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A Prospective, Blinded Comparison of Magnetic Resonance (MR) Imaging-Ultrasound Fusion and Visual Estimation in the Performance of MR-targeted Prostate Biopsy: The PROFUS Trial

Wysock, James S; Rosenkrantz, Andrew B; Huang, William C; Stifelman, Michael D; Lepor, Herbert; Deng, Fang-Ming; Melamed, Jonathan; Taneja, Samir S
BACKGROUND: Increasing evidence supports the use of magnetic resonance (MR)-targeted prostate biopsy. The optimal method for such biopsy remains undefined, however. OBJECTIVE: To prospectively compare targeted biopsy outcomes between MR imaging (MRI)-ultrasound fusion and visual targeting. DESIGN, SETTING, AND PARTICIPANTS: From June 2012 to March 2013, prospective targeted biopsy was performed in 125 consecutive men with suspicious regions identified on prebiopsy 3-T MRI consisting of T2-weighted, diffusion-weighted, and dynamic-contrast enhanced sequences. INTERVENTION: Two MRI-ultrasound fusion targeted cores per target were performed by one operator using the ei-Nav|Artemis system. Targets were then blinded, and a second operator took two visually targeted cores and a 12-core biopsy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Biopsy information yield was compared between targeting techniques and to 12-core biopsy. Results were analyzed using the McNemar test. Multivariate analysis was performed using binomial logistic regression. RESULTS AND LIMITATIONS: Among 172 targets, fusion biopsy detected 55 (32.0%) cancers and 35 (20.3%) Gleason sum >/=7 cancers compared with 46 (26.7%) and 26 (15.1%), respectively, using visual targeting (p=0.1374, p=0.0523). Fusion biopsy provided informative nonbenign histology in 77 targets compared with 60 by visual (p=0.0104). Targeted biopsy detected 75.0% of all clinically significant cancers and 86.4% of Gleason sum >/=7 cancers detected on standard biopsy. On multivariate analysis, fusion performed best among smaller targets. The study is limited by lack of comparison with whole-gland specimens and sample size. Furthermore, cancer detection on visual targeting is likely higher than in community settings, where experience with this technique may be limited. CONCLUSIONS: Fusion biopsy was more often histologically informative than visual targeting but did not increase cancer detection. A trend toward increased detection with fusion biopsy was observed across all study subsets, suggesting a need for a larger study size. Fusion targeting improved accuracy for smaller lesions. Its use may reduce the learning curve necessary for visual targeting and improve community adoption of MR-targeted biopsy.
PMID: 24262102
ISSN: 0302-2838
CID: 666702

A PROSPECTIVE COMPARATIVE STUDY OF TARGETED PROSTATE BIOPSY DIRECTED TO MRI-SUSPICIOUS REGIONS VERSUS ARTEMIS (TM) COMPUTERIZED 12 CORE TEMPLATE BIOPSY [Meeting Abstract]

Wysock, James S; Rosenkrantz, Andrew B; Huang, William C; Stifelman, Michael; Lepor, Herbert; Taneja, Samir S
ISI:000320281603061
ISSN: 0022-5347
CID: 1871422

National Trends in the Utilization of Partial Nephrectomy Before and After the Establishment of AUA Guidelines for the Management of Renal Masses

Bjurlin, Marc A; Walter, Dawn; Taksler, Glen B; Huang, William C; Wysock, James S; Sivarajan, Ganesh; Loeb, Stacy; Taneja, Samir S; Makarov, Danil V
OBJECTIVE: To assess the impact of the American Urological Association (AUA) guidelines advocating partial nephrectomy for T1 tumors guidelines on the likelihood of undergoing partial nephrectomy. MATERIALS AND METHODS: We analyzed the Nationwide Inpatient Sample (NIS), a dataset encompassing 20% of all United States inpatient hospitalizations, from 2007 through 2010. Our dependent variable was receipt of radical vs partial nephrectomy (55.50, 55.51, 55.52, and 55.54 vs 55.4) for a renal mass (International Classification of Disease, 9th Revision [ICD-9] code 189.0). The independent variable of interest was time of surgery (before or after the establishment of AUA guidelines); covariates included a diagnosis of chronic kidney disease (CKD), overall comorbidity, age, race, gender, geographic region, income, and hospital characteristics. Bivariate and multivariable adjusted logistic regression was used to determine the association between receipt of partial nephrectomy and time of guideline establishment. RESULTS: We identified 26,165 patients with renal tumors who underwent surgery. Before the guidelines, 4031 patients (27%) underwent partial nephrectomy compared to 3559 (32%) after. On multivariable analysis, undergoing surgery after the establishment of guidelines (odds ratio [OR] 1.20, 95% confidence interval [CI] 1.08-1.32, P <.01) was an independent predictor of partial nephrectomy. Other factors associated with partial nephrectomy were urban location, surgery at a teaching hospital, large hospital bed size, Northeast location, and Black race. Female gender and CKD were not associated with partial nephrectomy. CONCLUSION: Although adoption of partial nephrectomy increased after establishment of new guidelines on renal masses, partial nephrectomy remains an underutilized procedure. Future research must focus on barriers to adoption of partial nephrectomy and how to overcome them.
PMCID:3852430
PMID: 24295245
ISSN: 0090-4295
CID: 666322

Multiphoton microscopy in the evaluation of human bladder biopsies

Jain, Manu; Robinson, Brian D; Scherr, Douglas S; Sterling, Joshua; Lee, Ming-Ming; Wysock, James; Rubin, Mark A; Maxfield, Frederick R; Zipfel, Warren R; Webb, Watt W; Mukherjee, Sushmita
CONTEXT/BACKGROUND:Multiphoton microscopy (MPM) is a nonlinear imaging approach, providing cellular and subcellular details from fresh (unprocessed) tissue by exciting intrinsic tissue emissions. With miniaturization and substantially decreased cost on the horizon, MPM is an emerging imaging technique with many potential clinical applications. OBJECTIVES/OBJECTIVE:To assess the imaging ability and diagnostic accuracy of MPM for human bladder biopsies. DESIGN/METHODS:Seventy-seven fresh bladder biopsies were imaged by MPM and subsequently submitted for routine surgical pathology diagnosis. Twelve cases were excluded because of extensive cautery artifact that prohibited definitive diagnosis. Comparison was made between MPM imaging and gold standard sections for each specimen stained with hematoxylin-eosin. RESULTS:In 57 of 65 cases (88%), accurate MPM diagnoses (benign or neoplastic) were given based on the architecture and/or the cytologic grade. The sensitivity and specificity of MPM in our study were 90.4% and 76.9%, respectively. A positive (neoplastic) diagnosis on MPM had a high predictive value (94%), and negative (benign) diagnoses were sustained on histopathology in two-thirds of cases. Architecture (papillary versus flat) was correctly determined in 56 of 65 cases (86%), and cytologic grade (benign/low grade versus high grade) was assigned correctly in 38 of 56 cases (68%). CONCLUSIONS:The MPM images alone provided sufficient detail to classify most lesions as either benign or neoplastic using the same basic diagnostic criteria as histopathology (architecture and cytologic grade). Future developments in MPM technology may provide urologists and pathologists with additional screening and diagnostic tools for early detection of bladder cancer. Additional applications of such emerging technologies warrant exploration.
PMCID:3640548
PMID: 22540300
ISSN: 1543-2165
CID: 6059182

PREDICTION OF HIGH RISK PATHOLOGIC FEATURES AND PROGNOSTIC SIGNIFICANCE OF HYDRONEPHROSIS IN UPPER TRACT UROTHELIAL CARCINOMA (UTUC) [Meeting Abstract]

Ito, Timothy; Boas, Rebecca; Han, Justin S; Kheterpal, Emil; Wysock, James S; Stifelman, Michael D; Huang, William C; Taneja, Samir S; Shah, Ojas
ISI:000302912501075
ISSN: 0022-5347
CID: 1872322

Single port donor nephrectomy

Leeser, David B; Wysock, James; Gimenez, S Elena; Kapur, Sandip; Del Pizzo, Joseph
In 2007, Rane presented the first single port nephrectomy for a small non-functioning kidney at the World Congress of Endourology. Since that time, the use of single port surgery for nephrectomy has expanded to include donor nephrectomy. Over the next two years the technique was adopted for many others types of nephrectomies to include donor nephrectomy. We present our technique for single port donor nephrectomy using the Gelpoint device. We have successfully performed this surgery in over 100 patients and add this experience to our experience of over 1000 laparoscopic nephrectomies. With the proper equipment and technique, single port donor nephrectomy can be performed safely and effectively in the majority of live donors. We have found that our operative times and most importantly our transplant outcomes have not changed significantly with the adoption of the single port donor nephrectomy. We believe that single port donor nephrectomy represents a step forward in the care of living donors.
PMCID:3197287
PMID: 21445037
ISSN: 1940-087x
CID: 162276

Outcomes and complications after 532 nm laser prostatectomy in anticoagulated patients with benign prostatic hyperplasia

Chung, Doreen E; Wysock, James S; Lee, Richard K; Melamed, Scott R; Kaplan, Steven A; Te, Alexis E
PURPOSE: Patients on anticoagulation are at high risk for bleeding after electrocautery transurethral resection of the prostate or open prostatectomy and they are often denied surgery for symptomatic benign prostatic hyperplasia. Using photoselective vaporization of the prostate, patients at high risk may safely undergo surgery. We explored outcomes and complications after photoselective vaporization of the prostate in an anticoagulated, high risk cohort. MATERIALS AND METHODS: Between 2002 and 2008, 162 men on systemic anticoagulation underwent photoselective vaporization of the prostate. Data were collected on demographics, comorbidities, complications, serum sodium, hematocrit, maximum flow rate, post-void residual urine, International Prostate Symptom Score and complications. RESULTS: Mean+/-SD age was 72+/-8 years, mean baseline prostate volume was 91+/-49 gm and mean prostate specific antigen was 4.1+/-5 ng/ml. Of the patients 31 (19%) were on warfarin, 101 (62%) were on acetylsalicylic acid, 19 (12%) were on clopidogrel and 11 (7%) were on 2 or more anticoagulants. Median American Society of Anesthesiologists class was 3 and mean Charlson comorbidity index was 5. Median operative time was 105 minutes and mean energy use was 280+/-168 kJ. The immediate mean hematocrit decrease was 1.94%+/-2.42%. One patient who received excessive intravenous fluids experienced heart failure. Complications within 30 days included urinary tract infection in 4 patients (2.5%) and delayed bleeding in 6 (4%). Three of these patients (50%) required blood transfusion and 1 (17%) required reoperation. In 2 years of followup 3 patients (2%) required repeat photoselective vaporization of the prostate. No incontinence or urethral stricture developed. Significant improvements occurred in International Prostate Symptom Score, maximum flow rate and post-void residual urine. CONCLUSIONS: Results support using 532 nm photoselective vaporization of the prostate in patients at high risk on systemic anticoagulation, even those on 2 or more anticoagulation agents and with a large prostate requiring longer operative time. Few complications developed and significant durable clinical improvement was seen.
PMID: 21791350
ISSN: 0022-5347
CID: 162275

Laparoendoscopic single site live donor nephrectomy: initial experience

Gimenez, Elena; Leeser, David B; Wysock, James S; Charlton, Marian; Kapur, Sandip; Del Pizzo, Joseph J
PURPOSE: We present our initial experience in 40 patients undergoing laparoendoscopic single site donor nephrectomy. MATERIALS AND METHODS: We prospectively collected data on 40 consecutive patients. A single access GelPOINT device was inserted into the abdomen through a 4 to 5 cm periumbilical incision. We used a bariatric camera with a right angle attachment for the light cord to maximize triangulation. Parameters analyzed included warm ischemia time, operative time, estimated blood loss, visual analog pain score, time to recipient creatinine less than 3 mg/dl, and recipient creatinine at discharge home, and 3 and 6 months. RESULTS: A total of 38 left and 2 right donor nephrectomies were performed. Complete laparoendoscopic single site donor nephrectomy was successful in 38 cases. One left and 1 right case were converted to a hand assisted approach. Average +/- SD body mass index was 26.1 +/- 5.2 kg/m(2). Mean operative time to allograft extraction was 93.5 +/- 27.5 minutes and mean total operative time was 166.7 +/- 33.8 minutes. Average estimated blood loss was 106.7 +/- 93.5 cc. Mean warm ischemia time was 3.96 +/- 0.72 minutes. Mean hospital stay was 1.77 +/- 0.43 days and median time to recipient creatinine less than 3.0 mg/dl was 54.2 +/- 110.3 hours. Mean recipient creatinine at discharge home, and at 3 and 6 months was 1.48 +/- 0.67, 1.29 +/- 0.38 and 1.19 +/- 0.34 mg/dl, respectively. Complications included hyponatremia in 1 patient, wound infection in 1, and a grade III laceration in an allograft that was sustained during extraction. CONCLUSIONS: Our initial experience with laparoendoscopic single site donor nephrectomy is encouraging. This approach to kidney donation without an extra-umbilical incision could become particularly relevant to minimize morbidity in young, healthy organ donors.
PMID: 20850822
ISSN: 0022-5347
CID: 162277

Anatomical retro-apical technique of synchronous (posterior and anterior) urethral transection: a novel approach for ameliorating apical margin positivity during robotic radical prostatectomy

Tewari, Ashutosh K; Srivastava, Abhishek; Mudaliar, Kumaran; Tan, Gerald Y; Grover, Sonal; El Douaihy, Youssef; Peters, David; Leung, Robert; Yadav, Rajiv; John, Majnu; Wysock, James; Vaughan, E Daracott; Muir, Sara; Amin, Mahul B; Rubin, Mark; Tu, Jiangling; Akthar, Mohammed; Shevchuk, Maria
OBJECTIVE: To describe a novel synchronous approach to apical dissection during robotic-assisted radical prostatectomy (RARP) which augments circumferential visual appreciation of the prostatic apex and membranous urethra anatomy, and assess its effect on apical margin positivity. PATIENTS AND METHODS: Positive surgical margins (PSM) during RP predispose to earlier biochemical recurrence, and occur most frequently at the prostatic apex. Conventional apical transection after early ligation of the dorsal venous complex (DVC) remains suboptimal, as this approach obscures visualization of the intersection between prostatic apex and membranous urethra, leading to inadvertent apical capsulotomy and eventual margin positivity. A synchronous urethral transection commenced via a retro-apical approach was adopted in 209 consecutive patients undergoing RARP by one surgeon (A.T.) between April to September 2009. The apical margin rates for this group were compared with those of 1665 previous patients who received conventional urethral transection via an anterior approach after DVC ligation. Outcomes were adjusted for differences in clinicopathological variables. All RP specimens were processed according to institutional protocols, and examined by dedicated genitourinary pathologists. The location of PSMs was identified as apex, posterior, posterolateral, bladder neck, anterior, base, or multifocal. RESULTS: Patients receiving synchronous urethral transection had significantly lower apical PSM rates than the control group (1.4% vs 4.4%, P = 0.04). This marked improvement in the retro-apical group occurred despite a significantly higher incidence of aggressive cancer (>/= pT3a) documented on final specimen pathology (16% vs 10%, P = 0.027).Technical difficulty was encountered in three of 209 study patients, in whom urethral transection had to be completed using the classic anterior approach. CONCLUSION: Improved circumferential visualization of the prostatic apex, membranous urethra and their anatomical intersection facilitates precise dissection of the apex and its surrounding neural scaffold, and optimizes membranous urethral preservation. This has significantly ameliorated apical PSM rates in patients undergoing RARP, despite having to deal with more aggressive cancer on final specimen pathology.
PMID: 20377582
ISSN: 1464-4096
CID: 162278

Human bladder cancer diagnosis using Multiphoton microscopy

Mukherjee, S; Wysock, JS; Ng, CK; Akhtar, M; Perner, S; Lee, MM; Rubin, MA; Maxfield, FR; Webb, WW; Scherr, DS
At the time of diagnosis, approximately 75% of bladder cancers are non-muscle invasive. Appropriate diagnosis and surgical resection at this stage improves prognosis dramatically. However, these lesions, being small and/or flat, are often missed by conventional white-light cystoscopes. Furthermore, it is difficult to assess the surgical margin for negativity using conventional cystoscopes. Resultantly, the recurrence rates in patients with early bladder cancer are very high. This is currently addressed by repeat cystoscopies and biopsies, which can last throughout the life of a patient, increasing cost and patient morbidity. Multiphoton endoscopes offer a potential solution, allowing real time, non-invasive biopsies of the human bladder, as well as an up-close assessment of the resection margin. While miniaturization of the Multiphoton microscope into an endoscopic format is currently in progress, we present results here indicating that Multiphoton imaging (using a bench-top Multiphoton microscope) can indeed identify cancers in fresh, unfixed human bladder biopsies. Multiphoton images are acquired in two channels: (1) broadband autofluorescence from cells, and (2) second harmonic generation (SHG), mostly by tissue collagen. These images are then compared with gold standard hematoxylin/eosin (H&E) stained histopathology slides from the same specimen. Based on a "training set" and a very small "blinded set" of samples, we have found excellent correlation between the Multiphoton and histopathological diagnoses. A larger blinded analysis by two independent uropathologists is currently in progress. We expect that the conclusion of this phase will provide us with diagnostic accuracy estimates, as well as the degree of inter-observer heterogeneity.
PMCID:2666914
PMID: 19360140
ISSN: 1018-4732
CID: 162279