93%), and 88% (95% CI: 83%, 93%); and LPFS of 97% (95% CI: 94%, 99%), 95% (95% CI: 93%, 98%), 95% (95% CI: 93%, 98%), and 95% (95% CI: 93%, 98%). Survival did not significantly differ between CT and MRI guidance, with univariable Cox regression analysis hazard ratios of 0.97 (95% CI: 0.57, 1.67; P = .92) for OS, 0.63 (95% CI: 0.26, 1.52; P = .30) for DFS, and 0.83 (95% CI: 0.26, 2.74; P = .77) for LPFS. Primary and secondary technique efficacy were 96% and 99%, respectively. Overall adverse event rate was 14% (43 of 307), including 11 grade 3 events and three grade 4 events according to the Common Terminology Criteria for Adverse Events. Conclusion Percutaneous CT- and MRI-guided cryoablation of cT1 renal cell carcinoma had similar excellent intermediate- and long-term outcomes. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Georgiades in this issue.

Differences in survival and impact of adjuvant chemotherapy in patients with variant histology of tumors of the renal pelvis.

BACKGROUND: The impact of variant histologies on overall survival (OS), as well as their influence on the response to neoadjuvant and adjuvant chemotherapy (AC) is well studied in patients diagnosed with bladder cancer. However, little is known about tumors with variant histologies of the upper urinary tract. The objective of this study was to assess the survival of the predominant variant histologies of tumors of the renal pelvis (RPT) after surgical intervention, and to examine the influence of AC on the OS of the different variant histologies. METHODS: We identified 21,318 patients with RPT undergoing surgical intervention using the National Cancer Database for the period 2004-2015. We employed multivariable Cox proportional hazards regression models and Kaplan-Meier curves to evaluate the OS according to variant histology. Separate multivariable Cox regression models were used to assess the specific effect of AC on OS of the histological subgroups. RESULTS: The majority of patients were diagnosed with pure urothelial carcinoma (PUC) (96.1%). Overall, 826 patients were diagnosed with variant histologies (adenocarcinoma N = 298, squamous cell carcinoma N = 291, sarcomatoid N = 137, others N = 100). Compared to PUC, adenocarcinomas showed longer OS (HR 0.76, 95% confidence interval (CI) 0.62-0.94, p = 0.01), while sarcomatoid tumors had shorter OS (HR 1.59, 95% CI 1.12-2.26, p = 0.011). A subgroup analysis of patients undergoing AC showed a survival benefit in patients with PUC (HR 0.81, 95% CI 0.73-0.9, p < 0.001). CONCLUSION: We found that variant histologies of upper urinary tract carcinomas exhibit different survival rates and that AC was only associated with an OS benefit in patients with PUC.

Examining the relationship between complications and perioperative mortality following radical cystectomy: a population-based analysis.

OBJECTIVE: To examine the incidence of perioperative complications after radical cystectomy (RC) and assess their impact on 90-day postoperative mortality during the index stay and upon readmission. PATIENTS AND METHODS: A total of 57 553 patients with bladder cancer (unweighted cohort: 9137 patients) treated with RC, at 360 hospitals in the USA between 2005 and 2013 within the Premier Healthcare Database, were used for analysis. The 90-day perioperative mortality was the primary outcome. Multivariable regression was used to predict the probability of mortality; models were adjusted for patient, hospital, and surgical characteristics. RESULTS: An increase in the number of complications resulted in an increasing predicted probability of mortality, with a precipitous increase if patients had four or more complications compared to one complication during hospitalisation following RC (index stay; 1.0-9.7%, P < 0.001) and during readmission (2.0-13.1%, P < 0.001). A readmission complication nearly doubled the predicted probability of postoperative mortality as compared to an initial complication (3.9% vs 7.4%, P < 0.001). During the initial hospitalisation cardiac- (odds ratio [OR] 3.1, 95% confidence interval [CI] 1.9-5.1), pulmonary- (OR 4.8, 95% CI 2.8-8.4), and renal-related (OR 3.6, 95% CI 2-6.7) complications had the most significant impact on the odds of mortality across categories examined. CONCLUSIONS: The number and nature of complications have a distinct impact on mortality after RC. As complications increase there is an associated increase in perioperative mortality.

Trends in penile prosthesis implantation and analysis of predictive factors for removal.

PURPOSE: This study aims to analyze patient demographics, hospital characteristics, and clinical risk factors which predict penile prosthesis removal. We also examine costs of penile prosthesis removal and trends in inflatable versus non-inflatable penile prostheses implantation in the USA from 2003 to 2015. METHODS: Cross-sectional analysis from Premier Perspective Database was completed using data from 2003 to 2015. We compared the relative proportion of inflatable versus non-inflatable penile prostheses implanted. We separated the prosthesis removal group based on indication for removal-Group 1 (infection), Group 2 (mechanical complication), and Group 3 (all explants). All groups were compared to a control group of patients with penile implants who were never subsequently explanted. Multivariate analysis was performed to analyze patient and hospital factors which predicted removal. Cost comparison was performed between the explant groups. RESULTS: There were 5085 penile prostheses implanted with a stable relative proportion of inflatable versus non-inflatable prosthesis over the 13-year study period. There were 3317 explantations. Patient factors associated with prosthesis removal were non-black race, Charlson Comorbidity Index, diabetes, and HIV status. Hospital factors associated with removal included non-teaching status, hospital region, year of removal, and annual surgeon volume. Median hospitalization costs of all explantations were $10,878. Explantations due to infection cost $11,252 versus $8602 for mechanical complications. CONCLUSIONS: This large population-based study demonstrates a stable trend in inflatable versus non-inflatable prosthesis implantation. We also identify patient and hospital factors that predict penile prosthesis removal which has clinical utility for patient risk stratification and counseling.

Evaluating the cost of surveillance for non-muscle-invasive bladder cancer: an analysis based on risk categories.

INTRODUCTION: Non-muscle-invasive bladder cancer (NMIBC) is a biologically heterogeneous disease and is one of the most expensive malignancies to treat on a per patient basis. In part, this high cost is attributed to the need for long-term surveillance. We sought to perform an economic analysis of surveillance strategies to elucidate cumulative costs for the management of NMIBC. METHODS: A Markov model was constructed to determine the average 5-year costs for the surveillance of patients with NMIBC. Patients were stratified into low, intermediate, and high-risk groups based on the EORTC risk calculator to determine recurrence and progression rates according to each category. The index patient was a compliant 65-year-old male. A total of four health states were utilized in the Markov model: no evidence of disease, recurrence, progression and cystectomy, and death. RESULTS: Cumulative costs of care over a 5-year period were $52,125 for low-risk, $146,250 for intermediate-risk, and $366,143 for high-risk NMIBC. The primary driver of cost was progression to muscle-invasive disease requiring definitive therapy, contributing to 81% and 92% of overall cost for intermediate- and high-risk disease. Although low-risk tumors have a high likelihood of 5-year recurrence, the overall cost contribution of recurrence was 8%, whereas disease progression accounted for 71%. CONCLUSION: Although protracted surveillance cystoscopy contributes to the expenditures associated with NMIBC, progression increases the overall cost of care across all three patient risk groups and most notably for intermediate- and high-risk disease patients.

Associations of specific postoperative complications with costs after radical cystectomy.

OBJECTIVE: To quantify the financial impact of complications after radical cystectomy (RC) and their associations with respective 90-day costs, as RC is a morbid surgery plagued by complications and the expenditure attributed to specific complications after RC is not well characterised. PATIENTS AND METHODS: We used the Premier Hospital Database (Premier Inc., Charlotte, NC, USA) to identify 9 137 RC patients (weighted population of 57 553) from 360 hospitals between 2003 and 2013. Complications were categorised according to Agency for Healthcare Research and Quality Clinical Classifications. Patients with and without complications were compared, and multivariable analysis was performed. RESULTS: An index complication increased costs by $9 262 (95% confidence interval [CI] 8 300-10 223) and a readmission complication increased costs by $20 697 (95% CI 18 735-22 660). The four most costly index complications (descending order) were venous thromboembolism (VTE), infection, wound and soft tissue complications, and pulmonary complications (P < 0.001, vs no complication). A complication increased length of stay by 4 days (95% CI 3.6-4.3). One in five patients were readmitted in 90 days and the four costliest readmission complications (descending order) were pulmonary, bleeding, VTE, and gastrointestinal complications (P < 0.001, vs no complication). Readmitted patients had multiple complications upon readmission (median of 3, interquartile range 2-4). On multivariable analysis, more comorbidities, longer surgery (>6 h), transfusions of >3 units, and teaching hospitals were associated with higher costs (P < 0.05), whilst high-volume surgeons and shorter surgeries (<4 h) were associated with lower costs (P < 0.05). CONCLUSIONS: Complications after RC increase index and readmission costs for hospitals, and can be categorised based on magnitude. Future initiatives in RC may also consider costs of complications when establishing quality improvement priorities for patients, providers, or policymakers.

Human vascular progenitor cells derived from renal arteries are endothelial-like and assist in the repair of injured renal capillary networks.

Vascular progenitor cells show promise for the treatment of microvasculature endothelial injury. We investigated the function of renal artery progenitor cells derived from radical nephrectomy patients, in animal models of acute ischemic and hyperperfusion injuries. Present in human adventitia, CD34positive/CD105negative cells were clonal and expressed transcription factors Sox2/Oct4 as well as surface markers CXCR4 (CD184)/KDR(CD309) consistent with endothelial progenitor cells. Termed renal artery-derived vascular progenitor cells (RAPC), injected cells were associated with decreased serum creatinine after ischemia/reperfusion, reduced albuminuria after hyperperfusion, and improved blood flow in both models. A small population of RAPC integrated with the renal microvasculature following either experimental injury. At a cellular level, RAPC promoted local endothelial migration in co-culture. Profiling of RAPC microRNA identified high levels of miRNA 218; also found at high levels in exosomes isolated from RAPC conditioned media after cell contact for 24 hours. After hydrogen peroxide-induced endothelial injury, RAPC exosomes harbored Robo-1 transcript; a gene known to be regulated by mir218. Such exosomes enhanced endothelial cell migration in culture in the absence of RAPC. Thus, our work shows the feasibility of pre-emptive pro-angiogenic progenitor cell procurement from a targeted patient population and potential therapeutic use in the form of autologous cell transplantation.

Prophylactic Antibiotics and Postoperative Complications of Radical Cystectomy: A Population Based Analysis in the United States.

PURPOSE: Infectious, wound and soft tissue events contribute to the morbidity of radical cystectomy but the association between these events and antibiotic prophylaxis is not clear. We sought to describe the contemporary use of antibiotic prophylaxis in radical cystectomy and adherence to published guidelines, and identify regimens with the lowest rates of infectious events. MATERIALS AND METHODS: We identified the intraoperative antibiotic prophylaxis regimen in a population based, retrospective cohort study of patients who underwent radical cystectomy across the United States between 2003 and 2013. Multivariable regression was done to evaluate 90-day infectious events and length of stay. RESULTS: In a weighted cohort of 52,349 patients there were 579 unique antibiotic prophylaxis regimens. Cefazolin was the most commonly used antibiotic (16% of cases). The overall infectious event rate was 25%. Only 15% of patients received antibiotic prophylaxis based on guidelines. Of guideline based antibiotic prophylaxis ampicillin/sulbactam had the lowest odds of infectious events (OR 0.34, p <0.001). In 2.7% of patients a penicillin based regimen with a ß-lactamase inhibitor was associated with a prominent reduction in the odds of infectious events (OR 0.45, p = 0.001) and decreased length of stay (-1.3 days, p = 0.016). CONCLUSIONS: Antibiotic prophylaxis practices are highly heterogeneous in radical cystectomy. There is a lack of adherence to published guidelines. We observed decreased infectious event rates and shorter length of stay with regimens that included broad coverage of common skin, genitourinary and gastrointestinal flora. The ideal antibiotic regimen requires further study to optimize perioperative outcomes.

Patient driven care in the management of prostate cancer: analysis of the United States military healthcare system.

BACKGROUND: Patient preferences are assumed to impact healthcare resource utilization, especially treatment options. There is limited data exploring this phenomenon. We sought to identify factors associated with patients transferring care for prostatectomy, from military to civilian facilities, and the receipt of minimally invasive radical prostatectomy (MIRP). METHODS: Retrospective review of 2006-2010 TRICARE data identified men diagnosed with prostate cancer (ICD-9 185) receiving open radical prostatectomy (ORP; ICD-9: 60.5) or MIRP (ICD-9 60.5 + 54.21/17.42). Patients diagnosed at military facilities but underwent surgery at civilian facilities were defined as "transferring care". Logistic regression models identified predictors of transferring care for patients diagnosed at military facilities. A secondary analysis identified the predictors of MIRP receipt at civilian facilities. RESULTS: Of 1420 patients, 247 (17.4%) transferred care. These patients were more likely to undergo MIRP (OR = 7.83, p < 0.01), and get diagnosed at low-volume military facilities (OR = 6.10, p < 0.01). Our secondary analysis demonstrated that transferring care was strongly associated with undergoing MIRP (OR = 1.51, p = 0.04). CONCLUSIONS: Patient preferences induced a demand for greater utilization of MIRP and civilian facilities. Further work exploring factors driving these preferences and interventions tailoring them, based on evidence and cost considerations, is required.

Adrenalectomy for benign and malignant disease: utilization and outcomes by surgeon specialty and surgical approach from 2003-2013.

INTRODUCTION: Data on the utilization of open, laparoscopic and robotic adrenalectomy on a national level is limited. MATERIALS AND METHODS: Data on patients who underwent open, laparoscopic, or robotic adrenalectomy for benign or malignant disease in the US from 2003-2013 were extracted using ICD-9 codes from the Premier Hospital Database. Surgeon specialty, patient demographics, hospital characteristics, and complications were compared. Data were analyzed using univariate and multivariable logistic regression analyses. RESULTS: A total of 8,831 adrenalectomies were performed for benign and malignant tumors. There was no significant difference in rate of adrenalectomy with regards to comorbidities, insurance status, or hospital characteristics. Non-urologists performed adrenalectomy more often for both benign (57% versus 43%; p = 0.011) and malignant disease (66% versus 34%; p = 0.011). Across all indications, non-urologists performed open surgery most often followed by laparoscopic and robotic approaches (56.3% versus 37.4% versus 6.4%, respectively), compared to urologists (48.8% versus 38.4% versus 12.9%, respectively). Overall, urologists were more likely to use laparoscopic or robotic approaches (p = 0.001). There was no difference in complication rates or operative times between surgical specialties or by surgeon/hospital case volume. On multivariable regression analysis, the best predictor of major complication was a Charlson Comorbidity Index (CCI) ≥ 2 (OR 3.9, 95%CI 2.1-7.1; p = < 0.001). Compared to open surgery, laparoscopy had significantly reduced odds of major complication (OR 0.6, 95%CI 0.3-0.9; p = 0.03). Patients undergoing robotic procedures had the shortest length of stay. CONCLUSION: In this retrospective study, adrenalectomy was more commonly performed by non-urologists via an open approach. Patients with CCI ≥ 2 were more likely to have postoperative complications while surgeon volume, hospital volume, and surgical approach did not influence complication rates.

Association of Robotic-Assisted vs Laparoscopic Radical Nephrectomy With Perioperative Outcomes and Health Care Costs, 2003 to 2015.

IMPORTANCE: Use of robotic surgery has increased in urological practice over the last decade. However, the use, outcomes, and costs of robotic nephrectomy are unknown. OBJECTIVES: To examine the trend in use of robotic-assisted operations for radical nephrectomy in the United States and to compare the perioperative outcomes and costs with laparoscopic radical nephrectomy. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used the Premier Healthcare database to evaluate outcomes of patients who had undergone robotic-assisted or laparoscopic radical nephrectomy for renal mass at 416 US hospitals between January 2003 and September 2015. Multivariable regression modeling was used to assess outcomes. EXPOSURES: Robotic-assisted vs laparoscopic radical nephrectomy. MAIN OUTCOMES AND MEASURES: The primary outcome of the study was the trend in use of robotic-assisted radical nephrectomy. The secondary outcomes were perioperative complications, based on the Clavien classification system, and defined as any complication (Clavien grades 1-5) or major complications (Clavien grades 3-5, for which grade 5 results in death); resource use (operating time, blood transfusion, length of hospital stay); and direct hospital cost. RESULTS: Among 23 753 patients included in the study (mean age, 61.4 years; men, 13 792 [58.1%]), 18 573 underwent laparoscopic radical nephrectomy and 5180 underwent robotic-assisted radical nephrectomy. Use of robotic-assisted surgery increased from 1.5% (39 of 2676 radical nephrectomy procedures in 2003) to 27.0% (862 of 3194 radical nephrectomy procedures) in 2015 (P for trend <.001). In the weighted-adjusted analysis, there were no significant differences between robotic-assisted and laparoscopic radical nephrectomy in the incidence of any (Clavien grades 1-5) postoperative complications (adjusted rates, 22.2% vs 23.4%, difference, -1.2%; 95% CI, -5.4 to 3.0%) or major (Clavien grades 3-5) complications (adjusted rates, 3.5% vs 3.8%, difference, -0.3%; 95% CI, -1.0% to 0.5%). The rate of prolonged operating time (>4 hours) for patients undergoing the robotic-assisted procedure was higher than for patients receiving the laparoscopic procedure in the adjusted analysis (46.3% vs 25.8%; risk difference, 20.5%; 95% CI, 14.2% to 26.8%). Robotic-assisted radical nephrectomy was associated with higher mean 90-day direct hospital costs ($19 530 vs $16 851; difference, $2678; 95% CI, $838 to $4519), mainly accounted for operating room ($7217 vs $5378; difference, $1839; 95% CI, $1050 to $2628) and supply costs ($4876 vs $3891; difference, $985; 95% CI, $473 to $1498). CONCLUSIONS AND RELEVANCE: Among patients undergoing radical nephrectomy for renal mass between 2003 and 2015, the use of robotic-assisted surgery increased substantially. The use of robotic-assistance was not associated with increased risk of any or major complications but was associated with prolonged operating time and higher hospital costs compared with laparoscopic surgery.

Outcomes of Robotic versus Laparoscopic Partial Nephrectomy: an Updated Meta-Analysis of 4,919 Patients.

PURPOSE: We evaluated the current literature comparing outcomes of robotic vs laparoscopic partial nephrectomy. MATERIALS AND METHODS: We performed a literature search according to Cochrane guidelines up to December 2015 including studies comparing robotic and laparoscopic partial nephrectomy, and we compared baseline patient and tumor characteristics. We performed a meta-analysis to evaluate safety, effectiveness and functional outcomes of robotic vs laparoscopic partial nephrectomy using weighted mean difference and inverse variance pooled risk ratios, respectively. RESULTS: A total of 4,919 patients were included from 25 studies (robotic partial nephrectomy 2,681, laparoscopic partial nephrectomy 2,238). There were no significant differences between the 2 groups in terms of age, gender, laterality and final malignant pathology. Patients treated with robotic partial nephrectomy had larger tumors (WMD 0.17 cm, p=0.001) and higher mean R.E.N.A.L. nephrometry scores (WMD 0.59, p=0.002), and were associated with a decreased likelihood of conversion to laparoscopic/open surgery compared to laparoscopic partial nephrectomy (RR 0.36, p <0.001), any (Clavien 1 or greater) (RR 0.84, p=0.007) and major (Clavien 3 or greater) (RR 0.71, p=0.023) complications, positive margins (RR 0.53, p <0.001) and shorter warm ischemia time by 4.3 minutes (p <0.001). Both approaches had similar operative times (WMD -12.2 minutes, p=0.34), estimated blood loss (WMD -24.6 ml, p=0.15) and postoperative change in estimated glomerular filtration rate. CONCLUSIONS: This updated meta-analysis of retrospective cohort studies demonstrated that robotic partial nephrectomy confers a superior morbidity profile compared to laparoscopic partial nephrectomy in most of the examined perioperative outcomes. Despite being the strongest available evidence (Level 2b) for outcomes of robotic vs laparoscopic partial nephrectomy thus far, there have been no completed or ongoing randomized trials to lend Level 1 support for either approach.

Surgeon and Hospital Level Variation in the Costs of Robot-Assisted Radical Prostatectomy.

PURPOSE: We assessed surgeon and hospital level variation in robot-assisted radical prostatectomy costs and predictors of high and low cost surgery. MATERIALS AND METHODS: The study population consisted of a weighted sample of 291,015 men who underwent robot-assisted radical prostatectomy for prostate cancer by 667 surgeons at 197 U.S. hospitals from 2003 to 2013. We evaluated 90-day direct hospital costs (2014 USD) in the Premier Hospital Database. High costs per robot-assisted radical prostatectomy were those above the 90th percentile and low costs were those below the 10th percentile. RESULTS: Mean hospital cost per robot-assisted radical prostatectomy was $11,878 (95% CI $11,804-$11,952). Mean cost was $2,837 (95% CI $2,805-$2,869) in the low cost group vs $25,906 (95% CI $24,702-$25,490) in the high cost group. Nearly a third of the variation in robot-assisted radical prostatectomy cost was attributable to hospital characteristics and more than a fifth was attributable to surgeon characteristics (R-squared 30.43% and 21.25%, respectively). High volume surgeons and hospitals (90th percentile or greater) had decreased odds of high cost surgery (surgeons: OR 0.24, 95% CI 0.11-0.54; hospitals: OR 0.105, 95% CI 0.02-0.46). The performance of robot-assisted radical prostatectomy at a high volume hospital was associated with increased odds of low cost robot-assisted radical prostatectomy (OR 839, 95% CI 122-greater than 999). CONCLUSIONS: This study provides insight into the role of surgeons and hospitals in robot-assisted radical prostatectomy costs. Given the substantial variability, identifying and remedying the root cause of outlier costs may yield substantial benefits.