Interferon gene therapy with nadofaragene firadenovec for bladder cancer: from bench to approval.

Bladder cancer is a prevalent malignancy with limited therapeutic options, particularly for patients who are unresponsive to Bacillus Calmette-Guérin (BCG). The approval of interferon-α (IFNα) gene therapy with nadofaragene firadenovec (Adstiladrin®), the first gene therapy for genitourinary malignancies, has provided a promising alternative. This article reviews the research and milestones that led to the development and approval of nadofaragene firadenovec. Bladder cancer is well-suited for gene therapy due to direct access to the bladder and the availability of urine and tissue samples for monitoring. Early challenges included effective gene transfer across the urothelium, which was overcome initially by modulating the expression of coxsackie/adenovirus receptor (CAR) and, ultimately, by disrupting the urothelial barrier with Syn3. Nadofaragene firadenovec is a modified adenoviral vector carrying the IFNα gene. Clinical trials have shown promising results, with high response rates and manageable adverse events. Ongoing research focuses on improving patient selection, identifying biomarkers for response prediction, exploring alternative vectors for enhanced transfection efficiency, and developing combination strategies targeting resistance mechanisms. The approval of nadofaragene firadenovec marks a significant milestone in the field of gene therapy for bladder cancer, and future developments hold promise for further enhancing its efficacy and impact.

The current status of gene therapy in bladder cancer.

INTRODUCTION: Gene therapy aims to alter the biological properties of cells through the therapeutic delivery of nucleotides to treat a disease. Although originally developed to treat genetic disorders, the majority of gene therapy development today is for the treatment of cancer, including bladder cancer. AREAS COVERED: Following a brief history and a discussion of the mechanisms of gene therapy, we will focus on the current and future gene therapy strategies for bladder cancer. We will review the most consequential clinical trials published in the field. EXPERT OPINION: Recent transformative breakthroughs in bladder cancer research have deeply characterized the major epigenetic and genetic alterations of bladder cancer and have radically transformed our view of tumor biology and generated new hypotheses for therapy. These advances provided the opportunity to begin to optimize strategies for effective gene therapy for bladder cancer. Clinical trials have shown promising results, especially in BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC), where effective second-line therapy remains an unmet need for patients facing cystectomy. Efforts are underway to develop effective combination strategies targeting resistance mechanisms to gene therapy for NMIBC.

Global experience and progress in GreenLight-XPS 180-Watt photoselective vaporization of the prostate.

PURPOSE: To evaluate changes in global perioperative data of GreenLight-XPS 180-Watt photo-selective vaporization of the prostate (GL-XPS) of the Global Greenlight Group (GGG) database. METHODS: 3441 men, who underwent GL-XPS for symptomatic BPH between 2011 and 2019 at seven high volume international centers, were included. Primary outcome measurements were operative time (OT; min), effective laser time (LT; min of OT), as well as intraoperative and postoperative adverse events (AEs), all analyzed by year of surgery (2011-2019) and prostate volume (PV) group (< 80 ml vs. 80-150 ml vs. > 150 ml). RESULTS: The median age was 70 years (interquartile range 64-77), the median PV was 64 ml (IQR 47-90). The OT and LT slightly increased but stayed highly efficient all in all. Median OT was 60 min (IQR 45-83) and LT was 33 min (IQR 23-46). Median energy use was 253 kJ (IQR 170-375) with an energy density of 3.94 kJ/ml (IQR 2.94-5.02). The relative probability of perioperative AEs decreased by 17% each year (p < 0.001). The relative probability of perioperative transfusion dropped significantly from 2% in 2011 to 0% in 2019 (p = 0.007). The early postoperative complications (within 30 days after surgery) decreased significantly from 48.8% (n = 106) in 2011 to 24.7% (n = 20) in 2019 (p > 0.001). CONCLUSION: These findings from the GGG demonstrate significant improvement secondary to growing experience with GL-XPS between 2011 and 2019 in intraoperative AEs, including transfusions, and postoperative AEs. While staying highly efficient in OT and LT of GL-XPS within a 9-year period of experience.

Role of Systematic Control Biopsies following Partial Gland Ablation with High-Intensity Focused Ultrasound for Clinically Significant Prostate Cancer.

PURPOSE: Partial gland ablation (PGA) using high-intensity focused ultrasound (HIFU) is currently under investigation for clinically significant prostate cancer (Cs-PCa). Our primary objective was to assess the role of systematic control biopsies following HIFU-PGA in a cohort of Cs-PCa patients. MATERIALS AND METHODS: We studied a single-center retrospective cohort of 77 men treated with HIFU-PGA between October 2015 and December 2019. Patients with unilateral Cs-PCa, defined as Gleason grade group (GGG) ≥2, with visible lesion on multiparametric magnetic resonance imaging (mpMRI) and prostate specific antigen (PSA) ≤15 ng/ml were included. All patients underwent mpMRI with systematic and targeted biopsies before and after HIFU-PGA. The primary outcome was the rate of Cs-PCa at control biopsy within 1 year of treatment. Logistic regression was performed to identify predictive factors of our primary outcome. RESULTS: Median age was 67 years (IQR 61-71), median PSA was 7 ng/ml (IQR 5.5-8.9). Pre-treatment biopsies revealed 48 (62.3%) GGG2 lesions, 24 (31.2%) GGG3 and 5 (6.5%) GGG4 lesions. Cs-PCa was found in 24 (31.2%) patients at systematic control biopsy post-HIFU; Cs-PCa was in the treated lobe for 18 (27%) patients. No variables were identified as significant predictors of Cs-PCa at control biopsy, including PSA kinetics and control mpMRI. Median followup time was 17 months (95% CI 15-21). Median time to any retreatment was 32 months (95% CI 23-42). CONCLUSIONS: Systematic control biopsy within a year after PGA for Cs-PCa can identify the presence of residual Cs-PCa in up to a third of patients. From our early experience, control biopsy should be systematically offered patients regardless of PSA kinetics or control mpMRI results.

Global Greenlight Group: largest international Greenlight experience for benign prostatic hyperplasia to assess efficacy and safety.

INTRODUCTION: Greenlight photo-selective vaporization of the prostate (GL-PVP) has gained international acceptance as a safe and effective alternative procedure for the treatment of benign prostatic hyperplasia (BPH), especially in anticoagulated men. This descriptive analysis aims to characterize the current state of GL-PVP, pooling data from international centers. METHODS: Data from 3627 patients who underwent GL-PVP with the XPS-180 W system in seven international centers performed by eight expert surgeons between 2011 and 2019 were retrospectively analyzed. Demographic, perioperative, and postoperative data were collected, including IPSS, QoL, Qmax, PVR, and PSA, and complications. RESULTS: At baseline, median age, prostate volume, PSA, and IPSS were 70 years (interquartile range 64-77), 64 (47-90), 3.1 ng/mL (1.8-6), and 22 (19-27), respectively. Median lasing and operative time were 34 (23-48) and 62 min (46-85), respectively. Median energy use was 250.0 kJ (168.4-367.9), with 92.6% of procedures being completed with one laser fiber. In 60.1% of cases, catheter was removed on postoperative day 1 with median length of 2 days. All-cause mortality within 30 days was 0.3%. Median PSA reduction at 3 months and 60 months compared to baseline was 43.9 and 46.4%, respectively (p < 0.001). All functional outcomes (IPSS, QoL, Qmax, and PVR) were significantly improved across study period when compared to baseline (p < 0.001). For those men with longer follow-up available, the observed surgical BPH retreatment rate was 1.5% CONCLUSION: Using the largest multi-user, international database of GL-PVP, Greenlight XPS laser treatment in experienced hands is a safe, effective, and durable BPH treatment option.

Accuracy of Clarius, Handheld Wireless Point-of-Care Ultrasound, in Evaluating Prostate Morphology and Volume Compared to Radical Prostatectomy Specimen Weight: Is There a Difference between Transabdominal vs Transrectal Approach?

Background: Prostate size estimation is a valuable clinical measure widely utilized in urology. This study evaluated the accuracy of preoperative transabdominal ultrasound (TAUS) compared to radical prostatectomy specimens and transrectal ultrasound (TRUS) in estimating prostate volume and identifying presence of median lobe, across different size groups, using the standard ellipsoid formula. The effect of median lobe on accuracy was also assessed. Materials and Methods: Ninety-eight men undergoing robot-assisted radical prostatectomy were enrolled in this study. Preoperative evaluation of prostate volume was done using measurements obtained from TAUS using the Clarius C3 handheld wireless point-of-care ultrasound (POCUS) and from TRUS Clarius EC7. Participants were grouped based on prostate size (<30, 30-60, and >60 g). Mean absolute percentage of error was used to evaluate accuracy. Mean percentage of error determined if there was an overestimation or underestimation. Correlation between each TAUS size group, true prostate weight and TRUS was assessed. Results: Irrespective of body mass index, TAUS accurately identified median lobe in all men. No statistically significant difference was found between specimen weight and TAUS prostate size for the >60 g group. Among this same group, a strong correlation was noted between specimen weight and TAUS prostate size (r = 0.911, p < 0.001). There was also a strong correlation between TAUS and TRUS measurements for this group (r = 0.950, p < 0.001). Presence of median lobe did not have an impact on measurement accuracy. Conclusions: Bedside handheld wireless POCUS provides rapid, inexpensive, noninvasive, and clinically accurate TAUS prostate assessments for larger prostates. Such features as identifying median lobes and measuring prostate volumes are valuable tools, whereas patient counseling on lower urinary tract symptoms, elevated prostate-specific antigen, and benign prostate hyperplasia are surgical options.

Detectable Prostate-specific antigen value between 0.01 and 0.1 ng/ml following robotic-assisted radical prostatectomy (RARP): does it correlate with future biochemical recurrence?

PURPOSE: The aim of the study is to evaluate the impact of having a nadir and persistently detectable ultrasensitive prostate-specific antigen (uPSA) between 0.01 and 0.1 ng/ml post-robot-assisted radical prostatectomy (RARP), on future biochemical recurrence (BCR). METHODS: We conducted a retrospective analysis of a prospectively maintained cohort of 1359 men who underwent RARP, between 2006 and 2019. Patients were followed with uPSA at 1, 3, 6, 9, 12, 18, 24, 30, 36 months and annually thereafter. We included patients with PSA nadir values between 0.01 and 0.1 ng/ml within 6 months of surgery and with at least 2 follow-up measurements within the same range. We divided patients based on their BCR status and analyzed uPSA changes. Multivariable Cox-regression models (CRMs) were used to analyze variables predicting BCR-free survival (BCR-FS). RESULTS: We identified 167 (12.3%) patients for analyses, with a mean follow-up time of 60.2 ± 31.4 months. In our cohort, 5-year BCR-FS rate was 86%. Overall, 32 (19.1%) patients had BCR, with a mean time to BCR of 43.7 ± 24.3 months. BCR-free patients had stable mean uPSA values ≤ 0.033 ng/ml, while patients who developed BCR showed a slowly rising trend over time, with a significant difference between groups starting at 9 months (p < 0.02). In multivariable CRMs, a rising uPSA starting at 9 months was an independent predictor of BCR (HR: 2.7; 95% CI 1.6-3.82; p = 0.013). CONCLUSION: In the present cohort, our results demonstrated that a considerable number of men have detectable uPSA values ranging between 0.01 and 0.1 ng/ml post-RARP. They can still be followed regularly to avoid patients' anxiety and salvage radiotherapy. Close follow-up is still required.

Impact of surgical wait times during summer months on the oncological outcomes following robotic-assisted radical prostatectomy: 10 years' experience from a large Canadian academic center.

PURPOSE: Most Canadian hospitals face significant reductions in operating room access during the summer. We sought to assess the impact of longer wait times on the oncological outcomes of localized prostate cancer patients following robotic-assisted radical prostatectomy (RARP). METHODS: We conducted a retrospective review of a prospectively maintained RARP database in two high-volume academic centers, between 2010 and 2019. Assessed outcomes included the difference between post-biopsy UCSF-CAPRA and post-surgical CAPRA-S scores, Gleason score upgrade and biochemical recurrence rates (BCR). Multivariable regression analyses (MVA) were used to evaluate the effect of wait times. RESULTS: A total of 1057 men were included for analysis. Consistent over a 10 year period, summer months had the lowest surgical volumes despite above average booking volumes. The lowest surgical volume occurred during the month of July (7.1 cases on average), which was 35% less than the cohort average. The longest average wait times occurred for patients booked in June (93 ± 69 days, p < 0.001). On MVA, patients booked in June had significantly more chance of having an increase in CAPRA score [HR (95% CI) 1.64 (1.02-2.63); p = 0.04] and in CAPRA risk group [HR (95% CI) 1.82 (1.04-3.19); p = 0.03]. Cohort analysis showed fair correlation between CAPRA-score difference and wait time (Pearson correlation: r = - 0.062; p = 0.044). CONCLUSION: Our cohort results demonstrate that conventional RARP wait times are significantly and consistently prolonged during summer months over the past 10 years, with worse post-RARP oncological outcomes in terms of CAPRA scores. Other compensatory mechanisms to sustain consistent yearly operative output should be considered.

Bladder-sparing protocols in the treatment of muscle-invasive bladder cancer.

Bladder-sparing protocols (BSP) have been gaining widespread popularity as an attractive alternative to radical cystectomy (RC) for muscle-invasive bladder cancer. Unimodal therapies are inferior to multimodal regimens. The most promising regimen is trimodal therapy (TMT), which is a combination of maximal transurethral resection of bladder tumor (TURBT), radiotherapy, and chemotherapy. In appropriately selected patients (low volume unifocal T2 disease, complete TURBT, no hydronephrosis and no carcinoma-in-situ), comparable oncological outcomes to RC have been reported in large retrospective studies, with a potential improvement in overall quality of life (QOL). TMT also offers the possibility for definitive therapy for patients who are not surgically fit to undergo RC. Routine biopsy of previous tumor resection is recommended to assess response. Prompt salvage RC is required in non-responders and for recurrent muscle-invasive disease, while non-muscle-invasive recurrence can be managed conservatively with TURBT +/- intravesical BCG. Long-term follow-up consisting of routine cystoscopy, urine cytology, and cross-section imaging is required. Further studies are warranted to better define the role of neoadjuvant or adjuvant chemotherapy in the setting of TMT. Finally, future research on predictive markers of response to TMT and on the integration of immunotherapy in bladder sparing protocols is ongoing and is highly promising.

Oncological and functional outcomes of a large Canadian robotic-assisted radical prostatectomy database with 10 years of surgical experience.

INTRODUCTION: Robotic-assisted radical prostatectomy (RARP) has grown to be the predominant global surgical approach to treat localized prostate cancer. However, there is still limited access to robotic technology and little data from Canadian cohorts. Herein, we report on our oncological and functional outcomes after 10 years of surgical experience. MATERIALS AND METHODS: Prospective data from 1,034 RARP cases performed by two high-volume experienced surgeons at two academic centers were collected from October 2006 to June 2017. Preoperative characteristics, surgical, oncological and functional outcomes were assessed up to 72 months postoperative. RESULTS: D'Amico risk distribution was 26.1%, 59.8% and 14.1% for low, intermediate and high risk prostate cancer. Median (interquartile range) operative time, blood loss and hospital stay were 170 minutes (145-200), 200 mL (150-300) and 1day (1-1), respectively and 1.4% received blood transfusion. Intraoperative complications occurred in 3.8%. Postoperatively, 32 (3.1%) and 138 (13.3%) men harbored major (Clavien III-IV) and minor complications (Clavien I-II), respectively. Among the 630 men (64.2%) with pT2 and 349 men (35.6%) with pT3 disease, stage-specific positive surgical margin rates were 15.7% and 39.0%, respectively. Urinary continence rates at 6, 12 and 72 months were 72.7%, 83.5% and 84.9%, respectively. In men without preoperative erectile dysfunction, potency was observed in 45.6%, 59.4% and 69.5% at 6, 12 and 72 months, respectively. Biochemical recurrence occurred in 105 patients (10.2%). CONCLUSION: Mid-term oncological outcomes in two large Canadian centers demonstrate comparable results to non-Canadian centers of excellence. RARP appears to be safe with acceptable surgical, oncological and functional outcomes in a publicly funded single-payer healthcare system.

Biliary mucinous cystic neoplasm mimicking a hydatid cyst: a case report and literature review.

BACKGROUND: Biliary mucinous cystic neoplasms are rare cystic lesions of the liver which carry pre-malignant potential. Given the scarcity of reports in the literature, they pose a considerable challenge to clinical management, particularly with regards to accurate pre-operative diagnosis. CASE PRESENTATION: We present the case of a 37-year-old Tunisian woman who presented with subacute right upper quadrant pain and a large multi-loculated cystic lesion, most consistent with a hydatid cyst. She underwent an open right hepatectomy, and pathology surprisingly revealed a biliary mucinous cystadenoma. Herein, we review the current literature on biliary mucinous cystic neoplasms, with a particular emphasis on diagnostic investigations, key radiological features and optimal treatment modalities. CONCLUSION: Biliary mucinous cystic neoplasms require a high index of suspicion and should be managed with complete surgical resection, as conservative techniques are associated with high recurrence rates. Considering the potential for malignant transformation, periodical surveillance imaging is recommended in the post-operative period.

Predictors of deviation in neurovascular bundle preservation during robotic prostatectomy.

INTRODUCTION: Neurovascular bundle (NVB) preservation during robot-assisted radical prostatectomy (RARP) directly affects patient functional outcomes. Despite careful surgical planning, many NVB preservation techniques are changed intraoperatively from their preoperative plan. Our objective was to identify risk factors predicting intraoperative change in NVB preservation technique during RARP. MATERIALS AND METHODS: Prospective data from 578 RARPs performed by a single surgeon between 2010 and 2017 at a tertiary care center. Side-specific NVB preservation technique was planned preoperatively. Surgical techniques were either complete nerve sparing (CNS), or incomplete nerve sparing (INS). Variables included age, tumor grade, prostate volume, number of lifetime biopsies, history of post-biopsy sepsis, and laterality. Variables were modeled in multivariable logistic regressions as potential predictors of deviation in surgical technique. Functional and oncological outcomes were also assessed. RESULTS: A total of 46.9% of cases underwent some intraoperative change in NVB preservation from their preoperative plan. A total of 37.7% of 880 prostate sides planned for CNS underwent unplanned INS. Older age, Gleason ≥ 3+4, post-biopsy sepsis, prostate volume, and left-sided dissections were significantly associated with unplanned INS. Number of lifetime biopsies was not a predictor of unplanned INS. Patients with an intraoperative change to INS had poorer potency and continence. Study limitations included the retrospective nature of analysis and lack of pathological assessment of NVB preservation. CONCLUSIONS: Age, Gleason ≥ 3+4, post-biopsy sepsis, prostate volume, and laterality were significant predictors of unplanned INS during RARP, which should guide patient counseling when discussing risks and functional outcomes. The number of lifetime biopsies did not predict unplanned INS, a valuable finding for patients on active surveillance. Our findings highlight the importance of careful preoperative planning and novel adjuncts such as multiparametric MRI.

Use of the AccuVein AV400 during RARP: an infrared augmented reality device to help reduce abdominal wall hematoma.

INTRODUCTION: Abdominal wall hematoma (AWH) is a self-resolving, yet common complication from the insertion of trocars during laparoscopic surgery. Particularly, its appearance may increase patient anxiety and may reduce overall surgical satisfaction. MATERIALS AND METHODS: In a retrospective study analyzing data from 724 robot-assisted radical prostatectomy cases (RARP), trocar insertion sites were examined on postoperative day 7 with Foley removal for AWH. AWH was defined by a sizable collection of blood below the skin as a result of the surgery. The AccuVein AV400 system was utilized to generate real-time images of venous structures beneath the skin. Comparative outcomes were performed with a series of 114 men where the AccuVein AV400 device was applied over trocar insertion markings to help modify port placement. RESULTS: The pre-incision imaging of the AccuVein system modified port placement in 74 of 114 cases (65%), and reduced AWH from 8.8% to 2.6% (p = 0.03) as compared to transabdominal illumination. Port placement adjustments were most prevalent in the lateral regions of the abdomen, prompting attention for lateral trocar insertion to avoid vessels such as the thoracoepigastric veins. Notably, the body mass index (BMI) of patients experiencing AWH who received the pre-incision imaging of AccuVein was significantly higher than patients receiving standard transabdominal illumination (34.2 and 27.9 kg/m² respectively; p = 0.02). CONCLUSION: The AccuVein AV400 device appears to be an effective adjuvant for decreasing rates of AWH during lower abdominal wall trocar insertion, though its effectiveness is limited in patients with extreme BMI. Additionally, special attention should be directed towards trocar insertion in the lateral regions of the abdomen.

Photoselective vaporization of the prostate with the 180-W XPS-Greenlight laser: Five-year experience of safety, efficiency, and functional outcomes.

INTRODUCTION: Transurethral resection of the prostate (TURP) is still considered the gold standard surgical treatment for symptomatic benign prostatic hyperplasia (BPH). However, photoselective vaporization of the prostate (PVP) has gained widespread global acceptance in national guidelines as a safe and effective alternative option. Nevertheless, further evidence is required to assess the durability of Greenlight PVP. Herein, we report our five years of PVP experience with the Greenlight 180W XPS laser system. METHODS: A retrospective analysis was conducted on a prospectively gathered database of 370 consecutively included patients who underwent PVP using Greenlight XPS-180 W laser system (Boston Scientific, Boston, MA, U.S.) performed by a single experienced laser surgeon between 2011 and 2016. Preoperative characteristics, intervention parameters, postoperative functional, uroflowmetry outcomes, and complications were collected. Outcomes are reported over a period of five years. RESULTS: Mean age was 68 years, with a mean prostate volume of 78.8 cc (95% confidence interval [CI] 70.9-78.7]). The mean followup was 59.4 months (55.4-63.5). Mean energy, operative time, and energy/cc were 270.2 kJ (255.2-285.2), 62.7 minutes (59.6-65.7), and 3.7 kJ/cc (3.6-3.9), respectively. Compared to preoperative values, International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), and post-void residual (PVR) parameters were significantly improved and sustained over the five postoperative years. Of note, only 66 patients (out of 370) had a complete five-year followup. Prostate-specific antigen (PSA) reached nadir at one year, with a drop of 67% from the mean preoperative value of 6.2 ng/mL. Mean IPSS nadir was reached at three years, with a drop of 80.4% (-21.1 points). Similarly, mean quality of life (QoL) score dropped by 82.8% after three years (preoperative mean of 4.7). With respect to mean Qmax, there was an increase by 72.7% (+14.7 mL/s) at one year, reaching the value of 19.9 mL/s. Moreover, mean PVR was 32.8 mL at four years compared to 345 mL preoperatively. At five years followup, PSA, IPSS, QoL, and PVR dropped by 59.7% (3.7 ng/mL), 75.2% (19.7 points), 78.72% (3.7 points), and 84.4% (291.3 mL), respectively. Qmax increased by 12.9 mL/s. Clavien complication rates were low, with bladder neck stenosis observed in seven (1.6%) men. During the five-year followup, only four patients (1%) required BPH surgical re-intervention. CONCLUSIONS: This is the first long-term reporting of Greenlight XPS-180W laser system. In experienced hands, the observed outcomes appear to demonstrate that Greenlight XPS-180 W laser system is safe, efficacious, and durable for the treatment of bladder outlet obstruction (BOO) secondary to BPH.

180W-LBO GreenLight XPS laser vaporization for benign prostatic hyperplasia: our experience with current markers of surgical proficiency for durable and reproducible outcomes.

INTRODUCTION: This study aims at analyzing the impact of reaching current markers of proficiency on intra and postoperative clinical outcomes of laser vaporization with 180W GreenLight XPS in the treatment of benign prostatic hyperplasia. MATERIALS AND METHODS: A retrospective analysis was conducted on a prospectively collected database of 328 consecutive patients who underwent photoselective vaporization of the prostate (PVP) using Greenlight XPS performed by a single experienced laser surgeon. A logarithmic model was used to evaluate the case number to attain benchmark criteria for durable treatment. We compared clinical outcomes before and after current markers of proficiency, defined as either an energy density of 4kJ/cm³ or a 6 month prostate-specific antigen (PSA) drop of = 50%, were attained. RESULTS: Energy delivered per prostate volume increased significantly with experience. The published benchmark values of 4kJ/cm³ and 6 month PSA drop of 50% were attained after 190 and 155 cases, respectively. There were no significant differences between groups in intraoperative complications or postoperative functional outcomes. However, the number of Clavien-Dindo category I adverse events significantly decreased with experience. Sub-analysis evaluating prostate volumes ≤ 80 cm³ and > 80 cm³ demonstrated comparable clinical outcomes before and after technical proficiency. CONCLUSION: In our experience, the case volume required to achieve consistent reference values related to durable clinical outcomes and surgical proficiency was > 150 cases. However, desirable clinical outcomes were attained before reaching current markers of proficiency, regardless of preoperative prostate size. This suggests that current thresholds of technical proficiency may not be a good predictor of satisfying clinical outcomes.

Efficacy, Safety, and Durability of 532 nm Laser Photovaporization of the Prostate with GreenLight 180 W XPS in Men with Acute Urinary Retention.

OBJECTIVE: We assessed the effectiveness and durability of 532 nm laser photovaporization with GreenLight XPS in men with and without preoperative urinary retention. MATERIALS AND METHODS: From 2010 to 2017 we prospectively studied men who underwent photovaporization of the prostate (PVP) for obstructive lower urinary tract symptoms (LUTS) secondary to BPH. The cohort was retrospectively divided into those with catheter dependent retention and those with elective PVP. Primary endpoints were catheter-free rate and improvement in quality of life (QoL) scores, international prostate symptom score (IPSS), maximum urinary flow rate (Qmax), and postvoid residual (PVR). The secondary endpoints of the study were complication outcomes as defined by the standardized Clavien-Dindo grading system. RESULTS: One hundred thirty-seven men with preoperative retention and 195 men without preoperative retention underwent PVP. Men with preoperative retention were older (70 years vs 66 years; p < 0.001), had a higher American Society of Anesthesiology (ASA) score, and had a higher prevalence of neurologic disease (8% vs 2.6%; p = 0.04). These men also had a larger prostate volume (76 cc vs 69 cc; p < 0.001) and higher prostate specific antigen (5 ng/mL vs 2.7 ng/mL; p < 0.001) than those without retention. Patients with preoperative retention also had higher preoperative baseline IPSS and QoL score. After PVP they improved to values similar to those without retention, with durability up to 24 months. After PVP, men in preoperative retention had similar rates to fail their first void trial (18.2% vs 10.3%, p = 0.053). There was a 96% catheter-free rate in the men with preoperative retention. The rate of complication was higher in the nonretention group, specifically at 90 days (35.4% vs 21.2%; p = 0.009), with almost all the complications being Clavien-Dindo grade 2. CONCLUSION: PVP is an effective, safe, and durable treatment for men in acute urinary retention (AUR) with a catheter-free rate of 96%. The improvement is similar to those who did not present in AUR.

Error reporting from the da Vinci surgical system in robotic surgery: A Canadian multispecialty experience at a single academic centre.

INTRODUCTION: The goal of the study is to evaluate and report on the third-generation da Vinci surgical (Si) system malfunctions. METHODS: A total of 1228 robotic surgeries were performed between January 2012 and December 2015 at our academic centre. All cases were performed by using a single, dual console, four-arm, da Vinci Si robot system. The three specialties included urology, gynecology, and thoracic surgery. Studied outcomes included the robotic surgical error types, immediate consequences, and operative side effects. Error rate trend with time was also examined. RESULTS: Overall robotic malfunctions were documented on the da Vinci Si systems event log in 4.97% (61/1228) of the cases. The most common error was related to pressure sensors in the robotic arms indicating out of limit output. This recoverable fault was noted in 2.04% (25/1228) of cases. Other errors included unrecoverable electronic communication-related in 1.06% (13/1228) of cases, failed encoder error in 0.57% (7/1228), illuminator-related in 0.33% (4/1228), faulty switch in 0.24% (3/1228), battery-related failures in 0.24% (3/1228), and software/hardware error in 0.08% (1/1228) of cases. Surgical delay was reported only in one patient. No conversion to either open or laparoscopic occurred secondary to robotic malfunctions. In 2015, the incidence of robotic error rose to 1.71% (21/1228) from 0.81% (10/1228) in 2014. CONCLUSIONS: Robotic malfunction is not infrequent in the current era of robotic surgery in various surgical subspecialties, but rarely consequential. Their seldom occurrence does not seem to affect patient safety or surgical outcome.

Evaluation of Surgical Outcomes with Photoselective GreenLight XPS Laser Vaporization of the Prostate in High Medical Risk Men with Benign Prostatic Enlargement: A Multicenter Study.

OBJECTIVE: To evaluate the safety and short-term outcomes of photoselective vaporization of the prostate (PVP) using GreenLight XPS™ in treatment of high medical risk (HMR) men. METHODS: A multicenter retrospective analysis of 941 men who underwent PVP between August 2010 and August 2014 was performed. Patients were considered HMR if they had an American Society of Anesthesiologists physical status score ≥3. Postoperative adverse events, unexpected postoperative medical provider visits after intervention, and functional urinary outcomes were examined. RESULTS: HMR men (n = 273) were older (mean age 72.3 ± 8.1 years vs 67.1 ± 9 years, p ≤ 0.01), had larger prostate volumes (82.8 ± 48.2 g vs 73.7 ± 49.4 g, p < 0.01), and were more likely to be on anticoagulant and antiplatelet medications (all p ≤ 0.01). Moreover, overall operative time (65 ± 35.1 minutes vs 53.9 ± 24.9 minutes), energy delivered (313.4 ± 207 kJ vs 258 ± 164 kJ), and energy density used (4.2 ± 3.8 kJ/g vs 3.8 ± 3 kJ/g) were greater in the HMR group (all p ≤ 0.05). Although HMR men were more often treated in a hospital setting (p ≤ 0.01), there were no differences in intraoperative adverse events. At 6 months, both groups had notable improvements from baseline for International Prostate Symptom Score, quality of life due to urinary symptoms, maximum urinary flow rate, postvoid residual urine volume, and prostate-specific antigen. Regarding safety, the two groups had comparable 90-day Clavien-Dindo complication rates, numbers of urgent care visits, and numbers of outpatient consultations. HMR men, however, had more hospital readmissions within 90 days postsurgery (3.7% vs 1.3%; p = 0.04). CONCLUSIONS: Despite older age, greater comorbidity, and significant use of anticoagulants, HMR men who undergo photoselective vaporization benefit from symptom improvement and show no clinical difference in adverse event profiles. GreenLight-XPS produces similar short-term outcomes in patients with significant comorbidities when compared with healthy patients.