Multipotent bone marrow cell-seeded polymeric composites drive long-term, definitive urinary bladder tissue regeneration.

To date, there are no efficacious translational solutions for end-stage urinary bladder dysfunction. Current surgical strategies, including urinary diversion and bladder augmentation enterocystoplasty (BAE), utilize autologous intestinal segments (e.g. ileum) to increase bladder capacity to protect renal function. Considered the standard of care, BAE is fraught with numerous short- and long-term clinical complications. Previous clinical trials employing tissue engineering approaches for bladder tissue regeneration have also been unable to translate bench-top findings into clinical practice. Major obstacles still persist that need to be overcome in order to advance tissue-engineered products into the clinical arena. These include scaffold/bladder incongruencies, the acquisition and utility of appropriate cells for anatomic and physiologic tissue recapitulation, and the choice of an appropriate animal model for testing. In this study, we demonstrate that the elastomeric, bladder biomechanocompatible poly(1,8-octamethylene-citrate-co-octanol) (PRS; synthetic) scaffold coseeded with autologous bone marrow-derived mesenchymal stem cells and CD34+ hematopoietic stem/progenitor cells support robust long-term, functional bladder tissue regeneration within the context of a clinically relevant baboon bladder augmentation model simulating bladder trauma. Partially cystectomized baboons were independently augmented with either autologous ileum or stem-cell-seeded small-intestinal submucosa (SIS; a commercially available biological scaffold) or PRS grafts. Stem-cell synergism promoted functional trilayer bladder tissue regeneration, including whole-graft neurovascularization, in both cell-seeded grafts. However, PRS-augmented animals demonstrated fewer clinical complications and more advantageous tissue characterization metrics compared to ileum and SIS-augmented animals. Two-year study data demonstrate that PRS/stem-cell-seeded grafts drive bladder tissue regeneration and are a suitable alternative to BAE.

Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial.

BACKGROUND: Temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis was previously reported as superior to a sham-control procedure at 3 months postprocedure in a randomized controlled trial (RCT). The primary endpoint was a responder rate of ≥30% improvement (decrease) for 24-hour reflective total nasal symptom score (rTNSS) compared with baseline. Herein, 12-month outcomes after active treatment are reported. METHODS: In this prospective, multicenter, patient-blinded RCT, patients in the index active treatment arm were unblinded at 3 months and followed through 12 months. At 3 months, eligible patients from the sham-control arm of the study were invited to crossover to active treatment. Eligibility criteria included rTNSS ≥6, with moderate-severe rhinorrhea and mild-severe congestion. The TCRF stylus was applied bilaterally to nonoverlapping areas in the region of the PNN. RESULTS: Patients in the index active treatment arm (n = 77) had a mean baseline rTNSS of 8.3 (95% confidence interval [CI], 7.9-8.7). At 12 months, the responder rate was 80.6% (n = 67) (95% CI, 69.1%-89.2%). At 12 months, the mean change in rTNSS was -4.8 (95% CI, -5.5 to -4.1; p < 0.001), a 57.8% improvement. The available initial rTNSS-based outcomes in the crossover active treatment arm (n = 27) were following the same course as the index treatment arm. No serious adverse events and 8 adverse events related to the device/procedure were reported in the trial to date. CONCLUSION: TCRF neurolysis of the PNN area is safe and the symptom burden improvement that was superior to a sham procedure at 3 months was sustained through 12 months.

Emergency medical admissions and COVID-19: impact on 30-day mortality and hospital length of stay.

BACKGROUND: The COVID-19 pandemic has put considerable strain on healthcare systems. AIM: To investigate the effect of the COVID-19 pandemic on 30-day in-hospital mortality, length of stay (LOS) and resource utilization in acute medical care. METHODS: We compared emergency medical admissions to a single secondary care centre during 2020 to the preceding 18 years (2002-2019). We investigated 30-day in-hospital mortality with a multiple variable logistic regression model. Utilization of procedures/services was related to LOS with zero truncated Poisson regression. RESULTS: There were 132,715 admissions in 67,185 patients over the 19-year study. There was a linear reduction in 30-day in-hospital mortality over time; over the most recent 5 years (2016-2020), there was a relative risk reduction of 36%, from 7.9 to 4.3% with a number needed to treat of 27.7. Emergency medical admissions increased 18.8% to 10,452 in 2020 with COVID-19 admissions representing 3.5%. 18.6% of COVID-19 cases required ICU admission with a median stay of 10.1 days (IQR 3.8, 16.0). COVID-19 was a significant univariate predictor of 30-day in-hospital mortality, 18.5% (95%CI: 13.9, 23.1) vs. 3.0% (95%CI: 2.7, 3.4)-OR 7.3 (95%CI: 5.3, 10.1). ICU admission was the dominant outcome predictor-OR 12.4 (95%CI: 7.7, 20.1). COVID-19 mortality in the last third of 2020 improved-OR 0.64 (95%CI: 0.47, 0.86). Hospital LOS and resource utilization were increased. CONCLUSION: A diagnosis of COVID-19 was associated with significantly increased mortality and LOS but represented only 3.5% of admissions and did not attenuate the established temporal decline in overall in-hospital mortality.

Effect of Radiofrequency Neurolysis on the Symptoms of Chronic Rhinitis: A Randomized Controlled Trial.

OBJECTIVE: To determine the safety and efficacy of temperature-controlled radiofrequency (RF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis. STUDY DESIGN: A multicenter, prospective, single-blinded, randomized controlled trial, in which the control arm underwent a sham procedure. SETTING: Sixteen otolaryngology centers. METHODS: Patients with 24-hour reflective Total Nasal Symptom Score (rTNSS) ≥6, including moderate to severe rhinorrhea and mild to severe congestion, were randomized 2:1 to active treatment of the posterior nasal nerve area with a temperature-controlled RF device or a sham procedure, with no RF energy delivery. The stylus was applied bilaterally to nonoverlapping areas of the posterior middle meatus and posterior inferior turbinate in each nostril in the region of the PNN. The primary endpoint was responder rate at 3 months, where a response was defined as ≥30% improvement (decrease) in rTNSS from baseline. RESULTS: Patients had a mean baseline rTNSS of 8.3 (95% CI, 7.9-8.7) and 8.2 (95% CI, 7.6-8.8) (P = .797) in the active treatment (n = 77) and sham control (n = 39) arms, respectively. At 3 months, responder rate was significantly higher in the active treatment arm: 67.5% (95% CI, 55.9%-77.8%) vs 41.0% (95% CI, 25.6%-57.9%) (P = .009). The active treatment arm had a significantly greater decrease in rTNSS (mean, -3.6 [95% CI, -4.2 to -3.0] vs -2.2 [95% CI, -3.2 to -1.3]) (P = .013). Three adverse events related to the device/procedure were reported, and all resolved. CONCLUSION: This randomized controlled trial showed temperature-controlled neurolysis of the PNN area is free from significant adverse events and superior to a sham procedure in decreasing the symptom burden of chronic rhinitis.

Role of portable ultrasound during a short-term medical service trip to rural Guatemala: a collaborative mission of trainees and physicians.

INTRODUCTION: Access to health care in developing countries is scarce. One solution to this problem has been for doctors from the USA to provide single-visit care through short-term medical service trips. There is interest in using ultrasound imaging as a portable diagnostic tool; however, data describing its usefulness are scarce. Therefore, the goal of this study was to determine the usefulness of portable ultrasound imaging during a medical service trip to rural Guatemala. METHODS: A multidisciplinary team of physicians examined patients at a mobile clinic in Antigua, Guatemala. Patients with clinical indications for ultrasound had their suspected diagnoses recorded before ultrasound testing. After imaging, updated diagnoses were recorded and compared with the pre-test suspected diagnoses to determine how often ultrasound results changed the medical management of the patients and to assess the most common indications for ultrasound imaging. RESULTS: During the trip, 205 patients were seen. Of these, 24 (12%) were given ultrasound exams. The results of 13 (54%) exams altered their medical management, and the remaining 11 (46%) exams confirmed the pre-test suspected diagnoses. The most common indications for ultrasound testing were suspected cardiac (11 patients, 46%) and gastrointestinal (8 patients, 33%) diseases. CONCLUSION: Portable ultrasound imaging improved the medical team's ability to diagnose disease and clinically manage patients in a rural medical service trip. Ultrasound imaging may provide a low-cost solution to the growing demand for care in developing countries.

Morphological ultrasound types known as 'blob' and 'bagel' signs should be reclassified from suggesting probable to indicating definite tubal ectopic pregnancy.

OBJECTIVE: In a recent consensus statement on early pregnancy nomenclature by Barnhart, a definite ectopic pregnancy (EP) was defined morphologically on transvaginal sonography (TVS) as an extrauterine gestational sac with yolk sac and/or embryo, with or without cardiac activity, whilst a probable EP was defined as an inhomogeneous adnexal mass ('blob' sign) or extrauterine sac-like structure ('bagel' sign). This study aims to determine whether these ultrasound markers used to define probable EP can be used to predict a definite tubal EP. METHODS: This was a retrospective cohort study of women presenting to the Early Pregnancy Unit (EPU) at Nepean Hospital, Sydney, Australia between November 2006 and June 2016. Women classified with a probable EP or a pregnancy of unknown location (PUL), i.e. with no signs of extra- or intrauterine pregnancy (IUP), at their first TVS were included, whilst those with a definite tubal EP, IUP or non-tubal EP were excluded from the final analysis. The gold standard for tubal EP was histological confirmation of chorionic villi in Fallopian tube removed at laparoscopy. The performance of blob or bagel sign on TVS in the prediction of definite tubal EP was evaluated in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). This was compared with the performance of extrauterine gestational sac with yolk sac and/or embryo on TVS to predict definite tubal EP. RESULTS: During the study period, 7490 consecutive women attended the EPU, of whom 849 were analyzed. At primary TVS, 240/849 were diagnosed with probable EP, of which 174 (72.5%) were classified as blob sign and 66 (27.5%) as bagel sign. The remaining 609/849 were diagnosed with PUL, of which 47 had a final diagnosis of EP (including 24 blob sign, 19 bagel sign and four gestational sac with embryo/yolk sac). 101 of all 198 (51%) blob sign cases and 50 of all 85 (59%) bagel sign cases underwent laparoscopy and salpingectomy; histology proved a tubal EP in 98 (97%) of these blob-sign cases and 48 (96.0%) of the bagel-sign cases. The sensitivity for the blob and bagel signs in the prediction of definite tubal EP was 89.8% and 83.3%, respectively, the specificity was 99.5% and 99.6%, PPV was 96.7% and 95.2% and NPV was 98.3% and 98.6%. This was comparable to the sensitivity of extrauterine gestational sac with yolk sac and/or embryo on TVS in the prediction of definite tubal EP (sensitivity, 84.0%; specificity, 99.9%; PPV, 97.7%; NPV, 99.3% (P = 0.5)). CONCLUSIONS: Blob and bagel signs seem to be the most common presentations of a tubal EP on TVS. Although they cannot be considered as a definitive sign of EP, their PPV is very high (> 95%); such women should therefore be considered at very high risk for having a tubal EP and should be treated as such. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Association between three-dimensional transvaginal sonographic markers and outcome of pregnancy of unknown location: a pilot study.

OBJECTIVE: To assess the accuracy of three-dimensional (3D) transvaginal sonographic (TVS) parameters in predicting the evolution of a pregnancy of unknown location (PUL). METHODS: This was a prospective observational study performed at the early pregnancy unit of a university hospital from September 2008 to June 2012. Women with a positive pregnancy test without any signs of intra- or extrauterine pregnancy at their first TVS examination were considered eligible and a 3D dataset containing the entire uterus was acquired. An experienced observer analyzed all 3D datasets for assessment of the following parameters: endometrial thickness, volume, mean gray-scale index and asymmetry. Women were followed until they were classified as having: (i) non-visualized pregnancy loss (NVPL); (ii) intrauterine pregnancy (IUP); or (iii) ectopic pregnancy or persistent PUL. We compared the values of the TVS parameters across the three groups. We also assessed the area under the receiver-operating characteristics curve of the 3D-TVS parameters in comparison to that for serum ß-human chorionic gonadotropin (ß-hCG) ratio (48 h/baseline) to predict PUL outcome. We then evaluated whether combining the 3D-TVS parameters with serum ß-hCG ratio improved the predictive accuracy for PUL outcome by performing a logistic regression analysis. RESULTS: During the study period 4939 consecutive pregnant women presented at the unit for their initial TVS examination and 325 (7%) were classified as having a PUL, of whom 161 women were enrolled and had a 3D scan of the uterus. However, 19 were excluded because of incomplete follow-up. Data from 142 women with PUL were therefore included in the analysis and the outcomes of these women were: NVPL in 98 (69%), IUP in 27 (19%) and ectopic pregnancy + persistent PUL in 14 + 3 = 17 (12%). Endometrial thickness, endometrial volume and the proportion of women with asymmetric endometrial shape differed significantly between the outcome groups. Endometrial thickness and volume could be used as reasonable predictors of both NVPL and IUP, whereas asymmetric endometrial shape and mean gray-scale index could be used as reasonable predictors of IUP only. The best single parameter to predict PUL outcomes was the ß-hCG ratio. Regression analysis demonstrated that endometrial volume and endometrial shape asymmetry added significantly to the ß-hCG ratio in predicting IUP but not NVPL. CONCLUSIONS: 3D-TVS markers have a low diagnostic accuracy in predicting PUL outcome. The addition of endometrial volume and shape asymmetry improves the accuracy of the ß-hCG ratio in predicting IUP. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

Contemporary management of nasal polyps.

Nasal polyposis is a multifactorial disease process resulting in a common pathologic structure. Better understanding of the pathophysiology has resulted in improved protocols for treatment. Different causes of polyposis are discussed with attention to both medical and surgical therapy. Recent advances in aspirin desensitization are detailed.

Incidence of complications for subtotal ionized field ablation of the tonsils.

OBJECTIVE: Ionized field ablation, or coblation-assisted subtotal tonsillectomy, has been described as a new alternative technique for the management of tonsillar disease. This study was designed to review the incidence of complications in patients undergoing this procedure. STUDY DESIGN: A 10-surgeon retrospective chart review of the intraoperative and postoperative complications of patients undergoing ionized field ablation subtotal removal of tonsils was performed. Postoperative pain, dietary restrictions, and activity level were not reviewed. RESULTS: Of the 528 patients who underwent ionized field ablation of their tonsils, the incidence of intraoperative and postoperative complications compared favorably with those reported in retrospective studies in the literature for traditional subcapsular tonsillectomy. Significant postoperative bleeding occurred in less than 1%, and only 1 patient required surgical control of bleeding in the operating room. No patients required transfusions of any blood products. CONCLUSIONS: Ionized field ablation subtotal tonsillectomy may offer an alternative to traditional subcapsular tonsillar surgery with a decreased incidence of postoperative complications. Further study is necessary to establish the complication rate of this technique.