Complications associated with minimally invasive surgical therapies (MIST) for surgical management of benign prostatic hyperplasia: a Manufacturer and User Facility Device Experience (MAUDE) database review.

PURPOSE: MAUDE database houses medical device reports of suspected device-related complications received by Food and Drug Administration. In the present study we aim to evaluate the MAUDE database for reported complications of MIST procedures. METHODS: The database was queried using keywords: rezum, urolift, prostate embolization (PAE), transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), prostate stent and Temporarily Implanted Nitinol Device (iTIND) on 10/1/22 to extract information regarding device problems and procedure-related complications. Gupta classification system was used to stratify complications. Statistical analysis was performed to compare frequency of complications among MIST procedures. RESULTS: We found a total of 692 reports (Rezum-358, urolift-226, PAE-53, TUNA-31, TUMT-19, prostatic stent-4, and iTIND-1). Most complications related to device or users were minor (level 1 and 2) and there was no significant difference among various MIST procedures. The screen/system error was responsible for 93% and 83% aborted cases in Rezum and TUNA, respectively, and PAE showed 40% of device component detachment/fracture. Overall Urolift and TUMT were associated with statistically significant higher incidence of major (level 3 and 4) complications (23% and 21%, respectively) as compared with Rezum (7%). Most major complications needing hospitalization after Urolift included hematoma and hematuria with clots and those after Rezum included urinary tract infection and sepsis. Thirteen deaths were reported, mostly due to cardiovascular events, which were classified as not associated with the proposed treatment. CONCLUSION: MIST for BPH can occasionally cause significant morbidity. Our data should assist urologists and patients in shared decision-making process.

Validation of dominant and secondary sequence utilization in PI-RADS v2 for classifying prostatic lesions.

INTRODUCTION: To assess the secondary sequence rule in The Prostate Imaging Reporting Data System (PI-RADS) version 2 by comparing the detection of Grade group 1+ (GG1+) and 2+ (GG2+) cancers in PI-RADS 3, an upgraded PI-RADS 4, and true (non-upgraded) PI-RADS 4 targets. MATERIALS AND METHODS: We analyzed a total of 589 lesions scored as PI-RADS 3 or 4 obtained from 434 men who underwent mpMRI-US fusion biopsy from September 2015 to November 2017 for evaluation of GG1+ and GG2+ prostate cancer. PI-RADS 4 lesions were differentiated into those that were 'upgraded' to PI-RADS 4 based on the secondary sequence and those that were 'true' PI-RADS 4 based on the dominant sequence. RESULTS: The odds of detecting a GG2+ cancer was significantly higher for an upgraded 4 (peripheral zone (PZ): OR 5.06, 95%CI 2.04-12.54, p < 0.001, transitional zone (TZ): OR 3.08, 95%CI 1.04-9.08, p = 0.042) and true 4 (PZ: OR 5.82, 95%CI 3.10-10.94, p < 0.0001, TZ: OR 2.43, 95%CI 1.14-5.18, p = 0.022) lesions compared to PI-RADS 3 lesions. Additionally, we found no difference in the odds of detecting a GG2+ prostate cancer between a true PI-RADS 4 (OR 1.15, 95%CI 0.49-2.71 p = 0.746) and upgraded 4 (referent) in the PZ. Similar non-significance was noted between true 4 (OR 0.79, 95%CI 0.26-2.38 p = 0.674) and upgraded 4 lesions in the TZ for detection of GG2+ cancers. CONCLUSIONS: Upgraded PI-RADS 4 and true 4 targets have a higher odds of detecting GG1+ and GG2+ compared to PI-RADS 3 in the PZ and TZ. Our findings validate the revised scoring system for PI-RADS.

Perioperative outcomes and complication predictors associated with open and minimally invasive nephroureterectomy.

INTRODUCTION: Minimally invasive nephroureterectomy (MINU) and open nephroureterectomy (ONU) have similar oncological outcomes for treatment of upper tract urothelial carcinoma (UTUC). We investigated perioperative outcomes and predictors of complications associated with MINU and ONU. MATERIAL AND METHODS: Using the National Surgical Quality Improvement Program (NSQIP) database, 912 patients were identified that underwent radical nephroureterectomy for UTUC between 2005 and 2013. Logistic regression and contingency table methods used preoperative covariates to predict rates of major (Clavien-Dindo grade ≥ 3) and 16 common perioperative complications. Additional comparisons between treatment groups were performed using unpaired t-tests, Wilcoxon rank-sum tests, or Fisher's Exact tests. P values were adjusted to maintain an experiment-wise p < 0.05. RESULTS: A total of 625 (69%) and 287 (31%) patients underwent MINU and ONU, respectively. ONU was associated with a higher rate of major complications (OR: 2.5, CI: 1.2-5.1, p < 0.03). The incidence of pulmonary embolism (bias adjusted OR: 24, CI: 1.3-441, p < 0.003), postoperative pneumonia (OR: 4.9, CI: 1.7-16, p < 0.0016), and transfusion (OR: 2.7, CI: 1.8-4.0, p < 0.0001) was higher for ONU compared to MINU. There were no significant differences in the incidence of other complications. MINU took longer on average (median 223 versus 213 mins, p < 0.02). Time to discharge was longer for ONU (median 5 versus 4 days, p < 0.0001). No other covariates were independent predictors of major complications regardless of surgical approach. CONCLUSIONS: Occurrence of major complications were higher for ONU compared to MINU. These data suggest that MINU is an acceptable surgical option with lower morbidity compared to ONU for the management of UTUC.

Prevention and treatment of biopsy-related complications.

Transrectal biopsy of the prostate is necessary in the diagnosis of prostate cancer (PC). Though generally considered safe, patients encounter minor complications such as bleeding and urinary symptoms, and uncommonly, serious infections that may require antibiotic therapy, visits to the emergency room (ER) or hospital admission, causing morbidity and rarely even mortality. It is concerning that infections are on the rise due to resistant bacteria. Urologists will have to be aware of bacterial susceptibility studies to reduce such complications. This review focuses on prostate biopsy and its complications, and measures to reduce these complications in our practice.

Acquired Urethral Diverticulum After Holmium Laser Enucleation of the Prostate: A Case Report.

Acquired urethral diverticula (UD) in males is an uncommon entity, and it is rarely reported after an open simple prostatectomy or transurethral resection of the prostate. Here, we report a unique case of a UD presenting after holmium laser enucleation of the prostate (HoLEP) in a 69-year-old male with a prostate of 372 g who had five episodes of urine retention over one year despite combined medical treatment with tamsulosin 0.8 mg and finasteride 5 mg. The patient also has elevated prostate-specific antigen (PSA) with five negative prostate biopsies over the last few years. The procedure lasted six hours with difficult morcellation due to beach balls that took 3.5 hours. There were no intraoperative complications. However, he continued to have mixed urine incontinence and recurrent (six) episodes of urinary tract infection (UTI) in the first postoperative year. On evaluation, his urodynamic study did not reproduce stress urinary incontinence (SUI); however, cystoscopy and retrograde urethrogram diagnosed a 6-cm UD in the bulbar penile urethra with penoscrotal mass. The patient underwent urethral diverticulectomy and urethroplasty with a buccal mucosa graft to correct the defect. Six months after his urethral reconstruction, he continued to have mixed urine incontinence needing two pads/day. Although male UD is a rare condition, our case report seeks to heighten awareness of such a potential rare complication in men with recurrent UTIs and refractory urinary incontinence after prolonged HoLEP for extremely large prostates.

Chemokine and chemokine receptor expression in kidney tumors: molecular profiling of histological subtypes and association with metastasis.

PURPOSE: Molecular characterization of renal cell carcinoma may help differentiate benign oncocytoma from malignant renal cell carcinoma subtypes and predict metastasis. Chemokines, eg IL-8 and chemokine receptors such as CXCR4 and 7, promote inflammation and metastasis. SDF-1 is a CXCR4 and 7 ligand with 6 known isoforms. We evaluated the expression of these chemokines and chemokine receptors in kidney specimens. MATERIALS AND METHODS: Using quantitative polymerase chain reaction we measured mRNA levels of IL-8, CXCR4 and 7, and SDF1 isoforms α, ß and γ in a total of 166 specimens from 86 patients, including 86 tumor samples and 80 matched normal kidney samples. Mean ± SD followup was 18.9 ± 12 months (median 19.5). Renal cell carcinoma specimens included the clear cell, papillary and chromophobe subtype in 65, 10 and 5 cases, respectively, and oncocytoma in 6. A total of 17 cases were positive for metastasis. RESULTS: Median CXCR4 and 7, and SFD1-γ levels were increased twofold to tenfold. SDF1-α and ß were unchanged or lower in clear cell renal cell carcinoma and papillary tumors than in normal tissue. Median SDF1-γ, IL-8, and CXCR4 and 7 were increased threefold to fortyfold in chromophobe tumors compared to oncocytoma. CXCR4 and 7 were increased in tumors less than 4 cm (mean 3,057 ± 2,230 and 806 ± 691) compared to oncocytoma (336 ± 325 and 201 ± 281, respectively, p ≤0.016). On multivariate analysis CXCR4 (p = 0.01), CXCR7 (p = 0.02) and SDF1-ß (p = 0.005) were independently associated with metastasis. Combined CXCR7 plus SDF1-α and CXCR7 plus IL-8 markers showed the highest sensitivity (71% to 81%) and specificity (75% to 80%) of all individual or combined markers. CONCLUSIONS: Chemokines and chemokine receptors differentiate renal cell carcinoma and oncocytoma. Combined SDF1-α plus CXCR7 and IL-8 plus CXCR7 markers have about 80% accuracy for predicting renal cell carcinoma metastasis.

Surgical margin status does not affect overall survival following radical prostatectomy: a single institution experience with expectant management.

INTRODUCTION: The objective of this report is to describe the oncologic outcomes of men with margin-positive prostate cancer who were managed expectantly following radical prostatectomy. MATERIALS AND METHODS: Between January 1992 and January 2011, 2166 men underwent an open radical prostatectomy by a single surgeon. Of these patients, 1592 (74%) had complete data and met the inclusion criteria of negative lymph nodes and no history of neoadjuvant or adjuvant therapy. This cohort was dichotomized by the presence or absence of at least one positive surgical margin. Groups were compared for differences in recurrence-free and overall survival. RESULTS: In total, 507 (32%) of 1592 patients had at least one positive surgical margin. Clinical and pathological characteristics of these patients indicated more aggressive disease. The median follow up for biochemical recurrence and overall survival was 3.4 years and 7.7 years, respectively. Of those patients with a positive margin, 147 (29%) recurred, with estimated 5 and 10 year biochemical recurrence rates of 31% and 47%, respectively. Multivariate analysis demonstrated that the presence of a positive margin was associated with a 2.45-fold increased hazard of recurrence (p < 0.001). Despite initial observation, surgical margin status was not associated with a decrease in overall survival on both uni- (p = 0.684) and multivariate analyses (p = 0.177). CONCLUSION: Although a positive surgical margin is associated with an increased risk of biochemical recurrence, patients in our series were not at an increased risk of all-cause mortality.

Primary seminal vesicle adenocarcinoma: a lethal yet cryptic malignancy with review of literature.

The rarity of primary seminal vesical adenocarcinoma (PSVA) coupled with mostly late and advanced presentation with high mortality makes it an unanticipated malignancy with poor prognosis. Although there has been sporadic reporting of cases, the dearth of literature makes standardised care a challenge. The detection has incorporated immunohistochemistry for establishing the site of origin as well as the differentiation of primary from metastatic cancer. Surgical management with seminal vesiculectomy continues to be the mainstay of treatment, but difficult anatomy and delayed intervention do lead to an increased chance of residual disease that may warrant further adjuvant chemoradiation. We present a case report where PSVA developed in a patient with Zinner syndrome-an observation that is extremely rare with a literature review of PSVA including the various aspects of management including contemporary diagnosis techniques.

Current Status of Nephron-Sparing Surgery (NSS) in the Management of Renal Tumours.

Nephron-sparing surgery has emerged as the surgical treatment of choice for small renal masses over the past two decades, replacing the traditional teaching of radical nephrectomy for renal cell carcinoma. With time, there has been an evolution in the techniques and indications for partial nephrectomy. This review summarizes the current status of nephron-sparing surgery for renal carcinoma and also deals with the future of this procedure.

Reclassification Rates of Patients Eligible for Active Surveillance After the Addition of Magnetic Resonance Imaging-Ultrasound Fusion Biopsy: An Analysis of 7 Widely Used Eligibility Criteria.

OBJECTIVES: To evaluate the impact of adding magnetic resonance imaging-ultrasound (MRI-US) fusion biopsy cores to standard 12-core biopsy in selecting men for active surveillance (AS). MATERIALS AND METHODS: Among men undergoing a fusion biopsy for evaluation of prostate cancer, we selected men who were eligible for at least 1 of 7 different AS criteria based on the standard biopsy alone. We assessed each patient's eligibility for each AS criterion with and without the inclusion of fusion biopsy cores. The primary end point was the proportion of men who were initially eligible for AS but became ineligible after addition of the fusion biopsy cores. RESULTS: A total of 100 men were eligible for at least 1 AS criterion. After addition of fusion biopsy cores, the proportion of men who became ineligible for AS varied from 10.3% to 40.7%. Criteria that incorporated an absolute maximum number of cores positive had the highest rates of ineligibility. Using a percentage of cores positive helped to reduce the number of patients who would have been excluded. Combining the targeted biopsy cores into one, or taking the single core with the highest grade or volume did not appear to reduce the proportion of men who became ineligible. CONCLUSIONS: The addition of fusion biopsy to standard 12-core biopsy significantly increased the number of men who became ineligible for AS. Using the percent of cores positive, instead of an absolute number, allowed fewer exclusions. AS criteria may need to be updated to prevent the unnecessary exclusion of men due to an oversampling of low-risk disease.

Re-examining Prostate-specific Antigen (PSA) Density: Defining the Optimal PSA Range and Patients for Using PSA Density to Predict Prostate Cancer Using Extended Template Biopsy.

OBJECTIVE: To compare the predictive accuracy of prostate-specific antigen (PSA) density vs PSA across different PSA ranges and by prior biopsy status in a prospective cohort undergoing prostate biopsy. MATERIALS AND METHODS: Men from a prospective trial underwent an extended template biopsy to evaluate for prostate cancer at 26 sites throughout the United States. The area under the receiver operating curve assessed the predictive accuracy of PSA density vs PSA across 3 PSA ranges (<4 ng/mL, 4-10 ng/mL, >10 ng/mL). We also investigated the effect of varying the PSA density cutoffs on the detection of cancer and assessed the performance of PSA density vs PSA in men with or without a prior negative biopsy. RESULTS: Among 1290 patients, 585 (45%) and 284 (22%) men had prostate cancer and significant prostate cancer, respectively. PSA density performed better than PSA in detecting any prostate cancer within a PSA of 4-10 ng/mL (area under the receiver operating characteristic curve [AUC]: 0.70 vs 0.53, P < .0001) and within a PSA >10 mg/mL (AUC: 0.84 vs 0.65, P < .0001). PSA density was significantly more predictive than PSA in detecting any prostate cancer in men without (AUC: 0.73 vs 0.67, P < .0001) and with (AUC: 0.69 vs 0.55, P < .0001) a previous biopsy; however, the incremental difference in AUC was higher among men with a previous negative biopsy. Similar inferences were seen for significant cancer across all analyses. CONCLUSION: As PSA increases, PSA density becomes a better marker for predicting prostate cancer compared with PSA alone. Additionally, PSA density performed better than PSA in men with a prior negative biopsy.

Autologous tunica vaginalis and subcapsular orchiectomy: a hormonal therapy for prostate cancer.

Two novel surgical procedures that combine an autologous tunica vaginalis pedicle graft (TVG) with a subcapsular orchiectomy (SCOT) were evaluated in asymptomatic patients with rising prostate-specific antigen (PSA) values following radiation therapy, a radical retropubic prostatectomy, or a newly diagnosed prostatic cancer with bony metastasis. In the SCOT I procedure, the TVG was secured to the inner wall of the tunica albuginea. In the SCOT II procedure, the TVG was folded and secured to the external wall of the tunica albuginea. Between December 1, 1999, and July 1, 2000, 26 patients were offered hormonal therapy. Twelve patients selected the SCOT I procedure, 12 selected a luteinizing hormone-releasing hormone (LHRH) agonist, and 2 selected a bilateral total orchiectomy (BTO). Because the cosmetic outcome of the SCOT I procedure was less than ideal, this procedure was modified in December 2001. Between December 1, 2001, and July 1, 2002, 28 hormonal candidates were evaluated. Twelve patients selected the SCOT II procedure, 11 selected an LHRH agonist, and 5 selected a BTO. Preoperative measurements of the testicular area and PSA were obtained. During postoperative visits, the total testosterone, PSA, and testicular area were determined, and the Fugl-Meyer questionnaire (FMQ) and SCOT-specific questionnaire (SSQ) were completed. Between March 1, 2000, and December 1, 2002, 10 patients underwent a BTO. This group was the control for the postoperative SCOT total testosterone values. Sixty-three percent of the mean preoperative testicular area was preserved in the SCOT II group vs 43% in the SCOT I group at the 9- to 12-month visit (P <.01). The mean postoperative total testosterone values for the SCOT I, SCOT II, and BTO groups were in the castrate range. No statistically significant difference was noted between the preoperative and postoperative FMQ scores among the SCOT I and SCOT II groups. Eighty-three percent of the SCOT II patients experienced no change in masculine identity, and 58% noted no change in testicular size. One hundred percent of the SCOT I patients experienced no change in masculine identity and noted no change in testicular size. The SCOT II procedure preserved a greater testicular area than the SCOT I. Both SCOT procedures achieved castrate levels of total testosterone and maintained masculine identity in 83%-100% of patients.

Safety profile of robot-assisted radical prostatectomy: a standardized report of complications in 3317 patients.

BACKGROUND: Previous studies attempting to assess complications after robot-assisted radical prostatectomy (RARP) are limited by their small numbers, short follow-up, or lack of risk factor analysis. OBJECTIVE: To document complications after RARP by strict application of standardized reporting criteria. DESIGN, SETTING, AND PARTICIPANTS: Between January 2005 and December 2009, 3317 consecutive patients underwent RARP at a tertiary referral center. Median follow-up was 24.2 mo (interquartile range: 12.4-36.9). INTERVENTION: Transperitoneal RARP was performed by one of five surgeons-two experienced, three beginners. MEASUREMENTS: Complications were captured by exhaustive review of multiple datasets, including our prospective prostate cancer database, claims data, and electronic medical and institutional morbidity and mortality records, and reported according to the Martin-Donat criteria. Complications were stratified by type (medical/surgical), Clavien classification, and timing of onset. Multivariable analysis of factors predictive of complications was performed. RESULTS AND LIMITATIONS: The median hospitalization time was 1 d. There were 368 complications in 326 patients (9.8%), including a transfusion rate of 2.2%. We detected 79 medical complications in 78 patients (2.4%) and 289 surgical complications in 264 patients (8.0%). There were 242 minor (Clavien 1-2) and 126 major (Clavien 3-5) complications. Two hundred ninety-nine (81.3%) complications occurred within 30 d, 17 (4.6%) within 31-90 d, and 52 (14.1%) after 90 d from surgery. On multivariable analysis, preoperative prostate-specific antigen values and cardiac comorbidity were predictive for medical complications, whereas age, gastroesophageal reflux disease, and biopsy Gleason score were predictive of surgical complications. Limitations of this study include representing results from a single high-volume referral center and not including the learning curve of the two most experienced surgeons. CONCLUSIONS: RARP is a safe operation, with an overall complication rate of 9.8%. Most complications occurred within 30 d of surgery.

Vattikuti Institute prostatectomy: technical modifications in 2009.

BACKGROUND: Since we last published our technique of robotic prostatectomy, we have introduced three technical refinements: superveil nerve sparing, bladder drainage with a percutaneous suprapubic tube (PST), and limited node dissection of the obturator and internal iliac nodes in preference to the external iliac nodes in selected patients. OBJECTIVE: To describe selection criteria, to explain the three techniques, and to evaluate functional and oncologic results. DESIGN, SETTING, AND PARTICIPANTS: Single-institution study of 1151 radical prostatectomies performed from 2006 to 2008 by one surgeon. SURGICAL PROCEDURE: The superveil nerve-sparing technique spares nerves from the 11-o'clock position to the 1-o'clock position. The bladder is drained with a PST rather than a urethral catheter. For low- or intermediate-risk disease, limited lymphadenectomy concentrates on the internal iliac and obturator nodes, excluding the external iliac lymph nodes. MEASUREMENTS: Erectile function and patient comfort were evaluated using questionnaires administered by a third party. Lymph node yield was quantified by a qualified uropathologist. RESULTS AND LIMITATIONS: At 6-18 months after surgery, 94% of men who attempted sexual intercourse were successful with a median Sexual Health Inventory For Men (SHIM) score of 18 out of 25. PST bladder drainage resulted in less patient discomfort; visual analog scores were 2 at 2 days after prostatectomy and 0 at 6 days after prostatectomy. The modified lymphadenectomy harvested few overall nodes, but it increased the yield of positive nodes >13-fold in patients with low-risk stratification (6.7% compared with 0.5%). CONCLUSION: In this single-institution, single-surgeon study, these modifications improved erectile function outcomes, decreased catheter-associated discomfort, and enhanced the detection of positive nodes.

Robotic-assisted radical prostatectomy in patients receiving chronic anticoagulation therapy: role of perioperative bridging.

OBJECTIVES: Patients requiring chronic anticoagulation therapy (CAT) with warfarin require special attention perioperatively. We retrospectively reviewed our experience of treating patients requiring CAT who underwent robotic-assisted radical prostatectomy (RARP) to evaluate the role of perioperative bridging therapy. METHODS: A total of 60 patients receiving cat with warfarin who underwent rarp were identified as having been treated using 1 of 2 protocols: protocol 1, the cessation of CAT 7 days before surgery and its resumption the evening of catheter removal (postoperative day 4-21); or protocol 2, warfarin substituted with perioperative subcutaneous low-molecular-weight heparin, with oral anticoagulation restarted after catheter removal. The decision to use perioperative bridging was made in conjunction with the patient's primary care physician. The peri- and postoperative parameters and complications were compared with a matched control group of 181 contemporary patients who underwent RARP but did not require CAT. RESULTS: The most common indications for CAT were atrial fibrillation (58%) and recurrent deep vein thrombosis (22%). Compared with the control cohort, the patients with CAT had an increased operative time (189 vs 170 minutes, P = .005) and hospital stay (1.4 vs 1.1 days, P = .004). The estimated blood loss (123.9 vs 146.6 mL, P = .07) and 24-hour change in hemoglobin (2.2 vs 2.3 g/dL, P = .44) were similar. When comparing the 2 protocols, a significantly greater transfusion rate (23% vs 2%, P = .042) occurred with protocol 2, but no increase was seen in the complication or readmission rate. One nonfatal thromboembolic event occurred in 1 patient treated using protocol 1. CONCLUSIONS: The results of our study have shown that RARP can be performed safely in patients requiring CAT, with and without bridging therapy. Patients in protocol 2 had greater transfusion rates, but this did not translate into increased complications or readmissions.