Technique Description and Outcomes of Robotic Transvaginal-Assisted Living Donor Kidney Transplantation.

OBJECTIVE: The aim of the study was to describe the surgical technique of totally robotic kidney transplantation with transvaginal insertion and to assess its safety and feasibility. METHODS: It is a prospective analysis of the first 5 cases of robotic kidney transplantation with transvaginal insertion. Robotic-assisted kidney transplantation was performed after transvaginal insertion of a living donor kidney graft. Donor's and recipient's characteristics, intraoperative variables, postoperative complications, and surgical outcomes were assessed. RESULTS: The median operative time was 220 min. Mean rewarming ischemia time of 53 min, with immediate diuresis. No intraoperative complications were observed. Mean hospitalization period was 9 days, with mean Cr of 1.5 mg/dL at discharge. CONCLUSIONS: Robotic kidney transplantation with transvaginal insertion is feasible and safe. A greater number of procedures are required to confirm the results of this new technique.

Cost analysis of prostate cancer detection including the prostate health index (phi).

OBJECTIVE: To assess the economic impact of introducing the prostate health index (phi) for prostate cancer (PCa) detection. METHODS: A total of 177 patients who presented in an academic institution with a tPSA between 2 and 10 ng/ml and underwent prostate biopsies within the 3 months were enrolled. With phi and tPSA thresholds of 43 and 4 ng/ml, respectively, probability for each branch of a decision tree model for PCa diagnosis and corresponding mean cost were estimated with "Monte Carlo" simulations. A sensitivity analysis was performed. RESULTS: With a similar sensitivity, phi strategy increased positive predictive value by 13.9 points and negative predictive value by 31.6 points in comparison to tPSA strategy. Mean costs per patient with tPSA and phi strategies were €514 and €528, respectively, for a phi test price at 50€. One-way sensitivity analysis showed that phi strategy was less expensive (508€/patient) than tPSA strategy with a phi test price below 30€. In multi-criteria sensitivity analysis, PPV and the rates of positive phi and tPSA were the parameters with the largest impact on the final cost as opposed to the cost of the biopsy or imaging which have less influence. With an expected rate of positive phi test < 60%, tPSA strategy was more expensive than phi strategy. CONCLUSIONS: The introduction of phi index in PCa detection would result in a significant clinical benefit compared to tPSA strategy. In our economic model, the phi strategy was equivalent or slightly more expensive than the current tPSA strategy.

Does training of fellows affect peri-operative outcomes of robot-assisted partial nephrectomy?

OBJECTIVE: To evaluate the impact of fellows' involvement on the peri-operative outcomes of robot-assisted partial nephrectomy (RAPN). MATERIALS AND METHODS: We analysed 216 patients who underwent RAPN for a small renal tumour. We stratified our cohort into two groups according to the involvement of a fellow surgeon during the procedure: expert surgeon operating alone (expert group) and fellow operating under the supervision of the expert surgeon (fellow group). Peri-operative data were compared between the two groups. Linear and logistic regression analyses were performed to assess the impact of fellows' involvement on peri-operative and postoperative outcomes. Trifecta and margins ischaemia complications (MIC) score achievement rates were used to assess the quality of surgery in both the expert and fellow groups. Trifecta was defined as a combination of warm ischaemia time <25 min, negative surgical margins and no peri-operative complications. MIC score was defined as negative surgical margins, ischaemia time <20 min, and absence of complications grade ≥3. RESULTS: Fellows were involved in a total of 89 procedures (41%). Patients' characteristics were similar in the two groups. Operating time and warm ischaemia time (WIT) were longer in the fellow group (180 vs 120 min, P < 0.001, and 18 vs 14 min, P = 0.002, respectively). Length of hospital stay (LOS) was longer in the fellow group (5 vs 4.3 days; P = 0.05) and patients in this group had higher estimated blood loss (EBL; 400 vs 300 mL; P = 0.01), but this had no impact on transfusion rate (14% vs 11%; P = 0.43). Positive surgical margin rates were similar in the fellow and expert groups (2.2% vs 3.1%; P = 0.70). Major complications were more frequent in the fellow group (12.3% vs 6.3%), but the difference was not significant (P = 0.10). In multivariable analysis, fellow involvement was predictive of longer WIT (ß = 0.22; P = 0.003) and operating time (ß = 0.49; P < 0.001), but was not associated with EBL (ß = 0.12, P = 0.09) or LOS (ß = 0.12, P = 0.11). Finally, fellow involvement was associated with a lower rate of trifecta and MIC score accomplishment (odds ratio [OR] 0.53, P = 0.05 and OR 0.46, P = 0.01, respectively). CONCLUSION: Training fellows to perform RAPN is associated with longer operating time and WIT but does not appear to compromise other peri-operative outcomes.

Analysis of the impact of adherent perirenal fat on peri-operative outcomes of robotic partial nephrectomy.

INTRODUCTION: Adherent perirenal fat (APF) can be defined as inflammatory fat sticking to renal parenchyma, whose dissection is difficult and makes it troublesome to expose the tumour. Our objective was to evaluate the impact of APF on the technical difficulty of robot-assisted partial nephrectomy (RPN). PATIENTS AND METHODS: We analysed data of 202 patients who underwent RPN for a small renal tumour. Patients were divided into two groups according to the presence of APF. Peri-operative data were compared between the two groups. Predictors of APF were evaluated by univariate and multivariate analysis. The validity of the MAP score (radiological scoring system) was also assessed. RESULTS: APF was observed in 80 patients (39.6 %). Tumour complexity and surgeon's experience were similar between both groups. Operative time was 40 min longer in the APF group (188.5 vs. 147.9 min, p < 0.0001). Blood loss was twice higher, and transfusions were more common in the APF group (694 vs. 330 ml, p < 0.0001 and 19 vs. 5.8 %, p = 0.003, respectively). APF was associated with an increased risk of conversion to open surgery (11.2 vs. 0 %, p = 0.0002) or radical nephrectomy (6.2 vs. 0.8 %, p = 0.03). In multivariate analysis, male gender (OR 13.2, p < 0.0001), obesity (OR 1.2, p = 0.007), hypertension (OR 3.7, p = 0.02), and MAP score (OR 3.3; p < 0.0001) were significant predictors of APF. CONCLUSION: During RPN, APF is associated with increased bleeding and a higher risk of conversion to open surgery and to radical nephrectomy. Male gender, hypertension, obesity, and MAP score are predictors of APF.

Neoadjuvant targeted molecular therapies in patients undergoing nephrectomy and inferior vena cava thrombectomy: is it useful?

OBJECTIVE: To assess the effect of neoadjuvant targeted molecular therapies (TMTs) on size and level of inferior vena cava tumor thrombi and to evaluate their impact on surgical management. METHODS: We retrospectively analyzed the data of 14 patients treated for a clear cell renal cell carcinoma with inferior vena cava thrombi by neoadjuvant TMT before nephrectomy. Clinical, pathological and perioperative data were gathered retrospectively at each institution. The primitive tumor size and the thrombus size were defined by computed tomography before TMT. The tumor thrombus level was defined according to the Novick's classification. RESULTS: Before TMT, thrombus level was staged I for 1 (7%), II for 10 (72%) and III (21%) for 3 patients. First-line therapy was sunitinib in 11 cases and sorafenib in 3 cases. Median therapy duration was two cycles (1-5). Three patients experienced major adverse effects (grade III) during TMT. Following TMT, 6 (43%) patients had a measurable decrease, 6 (43%) had no change, and 2 (14%) had an increase in the thrombus. One patient (7%) had a downstage of thrombus level, 12 (85%) had stable thrombi, and 1 (7%) had an upstage. Regarding primary tumor, 7 (50%), 5 (36%) and 2 (14%) patients had a decrease, stabilization and an increase in tumor size, respectively. CONCLUSION: Neoadjuvant TMT appears to have limited effects on renal tumor thrombi. This retrospective study failed to demonstrate a significant impact of neoadjuvant TMT on surgical management of clear cell renal cell carcinoma with inferior vena cava tumor thrombi.

Clinical outcomes after salvage radiotherapy without androgen deprivation therapy in patients with persistently detectable PSA after radical prostatectomy: results from a national multicentre study.

PURPOSE: To assess oncologic outcomes after salvage radiotherapy (SRT) without androgen deprivation therapy (ADT) in patients with persistently detectable PSA after radical prostatectomy (RT). METHODS: Two hundred and one patients who failed to achieve an undetectable PSA received SRT without ADT. The primary endpoint was failure to SRT that was defined by clinical progression or use of second-line ADT. Clinicopathological parameters, 6-week PSA level, PSAV and pre-SRT PSA levels were assessed using time-dependent analyses. RESULTS: Median postoperative 6-week PSA and pre-SRT PSA levels were 0.25 and 0.48 ng/mL, respectively. Median time between surgery and SRT was 7 months. Failure to SRT was reported in 42.8 % of cases with the need for second-line ADT in 26.9 % of cases. Pre-SRT PSA was strongly correlated with postoperative 6-week PSA (p < 0.001) but not with PSAV. The risk of SRT failure was increased by threefold in case of Gleason score 8-10 (p = 0.036) or pT3b cancer (p = 0.006). Risk group classification based on these prognostic factors improved SRT failure prediction. Survival curves confirmed that 5-year ADT-free survival rates were significantly influenced by PSAV (p = 0.002) and pre-SRT PSA (p = 0.030). CONCLUSIONS: In patients with persistently detectable PSA after RP and selected for local salvage treatment, SRT offers good oncologic clinical outcomes. The most powerful pathologic predictive factors of SRT failure include a pT3b stage, a Gleason score 8 or more cancer and high PSAV and pre-SRT PSA levels. Patients having a high PSAV >0.04 ng/mL/mo would be potentially better candidates for a systemic therapy due to a high SRT failure rate.

Predictive factors of oncologic outcomes in patients who do not achieve undetectable prostate specific antigen after radical prostatectomy.

PURPOSE: We identified factors predicting oncologic outcomes in cases of persistently detectable prostate specific antigen. MATERIALS AND METHODS: We reviewed the charts of patients treated with radical prostatectomy between 1998 and 2011 at a total of 14 centers. Study inclusion criteria were radical prostatectomy for presumed localized prostate cancer, absent positive nodes and detectable prostate specific antigen, defined as prostate specific antigen 0.1 ng/ml or greater 6 weeks postoperatively. Of the 9,735 radical prostatectomy cases reviewed 496 (5.1%) were eligible for analysis. Predictive factors for oncologic outcomes were assessed in time dependent analyses using the Kaplan-Meier method and Cox regression models. RESULTS: At 6 weeks prostate specific antigen was 0.1 to 6.8 ng/ml. Biochemical progression was noted in 74.4% of patients and clinical metastasis was noted in 5%. The 2 most powerful predictors of general salvage treatment (vs radiotherapy) were postoperative prostate specific antigen greater than 1 ng/ml (OR 3.46, p=0.032) and prostate specific antigen velocity greater than 0.2 ng/ml per year (HR 6.01, p=0.001). Positive prostate specific antigen velocity was the single factor that independently correlated with the risk of failed salvage therapy (HR 2.6, p=0.001). The 5-year disease-free survival rate was 81.0% in patients with stable or negative prostate specific antigen velocity compared with 58.4% in those with positive prostate specific antigen velocity (p<0.001). CONCLUSIONS: Patients with detectable prostate specific antigen after radical prostatectomy have a poor biochemical outcome. We identified postoperative prostate specific antigen and prostate specific antigen velocity as independent predictors of progression and failed salvage treatment. In addition to pathological prognostic factors, these factors should be considered early to better stratify patients for adjuvant therapy.

Detailed analysis of morbidity following nephrectomy for renal cell carcinoma in octogenarians.

PURPOSE: We evaluated the morbidity of nephrectomy in patients older than age 80 years. MATERIALS AND METHODS: Between June 2002 and March 2011, 2,530 patients underwent surgery for renal tumor at 5 French academic centers. Of these patients 180 (7.1%) were age 80 years or older, including 22 (12%) and 158 (88%) who underwent partial and radical nephrectomy, respectively, and 47 (26.1%) who were treated with a laparoscopic approach. RESULTS: Mean patient age was 82.3 years. Median Charlson score was 4. Mean preoperative glomerular filtration rate was 47 ml/minute. A total of 136 complications were recorded in 70 patients (38.8% of all patients). Of the patients 28 (15.5%), 25 (13.9%) and 17 (9.4%) experienced 1, 2 and 3 or more complications, respectively. According to the modified Clavien classification grade I, II, III, IV and V complications were observed in 7, 81, 19, 23 and 6 patients, respectively. The transfusion rate was 31.1% (56). On logistic regression analysis the parameters of Eastern Cooperative Oncology Group Performance Status 2 to 4 (p = 0.035) and preoperative glomerular filtration rate less than 30 ml/minute (p = 0.03) were independent predictive factors of morbidity. CONCLUSIONS: Morbidity and mortality are significant in the octogenarian population. The risk of complications should be considered in decision making for patients with renal cell carcinoma older than age 80 years.

Overall mortality after radical nephrectomy in patients aged over 80 years with renal cancer: a retrospective study on preoperative prognostic factors.

OBJECTIVES: To evaluate the overall survival postnephrectomy for renal cancer for patients aged over 80 years, and to identify preoperative prognostic factors that might influence therapeutic strategies. METHODS: In a retrospective study in five French departments of urology, 179 patients aged over 80 years with renal cell carcinoma underwent radical nephrectomy between 1990 and 2011. The following data were collected: age, sex, body mass index, Charlson Comorbidity Index, American Society of Anesthesiology class, Eastern Cooperative Oncology Group Performance Status, type of surgery, period of follow-up, survival, death etiology, symptoms, Fuhrman grade and tumor-nodes-metastasis stage. RESULTS: After a 29.6-month follow up, 89 patients (49.7%) died. Death etiologies were: cancer for 46 (52%) patients, immediate or distant perioperative complications for five patients (6%) and three patients (3%) respectively, cardiovascular disease for 16 patients (18%), other cancers for three patients (3%) and unknown for 16 patients (18%). In a multivariate analysis, T-stage, M-stage and Charlson Comorbidity Index were identified as independent prognostic factors. Patients were divided into three groups (good, intermediate and bad prognosis) with significantly different survivals of 91, 36 and 22 months (P < 0.0001), respectively. CONCLUSIONS: Preoperative data, including T-stage, M-stage and Charlson Comorbidity Index represent significant independent prognostic factors for survival for patients aged over 80 years. These data might help the clinician in selecting the most suitable candidates for radical nephrectomy among elderly patients with renal cancer.

Nephron-sparing surgery for renal tumors measuring more than 7 cm: morbidity, and functional and oncological outcomes.

BACKGROUND: The purpose of this study was to evaluate morbidity, functional, and oncological outcomes after NSS in renal tumors > 7 cm. MATERIALS AND METHODS: We retrospectively analyzed data from 168 patients with tumors > 7 cm who were treated using NSS between 1998 and 2012. RESULTS: Imperative and elective indications accounted for 76 (45.2%) and 92 (54.8%) patients, respectively. Major perioperative complications and renal function deterioration occurred in 33 (19.6%) and 51 patients (30.4%), respectively. In multivariate analysis, age older than 60 years (P = .001; hazard ratio [HR], 5) and tumor malignancy (P = .014; HR, 6.7) were prognostic factors for renal function deterioration whereas imperative indication was a risk factor for major postoperative complications (P = .0019; HR, 2.7). In 126 (75%) patients with malignant tumors, after a median follow-up of 30 months (range, 1-254 months), 25 patients (20.2%) died. In multivariate analysis, imperative indication (P = .023; HR, 4.2), positive surgical margin (P = .021; HR, 3.3), and Fuhrman grade > II (P = .013; HR, 3.7) were prognostic indicators for cancer-free survival (CFS). Imperative indication (P = .04; HR, 8.5) and Fuhrman grade > II (P = .04; HR, 3.9) were predictive factors of cancer-specific survival (CSS). In case of elective indication, positive surgical margin, local recurrence, and cancer-related death occurred in 4 (7.6%), 1 (1.1%), and 1 (1.1%) cases, respectively. For elective indication, 5-year estimates of CFS, CSS, and overall survival rates were: 85.7%, 98%, and 93.9%, respectively. CONCLUSION: In this selected population, imperative vs. elective indication status seems to play a critical role in oncologic outcomes. Oncologic results for elective indications are close to those reported with radical nephrectomy.