Polydactylous Squamous Cell Carcinoma of the Nail Unit: A Structured Review of the Literature.

Squamous cell carcinoma of the nail unit (SCCNU) is a rare neoplastic condition that involves multiple digits (polydactylous SCCNU) in only 3.9% of cases. Here, we report a case of polydactylous SCCNU and perform a comprehensive review of MEDLINE and Embase to collate 44 cases of polydactylous SCCNU reported to date. Polydactylous patients were younger on average (48 to 61-63 years) and had a longer diagnostic delay (44 vs 35.1 months) compared with reported monodactylous cases. Human papillomavirus (HPV) positivity was observed in 49% of cases, and the most common serotypes noted were 16 (25.8%), 73 (16.1%), 58 (9.7%), 18 (6.5%), and 33 (6.5%). Twenty percent of the cases were in immunosuppressed individuals who had a statistically significant lower age at diagnosis (39.33 years vs 51.12 years; P = .01) and diagnostic delay (2.50 months vs 132.46 months, P = .04). Patients with HPV positivity had a lower age at diagnosis (43.74 years vs 53.29 years, P = .04). Environmental exposures noted to be associated with polydactylous disease included X-rays, paint/solvents, soluble oils, and stagnant water. This comprehensive literature review serves to characterize polydactylous SCCNU and distinguish the differences in its characteristics to improve diagnosis and clinical recognition.

Inhaled vitamin A is more effective than intramuscular dosing in mitigating hyperoxia-induced lung injury in a neonatal rat model of bronchopulmonary dysplasia.

Prevention of bronchopulmonary dysplasia (BPD) in premature-birth babies continues to be an unmet medical need. Intramuscular vitamin A is currently employed in preterm neonates to prevent BPD but requires intramuscular injections in fragile neonates. We hypothesized that noninvasive inhaled delivery of vitamin A, targeted to lung, would be a more effective and tolerable strategy. We employed our well-established hyperoxia-injury neonatal rat model, exposing newborn rats to 7 days of constant extreme (95% O2) hyperoxia, comparing vitamin A dosed every 48 h via either aerosol inhalation or intramuscular injection with normoxic untreated healthy animals and vehicle-inhalation hyperoxia groups as positive and negative controls, respectively. Separately, similar vitamin A dosing of normoxia-dwelling animals was performed. Analyses after day 7 included characterization of alveolar histomorphology and protein biomarkers of alveolar maturation [surfactant protein C (SP-C), peroxisome proliferator-activated receptor (PPAR) γ, cholinephosphate cytidylyl transferase, vascular endothelial growth factor and its receptor, FLK-1, and retinoid X receptors (RXR-α, -ß, and -γ], apoptosis (Bcl2 and Bax) key injury repair pathway data including protein markers (ALK-5 and ß-catenin) and neutrophil infiltration, and serum vitamin A levels. Compared with intramuscular dosing, inhaled vitamin A significantly enhanced biomarkers of alveolar maturation, mitigated hyperoxia-induced lung damage, and enhanced surfactant protein levels, suggesting that it may be more efficacious in preventing BPD in extremely premature infants than the traditionally used IM dosing regimen. We speculate lung-targeted inhaled vitamin A may also be an effective therapy against other lung damaging conditions leading to BPD or, more generally, to acute lung injury.

Inflatable Penile Prosthesis in the Ambulatory Surgical Setting: Outcomes From a Large Urological Group Practice.

BACKGROUND: The definitive treatment for erectile dysfunction is the surgical implantation of a penile prosthesis, of which the most common type is the 3-piece inflatable penile prosthesis (IPP) device. IPP surgery in outpatient freestanding ambulatory surgical centers (ASC) is becoming more prevalent as payers and health systems alike look to reduce healthcare costs. AIM: To evaluate IPP surgical outcomes in an ASC as compared to contemporaneously-performed hospital surgeries. METHODS: A database of all patients undergoing IPP implantation by practitioners in the largest private community urology group practice in the United States, from January 1, 2013 to August 1, 2019, was prospectively compiled and retrospectively reviewed. Cohorts of patients having IPP implantation performed in the hospital vs ASC setting were compared. MAIN OUTCOME MEASURE: The primary outcome measure was to compare surgical data (procedural and surgical times, need for hospital transfer from ASC) and outcomes (risk for device infection, erosion, and need for surgical revision) between ASC and hospital-based surgery groups. RESULTS: A total of 923 patients were included for this analysis, with 674 (73%) having ASC-based surgery and 249 (27%) hospital-based, by a total of 33 surgeons. Median procedural (99.5 vs 120 minutes, P < .001) and surgical (68 vs 75 minutes, P < .001) times were significantly shorter in the ASC. While the risk for device erosion and need for surgical revision were similar between groups, there was no higher risk for prosthetic infection when surgery was performed in the ASC (1.7% vs 4.4% [hospital], P = .02), corroborated by logistic regression analysis (odds ratio 0.39, P = .03). The risk for postoperative transfer of an ASC patient to the hospital was low (0.45%). The primary reason for mandated hospital-based surgery was medical (51.4%), though requirement as a result of insurance directive (39.7%) was substantial. CLINICAL IMPLICATIONS: IPP implantation in the ASC is safe, has similar outcomes compared to hospital-based surgery with a low risk for need for subsequent hospital transfer. STRENGTHS & LIMITATIONS: The strengths of this study include the large patient population in this analysis as well as the real-world nature of our practice. Limitations include the retrospective nature of the review as well as the potential for residual confounding. CONCLUSION: ASC-based IPP implantation is safe, with shorter surgical and procedural times compared to those cases performed in the hospital setting, with similar functional outcomes. These data suggest no added benefit to hospital-based surgery in terms of prosthetic infection risk. Weinberg AC, Siegelbaum MH, Lerner BD, et al. Inflatable Penile Prosthesis in the Ambulatory Surgical Setting: Outcomes From a Large Urological Group Practice. J Sex Med 2020;17:1025-1032.

Allergenic potential, marketing claims, and pricing of facial moisturizers.

Ingredients found in facial moisturizers can impact a myriad of skin conditions, including sensitive skin syndrome and contact dermatitis. There is a paucity of evidence on the allergenic potential and marketing claims of facial moisturizers, posing challenges to clinician recommendation and consumer selection. In this study, we systematically evaluate the 100 top-selling sun protective facial moisturizers that claim to be natural, fragrance free, expert-approved, age preventing, beneficial for sensitive skin, and sun protective. Allergenic potential of these moisturizers is evaluated based on ingredients used and prices and consumer ratings are compared. Accordingly, 75 of 100 marketed at least one additional benefit. "Anti-aging" products had the highest average price ($14.99/oz) and "expert-approved" had the lowest ($5.91/oz). Consumer rating was highest for facial moisturizers that were "fragrance-free" (4.35/5.00) whereas products that were "natural" received the lowest ratings (3.49/5.00). The most prevalent allergens found in these moisturizers were ethylenediamine tetraacetic acid (EDTA), phenoxyethanol, and cetyl alcohol. "Expert-approved" products had the fewest average allergens in their ingredient lists (P=0.033), whereas products advertising "SPF" had significantly more (P<0.001). Marketing claims play a role in product sales and ratings. When recommending products, physicians should balance allergenic risk with affordability and consumer preferences.

Prospective observational study of early respiratory management in preterm neonates less than 35 weeks of gestation.

BACKGROUND: Current guidelines for management of respiratory distress syndrome (RDS) recommend continuous positive airway pressure (CPAP) as the primary mode of respiratory support even in the most premature neonates, reserving endotracheal intubation (ETI) for rescue surfactant or respiratory failure. The incidence and timing of ETI in practice is poorly documented. METHODS: In 27 Level III NICUs in the US (n = 19), Canada (n = 3) and Poland (n = 5), demographics and baseline characteristics, respiratory support modalities including timing of ETI, administration of surfactant and caffeine/other methylxanthines, and neonatal morbidities were prospectively recorded in consecutive preterm neonates following written parental consent. Infants were divided into three groups according to gestational age (GA) at birth, namely 26-28, 29-32 and 33-34 weeks. Statistical comparisons between groups were done using Chi-Square tests. RESULTS: Of 2093 neonates (US = 1507, 254 Canada, 332 Poland), 378 (18%) were 26-28 weeks gestational age (GA), 835 (40%) were 29-32 weeks, and 880 (42%) were 33-34 weeks. Antenatal steroid use was 81% overall, and approximately 89% in neonates ≤32 weeks. RDS incidence and use of ventilatory or supplemental oxygen support were similar across all sites. CPAP was initiated in 43% of all infants, being highest in the 29-32-week group, with a lower proportion in other GA categories (p < 0.001). The overall rate of ETI was 74% for neonates 26-28 weeks (42% within 15 min of birth, 49% within 60 min, and 57% within 3 h), 33% for 29-32 weeks (13 16 and 21%, respectively), and 16% for 33-34 weeks (5, 6 and 8%, respectively). Overall intubation rates and timing were similar between countries in all GAs. Rates within each country varied widely, however. Across US sites, overall ETI rates in 26-28-week neonates were 30-60%, and ETI within 15 min varied from 0 to 83%. Similar within 15-min variability was seen at Polish sites (22-67%) in this GA, and within all countries for 29-32 and 33-34-week neonates. CONCLUSION: Despite published guidelines for management of RDS, rate and timing of ETI varies widely, apparently unrelated to severity of illness. The impact of this variability on outcome is unknown but provides opportunities for further approaches which can avoid the need for ETI.

Differences between Men and Women Regarding Early Maladaptive Schemas in an Australian Adult Alcohol Dependent Clinical Sample.

BACKGROUND: Recent research indicates that there are widespread differences between men and women's Early Maladaptive Schemas (EMSs) in alcohol dependent populations. This study examined this claim. OBJECTIVE: The purpose of this study was to examine differences between men and women's EMSs in an Australian clinical sample who had sought treatment specifically for alcohol dependence. METHODS: A total of 111 men and 114 women completed the Young Schema Questionnaire-Long Form (YSQ-L3) between 2012 and 2015 in order to assess them on 18 EMSs. RESULTS: Despite previous findings suggesting that women report higher levels across a number of EMSs, the strongest evidence pointed to women scoring significantly higher than men on the EMS of self-sacrifice (the tendency to excessively help others whilst continually sacrificing one's own needs). Smaller differences between men and women were noted for the subjugation and failure EMSs. Conclusions/Importance: With the exception regarding the finding that woman scored higher on the self-sacrifice EMS than men, the homogeneity of the remaining EMS scores across men and women found in this study support the use of inter-gender group Schema Therapy (ST) with alcohol-dependent adults in Australia.

The occurrence of Graves disease (autoimmune thyrotoxicosis) in endocrinologists at the Mount Sinai Hospital in New York City from 1954 to 2011.

OBJECTIVE: We report on the unique occurrence of Graves disease (thyrotoxicosis) in 7 male endocrinologists at the Mount Sinai Hospital (MSH) in New York City, New York between 1954 and 2011. METHODS: We followed the endocrinologists and fellows assigned to the division over a period of 57 years by survey and personal contact. In the statistical studies, we assumed that the number of cases had a Poisson distribution and computed the exact probability based on the expected values. RESULTS: Seven male endocrinologists had proven thyrotoxicosis during or following their service in the Endocrine Division at MSH. Six had a family history of thyrotoxicosis. None had known iodine 131 (131-I) thyroid contamination. CONCLUSION: The incidence of thyrotoxicosis greatly exceeds the rate predicted. Postulated factors in the causation of this unique occurrence are discussed.

Characterization of a nose-only inhaled phosgene acute lung injury mouse model.

CONTEXT: Phosgene's primary mode of action is as a pulmonary irritant characterized by its early latent phase where life-threatening, non-cardiogenic pulmonary edema is typically observed 6-24 h post-exposure. OBJECTIVE: To develop an inhaled phosgene acute lung injury (ALI) model in C57BL/6 mice that can be used to screen potential medical countermeasures. METHODS: A Cannon style nose-only inhalation exposure tower was used to expose mice to phosgene (8 ppm) or air (sham). An inhalation lethality study was conducted to determine the 8 ppm median lethal exposure (LCt50) at 24 and 48 h post-exposure. The model was then developed at 1.2 times the 24 h LCt50. At predetermined serial sacrifice time points, survivors were euthanized, body and lung weights collected, and lung tissues processed for histopathology. Additionally, post-exposure clinical observations were used to assess quality of life. RESULTS AND DISCUSSION: The 24-hour LCt50 was 226 ppm*min (8 ppm for 28.2 min) and the 48-hour LCt50 was 215 ppm*min (8 ppm for 26.9 min). The phosgene exposed animals had a distinct progression of clinical signs, histopathological changes and increased lung/body weight ratios. Early indicators of a 1.2 times the 24-hour LCt50 phosgene exposure were significant changes in the lung-to-body weight ratios by 4 h post-exposure. The progression of clinical signs and histopathological changes were important endpoints for characterizing phosgene-induced ALI for future countermeasure studies. CONCLUSION: An 8 ppm phosgene exposure for 34 min (1.2 × LCt50) is the minimum challenge recommended for evaluating therapeutic interventions. The predicted higher mortality in the phosgene-only controls will help demonstrate efficacy of candidate treatments and increase the probability that a change in survival rate is statistically significant.

External validation of a prediction model for penile prosthesis implantation for erectile dysfunction management.

INTRODUCTION: Penile prosthesis implantation (PPI) is the definitive surgical treatment for erectile dysfunction (ED), yet it is often delayed for a variety of reasons. From commercial and Medicare claims data, we previously developed a tool for determining a patient's likelihood of eventually receiving PPI. We validated this instrument's utility by comparing cohorts receiving surgical (PPI) versus non-surgical ED management at a single institution. MATERIAL AND METHODS: The prediction model was based on a logistic regression incorporating claims data on demographics, comorbidities and ED therapy. A risk score is calculated from the model as the product of relative risks for the individual variables. The current validation was a retrospective analysis of ED patients seen at this institution from January to December 2012. Inclusion criteria included ED diagnosis and either first-time PPI or non-surgical treatment (controls). Risk scores for patients receiving PPI were compared to those of non-surgical controls. RESULTS: We established a cohort of 60 PPI patients (mean age 54.4 ± 9.5) and compared them with 120 non-PPI patients (mean age 53.4 ± 11.2 years). The median score of the PPI cohort was 5.7 (IQR 2.8-9.9) versus the non-PPI cohort's 1.8 (IQR 0.9-5.5) (p < 0.0001). The area under the receiver operator characteristic curve for predicting eventual PPI was 0.72 (95% CI, 0.64-0.79) (p < 0.0001). CONCLUSION: The prediction model risk-stratified men who ultimately underwent PPI compared to non-surgically managed controls. This external validation study suggests that the prediction model may be used on an individual patient basis to support a recommendation of PPI for managing ED.

Corporal Burnett "Snake" surgical maneuver for the treatment of ischemic priapism: long-term followup.

PURPOSE: We provide long-term followup on a modification of the Al-Ghorab distal penile corporoglanular shunt surgery for the treatment of ischemic priapism. MATERIALS AND METHODS: We conducted a retrospective review of patients surgically treated for ischemic priapism at The Johns Hopkins Hospital from January 2008 to April 2012 with the Burnett "Snake" maneuver of the Al-Ghorab shunt. Electronic medical records were reviewed to collect demographic information and telephone followup was performed to verify treatment outcomes. Patients completed the SHIM (Sexual Health Inventory for Men) to assess current erectile function. RESULTS: A total of 10 patients were analyzed (age range 31 to 59 years). Mean followup was 6.7 months (range 0.5 to 17). Priapism etiologies were idiopathic (3), trazodone (2), trazodone and cocaine (3), intracavernous injection of trimix (1) and spinal cord injury (1). There were 6 patients who had previously undergone unsuccessful surgical attempts at priapism decompression and mean priapism duration was 75 hours (range 24 to 288). Of the 10 men 8 achieved successful resolution of priapism with no recurrence. There were 2 men with recurrent priapism refractory to all management who were definitively treated with insertion of an inflatable penile prosthesis. Of 9 men 6 had normal erectile function preoperatively, of whom 2 achieved at least partial erectile function postoperatively. Complications were sustained by 2 men, including wound infection with skin necrosis in 1, and an intraoperative urethral injury in the other with subsequent urethrocutaneous fistula formation and wound infection with skin necrosis. CONCLUSIONS: The modified Al-Ghorab corporoglanular shunt using the Burnett snake maneuver is successful in resolving ischemic priapism, particularly in cases refractory to first line management, and in preventing further episodes of priapism.

Combined inflatable penile prosthesis-artificial urinary sphincter implantation: no increased risk of adverse events compared to single or staged device implantation.

PURPOSE: Little data exist on the outcome of combined inflatable penile prosthesis and artificial urinary sphincter insertion for erectile dysfunction and stress urinary incontinence. We assessed patient outcomes for combined vs single device implantation at a single institution. MATERIALS AND METHODS: We retrospectively reviewed the records of all patients who underwent inflatable penile prosthesis and artificial urinary sphincter insertion at our hospital from January 2000 to December 2011. A total of 55 combined procedures were performed compared to the single insertion of 336 inflatable penile prostheses and 279 artificial urinary sphincters. RESULTS: The surgical approach consisted of penoscrotal incisions for inflatable penile prostheses and transperineal incisions for artificial urinary sphincter cuff placement with a secondary lower abdominal incision for reservoir placement. Men treated with combined implantation had greater mean age and were at greater risk for prostate cancer diagnosis and treatment, and at lesser risk for Peyronie disease than men who received an inflatable penile prosthesis alone (each p<0.05). Although operative time was significantly longer for the combined procedure than for the inflatable penile prosthesis alone and the AUS alone (mean 218.1 vs 145.9 and 114.7 minutes, respectively, p<0.0001), the rate of device infection, erosion or malfunction was not increased irrespective of combined or staged procedures (p>0.05). CONCLUSIONS: Combined inflatable penile prosthesis-artificial urinary sphincter implantation and staged prosthesis implantation are feasible without an increased risk of adverse outcomes compared to implantation of a single prosthesis. Patients with concomitant erectile dysfunction and stress urinary incontinence should be counseled about the possible advantages of this surgical option, which include a single anesthesia event and faster resumption of sexual activity and urinary control.

Radical cystectomy in patients with preexisting three-piece inflatable penile prosthesis.

INTRODUCTION: Radical cystectomy with urinary diversion is the treatment of choice for muscle-invasive, and certain populations with non-invasive, urothelial carcinoma of the bladder. There have not been any reports to date on patients undergoing this surgery who have had previous placement of an inflatable penile prosthesis. AIM: To present the outcomes of four patients with pre-existing inflatable penile prostheses (IPP) with reservoirs within the space of Retzius who were subsequently treated with radical cystectomy for bladder cancer management. METHODS: After obtaining institutional review board approval, the demographic, clinical, and pathologic data were reviewed in the Johns Hopkins Cystectomy Database for patients who underwent radical cystectomy for bladder cancer from 1994 to 2012. A case series of four patients is presented who had a preexisting IPP and their post-operative course and long-term outcomes are reviewed. RESULTS: All four patients had radical cystectomy and ileal conduit urinary diversion with no intra-operative or post-operative complications. One patient was not sexually active and therefore had the reservoir explanted and not replaced. The other three patients had the reservoir removed prior to bladder extirpation and the tubing capped, with reservoir replacement in the pseudocapsule at the termination of the procedure. In one patient an omental flap was used to ensure separation between the reservoir and ileal conduit. The devices were all functional intra-operatively and on follow-up. CONCLUSIONS: As erectile dysfunction is more commonly being diagnosed and treated with IPP insertion at younger ages, surgeons will increasingly encounter pre-placed abdominal reservoirs when performing pelvic surgery. This case series of four patients undergoing radical cystectomy with prior-placed IPPs reveals that the functionality of the IPP can be preserved while still performing oncologically sound extirpative procedures.

Viberect penile vibratory stimulation system: evaluation of its erectogenic efficacy.

INTRODUCTION: Current non-surgical strategies employed to treat erectile dysfunction (ED) target the vascular component of erection physiology. The Viberect handheld device (Reflexonic, LLC, Chambersburg, PA, USA) is a new FDA-cleared ED treatment, which exploits vibratory stimulation of genital afferent nerves for provoking erections. The aim of this study was to evaluate the clinical feasibility of the Viberect device for the achievement of penile erection and rigidity. MATERIALS AND METHODS: Subjects for this study were five healthy men (mean age 26.4 years) with normal erectile function as measured by responses to the IIEF-EF. The Viberect treatment at 75 Hz with ventral stimulation was initiated without any external visual sexual stimulation. Both objective Rigiscan measurements of rigidity and subjective Erection Hardness Score (EHS) responses were recorded and correlated. Toleration and safety were monitored. RESULTS: Rigiscan demonstrated that 4/5 subjects achieved tumescence episodes beyond 60% total rigidity (considered the minimum required to achieve a non-buckling erection capable of vaginal intromission). According to EHS, the Viberect treatment yielded scores of 4/4 (penis is completely hard and fully rigid) in 2 subjects, 3/4 (penis hard enough for penetration but not completely hard) in 2 and 2/4 (penis is hard but not enough for penetration) in 1. There were no complications, and all subjects felt that Viberect would be a reasonable, practical ED treatment. CONCLUSION: This study provides evidence that Viberect produces a non-invasive, well-tolerated erectogenic effect. These results indicate that penile vibratory stimulation provokes erections via neurostimulatory principles and support further study of this modality in treating men with ED.

Irbesartan promotes erection recovery after nerve-sparing radical retropubic prostatectomy: a retrospective long-term analysis.

UNLABELLED: Study Type--Therapy (retrospective cohort) Level of Evidence 2b. What's known on the subject? and What does the study add? Erectile dysfunction following radical prostatectomy (RP) is among the most common and dreaded adverse effects of the surgery. Multiple studies confirm the potential benefit of various drug classes to accelerate the return of erectile function (EF) after RP. There is pre-clinical evidence supporting the use of angiotensin-receptor blockers (ARBs) for this purpose, although this has not been studied in humans. The present study shows that there may be a benefit in the recovery of EF post-RRP in patients taking a daily dose of irbesartan, an ARB, following RRP. In addition, the use of irbesartan may curb the loss of stretched penile length which occurs postoperatively. Further study in the form of prospective, randomized, placebo-controlled clinical trials are necessary to confirm these findings. OBJECTIVE: • To evaluate retrospectively the potential benefit of administering irbesartan, an angiotensin-receptor blocker, to improve erectile function (EF) recovery after nerve-sparing radical retropubic prostatectomy (RRP). PATIENTS AND METHODS: • Before surgery potent patients who underwent nerve-sparing RRP between April and December 2009 elected to start daily oral irbesartan 300 mg on postoperative day 1 (n= 17). A contemporaneously clinically matched cohort consisting of patients who declined irbesartan use served as the control group (n= 12). • Postoperative 'on demand' use of erectile aids (phosphodiesterase type 5 [PDE5] inhibitors and intracavernous injections) was adopted. • Potency was monitored by the administration of International Index of Erectile Function-5 (IIEF-5) questionnaires before surgery and at early (3 months) and long-term (12 and 24 months) postoperative intervals. • Stretched penile length (SPL) was measured both immediately and 3 months after surgery. RESULTS: • EF status was no different between groups at baseline (P > 0.05). • While the IIEF-5 scores at 24 months after surgery were statistically similar between the two groups (control = 15.2 ± 2.0, irbesartan = 14.1 ± 3.1, P = 0.77), at 12 months the IIEF-5 scores of the irbesartan group were significantly higher than those of the control group (14 ± 2.6 vs. 7.2 ± 1.6, P < 0.05). • The proportional loss of SPL after RRP was less in the irbesartan than in the control group at 3 months (-0.9 ± 1.5% vs -5.6 ± 1.5, P < 0.05). CONCLUSION: • Regular irbesartan use after nerve-sparing RRP in patients with normal preoperative erectile function could improve EF recovery after surgery and mitigate early loss of SPL.

Prognostic factors and outcome in patients with T1 high-grade bladder cancer: can we identify patients for early cystectomy?

OBJECTIVE: To assess outcome in patients with T1 high-grade (T1HG) bladder cancer treated at a single academic institution and to determine the prognostic factors that can help in counselling patients towards early cystectomy. PATIENTS AND METHODS: Records of 2570 patients with bladder cancer treated from 1995 to 2005 were reviewed. Only patients diagnosed with T1HG disease were included in the analysis. Collected variables included various clinicopathological parameters, use of statins, smoking, as well as dates of recurrence, progression, radical cystectomy and death. Recurrence-free survival (RFS) and worsening-free survival (WFS) were analyzed. Multivariate Cox proportional regression analysis was employed to verify the prognostic significance of various variables. RESULTS: In total, 278 (10.8%) patients were identified as having T1HG disease on transurethral resection. 66% of patients who recurred, and 36.3% developed stage progression after a median (range) follow-up of 3 (0.1-15.4) years. 30% patients who underwent radical cystectomy, and 9% were dead of disease. The 5-year RFS and WFS rates were 26.6% and 49.4%, respectively. On multivariate analysis, only non-trigonal tumour location, restaging transurethral resection, history of previous carcinoma not invading bladder muscle and adjuvant bacille Calmette-Guérin (BCG) therapy were significantly associated with prolonged RFS, whereas papillary tumour architecture, history of previous carcinoma not invading bladder muscle and adjuvant BCG therapy were significantly associated with prolonged WFS. CONCLUSIONS: Patients with T1HG bladder cancer are at a significant risk of progression and death from disease. Primary tumours, sessile architecture and trigonal location are factors associated with a worse outcome and may be used to counsel patients towards early cystectomy.

A pilot, randomized, controlled clinical trial of lucinactant, a peptide-containing synthetic surfactant, in infants with acute hypoxemic respiratory failure.

OBJECTIVE: Inhibition of surfactant function and abnormal surfactant synthesis lead to surfactant dysfunction in children with acute hypoxemic respiratory failure. We evaluated whether intratracheal lucinactant, a synthetic, peptide-containing surfactant, was safe and well-tolerated in infants with acute hypoxemic respiratory failure, and assessed its effects on clinical outcomes. METHODS AND MAIN RESULTS: Infants ≤ 2 yrs of age with acute hypoxemic respiratory failure were enrolled in a phase II, double-blind, multinational, placebo-controlled randomized trial across 36 pediatric intensive care units. Infants requiring mechanical ventilation with persistent hypoxemia meeting acute lung injury criteria were randomized to receive intratracheal lucinactant (175 mg/kg) or air placebo. One retreatment was allowed 12-24 hrs after initial dosing if hypoxemia persisted. Peri-dosing tolerability of intratracheal lucinactant and adverse experiences were assessed. Mechanical ventilation duration was analyzed using analysis of variance. The Cochran-Mantel-Haenszel test was used for categorical variables.We enrolled 165 infants (84 lucinactant; 81 placebo) with acute hypoxemic respiratory failure. There were no significant differences in baseline subject characteristics, with the exception of a lower positive end-expiratory pressure and higher tidal volume in placebo subjects. The incidence of transient peri-dosing bradycardia and desaturation was significantly higher in the lucinactant treatment group. There were no statistical differences between groups for other adverse events or mortality. Oxygenation improved in infants randomized to receive lucinactant as indicated by fewer second treatments (67% lucinactant vs. 81% placebo, p = .02) and a trend in improvement in partial pressure of oxygen in arterial blood to fraction of inspired oxygen from eligibility to 48 hrs after dose (p = .06). There was no significant reduction in duration of mechanical ventilation with lucinactant (geometric least square means: 4.0 days lucinactant vs. 4.5 days placebo; p = .254). In a subset of infants (n = 22), the duration of mechanical ventilation in children with acute lung injury (partial pressure of oxygen in arterial blood to fraction of inspired oxygen >200) was significantly shorter with lucinactant (least square means: 2.4 days lucinactant vs. 4.3 days placebo; p = .006). CONCLUSIONS: In mechanically ventilated infants with acute hypoxemic respiratory failure, treatment with intratracheal lucinactant appeared to be generally safe. An improvement in oxygenation and a significantly reduced requirement for retreatment suggests that lucinactant might improve lung function in infants with acute hypoxemic respiratory failure.

Pulmonary distribution of lucinactant and poractant alfa and their peridosing hemodynamic effects in a preterm lamb model of respiratory distress syndrome.

Tracheal instillation of surfactant to premature newborns improves their survivability but may transiently obstruct airways resulting in undesirable acute effects on cerebral blood flow (CBF) and oxygenation. The acute peridosing hemodynamic effects of surfactant administration may be avoided by minimizing the volume of surfactant administered, but smaller surfactant volumes may also result in less even distribution of surfactant throughout the lung. These experiments were undertaken to compare responses to two surfactants with different dose volumes (porcine-derived poractant alfa, 2.5 mL/kg vs peptide-based synthetic lucinactant, 5.8 mL/kg) given to newly delivered lambs at 85% gestation. Both surfactants resulted in similar improvements in blood gas values, a doubling of dynamic compliance, increases in brain tissue oxygen tension, and stable blood pressure with no significant change in CBF. Distribution of surfactant throughout the lungs was more uniform with lucinactant than poractant alfa when assessed by labeled microspheres. We conclude that improvements in lung mechanics, gas exchange, and changes in CBF are comparable for a porcine-derived and peptide-containing synthetic surfactant, despite instilled volumes differing by 2-fold. Intrapulmonary distribution of surfactant is more uniform after a larger volume is instilled.

Inflatable Penile Prosthesis Implantation in the Ambulatory Setting: A Systematic Review.

INTRODUCTION: Erectile dysfunction is a common problem that may be definitively treated with the implantation of an inflatable penile prosthesis (IPP). The preponderance of available data on IPP surgery derives from institutional studies, most notably from academic centers or large single-surgeon series, where the majority of procedures are performed in a hospital setting. Because insurance companies and health systems look to reduce health care costs, IPP surgery in outpatient freestanding ambulatory surgery centers (ASC) is becoming more prevalent. AIM: To review the utility of surgery in an ASC setting and to explore its role in the modern practice of urology, focusing on IPP implantation. METHODS: A critical review was performed of the literature on ambulatory surgery, with specific focus on IPP surgery, using the PubMed database. Key search terms and phrases included erectile dysfunction, penile prosthesis, ambulatory surgery, ambulatory surgery center, outpatient surgery. MAIN OUTCOME MEASURE: The main outcome measure was the use of IPP implantation in an ASC. RESULTS: In contemporary surgical practice, the implementation of ambulatory surgery in free-standing centers is increasing. The principal benefits include reducing cost and improving efficiency. Studies on the modern use of IPPs support the prospect of implantation in an ambulatory setting, which can achieve similar outcomes to surgeries classically performed in the inpatient hospital setting. Novel approaches to anesthesia, surgical, and nursing care have revolutionized IPP surgery so that it can now be safely and effectively performed in the ambulatory setting. CONCLUSION: The role of ambulatory IPP implantation has increased, with the majority of cases being performed outside the hospital. Although there will always be a need for hospital-based surgery, such as significant medical comorbidities, more studies demonstrating the safety and feasibility of ambulatory surgery are needed. For those men who would otherwise be candidates for ambulatory surgery but whose insurance mandates hospital-based treatment, such studies proving utility, safety, and reduced cost could inspire policy change and broaden the ambulatory practice of IPP surgery. Segal RL, Siegelbaum MH, Lerner BD, et al. Inflatable Penile Prosthesis Implantation in the Ambulatory Setting: A Systematic Review. Sex Med Rev 2020;8:338-347.

Treatment with 24 hour istaroxime infusion in patients hospitalised for acute heart failure: a randomised, placebo-controlled trial.

AIM: Istaroxime is a first-in-class agent which acts through inhibition of the sarcolemmal Na+ /K+ pump and activation of the SERCA2a pump. This study assessed the effects of a 24 h infusion of istaroxime in patients hospitalised for acute heart failure (AHF). METHODS AND RESULTS: We included patients hospitalised for AHF with left ventricular ejection fraction ≤40% and E/e' > 10. Patients were randomised to a 24 h intravenous infusion of placebo or istaroxime at doses of 0.5 µg/kg/min (cohort 1: placebo n = 19; istaroxime n = 41) or 1.0 µg/kg/min (cohort 2: placebo n = 20, istaroxime n = 40). The primary endpoint of change in E/e' ratio from baseline to 24 h decreased with istaroxime vs. placebo (cohort 1: -4.55 ± 4.75 istaroxime 0.5 µg/kg/min vs. -1.55 ± 4.11 placebo, P = 0.029; cohort 2: -3.16 ± 2.59 istaroxime 1.0 µg/kg/min vs. -1.08 ± 2.72 placebo, P = 0.009). Both istaroxime doses significantly increased stroke volume index and decreased heart rate. Systolic blood pressure increased with istaroxime, achieving significance with the high dose. Self-reported dyspnoea and N-terminal pro-brain natriuretic peptide improved in all groups without significant differences between istaroxime and placebo. No significant differences in cardiac troponin absolute values or clinically relevant arrhythmias were observed during or after istaroxime infusion. Serious cardiac adverse events (including arrhythmias and hypotension) did not differ between placebo and istaroxime groups. The most common adverse events were injection site reactions and gastrointestinal events, the latter primarily with istaroxime 1.0 µg/kg/min. CONCLUSIONS: In patients hospitalised for AHF with reduced ejection fraction, a 24 h infusion of istaroxime improved parameters of diastolic and systolic cardiac function without major cardiac adverse effects.

A New Era For Tattoos, with New Potential Complications.

The practice of adorning the body with permanent ink dates back to the late Neolithic period. Today, a large proportion of the younger generation has at least one tattoo. Despite the recent popularity of tattoos, there are prolific reports within the literature detailing the adverse cutaneous reactions that occur following the intradermal injection of tattoo inks. Such reactions can occur immediately or years later. In addition to these known reactions, consumer preference for "animal-friendly" products has shifted the ingredients used in tattoos and has ushered in the era of "vegan tattoos." Because of its recent emergence and the lack of regulation of intradermal pigment by the United States Food and Drug Administration, we remain unsure of the potential reactions of these new ingredients. Currently, we can only predict complications by extrapolating from the known reactions of the topical administration of these same plant-based ingredients. In this article, we elucidate some potential reactions in an effort to warn the dermatologic community of the need to educate patients and encourage Federal reporting and regulation.