Best practice considerations on the assessment of robotic assisted surgical systems: results from an international consensus expert panel.

BACKGROUND: Health technology assessments (HTAs) of robotic assisted surgery (RAS) face several challenges in assessing the value of robotic surgical platforms. As a result of using different assessment methods, previous HTAs have reached different conclusions when evaluating RAS. While the number of available systems and surgical procedures is rapidly growing, existing frameworks for assessing MedTech provide a starting point, but specific considerations are needed for HTAs of RAS to ensure consistent results. This work aimed to discuss different approaches and produce guidance on evaluating RAS. METHODS: A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements. RESULTS: A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits. CONCLUSIONS: Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.

Outcomes of Lymph Node Dissection in Nephroureterectomy in the Treatment of Upper Tract Urothelial Carcinoma: Analysis of the ROBUUST Registry.

PURPOSE: We sought to evaluate outcomes of lymph node dissection (LND) in patients with upper tract urothelial carcinoma. MATERIALS AND METHODS: We performed a multicenter retrospective analysis utilizing the ROBUUST (for RObotic surgery for Upper Tract Urothelial Cancer Study) registry for patients who did not undergo LND (pNx), LND with negative lymph nodes (pN0) and LND with positive nodes (pN+). Primary and secondary outcomes were overall survival (OS) and recurrence-free survival (RFS). Multivariable analyses evaluated predictors of outcomes and pathological node positivity. Kaplan-Meier analyses (KMAs) compared survival outcomes. RESULTS: A total of 877 patients were analyzed (LND performed in 358 [40.8%]/pN+ in 73 [8.3%]). Median nodes obtained were 10.2 for pN+ and 9.8 for pN0. Multivariable analyses noted increasing age (OR 1.1, p <0.001), pN+ (OR 3.1, p <0.001) and pathological stage pTis/3/4 (OR 3.4, p <0.001) as predictors for all-cause mortality. Clinical high-grade tumors (OR 11.74, p=0.015) and increasing tumor size (OR 1.14, p=0.001) were predictive for lymph node positivity. KMAs for pNx, pN0 and pN+ demonstrated 2-year OS of 80%, 86% and 42% (p <0.001) and 2-year RFS of 53%, 61% and 35% (p <0.001), respectively. KMAs comparing pNx, pN0 ≥10 nodes and pN0 <10 nodes showed no significant difference in 2-year OS (82% vs 85% vs 84%, p=0.6) but elicited significantly higher 2-year RFS in the pN0 ≥10 group (60% vs 74% vs 54%, p=0.043). CONCLUSIONS: LND during nephroureterectomy in patients with positive lymph nodes provides prognostic data, but is not associated with improved OS. LND yields ≥10 in patients with clinical node negative disease were associated with improved RFS. In high-grade and large tumors, lymphadenectomy should be considered.

Predicting factor analysis of postoperative complications after robot-assisted radical cystectomy: Multicenter KORARC database study.

OBJECTIVES: To evaluate postoperative complications following robot-assisted radical cystectomy in patients diagnosed with bladder cancer and reveal if there are predictors for postoperative complications. METHODS: Prospectively collected medical records of 730 robot-assisted radical cystectomy patients between 2007/04 and 2019/05 in 13 tertiary referral centers were reviewed. Perioperative outcomes were compared between two groups by postoperative complications (complication vs non-complication). We assessed recurrence-free survival, cancer-specific survival, and overall survival between groups. Regression analyses were implemented to identify factors associated with postoperative complications. RESULTS: Any total and high-grade complication (Clavien-Dindo grade ≥3) rates were 57.8% and 21.1%, respectively. Patients in complication group had significantly higher proportion of diabetes mellitus (P = 0.048), chronic kidney disease (P = 0.011), dyslipidemia (P < 0.001), longer operation time (P = 0.001), more estimated blood loss (P = 0.001), and larger intraoperative fluid volume (P < 0.001). There was a significant difference in cancer-specific survival (log-rank P = 0.038, median cancer-specific survival: both groups not reached). Dyslipidemia (odds ratio 2.59, P = 0.002) and intraoperative fluid volume (odds ratio 1.0002, P = 0.040) were significantly associated with high-grade postoperative complications. Diabetes mellitus (odds ratio 1.97, P = 0.028), chronic kidney disease (odds ratio 1.89, P = 0.046), dyslipidemia (odds ratio 5.94, P = 0.007), and intraoperative fluid volume (odds ratio 1.0002, P = 0.009) were significantly associated with any postoperative complications. CONCLUSIONS: Patients with diabetes mellitus, chronic kidney disease, dyslipidemia, or a relatively large intraoperatively infused fluid volume are more likely to develop postoperative complications. Patients with postoperative complications might have a possibility of lower cancer-specific survival rate.

Risk Factors for Intravesical Recurrence after Minimally Invasive Nephroureterectomy for Upper Tract Urothelial Cancer (ROBUUST Collaboration).

PURPOSE: Intravesical recurrence (IVR) after radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC) has an incidence of approximately 20%-50%. Studies to date have been composed of mixed treatment cohorts-open, laparoscopic and robotic. The objective of this study is to assess clinicopathological risk factors for intravesical recurrence after RNU for UTUC in a completely minimally invasive cohort. MATERIALS AND METHODS: We performed a multicenter, retrospective analysis of 485 patients with UTUC without prior or concurrent bladder cancer who underwent robotic or laparoscopic RNU. Patients were selected from an international cohort of 17 institutions across the United States, Europe and Asia. Univariate and multiple Cox regression models were used to identify risk factors for bladder recurrence. RESULTS: A total of 485 (396 robotic, 89 laparoscopic) patients were included in analysis. Overall, 110 (22.7%) of patients developed IVR. The average time to recurrence was 15.2 months (SD 15.5 months). Hypertension was a significant risk factor on multiple regression (HR 1.99, CI 1.06; 3.71, p=0.030). Diagnostic ureteroscopic biopsy incurred a 50% higher chance of developing IVR (HR 1.49, CI 1.00; 2.20, p=0.048). Treatment specific risk factors included positive surgical margins (HR 3.36, CI 1.36; 8.33, p=0.009) and transurethral resection for bladder cuff management (HR 2.73, CI 1.10; 6.76, p=0.031). CONCLUSIONS: IVR after minimally invasive RNU for UTUC is a relatively common event. Risk factors include a ureteroscopic biopsy, transurethral resection of the bladder cuff, and positive surgical margins. When possible, avoidance of transurethral resection of the bladder cuff and alternative strategies for obtaining biopsy tissue sample should be considered.

Retzius-sparing robot-assisted radical prostatectomy: early learning curve experience in three continents.

OBJECTIVE: To assess the effect of surgical experience on peri-operative, functional and oncological outcomes during the first 50 Retzius-sparing robot-assisted radical prostatectomy (RsRARP) cases performed by surgeons naïve to this novel approach. MATERIALS AND METHODS: We retrospectively evaluated the initial cases operated by 14 surgeons in 12 different international centres. Pre-, peri- and postoperative features of the first 50 patients operated by each surgeon in all the participating centres were collected. The effect of surgical experience on peri-operative, functional and oncological outcomes was firstly evaluated after stratification by level of surgical experience (initial [≤25 cases] and expert [>25 cases]) and after using locally weighted scatterplot smoothing to graphically explore the relationship between surgical experience and the outcomes of interest. RESULTS: We evaluated 626 patients. The median follow-up was 13 months in the initial group and 9 months in the expert group (P = 0.002). Preoperative features overlapped between the two groups. Shorter console time (140 vs 120 min; P = 0.001) and a trend towards lower complications rates (13 vs 5.5%; P = 0.038) were observed in the expert group. The relationship between surgical experience and console time, immediate urinary continence recovery and Clavien-Dindo grade ≥2 complications was linear, without reaching a plateau, after 50 cases. Conversely, a non-linear relationship was observed between surgical experience and positive surgical margins (PSMs). CONCLUSIONS: In this first report of a multicentre experience of RsRARP during the learning curve, we found that console time, immediate urinary continence recovery and postoperative complications are optimal from the beginning and further quickly improve during the learning process, while PSM rates did not clearly improve over the first 50 cases.

Outcomes in robot-assisted partial nephrectomy for imperative vs elective indications.

OBJECTIVES: To assess and compare peri-operative outcomes of patients undergoing robot-assisted partial nephrectomy (RAPN) for imperative vs elective indications. PATIENT AND METHODS: We retrospectively reviewed a multinational database of 3802 adults who underwent RAPN for elective and imperative indications. Laparoscopic or open partial nephrectomy (PN) were excluded. Baseline data for age, gender, body mass index, American Society of Anaesthesiologists score and PADUA score were examined. Patients undergoing RAPN for an imperative indication were matched to those having surgery for an elective indication using propensity scores in a 1:3 ratio. Primary outcomes included organ ischaemic time, operating time, estimated blood loss (EBL), rate of blood transfusions, Clavien-Dindo complications, conversion to radical nephrectomy (RN) and positive surgical margin (PSM) status. RESULTS: After propensity-score matching for baseline variables, a total of 304 patients (76 imperative vs 228 elective indications) were included in the final analysis. No significant differences were found between groups for ischaemia time (19.9 vs 19.8 min; P = 0.94), operating time (186 vs 180 min; P = 0.55), EBL (217 vs 190 mL; P = 0.43), rate of blood transfusions (2.7% vs 3.7%; P = 0.51), or Clavien-Dindo complications (P = 0.31). A 38.6% (SD 47.9) decrease in Day-1 postoperative estimated glomerular filtration rate was observed in the imperative indication group and an 11.3% (SD 45.1) decrease was observed in the elective indication group (P < 0.005). There were no recorded cases of permanent or temporary dialysis. There were no conversions to RN in the imperative group, and seven conversions (5.6%) in the elective group (P = 0.69). PSMs were seen in 1.4% (1/76) of the imperative group and in 3.3% of the elective group (7/228; P = 0.69). CONCLUSION: We conclude that RAPN is feasible and safe for imperative indications and demonstrates similar outcomes to those achieved for elective indications.

Oncological outcome according to attainment of pentafecta after robot-assisted radical cystectomy in patients with bladder cancer included in the multicentre KORARC database.

OBJECTIVES: To investigate the oncological significance of a robot-assisted radical cystectomy (RARC)-related pentafecta in patients with bladder cancer. PATIENTS AND METHODS: Using the KORARC database, which includes data from 12 centres, data from 730 patients who underwent RARC between April 2007 and May 2019 were prospectively collected and retrospectively analysed. Pentafecta was achieved if patients met all of the following criteria: (i) negative soft tissue surgical margin; (ii) ≥16 lymph nodes removed; (iii) no major complications (Clavien-Dindo grade 3-5) within 90 days; (iv) no clinical recurrence within the first 12 months; and (v) no ureteroenteric stricture. Patients were divided into two groups according to pentafecta attainment, and a comparison of overall survival (OS) and cancer-specific survival (CSS) using multivariate Cox proportional analysis was then carried out. RESULTS: Of the 730 patients included in this analysis, 208 (28.5%) attained the RARC pentafecta; the remaining 522 (71.5%) did not. The mean age of the patients was 64.67 years, 85.1% were men, 53.6% received a conduit, 37.7% received orthotopic neobladders and the total complication rate was 57.8%. Those who attained the pentafecta received more neobladders (P = 0.039), were more likely to be treated with the intracorporeal technique (P < 0.001), had longer operating times (P = 0.020) and had longer console time (P = 0.021) compared with those who did not attain the pentafecta. Over a mean of 31.1 months of follow-up, the pentafecta attainment group had significantly higher OS and CSS rates compared with the non-attainment group (10-year OS 70.4% vs 58.1%, respectively [P = 0.016]; 10-year CSS 87.8% vs 70.0%, respectively [P = 0.036]). Multivariate analysis showed that the RARC pentafecta was a significant predictor of overall mortality (hazard ratio 0.561; P = 0.038). CONCLUSIONS: Patients who attained the RARC pentafecta had significantly better survival outcomes compared with those who did not. These criteria could be used to standardize assessment of the surgical quality of RARC. In the future, a similar study using an independent cohort is warranted to confirm our results.

Management of patients who opt for radical prostatectomy during the coronavirus disease 2019 (COVID-19) pandemic: an international accelerated consensus statement.

OBJECTIVE: Coronavirus disease-19 (COVID-19) pandemic caused delays in definitive treatment of patients with prostate cancer. Beyond the immediate delay a backlog for future patients is expected. The objective of this work is to develop guidance on criteria for prioritisation of surgery and reconfiguring management pathways for patients with non-metastatic prostate cancer who opt for surgical treatment. A second aim was to identify the infection prevention and control (IPC) measures to achieve a low likelihood of coronavirus disease 2019 (COVID-19) hazard if radical prostatectomy (RP) was to be carried out during the outbreak and whilst the disease is endemic. METHODS: We conducted an accelerated consensus process and systematic review of the evidence on COVID-19 and reviewed international guidance on prostate cancer. These were presented to an international prostate cancer expert panel (n = 34) through an online meeting. The consensus process underwent three rounds of survey in total. Additions to the second- and third-round surveys were formulated based on the answers and comments from the previous rounds. The Consensus opinion was defined as ≥80% agreement and this was used to reconfigure the prostate cancer pathways. RESULTS: Evidence on the delayed management of patients with prostate cancer is scarce. There was 100% agreement that prostate cancer pathways should be reconfigured and measures developed to prevent nosocomial COVID-19 for patients treated surgically. Consensus was reached on prioritisation criteria of patients for surgery and management pathways for those who have delayed treatment. IPC measures to achieve a low likelihood of nosocomial COVID-19 were coined as 'COVID-19 cold' sites. CONCLUSION: Reconfiguring management pathways for patients with prostate cancer is recommended if significant delay (>3-6 months) in surgical management is unavoidable. The mapped pathways provide guidance for such patients. The IPC processes proposed provide a framework for providing RP within an environment with low COVID-19 risk during the outbreak or when the disease remains endemic. The broader concepts could be adapted to other indications beyond prostate cancer surgery.

Robot-assisted partial nephrectomy for high-complexity tumors (PADUA score ≥10): Perioperative, long-term functional and oncologic outcomes.

OBJECTIVES: To evaluate the safety and efficacy, and long-term functional and oncologic outcomes of robot-assisted partial nephrectomy in high-complexity tumors. METHODS: Data of 155 patients with a high-complexity tumor (PADUA score ≥10) were reviewed. Trifecta achievement, intra-, perioperative, functional, and oncologic outcomes were analyzed and compared between patients with increasing complexity. RESULTS: Of the 155 patients, 65 (41.9%) patients had a PADUA score of 10, 55 (35.5%) had a PADUA score of 11, and 35 (22.6%) had a PADUA score of 12-13, respectively. The median (interquartile range) operative time, warm ischemia time and estimated blood loss were 150 min (112-186 min), 26 min (23-32 min) and 250 mL (100-500 mL), respectively. Postoperatively, complications occurred in 25 (16.1%) patients, and positive surgical margins in 15 (10.5%) patients. Trifecta was achieved in 67 (43.2%) patients. At a median follow-up period of 58 months, the median estimated glomerular filtration rate preservation was 87% (78-110), and 12 (7.7%) patients developed new-onset chronic kidney disease. Recurrence-free survival and overall survival rates were 93.6% and 96.7%, respectively. Positive surgical margins were statistically different between the groups of PADUA score 10, 11 and 12-13 (P = 0.017), whereas functional and oncologic outcomes were similar. In multivariate logistic regression analysis, increasing tumor size (odds ratio 1.48, 95% confidence interval 1.21-1.87; P < 0.001) and the American Society of Anesthesiologists score 2/3 (odds ratio 0.48, 95% confidence interval 0.24-0.96; P = 0.041) were independent predictors of trifecta failure. CONCLUSIONS: Robot-assisted partial nephrectomy is a safe and effective treatment for high-complexity tumors providing excellent long-term functional and oncologic outcomes.

Retzius Sparing Robot-Assisted Radical Prostatectomy Conveys Early Regain of Continence over Conventional Robot-Assisted Radical Prostatectomy: A Propensity Score Matched Analysis of 1,863 Patients.

PURPOSE: We compared early continence recovery after surgical treatment of prostate cancer with Retzius sparing robot-assisted radical prostatectomy and conventional robot-assisted radical prostatectomy. MATERIALS AND METHODS: Robot-assisted radical prostatectomy was done by a single surgeon in 1,863 cases between October 2005 and May 2018 using the conventional and the Retzius sparing technique in 1,150 and 713, respectively. To compare continence outcomes between the groups propensity score matching was performed using 9 preoperative variables, including age, body mass index, prostate specific antigen, biopsy Gleason Grade Group, clinical T stage, prostate volume on transrectal ultrasound, and the I-PSS (International Prostate Symptom Score), I-PSS quality of life score and International Index of Erectile Function-5 scores. Continence was assessed by the pad count every month postoperatively until month 6 and was converted to a binary outcome. RESULTS: After propensity score matching 609 cases per group were matched with no significant difference in all 9 variables. The Kaplan-Meier curve analysis revealed that Retzius sparing robot-assisted radical prostatectomy was associated with a significantly better continence recovery rate than conventional robot-assisted radical prostatectomy during the 6-month study period (p <0.001). CONCLUSIONS: Based on propensity score matching with multiple variables and a large case series, Retzius sparing robot-assisted radical prostatectomy can be a candidate for future robot-assisted radical prostatectomy. It achieves better early continence recovery, a short operative time and early recovery compared to conventional robot-assisted radical prostatectomy.

Neoadjuvant Chemotherapy is Not Associated with Adverse Perioperative Outcomes after Robot-Assisted Radical Cystectomy: A Case for Increased Use from the IRCC.

PURPOSE: We sought to determine the trend of neoadjuvant chemotherapy use for nonmetastatic muscle invasive urothelial bladder cancer and whether it is associated with adverse perioperative morbidity after robot-assisted radical cystectomy. MATERIALS AND METHODS: We retrospectively reviewed the IRCC (International Robotic Cystectomy Consortium) database between 2006 and 2017. After excluding patients with nonmuscle invasive bladder cancer the patients were divided into 2 groups, including those who did vs did not receive neoadjuvant chemotherapy. Data were reviewed for demographics, preoperative, operative and 90-day perioperative outcomes. We used the Cochran-Armitage trend test to assess trends of neoadjuvant chemotherapy associations with high grade and overall complications with time. Multivariate stepwise regression analyses were done to determine whether neoadjuvant chemotherapy was associated with prolonged operative time, 90-day postoperative complications, readmissions, reoperations and mortality after robot-assisted radical cystectomy. RESULTS: A total of 298 patients (26%) received neoadjuvant chemotherapy. These patients were younger (age 67 vs 69 years, p=0.01) and more frequently had an ASA™ (American Society of Anesthesiologists™) score of 3 or greater (62% vs 55%, p=0.02) and pathological T3 stage or greater disease (28% vs 22%, p=0.04). The use of neoadjuvant chemotherapy increased significantly from 10% in 2006 to 2007 to 42% in 2016 to 2017 (p <0.01). On multivariate analysis neoadjuvant chemotherapy was not significantly associated with prolonged operative time, hospital stay, 90-day postoperative complications, reoperation or mortality. Neoadjuvant chemotherapy was associated with 90-day readmissions after robot-assisted radical cystectomy (OR 5.90, 95% CI 3.30-10.90, p <0.01). CONCLUSIONS: Neoadjuvant chemotherapy utilization has significantly increased in the last decade. It was not associated with perioperative surgical morbidity after robot-assisted radical cystectomy.

Predicting intra-operative and postoperative consequential events using machine-learning techniques in patients undergoing robot-assisted partial nephrectomy: a Vattikuti Collective Quality Initiative database study.

OBJECTIVE: To predict intra-operative (IOEs) and postoperative events (POEs) consequential to the derailment of the ideal clinical course of patient recovery. MATERIALS AND METHODS: The Vattikuti Collective Quality Initiative is a multi-institutional dataset of patients who underwent robot-assisted partial nephectomy for kidney tumours. Machine-learning (ML) models were constructed to predict IOEs and POEs using logistic regression, random forest and neural networks. The models to predict IOEs used patient demographics and preoperative data. In addition to these, intra-operative data were used to predict POEs. Performance on the test dataset was assessed using area under the receiver-operating characteristic curve (AUC-ROC) and area under the precision-recall curve (PR-AUC). RESULTS: The rates of IOEs and POEs were 5.62% and 20.98%, respectively. Models for predicting IOEs were constructed using data from 1690 patients and 38 variables; the best model had an AUC-ROC of 0.858 (95% confidence interval [CI] 0.762, 0.936) and a PR-AUC of 0.590 (95% CI 0.400, 0.759). Models for predicting POEs were trained using data from 1406 patients and 59 variables; the best model had an AUC-ROC of 0.875 (95% CI 0.834, 0.913) and a PR-AUC 0.706 (95% CI, 0.610, 0.790). CONCLUSIONS: The performance of the ML models in the present study was encouraging. Further validation in a multi-institutional clinical setting with larger datasets would be necessary to establish their clinical value. ML models can be used to predict significant events during and after surgery with good accuracy, paving the way for application in clinical practice to predict and intervene at an opportune time to avert complications and improve patient outcomes.

A comparative propensity score-matched analysis of perioperative outcomes of intracorporeal vs extracorporeal urinary diversion after robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium.

OBJECTIVE: To compare the perioperative outcomes of intracorporeal (ICUD) vs extracorporeal urinary diversion (ECUD) after robot-assisted radical cystectomy (RARC). PATIENTS AND METHODS: We retrospectively reviewed the prospectively maintained International Robotic Cystectomy Consortium (IRCC) database. A total of 972 patients from 28 institutions who underwent RARC were included. Propensity score matching was used to match patients based on age, gender, body mass index (BMI), American Society of Anesthesiologists Score (ASA) score, Charlson Comorbidity Index (CCI) score, prior radiation and abdominal surgery, receipt of neoadjuvant chemotherapy, and clinical staging. Matched cohorts were compared. Multivariate stepwise logistic and linear regression models were fit to evaluate variables associated with receiving ICUD, operating time, 90-day high-grade complications (Clavien-Dindo Classification Grade ≥III), and 90-day readmissions after RARC. RESULTS: Utilisation of ICUD increased from 0% in 2005 to 95% in 2018. The ICUD patients had more overall complications (66% vs 58%, P = 0.01) and readmissions (27% vs 17%, P = 0.01), but not high-grade complications (21% vs 24%, P = 0.22). A more recent RC era and ileal conduit diversion were associated with receiving an ICUD. Higher BMI, ASA score ≥3, and receiving a neobladder were associated with longer operating times. Shorter operating time was associated with male gender, older age, ICUD, and centres with a larger annual average RC volume. Longer intensive care unit stay was associated with 90-day high-grade complications. Higher CCI score, prior radiation therapy, neoadjuvant chemotherapy, and ICUD were associated with a higher risk of 90-day readmissions. CONCLUSIONS: Utilisation of ICUD has increased over the past decade. ICUD was associated with more overall complications and readmissions compared to ECUD, but not high-grade complications.

Long short-term memory artificial neural network model for prediction of prostate cancer survival outcomes according to initial treatment strategy: development of an online decision-making support system.

PURPOSE: The delivery of precision medicine is a primary objective for both clinical and translational investigators. Patients with newly diagnosed prostate cancer (PCa) face the challenge of deciding among multiple initial treatment modalities. The purpose of this study is to utilize artificial neural network (ANN) modeling to predict survival outcomes according to initial treatment modality and to develop an online decision-making support system. METHODS: Data were collected retrospectively from 7267 patients diagnosed with PCa between January 1988 and December 2017. The analyses included 19 pretreatment clinicopathological covariates. Multilayer perceptron (MLP), MLP for N-year survival prediction (MLP-N), and long short-term memory (LSTM) ANN models were used to analyze progression to castration-resistant PCa (CRPC)-free survival, cancer-specific survival (CSS), and overall survival (OS), according to initial treatment modality. The performances of the ANN and the Cox-proportional hazards regression models were compared using Harrell's C-index. RESULTS: The ANN models provided higher predictive power for 5- and 10-year progression to CRPC-free survival, CSS, and OS compared to the Cox-proportional hazards regression model. The LSTM model achieved the highest predictive power, followed by the MLP-N, and MLP models. We developed an online decision-making support system based on the LSTM model to provide individualized survival outcomes at 5 and 10 years, according to the initial treatment strategy. CONCLUSION: The LSTM ANN model may provide individualized survival outcomes of PCa according to initial treatment strategy. Our online decision-making support system can be utilized by patients and health-care providers to determine the optimal initial treatment modality and to guide survival predictions.

Lessons learned from clinical outcome and tumor features of patients underwent selective artery embolization due to postoperative bleeding following 2076 partial nephrectomies: propensity scoring matched study.

PURPOSE: To evaluate the clinical and tumor characteristics in patients undergoing selective artery embolization (SAE) for bleeding after partial nephrectomy (PN). METHODS: We retrospectively evaluated patients who underwent SAE from 2076 patients who underwent PN. The clinical and tumor characteristics of these patients were analyzed using entire data and propensity score matching (PSM). 76 patients who underwent PN (control, n = 38 patients; SAE, n = 38) were enrolled in PSM. RESULTS: SAE was performed in 41 patients who underwent open (19/1171), laparoscopic (4/60), and robot-assisted PN (18/845). The median period from PN to SAE was 12 days (interquartile range 8-24 day). The most common symptom of 31 (75.61%) patients was gross hematuria, followed by flank pain (3/41). Follow-up imaging revealed large pseudoaneurysm in 7 asymptomatic patients. The main reason for SAE on angiography was pseudoaneurysm (32/41), followed by arteriovenous fistula (5/41). Technical and clinical success was achieved in all patients. There was no statistical difference in the estimated glomerular filtration rate after 1 year, surgical methods, or baseline characteristics between the two groups. Conversely, there was statistically significant difference in ischemic time in the entire data and PSM. In the embolization group, renal masses showed statistically significant endophytic (p = 0.006) and posterior (p = 0.028) characteristics. CONCLUSIONS: SAE is an effective method for controlling postoperative bleeding while preserving renal function after PN. And, we suggest more attentive postoperative surveillance about vascular complications in patients with longer ischemia time or renal masses with endophytic and posterior locations.

Partial versus radical nephrectomy in very elderly patients: a propensity score analysis of surgical, functional and oncologic outcomes (RESURGE project).

PURPOSE: To compare the outcomes of PN to those of RN in very elderly patients treated for clinically localized renal tumor. PATIENTS AND METHODS: A purpose-built multi-institutional international database (RESURGE project) was used for this retrospective analysis. Patients over 75 years old and surgically treated for a suspicious of localized renal with either PN or RN were included in this database. Surgical, renal function and oncological outcomes were analyzed. Propensity scores for the predicted probability to receive PN in each patient were estimated by logistic regression models. Cox proportional hazard models were estimated to determine the relative change in hazard associated with PN vs RN on overall mortality (OM), cancer-specific mortality (CSM) and other-cause mortality (OCM). RESULTS: A total of 613 patients who underwent RN were successfully matched with 613 controls who underwent PN. Higher overall complication rate was recorded in the PN group (33% vs 25%; p = 0.01). Median follow-up for the entire cohort was 35 months (interquartile range [IQR] 13-63 months). There was a significant difference between RN and PN in median decline of eGFR (39% vs 17%; p < 0.01). PN was not correlated with OM (HR = 0.71; p = 0.56), OCM (HR = 0.74; p = 0.5), and showed a protective trend for CSM (HR = 0.19; p = 0.05). PN was found to be a protective factor for surgical CKD (HR = 0.28; p < 0.01) and worsening of eGFR in patients with baseline CKD. Retrospective design represents a limitation of this analysis. CONCLUSIONS: Adoption of PN in very elderly patients with localized renal tumor does not compromise oncological outcomes, and it allows better functional preservation at mid-term (3-year) follow-up, relative to RN. Whether this functional benefit translates into a survival benefit remains to be determined.

Effectiveness of Percutaneous Nephrolithotomy, Retrograde Intrarenal Surgery, and Extracorporeal Shock Wave Lithotripsy for Treatment of Renal Stones: A Systematic Review and Meta-Analysis.

Background and objectives: To perform a updated systematic review and meta-analysis comparing effectiveness of percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), and extracorporeal shock wave lithotripsy (ESWL) for treatment of renal stones (RS). Materials and Methods: A total of 37 studies were included in this systematic review and meta-analysis about effectiveness to treat RS. Endpoints were stone-free rates (SFR), incidence of auxiliary procedure, retreatment, and complications. We also conducted a sub-analysis of ≥2 cm stones. Results: First, PCNL had the highest SFR than others regardless of stone sizes and RIRS showed a higher SFR than ESWL in <2 cm stones. Second, auxiliary procedures were higher in ESWL than others, and it did not differ between PCNL and RIRS. Finally, in <2 cm stones, the retreatment rate of ESWL was higher than others. RIRS required significantly more retreatment procedures than PCNL in ≥2 cm stones. Complication was higher in PCNL than others, but there was no statistically significant difference in complications between RIRS and PCNL in ≥2 cm stones. For ≥2 cm stones, PCNL had the highest SFR, and auxiliary procedures and retreatment rates were significantly lower than others. Conclusions: We suggest that PCNL is a safe and effective treatment, especially for large RS.

The prognostic impact of downgrading and upgrading from biopsy to radical prostatectomy among men with Gleason score 7 prostate cancer.

BACKGROUND: Recently, a new prostate cancer (PC) grading system was introduced, where Gleason score (GS) 7 was divided into 3 + 4 = 7 and 4 + 3 = 7 due to the different prognoses associated with each tumor type. However, whether downgrading or upgrading from needle biopsy (NB) to radical prostatectomy (RP) affects oncologic outcomes is currently unknown. Herein, we investigated the prognostic impact of downgrading and upgrading from NB to RP among men with GS 7 PC. METHODS: We retrospectively reviewed the medical records of 3003 patients with localized PC who underwent RP between 2005 and 2014. We included 692 patients with GS 7 PC on both NB and RP specimens. We analyzed the data using Kaplan-Meier methods and Cox proportional hazard models. RESULTS: Of the 692 patients enrolled in this study, 389 (56.2%) and 303 (43.8%) patients had RP GS 3 + 4 = 7 and RP GS 4 + 3 = 7 PC, respectively. On the basis of NB and RP GS, 264 (38.1%), 125 (18.1%), 142 (20.5%), and 161 (23.3%) patients were classified as 3 + 4/3 + 4, 4 + 3/3 + 4, 3 + 4/4 + 3, and 4 + 3/4 + 3, respectively. Kaplan-Meier curves showed significant differences in biochemical recurrence (BCR)-free survival across the groups (P < .001). In the multivariate analyses, these groups were significantly associated with BCR (4 + 3/3 + 4: hazard ratio [HR], 1.675; 3 + 4/4 + 3: HR, 1.908; and 4 + 3/4 + 3: HR, 2.699). CONCLUSIONS: Downgrading and upgrading from NB to RP was an independent predictor of BCR in men with GS 7 PC, which could be due to the amount of Gleason pattern 4.

Ten-Year Oncologic Outcomes Following Robot-Assisted Radical Cystectomy: Results from the International Robotic Cystectomy Consortium.

PURPOSE: Radical cystectomy is the gold standard for nonmetastatic muscle invasive bladder cancer and for refractory nonmuscle invasive disease. Compared to open radical cystectomy, robot-assisted radical cystectomy has been shown to provide comparable early oncologic outcomes and improved perioperative outcomes. However, there is a paucity of data on long-term oncologic outcomes and concerns about a higher incidence of local recurrence after robot-assisted radical cystectomy. We report 10-year oncologic outcomes following robot-assisted radical cystectomy using a multinational database. MATERIALS AND METHODS: We retrospectively reviewed the prospective International Robotic Cystectomy Consortium database. Consecutive patients who underwent robot-assisted radical cystectomy 10 years ago or earlier were included in analysis. Data were reviewed for demographics, and perioperative, pathological and oncologic outcomes. Kaplan-Meier curves were used to depict recurrence-free, disease specific and overall survival. Multivariate stepwise Cox regression models were applied to identify variables associated with recurrence-free, disease specific and overall survival. RESULTS: We identified 446 patients with a median age of 67 years (IQR 59-76). Of the patients 10% received neoadjuvant chemotherapy, 51% experienced any complication, 23% had high grade complications and 4% died within 3 months of robot-assisted radical cystectomy. Disease was pT3 or greater in 43% of patients and pN+ in 24% while a positive soft tissue surgical margin was observed in 7%. At a median followup of 5 years (IQR 2-10, maximum 14) local and distant recurrence had developed in 15% and 29% of patients, respectively. Ten-year recurrence-free, disease specific and overall survival rates were 59%, 65% and 35%, respectively. Patients with pT3 or greater and pN+ disease showed worse recurrence-free, disease specific and overall survival. CONCLUSIONS: Long-term oncologic outcomes, and recurrence rates and patterns after robot-assisted radical cystectomy seem comparable to those in open series. Advanced disease stage and positive surgical margins remain the main determinants of survival after radical cystectomy.

Optimal sequencing strategy using docetaxel and androgen receptor axis-targeted agents in patients with castration-resistant prostate cancer: utilization of neutrophil-to-lymphocyte ratio.

PURPOSE: To investigate the prognostic value of neutrophil-to-lymphocyte ratio (NLR) for the selection of the optimal sequencing strategy using docetaxel and androgen receptor axis-targeted (ARAT) agents in patients with M0 or M1 castration-resistant prostate cancer (CRPC). Currently, there is a need to identify biomarkers to guide optimal sequential treatment in CRPC. METHODS: This multicenter, retrospective analysis included 303 consecutive patients initially diagnosed with M0 or M1 CRPC between September 2009 and March 2017. Of these, 52 (17.2%) patients received pre-docetaxel ARAT agents and 189 (62.4%) patients received post-docetaxel ARAT agents. The prognostic ability of NLR at CRPC diagnosis regarding radiographic progression-free survival (rPFS) and cancer-specific survival (CSS) were investigated. For the analysis, the NLR level was dichotomized at 2.5, and evaluated according to sequencing strategy. RESULTS: Multivariate analysis revealed NLR ≥ 2.5 as an independent predictor of a lower risk for CSS. During the median follow-up of 18.5 months, patients with NLR ≥ 2.5 exhibited significantly lower 1-year rPFS (p = 0.011) and 2-year CSS rates (p = 0.005) compared to patients with NLR < 2.5. Among patients with NLR < 2.5, the post-docetaxel ARAT agent sequencing group exhibited higher 1-year rPFS (p = 0.031) and 2-year CSS (p = 0.026) rates compared to the pre-docetaxel ARAT agent sequencing group. Among patients with NLR ≥ 2.5, rPFS and CSS rates were comparable regardless of ARAT agent sequencing. CONCLUSION: NLR ≥ 2.5 at CRPC diagnosis is associated with a lower risk for CSS. Patients with NLR < 2.5 should primarily be offered docetaxel considering the survival benefit of docetaxel-to-ARAT agent sequencing.