Incidence of missed canals during endodontic treatment of maxillary first and second molars.

Untreated canals are a primary cause of persistent apical periodontitis, and the inability to identify and adequately treat canals has been considered a major cause of failure of root canal therapy in maxillary molars. The purpose of this retrospective study was to use cone beam computed tomography (CBCT) to quantify the number of missed canals in maxillary first and second molars needing endodontic retreatment after treatment by general dentists. A total of 401 CBCT scans of maxillary first and second molars were examined. A total of 214 scan sets (53.37% [95% CI, 48.48%-58.25%]) showed evidence of an untreated canal, with the highest rate (49.38%; n = 198) observed in the second mesiobuccal canal. Imaging revealed that multiple canals were missed in some patients, for a total of 225 missed canals. The examinations showed untreated first mesiobuccal canals in 2.99% of CBCT scan sets (n = 12), untreated distobuccal canals in 2.99% of CBCT scan sets (n = 12), and untreated palatal canals in 0.75% of CBCT scan sets (n = 3). Preoperative CBCT imaging should be considered prior to initial root canal treatment of maxillary molars. When the risks and limitations of CBCT are taken into consideration, the additional information it provides can improve diagnostic accuracy, increase confidence in decision-making, and positively impact treatment planning.

Frequency of apical periodontitis in root-filled teeth restored with post and core: A 5-year retrospective study.

BACKGROUND: In conjunction with post placement in root-filled teeth with periapical healthy conditions, root canal retreatment may be performed to improve the seal of the root canal. Whether root canal retreatment for technical reasons (retreatments in teeth without apical periodontitis (AP)) results in lower frequency of AP is unknown. OBJECTIVE: To examine whether there is a difference in frequency of AP between roots with root canals retreated for technical reasons, and roots with root canals not retreated before post placement, with a minimum follow-up of 5 years. Also, to examine changes in root filling quality following root canal retreatment for technical reasons. METHODS: This retrospective study included radiographs of 441 root-filled roots without periapical radiolucencies at baseline, scheduled for post and core treatment. Follow-up data for a minimum of 5 years were available for 305 roots (loss to follow-up 30.8%), 46 of which were retreated for technical reasons. Two calibrated observers assessed root filling sealing quality and length, respectively, and periapical status according to the Periapical Index. The main outcome of the study, AP, was used as the dependent variable and all analyses were performed at root level. RESULTS: The overall frequency of AP at follow-up was 13.8%. The difference in frequency of AP between retreated (4.3%) and nonretreated (15.4%) root canals was not statistically significant, p = .061. Analyses including only roots with preoperatively inadequate root filling quality showed a statistically significant difference (p = .017) between the two treatment groups (2.4% vs. 22.9%). CONCLUSIONS: Root canal retreatment for technical reasons before post and core placement significantly reduces the frequency of AP in roots with inadequate root filling quality.

A critical analysis of the decreasing trends in tuberculosis cure indicators in Brazil, 2001-2022.

OBJECTIVE: To analyze the temporal trend of tuberculosis cure indicators in Brazil. METHODS: An ecological time-series study using administrative data of reported cases of the disease nationwide between 2001 and 2022. We estimated cure indicators for each federative unit (FU) considering individuals with pulmonary tuberculosis, tuberculosis-HIV coinfection, and those in tuberculosis retreatment. We used regression models using joinpoint regression for trend analysis, reporting the annual percentage change and the average annual percentage change. RESULTS: For the three groups analyzed, we observed heterogeneity in the annual percentage change in the Brazilian FUs, with a predominance of significantly decreasing trends in the cure indicator in most FUs, especially at the end of the time series. When considering national indicators, an average annual percentage change of -0.97% (95% CI: -1.23 to -0.74) was identified for the cure of people with pulmonary tuberculosis, of -1.11% (95% CI: -1.42 to -0.85) for the cure of people with tuberculosis-HIV coinfection, and of -1.44% (95% CI: -1.62 to -1.31) for the cure of people in tuberculosis retreatment. CONCLUSIONS: The decreasing trends of cure indicators in Brazil are concerning and underscore a warning to public authorities, as it points to the possible occurrence of other treatment outcomes, such as treatment discontinuity and death. This finding contradicts current public health care policies and requires urgent strategies aiming to promote follow-up of patients during tuberculosis treatment in Brazil.

Retreatment after primary spontaneous pneumothoraxes managed with primary tube thoracostomy or surgery.

BACKGROUND AND AIMS: There is a paucity of data on later healthcare visits and retreatments after primary treatment of spontaneous pneumothorax. The main purpose of this study was to describe retreatment rates up to 5 years after primary spontaneous pneumothorax treated with either surgery or tube thoracostomy (TT) at index hospitalization in Finland between 2005 and 2018 to estimate the burden of primary spontaneous pneumothorax on the healthcare system. METHODS: Retrospective registry-based study of patients with primary spontaneous pneumothorax treated with TT or surgery in Finland in 2005-2018. Rehospitalization and retreatment for recurrent pneumothorax and complications attributable to initial treatment were identified. RESULTS: The total study population was 1594 patients. At 5 years, 53.2% (384/722) of TT treated and 33.8% (295/872) of surgically treated patients had undergone any retreatment. Surgery was associated with a lower risk of recurrence than TT (hazard ratio (HR) 0.50, 95% confidence interval (CI) 0.43-0.56, p < 0.001). Male sex was associated with a lower risk of recurrent treatment (HR 0.75, 95% CI 0.63-0.90, p = 0.001). Higher age decreased the risk of recurrent treatment (HR 0.99, 95% CI 0.99-0.99, p < 0.001). At 5 years, 36.0% (260/722) of the TT treated and 18.8% (164/872) of the surgically treated had undergone reoperation at some point. CONCLUSIONS: Reintervention rates and repeat hospital visits after TT and surgery were surprisingly high at long-term follow-up. Occurrences of retreatment and reoperation were significantly higher among primary spontaneous pneumothorax patients treated with TT at index hospitalization than among patients treated with surgery.

Predicting the Efficacy of Repeated Shockwave Lithotripsy for Treating Patients with Upper Urinary Tract Calculi Using an Artificial Neural Network Model.

PURPOSE: To establish a prediction model for repeated shockwave lithotripsy (SWL) efficacy to help choose an appropriate treatment plan for patients with a single failed lithotripsy, reducing their treatment burden. PATIENTS AND METHODS: The clinical records and imaging data of 304 patients who underwent repeat SWL for upper urinary tract calculi (UUTC) at the Urology Centre of Shiyan People's Hospital between April 2019 and April 2023 were retrospectively collected. This dataset was divided into training (N = 217; 146 males [67.3%] and 71 females [32.7%]) and validation (N = 87; 66 males [75.9%] and 21 females [24.1%]) sets. The overall predictive accuracy of the models was calculated separately for the training and validation. Receiver operating characteristic (ROC) curves were plotted, and the area under the ROC curve (AUC) was calculated. The normalized importance of each independent variable (derived from the one-way analyses) in the input layer of the artificial neural network (ANN) model for the dependent variable (success or failure in repeat SWL) in the output layer was plotted as a bar chart. RESULTS: This study included 304 patients, of whom 154 (50.7%) underwent successful repeat SWL. Predictive models were constructed in the training set and assessed in the validation set. Fourteen influencing factors were selected as input variables to build an ANN model: age, alcohol, body mass index, sex, hydronephrosis, hematuria, mean stone density (MSD), skin-to-stone distance (SSD), stone heterogeneity index (SHI), stone volume (SV), stone retention time, smoking, stone location, and urinary irritation symptom. The model's AUC was 0.852 (95% confidence interval (CI): 0.8-0.9), and its predictive accuracy for stone clearance in the validation group was 83.3%. The order of importance of the independent variables was MSD > SV > SSD > stone retention time > SHI. CONCLUSION: Establishing an ANN model for repeated SWL of UUTC is crucial for optimizing patient care. This model will be pivotal in providing accurate treatment plans for patients with an initial unsuccessful SWL treatment. Moreover, it can significantly enhance the success rate of subsequent SWL treatments, ultimately alleviating patients' treatment burden.

Incidence of Middle Mesial Canals in Mandibular Molars during Root Canal Treatment and Nonsurgical Retreatment.

INTRODUCTION: Large-scale clinical studies on the incidence of middle mesial canals (MMCs) in nonsurgical root canal treatment (RCT) and retreatment of mandibular molars are lacking. The primary aim of this observational study was to determine the incidence of MMCs in mandibular first and second molars that received RCT or nonsurgical retreatment (NSRetx). The secondary aim was to determine factors associated with incidence of MMCs. METHODS: Included were 3018 mandibular molars that received RCT (n = 1624) or NSRetx (n = 1394) by 3 endodontists in a private practice. Demographic and procedural data were collected. Bivariate and multivariable (Poisson regression model) analyses were performed. RESULTS: Incidence of MMCs was 8.8% (n = 267). Although the bivariate analysis showed that NSRetx was significantly associated with incidence of MMCs, this association did not reach the threshold for statistical significance after controlling for all covariates (P = .07). Multivariable analysis on the entire cohort showed that incidence of MMCs was significantly associated with younger age (risk ratio [RR] = 1.62; 95% confidence interval [CI], 1.28-2.06), male gender (RR = 1.48; 95% CI, 1.18-1.85), preoperative cone-beam computed tomography (CBCT) (RR = 1.48; 95% CI, 1.17-1.89), and first molar (RR = 2.30; 95% CI:1.74-3.05). Subgroup multivariable analyses revealed that incidence of MMCs was associated with male gender only in the RCT group (RR = 2.26; 95% CI, 1.55-3.30) but not in the NSRetx group (RR = 1.11; 95% CI, 0.82, 1.50); and with preoperative CBCT only in the NSRetx group (RR = 1.78; 95% CI, 1.28, 2.50) but not in the RCT group (RR = 1.10; 95% CI, 0.71, 1.69). Associations with younger age and first molar remained unchanged. CONCLUSIONS: Overall incidence of MMCs was 8.8%. Incidence of MMCs was significantly higher in younger patients and in mandibular first molars but was not associated with the type of treatment.

Further Interventions after Root Canal Treatment Are Most Common in Molars and Teeth Restored with Direct Restorations: A 10-11-Year Follow-Up of the Adult Swedish Population.

INTRODUCTION: The aims were to investigate 1) the frequency of nonsurgical retreatment, root-end surgery, extraction, and further restorative treatment during a follow-up of 10-11 years after root filling and compare the frequencies according to tooth group and type of coronal restoration and 2) the timing of nonsurgical retreatment, root-end surgery, and extraction. METHODS: Data were collected from the Swedish Social Insurance Agency's register. A search for treatment codes identified teeth root filled in 2009 and the type of coronal restoration (direct, indirect, and unspecified) registered within 6 months of root filling. The root-filled teeth were followed 10-11 years, and further interventions were recorded. Descriptive statistics and chi-square tests were used for statistical analysis. RESULTS: In 2009, root fillings were registered for 215,611 individuals/teeth. Nonsurgical retreatment, root-end surgery, and extraction were undertaken in 3.5%, 1.4%, and 20% teeth, respectively. The frequency of further interventions varied with respect to tooth group and type of coronal restoration, but only slightly for endodontic retreatments. Further interventions, except for root-end surgery, were registered more often for molars and directly restored teeth (P < .001). The majority of endodontic retreatments were undertaken within 4 years, while extractions were evenly distributed over 10-11 years. CONCLUSIONS: The frequency numbers of nonsurgical retreatment and root-end surgery were low, despite 1 in 5 root-filled teeth registered as extracted. Further interventions were most common in molars and directly restored teeth. Endodontic retreatments were performed more often during the first 4 years.

Waiting Time for Second Kidney Transplantation and Mortality.

BACKGROUND AND OBJECTIVES: The median kidney transplant half-life is 10-15 years. Because of the scarcity of donor organs and immunologic sensitization of candidates for retransplantation, there is a need for quantitative information on if and when a second transplantation is no longer associated with a lower risk of mortality compared with waitlisted patients treated by dialysis. Therefore, we investigated the association of time on waiting list with patient survival in patients who received a second transplantation versus remaining on the waiting list. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this retrospective study using target trial emulation, we analyzed data of 2346 patients from the Austrian Dialysis and Transplant Registry and Eurotransplant with a failed first graft, aged over 18 years, and waitlisted for a second kidney transplantation in Austria during the years 1980-2019. The differences in restricted mean survival time and hazard ratios for all-cause mortality comparing the treatment strategies "retransplant" versus "remain waitlisted with maintenance dialysis" are reported for different waiting times after first graft loss. RESULTS: Second kidney transplantation showed a longer restricted mean survival time at 10 years of follow-up compared with remaining on the waiting list (5.8 life months gained; 95% confidence interval, 0.9 to 11.1). This survival difference was diminished in patients with longer waiting time after loss of the first allograft; restricted mean survival time differences at 10 years were 8.0 (95% confidence interval, 1.9 to 14.0) and 0.1 life months gained (95% confidence interval, -14.3 to 15.2) for patients with waiting time for retransplantation of <1 and 8 years, respectively. CONCLUSIONS: Second kidney transplant is associated with patient survival compared with remaining waitlisted and treatment by dialysis, but the survival difference diminishes with longer waiting time.

Does MOSES pulse modulation reduce short-term catheter reinsertion following holmium laser enucleation of the prostate?

PURPOSE: Previously published studies have shown small prostate size, capsular perforation and intraoperative bladder distension are associated with failed trial without a catheter (TWOC) after HoLEP. The study objective was to determine the relationship between MOSES pulse modulation versus standard laser technology and short-term catheter reinsertion following failed TWOC. MATERIALS AND METHODS: The study included 487 patients who underwent HoLEP, using standard holmium laser settings (180 patients) or MOSES pulse modulation (255 patients), between August 2018 and February 2021. Catheter reinsertion defined as reinsertion following failed TWOC within 30 days of surgery. Association of pulse modulation with catheter reinsertion was examined using single and multivariable logistic regression models. Comparisons of pre and intraoperative characteristics between patients treated without and with pulse modulation were made using a Wilcoxon rank sum test for numeric characteristics or Fisher's exact test for categorical characteristics. RESULTS: Short-term catheter reinsertion occurred in 14% (26/180) of the standard laser setting group as compared with 10% (24/252) of the pulse modulation group. There was no statistically significant association with short-term catheter reinsertion in single (unadjusted OR [standard settings vs. pulse modulation], 1.60; 95% CI, 0.80-2.91; p=0.12) or multivariable analysis adjusting for specimen weight and operative time (adjusted OR [standard settings vs. pulse modulation], 1.44; 95% CI, 0.77-2.68; p=0.25). CONCLUSIONS: In this study, we found no association between post-HoLEP short-term catheter reinsertion following failed TWOC and MOSES pulse modulation. Although MOSES pulse modulation offers several well-documented advantages, catheter reinsertion events appear to be attributable to other factors.

Continuity and coordination of care in highly selected chronic cancer patients treated with multiple repeat radiation therapy.

INTRODUCTION AND BACKGROUND: As cancer is developing into a chronic disease due to longer survival, continuity and coordination of oncological care are becoming more important for patients. As radiation oncology departments are an integral part of cancer care and as repeat irradiation becomes more commonplace, the relevance of continuity and coordination of care in operating procedures is increasing. This study aims to perform a single-institution analysis of cancer patients in which continuity and coordination of care matters most, namely the highly selected group with multiple repeat course radiotherapy throughout their chronic disease. MATERIALS AND METHODS: All patients who received at least five courses of radiotherapy at the Department of Radiation Oncology at the University Hospital Zurich from 2011 to 2019 and who were alive at the time of the initiation of this project were included into this study. Patient and treatment characteristics were extracted from the hospital information and treatment planning systems. All patients completed two questionnaires on continuity of care, one of which was designed in-house and one of which was taken from the literature. RESULTS: Of the 33 patients identified at baseline, 20 (60.6%) participated in this study. A median of 6 years (range 3-13) elapsed between the first and the last visit at the cancer center. The median number of involved primary oncologists at the radiation oncology department was two (range 1-5). Fifty-seven percent of radiation therapy courses were preceded by a tumor board discussion. Both questionnaires showed high levels of experienced continuity of care. No statistically significant differences in experienced continuity of care between groups with more or less than two primary oncologists was found. DISCUSSION AND CONCLUSION: Patients treated with multiple repeat radiation therapy at our department over the past decade experienced high levels of continuity of care, yet further efforts should be undertaken to coordinate care among oncological disciplines in large cancer centers through better and increased use of interdisciplinary tumor boards.

Effect of Amoxicillin Dose and Treatment Duration on the Need for Antibiotic Re-treatment in Children With Community-Acquired Pneumonia: The CAP-IT Randomized Clinical Trial.

Importance: The optimal dose and duration of oral amoxicillin for children with community-acquired pneumonia (CAP) are unclear. Objective: To determine whether lower-dose amoxicillin is noninferior to higher dose and whether 3-day treatment is noninferior to 7 days. Design, Setting, and Participants: Multicenter, randomized, 2 × 2 factorial noninferiority trial enrolling 824 children, aged 6 months and older, with clinically diagnosed CAP, treated with amoxicillin on discharge from emergency departments and inpatient wards of 28 hospitals in the UK and 1 in Ireland between February 2017 and April 2019, with last trial visit on May 21, 2019. Interventions: Children were randomized 1:1 to receive oral amoxicillin at a lower dose (35-50 mg/kg/d; n = 410) or higher dose (70-90 mg/kg/d; n = 404), for a shorter duration (3 days; n = 413) or a longer duration (7 days; n = 401). Main Outcomes and Measures: The primary outcome was clinically indicated antibiotic re-treatment for respiratory infection within 28 days after randomization. The noninferiority margin was 8%. Secondary outcomes included severity/duration of 9 parent-reported CAP symptoms, 3 antibiotic-related adverse events, and phenotypic resistance in colonizing Streptococcus pneumoniae isolates. Results: Of 824 participants randomized into 1 of the 4 groups, 814 received at least 1 dose of trial medication (median [IQR] age, 2.5 years [1.6-2.7]; 421 [52%] males and 393 [48%] females), and the primary outcome was available for 789 (97%). For lower vs higher dose, the primary outcome occurred in 12.6% with lower dose vs 12.4% with higher dose (difference, 0.2% [1-sided 95% CI -∞ to 4.0%]), and in 12.5% with 3-day treatment vs 12.5% with 7-day treatment (difference, 0.1% [1-sided 95% CI -∞ to 3.9]). Both groups demonstrated noninferiority with no significant interaction between dose and duration (P = .63). Of the 14 prespecified secondary end points, the only significant differences were 3-day vs 7-day treatment for cough duration (median 12 days vs 10 days; hazard ratio [HR], 1.2 [95% CI, 1.0 to 1.4]; P = .04) and sleep disturbed by cough (median, 4 days vs 4 days; HR, 1.2 [95% CI, 1.0 to 1.4]; P = .03). Among the subgroup of children with severe CAP, the primary end point occurred in 17.3% of lower-dose recipients vs 13.5% of higher-dose recipients (difference, 3.8% [1-sided 95% CI, -∞ to10%]; P value for interaction = .18) and in 16.0% with 3-day treatment vs 14.8% with 7-day treatment (difference, 1.2% [1-sided 95% CI, -∞ to 7.4%]; P value for interaction = .73). Conclusions and Relevance: Among children with CAP discharged from an emergency department or hospital ward (within 48 hours), lower-dose outpatient oral amoxicillin was noninferior to higher dose, and 3-day duration was noninferior to 7 days, with regard to need for antibiotic re-treatment. However, disease severity, treatment setting, prior antibiotics received, and acceptability of the noninferiority margin require consideration when interpreting the findings. Trial Registration: ISRCTN Identifier: ISRCTN76888927.

Comparative effect of statin intensity between prediabetes and type 2 diabetes mellitus after implanting newer-generation drug-eluting stents in Korean acute myocardial infarction patients: a retrospective observational study.

BACKGROUND: Comparative studies regarding the long-term clinical outcomes of statin intensity between acute myocardial infarction (AMI) patients with prediabetes and those with type 2 diabetes mellitus (T2DM), after successful implantation of newer-generation drug-eluting stents (DES) with statin treatment, are limited. We compared the 2-year clinical outcomes between these patients. METHODS: A total of 11,612 AMI patients were classified as statin users (n = 9893) and non-users (n = 1719). Thereafter, statin users were further divided into high-intensity (n = 2984) or low-moderate-intensity statin (n = 6909) treatment groups. Those in these two groups were further classified into patients with normoglycemia, prediabetes, and T2DM. The major outcomes were the occurrence of major adverse cardiac events (MACE), defined as all-cause death, recurrent myocardial infarction (Re-MI), or any repeat coronary revascularization. RESULTS: After adjusting for both high-intensity and low-moderate-intensity statin users, the cumulative incidences of MACE (p = 0.737, p = 0.062, respectively), all-cause death, Re-MI, and any repeat revascularization were similar between the prediabetes and T2DM groups. In the total study population, both high-intensity and low-moderate-intensity statin treatments showed comparable results. However, in the patients who enrolled after October 2012, the cumulative incidences of MACE (aHR 1.533; 95% CI 1.144-2.053; p = 0.004) and any repeat revascularization (aHR, 1.587; 95% CI 1.026-2.456; p = 0.038) were significantly lower in high-intensity statin users than in low-moderate intensity statin users. The beneficial effects of high-intensity compared to low-moderate-intensity statin therapy were more apparent in the normoglycemia group than hyperglycemia group, as it reduced the cumulative incidences of MACE (aHR 1.903; 95% CI 1.203-3.010; p = 0.006) and any repeat revascularization (aHR 3.248; 95% CI 1.539-6.854; p = 0.002). CONCLUSIONS: In this retrospective registry study, prediabetes and T2DM groups showed comparable clinical outcomes, after administering both high-intensity and low-moderate-intensity statin treatments. However, these results are likely to be clearly proved by further studies, especially in patients with AMI who are being treated in contemporary practice. TRIAL REGISTRATION: Retrospectively registered.

Role of Systematic Control Biopsies following Partial Gland Ablation with High-Intensity Focused Ultrasound for Clinically Significant Prostate Cancer.

PURPOSE: Partial gland ablation (PGA) using high-intensity focused ultrasound (HIFU) is currently under investigation for clinically significant prostate cancer (Cs-PCa). Our primary objective was to assess the role of systematic control biopsies following HIFU-PGA in a cohort of Cs-PCa patients. MATERIALS AND METHODS: We studied a single-center retrospective cohort of 77 men treated with HIFU-PGA between October 2015 and December 2019. Patients with unilateral Cs-PCa, defined as Gleason grade group (GGG) ≥2, with visible lesion on multiparametric magnetic resonance imaging (mpMRI) and prostate specific antigen (PSA) ≤15 ng/ml were included. All patients underwent mpMRI with systematic and targeted biopsies before and after HIFU-PGA. The primary outcome was the rate of Cs-PCa at control biopsy within 1 year of treatment. Logistic regression was performed to identify predictive factors of our primary outcome. RESULTS: Median age was 67 years (IQR 61-71), median PSA was 7 ng/ml (IQR 5.5-8.9). Pre-treatment biopsies revealed 48 (62.3%) GGG2 lesions, 24 (31.2%) GGG3 and 5 (6.5%) GGG4 lesions. Cs-PCa was found in 24 (31.2%) patients at systematic control biopsy post-HIFU; Cs-PCa was in the treated lobe for 18 (27%) patients. No variables were identified as significant predictors of Cs-PCa at control biopsy, including PSA kinetics and control mpMRI. Median followup time was 17 months (95% CI 15-21). Median time to any retreatment was 32 months (95% CI 23-42). CONCLUSIONS: Systematic control biopsy within a year after PGA for Cs-PCa can identify the presence of residual Cs-PCa in up to a third of patients. From our early experience, control biopsy should be systematically offered patients regardless of PSA kinetics or control mpMRI results.

Impact of Patient Prosthesis Mismatch on the Outcome of Transcatheter Pulmonic Valve Implantation.

Patient prosthesis mismatch (PPM) is an important factor of the outcome in transcatheter aortic valve implantation. However, the impact of PPM in transcatheter pulmonic valve implantation (TPVI) has not been studied. Based on the narrowest valve stent diameters in two views of fluoroscopy, internal geometric orifice area (GOA) of the valve stent was calculated and indexed by body surface area (BSA), deriving iGOA. To define PPM in TPVI, receiver operating characteristics (ROC) curve analysis for iGOA for predicting significant residual right ventricular outflow tract (RVOT) gradient was used to derive the optimal cut-off value of iGOA. Our cohort were divided into 2 groups: PPM versus non-PPM. The clinical data were compared between 2 groups. TPVI was performed using Melody valve in 101 patients. Significant RVOT residual pressure gradient (≥ 15 mmHg) was observed in 31 patients (39.6%). Over a mean follow up periods of 6.9 ± 2.7 years, 22 patients (21.8%) required repeat interventions (16 transcatheter, 11 surgical, and both in 5 patients). Based on the ROC analysis, the best cut-off value of iGOA was 1.25 cm2/m2 (area under the curve 0.873, p < 0.001) to define PPM. PPM was present in 42 patients (42%). On the Kaplan-Meier survival analysis, PPM was associated with the need of repeat intervention (p = 0.02). In conclusion, in TPVI, PPM was a strong predictor for the need of re-intervention. Considering PPM, target diameter of valve stent would depend on the patient body size and should be taken into account for optimal outcome of TPVI.

Female Sexual Function following Sling Surgery: A Prospective Parallel Cohort, Multi-Center Study of the Solyx™ Single Incision Sling System versus the Obtryx™ II Sling System.

PURPOSE: Limited data exist regarding sexual function after single incision sling (SIS) surgery. We compared sexual function 36 months postoperatively between patients undergoing SIS and transobturator sling (TMUS) for treatment of stress urinary incontinence. MATERIALS AND METHODS: Assessment of sexual function was a planned secondary objective of this prospective, multi-center study that enrolled women to Solyx SIS or Obtryx II TMUS. The primary study aim was to compare efficacy and safety using non-inferiority design at 36 months. Patient-reported outcomes of sexual function were assessed at baseline and 6, 12, 18, 24 and 36 months using Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Changes in sexual function were analyzed within and between groups. Outcomes for patients requiring surgical retreatment were determined. RESULTS: Baseline characteristics were balanced using propensity score stratification (N=141 SIS, N=140 TMUS). Groups were similar in age, body mass index and concomitant surgery performed. Average length of followup was 30 months. Baseline sexual activity was similar (123/141 SIS, 114/140 TMUS, p=0.18). Severity of urinary incontinence did not correlate with baseline sexual activity. Mean PISQ-12 scores increased significantly from baseline to 36 months for both groups, indicating better sexual function at each visit. There were no significant differences in PISQ-12 scores between groups except at 36 months, where the difference was small (-2.5, 95% CI [-4.7, 0.2]). Among patients undergoing surgical retreatment (9/281, 3%), improvement in sexual function was maintained. De novo dyspareunia was rare following both treatments (SIS 1/141, TMUS 0/140, p=1.00). CONCLUSIONS: Patients have significant improvement in sexual function after SIS and TMUS. De novo sexual pain is low after sling surgery.

Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

PURPOSE: We present final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor therapy (Rezum™) for treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia. MATERIALS AND METHODS: A total of 197 subjects >50 years of age with International Prostate Symptom Score ≥13, maximum flow rate ≤15 ml/second and prostate volume 30 to 80 cc were randomized and followed for 5 years. From the control arm of 61 subjects, a subset of 53 subjects requalified and after 3 months received treatment as part of the crossover group and were also followed for 5 years. The total number of vapor treatments to each lobe of the prostate was determined by length of prostatic urethra and included middle lobe treatment per physician discretion. RESULTS: Significant improvement of lower urinary tract symptoms was observed at <3 months post-thermal therapy, remaining durable through 5 years in the treatment group (International Prostate Symptom Score reduced 48%, quality of life increased 45%, maximum flow rate improved 44%, Benign Prostatic Hyperplasia Impact Index decreased 48%). Surgical re-treatment rate was 4.4% with no reports of device or procedure related sexual dysfunction or sustained de novo erectile dysfunction. Results within the crossover group were similar through 5 years. CONCLUSIONS: Minimally invasive treatment with water vapor thermal therapy provides significant and durable symptom relief as well as flow rate improvements through 5 years, with low surgical re-treatment rates and without impacting sexual function. It is a versatile therapy, providing successful treatment to obstructive lateral and middle lobes.

Comparison of the efficacy and safety of cuffed versus uncuffed endotracheal tubes for infants in the intensive care setting: a pilot, unblinded RCT.

OBJECTIVE: To study effectiveness and safety of cuffed versus uncuffed endotracheal tubes (ETTs) in small infants in the intensive care unit (ICU). DESIGN: Pilot RCT. SETTING: Neonatal and paediatric ICUs of children's hospital in Western Australia. PARTICIPANTS: Seventy-six infants ≥35 weeks gestation and infants <3 months of age, ≥3 kg. INTERVENTIONS: Patients randomly assigned to Microcuff cuffed or Portex uncuffed ETT. MAIN OUTCOMES MEASURES: Primary outcome was achievement of optimal ETT leak in target range (10%-20%). Secondary outcomes included: reintubations, ventilatory parameters, ventilatory complications, postextubation complications and long-term follow-up. RESULTS: Success rate (achievement of mean leak in the range 10%-20%) was 13/42 (30.9%) in the cuffed ETT group and 6/34 (17.6%) in uncuffed ETT group (OR=2.09; 95% CI (0.71 to 6.08); p=0.28). Mean percentage time within target leak range in cuffed ETT group 28% (IQR: 9-42) versus 15% (IQR: 0-28) in uncuffed ETT group (p=0.01). There were less reintubations to optimise size in cuffed ETT group 0/40 versus 10/36 (p<0.001). No differences were found in gaseous exchange, ventilator parameters or postextubation complications. There were fewer episodes of atelectasis in cuffed ETT group 0/42 versus 4/34 (p=0.03). No patient had been diagnosed with subglottic stenosis at long-term follow-up. CONCLUSIONS: There was no difference in the primary outcome, though percentage time spent in optimal leak range was significantly higher in cuffed ETT group. Cuffed ETTs reduced reintubations to optimise ETT size and episodes of atelectasis. Cuffed ETTs may be a feasible alternative to uncuffed ETTs in this group of patients. TRIAL REGISTRATION NUMBER: ACTRN12615000081516.

Natural History of Post-Treatment Kidney Stone Fragments: A Systematic Review and Meta-Analysis.

PURPOSE: We assessed the literature around post-treatment asymptomatic residual stone fragments and performed a meta-analysis. The main outcomes were intervention rate and disease progression. MATERIALS AND METHODS: We searched Ovid®, MEDLINE®, Embase™, the Cochrane Library and ClinicalTrials.gov using search terms: "asymptomatic", "nephrolithiasis", "ESWL", "PCNL", "URS" and "intervention." Inclusion criteria were all studies with residual renal fragments following treatment (shock wave lithotripsy, ureteroscopy or percutaneous nephrolithotomy). Analysis was performed using 'metafor' in R and bias determined using Newcastle-Ottawa scale. RESULTS: From 273 articles, 18 papers (2,096 patients) had details of intervention rate for residual fragments. Aggregate intervention rates for ≤4 mm fragments rose from 19% (20 months) to 22% (50 months), while >4 mm fragments rose from 22% to 47%. Aggregate disease progression rates for ≤4 mm rose from 25% to 47% and >4 mm rose from 26% to 88%. However, there was substantial difference in definition of "disease progression." Meta-analysis comparing >4 mm against ≤4 mm fragments: intervention rate for >4 mm (vs ≤4 mm): OR=1.50 (95% CI 0.70-2.30), p <0.001, I2=67.6%, tau2=0.48, Cochran's Q=11.4 (p=0.02) and Egger's regression: z=3.11, p=0.002. Disease progression rate for >4 mm: OR=0.06 (95% CI -0.98-1.10), p=0.91, I2=53.0%, tau2=0.57, Cochran's Q=7.11 (p=0.07) and Egger's regression: z=-0.75, p=0.45. Bias analysis demonstrated a moderate risk. CONCLUSIONS: Larger post-treatment residual fragments are significantly more likely to require further intervention especially in the long term. Smaller fragments, although less likely to require further intervention, still carry that risk. Notably, there is no significant difference in disease progression between fragment sizes. Patients with residual fragments should be appropriately counselled and informed decision-making regarding further management should be done.

Immune-related adverse events and immune checkpoint inhibitor tolerance on rechallenge in patients with irAEs: a single-center experience.

BACKGROUND: Given the widespread use of immune checkpoint inhibitors (ICIs), newer immune related adverse events (irAEs) have come to light, including flare-ups of preexisting autoimmune disorders (AIDs) and delayed immune-related events. We aimed to identify the frequency and severity of new IRAEs, including AID flares in cancer patients treated with ICIs at our institution. We also studied the tolerability of ICIs upon rechallenge in patients with irAEs and hospital admissions due to irAEs in a community setting in rural Maine. METHODS: We conducted a retrospective chart review analysis of all patients with cancer who received anti-PDL1/PDL1 inhibitors nivolumab, pembrolizumab, atezolizumab, and durvalumab at our tertiary care center from November 2015 to March 2019. Demographic data, cancer type and stage, irAEs, hospital admissions due to irAEs, and drug treatment information was extracted. RESULTS: We included 465 patients who received ICIs, 115 (out of 465 25%) developed new irAEs. Preexisting AID were identified in 47 (out of 465) (10%), AID flares were observed in 12 patients (25% of 47). 17 (out of 47 36%) were on immunosuppression for underlying AID, 5 (out of 17, 29%) developed flares. Overall, 148 (32% of 465) irAEs occurred, as some patients had multiple toxicities. Majority were treated for Lung cancer (63%), followed by melanoma and genitourinary cancers. Due to irAE severity, treatment was permanently discontinued in 15% (out of 465) patients. Hospital admissions due to irAEs were required for 34 patients (7.3% of 465). ICI rechallenge was performed in 27 patients (6% of 465), and majority tolerated well. CONCLUSION: Our study shows that ICIs were generally well tolerated and can be used safely even in patients with preexisting AIDs; it is encouraging to see majority tolerated rechallenge with ICIs well.

Frequency of pre-treatment may not increase the immune-related adverse events of RCC patients treated with nivolumab.

ABSTRACT: Nivolumab has shown good prognosis in renal cell carcinoma (RCC) patients previously treated with targeted therapy. We aimed to study irAE (immune-related adverse event) due to nivolumab and numbers of previous treatment lines in RCC patients. Between October 2016 and November 2019, 114 patients were treated with nivolumab as second- and later-line therapy. Among them, 110 patients with complete data were evaluated in this retrospective observational study. The primary endpoint was the relation between irAE and numbers of previous targeted therapies. Secondary endpoints were the relation of irAE with the duration of nivolumab treatment and with best overall response. For the primary analysis, proportional odds logistic regression was used to assess the effect of the number of prior therapies on the grade of any irAE as the ordinal variable. For the secondary analysis, binomial logistic regression models adjusted for the covariates were prepared to confirm the association between the incidence of irAE and the number of courses, number of nivolumab treatments and best overall response. Overall, 69, 66, 33, 13, 9 and 9 patients were treated with sunitinib, axitinib, pazopanib, sorafenib, temsirolimus and everolimus, respectively, prior to nivolumab. In total, 60 adverse events (Grade 1, 21; Grade 2, 21; Grade 3, 14; Grade 4, 2; not evaluated, 2) were identified in the patients treated with nivolumab. Ordered logistic regression analysis showed that the adjusted odds ratios of numbers of prior treatment for grade of irAE were 1.12 (numbers of prior treatment: 2 to 1) and 1.31 (3 to 1). Odds ratios of the numbers of nivolumab treatments and best overall response for the incidence of irAE were not significant. No statistically significant relations were found between grade of irAE and numbers of treatments prior to nivolumab. Patients treated with nivolumab should be closely monitored for irAE regardless number of previous therapies.