Publications by authors named "Peter Wiklund"

257 Publications

Neobladder creation in patients with chronic kidney disease: A viable diversion strategy.

Urol Oncol 2022 Jan 14. Epub 2022 Jan 14.

Department of Urologic Surgery, Icahn School of Medicine at Mount Sinai, New York, NY.

Introduction: Renal function impairment is often cited as a contraindication to continent diversion strategies. There is little evidence exploring renal function changes between continent and incontinent surgery in patients with preoperative chronic kidney disease (CKD), in particular CKD3B.

Methods: This was a retrospective review of two high-volume centers performing robotic assisted radical cystectomy (RARC) with orthotopic neobladder (ONB) or ileal conduit (IC) between 2014 to 2020. Patients were stratified based on CKD estimated glomerular filtration (eGFR) stage, which was estimated via the CKD-EPI equation. Postoperative renal function was compared for up to 60 months postoperative. Surgical, post-surgical, complications, and readmission data were gathered and compared between all patients RESULTS: 522 cystectomy patients, 430 with IC and 125 with ONB, were included. eGFR decline was statistically significant in a matched cohort of IC and ONB patients only at 3 months. There were no statistically significant differences between readmission rates, time to readmission, or complications. 34.6% of stage 3B patients had hydronephrosis on imaging prior to surgery, compared to 11.4%, 22.1% and 21.8% of CKD stage 1, 2, and 3A patients. CKD stage 3B had statistically and clinically improved eGFR through 24 months.

Conclusion: ONB surgery may be a viable diversion strategy in patients previously thought to be contraindicated due to low renal function.
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http://dx.doi.org/10.1016/j.urolonc.2021.11.023DOI Listing
January 2022

Functional and Oncological Outcomes of Female Pelvic Organ-preserving Robot-assisted Radical Cystectomy.

Eur Urol Open Sci 2022 Feb 27;36:34-40. Epub 2021 Dec 27.

Department of Urology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA.

Background: For females undergoing cystectomy and urinary diversion, decreases in sexual and urinary functions can have a significant impact on quality of life. Pelvic organ-preserving (POP) radical cystectomy (RC) has been proposed as an approach to improve postoperative functional outcomes.

Objective: To evaluate postoperative functional outcomes of a robotic approach for female POP RC with intracorporeal urinary diversion.

Design Setting And Participants: This was a multicenter retrospective study evaluating sexual, urinary, and oncological outcomes for sexually active females undergoing POP robot-assisted RC for ≤T2 bladder cancer. Exclusion criteria included multifocal, trigonal, or locally advanced tumors.

Surgical Procedure: We describe a step-by-step technique for POP robot-assisted RC with intracorporeal urinary diversion.

Measurements: The primary outcome of the study was evaluation of sexual and urinary functions following surgery. Oncological outcomes were evaluated as a secondary endpoint.

Results And Limitations: Our study included 23 females who underwent POP robot-assisted RC between 2008 and 2020 with intracorporeal neobladder (87%) or ileal conduit (13%) reconstruction. The median follow-up was 20 mo. A postoperative sexual function questionnaire was completed by 15 patients (65%). Of those, 13 (87%) resumed sexual activity at a median of 6 mo after surgery. Of the patients with a neobladder, 14 (70%) achieved daytime continence and 16 (80%) achieved nighttime continence. Cancer-specific and overall survival were both 91%. The results are limited by their retrospective nature.

Conclusions: POP robot-assisted RC with orthotopic neobladder allows a majority of female patients to return to sexual activity after surgery. This approach should be considered for selected sexually active women.

Patient Summary: We evaluated 23 women with bladder cancer who underwent surgical removal of the bladder with preservation of their reproductive organs. Following this surgery, a majority of patients resumed sexual activity. For selected patients, this technique can be performed without compromising cancer control.
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http://dx.doi.org/10.1016/j.euros.2021.11.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8718832PMC
February 2022

Development and External Validation of a Prediction Model to Identify Candidates for Prostate Biopsy.

Urol J 2022 Jan 3. Epub 2022 Jan 3.

Department of Urology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA.

Purpose: Prostate biopsies are associated with infectious complications and approximately 80% are either benign or clinically insignificant prostate cancer. Our aim is to develop and independently validate prediction model to avoid unnecessary prostate biopsies by predicting clinically significant prostate cancer (csPCa) Materials and Methods: Retrospective analysis of single-center cohort (Mount Sinai Hospital, NY) of 1632 men who underwent systematic or combined systematic and Magnetic Resonance Imaging (MRI)/ultrasound fusion targeted prostate biopsy between 2014-2020. External cohort (University of Miami) included 622 men that underwent biopsy. Outcome for predicting csPCa was defined as International Society of Urologic Pathology (ISUP) Gleason grade  ³ 2 on biopsy. Multivariable logistic regression analysis was performed to build nomogram using coefficients of logit function. Nomogram validation was performed in external cohort by plotting receiver operating characteristics (ROC). We also plotted decision curve analysis (DCA) and compared nomogram-predicted probabilities with actual rates of csPCa probabilities in external cohort.     Results: Of 1632 men, 43% showed csPCa on biopsy. PSA density, prior negative biopsy, and Prostate Imaging and Reporting Data System (PI-RADS) scores 3, 4, and 5 were significant predictors for csPCa. ROC for prediction of csPCa was 0.88 in external cohort. There was agreement between predicted and actual rate of csPCa in external cohort. DCA demonstrated net benefit using the model. Using the prediction model at threshold of 30, 35% of biopsies and 46% of diagnosed indolent PCa could be avoided, while missing 5% of csPCa.

Conclusion: Using our prediction model can help reduce unnecessary prostate biopsies with minimal impact on csPCa detection rates.
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http://dx.doi.org/10.22037/uj.v18i.6852DOI Listing
January 2022

Impact of neoadjuvant chemotherapy on survival and recurrence patterns after robot-assisted radical cystectomy for muscle-invasive bladder cancer: Results from the International Robotic Cystectomy Consortium.

Int J Urol 2021 Dec 19. Epub 2021 Dec 19.

Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA.

Objectives: To analyze the impact of neoadjuvant chemotherapy on survival and recurrence patterns in muscle-invasive bladder cancer after robot-assisted radical cystectomy.

Materials And Methods: The International Robotic Cystectomy Consortium database was reviewed to identify patients who underwent robot-assisted radical cystectomy for muscle-invasive bladder cancer between 2002 and 2019. Survival outcomes, response rates, and recurrence patterns were compared between patients who received neoadjuvant chemotherapy and those who did not. Survival distributions were estimated using Kaplan-Meier analyses and compared using the log-rank test.

Results: A total of 1370 patients with muscle-invasive bladder cancer were identified, of whom 353 (26%) received neoadjuvant chemotherapy. After a median follow-up of 27 months, neoadjuvant chemotherapy recipients had higher 3-year overall survival (74% vs 57%; log-rank P < 0.01), 3-year cancer-specific survival (83% vs 73%; log-rank P = 0.03), and 3-year relapse-free survival (64% vs 48%; log-rank P < 0.01). Neoadjuvant chemotherapy was a predictor of higher overall survival, cancer-specific survival, and relapse-free survival in univariate but not multivariate analysis. Pathological downstaging (46% vs 23%; P < 0.01), complete responses (24% vs 8%; P < 0.01), and margin negativity (95% vs 91%; P < 0.01) at robot-assisted radical cystectomy were more common in the neoadjuvant chemotherapy group. Neoadjuvant chemotherapy recipients had lower distant (15% vs 22%; P < 0.01) but similar locoregional (12% vs 13%; P = 0.93) recurrence rates.

Conclusions: In this analysis from a large international database, patients with muscle-invasive bladder cancer who received neoadjuvant chemotherapy before robot-assisted radical cystectomy had higher rates of survival, pathological downstaging, and margin-negative resections. They also experienced fewer distant recurrences.
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http://dx.doi.org/10.1111/iju.14749DOI Listing
December 2021

The Studer Neobladder: An Established and Reproducible Technique for Intracorporeal Urinary Diversion.

Eur Urol Open Sci 2022 Jan 24;35:18-20. Epub 2021 Nov 24.

Department of Urology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA.

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http://dx.doi.org/10.1016/j.euros.2021.09.019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8637466PMC
January 2022

Bladder Cancer (NMIBC) in a population-based cohort from Stockholm County with long-term follow-up; A comparative analysis of prediction models for recurrence and progression, including external validation of the updated 2021 E.A.U. model.

Urol Oncol 2021 Nov 25. Epub 2021 Nov 25.

Department of Urology, Icahn School of Medicine at Mount Sinai, New York, U.S.A.; Department of Urology, Karolinska University Hospital Solna, Sweden.

Introduction: Non muscle invasive bladder cancer (NMIBC) has recurrence and progression rates of approximately 55-75% and 5-45% respectively. After diagnosis, risk stratification guides management decisions regarding surveillance, intravesical therapy or surgery. This prospective cohort of patients from Stockholm County is ideal for external validation of the current risk stratification models used in clinical practice.

Patients & Methods: The cohort consisted of 395 patients diagnosed with bladder cancer across all the hospitals in Stockholm County between the years 1995-96, with up to 25 years follow up. All patients with pathologic Ta or T1 disease were included. Patients with muscle invasive disease (MIBC) referred for radical treatment at diagnosis were excluded. External validation of EORTC, CUETO and updated EAU Sylvester et al. (2021) models was done and multivariate Cox regression analysis was performed to generate hazard ratios for covariables of interest using both WHO '73 and WHO '04/16 pathological grade classifications.

Results: Overall Harrel's C-indices (CIs) for EORTC and CUETO models for recurrence were 0.66 and 0.63 respectively. The CIs for the EORTC, CUETO and EAU Sylvester et al. (2021) WHO '73 and '04/16 models for progression were higher at 0.82, 0.84, 0.83 and 0.83 respectively. All models tended to underestimate both recurrence and progression rates at 1 and 5 yrs. A simplified model devised to include only multifocality, tumor stage, size and grade performed with similar accuracy to all models for both recurrence and progression.

Conclusion: Current risk stratification models are clinically useful but only moderately accurate across different patient populations, and the results of this study suggest a model using fewer variables is of similar accuracy to all models tested. In the future, research into the use of genomic classifiers will hopefully contribute to more accurate, modern risk stratification models.
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http://dx.doi.org/10.1016/j.urolonc.2021.10.008DOI Listing
November 2021

Intracorporeal Versus Extracorporeal Neobladder After Robot-assisted Radical Cystectomy: Results From the International Robotic Cystectomy Consortium.

Urology 2022 Jan 25;159:127-132. Epub 2021 Oct 25.

Department of Urology, Roswell Park Comprehensive Cancer Center, Buffalo, NY. Electronic address:

Objective: To compare perioperative and oncologic outcomes of intracorporeal (ICNB) and extracorporeal neobladder (ECNB) following robot assisted radical cystectomy (RARC) from a multi-institutional, prospectively maintained database, the International Robotic Cystectomy Consortium (IRCC).

Methods: A retrospective review of IRCC database between 2003 and 2020 (3742 patients from 33 institutions across 14 countries) was performed (I-79606). The Cochran-Armitage trend test was used to assess utilization of ICNB over time. Multivariate logistic regression models were fit to evaluate variables associated with receiving ICNB, overall complications, high-grade complications, and readmissions after RARC. Kaplan Meier curves were used to depict recurrence-free, disease-specific, and overall survival.

Results: Four hundred eleven patients received neobladder, 64% underwent ICNB. ICNB utilization increased significantly over time (P <.01). Patients who received ICNB were readmitted and received neoadjuvant chemotherapy more frequently (36% vs 24%, P = .03, 35% vs 8%, P <.01, respectively). ICNB was associated with older age (OR 1.04, 95% CI 1.01-1.07, P = .001), receipt of neoadjuvant chemotherapy (OR 4.63, 95% CI 2.34-9.18, P <.01), and more recent RARC era (2016-2020) (OR 12.6, 95% CI 5.6-28.4, P <.01). On multivariate analysis, ICNB (OR 5.43, 95% CI 2.34-12.58, P <.01), positive surgical margin (OR 4.88, 95% CI 1.29-18.42, P = .019), longer operative times (OR 1.26, 95% CI 1.00-1.58, P = .048), and institutional annual RARC volume (OR 1.09, 95% CI 1.05-1.12, P <.01) were associated with readmissions.

Conclusion: Utilization of ICNB increased significantly over time. Patients who underwent RARC and ICNB had shorter hospital stays and fewer 30-d reoperations but were readmitted more frequently compared to those who underwent ECNB.
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http://dx.doi.org/10.1016/j.urology.2021.10.012DOI Listing
January 2022

The Evolving Clinical Management of Genitourinary Cancers Amid the COVID-19 Pandemic.

Front Oncol 2021 27;11:734963. Epub 2021 Sep 27.

Department of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, United States.

Coronavirus disease-2019 (COVID-19), a disease caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, has become an unprecedented global health emergency, with fatal outcomes among adults of all ages throughout the world. There is a high incidence of infection and mortality among cancer patients with evidence to support that patients diagnosed with cancer and SARS-CoV-2 have an increased likelihood of a poor outcome. Clinically relevant changes imposed as a result of the pandemic, are either primary, due to changes in timing or therapeutic modality; or secondary, due to altered cooperative effects on disease progression or therapeutic outcomes. However, studies on the clinical management of patients with genitourinary cancers during the COVID-19 pandemic are limited and do little to differentiate primary or secondary impacts of COVID-19. Here, we provide a review of the epidemiology and biological consequences of SARS-CoV-2 infection in GU cancer patients as well as the impact of COVID-19 on the diagnosis and management of these patients, and the use and development of novel and innovative diagnostic tests, therapies, and technology. This article also discusses the biomedical advances to control the virus and evolving challenges in the management of prostate, bladder, kidney, testicular, and penile cancers at all stages of the patient journey during the first year of the COVID-19 pandemic.
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http://dx.doi.org/10.3389/fonc.2021.734963DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8504458PMC
September 2021

Potential Contenders for the Leadership in Robotic Surgery.

J Endourol 2021 Oct 26. Epub 2021 Oct 26.

ORSI Academy, Melle, Belgium.

To summarize the scientific published literature on new robotic surgical platforms with potential use in the urological field, reviewing their evolution from presentation until the present day. Our goal is to describe the current characteristics and possible prospects for these platforms. A nonsystematic search of the PubMed, Cochrane library's Central, EMBASE, MEDLINE, and Scopus databases was conducted to identify scientific literature about new robotic platforms other than the Da Vinci system, reviewing their evolution from inception until December 2020. Only English language publications were included. The following keywords were used: "new robotic platforms," "Revo-I robot," "Versius robot," and "Senhance robot." All relevant English-language original studies were analyzed by one author (R.F.) and summarized after discussion with an independent third party (E.M., S.Y., S.P., and M.A.). Since 1995, Intuitive Surgical, Inc., with the Da Vinci surgical system, is the leading company in the robotic surgical market. However, Revo-I, Versius, and Senhance are the other three platforms that recently appeared on the market with available articles published in peer-reviewed journals. Among these three new surgical systems, the Senhance robot has the most substantial scientific proof of its capacity to perform minimally invasive urological surgery and as such, it might become a contender of the Da Vinci robot. The Da Vinci surgical platform has allowed the diffusion of robotic surgery worldwide and showed the different advantages of this type of technique. However, its use has some drawbacks, especially its price. New robotic platforms characterized by unique features are under development. Of note, they might be less expensive compared with the Da Vinci robotic system. We found that these new platforms are still at the beginning of their technical and scientific validation. However, the Senhance robot is in a more advanced stage, with clinical studies supporting its full implementation.
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http://dx.doi.org/10.1089/end.2021.0321DOI Listing
October 2021

Functional and Oncological Outcomes After Open Versus Robot-assisted Laparoscopic Radical Prostatectomy for Localised Prostate Cancer: 8-Year Follow-up.

Eur Urol 2021 11 15;80(5):650-660. Epub 2021 Sep 15.

Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Surgery, Sahlgrenska University Hospital-Västra Götaland/Östra, Gothenburg, Sweden.

Background: Radical prostatectomy reduces mortality among patients with localised prostate cancer. Evidence on whether different surgical techniques can affect mortality rates is lacking.

Objective: To evaluate functional and oncological outcomes 8 yr after robot-assisted laparoscopic prostatectomy (RALP) and open retropubic radical prostatectomy (RRP).

Design, Setting, And Participants: We enrolled 4003 patients in a prospective, controlled, nonrandomised trial comparing RALP and RRP in 14 Swedish centres between 2008 and 2011. Data for functional outcomes were assessed via validated patient questionnaires administered preoperatively and at 12 and 24 mo and 8 yr after surgery.

Outcome Measurements And Statistical Analysis: The primary endpoint was urinary incontinence. Functional outcomes at 8 yr were analysed using the modified Poisson regression approach.

Results And Limitations: Urinary incontinence was not significantly different at 8 yr after surgery between RALP and RRP (27% vs 29%; adjusted risk ratio [aRR] 1.05, 95% confidence interval [CI] 0.90-1.23). Erectile dysfunction was significantly lower in the RALP group (66% vs 70%; aRR 0.93, 95% CI 0.87-0.99). Prostate cancer-specific mortality (PCSM) was significantly lower in the RALP group at 8 yr after surgery (40/2699 vs 25/885; aRR 0.56, 95% CI 0.34-0.93). Differences in oncological outcomes were mainly seen in the group with high D'Amico risk, with a lower risk of positive surgical margins (21% vs 34%), biochemical recurrence (51% vs 69%), and PCSM (14/220 vs 11/77) for RALP versus RRP. The main limitation is the nonrandomised design.

Conclusions: In this prospective multicentre controlled trial, PCSM at 8 yr after surgery was lower for RALP in comparison to RRP. A causal relationship between surgical technique and mortality cannot be inferred, but the result confirms that RALP is oncologically safe. Taken together with better short-term results reported elsewhere, our findings confirm that implementation of RALP may continue.

Patient Summary: Our study comparing two surgical techniques for removal of the prostate for localised prostate cancer shows that a robot-assisted minimally invasive technique is safe in the long term. Together with previous results showing some better short-term effects with this approach, our findings support continued use of robot-assisted surgery.
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http://dx.doi.org/10.1016/j.eururo.2021.07.025DOI Listing
November 2021

Update on robotic cystectomy.

Curr Opin Urol 2021 11;31(6):537-541

Department of Urology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Purpose Of Review: This article aims to discuss recently published (2019-2021) studies on robot-assisted radical cystectomy (RARC) with attention to evidence comparing intracorporeal (ICUD) and extracorporeal urinary diversion (ECUD) in terms of intraoperative and perioperative metrics.

Recent Findings: RARC produces equivalent oncological outcomes compared to open radical cystectomy (ORC). The benefits of RARC are most pronounced perioperatively. ICUD has been increasingly used at centers of excellence as it reduces intestinal exposure, which may incrementally minimize morbidity compared to ECUD or ORC. As the learning curve for ICUD diversion has flattened, retrospective analyses have emerged that suggest this technique may hold benefit over both ORC and RARC with ECUD, though current data is conflicting, and a randomized controlled study is forthcoming.

Summary: ORC is the current 'gold standard' management for muscle-invasive bladder cancer. Based on the premise of the minimization of perioperative morbidity, the development of RARC, most recently with ICUD, seeks to improve patient outcomes. Despite a protracted learning curve, many expert bladder cancer centers have adopted an intracorporeal approach. As more centers adopt, refine, and climb the learning curve for ICUD, a clearer insight of its effect on morbidity will be revealed-informing further adoption of the technique.
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http://dx.doi.org/10.1097/MOU.0000000000000930DOI Listing
November 2021

The impact of discharge location on outcomes following radical cystectomy.

Urol Oncol 2021 Aug 12. Epub 2021 Aug 12.

Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY.

Purpose: Hospital readmission is associated with adverse outcomes and increased cost, and as such, has been identified as a metric for surgical quality and a target for shifts in health policy. However, the disposition of patients who undergo radical cystectomy for bladder cancer and the association between discharge locations and readmission rates is poorly understood. Understanding the patterns and characteristics of readmission after radical cystectomy will help inform discharge planning and expectations and may have long-term impacts on quality and cost of care delivery. We hypothesize that patients will have varying readmission rates based on their discharge location.

Materials And Methods: An observational analysis of the Nationwide Readmissions Database was performed for all patients who underwent elective radical cystectomy in 2016 to 2017. The patients were grouped by the following criteria: whether they were discharged home, home with care, or to a facility. Univariate analysis was performed using the Chi-square test for categorical variables and the Kruskal-Wallis test for continuous variables. A multivariable logistic regression was conducted to evaluate if discharge locations impact patient readmissions at 30- and 90-days.

Results: The final dataset included 4,947 patients discharged home with care, 2,127 patients discharged to home or self-care, and 1,232 patients discharged to a facility. Discharge to a facility was strongly associated with higher 30-day (OR 1.49, CI 1.26-1.76) and 90-day readmission rates (OR 1.46, CI 1.23-1.74). Additionally, home health care was strongly associated with increased 30-day readmission rates (OR 1.22, CI 1.08-1.37) relative to routine discharge home.

Conclusions: Our analysis suggests that discharge location independently predicts readmission following RC. Further study with more granular patient- and system-level data may aid in identifying structural characteristics and processes that can reduce readmissions and their associated economic impact, while maintaining quality of care delivered.
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http://dx.doi.org/10.1016/j.urolonc.2021.07.020DOI Listing
August 2021

Degree of Preservation of Neurovascular Bundles in Radical Prostatectomy and Recurrence of Prostate Cancer.

Eur Urol Open Sci 2021 Aug 19;30:25-33. Epub 2021 Jun 19.

Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Background: Reports on possible benefits for continence with nerve-sparing (NS) radical prostatectomy have expanded the indications beyond preservation of erectile function. It is unclear whether NS surgery affects oncological outcomes.

Objective: To determine whether the degree of NS during radical prostatectomy influences oncological outcomes.

Design Setting And Participants: Of 4003 patients enrolled in a prospective, controlled trial comparing open and robotic radical prostatectomy during 2008-2011, we evaluated 2401 patients who received robotic radical prostatectomy at seven Swedish centres. Patients were followed for 8 yr.

Outcome Measurements And Statistical Analysis: Data for recurrence and positive surgical margin status were assessed using validated patient questionnaires, patient interviews, and clinical record forms before and at 3, 12, and 24 mo and 6 and 8 yr after surgery. Cox and logistic regressions were used to model the effect on recurrence and positive surgical margins (PSM), respectively.

Results And Limitations: A total of 481 men had PSM and 467 experienced recurrence during follow-up. Median follow-up for men without recurrence was 6.6 yr. There were no statistically significant differences in recurrence rate between degrees of NS. The PSM rate was significantly higher with a higher degree of NS: interfascial NS, odds ratio (OR) 2.32 (95% confidence interval [CI] 1.69-3.16); intrafascial NS, OR 3.23 (95% CI 2.17-4.80). Recurrence rates were higher for patients with pT2 disease and PSM (hazard ratio [HR] 3.32, 95% CI 2.43-4.53) than for patients with pT3 disease without PSM (HR 2.08, 95% CI 1.66-2.62). The lack of central review of pathological specimens is a limitation.

Conclusions: A higher degree of NS significantly increased the risk of PSM but did not significantly increase the risk of cancer recurrence. Combined with the known functional benefits of NS surgery, these results underscore the need to identify an individualised balance.

Patient Summary: In this report we looked at the effect of a nerve-sparing approach during removal of the prostate on cancer outcomes for patients having robot-assisted surgery at seven Swedish hospitals. We found that a high degree of nerve-sparing increased the rate of cancer positivity at the margins of surgical specimens and that positive surgical margins increased the risk of recurrence of prostate cancer.
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http://dx.doi.org/10.1016/j.euros.2021.06.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8317882PMC
August 2021

Clinical Utility of Negative Multiparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer and Clinically Significant Prostate Cancer.

Eur Urol Open Sci 2021 Jun 19;28:9-16. Epub 2021 Apr 19.

Department of Urology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA.

Background: Multiparametric magnetic resonance imaging (MRI) is increasingly used to diagnose prostate cancer (PCa). It is not yet established whether all men with negative MRI (Prostate Imaging-Reporting and Data System version 2 score <3) should undergo prostate biopsy or not.

Objective: To develop and validate a prediction model that uses clinical parameters to reduce unnecessary prostate biopsies by predicting PCa and clinically significant PCa (csPCa) for men with negative MRI findings who are at risk of harboring PCa.

Design Setting And Participants: This was a retrospective analysis of 200 men with negative MRI at risk of PCa who underwent prostate biopsy (2014-2020) with prostate-specific antigen (PSA) >4 ng/ml, 4Kscore of >7%, PSA density ≥0.15 ng/ml/cm, and/or suspicious digital rectal examination. The validation cohort included 182 men from another centre (University of Miami) with negative MRI who underwent systematic prostate biopsy with the same criteria.

Outcome Measurements And Statistical Analysis: csPCa was defined as Gleason grade group ≥2 on biopsy. Multivariable logistic regression analysis was performed using coefficients of logit function for predicting PCa and csPCa. Nomogram validation was performed by calculating the area under receiver operating characteristic curves (AUC) and comparing nomogram-predicted probabilities with actual rates of PCa and csPCa.

Results And Limitations: Of 200 men in the development cohort, 18% showed PCa and 8% showed csPCa on biopsy. Of 182 men in the validation cohort, 21% showed PCa and 6% showed csPCa on biopsy. PSA density, 4Kscore, and family history of PCa were significant predictors for PCa and csPCa. The AUC was 0.80 and 0.87 for prediction of PCa and csPCa, respectively. There was agreement between predicted and actual rates of PCa in the validation cohort. Using the prediction model at threshold of 40, 47% of benign biopsies and 15% of indolent PCa cases diagnosed could be avoided, while missing 10% of csPCa cases. The small sample size and number of events are limitations of the study.

Conclusions: Our prediction model can reduce the number of prostate biopsies among men with negative MRI without compromising the detection of csPCa.

Patient Summary: We developed a tool for selection of men with negative MRI (magnetic resonance imaging) findings for prostate cancer who should undergo prostate biopsy. This risk prediction tool safely reduces the number of men who need to undergo the procedure.
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http://dx.doi.org/10.1016/j.euros.2021.03.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8317880PMC
June 2021

Risk of Recurrent Disease 6 Years After Open or Robotic-assisted Radical Prostatectomy in the Prospective Controlled Trial LAPPRO.

Eur Urol Open Sci 2020 Jul 19;20:54-61. Epub 2020 Aug 19.

Department of Urology, Skåne University Hospital, Malmö, Sweden.

Background: Conclusive evidence of superiority in oncological outcome for robot-assisted laparoscopic prostatectomy (RALP) over retropubic radical prostatectomy (RRP) is lacking.

Objective: To compare RALP and RRP regarding recurrent disease and to report the mortality rate 6 yr after surgery.

Design Setting And Participants: A total of 4003 men with localized prostate cancer were enrolled between 2008 and 2011 in Laparoscopic Prostatectomy Robot Open (LAPPRO)- a prospective, controlled, nonrandomized trial performed at 14 Swedish centers.

Outcome Measurements And Statistical Analysis: Data were collected at visits and by patient questionnaires at 3, 12, and 24 mo, and through a structured telephone interview at 6 yr. Cause of death was retrieved from the National Cause of Death Register in Sweden. The modified Poisson regression approach was used for analyses.

Results And Limitations: After adjustment for patient-, tumor-, and surgeon-related confounders, no statistically significant difference was observed between RALP and RRP in biochemical recurrence rate (14 vs 16%, relative risk [RR] 0.77, 95% confidence interval [CI] 0.56-1.06) or in not cured endpoint (22% vs 23%, RR 0.82, 95% CI 0.6-1.11). Stratified by D'Amico risk group, a significant benefit for RALP existed for recurrent disease in high-risk patients (RR 0.47, 95% CI 0.26-0.86,  = 0.02). All-cause mortality was 3% ( = 96). Prostate cancer-specific mortality was 0.6% ( = 21) overall, 0.3% ( = 8) after RALP, and 1.5% ( = 13) after RRP. The nonrandomized design is a limitation.

Conclusions: No significant difference was observed for cancer recurrence rate between RALP and RRP 6 yr after surgery. However, in a subgroup analysis, we found a significant benefit for RALP regarding recurrence rate in the high-risk group. Larger studies with longer follow-up are needed to make a firm conclusion and to evaluate a possible survival benefit.

Patient Summary: In general, the oncological outcome is comparable between robotic and open radical prostatectomy 6 yr after surgery. For high-risk patients, our findings indicate that there is an advantage for robotics, but further studies with longer follow-up time is needed to make a firm conclusion.
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http://dx.doi.org/10.1016/j.euros.2020.06.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8317794PMC
July 2020

Impact of COVID-19 on Prostate Cancer Management: Guidelines for Urologists.

Eur Urol Open Sci 2020 Jul 16;20:1-11. Epub 2020 Jun 16.

Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Context: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has resulted in a global health emergency, the like of which has never been seen before. Prostate cancer (PCa) services across the globe have been on hold due to changing medical and surgical priorities. There is also epidemiological evidence that PCa patients have increased incidence and mortality from SARS-CoV-2 infection due to gender differences, age, and higher propensity for risk factors (eg, respiratory disease, obesity, hypertension, and smoking status).

Objective: To contribute to the emerging body of knowledge on the risks of SARS-CoV-2 infection to PCa patients and, in the face of PCa treatment delays, provide evidence-based recommendations for ongoing management of specific PCa patient groups.

Evidence Acquisition: A literature search was performed using all sources (MEDLINE, EMBASE, ScienceDirect, Cochrane Libraries, and Web of Science) as well as the media to harness emerging data on the SARS-CoV-2 pandemic and its influence on PCa. Eligibility criteria were originality of data and relevance to PCa management. The authors note that during these unprecedented times, retrospective data are constantly being updated from multiple sources globally.

Evidence Synthesis: A total of 72 articles and data sources were found initially. Owing to repetition, lack of originality, or nonrelevance, six articles were rejected, leaving 23 retrospective studies, seven basic science research articles, 15 societal and journal guidelines, and 21 epidemiological data sources, from countries at different stages of SARS-CoV-2 pandemic. These were analyzed qualitatively to produce evidence-based guidelines for the management of PCa patients at different stages of the patient journey, with strategies to reduce the risk of viral spread.

Conclusions: PCa patients may have an increased risk of SARS-CoV-2 infection as well as morbidity and mortality if infected. Once appropriately triaged, and to reduce viral spread, PCa patients can have surveillance by telemedicine, and institute lifestyle changes and social quarantining measures. If risk stratification suggests that treatment should be planned, androgen deprivation therapy can be started, or potentially surgery or radiation therapy is possible on a case-by-case basis.

Patient Summary: Prostate cancer patients can be followed up remotely until the severe acute respiratory syndrome coronavirus 2 pandemic resolves, but higher-risk cases may have treatment expedited to limit any negative impact on prostate cancer outcomes.
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http://dx.doi.org/10.1016/j.euros.2020.05.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7296308PMC
July 2020

Robotic assisted radical cystectomy versus open radical cystectomy: a review of what we do and don't know.

Transl Androl Urol 2021 May;10(5):2209-2215

Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Radical cystectomy (RC) is the gold standard treatment for muscle-invasive and high-risk, noninvasive bladder cancer. Since 2003, robot-assisted radical cystectomy (RARC) has been gaining popularity. Metanalyses show that the primary advantage of RARC is less blood loss and the primary advantage of open radical cystectomy (ORC) is shorter operative times. There do not appear to be significant differences in complications, cancer-related outcomes or survival between the two approaches. Cost analyses comparing RARC and ORC are complicated by the often-ill-defined distinction between the cost to the hospital versus the cost to payors. However, it is likely that for both hospitals and payors, RARC is cost effective at high-volume centers. It is feasible that in the future, increased experience with RARC will lead to improved outcomes and justify the use of RARC over ORC.
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http://dx.doi.org/10.21037/tau.2019.11.32DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8185680PMC
May 2021

Upstaging and Survival Outcomes for Non-Muscle Invasive Bladder Cancer After Radical Cystectomy: Results from the International Robotic Cystectomy Consortium.

J Endourol 2021 Oct;35(10):1541-1547

Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA.

We sought to describe the incidence, risk factors, and survival outcomes associated with pathologic upstaging from non-muscle invasive bladder cancer (NMIBC) to muscle invasive bladder cancer (MIBC) after robot-assisted radical cystectomy (RARC). We reviewed the International Robotic Cystectomy Consortium database between 2004 and 2020. Upstaging was defined as ≥pT or pathologic node positive (pN+) at final pathology analysis from clinical
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http://dx.doi.org/10.1089/end.2021.0013DOI Listing
October 2021

Clinical characteristics and oncological outcomes in negative multiparametric MRI patients undergoing robot-assisted radical prostatectomy.

Prostate 2021 Aug 31;81(11):772-777. Epub 2021 May 31.

Department of Urology, Icahn School of Medicine at Mount Sinai Hospital, New York City, New York, USA.

Background: Efforts are ongoing to try and find ways to reduce the number of unnecessary prostate biopsies without missing clinically significant prostate cancers (csPCa). The utility of multiparametric magnetic resonance imaging (mpMRI) in detecting prostate cancer (PCa) shows promise to be used as triage test for systematic prostate biopsy. Our aim is to Study clinical parameters and oncological outcomes in men with negative mpMRI (nMRI; PI-RADS v2 scores of ≤ 2) who underwent robot-assisted radical prostatectomy (RARP) to evaluate nMRI's practicality as a biopsy triage test.

Methods: Retrospective analysis of 331 men with nMRI who underwent RARP between 2014 and 2020 compared with men with positive mpMRI (pMRI; PI-RADS v2 scores ≥ 3, N = 1770). csPCa was defined as Gleason score ≥ 3 + 4 and biochemical recurrence (BCR) was defined as PSA > 0.2 ng/ml on two occasions. Biopsies were graded with the International Society of Urologic Pathology [ISUP] grade. Descriptive statistics for nMRI and pMRI were performed. Mann-Whitney U test was used for continuous variables and χ for categorical variables. Univariable and multivariable regression analyses were performed.

Results: Univariable analysis shows statistically significant difference (p < .05) between median age (nMRI-61 years vs. pMRI 63 years), race (higher incidence of nMRI in African American men), use of 5-alpha reductase inhibitors (higher rate in nMRI). While incidence rates of family history of PCa, suspicious digital rectal examination (DRE) findings, median PSA levels and 4Kscore, were lower in nMRI versus pMRI. Rates of positive surgical margins and BCR were comparable in nMRI versus pMRI. Biopsy ISUP Grades I and II upgraded by 51% and 12%, respectively in final pathology. African American race and no history of the prior negative biopsy were significant predictors for upgrading.

Conclusion: Men with nMRI pose diagnostic challenges as they tend to be younger patients with lower rates of suspicious DRE findings and lower 4K scores, yet comparable oncological outcomes in csPCa rates, positive surgical margins, and BCR rates.
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http://dx.doi.org/10.1002/pros.24174DOI Listing
August 2021

Impact of the Implementation of the EAU Guidelines Recommendation on Reporting and Grading of Complications in Patients Undergoing Robot-assisted Radical Cystectomy: A Systematic Review.

Eur Urol 2021 08 19;80(2):129-133. Epub 2021 May 19.

University of Southern California Institute of Urology & Catherine and Joseph Aresty Department of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. Electronic address:

In 2012, the European Association of Urology (EAU) Ad Hoc Panel proposed a standardised methodology on reporting and grading complications after urological surgical procedures. The aim of the current study was to assess the impact of this implementation on complications reporting for patients undergoing robot-assisted radical cystectomy (RARC). A systematic review of all English-language original articles published on RARC until March 2020 was performed using PubMed, Scopus, and Web of Science databases. The study selection process followed the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) criteria. The quality of reporting and grading complication was evaluated according to the EAU recommendations. Our analysis failed to observe a statistically significant improvement in reporting outcomes after the EAU guidelines recommendations except for three of the 14 criteria proposed (ie, follow-up duration, utilisation of a severity grade system, and risk factors included in the analyses). A lower statistically significant adherence to outcome reporting in terms of inclusion of readmissions and causes (p = 0.02), was observed. PATIENT SUMMARY: In this study, we evaluated the impact of the proposed European Association of Urology (EAU) standardised reporting tool for urological complications, in patients treated with robot-assisted radical cystectomy. A low adherence to EAU guidelines recommendations for complications reporting was observed.
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http://dx.doi.org/10.1016/j.eururo.2021.04.030DOI Listing
August 2021

Increased Hospitalization and Mortality from COVID-19 in Prostate Cancer Patients.

Cancers (Basel) 2021 Apr 1;13(7). Epub 2021 Apr 1.

Department of Urology and The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.

Background: Cancer patients with COVID-19 have a poor disease course. Among tumor types, prostate cancer and COVID-19 share several risk factors, and the interaction of prostate cancer and COVID-19 is purported to have an adverse outcome.

Methods: This was a single-institution retrospective study on 286,609 patients who underwent the COVID-19 test at Mount Sinai Hospital system from March 2020 to December 2020. Chi-square/Fisher's exact tests were used to summarize baseline characteristics of categorical data, and Mann-Whitney U test was used for continuous variables. Univariable logistic regression analysis to compare the hospitalization and mortality rates and the strength of association was obtained by the odds ratio and confidence interval.

Results: This study aimed to compare hospitalization and mortality rates between men with COVID-19 and prostate cancer and those who were COVID-19-positive with non-prostate genitourinary malignancy or any solid cancer, and with breast cancer patients. We also compared our studies to others that reported the incidence and severity of COVID-19 in prostate cancer patients. Our studies highlight that patients with prostate cancer had higher susceptibility to COVID-19-related pathogenesis, resulting in higher mortality and hospitalization rates. Hospitalization and mortality rates were higher in prostate cancer patients with COVID-19 when compared with COVID-19 patients with non-prostate genitourinary (GU) malignancies.
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http://dx.doi.org/10.3390/cancers13071630DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8037308PMC
April 2021

Myeloid Cell-associated Resistance to PD-1/PD-L1 Blockade in Urothelial Cancer Revealed Through Bulk and Single-cell RNA Sequencing.

Clin Cancer Res 2021 08 9;27(15):4287-4300. Epub 2021 Apr 9.

Division of Hematology Oncology, Department of Medicine, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, New York.

Purpose: To define dominant molecular and cellular features associated with PD-1/PD-L1 blockade resistance in metastatic urothelial cancer.

Experimental Design: We pursued an unbiased approach using bulk RNA sequencing data from two clinical trials to discover (IMvigor 210) and validate (CheckMate 275) pretreatment molecular features associated with resistance to PD-1/PD-L1 blockade in metastatic urothelial cancer. We then generated single-cell RNA sequencing (scRNA-seq) data from muscle-invasive bladder cancer specimens to dissect the cellular composition underlying the identified gene signatures.

Results: We identified an adaptive immune response gene signature associated with response and a protumorigenic inflammation gene signature associated with resistance to PD-1/PD-L1 blockade. The adaptive immune response:protumorigenic inflammation signature expression ratio, coined the 2IR score, best correlated with clinical outcomes, and was externally validated. Mapping these bulk gene signatures onto scRNA-seq data uncovered their underlying cellular diversity, with prominent expression of the protumorigenic inflammation signature by myeloid phagocytic cells. However, heterogeneity in expression of adaptive immune and protumorigenic inflammation genes was observed among single myeloid phagocytic cells, quantified as the myeloid single cell immune:protumorigenic inflammation ratio (M2IR) score. Single myeloid phagocytic cells with low M2IR scores demonstrated upregulation of proinflammatory cytokines/chemokines and downregulation of antigen presentation genes, were unrelated to M1 versus M2 polarization, and were enriched in pretreatment blood samples from patients with PD-L1 blockade-resistant metastatic urothelial cancer.

Conclusions: The balance of adaptive immunity and protumorigenic inflammation in individual tumor microenvironments is associated with PD-1/PD-L1 resistance in urothelial cancer with the latter linked to a proinflammatory cellular state of myeloid phagocytic cells detectable in tumor and blood..
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http://dx.doi.org/10.1158/1078-0432.CCR-20-4574DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8338756PMC
August 2021

Urinary continence recovery and oncological outcomes after surgery for prostate cancer analysed by risk category: results from the LAParoscopic prostatectomy robot and open trial.

World J Urol 2021 Sep 20;39(9):3239-3249. Epub 2021 Mar 20.

Department of Molecular Medicine, Surgery and Pelvic Cancer, Karolinska Institutet, Karolinska University Hospital, 17176, Stockholm, Sweden.

Purpose: To evaluate urinary continence (UC) recovery and oncological outcomes in different risk-groups after robot-assisted radical prostatectomy (RALP) and open retropubic radical prostatectomy (RRP).

Patients And Methods: We analysed 2650 men with prostate cancer from seven open (n = 805) and seven robotic (n = 1845) Swedish centres between 2008 and 2011 in a prospective non-randomised trial, LAPPRO. UC recovery was defined as change of pads less than once in 24 h. Information was collected through validated questionnaires. Rate of positive surgical margins (PSM) and biochemical recurrence (BCR), defined as prostate-specific antigen (PSA) > 0.25 mg/ml, were recorded. We stratified patients into two risk groups (low-intermediate and high risk) based on the D'Amico risk classification system.

Result: Among men with high-risk prostate cancer, we found significantly higher rates of UC recovery up to 24 months after RRP compared to RALP (66.1% vs 60.5%) RR 0.85 (CI 95% 0.73-0.99) while PSM was more frequent after RRP compared to RALP (46.8% vs 23.5%) RR 1.56 (CI 95% 1.10-2.21). In the same group no significant difference was seen in BCR. Overall, however, BCR was significantly more common after RRP compared to RALP at 24 months (9.8% vs 6.6%) RR 1.43 (Cl 95% 1.08-1.89). The limitations of this study are its non-randomized design and the relatively short time of follow-up.

Conclusions: Our study indicates that men with high-risk tumour operated with open surgery had better urinary continence recovery but with a higher risk of PSM than after robotic-assisted laparoscopic surgery. No significant difference was seen in biochemical recurrence.  TRIAL REGISTRATION: ISRCTN06393679.
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http://dx.doi.org/10.1007/s00345-021-03662-0DOI Listing
September 2021

A 4K score/MRI-based nomogram for predicting prostate cancer, clinically significant prostate cancer, and unfavorable prostate cancer.

Cancer Rep (Hoboken) 2021 08 4;4(4):e1357. Epub 2021 Mar 4.

Department of Urology, Icahn School of Medicine at Mount Sinai Hospital, New York, New York, USA.

Background: The detection of prostate cancer requires histological confirmation in biopsy core. Currently, number of unnecessary prostate biopsies are being performed in the United States. This is due to the absence of appropriate biopsy decision-making protocol.

Aim: To develop and validate a 4K score/multiparametric magnetic resonance imaging (mpMRI)-based nomogram to predict prostate cancer (PCa), clinically significant prostate cancer (csPCa), and unfavorable prostate cancer (uPCa).

Methods And Results: Retrospective, single-center study evaluating a cohort of 574 men with 4K score test >7% or suspicious digital rectal examination (DRE) or Prostate Imaging Reporting and Data System (PI-RADS) scores 3, 4, or 5 on mpMRI that underwent systematic and/or mpMRI/ultrasound fusion-targeted prostate biopsy between 2016 and 2020. External cohort included 622 men. csPCa and uPCa were defined as Gleason score ≥3 + 4 and ≥4 + 3 on biopsy, respectively. Multivariable logistic regression analysis was performed to build nomogram for predicting PCa, csPCa, and uPCa. Validation was performed by plotting the area under the curve (AUC) and comparing nomogram-predicted probabilities with actual rates of PCa, csPCa, and uPCa probabilities in the external cohort. 4K score, a PI-RADS ≥4, prostate volume and prior negative biopsy were significant predictors of PCa, csPCa, and uPCa. AUCs were 0.84, 0.88, and 0.86 for the prediction of PCa, csPCa, and uPCa, respectively. The predicted and actual rates of PCa, csPCa, and uPCa showed agreement across all percentage probability ranges in the validation cohort. Using the prediction model at threshold of 30, 30% of overall biopsies, 41% of benign biopsies, and 19% of diagnosed indolent PCa could be avoided, while missing 9% of csPCa.

Conclusion: This novel nomogram would reduce unnecessary prostate biopsies and decrease detection of clinically insignificant PCa.
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http://dx.doi.org/10.1002/cnr2.1357DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8388161PMC
August 2021

Implementation of a nonopioid protocol following robot-assisted radical cystectomy with intracorporeal urinary diversion.

Urol Oncol 2021 07 23;39(7):436.e9-436.e16. Epub 2021 Jan 23.

Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY.

Purpose: The implementation of robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) for management of patients with muscle-invasive or high-risk noninvasive bladder cancer has increased in utilization over the last decade. Here, we seek to describe institutional opioid prescription and utilization patterns following implementation of a nonopioid (NOP) perioperative pain management protocol in patients who received RARC with ICUD.

Materials And Methods: The records of all patients who underwent RARC that utilized a NOP perioperative pain management protocol at a single academic institution from 2016 to 2020 were retrospectively reviewed. Descriptive statistical analyses were performed. For comparison, we included 74 consecutive patients who received the same NOP protocol with extracorporeal urinary diversion (ECUD).

Results: A total of 116 patients who received ICUD were included in our analysis. The median operation time for the ICUD group was 305 minutes (interquartile range [IQR]: 262-352). 12.1% (n = 14) of patients who underwent ICUD required narcotics during inpatient hospitalization. For these patients, the median morphine milligram equivalent requirement was 52.0 (IQR: 7.62-157). Additionally, only 12.1% (n = 14) of patients were prescribed opioids postoperatively at discharge. We identified that within 6 months of surgery only 5 (4.3%) patients required a second narcotic prescription. Furthermore, of patients who did not use mu-opioid blockers, a minority experienced postoperative ileus (15.7%, n = 16). 30- and 90-day all Clavien complication rates for patients were 44.8% (n = 52) and 49.1% (n = 57), respectively. Nineteen (16.4%) patients were readmitted within 30 days of discharge, of which none were pain related. When compared to ECUD, patients who received ICUD experienced similar complication and readmission rates.

Conclusions: The implementation of a NOP protocol for patients undergoing RARC with ICUD allows for both decreased postoperative narcotic use and reduced need for narcotic prescriptions at discharge with acceptable complication and readmission rates.
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http://dx.doi.org/10.1016/j.urolonc.2021.01.002DOI Listing
July 2021

Definition of a Structured Training Curriculum for Robot-assisted Radical Cystectomy with Intracorporeal Ileal Conduit in Male Patients: A Delphi Consensus Study Led by the ERUS Educational Board.

Eur Urol Focus 2021 Jan 2. Epub 2021 Jan 2.

ORSI, Academy, Melle, Belgium; Department of Urology, Onze Lieve Vrouw Hospital, Aalst, Belgium.

Robot-assisted radical cystectomy (RARC) continues to expand, and several surgeons start training for this complex procedure. This calls for the development of a structured training program, with the aim to improve patient safety during RARC learning curve. A modified Delphi consensus process was started to develop the curriculum structure. An online survey based on the available evidence was delivered to a panel of 28 experts in the field of RARC, selected according to surgical and research experience, and expertise in running training courses. Consensus was defined as ≥80% agreement between the responders. Overall, 96.4% experts completed the survey. The structure of the RARC curriculum was defined as follows: (1) theoretical training; (2) preclinical simulation-based training: 5-d simulation-based activity, using models with increasing complexity (ie, virtual reality, and dry- and wet-laboratory exercises), and nontechnical skills training session; (3) clinical training: modular console activity of at least 6 mo at the host center (a RARC case was divided into 11 steps and steps of similar complexity were grouped into five modules); and (4) final evaluation: blind review of a video-recorded RARC case. This structured training pathway will guide a starting surgeon from the first steps of RARC toward independent completion of a full procedure. Clinical implementation is urgently needed. PATIENT SUMMARY: Robot-assisted radical cystectomy (RARC) is a complex procedure. The first structured training program for RARC was developed with the goal of aiding surgeons to overcome the learning curve of this procedure, improving patients' safety at the same time.
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http://dx.doi.org/10.1016/j.euf.2020.12.015DOI Listing
January 2021

Objective assessment of intraoperative skills for robot-assisted radical prostatectomy (RARP): results from the ERUS Scientific and Educational Working Groups Metrics Initiative.

BJU Int 2021 07 20;128(1):103-111. Epub 2020 Dec 20.

Orsi Academy, Melle, Belgium.

Objective: To develop and seek consensus from procedure experts on the metrics that best characterise a reference robot-assisted radical prostatectomy (RARP) and determine if the metrics distinguished between the objectively assessed RARP performance of experienced and novice urologists, as identifying objective performance metrics for surgical training in robotic surgery is imperative for patient safety.

Materials And Methods: In Study 1, the metrics, i.e. 12 phases of the procedure, 81 steps, 245 errors and 110 critical errors for a reference RARP were developed and then presented to an international Delphi panel of 19 experienced urologists. In Study 2, 12 very experienced surgeons (VES) who had performed >500 RARPs and 12 novice urology surgeons performed a RARP, which was video recorded and assessed by two experienced urologists blinded as to subject and group. Percentage agreement between experienced urologists for the Delphi meeting and Mann-Whitney U- and Kruskal-Wallis tests were used for construct validation of the newly identified RARP metrics.

Results: At the Delphi panel, consensus was reached on the appropriateness of the metrics for a reference RARP. In Study 2, the results showed that the VES performed ~4% more procedure steps and made 72% fewer procedure errors than the novices (P = 0.027). Phases VIIa and VIIb (i.e. neurovascular bundle dissection) best discriminated between the VES and novices.

Limitations: VES whose performance was in the bottom half of their group demonstrated considerable error variability and made five-times as many errors as the other half of the group (P = 0.006).

Conclusions: The international Delphi panel reached high-level consensus on the RARP metrics that reliably distinguished between the objectively scored procedure performance of VES and novices. Reliable and valid performance metrics of RARP are imperative for effective and quality assured surgical training.
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http://dx.doi.org/10.1111/bju.15311DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8359192PMC
July 2021

Predicting morbidity and mortality after radical cystectomy using risk calculators: A comprehensive review of the literature.

Urol Oncol 2021 02 19;39(2):109-120. Epub 2020 Nov 19.

Department of Urology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY. Electronic address:

Introduction: Radical cystectomy (RC) with urinary diversion is associated with significant perioperative morbidity and mortality, varying between 30% and 70% and between 0.3% and 10.6%, respectively. Risk calculators have been extensively studied in the general surgery literature to predict 30- and 90-day postoperative morbidity and mortality but have not been widely accepted in the RC literature.

Materials And Methods: We performed a search of MEDLINE and Embase databases during May 2020 to identify all relevant studies using the following keywords: radical cystectomy, surgical complication predictive model, surgical complication predictive equation, surgical complication predictive nomogram, surgical risk calculator, morbidity, and mortality. We determined the existing surgical predictive nomograms, calculators, and indices and their accuracy in predicting morbidity, mortality, and major complications after RC.

Results: National Surgical Quality Improvement Program had poor accuracy at predicting 30-day morbidity at mortality (AUC 0.5-0.6). LACE index showed good discrimination at predicting 90-day mortality (AUC 0.7). The various frailty and sarcopenia indices have shown poor to fair accuracy at predicting (AUC 0.5-0.7). The Isbarn and Aziz nomograms have equivalent accuracy at predicting 90-day mortality (AUC 0.7) but are limited by inclusion of tumor histology and presence of metastatic disease as variables. POSSUM and P-POSSUM have poor ability at predicting morbidity and mortality (AUC 0.5) and are cumbersome calculators. The surgical Apgar score has been able to predict 30-day morbidity and mortality but can only be used in the postoperative setting.

Discussion: The currently available surgical risk calculators have either poor accuracy at predicting post-RC morbidity and mortality or are limited by types of variables included. An ideal risk calculator would be comprised of preoperative factors only and have a high accuracy to serve as a tool for preoperative patient counseling prior to surgery.

Conclusion: There exists a strong need to develop a comprehensive and accurate preoperative risk calculator that predicts morbidity and mortality after RC.
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http://dx.doi.org/10.1016/j.urolonc.2020.09.032DOI Listing
February 2021
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