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Background Multiparametric MRI can help identify clinically significant prostate cancer (csPCa) (Gleason score ≥7) but is limited by reader experience and interobserver variability. In contrast, deep learning (DL) produces deterministic outputs. Purpose To develop a DL model to predict the presence of csPCa by using patient-level labels without information about tumor location and to compare its performance with that of radiologists. Materials and Methods Data from patients without known csPCa who underwent MRI from January 2017 to December 2019 at one of multiple sites of a single academic institution were retrospectively reviewed. A convolutional neural network was trained to predict csPCa from T2-weighted images, diffusion-weighted images, apparent diffusion coefficient maps, and T1-weighted contrast-enhanced images. The reference standard was pathologic diagnosis. Radiologist performance was evaluated as follows: Radiology reports were used for the internal test set, and four radiologists' PI-RADS ratings were used for the external (ProstateX) test set. The performance was compared using areas under the receiver operating characteristic curves (AUCs) and the DeLong test. Gradient-weighted class activation maps (Grad-CAMs) were used to show tumor localization. Results Among 5735 examinations in 5215 patients (mean age, 66 years ± 8 [SD]; all male), 1514 examinations (1454 patients) showed csPCa. In the internal test set (400 examinations), the AUC was 0.89 and 0.89 for the DL classifier and radiologists, respectively (P = .88). In the external test set (204 examinations), the AUC was 0.86 and 0.84 for the DL classifier and radiologists, respectively (P = .68). DL classifier plus radiologists had an AUC of 0.89 (P < .001). Grad-CAMs demonstrated activation over the csPCa lesion in 35 of 38 and 56 of 58 true-positive examinations in internal and external test sets, respectively. Conclusion The performance of a DL model was not different from that of radiologists in the detection of csPCa at MRI, and Grad-CAMs localized the tumor. © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Johnson and Chandarana in this issue.
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Aprendizaje Profundo , Imagen por Resonancia Magnética , Neoplasias de la Próstata , Masculino , Humanos , Neoplasias de la Próstata/diagnóstico por imagen , Estudios Retrospectivos , Anciano , Persona de Mediana Edad , Imagen por Resonancia Magnética/métodos , Interpretación de Imagen Asistida por Computador/métodos , Imágenes de Resonancia Magnética Multiparamétrica/métodos , Próstata/diagnóstico por imagen , Próstata/patologíaRESUMEN
BACKGROUND: Postoperative stress urinary incontinence (SUI) after Holmium Laser Enucleation of the Prostate (HoLEP) has improved with the early apical release (EAR) technique. However, some patients develop SUI despite using EAR HoLEP. The aim of this study is to investigate whether a novel classification of the external sphincter is correlated with postoperative SUI. METHODS: The data of 98 patients who underwent EAR HoLEP for benign prostatic hyperplasia were prospectively analyzed. We propose a novel endoscopic classification of external sphincter appearance after HoLEP graded from 0 (best preserved) to 3 (most degraded). Patients were followed for 6 months postoperatively and administered validated questionnaires. A logistic regression was performed to compare moderate SUI rates at sphincter grade 3, controlling for age, obesity, catheter dependency and grams resected at 6 weeks and 3 months. RESULTS: The sphincter grades included 6 grade 0, 47 grade 1, 30 grade 2, and 15 grade 3. Patients were divided into a group without SUI (n= 51), and a group with SUI (n=47) at 6 weeks postoperatively by International Consultation on Incontinence Questionnaire (ICIQ). Patients with reported SUI on ICIQ were more likely to have sphincter grades > 2 at 6 weeks (p= 0.001) and 3 months (p< 0.0001). At 6 months, persistent SUI was associated with sphincter grade 3 (p< 0.0001). Logistic regression demonstrated that sphincter grade 3 was associated with clinically significant SUI at 3 months (p <0.01) Conclusions: Lower sphincter grades are associated with improved return of continence after EAR HoLEP.
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OBJECTIVE: To evaluate the relationship between patient complexity, practice setting, and surgeon reimbursement for ureteroscopy and percutaneous nephrolithotomy (PCNL). METHODS: The "2021 Medicare Physician and Other Provider" file was used to collect Rural-Urban Commuting Area (RUCA) codes and hierarchical condition category (HCC) scores of urologists. Higher HCC score corresponds to higher medical complexity and higher RUCA code corresponds to a more rural area. Medicare reimbursement for ureteroscopy and PCNL were collected. Linear regressions were performed to predict change in reimbursement based on RUCA and HCC scores. RESULTS: In 2021, 52,816 procedures under Current Procedural Terminology (CPT) code 52356 (ureteroscopy) and 1649 procedures under 50080 or 50081 (PCNL) were billed to Medicare. Mean reimbursement was $338.24 for ureteroscopy and $957.89 for PCNL. For ureteroscopy, higher HCC score predicted lower reimbursement (P <.001). Higher HCC score predicted higher reimbursement for PCNL (P <.01). Average RUCA for ureteroscopy was higher than for PCNL (P = .02). Rural location predicted lower reimbursement for ureteroscopy (P <.001), however, there was no association for PCNL. CONCLUSION: For ureteroscopy, higher-risk patients are associated with lower reimbursement while the opposite holds true for PCNL. Rural practices were associated with lower reimbursement for ureteroscopy, but there was no association between location and PCNL reimbursement. Together, these findings suggest practice pattern variation between ureteroscopy and PCNL and highlight gaps in reimbursement policy. Risk-adjusted reimbursement should be considered to incentivize urologists to treat complex patients within their practice scope.
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OBJECTIVES: To develop an automated pipeline for extracting prostate cancer-related information from clinical notes. MATERIALS AND METHODS: This retrospective study included 23,225 patients who underwent prostate MRI between 2017 and 2022. Cancer risk factors (family history of cancer and digital rectal exam findings), pre-MRI prostate pathology, and treatment history of prostate cancer were extracted from free-text clinical notes in English as binary or multi-class classification tasks. Any sentence containing pre-defined keywords was extracted from clinical notes within one year before the MRI. After manually creating sentence-level datasets with ground truth, Bidirectional Encoder Representations from Transformers (BERT)-based sentence-level models were fine-tuned using the extracted sentence as input and the category as output. The patient-level output was determined by compilation of multiple sentence-level outputs using tree-based models. Sentence-level classification performance was evaluated using the area under the receiver operating characteristic curve (AUC) on 15% of the sentence-level dataset (sentence-level test set). The patient-level classification performance was evaluated on the patient-level test set created by radiologists by reviewing the clinical notes of 603 patients. Accuracy and sensitivity were compared between the pipeline and radiologists. RESULTS: Sentence-level AUCs were ≥ 0.94. The pipeline showed higher patient-level sensitivity for extracting cancer risk factors (e.g., family history of prostate cancer, 96.5% vs. 77.9%, p < 0.001), but lower accuracy in classifying pre-MRI prostate pathology (92.5% vs. 95.9%, p = 0.002) and treatment history of prostate cancer (95.5% vs. 97.7%, p = 0.03) than radiologists, respectively. CONCLUSION: The proposed pipeline showed promising performance, especially for extracting cancer risk factors from patient's clinical notes. CLINICAL RELEVANCE STATEMENT: The natural language processing pipeline showed a higher sensitivity for extracting prostate cancer risk factors than radiologists and may help efficiently gather relevant text information when interpreting prostate MRI. KEY POINTS: When interpreting prostate MRI, it is necessary to extract prostate cancer-related information from clinical notes. This pipeline extracted the presence of prostate cancer risk factors with higher sensitivity than radiologists. Natural language processing may help radiologists efficiently gather relevant prostate cancer-related text information.
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OBJECTIVE: To investigate the difference in postoperative incontinence and quality of life comparing standard vs early apical release (EAR) Holmium Laser Enucleation of the Prostate (HoLEP). METHODS: A retrospective review was performed to identify patients who underwent HoLEP from December 2021 to December 2022 at a single tertiary referral center with two participating consultant urologists. Patients were assessed with questionnaires and evaluated clinically. We performed propensity score matching with a logistic regression and a 1:1 matching method. A propensity score-adjusted logistic regression (PSRM) was performed to compare the pads per day between surgical techniques controlling for age, prostate size, preoperative survey data, uroflow, and postvoid residual. RESULTS: One hundred fourteen patients underwent HoLEP, of which 60 patients were treated with EAR and 54 patients with standard technique. EAR technique demonstrated shorter operative times (P = .046). The EAR cohort demonstrated improved AUASS (P = .034, P = .001), QOL (P = .001, P <.001), and continence rates (P <.001, P <.001) at 6 and 12weeks postoperatively. PSRM showed that the standard HoLEP increased the risk of requiring ≥2 pads per day 4.2x (P = .031, HR 95%, CI=1.16, 15.35) and 8.3x (P <.001, HR 95% CI 3.17, 21.6) at 6 and 12weeks postoperatively. CONCLUSION: EAR technique promoted earlier return of continence and improved quality of life within 6weeks of surgery.
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Láseres de Estado Sólido , Complicaciones Posoperatorias , Prostatectomía , Hiperplasia Prostática , Calidad de Vida , Incontinencia Urinaria , Humanos , Masculino , Láseres de Estado Sólido/uso terapéutico , Estudios Retrospectivos , Anciano , Hiperplasia Prostática/cirugía , Hiperplasia Prostática/complicaciones , Prostatectomía/métodos , Prostatectomía/efectos adversos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Persona de Mediana Edad , Incontinencia Urinaria/cirugía , Incontinencia Urinaria/etiología , Incontinencia Urinaria/prevención & control , Terapia por Láser/métodosRESUMEN
PURPOSE: The Manufacturer and User Facility Device Experience database contains anonymous, voluntary medical device reports. A review of device-related adverse events associated with Benign Prostatic Hyperplasia surgeries was completed. The objective was to evaluate the occurrence and contributing factors to clinically significant complications in a cohort of patients electing to undergo surgical intervention for Benign Prostatic Hyperplasia. METHODS: The Manufacturer and User Facility Device Experience database was queried for "Aquablation, Greenlight Laser, Holmium Laser, Morcellator, Water Vapor Thermal Therapy, Loop Resection, and Prostatic Urethral Lift" from 2018 through 2021. A complication classification system (Level I-IV) based on the Clavien-Dindo system was used to categorize events. These events were then correlated with procedural technology malfunctions and classified as "device related" and "non-device related." Chi squared analysis was performed to identify associations between procedural technology and complication classification distribution. RESULTS: A total of 873 adverse events were identified. The adverse events were classified into level I (minimal harm) versus levels II-IV (clinically significant). Aquablation (p < 0.017) and Water Vapor Thermal Therapy (p < 0.012) were associated with a higher proportion of reports with Level II-IV complications compared with other procedure types. Level II-IV complications were not associated with a reported device related malfunction. CONCLUSIONS: Aquablation and water vapor thermal therapy demonstrated noteworthy clinically significant complications which were not driven by device-related malfunctions.
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Bases de Datos Factuales , Hiperplasia Prostática , Hiperplasia Prostática/cirugía , Humanos , Masculino , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Prostatectomía/efectos adversos , Prostatectomía/métodos , Procedimientos Quirúrgicos Urológicos Masculinos/métodos , Procedimientos Quirúrgicos Urológicos Masculinos/efectos adversos , Complicaciones Intraoperatorias/etiología , Complicaciones Intraoperatorias/epidemiologíaRESUMEN
OBJECTIVE: To characterize the impact of nephrolithiasis diagnosis and treatment on health care utilization and identify predictors of barriers to care in the patient population. METHODS: We conducted a retrospective cohort study using the All of Us Database, a National Institutes of Health database targeting recruitment of underrepresented populations. Patients with a diagnosis of kidney stones were included and matched to a control group. Primary outcomes were patients' self-reported health care access and utilization. Univariable and multivariable regression analyses were performed. RESULTS: 9173 patients with a diagnosis of nephrolithiasis were included and matched to 9173 controls without a diagnosis of nephrolithiasis. Patients with kidney stones were less likely to have had >1 year since last provider visit (1.7% vs 3.8%, P <.001), but did not report increased delays obtaining care (31%), inability to afford care (11.4%), or higher likelihood of skipping medications (12.9%). Among patients with stones, 1208 (13.2%) had been treated surgically. On multivariable analysis, younger age, female sex, lower income, lower education, non-insured status, and lower physical and mental health were all associated with delays obtaining care, difficulty affording care, skipping medications, and/or prolonged time since seeing a provider. CONCLUSION: A diagnosis of nephrolithiasis and subsequent surgical intervention were not associated with an increase in patient-reported barriers to care. However, among patients with nephrolithiasis, younger, comorbid, female patients from lower socioeconomic status are at significant risk of being unable to access and utilize treatment.
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Accesibilidad a los Servicios de Salud , Nefrolitiasis , Aceptación de la Atención de Salud , Humanos , Masculino , Femenino , Estudios Retrospectivos , Persona de Mediana Edad , Nefrolitiasis/terapia , Nefrolitiasis/epidemiología , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Aceptación de la Atención de Salud/estadística & datos numéricos , Adulto , Estados Unidos , Anciano , Estudios de CohortesRESUMEN
PURPOSE: The aim of this study was to evaluate the utility of cancer detection rate (CDR) and abnormal interpretation rate (AIR) in prostate MRI for patients with low-grade prostate cancer (PCa). METHODS: This three-center retrospective study included patients who underwent prostate MRI from 2017 to 2021 with known low-grade PCa (Gleason score 6) without prior treatment. Patient-level highest Prostate Imaging Reporting & Data System (PI-RADS®) score and pathologic diagnosis within 1 year after MRI were used to evaluate the diagnostic performance of prostate MRI in detecting clinically significant PCa (csPCa; Gleason score ≥ 7). The metrics AIR, CDR, and CDR adjusted for pathologic confirmation rate were calculated. Radiologist-level AIR-CDR plots were shown. Simulation AIR-CDR lines were created to assess the effects of different diagnostic performances of prostate MRI and the prevalence of csPCa. RESULTS: A total of 3,207 examinations were interpreted by 33 radiologists. Overall AIR, CDR, and CDR adjusted for pathologic confirmation rate at PI-RADS 3 to 5 (PI-RADS 4 and 5) were 51.7% (36.5%), 22.1% (18.8%), and 30.7% (24.6%), respectively. Radiologist-level AIR and CDR at PI-RADS 3 to 5 (PI-RADS 4 and 5) were in the 36.8% to 75.6% (21.9%-57.5%) range and the 16.3%-28.7% (10.9%-26.5%) range, respectively. In the simulation, changing parameters of diagnostic performance or csPCa prevalence shifted the AIR-CDR line. CONCLUSIONS: The authors propose CDR and AIR as performance metrics in prostate MRI and report reference performance values in patients with known low-grade PCa. There was variability in radiologist-level AIR and CDR. Combined use of AIR and CDR could provide meaningful feedback for radiologists to improve their performance by showing relative performance to other radiologists.
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Próstata , Neoplasias de la Próstata , Masculino , Humanos , Próstata/patología , Neoplasias de la Próstata/patología , Estudios Retrospectivos , Imagen por Resonancia Magnética/métodos , Clasificación del TumorRESUMEN
PURPOSE: To report cancer detection rate (CDR) and abnormal interpretation rate (AIR) in prostate MRI performed for clinical suspicion of prostate cancer (PCa). MATERIALS AND METHODS: This retrospective single-institution, three-center study included patients who underwent MRI for clinical suspicion of PCa between 2017 and 2021. Patients with known PCa were excluded. Patient-level Prostate Imaging-Reporting and Data System (PI-RADS) score was extracted from the radiology report. AIR was defined as number of abnormal MRI (PI-RADS score 3-5) / total number of MRIs. CDR was defined as number of clinically significant PCa (csPCa: Gleason score ≥7) detected at abnormal MRI / total number of MRI. AIR, CDR, and CDR adjusted for pathology confirmation rate were calculated for each of three centers and pre-MRI biopsy status (biopsy-naive and previous negative biopsy). RESULTS: A total of 9,686 examinations (8,643 unique patients) were included. AIR, CDR, and CDR adjusted for pathology confirmation rate were 45.4%, 23.8%, and 27.6% for center I; 47.2%, 20.0%, and 22.8% for center II; and 42.3%, 27.2%, and 30.1% for center III, respectively. Pathology confirmation rate ranged from 81.6% to 88.0% across three centers. AIR and CDR for biopsy-naive patients were 45.5% to 52.6% and 24.2% to 33.5% across three centers, respectively, and those for previous negative biopsy were 27.2% to 39.8% and 11.7% to 14.2% across three centers, respectively. CONCLUSION: We reported CDR and AIR in prostate MRI for clinical suspicion of PCa. CDR needs to be adjusted for pathology confirmation rate and pre-MRI biopsy status for interfacility comparison.
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Próstata , Neoplasias de la Próstata , Masculino , Humanos , Neoplasias de la Próstata/diagnóstico por imagen , Imagen por Resonancia Magnética , Estudios Retrospectivos , Biopsia , Biopsia Guiada por ImagenRESUMEN
BACKGROUNDS: With an increased prevalence and burden of benign prostatic hyperplasia (BPH), effective and equitable treatment is a priority. Limited data exist evaluating treatment disparities for patients with BPH by race. This study examined the association between race and BPH surgical treatment rates among Medicare beneficiaries. METHODS: Medicare claims data were used to identify men newly diagnosed with BPH from January 1, 2010 through December 31, 2018. Patients were followed until their first BPH surgery, a diagnosis of prostate/bladder cancer, termination of Medicare enrollment, death, or end of study. Cox proportional hazards regression compared the likelihood of BPH surgery between men of different races (White vs. Black, Indigenous, and People of Color (BIPOC)), controlling for patients' geographical region, Charlson comorbidity score, and baseline comorbidities. RESULTS: The study included 31,699 patients (13.7% BIPOC). BIPOC men had significantly lower BPH surgery rates (9.5% BIPOC vs. 13.4% White; p=0.02). BIPOC race was associated with a 19% lower likelihood of receiving BPH surgery than White race (HR, 0.81; 95% CI 0.70, 0.94). Transurethral resection of the prostate was the most common surgery for both groups (49.4% Whites vs. 56.8% BIPOC; p=0.052). A higher proportion of BIPOC men underwent procedures in inpatient settings compared to White men (18.2% vs. 9.8%; p<0.001). CONCLUSIONS: Among a cohort of Medicare beneficiaries with BPH, there were notable treatment disparities by race. BIPOC men had lower rates of surgery than White men and were more likely to undergo procedures in the inpatient setting. Improving patient access to outpatient BPH surgical procedures may help address treatment disparities.
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Hiperplasia Prostática , Neoplasias de la Próstata , Resección Transuretral de la Próstata , Masculino , Humanos , Anciano , Estados Unidos/epidemiología , Medicare , Hiperplasia Prostática/cirugía , Neoplasias de la Próstata/cirugíaRESUMEN
OBJECTIVE: To evaluate and compare the financial burden of various surgical interventions for the management of benign prostatic hyperplasia (BPH). METHODS: We identified commercially insured men with a diagnosis of BPH who underwent a procedure of interest (simple prostatectomy (SP), transurethral resection of the prostate (TURP), holmium laser enucleation of the prostate (HoLEP), photovaporization of the prostate (PVP), prostatic urethral lift (PUL), or water vapor thermal therapy (WVTT)) between 2015 and 2021 with the OptumLabs Data Warehouse. Primary outcome was total health care costs (THC) which included both patient out-of-pocket (OOP) and health plan paid costs for the index procedure and combined follow-up years 1-5. A generalized linear model was used to estimate adjusted costs controlling for demographic and clinical characteristics. Patients undergoing WVTT were excluded from extended follow-up analyses due to limited data. RESULTS: Among 25,407 patients with BPH, 10,117 (40%) underwent TURP, 6353 (25%) underwent PUL, 5411 (21%) underwent PVP, 1319 (5%) underwent SP, 1243 (5%) underwent WVTT, and 964 (4%) underwent HoLEP. Index procedure costs varied significantly with WVTT being the least costly [THC: $2637 (95% confidence interval (CI): $2513-$2761)], and SP being the costliest [THC: $14,423 (95% CI: $12,772-$16,075)]. For aggregate index and 5-year follow-up costs, HoLEP ($31,926 [95% CI: $29,704-$34,148]) was the least costly and PUL ($36,596 [95% CI: $35,369-37,823]) was the costliest. CONCLUSION: BPH surgical treatment is associated with significant system-level health care costs. The level of impact varies between procedures. Minimally invasive options, such as WVTT, may offer initial cost reductions; however, HoLEP and SP are associated with lower follow-up costs.
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Hiperplasia Prostática , Resección Transuretral de la Próstata , Masculino , Humanos , Gastos en Salud , Hiperplasia Prostática/cirugía , Próstata , Prostatectomía , VaporRESUMEN
OBJECTIVES: To evaluate the impact of susceptibility artifacts from hip prosthesis on cancer detection rate (CDR) in prostate MRI. MATERIALS AND METHODS: This three-center retrospective study included prostate MRI studies for patients without known prostate cancer between 2017 and 2021. Exams with hip prosthesis were searched on MRI reports. The degree of susceptibility artifact on diffusion-weighted images was retrospectively categorized into mild, moderate, and severe (> 66%, 33-66%, and < 33% of the prostate volume are evaluable) by blind reviewers. CDR was defined as the number of exams with Gleason score ≥7 detected by MRI (PI-RADS ≥3) divided by the total number of exams. For each artifact grade, control exams without hip prosthesis were matched (1:6 match), and CDR was compared. The degree of CDR reduction was evaluated with ratio, and influential factors were evaluated by expanding the equation. RESULTS: Hip arthroplasty was present in 548 (4.8%) of the 11,319 MRI exams. CDR of the cases and matched control exams for each artifact grade were as follows: mild (n = 238), 0.27 vs 0.25, CDR ratio = 1.09 [95% CI: 0.87-1.37]; moderate (n = 143), 0.18 vs 0.27, CDR ratio = 0.67 [95% CI: 0.46-0.96]; severe (n = 167), 0.22 vs 0.28, CDR ratio = 0.80 [95% CI: 0.59-1.08]. When moderate and severe artifact grades were combined, CDR ratio was 0.74 [95% CI: 0.58-0.93]. CDR reduction was mostly attributed to the increased frequency of PI-RADS 1-2. CONCLUSION: With moderate to severe susceptibility artifacts from hip prosthesis, CDR was decreased to 74% compared to the matched control. CLINICAL RELEVANCE STATEMENT: Moderate to severe susceptibility artifacts from hip prosthesis may cause a non-negligible CDR reduction in prostate MRI. Expanding indications for systematic prostate biopsy may be considered when PI-RADS 1-2 was assigned. KEY POINTS: ⢠We proposed cancer detection rate as a diagnostic performance metric in prostate MRI. ⢠With moderate to severe susceptibility artifacts secondary to hip arthroplasty, cancer detection rate decreased to 74% compared to the matched control. ⢠Expanding indications for systematic prostate biopsy may be considered when PI-RADS 1-2 is assigned.
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INTRODUCTION: Surgical site infections are common postoperative complications. Some operating rooms have open-floor drainage systems for fluid disposal during endourologic cases, although nonendoscopy cases are not always allowed in these rooms. We hypothesized that operating rooms with open-floor drainage systems would not materially affect risk of surgical site infections for patients undergoing open and laparoscopic procedures. METHODS: Patients who had surgical site infections from 2016 through 2020 were identified from data of the National Surgical Quality Improvement Program. Patients without surgical incisions, with open wounds, and with surgical site infections at surgery were excluded. The primary outcome was surgical site infection occurrence within 30 days of surgery. Multilevel multivariable logistic regression was used to estimate the observed-to-expected surgical site infection ratio for each operating room (2 with and 23 without open-floor drainage systems). RESULTS: We identified 8,419 surgical cases, of which 802 (9.5%) were performed in operating rooms with open-floor drainage systems; 166 patients (2.0%) had surgical site infections. Of the surgical site infections, 7 (4.2%) occurred in operating rooms with open-floor drainage systems. Surgical specialty, American Society of Anesthesiologists physical status, higher case acuity, dyspnea, immunosuppression, longer surgical duration, and wound classification were associated with surgical site infections (P < .05 for all). The observed-to-expected ratios of surgical site infections occurring in the 2 operating rooms with open-floor drainage systems were 0.85 and 1.15. The odds ratio of surgical site infections for urologic cases performed in room with vs without open-floor drainage systems was 1.30 (P = .65). CONCLUSIONS: Urology operating room designs often include open-floor drainage systems for water-based cases. These drainage systems were not associated with an increased risk of surgical site infections.
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Introduction: Recent retrospective literature suggests that the quick sequential organ failure assessment (qSOFA) scoring tool is a potentially superior tool over use of the systemic inflammatory response syndrome (SIRS) criteria to predict septic shock after percutaneous nephrolithotomy (PCNL) surgery. Here we examine use of qSOFA and SIRS to predict septic shock within data series collected prospectively on PCNL patients as part of a greater study of infectious complications. Materials and Methods: We performed a secondary analysis of two prospective multicenter studies including PCNL patients across nine institutions. Clinical signs informing SIRS and qSOFA scores were collected no later than postoperative day 1. The primary outcome was sensitivity and specificity of SIRS and qSOFA (high-risk score of greater-or-equal to two points) in predicting admission to the intensive care unit (ICU) for vasopressor support. Results: A total of 218 cases at 9 institutions were analyzed. One patient required vasopressor support in the ICU. The sensitivity/specificity was 100%/72.4% (McNemar's test p < 0.001) for SIRS and was 100%/90.8% (McNemar's test p < 0.001) for qSOFA. Conclusion: Although positive predictive value for both qSOFA and SIRS in prediction of post-PCNL septic shock is low, prospectively collected data demonstrate use of qSOFA may offer greater specificity than SIRS criteria when predicting post-PCNL septic shock.
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Nefrolitotomía Percutánea , Sepsis , Choque Séptico , Humanos , Choque Séptico/diagnóstico , Choque Séptico/etiología , Puntuaciones en la Disfunción de Órganos , Estudios Retrospectivos , Estudios Prospectivos , Pronóstico , Mortalidad Hospitalaria , Síndrome de Respuesta Inflamatoria Sistémica/diagnóstico , Síndrome de Respuesta Inflamatoria Sistémica/etiología , Curva ROCRESUMEN
BACKGROUND: Intracavitary UGN-101 is approved for the treatment of low-grade noninvasive upper tract urothelial carcinoma (UTUC). Post-commercialization studies underscore the benefit of UGN-101 administration for patients with imperative indications for whom radical nephroureterectomy (RNU) is not a viable option. OBJECTIVE: To describe the use, efficacy, and safety of UGN-101 in patients with UTUC with imperative indications for renal preservation, including high-grade disease. DESIGN, SETTING, AND PARTICIPANTS: Patients receiving UGN-101 with imperative indications were retrospectively analyzed using a multicenter centralized registry from 15 high-volume academic and community centers. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We defined imperative indications as patients with a solitary kidney, the presence of chronic kidney disease (CKD) with a glomerular filtration rate <30 ml/min, bilateral UTUC, and patients unfit for or unwilling to undergo surgical extirpation. Tumor characteristics, disease progression/recurrence, and adverse events were recorded on a per-renal-unit basis. RESULTS AND LIMITATIONS: UGN-101 was instilled into 52 renal units (38%) in 48 patients for imperative indications, including 29 patients (56%) with a solitary kidney, 11 kidneys (21%) in the setting of bilateral UTUC, six patients (12%) with CKD, and six patients (12%) who were unfit for or unwilling to undergo RNU. Twelve renal units had biopsy-proven high-grade papillary disease. Tumors were completely ablated before induction therapy in 34% of cases, while 66% had tumor present. Following induction therapy, 17 patients (40%) had no evidence of disease (NED) on ureteroscopy, 88% of whom maintained this status at median follow-up of 10.8 mo. In the cohort with high-grade disease, five patients (45%) had NED at initial post-induction primary disease evaluation. Adverse events included pyelonephritis (8%), ureteral stenosis (8%), anemia (6%), and acute renal failure (4%). Limitations include the retrospective study design, the lack of long-term follow up, and patient selection bias. CONCLUSIONS: Intracavitary therapy with UGN-101 in patients with UTUC and imperative indications shows promise as a kidney-sparing treatment modality. While long-term follow-up is needed, this intracavitary treatment may help in prolonging time to RNU and delaying the morbidity of hemodialysis in this comorbid population. PATIENT SUMMARY: We reviewed results for patients with cancer in the upper urinary tract and an additional condition that would not allow kidney removal who received treatment with a gel called UGN-101. Our results suggest that UGN-101 shows promise as a kidney-sparing treatment. It may delay the time until kidney removal is needed in these patients and avoid the negative effects associated with dialysis.
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Carcinoma de Células Transicionales , Neoplasias Renales , Insuficiencia Renal Crónica , Riñón Único , Neoplasias de la Vejiga Urinaria , Humanos , Mitomicina , Carcinoma de Células Transicionales/tratamiento farmacológico , Carcinoma de Células Transicionales/cirugía , Carcinoma de Células Transicionales/patología , Estudios Retrospectivos , Neoplasias Renales/tratamiento farmacológico , Neoplasias Renales/cirugía , Neoplasias Renales/patología , Recurrencia Local de Neoplasia , Riñón/patología , Insuficiencia Renal Crónica/complicaciones , Estudios Multicéntricos como AsuntoRESUMEN
In 2018, the Endourology Disease Group for Excellence (EDGE) published a prospective trial comparing dusting versus basketing during ureteroscopy. One hundred fifty-nine patients were included in the original analysis, which found no difference in stone-free rate at 3 months. We report the intermediate and long-term outcomes of patients included in the original trial. Two analyses were performed. At 1-year, a retrospective chart review was performed, and data collected on stone episodes, Emergency Department (ED) visits, hospital admissions and surgical interventions. To obtain long-term outcomes, the four sites with the largest initial accrual were included in a second phase of data collection with updated analyses. The patients from those sites were contacted, re-consented, and data were collected on stone surgical interventions, stone episodes, stone recurrences on imaging, emergency department (ED) visits, and hospital admissions for stone-related care since their original procedure. One-year follow-up data were collected in 111 of the original 159 (69.8%) patients from the nine sites. There were no statistically significant differences in the number of painful episodes, ED visits, hospital admissions, or surgical interventions. 94 patients from four sites were included in the long-term analysis. There were no statistically significant differences in surgical interventions, painful stone episodes, stone recurrence on imaging, ED visits or hospitalizations for stone-related events between the two groups. Long-term outcomes of dusting versus basketing during ureteroscopy indicate that there are no significant differences in clinical outcomes between the two surgical modalities.
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Cálculos Renales , Ureteroscopía , Humanos , Estudios de Seguimiento , Estudios Prospectivos , Ureteroscopía/métodos , Masculino , Femenino , Cálculos Renales/terapia , Resultado del TratamientoRESUMEN
BACKGROUND: Clear cell renal cell cancer (ccRCC), the 8th leading cause of cancer-related death in the US, is challenging to treat due to high level intratumoral heterogeneity (ITH) and the paucity of druggable driver mutations. CcRCC is unusual for its high frequency of epigenetic regulator mutations, such as the SETD2 histone H3 lysine 36 trimethylase (H3K36me3), and low frequency of traditional cancer driver mutations. In this work, we examined epigenetic level ITH and defined its relationships with pathologic features, aspects of tumor biology, and SETD2 mutations. RESULTS: A multi-region sampling approach coupled with EPIC DNA methylation arrays was conducted on a cohort of normal kidney and ccRCC. ITH was assessed using DNA methylation (5mC) and CNV-based entropy and Euclidian distances. We found elevated 5mC heterogeneity and entropy in ccRCC relative to normal kidney. Variable CpGs are highly enriched in enhancer regions. Using intra-class correlation coefficient analysis, we identified CpGs that segregate tumor regions according to clinical phenotypes related to tumor aggressiveness. SETD2 wild-type tumors overall possess greater 5mC and copy number ITH than SETD2 mutant tumor regions, suggesting SETD2 loss contributes to a distinct epigenome. Finally, coupling our regional data with TCGA, we identified a 5mC signature that links regions within a primary tumor with metastatic potential. CONCLUSION: Taken together, our results reveal marked levels of epigenetic ITH in ccRCC that are linked to clinically relevant tumor phenotypes and could translate into novel epigenetic biomarkers.
Asunto(s)
Carcinoma de Células Renales , Neoplasias Renales , Humanos , Carcinoma de Células Renales/metabolismo , Neoplasias Renales/patología , Metilación de ADN , Riñón/metabolismo , Epigénesis Genética , MutaciónRESUMEN
PURPOSE: Post-ureteroscopy stent placement carries significant morbidity which can interfere with daily life. This discomfort unfortunately leads to high utilization of opioid pain medications, which have a known risk of addiction. Cannabidiol oil represents an alternative analgesic that has proven anti-inflammatory and antinociceptive effects. The purpose was to evaluate the effect of a Food and Drug Administration-approved cannabidiol oil (Epidiolex) on pain control and opioid usage in the post-ureteroscopy setting. MATERIALS AND METHODS: This was a prospective, randomized, double-blind, placebo-controlled trial at a tertiary care center. Ninety patients undergoing ureteroscopy with stent placement for urinary stone disease were randomized 1:1 to placebo or 20 mg cannabidiol oil daily for 3 days postoperatively. Both groups were prescribed a rescue narcotic, tamsulosin, oxybutynin, and phenazopyridine. Daily pain scores, medication usage, and ureteral stent symptoms using the validated Ureteral Stent Symptom Questionnaire were recorded postoperatively. RESULTS: Both the placebo and cannabidiol oil groups were not different in pre- and perioperative characteristics. There was no difference in pain scores or opioid usage between groups postoperatively. The level of discomfort with ureteral stents was also not different between groups when comparing physical activity, sleep, urination, and activities of daily life. CONCLUSIONS: This randomized, blinded, placebo-controlled trial showed that cannabidiol oil is safe but ineffective when compared to placebo in reducing post-ureteroscopic stent discomfort or opioid usage. Despite the availability of numerous analgesic agents, stent symptoms continue to be a dissatisfier for most patients, suggesting additional work needs to focus on novel interventions and pain control.
Asunto(s)
Cannabidiol , Cálculos Ureterales , Cálculos Urinarios , Humanos , Ureteroscopía/efectos adversos , Analgésicos Opioides , Estudios Prospectivos , Dolor , Stents , Cálculos Ureterales/cirugíaRESUMEN
Background: Residual fragments (RFs) after percutaneous nephrolithotomy (PCNL) have a significant impact on patients' quality of life and clinical course. There is a paucity of studies that evaluate the natural history of RFs after PCNL. The objective of this study is to compare rates of reintervention, complications, stone growth, and passage in patients with RFs >4, ≤4, and ≤2 mm after PCNL. Methods: Sites from the Endourologic Disease Group for Excellence (EDGE) research consortium examined data of PCNL patients from 2015 to 2019 with at least 1-year follow-up. RF passage, regrowth, reintervention, and complications were recorded and RFs were stratified into >4 and ≤4 mm groups, as well as >2 and ≤2 mm groups. Potential predictors for stone-related events after PCNL were determined using multivariable logistic regression analysis. It was hypothesized that larger RF thresholds would result in lower passage rates, faster regrowth, and greater clinically significant events (complications and reinterventions) than smaller RF thresholds. Results: A total of 439 patients with RFs >1 mm on CT postoperative day 1 were included in this study. For RFs >4 mm, rates of reintervention were found to be significantly higher and Kaplan-Meier curve analysis showed significantly higher rates of stone-related events. Passage and RF regrowth were not found to be significantly different compared with RFs ≤4 mm. However, RFs ≤2 mm had significantly higher rates of passage, and significantly lower rates of fragment regrowth (>1 mm), complications, and reintervention compared with RFs >2 mm. On multivariable analysis, older age, body mass index, and RF size were found to be predictive of stone-related events. Conclusions: With the largest cohort to date, this study by the EDGE research consortium further confirms that clinically insignificant residual fragment is problematic for patients after PCNL, particularly in older more obese patients with larger RFs. Our study underscores the importance of complete stone clearance post-PCNL and challenges the use of Clinically insignificant residual fragment (CIFR).