Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept study.

BACKGROUND: Retained surgical sharps (RSS) is a "never event" that is preventable but may still occur despite of correct count and negative X-ray. This study assesses the feasibility of a novel device ("Melzi Sharps Finder®" or MSF) in effective detection of RSS. METHODS: The first study consisted of determination of the presence of RSS or identification of RSS in an ex-vivo model (a container with hay in a laparoscopic trainer box). The second study consisted of determining presence of RSS in an in-vivo model (laparoscopy in live adult Yorkshire pigs) with 3 groups: C-arm, C-arm with MSF and MSF. The third study used similar apparatus though with laparotomy and included 2 groups: manual search and MSF. RESULTS: In the first study, the MSF group had a higher rate of identification of a needle and decreased time to locate a needle versus control (98.1% vs. 22.0%, p < 0.001; 1.64 min ± 1.12vs. 3.34 min ± 1.28, p < 0.001). It also had increased accuracy of determining the presence of a needle and decreased time to reach this decision (100% vs. 58.8%, p < 0.001; 1.69 min ± 1.43 vs. 4.89 min ± 0.63, p < 0.001). In-the second study, the accuracy of determining the presence of a needle and time to reach this decision were comparable in each group (88.9% vs. 100% vs. 84.5%, p < 0.49; 2.2 min ± 2.2 vs. 2.7 min ± 2.1vs. 2.8 min ± 1.7, p = 0.68). In the third study, MSF group had higher accuracy in determining the presence of a needle and decreased time to reach this decision than the control (97.0% vs. 46.7%, p < 0.001; 2.0 min ± 1.5 vs. 3.9 min ± 1.4; p < 0.001). Multivariable analysis showed that MSF use was independently associated with an accurate determination of the presence of a needle (OR 12.1, p < 0.001). CONCLUSIONS: The use of MSF in this study's RSS models facilitated the determination of presence and localization of RSS as shown by the increased rate of identification of a needle, decreased time to identification and higher accuracy in determining the presence of a needle. This device may be used in conjunction with radiography as it gives live visual and auditory feedback for users during the search for RSS.

PSA and PSA Kinetics as Predictors for 18F-Fluciclovine PET/CT Positivity in Biochemically Recurrent Prostate Cancer.

INTRODUCTION: 18F-Fluciclovine PET/CT is one of the imaging techniques currently employed to restage prostate cancer (PCa). Due to the conflicting results reported in the literature, it is not yet known at what PSA threshold 18F-fluciclovine PET/CT could reliably demonstrate the presence of recurring disease. We explored the association between 18F-fluciclovine PET/CT positivity and prescan PSA, PSA doubling time, and PSA velocity in patients with biochemical recurrence (BCR) of PCa after curative-intent treatment. METHODS: Data from 59 patients who underwent 18F-fluciclovine PET/CT for BCR after radical prostatectomy or radiotherapy were retrieved from a single institution database. Patients already undergone salvage treatments at the time of PET/CT, with newly diagnosed PCa or with initial diagnosis of metastatic PCa were excluded. A 2-sided independent samples Bayesian t test and Bayesian Mann-Whitney U test were used to assess the association between PET/CT and prescan PSA, PSA doubling time, and PSA velocity. RESULTS: Evidence for no difference between PET/CT-positive and -negative patients for log-transformed PSA was found (BF01 3.61, % error: 0.01). Robustness check and sequential analysis showed stability across a wide range of prior distribution specifications. The hypothesis of no difference in terms of PSA-dt and for PSA-vel between groups was found to be more likely compared to the alternative hypothesis (BF01 of 3.44 and 3.48, respectively). CONCLUSION: PSA and PSA kinetics are unlikely to be associated with 18F-fluciclovine PET/CT positivity in patients with BCR, and none of these serum biomarkers might be used as single predictors of PET/CT detection. Larger studies might be needed to evaluate the role of different predictors.

Regulation of bladder dynamic elasticity: a novel method to increase bladder capacity and reduce pressure using pulsatile external compressive exercises in a porcine model.

PURPOSE: Dynamic elasticity is a biomechanical property of the bladder in which muscle compliance can be acutely adjusted through passive stretches and reversed with active contractions. The aim of this study was to determine if manipulating dynamic elasticity using external compression could be used as a novel method to acutely increase bladder capacity and reduce bladder pressure in a porcine model. METHODS: Ex vivo experiment: bladders underwent continuous or pulsatile compression after establishing a reference pressure at bladder capacity. Bladders were then filled back to the reference pressure to determine if capacity could be acutely increased. In-vivo experiments: bladders underwent five cycles of pulsatile external compression with ultrasound confirmation. Pre and post-compression pressures were measured, and pressure was measured again 10 min post-compression. RESULTS: Ex vivo experiment: pulsatile compression demonstrated increased bladder capacity by 16% (p = 0.01). Continuous compression demonstrated increased capacity by 9% (p < 0.03). Comparison of pulsatile to continuous compression showed that the pulsatile method was superior (p = 0.03). In-vivo experiments: pulsatile external compression reduced bladder pressure by 19% (p < 0.00001) with a return to baseline 10 min post-compression. CONCLUSIONS: These results suggest that regulation of bladder dynamic elasticity achieved with external compression can acutely decrease bladder pressure and increase bladder capacity. Pulsatile compression was found to be more effective as compared to continuous compression. These results highlight the clinical potential for use of non-invasive pulsatile compression as a therapeutic technique to increase bladder capacity, decrease bladder pressure, and reduce the symptoms of urinary urgency.

Risk factors and preventive strategies for unintentionally retained surgical sharps: a systematic review.

BACKGROUND: A retained surgical item (RSI) is defined as a never-event and can have drastic consequences on patient, provider, and hospital. However, despite increased efforts, RSI events remain the number one sentinel event each year. Hard foreign bodies (e.g. surgical sharps) have experienced a relative increase in total RSI events over the past decade. Despite this, there is a lack of literature directed towards this category of RSI event. Here we provide a systematic review that focuses on hard RSIs and their unique challenges, impact, and strategies for prevention and management. METHODS: Multiple systematic reviews on hard RSI events were performed and reported using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and AMSTAR (Assessing the methodological quality of systematic reviews) guidelines. Database searches were limited to the last 10 years and included surgical "sharps," a term encompassing needles, blades, instruments, wires, and fragments. Separate systematic review was performed for each subset of "sharps". Reviewers applied reciprocal synthesis and refutational synthesis to summarize the evidence and create a qualitative overview. RESULTS: Increased vigilance and improved counting are not enough to eliminate hard RSI events. The accurate reporting of all RSI events and near miss events is a critical step in determining ways to prevent RSI events. The implementation of new technologies, such as barcode or RFID labelling, has been shown to improve patient safety, patient outcomes, and to reduce costs associated with retained soft items, while magnetic retrieval devices, sharp detectors and computer-assisted detection systems appear to be promising tools for increasing the success of metallic RSI recovery. CONCLUSION: The entire healthcare system is negatively impacted by a RSI event. A proactive multimodal approach that focuses on improving team communication and institutional support system, standardizing reports and implementing new technologies is the most effective way to improve the management and prevention of RSI events.

Incidence and OR team awareness of "near-miss" and retained surgical sharps: a national survey on United States operating rooms.

INTRODUCTION: A retained surgical sharp (RSS) is a never event and defined as a lost sharp (needle, blade, instrument, guidewire, metal fragment) that is not recovered prior to the patient leaving the operating room. A "near-miss" sharp (NMS) is an intraoperative event where there is a lost surgical sharp that is recovered prior to the patient leaving the operating room. With underreporting of such incidents, it is unrealistic to expect aggressive development of new prevention and detection strategies. Moreover, awareness about the issue of "near-miss" or retained surgical sharps remains limited. The aim of this large-scale national survey-based study was to estimate the incidence of these events and to identify the challenges surrounding the use of surgical sharps in daily practice. METHODS: We hypothesized that there was a larger number of RSS and NMS events than what was being reported. We survived the different OR team members to determine if there would be discordance in reported incidence between groups and to also evaluate for user bias. An electronic survey was distributed to OR staff between December 2019 and April 2020. Respondents included those practicing within the United States from both private and academic institutions. Participants were initially obtained by designating three points of contact who identified participants at their respective academic institutions and while attending specialty specific medical conferences. Together, these efforts totaled 197 responses. To increase the number of respondents, additional emails were sent to online member registries. Approximately 2650 emails were sent resulting in an additional 250 responses (9.4% response rate). No follow up reminders were sent. In total, there were 447 survey responses, in which 411 were used for further analysis. Thirty-six responses were removed due to incomplete respondent data. Those who did not meet the definition of one of the three categories of respondents were also excluded. The 411 were then categorized by group to include 94 (22.9%) from anesthesiologist, 132 (32.1%) from resident/fellow/attending surgeon and 185 (45%) from surgical nurse and technologist. SURVEY: The survey was anonymous. Participants were asked to answer three demographic questions as well as eight questions related to their personal perception of NMS and RSS (Fig. 1). Demographic questions were asked with care to ensure no identifiable information was obtained and therefore unable to be traced back to a specific respondent or institution. Perception questions 4-6 and 11 were designed to understand the incidence of various sharp events (e.g. lost, retained, miscounted). Questions 7 and 10 were dedicated to understanding time spent managing sharps and questions 8 and 9 were dedicated to understanding the use x-ray and its effectiveness. RESULTS: Overall, most of each respondent group reported 1-5 lost sharp events over the last year. Roughly 20% of surgeons believed they never had a miscounted sharp over the last year, where only 5.3% of anesthesiologist reported the same (p = 0.002). Each group agreed that roughly 4 lost events occur every 1000 surgeries, but a significant difference was found between the three groups regarding the number of lost sharps not recovered per 10,000 surgeries with anesthesiologist, surgeon and nurse/technologist groups estimating 2.37, 2.56 and 2.94 respectively (p = 0.001). All groups noted x-ray to offer poor effectiveness at 26-50% with 31-40 min added for each time x-ray was used. More than half (56.8%) of surgeons reported using x-ray 100% of the time when managing a lost sharp whereas anesthesiologists and nurses/technologists believe it is closer to 1/3 of the time. An average of 21-30 min is spent managing each NMS, making a lost sharp event result in up to 70 min of added OR time. CONCLUSIONS: "Near-miss" and RSS are more prevalent than what is reported in current literature. Surgeons perceive a higher rate of success in retrieving the RSS when compared to anesthesiologists and OR nurses/technologists. We recognize several challenges surrounding "near-miss" and never events as contributing factors to their underreported nature and the higher degree of surgeon recall bias associated with these events. Additionally, we highlight that current methods for prevention are costly in time and resources without improvement in patient safety. As NMS and RSS have significant health system implications, a strong understanding of these implications is important as we strive to improve patient safety.

Simplified PADUA Renal (SPARE) Nephrometry Scoring System: External Validation, Interobserver Variability, and Comparison with RENAL and PADUA in a Single-center Robotic Partial Nephrectomy Series.

BACKGROUND: The RENAL (radius [R], exophytic/endophytic [E], nearness to collecting system/sinus [N], anterior/posterior [A], and location relative to polar lines [L]) and the PADUA (preoperative aspects and dimensions used for an anatomical classification) scores help in quantifying tumor complexity. However, nephrometry scoring systems have low interobserver variability. To simplify and improve score reproducibility, a new Simplified PADUA Renal (SPARE) scoring system was introduced. OBJECTIVE: To externally validate the SPARE nephrometry scoring system and to determine its interobserver variability. DESIGN, SETTING, AND PARTICIPANTS: A total of 202 patients were included in the analysis. We performed a retrospective analysis of robot-assisted partial nephrectomy (RAPN) cases for a single renal mass performed at a single academic institution during the period 2008-2018. For each renal mass, PADUA, RENAL, and SPARE nephrometry scores were calculated. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Three urology residents (URs), two urology attendings (UAs), two radiology residents (RRs), and one radiology attending (RA) retrospectively reviewed computed tomography scans blinded to clinical outcomes. The accuracy of the SPARE nephrometry score in the prediction of any complication (Clavien grade ≥1) was compared with other scoring systems in a univariable and a multivariate fashion. The area under the curve (AUC) and kappa statistics were used to assess interobserver variability of the SPARE score. RESULTS AND LIMITATIONS: The SPARE score was not inferior to the PADUA and RENAL scores (AUC 0.61, 0.59, and 0.57, respectively, p = 0.43). Patients with intermediate to high SPARE scores had longer operative time (158 vs 135 min, p = 0.10) and a higher rate of complications (28% vs 14%, p = 0.012). Univariable analysis predicting overall complications showed that RRs performed slightly better than URs and UAs using the SPARE score. Interobserver agreement was 84% between an RA and an RR (kappa 0.42), 85% between an RA and a UA (kappa 0.39), and 85% between an RA and a UR (kappa 0.45). CONCLUSIONS: These findings confirm that the SPARE nephrometry scoring system is a reproducible and easy tool offering overall fair interobserver agreement regardless of years of training or type of practice, while maintaining the predictive capabilities of more established nephrometry scores. PATIENT SUMMARY: In this study, a novel and simple classification system was assessed using a sample of cases from our institution to define surgical complexity renal masses detected on radiological imaging. Our findings suggest that this tool can be useful in clinical practice to facilitate the characterization of renal masses and predict the complications of surgical treatment.

Robot-assisted partial nephrectomy: 7-year outcomes.

BACKGROUND: The role of robot-assisted partial nephrectomy (RAPN) in the management of renal masses has exponentially grown over the past 10 years. Nevertheless, data on long term outcomes of the procedure remains limited. Herein we report oncological and functional outcomes of patients who underwent RAPN for a malignant mass with a median follow-up of 7 years, the longest follow-up to date. METHODS: A retrospective analysis of an international multicenter database was performed. All consecutive patients undergoing surgery between 2009 and 2013 with a minimum of 3-year follow-up and complete data on renal function were included. Demographics, surgical and perioperative outcomes were analyzed. Overall survival (OS), disease-free survival (DFS), and cancer-specific survival (CSS) were evaluated using Kaplan-Meier analysis. RESULTS: Overall, our study cohort was composed of eighty-five patients with a median follow-up of 88 months. Median clinical tumor size was 3 cm, with mostly (74.1%) clinical stage T1a, and median RENAL score 6. Final histopathologic analysis revealed clear cell RCC in 76.5% of cases. PSM was present in seven patients (8.2%). Eleven overall deaths (12.9%) occurred in the cohort during the follow-up period. Two of these (2.33%) were attributed to metastatic RCC. The OS, CSS, and DFS rates were 91.7%, 97.7%, and 91.7% at 84 months, respectively. Regarding the renal functional outcomes, seventeen patients (20.1%) presented a CKD upstaging in our cohort. CONCLUSIONS: Our findings show excellent 7-year oncologic and functional outcomes of the procedure, which duplicate those achieved in historical series of open and laparoscopic surgery.

Robotic-assisted surgery for the treatment of urologic cancers: recent advances.

INTRODUCTION: As the medical field is moving toward personalized and tailored approaches, we entered the era of precision surgery for the management of genitourinary cancers1. This is facilitated by the implementation of new technologies, among which robotic surgery stands out for the significant impact in the surgical field over the last two decades. AREAS COVERED: This article reviews the latest evidence on robotic surgery for the treatment of urologic cancers, including prostate, kidney, bladder, testis, and penile cancer. Functional and oncologic outcomes, new surgical techniques, new imaging modalities, and new robotic platforms are discussed. EXPERT OPINION: Robotic surgery had a growing role in the management of genitourinary cancers over the past 10 years. Despite a lack of high-quality evidence comparing the effectiveness of robotic to open surgery, the robotic approach allowed a larger adoption of a minimally invasive surgical approach, translating into lower surgical morbidity and shorter hospital stay. New robotic platforms might allow to explore novel surgical approaches, and new technologies might facilitate surgical navigation and intraoperative identification of anatomical structures, allowing a more tailored and precise surgery. It is an exciting time for robotic surgery, and upcoming technological advances will offer better outcomes to urologic cancer patients.

Association of Low Socioeconomic Status With Adverse Prostate Cancer Pathology Among African American Men Who Underwent Radical Prostatectomy.

BACKGROUND: We tested for associations between socioeconomic status (SES) and adverse prostate cancer pathology in a population of African American (AA) men treated with radical prostatectomy (RP). PATIENTS AND METHODS: We retrospectively reviewed data from 2 institutions for AA men who underwent RP between 2010 and 2015. Household incomes were estimated using census tract data, and patients were stratified into income groups relative to the study population median. Pathologic outcomes after RP were assessed, including the postsurgical Cancer of the Prostate Risk Assessment (CAPRA-S) score and a definition of adverse pathology (stage ≥ pT3, Gleason score ≥ 4+3, or positive lymph nodes), and compared between income groups. RESULTS: We analyzed data of 347 AA men. Median household income was $37,954. Low-SES men had significantly higher prostate-specific antigen values (mean 10.2 vs. 7.3; P < .01) and CAPRA-S scores (mean 3.4 vs. 2.5; P < .01), more advanced pathologic stage (T3-T4 31.8% vs. 21.5%; P = .03), and higher rates of seminal vesicle invasion (17.3% vs. 8.2%; P < .01), positive surgical margins (35.3% vs. 22.1%; P < .01), and adverse pathology (41.4% vs. 30.1%; P = .03). Linear and logistic regression showed significant inverse associations of SES with CAPRA-S score (P < .01) and adverse pathology (P = .03). CONCLUSION: In a population of AA men who underwent RP, we observed an independent association of low SES with advanced stage or aggressive prostate cancer. By including only patients in a single racial demographic group, we eliminated the potential confounding effect of race on the association between SES and prostate cancer risk. These findings suggest that impoverished populations might benefit from more intensive screening and early, aggressive treatment of prostatic malignancies.

Lower Genitourinary Foreign Bodies: An Institutional Experience and Description of a Novel, Minimally-invasive Extraction Technique for Anterior Urethral Objects.

OBJECTIVE: To describe our experience with management of lower genitourinary foreign bodies (FBs); to introduce our novel, but simple and minimally-invasive retrieval method compared with standard techniques for anterior urethral FBs; and to propose a derived, practical management algorithm. METHODS: We reviewed all male patients presenting with inserted urethral and/or bladder FBs between January2000 and October 2018. Patient characteristics and number of episodes were identified. Episodes were stratified by FB type, FB location, diagnostic modality, and removal method. We performed a subgroup analysis of anterior urethral FB management techniques comparing retrieval outcomes using our novel Retrieval of Anterior urethral Materials Safely (RAMS) technique which utilizes urethral hydrodistension via retrograde injection of lidocaine jelly to expel FBs vs forceps extraction. Cost analyses were performed, and a management algorithm was then derived. RESULTS: We identified 116 episodes. Eighty-seven of 116 (75%) episodes involved items located within the anterior urethra. A subset of episodes (14/116, 12%) was managed using the RAMS technique. There was no difference in FB extraction success rates between RAMS (13/14, 92.9%) and forceps extraction (37/40, 92.7%), P = 1.00. FBs were successfully removed using RAMS when utilized for nonembedded FBs located entirely within the anterior urethra. Among FBs located within the anterior urethra, the median total hospital cost was nearly 10 times less with utilization of RAMS compared with cystoscopic extraction ($379.09 v s$3,214.21, P <.05). CONCLUSION: Because an overwhelming majority of FBs are located within the anterior urethra, the RAMS technique represents a simple, cost-conscious, and minimally-invasive strategy with low risk and potentially high-yield for initial extraction in the emergency department.

Rationale for Robotic-assisted Simple Prostatectomy for Benign Prostatic Obstruction.

Current evidence supports the role of robotic-assisted simple prostatectomy as safe and effective minimally invasive surgical treatment of benign prostatic obstruction.

Small Cell Carcinoma of the Prostate: A Case Report and Brief Review of the Literature.

Small cell carcinoma of the prostate (SCCP) is a rare disorder. We present here a case of SCCP exhibiting multiple unique clinical findings, demonstrating the variability of SCCP at presentation.

Devising a Method to Study if Wernicke's Aphasia Patients are Aware That They Do Not Comprehend Language or Speak It Understandably.

Wernicke's Aphasia (WA) is characterized by an individual speaking fluent gibberish without the ability to understand anything that is said to them or anything they attempt to read. It is caused by damage to the left posterior temporoparietal cortex, also known as Wernicke's area. An additional intriguing symptom of WA patients is their apparent obliviousness to their own lack of understanding despite their intact reasoning or other cognitive abilities. Their only deficit seems to be in the basic rules of language that define word meaning, also known as phonology. Growing out of a project in an undergraduate class, we devised a phonology-free approach to communicating with WA patients that attempts to answer the questions of whether WA patients know that they do not understand what is said to them, that others do not understand what they have said, and if these patients are distressed by this lack of communication. We here describe the process and the resulting method.

Discrimination between lung homeostatic and injury-induced epithelial progenitor subsets by cell-density properties.

Stem/progenitor cells and their lineage derivatives are often identified by patterns and intensity of cell clusters of differentiation presentation. However, the cell biochemical façade can prove to be elusive, transient, and subject to interlaboratory disparities. To enhance current methods of lung stem cell isolation and identification and to investigate biophysical changes, which occur during homeostasis and in response to acute lung injury, we separated cells on a discontinuous density gradient, of 1.025-1.074 g/cm(3), and characterized the eluted lineages. At homeostasis, surfactant protein-C (SFTPC)-expressing cells of the alveolar type (AT)-2 lineage possessed average densities ≥1.039 g/cm(3) and aquaporin-5 producing AT1 cells equilibrated at densities <1.039 g/cm(3). While 0.74%±0.32% of lung cells were determined proliferating or postmitotic by BrdU nucleotide uptake, 73% of CD49f-, 72% of c-KIT-, and 61% of SCA-1-positive cells (putative alveolar progenitor lineage markers) showed densities ≤1.039 g/cm(3). CD49f/EpCAM(hi) progenitors, as well as c-KIT(pos)/CD45(neg) cells, could be enriched at the 1.039 g/cm(3) interface. Following acute bleomycin-induced injury, the frequency of BrdU-incorporating cells rose to 0.92%±0.36% and density could largely explain cell-lineage distribution. Specifically, a decline in the density of mitotic/postmitotic SFTPC-positive cells to ≤1.029 g/cm(3), in conjunction with an increase in CD45-positive, and proliferating CD45 and c-KIT cells in the heaviest fraction (≥1.074 g/cm(3)) were observed. These data attest to the generation of AT2 cells from low-density precursors and emphasize a relationship between cell density and molecular expression following injury, expanding on our current understanding of lung and progenitor cell dynamics.