Post-cystoscopy infections and device malfunctions in reprocessed flexible cystoscopes in a national database.

INTRODUCTION: Flexible cystoscopes can be multi-use devices that visually inspect genitourinary structures such as the bladder and urethra. The objective of this study is to characterize the adverse events and associated device malfunctions of reusable flexible cystoscopes and to provide information on contamination and post-procedural infections. MATERIALS AND METHODS: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for all adverse events and device malfunctions related to the use of flexible cystoscopes between January 2015 and December 2020. The MAUDE adverse event classification system was used to standardize the severity of complications and special focus was taken to identify clusters of events related to a single device. RESULTS: A total of 335 adverse events related to flexible cystoscopes were identified. Most adverse events associated with patient harm were caused by infection (n = 121), which included 19 cases of sepsis, one ICU admission, and one death. Among the infections, 29 cases showed growth of the same organism in both the device and patient. There were five infectious outbreaks identified and each outbreak was attributed to a single cystoscope. Other adverse events included mechanical malfunction (n = 6) and allergic reaction (n = 1). CONCLUSIONS: Our findings highlight the risk of post-procedural infection associated with flexible cystoscope contamination. Further studies are needed to characterize the prevalence and incidence of flexible cystoscope contamination and to develop strategies to prevent post-procedural infection.

Robotic distal ureterectomy and re-implant for obstructing metastatic melanoma - surgical considerations in the palliative setting.

Non-urothelial malignant ureteral obstruction (MUO) causes hydronephrosis, renal damage and infectious sequelae. The overall condition, symptoms, and plans for systemic therapy inform urologic intervention. In well-selected cases, there is a role for definitive reconstruction. We describe a robotic-assisted distal ureterectomy and reimplant for definitive repair of obstructive metastatic melanoma.

Implementation and Impact of a Risk-Stratified Prostate Cancer Screening Algorithm as a Clinical Decision Support Tool in a Primary Care Network.

BACKGROUND: Implementation methods of risk-stratified cancer screening guidance throughout a health care system remains understudied. OBJECTIVE: Conduct a preliminary analysis of the implementation of a risk-stratified prostate cancer screening algorithm in a single health care system. DESIGN: Comparison of men seen pre-implementation (2/1/2016-2/1/2017) vs. post-implementation (2/2/2017-2/21/2018). PARTICIPANTS: Men, aged 40-75 years, without a history of prostate cancer, who were seen by a primary care provider. INTERVENTIONS: The algorithm was integrated into two components in the electronic health record (EHR): in Health Maintenance as a personalized screening reminder and in tailored messages to providers that accompanied prostate-specific antigen (PSA) results. MAIN MEASURES: Primary outcomes: percent of men who met screening algorithm criteria; percent of men with a PSA result. Logistic repeated measures mixed models were used to test for differences in the proportion of individuals that met screening criteria in the pre- and post-implementation periods with age, race, family history, and PSA level included as covariates. KEY RESULTS: During the pre- and post-implementation periods, 49,053 and 49,980 men, respectively, were seen across 26 clinics (20.6% African American). The proportion of men who met screening algorithm criteria increased from 49.3% (pre-implementation) to 68.0% (post-implementation) (p < 0.001); this increase was observed across all races, age groups, and primary care clinics. Importantly, the percent of men who had a PSA did not change: 55.3% pre-implementation, 55.0% post-implementation. The adjusted odds of meeting algorithm-based screening was 6.5-times higher in the post-implementation period than in the pre-implementation period (95% confidence interval, 5.97 to 7.05). CONCLUSIONS: In this preliminary analysis, following implementation of an EHR-based algorithm, we observed a rapid change in practice with an increase in screening in higher-risk groups balanced with a decrease in screening in low-risk groups. Future efforts will evaluate costs and downstream outcomes of this strategy.

Influence of African American race on the association between preoperative biopsy grade group and adverse histopathologic features of radical prostatectomy.

BACKGROUND: The current study was performed to evaluate the influence of race on the association between biopsy grade group (GrGp) and the risk of detectable prostate-specific antigen (PSA) and adverse histopathological outcomes after radical prostatectomy (RP). METHODS: Data regarding 4073 men (1344 African American men; 33%) who were treated with RP were categorized based on the 5-tiered GrGp system. Logistic regression was used to test the association between biopsy GrGp and PSA nadir (<0.1 ng/mL) after RP as well as adverse pathological features among all patients and stratified by race. RESULTS: Those patients with a higher biopsy GrGp were found to have lower odds of achieving a PSA nadir <0.1 ng/mL after RP on unadjusted and multivariable analysis (both P < .001). On unadjusted and multivariable analysis, higher GrGp was associated with increased odds of each of the adverse pathological features, namely, GrGp ≥3, extraprostatic extension, seminal vesicle invasion, positive surgical resection margin, and positive lymph nodes (all P < .001). Race had no significant interaction with biopsy GrGp in the prediction of PSA nadir after RP (P = .91) or any adverse pathological features (all P > .06) except positive lymph nodes. When the models were stratified by race, the associations between preoperative biopsy GrGp and having a PSA nadir <0.1 ng/mL, high-grade final pathology, or other adverse histopathologic features were similar in both races except as noted for positive lymph nodes. CONCLUSIONS: Higher preoperative biopsy GrGp is associated with increased odds of adverse histopathological findings as well as lower odds of a PSA nadir <0.1 ng/mL after RP. These associations are largely independent of race, suggesting that GrGp is an accurate tool for risk stratification in both black and white men.

Anterior gland focal cryoablation: proof-of-concept primary prostate cancer treatment in select men with localized anterior cancers detected by multi-parametric magnetic resonance imaging.

BACKGROUND: Due to their location away from the nerve bundles, anterior prostate cancers (APC) represent a rational target for image-guided cryoablation. This report describes the feasibility and short-term outcomes of anterior focal cryosurgery. METHODS: A retrospective review between 2012 and 2016 of patients with clinically localized APC treated with anterior gland cryoablation was performed. Descriptive statistics were used to report: age, PSA, prostate volume, prostate cancer grade group (PGG), median time to follow-up, and changes in functional status measured with the International Prostate Symptom Score (IPSS) and the International Index of Erectile Function (IIEF-5) score. RESULTS: A total of 17 patients underwent anterior focal cryoablation with a median follow-up of 15 months. Median age and PSA at diagnosis were 67 years and 8.7 ng/mL. Pre-operative PGG1 was identified in 12 (71%) men and PGG2 in 5 (29%) men. Median (IQR) lesion volume was 2 mL(0.86, 3.1). Preoperative median IIEF-5 and IPSS scores were 19.5 and 5, and decreased to 19 and 4, post-operatively. All patients remained continent with no change in sexual function. All post-procedure targeted biopsies of the treated cancers were negative. CONCLUSION: Our pilot study demonstrates the feasibility of treating APCs with image-guided targeted focal cryoablation as a good balance between short-term oncologic control and near complete preservation of genitourinary function. Further follow-up is necessary to examine the potential benefits long-term.

Clinicopathological characteristics of surgically treated localized renal masses in patients previously exposed to chemotherapy.

PURPOSE: To explore the potential association between renal mass characteristics and a history of chemotherapy. MATERIALS AND METHODS: A retrospective review of records of patients surgically treated for a localized renal mass between 2000 and 2012 was undertaken following an institutional review board approval. Patients age and sex, renal mass clinical characteristics (radiological size and mode of presentation) and pathological characteristics (diagnosis, renal cell carcinoma subtype, Fuhrman grade and stage) were compared between patients with and without a history of chemotherapy, using Fisher's exact test, Student's t-test and Wilcoxon rank sum test. A multivariate logistic analysis was performed to evaluate the independent association of chemotherapy and tumor pathology. RESULTS: Of the 1,038 eligible patients, 33 (3%) had a history of chemotherapy. The distribution of clinical stage, renal mass diagnosis, renal cell carcinoma subtype, Fuhrman grade, pathological stage, sex and median age were similar between the general population and the chemotherapy group. However, the latter had a higher rate of incidental presentation (P = 0.003) and a significantly smaller median radiological tumor size (P = 0.01). In a subset analysis of T1a renal cell carcinoma, the chemotherapy group presented an increased rate of high Fuhrman grade (P = 0.03). On multivariate analysis adjusted for radiological tumor size, sex and age the chemotherapy cohort had a 3.92 higher odds for high Fuhrman grade. CONCLUSION: Patients with a history of chemotherapy typically present with smaller renal masses that, if malignant, have higher odds of harboring a high Fuhrman grade and thus may not be suitable for active surveillance.

Validation of the 2015 prostate cancer grade groups for predicting long-term oncologic outcomes in a shared equal-access health system.

BACKGROUND: A 5-tier prognostic grade group (GG) system was enacted to simplify the risk stratification of patients with prostate cancer in which Gleason scores of ≤6, 3 + 4, 4 + 3, 8, and 9 or 10 are considered GG 1 through 5, respectively. The authors investigated the utility of biopsy GG for predicting long-term oncologic outcomes after radical prostatectomy in an equal-access health system. METHODS: Men who underwent prostatectomy at 1 of 6 Veterans Affairs hospitals in the Shared Equal Access Regional Cancer Hospital database between 2005 and 2015 were reviewed. The prognostic ability of biopsy GG was examined using Cox models. Interactions between GG and race also were tested. RESULTS: In total, 2509 men were identified who had data available on biopsy Gleason scores, covariates, and follow-up. The cohort included men with GG 1 (909 patients; 36.2%), GG 2 (813 patients; 32.4%), GG 3 (398 patients; 15.9%), GG 4 (279 patients; 11.1%), and GG 5 (110 patients; 4.4%) prostate cancer. The cohort included 1002 African American men (41%). The median follow-up was 60 months (interquartile range, 33-90 months). Higher GG was associated with higher clinical stage, older age, more recent surgery, and surgical center (P < .001) as well as increased biochemical recurrence, secondary therapy, castration-resistant prostate cancer, metastases, and prostate cancer-specific mortality (all P < .001). There were no significant interactions with race in predicting measured outcomes. CONCLUSIONS: The 5-tier GG system predicted multiple long-term endpoints after radical prostatectomy in an equal-access health system. The predictive value was consistent across races. Cancer 2017;123:4122-4129. © 2017 American Cancer Society.

High-intensity focused ultrasound for focal therapy: reality or pitfall?

PURPOSE OF REVIEW: Progress in imaging, fusion software, and ablative modalities has fostered growth of the latest image-guided generation of high-intensity focused ultrasound (HIFU) for focal treatment of prostate cancer. Although early reports are encouraging, important questions remain regarding candidate selection, treatment, and outcomes. We review contemporary considerations for the use of HIFU for focal treatment of primary and radio-recurrent prostate cancer. RECENT FINDINGS: HIFU has been used to treat prostate cancer for over two decades. More recently, stage migration from screening and improvements in pelvic imaging and fusion technology has resulted in wider clinical application of focal HIFU as a first-line treatment for localized prostate cancer. Advanced imaging has also improved targeting for focal salvage therapy of radio-recurrent disease. Proponents point to the minimally invasive nature, limited morbidity profile, and ability to perform retreatments in the future. Critics emphasize positive post-treatment biopsies, nonuniform treatment protocols, and absence of long-term follow-up. Thus, a review of clinical considerations and recently published data is warranted. SUMMARY: Recent advances have strengthened support for the use of focal HIFU. Although HIFU has great potential, it must be applied judiciously, maintaining appropriate oncologic principles in the setting of standardized trials to determine its true clinical value.

The Contemporary Role of Multiparametric Magnetic Resonance Imaging in Active Surveillance for Prostate Cancer.

PURPOSE OF REVIEW: Growing research supports the use of multiparametric magnetic resonance imaging (mpMRI) for the evaluation of localized prostate cancer (PCa). We highlight contemporary evidence supporting its use in active surveillance (AS). RECENT FINDINGS: The emerging approach to localized PCa favors risk-adapted screening, image-guided biopsies, and selective therapeutic interventions. mpMRI is increasingly critical to achieve each of these aims. Early evidence suggests a value of mpMRI before initial biopsy to guide fusion targeting and to rule out non-organ confined disease as well as in the initiation and serial monitoring of men on AS. There remain concerns regarding understaging cancer with mpMRI and the standardization of expertise beyond the most experienced centers. mpMRI is emerging as a critical decision point for staging localized PCa and guiding AS strategies. While there is increasing enthusiasm, the optimal clinical scenario and sequencing remains to be defined.

Can men 75 and older safely receive a minimally invasive radical prostatectomy?

Men 75 and older presenting with localized prostate cancer have traditionally not been managed with surgery. Therefore, we compared the morbidity and operative outcomes of radical prostatectomy (RP) in men 75 and older to their younger counterparts. We utilized the American College of Surgeons National Surgical Quality Improvement Program database to gather subjects who received a minimally invasive RP (CPT: 55866) from 2016 to 2020. This cohort was then stratified by age to compare men 18-74 years old and men 75 and older. The preclinical profile, complications, and outcomes were analyzed. Chi-square and Mann-Whitney U test were used to analyze categorical and continuous variables, respectively. Of the 48,485 men identified, 2,009 (4.1%) were ≥ 75 years old. Within the 75 and older cohort, the median age was 76 (IQR: 75-78), the median BMI was 27.3 (IQR: 24.9-29.9), and 1,601 (79.7%) were Caucasian. Men 75 and older had higher rates of Clavien 3 (1.3% vs. 0.8%, p = 0.02) and Clavien 4 (7.8% vs. 5.0%, p < 0.001) complications. Reoperative rates (1.7% vs. 1.1%, p = 0.01), readmission rates (6.5% vs. 4.1%, p < 0.001), and mortality (0.4% vs. 0.1%, p < 0.001) were all higher in men 75 and older. Multivariate analysis shows older age to be a risk factor for readmission (OR 1.58, 95%CI 1.31-1.90). Complications and 30-day outcomes remain within an acceptable range to offer surgery in men 75 and older. Age alone should not disqualify men from receiving a RP, but appropriate patient selection and counseling are necessary.

Assessing the safety of minimally invasive partial nephrectomy in octogenarians.

As life expectancy continues to rise, there is a growing cohort of octogenarians that can have oncologic benefit from a partial nephrectomy. This study aims to analyze a large national dataset to compare the safety and outcomes in octogenarians receiving a nephrectomy. The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database was utilized. All subjects 80-89 years old who received a minimally invasive partial nephrectomy (CPT: 50543) or radical nephrectomy (CPT: 50545, 50546) from 2016 to 2020 were included. Baseline characteristics, comorbidities, and postoperative complications were compared. Chi-square analysis and student t-tests were used to analyze categorical and continuous variables, respectively. 1765 procedures were performed on octogenarians, of which 1299 (73.6%) received a radical nephrectomy and 466 (26.4%) received a partial nephrectomy. When comparing preoperative comorbidities, octogenarians undergoing partial nephrectomy had lower rates of dyspnea at exertion (7.3 vs. 10.6%, p = 0.04), COPD (2.8 vs. 5.9%, p = 0.01), and chronic steroid use (1.5 vs. 3.3%, p = 0.04). No statistically significant differences were seen in any minor (Clavien 1/2) or major post-operative complications (Clavien 3/4). Readmissions were higher in those who received a partial nephrectomy (10.5 vs. 6.5%, p = 0.01); however, there were no significant differences in reoperation (2.4 vs. 1.7%, p = 0.36) or mortality (1.3 vs. 1.8%, p = 0.48). Partial nephrectomy is a safe and feasible operation in octogenarians. Preoperative counseling and appropriate patient selection remain imperative.

Same-Day Discharge After Robot-Assisted Partial Nephrectomy: Is It Worth It?

Introduction and Objective: Robot-assisted partial nephrectomy (RAPN) has traditionally been performed as an inpatient procedure; however, recent studies have suggested the feasibility of same-day discharge (SDD) after RAPN. We aimed to evaluate the safety and cost-effectiveness of SDD for RAPN. Methods: A retrospective analysis was conducted on patients undergoing RAPN between January 2015 and July 2021. Comparison before and after the implementation of an SDD protocol was assessed through differences in postanesthesia care unit (PACU) time, length of stay, 30-day readmission rate, 30-day return to emergency department (ED) rates, unplanned office visits (OVs), and need for secondary procedures. A cost-efficacy model was generated to estimate the difference in expenditure between SDD and inpatient RAPN. Results: In total, 192 patients underwent RAPN with 74 being SDD and 118 being admitted postoperatively. After SDD protocol implementation, the percentage of patients discharged from the PACU increased from 0% to 76%. The safety profile of SDD was similar to the inpatient group, with no differences in readmission rates (1.4% vs 5.1%, p = 0.18) or return to ED (5.4% vs 9.3%, p = 0.33). Compared with inpatient RAPN, SDD was associated with increased time in PACU (375 vs 251 minutes, p < 0.001), resulting in an additional expenditure of $1,622 per patient. SDD patients were more likely to return for one or more unplanned OVs (17.6% vs 6.8%, p = 0.02). Overall, the total cost of SDD was significantly lower than inpatient RAPN ($5,222 per patient vs $8,425, p < 0.001). Conclusion: Despite a shorter postoperative monitoring period, SDD appears safe, with equivalent readmission rates, return to ED, and secondary procedures. SDD for RAPN saves ∼$3,000 per patient. In implementing an SDD protocol, clinicians should be cognizant of increased demands on PACU infrastructure and be willing to provide additional support in the office setting.

National Utilization, Reimbursement, and Urban Versus Rural Trends of Extracorporeal Shockwave Lithotripsy and Ureteroscopic Laser Lithotripsy.

OBJECTIVE: To describe temporal utilization and reimbursement trends of extracorporeal shockwave lithotripsy (ESWL) and ureteroscopy (URS) with laser lithotripsy. METHODS: The Medicare Provider Utilization and Payment Database was queried for all ESWL and URS performed between 2013 and 2020 using Current Procedural Terminology codes: ESWL - 50590; URS - 52352, 52353, 52356. Cases that lacked rural or urban identification codes were excluded. A total of 347,174 ESWL and 401,899 URS cases were identified. Linear regression was performed with statistical significance set to 95% confidence intervals. RESULTS: There was a significant upward trend for URS utilization over the study period (R2 = 0.91, P <.001), but there was not a significant trend for ESWL utilization. In 2013, ESWL was used more frequently than URS, but by 2016, URS was used more frequently than ESWL. From 2013 to 2019, URS utilization increased by 241% and 168% by urban and rural urologists, respectively. URS was also associated with a slight increase in physician reimbursement over time (R2 = 0.87, P <.001), whereas there was no association between ESWL and physician reimbursement. For URS, rural and urban urologists were reimbursed an average of $312.07 (standard deviation [SD] $14.03) and $404.86 (SD $21.96), respectively. For ESWL, rural and urban urologists were reimbursed an average of $456.22 (SD $5.74) and $562.66 (SD $16.68), respectively. CONCLUSION: According to the Medicare database, URS has surpassed ESWL in utilization, especially by urban urologists. Physician reimbursement for ESWL remained higher than URS reimbursement, though URS reimbursement increased slightly in recent years.

Primary urethral melanoma treated sucessfully with wide excision and combination immunotherapy: Case report and review of literature.

We report the rare case of a primary malignant melanoma of the urethra. An 89-year-old African American woman who was referred to our urology clinic for intermittent gross hematuria and a palpable vaginal mass of two months duration. Cystoscopy revealed a 3 cm mass in the distal urethra and urethral meatus that was surgically resected by wide local excision. The histopathologic diagnosis was primary malignant melanoma of the urethra. The patient was subsequently treated with adjuvant EBRT and immunotherapy with nivolumab and ipilimumab. Post-treatment PET-CT showed good response to treatment and patient remained in remission at eight month follow up.

Device-related complications during renal cryoablation: insights from the Manufacturer and User Facility Device Experience (MAUDE) database.

INTRODUCTION AND OBJECTIVES: Cryoablation offers a treatment option for small renal masses ideally suited ≤3 cm. In well-selected candidates, it is associated with less perioperative morbidity compared to more invasive options, such as partial or radical nephrectomy. However, little is known regarding device-related complications associated with the procedure. We provide an analysis of reports on renal cryoablation from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: Reports on renal cryoablation submitted to the MAUDE database from 2015 through 6/2021 were analyzed. Cases not pertaining to renal cryoablation were excluded (n = 33). Reports were examined to identify patient morbidity related to a potential device malfunction, as well as manufacturer assessment. Complications were graded based on an established MAUDE complication-reporting stratification. Fisher's Exact test was utilized to analyze for associations between device-related adverse events and severity of post-treatment sequelae. RESULTS: Two hundred and thirty-nine unique cases were identified. Adverse events were related to issues with the needles or system (212 cases), technical error (12 cases), or complication related to patient or tumor complexity (14 cases). There were 187 (78.6%) minor complications (MAUDE 1-2) and 52 (21.4%) major complications (MAUDE 3-4). The manufacturer performed formal device review in 164 (68.6%) cases, accepting responsibility for malfunction in 41. Notable MAUDE 3 complications included 29 (12.1%) cases aborted due to instrument/system malfunction and 14 (5.9%) cases of hemorrhage requiring a subsequent procedure. All 3 reported patient deaths (MAUDE 4) appeared to be a consequence of poor baseline health. On statistical analysis, major complications were seen in a significantly higher proportion of non-device related adverse events compared to device related events (85.2% vs. 13.7%, P < .001). CONCLUSION: While renal cryoablation is associated with low overall perioperative morbidity, there is a diverse set of device-related and procedural complications reported in recent years. Device-related adverse events were often associated with minor complications, and major complications were often seen in higher risk patients with comorbidities, more complex tumors, and after technical error. These findings highlight the need for standardized reporting of complications, optimized patient selection and counseling to ensure the best outcomes.

Aquablation, Prostatic Urethral Lift, and Transurethral Water Vapor Therapy: A Comparison of Device-Related Adverse Events in a National Registry.

Purpose: Aquablation, prostatic urethral lift (PUL), and transurethral water vapor therapy (TWVT) have demonstrated efficacy for the treatment of benign prostatic hyperplasia (BPH). Our objective was to describe device malfunctions and complications to help guide procedural selection and performance. Materials and Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was examined for reports related to the use of these three procedures for the treatment of BPH between January 1, 2015, and July 1, 2020. Reports were evaluated for device malfunctions and surgical complications using a previously described externally validated classification system developed for the MAUDE database. Chi square analysis was used for statistical comparison between groups. Results: A total of 391 adverse events were reported: aquablation (n = 102), PUL (n = 132), and TWVT (n = 157). There were 79 (78%) severe or life-threatening adverse events for aquablation vs 69 (52%) for PUL vs 24 (15%) for TWVT (p < 0.001). There were 4 cases of rectal perforation with aquablation and 25 cases of the PUL implants needing to be removed or causing a problem with a later procedure. Blood transfusion frequencies were aquablation-32 (31%), PUL-21 (16%), and TWVT-1 (1%). The most common device malfunctions were: aquablation-motion error (n = 8), handpiece fracture/attachment malfunction (n = 8); PUL-device misfire (n = 27), needle fragmentation (n = 21); TWVT-unresolvable error message (n = 19). Conclusions: In a national database, aquablation and PUL had noteworthy complications or device-related malfunctions such as rectal perforation and the improper placement or failed deployment of the PUL implants. Both patients and providers should be aware of potential risks when selecting these novel BPH treatments.