Video-Based Coaching for Laparoscopic Salpingectomy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of video-based coaching on the gynecology resident performance of laparoscopic salpingectomy. METHODS: PGY-1 and PGY-2 residents were randomized before their gynecology rotations to standard gynecology curriculum (control group) or standard curriculum plus two video-coaching sessions by a fellowship-trained minimally invasive gynecologic surgeon (VBC group). Residents were video recorded intraoperatively performing three unilateral laparoscopic salpingectomies. Participants in the VBC group were coached between the procedures. The primary outcome was the improvement in modified GOALS (Global Operative Assessment of Laparoscopic Skills) and OSA-LS (Objective Structured Assessment of Laparoscopic Salpingectomy) scores, compared with baseline, in the VBC and control groups, with videos independently graded by three blinded minimally invasive gynecologic surgeons. A minimum sample size of 18 participants (nine per group) was needed to achieve 90% power to detect a difference of 5.0 points. RESULTS: From October 2021 to December 2022, 28 PGY-1 and PGY-2 residents completed the study with 14 participants per group. Baseline characteristics were similar between groups. In the VBC group, modified GOALS scores significantly improved by 3.0 points from video 1 to video 2 ( P =.04) and by 3.2 points from video 1 to video 3 ( P =.02). Modified OSA-LS scores also increased significantly in the VBC group, by 6.1 points from video 1 to video 3 ( P =.02). In the control group, modified GOALS and OSA-LS scores improved from baseline but were not significant ( P =.2, P =.5). Video-based coaching also enhanced resident comfort and confidence in performing laparoscopic surgery. CONCLUSION: Video-based coaching improves resident performance of laparoscopic salpingectomy and can be used as an adjunct to resident surgical training. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT05103449.

Three-year outcomes of a randomized clinical trial of perioperative vaginal estrogen as adjunct to native tissue vaginal apical prolapse repair.

BACKGROUND: As the muscular and connective tissue components of the vagina are estrogen responsive, clinicians may recommend vaginal estrogen to optimize tissues preoperatively and as a possible means to reduce prolapse recurrence, but long-term effects of perioperative intravaginal estrogen on surgical prolapse management are uncertain. OBJECTIVE: This study aimed to compare the efficacy of perioperative vaginal estrogen vs placebo cream in reducing composite surgical treatment failure 36 months after native tissue transvaginal prolapse repair. STUDY DESIGN: This was an extended follow-up of a randomized superiority trial conducted at 3 tertiary US sites. Postmenopausal patients with bothersome anterior or apical vaginal prolapse were randomized 1:1 to 1-g conjugated estrogen cream (0.625 mg/g) or placebo, inserted vaginally twice weekly for ≥5 weeks preoperatively and continued twice weekly for 12 months postoperatively. All participants underwent vaginal hysterectomy (if the uterus was present) and standardized uterosacral or sacrospinous ligament suspension at the surgeon's discretion. The primary report's outcome was time to failure by 12 months postoperatively, defined by a composite outcome of objective prolapse of the anterior or posterior walls beyond the hymen or the vaginal apex descending below one-third the total vaginal length, subjective bulge symptoms, and/or retreatment. After 12 months, participants could choose to use-or not use-vaginal estrogen for atrophy symptom bother. The secondary outcomes included Pelvic Organ Prolapse Quantification points, subjective prolapse symptom severity using the Patient Global Impression of Severity and the Patient Global Impression of Improvement, and prolapse-specific subscales of the 20-Item Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire-Short Form 7. Data were analyzed as intent to treat and "per protocol" (ie, ≥50% of expected cream use per medication diary). RESULTS: Of 206 postmenopausal patients, 199 were randomized, and 186 underwent surgery. Moreover, 164 postmenopausal patients (88.2%) provided 36-month data. The mean age was 65.0 years (standard deviation, 6.7). The characteristics were similar at baseline between the groups. Composite surgical failure rates were not significantly different between the estrogen group and the placebo group through 36 months, with model-estimated failure rates of 32.6% (95% confidence interval, 21.6%-42.0%) and 26.8% (95% confidence interval, 15.8%-36.3%), respectively (adjusted hazard ratio, 1.55; 95% confidence interval, 0.90-2.66; P=.11). The results were similar for the per-protocol analysis. Objective failures were more common than subjective failures, combined objective and subjective failures, or retreatment. Using the Patient Global Impression of Improvement, 75 of 80 estrogen participants (94%) and 72 of 76 placebo participants (95%) providing 36-month data reported that they were much or very much better 36 months after surgery (P>.99). These data included reports from 51 of 55 "surgical failures." Pelvic Organ Prolapse Quantification measurements, Patient Global Impression of Severity scores, and prolapse subscale scores of the 20-Item Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire-Short Form 7 all significantly improved for both the estrogen and placebo groups from baseline to 36 months postoperatively without differences between the groups. Of the 160 participants providing data on vaginal estrogen usage at 36 months postoperatively, 40 of 82 participants (49%) originally assigned to the estrogen group were using prescribed vaginal estrogen, and 47 of 78 participants (60%) assigned to the placebo group were using vaginal estrogen (P=.15). CONCLUSION: Adjunctive perioperative vaginal estrogen applied ≥5 weeks preoperatively and 12 months postoperatively did not improve surgical success rates 36 months after uterosacral or sacrospinous ligament suspension prolapse repair. Patient perception of improvement remained very high at 36 months.

Somatic and autonomic nerve density and distribution within the clitoris: an immunohistochemical study in adult female cadavers.

INTRODUCTION AND HYPOTHESIS: Knowledge of clitoral neuroanatomy is critical to vulvar surgery. We sought to characterize the density and distribution of autonomic and somatic nerves supplying the clitoris. METHODS: Pelvic tissue harvested from female cadavers was sectioned axially at three anatomic levels: the proximal aspect of the clitoral body (CB), the distal CB, and the glans. The CB, glans, and the surrounding connective tissue (dorsal, lateral, and ventral) were outlined microscopically. An area containing large nerve bundles dorsal to the CB, referred to as the dorsal nerve subregion, was analyzed separately. Double-immunofluorescent staining for beta III tubulin (ßIIIT), a global axonal marker, and myelin basic protein (MBP), a myelinated nerve marker, was performed. Threshold-based automatic image-segmentation distinguished stained areas. Autonomic and somatic density were calculated as percentage of tissue stained with ßIIIT alone, and ßIIIT and MBP respectively. Comparisons were made using nonparametric Friedman tests. RESULTS: Seven cadavers, aged 22-81, were examined. Somatic (mean 4.42%, SD ± 1.97) and autonomic (2.14% ± 2.42) nerve density was highest in the dorsal nerve subregion and dorsal region at the distal CB level. Compared with the CB, somatic density was higher in proximal (0.05% ± 0.03 vs 1.27% ± 0.69, p = 0.03) and distal (0.29% ± 0.25 vs 1.09% ± 0.41, p = 0.05) dorsal regions. Somatic density was greater in the glans than in the surrounding lateral (0.78% ± 0.47 vs 0.43% ± 0.23, p = 0.03) and ventral (0.78% ± 0.47 vs 0.52% ± 0.2, p = 0.03) regions. Autonomic density was greater than somatic in all areas, except for the dorsal nerve subregion. CONCLUSIONS: Somatic and autonomic nerve density were greatest in a well-defined region dorsal to the CB. Surgical preservation of this region is critical for maintaining nerve supply to the clitoris.

Characteristics Associated With Surgical Failure After Native Tissue Apical Prolapse Repair.

OBJECTIVE: To identify clinical and demographic characteristics associated with prolapse recurrence by 12 months after native tissue transvaginal repair. METHODS: This was a planned secondary analysis of a randomized trial including postmenopausal participants with stage 2 or greater apical or anterior vaginal prolapse scheduled for surgical repair at three U.S. sites. Participants underwent vaginal hysterectomy (if uterus was present) and standardized uterosacral or sacrospinous ligament suspension at the surgeon's discretion. The intervention was perioperative (5 weeks or more preoperatively and 12 months postoperatively) vaginal estrogen compared with placebo cream. The primary outcome was time to failure by 12 months after surgery, defined by objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, symptomatic vaginal bulge, or retreatment. For this analysis, participants were grouped according to failure compared with success, and multiple factors were compared, including age, time since menopause, race and ethnicity, parity, body mass index (BMI), baseline genital hiatus measurement, prolapse stage and point of maximal prolapse, surgery type (uterosacral or sacrospinous ligament suspension), and concomitant procedures. Factors were assessed for association with the hazard of surgical failure using Cox proportional hazards models, adjusted for site and treatment group. Factors with P <.50 from this analysis were considered for inclusion in the final multivariable model; site and treatment group were kept in this model. RESULTS: One hundred eighty-six participants underwent surgery; 183 provided complete data. There were 30 failures (16.4%) and 153 successes (83.4%) at 12 months. On bivariate analysis, failure was associated with decreasing age, shorter duration since menopause, Latina ethnicity, and greater baseline genital hiatus. In the final multivariable model, which included age, BMI, and point of maximal prolapse, only age remained significantly associated with surgical failure (adjusted hazard ratio [per year] 0.92, 95% CI, 0.86-0.98, P =.016). CONCLUSION: Among postmenopausal women, younger age was associated with increased frequency of prolapse recurrence by 12 months after native tissue repair. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02431897.

Perioperative Vaginal Estrogen as Adjunct to Native Tissue Vaginal Apical Prolapse Repair: A Randomized Clinical Trial.

Importance: Surgical repairs of apical/uterovaginal prolapse are commonly performed using native tissue pelvic ligaments as the point of attachment for the vaginal cuff after a hysterectomy. Clinicians may recommend vaginal estrogen in an effort to reduce prolapse recurrence, but the effects of intravaginal estrogen on surgical prolapse management are uncertain. Objective: To compare the efficacy of perioperative vaginal estrogen vs placebo cream on prolapse recurrence following native tissue surgical prolapse repair. Design, Setting, and Participants: This randomized superiority clinical trial was conducted at 3 tertiary US clinical sites (Texas, Alabama, Rhode Island). Postmenopausal women (N = 206) with bothersome anterior and apical vaginal prolapse interested in surgical repair were enrolled in urogynecology clinics between December 2016 and February 2020. Interventions: The intervention was 1 g of conjugated estrogen cream (0.625 mg/g) or placebo, inserted vaginally nightly for 2 weeks and then twice weekly to complete at least 5 weeks of application preoperatively; this continued twice weekly for 12 months postoperatively. Participants underwent a vaginal hysterectomy (if uterus present) and standardized apical fixation (either uterosacral or sacrospinous ligament fixation). Main Outcomes and Measures: The primary outcome was time to failure of prolapse repair by 12 months after surgery defined by at least 1 of the following 3 outcomes: anatomical/objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment. Secondary outcomes included measures of urinary and sexual function, symptoms and signs of urogenital atrophy, and adverse events. Results: Of 206 postmenopausal women, 199 were randomized and 186 underwent surgery. The mean (SD) age of participants was 65 (6.7) years. The primary outcome was not significantly different for women receiving vaginal estrogen vs placebo through 12 months: 12-month failure incidence of 19% (n = 20) for vaginal estrogen vs 9% (n = 10) for placebo (adjusted hazard ratio, 1.97 [95% CI, 0.92-4.22]), with the anatomic recurrence component being most common, rather than vaginal bulge symptoms or prolapse repeated treatment. Masked surgeon assessment of vaginal tissue quality and estrogenization was significantly better in the vaginal estrogen group at the time of the operation. In the subset of participants with at least moderately bothersome vaginal atrophy symptoms at baseline (n = 109), the vaginal atrophy score for most bothersome symptom was significantly better at 12 months with vaginal estrogen. Conclusions and Relevance: Adjunctive perioperative vaginal estrogen application did not improve surgical success rates after native tissue transvaginal prolapse repair. Trial Registration: ClinicalTrials.gov Identifier: NCT02431897.

Effects of preoperative intravaginal estrogen on pelvic floor disorder symptoms in postmenopausal women with pelvic organ prolapse.

BACKGROUND: Menopause and the decline in systemic estrogen are associated with the development of pelvic floor disorders, such as prolapse, urinary incontinence, overactive bladder, and vulvovaginal atrophy symptoms. Past evidence suggests that postmenopausal women with symptomatic prolapse gain benefit from the preoperative application of intravaginal estrogen, but it is unknown whether they would experience improvement in other pelvic floor symptoms when treated with intravaginal estrogen. OBJECTIVE: This study aimed to determine the effects of intravaginal estrogen (compared with placebo) on stress and urgency urinary incontinence, urinary frequency, sexual function and dyspareunia, and vaginal atrophy symptoms and signs in postmenopausal women with symptomatic prolapse. STUDY DESIGN: This was a planned ancillary analysis of a randomized, double-blind trial, "Investigation to Minimize Prolapse Recurrence Of the Vagina using Estrogen," which included participants with ≥stage 2 apical and/or anterior prolapse scheduled for transvaginal native tissue apical repair at 3 US sites. The intervention was 1 g conjugated estrogen intravaginal cream (0.625 mg/g) or identical placebo (1:1), inserted nightly for 2 weeks and then twice weekly for ≥5 weeks total before surgery and continued twice weekly for 1 year postoperatively. For this analysis, question responses were compared from participants' baseline and preoperative visits: lower urinary tract symptoms (Urogenital Distress Inventory-6 Questionnaire); sexual health questions, including dyspareunia (Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire-IUGA-Revised); and atrophy-related symptoms (dryness, soreness, dyspareunia, discharge, and itching; each scored 1-4, 4 being quite a bit bothersome). Masked examiners assessed vaginal color, dryness, and petechiae (each scored 1-3, total range 3-9, with 9 being the most estrogenized appearing). Data were analyzed by intent to treat and "per protocol" (ie, those adherent with ≥50% of expected intravaginal cream use, per objective tube before and after weights). RESULTS: Of 199 participants randomized (mean age of 65 years) and contributing baseline data, 191 had preoperative data. The characteristics were similar between groups. Total Urogenital Distress Inventory-6 Questionnaire scores showed minimal change during this median time of 7 weeks between baseline and preoperative visits, but for those with at least moderately bothersome baseline stress urinary incontinence (32 in the estrogen group and 21 in the placebo group), 16 (50%) in the estrogen group and 9 (43%) in the placebo group showed improvement (P=.78). In addition, 43% of participants in the estrogen group and 31% of participants in the placebo group showed improvement in urgency urinary incontinence (P=.41), and 41% of participants in the estrogen group and 26% of participants in the placebo group showed improvement in urinary frequency (P=.18). There was minimal change in the Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire-IUGA-Revised scores among sexually active women; dyspareunia rates did not differ between intravaginal estrogen and placebo at the preoperative assessment: 42% and 48%, respectively (P=.49). The maximum score for most bothersome atrophy symptom (among those with baseline symptoms and adherent to study cream) improved slightly more with intravaginal estrogen (adjusted mean difference, -0.33 points; 95% confidence interval, -0.98 to 0.31), but this was not statistically significant (P=.19). However, on examination, among adherent participants, objective signs of atrophy were more improved with intravaginal estrogen treatment (+1.54 vs +0.69; mean difference, 0.85; 95% confidence interval, 0.05-1.65; P=.01). CONCLUSION: Despite objective changes in the vaginal epithelium consistent with increased estrogenization among drug-adherent participants, the results were inconclusive regarding whether 7 weeks of preoperative intravaginal estrogen cream in postmenopausal women with symptomatic pelvic organ prolapse was associated with improved urinary function, sexual function, dyspareunia symptoms, and other symptoms commonly attributed to atrophy. Additional study is needed.

Single-Stage Surgical Management of Atrioventricular Septal Defects with Coarctation of the Aorta.

Surgical options for coarctation of aorta (CoA) with atrioventricular septal defect (AVSD) include single-stage repair vs. staged approach with neonatal CoA repair and delayed AVSD repair. The durability of left atrioventricular valve (LAVV) function after neonatal repair is questioned, and the optimal approach remains controversial. Eighteen CoA-AVSD patients who underwent single-stage repair 2005-2015 by a single surgeon were retrospectively analyzed. Fifteen patients had complete and three had partial AVSD. Birth weight was 3.19 kg (2.17-4.08). Age at surgery was 16 days (6-127). One- and ten-year survival were 80% and 69%. Freedom from reintervention was 60% and 40% at one and ten-year respectively. Reinterventions included relief of left ventricular outflow tract obstruction (LVOTO) (n = 4), repair of cleft LAVV (n = 3), and LAVV and aortic valve replacement (n = 1). Freedom from LAVV reintervention was 85.6% and 66% at 1 and 10 years respectively. There were four deaths: two post-operative and two following hospital discharge. Mortality was due to sepsis in three patients, and heart failure related to LVOTO and LAVV insufficiency in one. At 68-month (0.6-144) follow-up the majority had mild or less LAVV regurgitation, and all had normal LV dimension and systolic function. There was no recurrent arch obstruction. Single-stage surgical repair of CoA-AVSD is feasible and reasonable. Survival and freedom from reintervention in our cohort approximate those outcomes of two-stage repair with durable left AV valve function and no recurrent arch obstruction. These patients are frequently syndromic and demonstrate mortality risk from non-cardiac causes. Consideration of a single-staged approach is warranted for appropriate patients with CoA-AVSD.

Cardiac transplantation in adults with congenital heart disease: A single center case series.

BACKGROUND: Adult congenital heart disease (CHD) transplant recipients historically experienced worse survival early after transplantation. We aim to review updated trends in adult CHD transplantation. METHODS: We performed a single center case series of adult cardiac transplants from January 2013 through July 2020. Outcomes of patients with CHD were compared to non-CHD. The primary outcome was overall survival. Secondary outcomes included a variety of post-operative complications. RESULTS: 18/262 (7%) transplants were CHD recipients. CHD patients were younger with median age 41 (32-47) versus 58 (48-65) (P < .001). Fontan circulation for single ventricle physiology was present in 4/18 (22%) of CHD recipients, while 16/18 (89%) had systemic right ventricles. CHD recipients had higher rates of previous cardiovascular operations (94% vs. 51%, P < .001). 9/18 (50%) of CHD patients required reconstructive procedures at the time of transplant. Operative and cardiopulmonary bypass times were longer for the CHD cohort (7.5 h [6.6-8.5] vs. 5.6 h [4.6-7] P < .001) and (197 min [158-240] vs. 130 [105-167] P < .001), respectively. There were no differences in operative complications or survival between CHD and non-CHD recipients. CONCLUSIONS: These data highlight the added technical challenges of performing adult CHD transplants. However, similar outcomes can be achieved as for non-CHD recipients. SUMMARY: Modern advances in palliation of congenital heart defects (CHD) has led to increased survival into adulthood. Many of these patients require heart transplantation as adults. There are limited data on adult CHD transplantation. Historically, these patients have had worse perioperative outcomes with improved long-term survival. We retrospectively analyzed 262 heart transplants at a single center, 18 of which were for adult CHD. Here, we report our series of 18 CHD recipients. We detail the palliative history of all CHD patients and highlight the added technical challenges for each of the 18 patients at transplant. In our analysis, CHD patients had more prior cardiovascular surgeries as well as longer transplant operative and bypass times. Despite this, there were no differences in perioperative and long-term outcomes. We have added patient and institution specific data for transplanting patients with adult CHD. We hope that our experience will add to the growing body of literature on adult CHD transplantation.

Comparing the rate of fiberoptic bronchoscopy use with a video double lumen tube versus a conventional double lumen tube-a randomized controlled trial.

BACKGROUND: Double lumen endotracheal tubes (DLT) are commonly used to provide single lung ventilation during thoracic surgery. A fiberoptic bronchoscope (FOB) is typically used to confirm accurate DLT placement. Accounting for initial purchase, maintenance, repair and cleaning, the use of an FOB can cost as much as $312 per procedure. The VivaSight DLT (VS-DLT) incorporates a built-in camera, which is aimed at reducing FOB use and its associated costs. In this study, we compared the rate of FOB use when intubating using either a VS-DLT or a conventional DLT (c-DLT). METHODS: This is a randomized controlled comparative study performed at a public county teaching hospital. A total of 50 patients were enrolled and randomly assigned to either a c-DLT (n=25) or a VS-DLT (n=25). The primary outcome was the rate of FOB use. Secondary outcomes included time to correct tube placement and incidence of malposition during surgery. RESULTS: Use of the VS-DLT required significantly less FOB use (28%) compared to use of the c-DLT (100%). While there was no difference in the ease of intubation, the time to correct tube placement was significantly faster using a VS-DLT (54 vs. 156 s, P<0.001). Additionally, the incidence of tube malposition was significantly reduced in the VS-DLT group. CONCLUSIONS: This study demonstrated a significantly lower rate of FOB use when using a VS-DLT compared to a c-DLT. Placement of the VS-DLT was significantly quicker and malposition during surgery occurred significantly less than with the c-DLT. While intubating with a VS-DLT provides clinical benefits, it may not result in significant cost reductions when compared to a c-DLT.

Predictive value of lateral soft tissue thickness for complications after total hip arthroplasty with a lateral incision.

The purpose of this study was to determine the relationship between soft tissue thickness lateral to the greater trochanter, as measured on anteroposterior pelvis radiograph, and postoperative complications following primary total hip arthroplasty. A retrospective review of 1110 consecutive patients treated at a single institution from 2003 to 2011 was conducted. Postoperative complications were divided into surgical site infections, deep wound infections, noninfectious surgical complications, need for revision surgery, and medical complications. Lateral soft tissue thickness (LSTT) was measured as the horizontal distance from the most lateral point on the greater trochanter to the skin edge obtained from anteroposterior hip radiographs. Among the 1110 study patients, 19.19% had a postoperative complication, with a deep infection rate of 3.42%. Of the previously identified risk factors, increased LSTT and body mass index were both associated with surgical site infection and deep infection, and LSTT was associated with revision surgery. An LSTT value of >5 cm was predictive of surgical site infection, deep infection, and revision surgery. This easily obtainable radiographic measurement, along with clinical examination near the operative site, might prove helpful in making preoperative risk assessments.

Sugammadex versus neostigmine for reversal of rocuronium-induced neuromuscular blockade: A randomized, double-blinded study of thoracic surgical patients evaluating hypoxic episodes in the early postoperative period.

STUDY OBJECTIVE: This objective of this study was to determine if reversal of rocuronium-induced neuromuscular blockade with sugammadex versus neostigmine results in a decreased number of hypoxic episodes in the early postoperative period in patients undergoing thoracic surgery with single lung ventilation. DESIGN: Single-center, randomized, double-blind, two-arm clinical trial. SETTING: Operating room and postanesthesia care unit. PATIENTS: 92 subjects aged ≥18, American Society of Anesthesiologists physical status II-IV, and undergoing a thoracic operation necessitating single lung ventilation. INTERVENTIONS: Subjects received either 2 mg/kg sugammadex or 50 µg/kg neostigmine with 8 µg/kg glycopyrrolate for reversal of moderate neuromuscular blockade. MEASUREMENTS: For the first 90 min postoperatively, all episodes of hypoxia were recorded. Neuromuscular monitoring was performed with acceleromyography (TOF-Watch® SX) and the train of four (TOF) was recorded at 2, 5, 10, and 15 min after administration of the neuromuscular reversal agent. MAIN RESULTS: Subjects who received neostigmine had a median of 1 episode (interquartile range IQR: 0-2.2) of hypoxia versus subjects who received sugammadex who had a median of 0 episodes (IQR: 0-1) (p = 0.009). The mean time to recovery of TOF ≥ 0.9 was significantly faster with sugammadex at 10 min (95% confidence interval CI: 5-15) compared with neostigmine at 40 min (95% CI: 15-53) (p < 0.001). CONCLUSIONS: In thoracic surgical patients necessitating single lung ventilation, sugammadex provides faster reversal of moderate neuromuscular blockade and results in a decreased number of postoperative hypoxic episodes compared with neostigmine.

Mitral Valve Surgery in the First Year of Life.

Data are limited on outcomes associated with mitral valve surgery in infants. Prior studies report high mortality and increased risk for late cardiac failure particularly for those with mitral stenosis. We sought to evaluate outcomes in patients with mitral stenosis (MS) or regurgitation (MR) who had mitral valvuloplasty or replacement in the first year of life. A retrospective analysis of all patients in a single institution who underwent mitral valvuloplasty or replacement in their first year of life from 2004 to 2016 (n = 25), excluding patients with single ventricle pathology or those undergoing surgery for atrioventricular canal defect, was carried out. Median age and weight at surgery were 76.5 days (range 2-329) and 4.5 kg (range 3.0-10.1), respectively. The primary mitral pathology was MR in 16 and MS in 9 patients. Median follow-up among living patients was 4 years (range 106 days-12.3 years). Overall survival was 96% at 30 days and 87.8% at 1, 5, and 10 years. There were three early deaths (12%), all within 6 weeks of surgery. There were no late deaths. Three patients required valve replacement, 1 of which had a primary mitral valve replacement and died within 30 days of surgery. Re-intervention-free survival (surgical and catheter based) was 83.8%, 73.3%, and 48.9% at 1, 5, and 10 years per Kaplan-Meier estimates. There was no difference in re-intervention-free survival between patients with MR versus MS. No risk factors for death or re-intervention were identified. Mitral valvuloplasty and replacement can be performed in infants under 1 year of age with acceptable survival and need for re-intervention.

Intensity modulated radiation therapy after extra-pleural pneumonectomy for malignant pleural mesothelioma is feasible without fatal pulmonary toxicity and provides good survival.

AIM: To analyze patterns of failure, toxicity, relapse-free survival (RFS), and overall survival (OS) in malignant pleural mesothelioma (MPM) patients treated with intensity-modulated radiation therapy following extrapleural pneumonectomy (EPP). METHODS: We reviewed 18 charts of patients with MPM from 2005 to 2014 who underwent EPP followed by hemithoracic intensity-modulated radiation therapy. Intensity-modulated radiation therapy dose delivery adhered to published lung dose constraints. Kaplan-Meier curves were used to assess the RFS and OS. Median survival times are reported for both RFS and OS. RESULTS: Median age was 65 years (range: 40-76 years). Chemotherapy was administered in four neo-adjuvant and seven adjuvant patients. Pathological American Joint Committee on Cancer stages II, III, IV, surgical margin, lympho-vascular space, pericardium, and chest wall involvement were seen in 3, 12, 3, 9, 7, 12 and 3 patients, respectively. The majority of the patients received 45 Gy in 25 fractions. The mean lung dose was 7.14 Gy (range: 5 Gy-9.3 Gy). The mean V20 was 2.23%. At a median follow-up of 3 years, eight patients were alive (44%); 10 experienced relapse (56%). Median RFS and OS were 24.4 months (95% CI: >16.3 months) and 38.2 months (95% CI: 17.4-78.1 months), respectively. Acute toxicities were fatigue, dermatitis, nausea, esophagitis/dysphagia, cough, and dyspnea on exertion. No grade III, IV, or fatal pulmonary toxicities were observed. CONCLUSION: Intensity-modulated radiation therapy following EPP for MPM resulted in RFS and OS comparable to the published literature without significant toxicity.

Risk factors for locoregional relapse after radical nephrectomy.

AIM: To identify risk factors for locoregional relapse after radical nephrectomy for renal cell carcinoma. METHODS: We retrospectively reviewed the charts of 259 patients who underwent radical nephrectomy for sporadic clinically localized unilateral renal cell carcinoma between 1998 and 2012. Relapse patterns (locoregional and/or distant) were identified. Relapse-free survival was calculated using Kaplan-Meier method. Factors associated with decreased relapse-free survival were identified using univariate and multivariate Cox proportional hazards regression model analysis. Locoregional relapse estimates were calculated for individual factors and combination of factors. RESULTS: At a median follow-up of 68 months (interquartile range: 75 months), 24% patients relapsed. Of these, 54% had locoregional relapse. High-grade, positive margin, large tumor size and stage III/IV were associated with worse relapse-free survival on multivariate analysis. Locoregional relapse occurred among patients with tumor size >7-10 cm (35%), stage III/IV (31%), grade III/IV (26%), renal vein invasion (22%), perinephric fat invasion (30%), 7 cm plus grade I/II (21%), >7 cm plus grade III/IV (48%), stage III/IV plus grade I/II (24%) and stage III/IV plus grade III/IV (45%). CONCLUSION: We were able to discern risk factors (individual or in combination) associated with increased risk of locoregional relapse after radical nephrectomy for renal cell carcinoma. This could help distinguish patients who may benefit from adjuvant locoregionally directed therapy.

Variation in Use of Prophylactic Antibiotics in Gynecologic Procedures Before and After an Educational Intervention.

OBJECTIVES: Guidelines for use of prophylactic antibiotics in gynecologic procedures are outlined by the American Congress of Obstetricians and Gynecologists. There remains, however, a high rate of unindicated administration of antibiotics for surgeries. A retrospective study performed at our institution in 2012-2013 demonstrated that unindicated prophylactic antibiotics were administered over half the time. This study aimed to examine variations in the use of prophylactic antibiotics in patients undergoing gynecologic surgery at Scott and White Memorial Hospital and determine whether an educational intervention to gynecology physicians was associated with a significant decrease in unindicated prophylactic antibiotics. METHODS: A retrospective chart review was performed for all women undergoing gynecologic surgery at Scott and White Memorial Hospital in Temple, Texas for 1 year. An educational intervention regarding prophylactic antibiotic usage was held for obstetricians and gynecologists in the middle of that year. Subjects were included if they had procedures with a Current Procedural Terminology code corresponding to a procedure that does not require prophylactic antibiotics. Subjects were excluded if they had concurrent procedures for which antibiotics are recommended. RESULTS: A total of 500 subjects met inclusion and exclusion criteria, with 243 before the educational intervention and 257 after the intervention. In our study, a significant decrease (P < 0.0001) in unindicated prophylactic antibiotic use was demonstrated: from 45.7% (111/243) preintervention to 24.9% (64/257) postintervention. Before the educational intervention, both the gynecology oncology and reproductive endocrinology and infertility divisions had the highest rates of unindicated antibiotic use-91.7% (44/48) and 91.7% (33/36), respectively. The generalist and urogynecology divisions had the lowest rates for specialists before the intervention: 20.6% (30/146) and 30.8% (4/13), respectively. After the intervention, all of the divisions demonstrated an improvement in their rates of unindicated prophylactic antibiotic use. The urogynecology division demonstrated an improvement that can be considered clinically significant while not meeting statistical significance. The adverse event rates were not different between subjects who received preoperative prophylactic antibiotics (2.9%) and subjects who did not (2.8%). CONCLUSIONS: A simple educational intervention was associated with a significant decrease in unindicated prophylactic antibiotics in gynecologic procedures.

Phosphodiesterase type 5 inhibitors usage and prostate cancer: a match-paired analysis.

BACKGROUND: To treat erectile dysfunction (ED), phosphodiesterase type 5 inhibitors (PDE5i) are commonly used. However, to date, only a few studies exist evaluate a possible effect on the incidence of prostate cancer. One such study completed by the authors' institution suggested men who use PDE5i for ED may have a lower incidence of prostate cancer. This study was meant to address some of the shortcomings of the former study and further characterize the link between prostate cancer and PDE5i use. METHODS: A retrospective, match-paired analysis was undertaken: 5,717 patients were identified between 2000 and 2011; a 1:2 match pair analysis ultimately identified 394 cases with cancer and 788 controls without cancer. Pairs were matched based on age, ethnicity, and PSA value. RESULTS: No correlation existed between PDE5i use and prostate cancer [OR 1.02, 95% confidence interval (CI): 0.78-1.35, P=0.8842] or diabetes mellitus and prostate cancer (OR 1.12, 95% CI: 0.84-1.48, P=0.4499). A statistically significant correlation was demonstrated with PSA and prostate cancer (OR 1.48, 95% CI: 1.38-1.58, P<0.0001). CONCLUSIONS: The data suggest that there is essentially no association with PDE5i use and prostate cancer.

Cigarette Smoking Attenuates Kidney Protection by Angiotensin-Converting Enzyme Inhibition in Nondiabetic Chronic Kidney Disease.

BACKGROUND: Cigarette smoking exacerbates the estimated glomerular filtration rate (eGFR) decline in nondiabetic chronic kidney disease (CKD) despite the kidney protection that is achieved by angiotensin converting enzyme inhibition (ACEI). Whether smoking cessation restores ACEI-related kidney protection is not known. METHODS: This 5-year, prospective, prevention trial recruited 108 smokers and 108 nonsmokers with stage-2 nondiabetic CKD with primary hypertension and urine albumin-to-creatinine ratio (Ualb) >200 mg/g. All smokers underwent smoking cessation intervention programs. Blood pressure was reduced in all participants toward achieving a goal of <130 mm Hg with regimens including ACEI. The primary outcome was eGFR change, and secondary outcomes included Ualb and urine levels of angiotensinogen (UATG), a surrogate for kidney angiotensin II (AII) levels, and isoprostane 8-isoprostaglandin F2α (U8-iso), an indicator of oxidative stress. RESULTS: One-year Ualb was lower than baseline in nonsmokers but not in either smoking group, supporting greater ACEI-related kidney protection in nonsmokers than smokers. Higher Ualb at 1 year in continued smokers was associated with higher UATG and higher U8-iso, consistent with smoking-induced AII and increased oxidative stress contributing to less ACEI-related kidney protection in smokers. Baseline eGFR was not different among groups (p = 0.92), but 5-year eGFR was higher in quitters than in continued smokers (62.0 ± 5.4 vs. 52.9 ± 5.6 mL/min/1.73 m2, p < 0.001); this value was lower in quitters than in nonsmokers (64.7 ± 5.6 mL/min/1.73 m2, p = 0.02). CONCLUSIONS: Smoking cessation compared with continued smoking ameliorates eGFR decline in nondiabetic CKD treated with ACEI, possibly by restoring kidney-protective effects of ACEI through reductions in kidney AII and oxidative stress.

Durability of Artificial Urinary Sphincter With Prior Radiation Therapy.

BACKGROUND: The aim of this study was to investigate the effect of prior radiation therapy on artificial urinary sphincter. METHODS: Group 1 was comprised of 63 men who underwent prior radical prostatectomy, and Group 2 was comprised of 31 men who received prior radiation therapy with or without prior radical prostatectomy. Social incontinence was defined as requiring to use > 1 pad per day and/or catheter-dependent at the time of last follow-up. RESULTS: The median age at artificial urinary sphincter placement was 71 years (interquartile range, 55-74 years). The median and mean follow-up was 62 months (interquartile range, 37-106 months) and 75 months (range, 2-205 months), respectively. At the time of last follow-up, 67% (63 of 94) of the men in the entire cohort (73% [46 of 63] and 55% [17 of 31] in Group 1 and Group 2, respectively [P = .078]) were socially continent. Sphincter revision, erosion, infection, and removal rates were 20%, 20%, 7%, and 10%, respectively, in Group 1, and 26%, 13%, 7%, and 23%, respectively, in Group 2. The differences in these rates were not statistically significant between the 2 groups. CONCLUSION: We found no significant difference in functionality (incontinence rates) and outcomes (rates of sphincter revision, erosion, infection, and removal) between the 2 groups. The message for patients is that prior radiation does not significantly alter the outcomes of artificial urinary sphincter.

Prostate Cancer in Patients With High Prostate-Specific Antigen Levels but Otherwise Very-Low-Risk Disease Behaves Like Prostate Cancer in High-Risk Patients.

INTRODUCTION: Rarely, patients with prostate cancer present with prostate-specific antigen (PSA) scores > 20 ng/mL but with otherwise very-low-risk disease. Oncologists have debated whether the malignancies in these patients behave more comparably to low-risk or high-risk disease. Our objective was to elucidate the behavior of these malignancies. MATERIALS AND METHODS: A retrospective review was conducted of prostate cancer patients treated with radiation from 2000 to 2013. The inclusion criteria for very-low-risk disease included stage T1a-T1c, Gleason score ≤ 6, ≤ 3 positive cores, ≤ 50% involvement of any core, and PSA level < 10 ng/mL. The divergent-risk group met all the same criteria but had a PSA score of 20 to 80 ng/mL. The high-grade, low-volume group consisted of patients with stage T1c-T2a, PSA level < 20 ng/mL, Gleason score of 4+4, and < 4 positive cores. Treatment failure was defined as a PSA nadir plus 2 ng/mL. RESULTS: A total of 18, 60, and 19 patients were in the divergent, low-risk, and high-grade groups, respectively. Biochemical progression-free survival at 5 years was 71.3% for the divergent group, 68.8% for the high-grade group, and 98.3% for the low-risk group. The biochemical failure rate for the divergent group differed significantly from the low-risk group (P = .021), and that for the low-risk group was significantly different from that of the high-grade group (P = .025). However, the divergent group did not appear different from the high-grade group (P = .53). CONCLUSION: The results of our study have shown that the disease prognosis for the divergent-risk group is worse than that for the very-low-risk disease group and does not appear to be different from that for the low-volume, high-grade disease group. Oncologists should be aware that the outcomes for divergent patients are similarly poor to their low-volume, classically high-risk counterparts.

Antibiotic Exposure and Risk for Death or Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.

We assessed the association between antibiotic exposure in the first 2 weeks of life and development of bronchopulmonary dysplasia in a cohort of very low birth weight infants. After controlling for the severity of illness, each additional day of antibiotic therapy was associated with both an increased risk for and severity of bronchopulmonary dysplasia.