Use of 18F-fluoro-2-deoxy-d-glucose (18F-FDG) PET/CT for lymph node assessment before radical cystectomy in bladder cancer patients.

OBJECTIVE: To assess the diagnostic performance of 18F-fluoro-2-deoxy-d-glucose (18F-FDG) positron emission tomograpy (PET)/computed tomography (CT) in nodal staging before radical cystectomy (RC) and pelvic lymph node dissection (PLND) for bladder cancer (BCa). MATERIALS AND METHODS: This analysis was based on a cohort of 199 BCa patients undergoing RC and bilateral PLND between 2015 and 2022. Neoadjuvant chemotherapy (NAC) or immunotherapy (NAI) was administered after oncological evaluation. All patients received preoperative 18F-FDG PET/CT to assess extravesical disease. Point estimates for true negative, false negative, false positive, true positive, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of conventional imaging and PET/CT were calculated. Subgroup analysis in patients receiving neoadjuvant treatment was performed. RESULTS: At preoperative evaluation, 30 patients (15.1%) had 48 suspicious nodal spots on 18F-FDG PET/CT. At RC and bilateral PLND, a total of 4871 lymph nodes (LNs) were removed with 237 node metastases corresponding to 126 different regions. Pathological node metastases were found in 17/30 (57%) vs 39/169 patients (23%) with suspicious vs negative preoperative 18F-FDG PET/CT, respectively (sensitivity = 0.30, specificity = 0.91, PPV = 0.57, NPV = 0.77, accuracy = 0.74). On per-region analysis including 1367 nodal regions, LN involvement was found in 19/48 (39%) vs 105/1319 (8%) suspicious vs negative regions at PET/CT, respectively (sensitivity = 0.15, specificity = 0.98, PPV = 0.40, NPV = 0.92, ACC = 0.90). Similar results were observed for patients receiving NAC (n = 44, 32.1%) and NAI (n = 93, 67.9% [per-patient: sensitivity = 0.36, specificity = 0.91, PPV = 0.59, NPV = 0.80, accuracy = 0.77; per-region: sensitivity = 0.12, specificity = 0.98, PPV = 0.32, NPV = 0.93, ACC = 0.91]). Study limitations include its retrospective design and limited patient numbers. CONCLUSIONS: In eight out of 10 patients with negative preoperative 18F-FDG PET/CT, pN0 disease was confirmed at final pathology. No differences were found based on NAC vs NAI treatment. These findings suggest that 18F-FDG PET/CT could play a role in the preoperative evaluation of nodal metastases in BCa patients, although its cost-effectiveness is uncertain.

Discrimination, Reliability, Sensitivity, and Specificity of Robotic Surgical Proficiency Assessment With Global Evaluative Assessment of Robotic Skills and Binary Scoring Metrics: Results From a Randomized Controlled Trial.

Objective: To compare binary metrics and Global Evaluative Assessment of Robotic Skills (GEARS) evaluations of training outcome assessments for reliability, sensitivity, and specificity. Background: GEARS-Likert-scale skills assessment are a widely accepted tool for robotic surgical training outcome evaluations. Proficiency-based progression (PBP) training is another methodology but uses binary performance metrics for evaluations. Methods: In a prospective, randomized, and blinded study, we compared conventional with PBP training for a robotic suturing, knot-tying anastomosis task. Thirty-six surgical residents from 16 Belgium residency programs were randomized. In the skills laboratory, the PBP group trained until they demonstrated a quantitatively defined proficiency benchmark. The conventional group were yoked to the same training time but without the proficiency requirement. The final trial was video recorded and assessed with binary metrics and GEARS by robotic surgeons blinded to individual, group, and residency program. Sensitivity and specificity of the two assessment methods were evaluated with area under the curve (AUC) and receiver operating characteristics (ROC) curves. Results: The PBP group made 42% fewer objectively assessed performance errors than the conventional group (P < 0.001) and scored 15% better on the GEARS assessment (P = 0.033). The mean interrater reliability for binary metrics and GEARS was 0.87 and 0.38, respectively. Binary total error metrics AUC was 97% and for GEARS 85%. With a sensitivity threshold of 0.8, false positives rates were 3% and 25% for, respectively, the binary and GEARS assessments. Conclusions: Binary metrics for scoring a robotic VUA task demonstrated better psychometric properties than the GEARS assessment.

A comprehensive assessment of frailty status on surgical, functional and oncologic outcomes in patients treated with partial nephrectomy-A large, retrospective, single-center study.

BACKGROUND: Partial nephrectomy (PN) is a challenging procedure, which can be associated with severe complications. In consequence, the search for accurate and independent indicators of unfavorable surgical outcomes appears warranted. We aimed at evaluating the impact of frailty status on surgical, functional and oncologic outcomes in patients undergoing PN for renal cell carcinoma (RCC). METHODS: A retrospective, single-center study including 1,282 patients treated with PN for clinically localized cT1 RCC was performed. The modified Frailty Index (mFI) was used to assess preoperative frailty. Multivariable logistic, Poisson and linear regression analyses(MVA) tested the effect of frailty on complications, acute kidney injury(AKI), renal function decline after PN. Cumulative incidence and competing-risk analyses investigated survival outcomes. RESULTS: Of 1,282 patients, 220 (17%) were frail. Overall, 982 (76%) vs. 123 (9.6%) vs. 171 (13%) patients underwent open vs. laparoscopic vs. robot-assisted PN. Median follow-up was 66 (IQR: 35-107) months. At MVA, frailty status predicted increased risk of complications [Odds ratio (OR): 1.46, 95%CI 1.17-1.84; P < 0.001]. Moreover, frail patients were at higher risk of postoperative AKI (OR: 1.95, 95%CI 1.13-3.35; P = 0.01). In frail patients, renal function permanently decreased over time (P = 0.01) without any renal function plateau or improvement during the follow-up, which were instead observed in the nonfrail cohort. At competing-risks analyses, frailty status predicted higher risk of other-cause mortality [Hazard ratio (HR): 1.67, 95%CI 1.05-2.66; P = 0.02], but not of cancer-specific mortality (P = 0.3). CONCLUSIONS: Frailty status predicts higher risk of adverse surgical outcomes after PN. Moreover, greater renal function decline was observed in frail patients, compared with nonfrail patients. Finally, the risk of OCM significantly overcomes the risk of dying due to RCC in frail patients.

Development and Validation of the Metric-Based Assessment of a Robotic Dissection Task on an Avian Model.

INTRODUCTION: The introduction of robot-assisted surgical devices requires the application of objective performance metrics to verify performance levels. OBJECTIVE: To develop and validate (face, content, response process, and construct) the performance metrics for a robotic dissection task using a chicken model. METHODS: In a procedure characterization, we developed the performance metrics (i.e., procedure steps, errors, and critical errors) for a robotic dissection task, using a chicken model. In a modified Delphi panel, 14 experts from four European Union countries agreed on the steps, errors, and critical errors (CEs) of the task. Six experienced surgeons and eight novice urology surgeons performed the robotic dissection task twice on the chicken model. In the Delphi meeting, 100% consensus was reached on five procedure steps, 15 errors and two CEs. Novice surgeons took 20 min to complete the task on trial 1 and 14 min during trial two, whereas experts took 8.2 min and 6.5 min. On average, the Expert Group completed the task 56% faster than the Novice Group and made 46% fewer performance errors. RESULTS: Sensitivity and specificity for procedure errors and time were excellent to good (i.e., 1.0-0.91) but poor (i.e., 0.5) for step metrics. The mean interrater reliability for the assessments by two robotic surgeons was 0.91 (Expert Group inter-rater reliability = 0.92 and Novice Group = 0.9). CONCLUSIONS: We report evidence which supports the demonstration of face, content, and construct validity for a standard and replicable basic robotic dissection task on the chicken model.

The effect of frailty on post-operative outcomes and health care expenditures in patients treated with partial nephrectomy.

OBJECTIVE: To examine the effect of frailty on short-term post-operative outcomes and total hospital charges (THCs) in patients with non-metastatic renal cell carcinoma, treated with partial nephrectomy (PN). METHODS: Within the National Inpatient Sample (NIS) database we identified 25,545 patients treated with PN from 2000 to 2015. We used the Johns Hopkins Adjusted Clinical Groups (ACG) frailty-defining indicator and we examined the rates of frailty over time, as well as its effect on overall complications, major complications, blood transfusions, non-home-based discharge, length of stay (LOS) and THCs. Time trends and multivariable logistic, Poisson and linear regression models were applied. RESULTS: Overall, 3574 (14.0%) patients were frail, 2677 (10.5%) were older than 75 years and 2888 (11.3%) had Charlson comorbidity index (CCI) ≥ 2. However, the vast majority of frail patients were neither elderly nor comorbid (83%). Rates of frail patients treated with PN increased over time, from 8.3 in 2000 to 18.1% in 2015 (all p < 0.001). Frail patients showed higher rates of overall complications (43.5 vs. 30.3%), major complications (16.6 vs. 9.8%), blood transfusions (11.6 vs 8.3%) and non-home-based discharge (9.9 vs. 5.4%). longer LOS [4 (IQR: 3-6) vs. 4 (IQR: 2-5) days] and higher THCs ($43,906 vs. $38,447 - all p < 0.001). Moreover, frailty status independently predicted overall complications (OR: 1.73), major complications (OR: 1.63), longer LOS (RR: 1.07) and higher THCs (RR: +$7506). Finally, a dose-response on the risk of suboptimal surgical outcomes was shown in patients with multiple risk factors. CONCLUSIONS: One out of seven patients is frail at time of surgery and this rate is on the rise. Moreover, frailty is associated with adverse outcomes after PN. In consequence, preoperative assessment of frailty status should be implemented, to identify patients who may benefit from pre- or postoperative measures aimed at improving surgical outcomes in this patient population.

Development and validation of the metric-based assessment of a robotic vessel dissection, vessel loop positioning, clip applying and bipolar coagulation task on an avian model.

The evolution of robotic technology and its diffusion does not seem to have been adequately accompanied by the development and implementation of surgeon training programs that ensure skilled and safe device use at the start of the learning curve. The objective of the study is to develop and validate performance metrics for vessel dissection, vessel loop positioning, clip applying and bipolar coagulation using an avian model. Three robotic surgeons and a behavioral scientist characterized the performance metrics of the task according to the proficiency-based progression methodology. Fourteen experienced robotic surgeons from different European countries participated in a modified online Delphi consensus. Eight experienced surgeons and eight novices performed the robotic task twice. In the Delphi meeting, 100% consensus was reached on the performance metrics. Novice surgeons took 26 min to complete the entire task on trial 1 and 20 min on trial 2. Experts took 10.1 min and 9.5 min. On average the Expert Group completed the task 137% faster than the Novice Group. The amount of time to reach the vessel part of the task was also calculated. Novice surgeons took 26 min on trial 1 and 20 min on trial 2. Experts took 5.5 min and 4.8 min. On average the experts reached the vessel 200% faster than the novices. The Expert Group made 155% fewer performance errors than the Novice Group. The mean IRR of video-recorded performance assessments for all metrics was 0.96 (95% confidence intervals (CI) lower = 0.94-upper = 0.98). We report the development and validation for a standard and replicable basic robotic vessel dissection, vessel loop positioning, clip applying and bipolar coagulation task on an avian model. The development of objective performance metrics, based on a transparent and fair methodology (i.e., PBP), is the first fundamental step toward quality assured training. This task developed on the avian model proved to have good results in the validation study.

Short Time Delay Between Previous Prostate Biopsy for Prostate Cancer Assessment and Holmium Laser Enucleation of the Prostate Correlates with Worse Perioperative Outcomes.

BACKGROUND: No data are available regarding the impact of time between a previous transrectal prostate biopsy (PB) and holmium laser enucleation of the prostate (HoLEP) on perioperative outcomes. OBJECTIVE: To evaluate the impact of time from PB to HoLEP on perioperative outcomes. DESIGN, SETTING, AND PARTICIPANTS: A total of 172 consecutive patients treated with HoLEP within 12 mo of a single previous transrectal PB at two tertiary centers were included. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Patients were stratified into two groups according to the median time from PB to HoLEP (namely, ≤6 and >6 mo). The primary outcome was intraoperative complications. Multivariate logistic regressions were used to identify the predictors of intraoperative complications. Linear regressions were used to test the association between the time from PB to HoLEP and intraoperative complications, enucleation efficiency, and enucleation time. RESULTS AND LIMITATIONS: In total, 93 (54%) and 79 (46%) patients had PB ≤ 6 and >6 mo before HoLEP, respectively. Patients in PB ≤ 6 mo group experienced higher rates of intraoperative complications than those in PB > 6 mo group (14% vs 2.6%, p = 0.04). At multivariable analysis, time between PB and HoLEP was an independent predictor of intraoperative complications (odds ratio: 0.74; 95% confidence interval: 0.6-0.9; p = 0.006). Finally, the risk of intraoperative complications reduced by 1.5%, efficiency of enucleation increased by 4.1%, and enucleation time reduced by 1.7 min for each month passed from PB to HoLEP (all p ≤ 0.006). Selection of patients with only one previous PB represents the main limitation. CONCLUSIONS: The time from PB to HoLEP of ≤6 mo is associated with a higher risk of intraoperative complications, lower enucleation efficacy, and longer enucleation time. PATIENT SUMMARY: Patients with a prostate biopsy (PB) ≤6 mo before holmium laser enucleation of the prostate (HoLEP) had significantly worse outcomes than those with a PB > 6 mo before HoLEP.

Assessment of other-cause mortality in localized renal cell carcinoma patients within 15 years: A population-based analysis.

BACKGROUND AND OBJECTIVE: Five-year other cause mortality (OCM) after nephrectomy for non-metastatic renal cell carcinoma (RCC) should be marginal in properly selected surgical candidates. We examined 5-year OCM rates as a quality of care indicator for patient selection. MATERIALS AND METHODS: Within the Surveillance, Epidemiology, and End Results database (1997-2011), we identified 59267 RCC patients treated with either radical (n = 27 804, 46.9%) or partial nephrectomy (n = 31 463, 53.1%). Temporal trends and multivariable Cox regression analyses assessed 5-year OCM. Data were stratified according to age group, year of diagnosis, race, marital status, gender, and socio-economic status. The overall OCM rates for the entire cohort at 5 years of follow-up was 4.7% and decreased from 9.4% to 5.6% over the study span (-3.8%, P < .001). The greatest decrease in 5-year OCM rates over time was recorded in patients >70 years (17.0%-9.6%, slope, -0.6%/y), as well as in African-Americans (12.0-6.2%; slope, -0.3%/y) and in males (8.9%-4.7%; slope, -0.3%, all P < .001). CONCLUSIONS: An important OCM decrease was recorded over the study span. Nonetheless, further improvement may be accomplished, especially in African-Americans, unmarried and older individuals, who exhibited higher OCM rates than others. These three groups may represent ideal targets for better patient selection based on OCM considerations.

Differences in short-term outcomes between open versus robot-assisted radical cystectomy in frail malnourished patients.

INTRODUCTION: We tested whether frail patients may benefit from robot-assisted (RARC) relative to open radical cystectomy (ORC). MATERIALS AND METHODS: Frail patients treated with RC were identified within the National Inpatient Sample database (2008-2015). The effect of RARC vs. ORC was tested in five separate multivariable models predicting: complications, failure to rescue (FTR), in-hospital mortality, length of stay (LOS) and total hospital charges (THCs). As internal validity measure, analyses were repeated among non-frail patients. All models were weighted and adjusted for clustering, as well as all available patient and hospital characteristics. RESULTS: Of 11,578 RC patients, 3477 (30.0%) were frail. RARC was performed in 488 (14.0%) frail patients and 1386 (17.1%) non-frail patients. Among frail, RARC was only independently associated with shorter LOS (median 8 vs. 9 days, relative ratio [RR] 0.79, p < 0.001). Conversely, among non-frail, RARC was independently associated with lower complications (57.3 vs. 59.1%, odds ratio [OR] 0.82, p = 0.004) and shorter LOS (median 6 vs. 7 days, RR 0.88, p < 0.001), but also predicted higher THCs (+2850.3 US dollars, p = 0.001). CONCLUSIONS: In frail patients, the use of RARC did not result in better short-term outcomes except for one-day advantage in LOS. Conversely, in non-frail patients, the use of RARC resulted in lower complication rates and shorter LOS at the cost of higher THCs. In consequence, the benefit of RARC appears relatively marginal in frail patients and our data do not suggest a clear and clinically-meaningful benefit of RARC over ORC in frail radical cystectomy population.

Patient frailty predicts worse perioperative outcomes and higher cost after radical cystectomy.

BACKGROUND: Relatively few studies investigated the importance of frailty in radical cystectomy (RC) patients. We tested the ability of frailty, using the Johns Hopkins Adjusted Clinical Groups indicator, to predict early perioperative outcomes after RC. METHODS: RC patients were identified within the National Inpatient Sample database (2000-2015). The effect of frailty, age and Charlson Comorbidity Index were tested in five separate multivariable models predicting: (1) complications, (2) failure to rescue (FTR), (3) in-hospital mortality, (4) length of stay (LOS) and (5) total hospital charges (THCs). All models were weighted and adjusted for clustering, as well as all available patient and hospital characteristics. RESULTS: Of 23,967 RC patients, 5833 (24.3%) were frail, 7721 (32.2%) were aged ≥75 years and 2832 (11.8%) had CCI ≥2. Frailty, age ≥75 years and CCI ≥2 were non-overlapping in 86.3% of the cohort. Any two or three of these features were recorded in 12.4 and 1.3%, respectively. Frailty was an independent predictor of all five examined endpoints and the magnitude of its association was stronger or at least equal than that of age ≥75 years and CCI ≥2. CONCLUSION: Frailty, advanced age and comorbidities represent non-overlapping patients' characteristics. Of those, frailty represents the most consistent and strongest predictor of early adverse outcomes after RC. Ideally, all three indicators should be considered in retrospective, as well as prospective analyses. Pre-surgical recognition of frail patients should be ideally incorporate in clinical practice in order to address these patients to multimodal pre-habilitation programs that may potentially improve the perioperative prognosis.