Higher obesity class is associated with more severe esophageal symptoms and reflux burden but not altered motor function or contractile reserve.

BACKGROUND: Patients with obesity often report esophageal symptoms, with abnormal reflux and esophageal motility suggested as potential mechanisms. However, prior studies showed varying results, often limited by study design/size and esophageal function/symptom measures utilized. We aimed to examine the relationship between obesity and objective esophageal function testing and patient-reported outcomes, utilizing prospective symptom, manometric and reflux monitoring data with impedance. METHODS: Adults referred for high-resolution impedance-manometry (HRiM) and multichannel intraluminal impedance-pH monitoring (MII-pH) to evaluate esophageal symptoms were enrolled. Validated symptom and health-related quality of life (HR-QOL) instruments were prospectively collected: GERDQ, reflux symptoms index (RSI), dominant symptom intensity (DSI, multiplied 5-point Likert scales for symptom frequency/severity), global symptom severity (GSS, 100-point visual analog scale), and Short Form-12 (SF-12) for HR-QOL. Esophageal function testing measures were compared across body mass index (BMI) categories and correlated with patient-reported outcomes. KEY RESULTS: Seven hundred and fifty four patients were included (Normal:281/Overweight:253/Class I obesity:137/Class II/III obesity:83). Reflux burden measures on MII-pH (acid exposure time, total reflux episodes, bolus exposure time), conclusive pathologic reflux (Lyon), and hiatal hernia were increased in higher obesity classes compared to normal BMI. Class II/III obesity was associated with more normal/hypercontractile swallows, less ineffective swallows, and better bolus transit on HRiM. BMI correlated positively with GERDQ/RSI/DSI/GSS, and negatively with physical component score (SF-12). Esophageal symptom severity and HR-QOL correlated strongly with MII-pH findings, but not HRiM measures. CONCLUSIONS/INFERENCES: Obesity is associated with increased esophageal symptom burden and worse physical HR-QOL, which correlate with higher acid/bolus reflux burden but not altered esophageal motility/transit/contractile reserve.

Perceptions of partial gland ablation for prostate cancer among men on active surveillance: A qualitative study.

OBJECTIVES ­: Partial gland ablation (PGA) therapy is an emerging treatment modality that targets specific areas of biopsy proven prostate cancer (PCa) to minimize treatment-related morbidity by sparing benign prostate. This qualitative study aims to explore and characterize perceptions and attitudes toward PGA in men with very-low-risk, low-risk, and favorable intermediate-risk PCa on active surveillance (AS). DESIGN ­: 92 men diagnosed with very-low-risk, low-risk, and favorable intermediate-risk PCa on AS were invited to participate in semi-structured telephone interviews on PGA. SETTING ­: Single tertiary care center located in New York City. PARTICIPANTS ­: 20 men with very-low-risk, low-risk, and favorable intermediate-risk PCa on AS participated in the interviews. MAIN OUTCOME MEASURES ­: Emerging themes on perceptions and attitudes toward PGA were developed from transcripts inductively coded and analyzed under standardized methodology. RESULTS ­: Four themes were derived from twenty interviews that represent the primary considerations in treatment decision-making: (1) the feeling of psychological safety associated with low-risk disease; (2) preference for minimally invasive treatments; (3) the central role of the physician; (4) and the pursuit of treatment options that align with disease severity. Eleven men (55%) expressed interest in pursuing PGA only if their cancer were to progress, while 9 men (45%) expressed interest at the current moment. CONCLUSIONS ­: Though an emerging treatment modality, patients were broadly accepting of PGA for PCa with men primarily debating the risks versus benefits of proactively treating low-risk disease. Additional research on men's preferences and attitudes toward PGA will further guide counseling and shared decision-making for PGA.

Comparative Effectiveness and Tolerability of Transperineal MRI-Targeted Prostate Biopsy under Local versus Sedation.

OBJECTIVES: To assess the prostate cancer diagnostic yield, complications, and costs of transperineal prostate biopsies when performed with local anesthesia versus sedation. METHODS: Data were prospectively collected for men undergoing transperineal MRI-targeted biopsy at the outpatient clinic and tertiary hospital of a single center between October 2017 to February 2020. These data included demographic, procedural, and pathologic variables and complications. Time-driven activity-based costing was performed to compare procedural costs. RESULTS: 126 men were included. Age, BMI and PSA were similar for local (n = 45) vs sedation (n = 81), all P>0.05. Detection of clinically significant prostate cancer (CSPC) on combined systematic and targeted biopsy was similar for local vs sedation (24% vs 36%; P = 0.2). Local had lower detection on targeted biopsies alone (8.9% vs 25%; P = 0.03). However, fewer targeted cores were obtained per region of interest with local vs sedation (median 3 vs 4 cores; P<0.01). For local vs sedation, the complication rate was 2.6% and 6.1% (P = 0.6). The median visual analog pain score for local vs sedation was 3/10 vs 0/10 (P<0.01). The mean procedure time for local vs sedation was 22.5 vs 17.5 minutes (48.3 minutes when including anesthesia time). Time-driven activity-based costs for local vs sedation were $961.64 vs $2208.16 (P<0.01). CONCLUSION: Transperineal biopsy with local anesthesia is safe with comparable outcomes to sedation. While the number of cores taken differed, there was no statistical difference in the detection of clinically significant cancer.

The Learning Curve for Magnetic Resonance Imaging/Ultrasound Fusion-guided Prostate Biopsy.

BACKGROUND: Magnetic resonance imaging/ultrasound-guided fusion biopsy (FBx) is more accurate at detecting clinically significant prostate cancer than conventional transrectal ultrasound-guided systematic biopsy. However, learning curves for attaining accuracy may limit the generalizability of published outcomes. OBJECTIVE: To delineate and quantify the learning curve for FBx by assessing the targeted biopsy accuracy and pathological quality of systematic biopsy over time. DESIGN, SETTING, AND PARTICIPANTS: We carried out a retrospective analysis of 173 consecutive men who underwent Artemis FBx with computer-template systematic sampling between July 2015 and May 2017. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The accuracy of targeted biopsy was determined by calculating the distance between planned and actual core trajectories stored on Artemis. Systematic sampling proficiency was assessed via pathological analysis of fibromuscular tissue in all cores and then comparing pathology elements from individual cores from men in the first and last tertiles. Polynomial linear regression models, change-point analysis, and piecewise linear regression were used to quantify the learning curve. RESULTS AND LIMITATION: A significant improvement in targeted biopsy accuracy occurred up to 98 cases (p<0.01). There was a significant decrease in fibromuscular tissue in the systematic biopsy cores up to 84 cases (p<0.01) and an improvement in pathological quality when comparing systematic cores from the first and third tertiles. Use of a different fusion platform may limit the generalizability of our results. CONCLUSIONS: There is a significant learning curve for targeted and systemic biopsy using the Artemis platform. Improvements in accuracy of targeted biopsy and better sampling for systematic biopsy can be achieved with greater experience. PATIENT SUMMARY: We define the learning curve for magnetic resonance imaging/ultrasound-guided fusion biopsy (FBx) using targeted biopsy accuracy and systematic core sampling quality as measures. Our findings underscore the importance of overcoming learning curves inherent to FBx to minimize patient discomfort and biopsy risk and improve the quality of care for accurate risk stratification, active surveillance, and treatment selection.

The PreOp Program: Intensive Preclinical Surgical Exposure is Associated With Increased Medical Student Surgical Interest and Competency.

OBJECTIVE: As medical students' interest in surgical fields wanes, we investigated the impact of a preclinical surgical exposure program on students' attitudes toward pursuing surgical careers. DESIGN: This is a prospective longitudinal study of PreOp, a preclinical rotation-based surgical exposure program for first-year medical students, from 2013 to 2017. Surveys assessed PreOp rotation quality, students' surgical interest, and students' self-reported preparedness for the surgical clerkship. Surgery clerkship grades were obtained as a measure of surgical competency and compared to class-wide peers. Match data was collected and compared to class-wide peers as well as historical norms. SETTING: NewYork-Presbyterian Hospital/Weill Cornell Medicine, New York, NY; tertiary care center. PARTICIPANTS: Fifty-four PreOp students from 2013 to 2017. RESULTS: Fifty-four PreOp participants were recruited. After completing the PreOp program, 66.7% of PreOp students reported being very likely to apply into a surgical field compared to 29.4% when they started medical school. Ultimately, 71.4% of PreOp students versus 21.7% of non-PreOp class-wide peers matched into surgical fields (p < 0.001). From the preceding 5 match years before PreOp implementation, 21.4% of all students matched into surgical fields compared to 25.6% of all students after PreOp was started (p = 0.26). In terms of preparedness, 75% of PreOp students reported feeling more prepared for the third-year surgery clerkship than their non-PreOp peers after the second year of medical school. PreOp students were significantly more likely than non-PreOp class-wide peers to receive honors in the surgery clerkship when controlling for cumulative clerkship GPA (p = 0.012, adjusted odds ratio = 5.5 [95% confidence interval 1.5-22.1]). CONCLUSIONS: Hands-on preclinical surgical exposure was associated with student-reported increased surgical interest that was maintained longitudinally and reflected in significantly increased surgical matches relative to non-PreOp class-wide peers. This study uniquely demonstrates that participation in PreOp was also associated with increased self-reported surgical preparedness and significantly higher surgery clerkship grades relative to overall academic performance.

IDEAL Stage 2a experience with in-office, transperineal MRI/ultrasound software fusion targeted prostate biopsy.

OBJECTIVE: Although the feasibility of transperineal biopsy under local anesthesia has been demonstrated, little is known regarding the application of MRI/ultrasound software fusion targeted biopsy for transperineal biopsy under local anesthesia. The objective of our study is to describe our initial experience with in-office transperineal MRI/ultrasound software fusion targeted biopsy (Idea, Development, Exploration, Assessment, Long-term Follow-up [IDEAL] Stage 2a). METHODS: Between October 2017 and July 2019, 33 men underwent in-office transperineal MRI-targeted biopsy using the Artemis (Eigen, Grass Valley, CA, USA) fixed-robotic arm system. The indication for biopsy was elevated prostate specific antigen (PSA) (n=14), prior negative biopsy (n=10), active surveillance (n=6), and surveillance after partial gland cryoablation (n=3). We prospectively captured patient demographic and clinical characteristics, biopsy outcomes, and complications. Complications were classified according to Common Terminology Criteria for Adverse Events (CTCAE) V.5.0. RESULTS: The median patient age was 67 years (IQR 61-71) and the median serum PSA level was 7.0 ng/mL (IQR 5.1-11.4). The median duration of in-office MRI-targeted transperineal biopsy was 26 min (IQR 23-28). Overall, transperineal MRI-targeted biopsy detected prostate cancer in 18 (54.6%) men, with 8 (24.2%) being clinically significant (Gleason Score ≥3+4, Grade Group ≥2). Clinically significant prostate cancer was detected in four (28.6%) biopsy naïve men, two (20.0%) men with a prior negative, one (16.7%) man on active surveillance and one (33.3%) man following partial gland ablation. Three (9.1%) men experienced complications: two hematuria and one urinary retention. CONCLUSION: Our findings demonstrate the feasibility of the fixed-robotic arm fusion platform for in-office transperineal MRI-targeted biopsy and a low rate of adverse events. However, larger prostate size precludes MRI/ultrasound software fusion and pubic arch interference hindered the transperineal MRI-targeted approach in 9.1% of men. Pubic arch interference was overcome by a free-hand approach with software fusion guidance.

Multiple Regions of Interest on Multiparametric Magnetic Resonance Imaging are Not Associated with Increased Detection of Clinically Significant Prostate Cancer on Fusion Biopsy.

PURPOSE: We sought to determine the association between multiple regions of interest on prebiopsy magnetic resonance imaging and the detection of clinically significant prostate cancer in men undergoing magnetic resonance imaging-ultrasound fusion biopsy. MATERIALS AND METHODS: We performed a retrospective, single institution analysis of men who underwent fusion biopsy. Men with prior positive biopsies, magnetic resonance imaging performed elsewhere and/or magnetic resonance imaging prior to release of the PI-RADS™ (Prostate Imaging Reporting and Data System) version 2 were excluded from study, resulting in 381 participants. Modeled independent variables included patient age, number of regions of interest with a PI-RADS categorization of 3 or greater, body mass index, prostate specific antigen, prostate volume and PI-RADS categorization. Multivariable logistic regression was performed to determine factors associated with finding clinically significant prostate cancer (Gleason 7 or greater) on biopsy. RESULTS: Median age was 67.2 years (IQR (61.6-73.0) and median prostate specific antigen was 6.6 ng/ml (5.0-10.0). Adjusted analysis demonstrated that age (OR 1.10, 95% CI 1.06-1.15, p ≤0.001), body mass index (OR 1.08, 95% CI 1.01-1.16, p = 0.038) and prostate specific antigen (OR 1.06, 95% CI 1.01-1.10, p = 0.015) were associated with detection of clinically significant prostate cancer. PI-RADS categories 4 (OR 4.62, 95% CI 2.23-9.33) and 5 (OR 6.75, 95% CI 2.72-16.71, each p <0.001) were associated with greater odds of clinically significant prostate cancer. Multiple regions of interest were not associated with the detection of clinically significant prostate cancer (OR 1.05, 95% CI 0.60-1.84, p = 0.857). CONCLUSIONS: Multiple regions of interest do not portend a greater likelihood of finding clinically significant prostate cancer. Physicians should recognize that multiple regions of interest should not influence the decision to perform fusion biopsy. Our findings may ease patient anxiety concerning these findings.

The Role of Systematic and Targeted Biopsies in Light of Overlap on Magnetic Resonance Imaging Ultrasound Fusion Biopsy.

BACKGROUND: The value of a systematic biopsy in men with magnetic resonance imaging (MRI)-visible regions of interest (ROIs) undergoing fusion biopsy (FBx) is unclear. OBJECTIVE: To determine the utility of concurrent systematic biopsy with ROI biopsy in detecting clinically significant prostate cancer (CSPC). DESIGN, SETTING, AND PARTICIPANTS: Retrospective study of 240 men who underwent FBx with the Artemis platform. Software captured biopsy distribution maps. Biopsy distribution maps were reviewed to determine which systematic cores overlapped with the ROI. Histopathology for overlapping systematic cores were reclassified as ROI cores. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Detection of CSPC on true systematic biopsy was the outcome measured. Multivariable logistic regression was used to determine if age, prostate-specific antigen, prostate volume, prior biopsy status, and Prostate Imaging-Reporting and Data System categorization were associated with CSPC detection and Gleason grade upgrading on systematic biopsy. RESULTS AND LIMITATIONS: The median number of systematic cores overlapping with ROIs was 2 (interquartile range 1-2). After accounting for overlap, 14 men (5.8%) had a higher Gleason grade on systematic biopsy. Of these, seven (2.9%) were upgraded from benign and three (1.3%) from clinically insignificant cancer on systematic biopsy. In adjusted analysis, prior negative biopsy (odds ratio [OR] 0.46, 95% confidence interval [CI] 0.21-0.99; p=0.046) was associated with absence of CSPC on systematic biopsy, while age (OR 1.11, 95% CI 1.02-1.21; p=0.015) was associated with upgrading. Limitations include the retrospective data and the use of a single biopsy platform. CONCLUSIONS: Detection of CSPC on systematic biopsy that might influence clinical decision-making is uncommon in men undergoing FBx. In men with a prior negative biopsy, a target-only FBx strategy could be considered because of the low yield on systematic biopsy. PATIENT SUMMARY: We found that random prostate sampling adds little diagnostic value in men who are undergoing a targeted biopsy of suspicious lesions found on imaging, especially for men who have had a prior negative biopsy.