Evaluation of Clinical Research on Novel Multiport Robotic Platforms for Urological Surgery According to the IDEAL Framework: A Systematic Review of the Literature.

Background and objective: Several novel multiport robotic systems have been developed and introduced in clinical practice after regulatory approval. The objective of this systematic review was to assess the evolution status of novel robotic platforms approved for clinical use in urological surgery according to the IDEAL framework. Methods: A systematic review was conducted using the Medline and Scopus databases according to the updated Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (CRD42024503227). Comparative or noncomparative studies reporting on any urological procedures performed with novel robotic platforms (Hugo RAS; Versius, KangDuo, Senhance, REVO-I, Avatera, Hinotori, Dexter, or Toumai) were selected and included in the analysis. Key findings and limitations: Seventy-four eligible studies were included, of which 67 (90.5%) were noncomparative surgical series representing developmental or explorative studies according to the IDEAL criteria. Only one randomised controlled trial (comparing KangDuo vs da Vinci robot-assisted partial nephrectomy) was included. The trial showed comparable perioperative outcomes between the two robotic systems. Four studies assessed clinical outcomes for patients undergoing urological procedures using a REVO-I (1 study), Senhance (2 studies), or Hinotori (1 study) system in comparison to the same procedures performed using a da Vinci system. All studies revealed outcomes comparable to those with the da Vinci system. Limitations include the small sample size in all studies, and assessment of first-generation novel platforms versus the fourth-generation multiarm da Vinci system in most of the comparative studies. Conclusions and clinical implications: A few poor-quality studies have compared the use of novel robotic platforms to da Vinci systems in urological surgery and demonstrated comparable results. Most studies can be classified as developmental or explorative, representing the initial steps of clinical research. Large multicentre series are needed to understand whether these novel robots could offer advantages beyond cost reductions over the da Vinci systems. Patient summary: We reviewed research on new robotic systems for surgery in urology. Several studies have shown the feasibility and safety of these new robots during the most common procedures. Very few studies have assessed clinical outcomes with the new robots in comparison to the reference standard, which is a fourth-generation da Vinci robot. Large multicentre studies are needed to understand whether the new robots could offer advantages other than cost savings over the da Vinci robot.

Proficiency score as a predictor of early trifecta achievement during the learning curve of robot-assisted radical prostatectomy for high-risk prostate cancer: Results of a multicentric series.

Background: Recently, an innovative tool called "proficiency score" was introduced to assess the learning curve for robot-assisted radical prostatectomy (RARP). However, the initial study only focused on patients with low-risk prostate cancer for whom pelvic lymph node dissection (PLND) was not required. To address this issue, we aimed to validate proficiency scores of a contemporary multicenter cohort of patients with high-risk prostate cancer treated with RARP plus extended PLND by trainee surgeons. Material and methods: Between 2010 and 2020, 4 Italian institutional prostate-cancer datasets were merged and queried for "RARP" and "high-risk prostate cancer." High-risk prostate cancer was defined according to the most recent European Association of Urology guidelines as follows: prostate-specific antigen >20 ng/mL, International Society of Urological Pathology ≥4, and/or clinical stage (cT) ≥ 2c on preoperative imaging. The selected cohort (n = 144) included clinical cases performed by trainee surgeons (n = 4) after completing their RARP learning curve (50 procedures for low-risk prostate cancer). The outcome of interest, the proficiency score, was defined as the coexistence of all the following criteria: a comparable operation time to the interquartile range of the mentor surgeon at each center, absence of any significant perioperative complications Clavien-Dindo Grade 3-5, no perioperative blood transfusions, and negative surgical margins. A logistic binary regression model was built to identify the predictors of 1-year trifecta achievement in the trainee cohort. For all statistical analyses, a 2-sided p < 0.05 was considered significant. Results: A proficiency score was achieved in 42.3% patients. At univariable level, proficiency score was associated with 1-year trifecta achievement (odds ratio, 8.77; 95% confidence interval, 2.42-31.7; p = 0.001). After multivariable adjustments for age, nerve-sparing, and surgical technique, the proficiency score independently predicted 1-year trifecta achievement (odds ratio, 9.58; 95% confidence interval, 1.83-50.1; p = 0.007). Conclusions: Our findings support the use of proficiency scores in patients and require extended PLND in addition to RARP.

Thermal Ablation for Small Renal Masses: Identifying Anthropometric Factors for Predicting Perioperative and Oncological Outcomes.

OBJECTIVES: To test for specific anthropometric parameters to predict perioperative outcomes after thermal ablation (TA) for renal cell carcinoma (RCC). MATERIALS AND METHODS: Retrospective single center (2008-2022) analysis of 538 T1a-b RCC patients treated with TA. We tested for specific anthropometric parameters, namely skin to tumor distance (STTD), perirenal fat thickness (PFT), median psoas muscle axial area (PMAA) and median paravertebral muscle axial area (PVMAA), to predict TRIFECTA achievement: (1) absence of CLAVIEN-DINDO≥ 3 complications; (2) complete ablation; (3) absence of ≥ 30% decrease in eGFR. Univariable (ULRM) and multivariable logistic regression models (MLRM) were used for testing TRIFECTA achievement. RESULTS: Overall, 103 patients (19%) did not achieve TRIFECTA. Of all anthropometric factors, only lower PMAA was associated with no TRIFECTA achievement (10 vs. 11 cm2, P = .02). However, ULRMs and MLRMs did not confirmed the aforementioned association. We than tested for the 3 specific TRIFECTA items. In separate ULRM and MLRM predicting incomplete ablation, both continuously coded STTD (Odds Ratio [OR]: 1.02; CI: 1.01-1.03; P = .02) and STTD strata (STTD > 10 cm; OR: 2.1; CI: 1.1-4.1; P = .03) achieved independent predictor status. Conversely, in separate ULRM and MLRM predicting CLAVIEN-DINDO ≥3 complications, both continuously coded PFT (OR: 1.04; CI: 1.01-1.07; P = .01) and PFT strata (PFT ≥ 14 mm; OR: 3.3; CI: 1.6-10.2; P = .003) achieved independent predictor status. Last, none of the anthropometric parameters were associated with eGFR decrease ≥ 30%. CONCLUSION: None of the tested anthropometric parameters predicted TRIFECTA achievement. However, when the 3 specific TRIFECTA items were tested, STTD and PFT were associated with, respectively, incomplete ablation and CLAVIEN-DINDO ≥ 3 complications.

Oncological Outcomes of Thulium-Yttrium-Aluminum-Garnet (Tm:YAG) Laser Ablation for Penile Cancer.

OBJECTIVE: To report oncological outcomes after thulium-yttrium-aluminum-garnet (Tm:YAG) laser ablation for penile cancer patients. MATERIALS AND METHODS: We retrospectively analyzed 71 patients with ≤cT1 penile cancer (2013-2022). All patients underwent Tm:YAG ablation with a RevoLix 200W continuous-wave laser. First, Kaplan-Meier plots and multivariable Cox regression models tested local tumor recurrence rates. Second, Kaplan-Meier plots tested progression-free survival (≥T3 and/or N1-3 and/or M1). RESULTS: Median (interquartile range) follow-up time was 38 (22-58) months. Overall, 33 (50.5%) patients experienced local tumor recurrence. Specifically, 19 (29%) vs 9 (14%) vs 5 (7.5%) patients had 1 vs 2 vs 3 recurrences over time. In multivariable Cox regression models, a trend for higher recurrence rates was observed for G3 tumors (hazard ratio:6.1; P = .05), relative to G1. During follow-up, 12 (18.5%) vs 4 (6.0%) vs 2 (3.0%) men were retreated with 1 vs 2 vs 3 Tm:YAG laser ablations. Moreover, 11 (17.0%) and 3 (4.5%) patients underwent glansectomy and partial/total penile amputation. Last, 5 (7.5%) patients experienced disease progression. Specifically, TNM stage at the time of disease progression was: (1) pT3N0; (2) pT2N2; (3) pTxN3; (4) pT1N1 and (5) pT3N3, respectively. CONCLUSION: Tm:YAG laser ablation provides similar oncological results as those observed by other penile-sparing surgery procedures. In consequence, Tm:YAG laser ablation should be considered a valid alternative for treating selected penile cancer patients.

Atlas of Intracorporeal Orthotopic Neobladder Techniques After Robot-assisted Radical Cystectomy and Systematic Review of Clinical Outcomes.

BACKGROUND: Multiple and heterogeneous techniques have been described for orthotopic neobladder (ONB) reconstruction after robot-assisted radical cystectomy. Nonetheless, a systematic assessment of all the available options is lacking. OBJECTIVE: To provide the first comprehensive step-by-step description of all the available techniques for robotic intracorporeal ONB together with individual intraoperative, perioperative and functional outcomes based on a systematic review of the literature. DESIGN, SETTING, AND PARTICIPANTS: We performed a systematic review of the literature, and MEDLINE/PubMed, Embase, Scopus, and Web of Science databases were searched to identify original articles describing different robotic intracorporeal ONB techniques and reporting intra- and perioperative outcomes. Studies were categorized according to ONB type, providing a synthesis of the current evidence. Video material was provided by experts in the field to illustrate the surgical technique of each intracorporeal ONB. SURGICAL PROCEDURE: Nine different ONB types were identified: Studer, Hautmann, Y shape, U shape, Bordeaux, Pyramid, Shell, Florence Robotic Intracorporeal Neobladder, and Padua Ileal Neobladder. MEASUREMENTS: Continuous and categorical variables are presented as mean ± standard deviation and as frequencies and proportions, respectively. RESULTS AND LIMITATIONS: Of 2587 studies identified, 19 met our inclusion criteria. No cohort studies or randomized control trials comparing different neobladder types are available. Available techniques for intracorporeal robotic ONB reconstruction have similar operative time, estimated blood loss, intraoperative complications, and length of stay. Major variability exists concerning postoperative complications and functional outcomes, likely related to reporting bias. CONCLUSIONS: Several techniques are described for intracorporeal ONB during robot-assisted radical cystectomy with comparable perioperative outcomes. We provide the first step-by-step surgical atlas for robot-assisted ONB reconstruction. Further comparative studies are needed to assess any advantage of one technique over others. PATIENT SUMMARY: Patients elected for radical cystectomy should be aware that multiple techniques for robotic orthotopic neobladder are available, but that current evidence does not favor one type over the others.

Multiparametric MRI-based 5-year Risk Prediction Model for Biochemical Recurrence of Prostate Cancer after Radical Prostatectomy.

Background Current predictive tools to estimate the risk of biochemical recurrence (BCR) after treatment of prostate cancer do not consider multiparametric MRI (mpMRI) information. Purpose To develop a risk prediction tool that considers mpMRI findings to assess the risk of 5-year BCR after radical prostatectomy. Materials and Methods In this retrospective single-center analysis in 1459 patients with prostate cancer who underwent mpMRI before radical prostatectomy (in 2012-2015), the outcome of interest was 5-year BCR (two consecutive prostate-specific antigen [PSA] levels > 0.2 ng/mL [0.2 µg/L]). Patients were randomly divided into training (70%) and test (30%) sets. Kaplan-Meier plots were applied to the training set to estimate survival probabilities. Multivariable Cox regression models were used to test the relationship between BCR and different sets of exploratory variables. The C-index of the final model was calculated for the training and test sets and was compared with European Association of Urology, University of California San Francisco Cancer of the Prostate Risk Assessment, Memorial Sloan-Kettering Cancer Center, and Partin risk tools using the partial likelihood ratio test. Five risk categories were created. Results The median duration of follow-up in the whole cohort was 59 months (IQR, 32-81 months); 376 of 1459 (25.8%) patients had BCR. A multivariable Cox regression model (referred to as PIPEN, and composed of PSA density, International Society of Urological Pathology grade group, Prostate Imaging Reporting and Data System category, European Society of Urogenital Radiology extraprostatic extension score, nodes) fitted to the training data yielded a C-index of 0.74, superior to that of other predictive tools (C-index 0.70 for all models; P ≤ .01) and a median higher C-index on 500 test set replications (C-index, 0.73). Five PIPEN risk categories were identified with 5-year BCR-free survival rates of 92%, 84%, 71%, 56%, and 26% in very low-, low-, intermediate-, high-, and very high-risk patients, respectively (all P < .001). Conclusion A five-item model for predicting the risk of 5-year BCR after radical prostatectomy for prostate cancer was developed and internally verified, and five risk categories were identified. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Aguirre and Ortegón in this issue.

Predicting Peri-Operative Outcomes in Patients Treated with Percutaneous Thermal Ablation for Small Renal Masses: The SuNS Nephrometry Score.

Our objective was to develop a new, simple, and ablation-specific nephrometry score to predict peri-operative outcomes and to compare its predictive accuracy to PADUA and RENAL scores. Overall, 418 patients were treated with percutaneous thermal ablation (microwave and radiofrequency) between 2008 and 2021. The outcome of interest was trifecta status (achieved vs. not achieved): incomplete ablation or Clavien-Dindo ≥ 3 complications or postoperative estimated glomerular filtration rate decrease ≥ 30%. First, we validated the discrimination ability of the PADUA and RENAL scoring systems. Second, we created and internally validated a novel scoring (SuNS) system, according to multivariable logistic regression models. The predictive accuracy of the model was tested in terms of discrimination and calibration. Overall, 89 (21%) patients did not achieve trifecta. PADUA and RENAL scores showed poor ability to predict trifecta status (c-indexes 0.60 [0.53-0.67] and 0.62 [0.55-0.69], respectively). We, therefore, developed the SuNS model (c-index: 0.74 [0.67-0.79]) based on: (1) contact surface area; (2) nearness to renal sinus or urinary collecting system; (3) tumour diameter. Three complexity classes were created: low (3-4 points; 11% of no trifecta) vs. moderate (5-6 points; 30% of no trifecta) vs. high (7-8 points; 65% of no trifecta) complexity. Limitations include the retrospective and single-institution nature of the study. In conclusion, we developed an immediate, simple, and reproducible ablation-specific nephrometry score (SuNS) that outperformed PADUA and RENAL nephrometry scores in predicting peri-operative outcomes. External validation is required before daily practice implementation.

What is the best time for postoperative radiation therapy in pN1 prostate cancer?

We retrospectively compared long-term biochemical recurrence rates (BCR) in pN1 PCa patients that underwent adjuvant radiotherapy (aRT) vs. no aRT/early salvage (esRT) after robot-assisted radical prostatectomy and extended pelvic lymphadenectomy. All PCa pN1 M0 patients treated at a single high-volume center between 2010 and 2020 were analyzed. Patients with <10 LNs yield, or >10 positive LNs, or persistently detectable PSA after RARP were excluded. Kaplan-Meier (KM) plots depicted BCR rates. Multivariable Cox regression models (MCRMs) focused on predictors of BCR. The cumulative incidence plot depicted BCR rates after propensity score (PS) matching (ratio 1:1). 220 pN1 patients were enrolled, 133 (60.4%) treated with aRT and 87 (39.6%) with no-aRT/esRT. aRT patients were older, with higher rates of postoperative ISUP grade group 4-5, and higher rates of pT3b stage. The actuarial BCR was similar (aRT 39.8% vs. no-aRT/esRT 40.2%; p=1). Median time to BCR was 62 vs. 38 months in aRT vs. no-aRT/esRT patients (p=0.001). In MCRMs, patients managed with no-aRT/esRT were associated with higher rates of BCR over time (hazard ratio [HR]: 3.27, p<0.001). ISUP grade group 5 (HR: 2.18, p<0.01) was an independent predictor of BCR. In PS-matched cumulative incidence plots, the BCR rate was significantly higher in the aRT group (76.4 vs. 40.4%; p<0.01). Patients managed with no-aRT/esRT experienced BCR approximately two years before the aRT group. Despite, the important BCR benefit after aRT, this treatment strategy is underused in daily practice.

Stage-dependent survival in patients treated with neoadjuvant chemotherapy and radical cystectomy.

BACKGROUND: The aim of this study is to investigate the differential stage-dependent outcomes of patients undergoing radical cystectomy (RC) with or without neoadjuvant chemotherapy (NAC). METHODS: We performed a retrospective analysis of 1422 patients with cT2-4N0 MIBC treated with RC, with/without cisplatin-based NAC, from our multicenter cooperation program (treated period: 1992-2021). Patients were stratified according to their pathologic stage at RC. Cancer-specific survival (CSS) and overall survival (OS) were calculated using mixed-effects Cox analysis. RESULTS: Analysis was conducted on 761 patients treated with NAC followed by RC and 661 treated with RC only (median follow-up 19 months). Of 337 (24%) patients who died, 259 (18%) died of bladder cancer. On univariable analyses, increased pathologic stage was significantly associated with worse CSS (HR=1.59, 95% CI 1.46-1.73; P<0.01) and OS (HR=1.58, 95% CI 1.47-1.71; P<0.001). On multivariable mixed-effects model, patients after RC only had significantly worse CSS with stage pT≥3/N1-3 and OS with stage pT≥2/N0-3 compared to those with stage pT≤1N0. Patients after RC and NAC had significantly worse CSS and OS already at stage ypT≥2/N0-3 compared to those with ypT≤1N0. On subgroup analyses, CSS (HR=4.26; 95% CI 2.03-8.95; P<0.001) but not OS (HR=1.1; 95% CI 0.5-2.4; P=0.81) was worse for pT2N0 patients after NAC versus no-NAC. This difference was not maintained on multivariable analysis. CONCLUSIONS: NAC improves pathologic stage at the time of RC. Patients with residual MIBC after NAC have worse survival outcomes compared to those with the same pathologic stage who did not receive NAC, suggesting a need for better adjuvant therapy in these patients.