Browsing by Subject "Clinical Research and Case Reports"
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Item 6-year Pulmonary Lobectomy Analysis Comparing Robotic to Thoracotomy and VATS: Impact to a State University Cardiothoracic Training Program(2017-01-17) Nawalaniec, James; Kernstine, Kemp; Elson, Matthew; Yuan, Chaofan; Madrigales, Alejandra; Lysikowski, JerzyOBJECTIVE: Current understanding of robotic lobectomy is largely from established thoracic surgical programs, often single-surgeon experience and does not involve trainees. Our objective is to assess the effect that a new robotic lobectomy program might have on a state university cardiothoracic (CT) training program to patient care, CT training, and the institution. METHODS: Our IRB-approved, prospectively maintained database and query of anatomic lung resections between 1/1/2006 to 6/30/2016 was verified with the medical center EMR and further verified with blinded double-entry. Inclusion criteria required a documented anatomic resection. Cost and oncologic data was obtained from the analytics department and tumor registry, respectively. Propensity scores were assigned based on age, sex, and five comorbidities. Lung cancer survival was analyzed by the Kaplan-Meier method and compared to the SEER database. Our robotic CT training method consists of a 6-month program over 3 years; the first 3 months focus on simulation and bedside-assist and the last 3 months, on complete case set-up and console training; adjustments made dependent upon the trainees' prior minimally invasive experience. RESULTS: 523 consecutive cases were identified, 91 cases were excluded. The query identified 212 robotic (179 non-small cell lung cancer (NSCLC)), 160 thoracotomy (117 NSCLC) and 60 video-assisted (VATS) (44 NSCLC) cases. Multiple surgeons performed each approach. Operative results and clinical outcomes favored robotic surgery compared to thoracotomy and showed little difference with VATS. Robotics increased lymph node stations, nodes, and upstaging rates, with similar R0 compared to thoracotomy and VATS; there was no significant difference in survival. A CT resident served as the console surgeon in 35% of all cases: 0% in the first two years increasing to 79% in the latest year. Minimally invasive surgeries increased from 32% of all cases in the first year of robotics to 89% in the latest year. The total volume of lung cancer treated at the center increased by 51%, surgical cases by 220%, and clinical trial accrual by 92%, since introducing robotics. CONCLUSION: A robotic surgery training component can be implemented at a state university cardiothoracic training program without sacrificing quality. Robotic surgery in this setting offers the same or better clinical results, is cost-effective, and is oncologically-sound. Additionally, a robotic program may increase an institution's lung cancer volume, enhancing both the CT resident training experience and clinical research. This analysis has also identified opportunities to further improve efficiency and reduce cost.Item Abdominal Based Free Flap Breast Reconstruction: Stratifying Complications with Perforator Numbers(2017-01-17) Wang, Jenny; Zhou, Michael; Kayfan, Samar; Teotia, Sumeet S.; Haddock, Nicholas T.BACKGROUND: Single perforator flaps in breast reconstruction have been reported to have increased fat necrosis. We were motivated to evaluate our experience and the effect of number of perforators on DIEP flap complications and donor site morbidity. METHODS: 199 patients underwent 328 DIEP flaps by two surgeons from 2010 to 2016 at a university hospital. Perforator selection was guided by CT imaging and clinical observation. First, perforator average size was compared among flaps with 1 perforator (n= 110 flaps), 2 perforators (n= 136 flaps), and 3 perforators (n= 82 flaps). Next, rates of fat necrosis, flap failure, and abdominal bulging were analyzed among the same three perforator groups. In addition, rates of postoperative abdominal bulge requiring surgical intervention was compared to the presence of a nerve-preserving type flap harvest. RESULTS: Average perforator size significantly decreased as the number of perforators increased (1 perforator = 2.11mm, 2 perforators = 1.80mm, 3 perforators = 1.65mm, p-value = 0.02 and 0.01 for 1 versus 2 perforator flaps and 1 versus 3 perforator flaps, respectively). However, no significant differences were noted in fat necrosis, flap failure, and abdominal bulging rates across perforator groups. Additionally, flap weights were not significantly different across the three groups (Average: 1 perforator-774 grams, 2 perforators-797 grams, and 3 perforators- 749 grams). Neither perforator number nor nerve preserving techniques were found to result in significant decreases in abdominal bulge rates. CONCLUSIONS: Contrary to other studies, we found that the number of perforators harvested in DIEP flap breast reconstruction was not associated with increase or decrease in flap survival or fat necrosis. This occurrence could be attributed to the surgeons' choosing to proceed with single perforator flaps only when perforator size was adequately large, maintaining consistent blood supply. There was no association among perforator number, utilization of nerve sparing procedures, and abdominal bulge that required subsequent surgical intervention. Despite this, we still cautiously advocate nerve-preserving techniques that may have a subclinical effect.Item Acceptability of Screening for Sexually Transmitted Infections in an Urban Pediatric Emergency Department in the Southern Region of the United States(2016-01-19) Pfaff, Jamie; Johnson, DawnBACKGROUND: Adolescents age 13 to 24 years old are the demographic most affected by sexually transmitted infections (STIs) in the USA. The CDC, USPSTF and the AAP recommend screening sexually active females less than 25 years old in all health care settings for Neisseria gonorrhea (GC) and Chlamydia trachomatis (CT) and all high-risk females of this age group also for HIV and Syphilis. In regions with a high prevalence of STIs, such as Dallas County, the diagnosis and treatment of STIs is a vital step toward reducing the spread of these communicable diseases in this population. METHODS: All adolescents age 13-24 presenting to the Pediatric Emergency Department (PED) during the study period who met the study criteria were asked to participate. A total of 197 adolescents and 198 parents, 183 of which comprised parent-child dyads, were enrolled and completed separate surveys. Participants answered questions about adolescent and parent acceptability of STI screening, STI risk behaviors, and adolescents' history of STI screening and treatment. RESULTS: Analysis thus far shows that non-invasive STI screening is acceptable to the majority of both adolescents (70%) and parents (84%). Among patient/parent dyads, 59% had positive responses from both. No demographic factors demonstrated statistical significance. However, some factors displayed greater variability than others. In terms of age, adolescents greater than 15 years old were more likely to indicate acceptance of STI testing (73%) than those younger than age 15 (62%). Breakdown by adolescent race and ethnicity demonstrated a range of acceptability with 83% for those who identified as White or Caucasian, 59% for those identifying as Black or African American, 64% for those identifying as Hispanic, and 100% of the five participants identifying outside of the previous categories, "other". CONCLUSIONS: These acceptability results are similar to those found in a study performed in Jefferson County, AL where adolescents reported a 71% acceptance rate for GC and CT screening. This suggests that implementation of STI screening in the PED would be successful and well tolerated by the majority of adolescents and their parents. The variation in acceptability demonstrated by age and race were not statistically significant but may be useful in determining the minimum age of PED intervention and preparing culturally sensitive answers for questions from adolescents and patients in future testing interventions. Implementation of new PED HIV screening protocols are utilizing evidence based on this study and will further be assessed for continued improvement of Dallas adolescent health.Item Acute Effect of High vs Low Dialysate Sodium on Endothelial Cell Function During Hemodialysis(2013-01-22) D'Silva, Kristin; Molina, Christopher; van Buren, Peter; Kim, Catherine; Inrig, JulaBACKGROUND: Intradialytic hypertension (HTN), a rise in blood pressure that occurs during hemodialysis (HD) treatments in up to 15% of patients, is associated with higher morbidity and mortality. The cause of intradialytic HTN is unknown but may be due to endothelial cell (EC) dysfunction. In vitro exposure of ECs to high sodium (Na+) concentration promotes EC stiffness and imbalances in vasoconstrictors (endothelin-1 [ET-1]) and vasodilators (nitric oxide [NO]). We hypothesized that, among patients with intradialytic HTN, exposure to high dialysate Na+ would lead to a decrease in NO and increase in ET-1 during HD. METHODS: We performed a 3-week, 2-arm, randomized crossover study among 16 HD patients with intradialytic HTN and compared the effects of high dialysate-to-serum Na+ gradients (5 mEq/L above participants' baseline Na+) vs low dialysate-to-serum Na+ gradients (5 mEq/L below baseline Na+ with lower limit of 134 mEq/L) on intradialytic changes in nitrite and ET-1. Differences between treatments were compared with repeated measures mixed linear regression and included randomization arm (high - low Na+ vs low - high Na+), treatment effect (high vs low Na+), subject, time and session. RESULTS: Study participants (N=16) had an average age of 58.8 years, 38% were black, 56% were Hispanic, and 94% were male. Intradialytic changes in NO and ET-1 with high and low dialysate-to-plasma Na+ gradients are shown in Figure 1. In the primary comparison of high vs low dialysate-to-serum Na+ gradient, there were no significant differences in intradialytic levels of NO or ET-1 (Table 1). However, when compared by randomization arm, participants who received the low dialysate-to-serum Na+ gradient followed by high compared to those who received the high dialysate-to-serum Na+ gradient followed by low had a significant decrease in ET-1 (parameter estimate -0.49 pg/mL, p=0.04) and significant increase in nitrite during hemodialysis (parameter estimate +0.16 nM, p=0.02) (Table 1). CONCLUSIONS: Patients who received the low dialysate-to-serum Na+ gradient before the high dialysate-to-serum Na+ gradient had higher levels of nitrite and lower levels of ET-1 throughout the three week study period compared to patients who received the high dialysate-to-serum Na+ gradient before the low dialysate-to-serum Na+ gradient. This suggests that the dialysate Na+ concentration may have longer-term effects on endothelial cell function.Item The Adult Spina Bifida Patient: Does a Delay in Referral Impact Urodynamic Findings and Clinical Outcomes? Recommendations for Transition of Care(2017-01-17) Eastman, Jessica; Lemack, Gary; Harris, Catherine; Howard, CatherineINTRODUCTION: Improvements in the management of children with myelomeningocele have resulted in an influx of such patients, many of whom have complex neurogenic bladder conditions, to adult urologists. We reviewed the presenting symptoms, urodynamic findings, and changes in clinical management of adults with spina bifida, specifically focusing on the relationship between the delay in urological follow-up and clinical outcomes. METHODS: All patients with neurological conditions that presented for urologic evaluation at a tertiary referral center have been prospectively entered into a database since 2000. Data from patients with spina bifida including, bladder management, chief complaint, urodynamic findings (UDS), surgical interventions and upper tract imaging were analyzed. RESULTS: Of the 1110 patients in the database, 60 patients with spina bifida were identified (51.7% male, 48.3% female). Median age at presentation was 33 (16-64). The majority of patients presented for symptom evaluation (75%) vs. establishing care (25%). The most common presenting symptoms were incontinence (n=18, 30%) and urinary tract infection (UTI) (n=15, 25%). Patients who had documented prior urologic evaluation were assessed for the interval to presentation (n=53). Patients were classified as having their last evaluation within the preceding 12 months (n=23, 43.3%), between 12 and 24 months (n=17, 32%), between 2 and 5 years (n=11, 20.8%) or greater than 5 years prior (n=2, 3.8%). Patients were significantly more likely to present within 12 months of their last evaluation if they were symptomatic (p=0.022). Patients presenting more than one year from their last evaluation were more likely to have DO (p=0.0215), though neither altered compliance nor DESD were associated with delay in diagnosis. As seen with children, the UDS diagnosis of impaired compliance was significantly associated with abnormal imaging findings (p=0.0328). Overall, 42% of this cohort required intervention following referral, and urologic workup including urodynamics altered clinical management in 58.9% of patients. CONCLUSION: Spina Bifida patients continue to require close surveillance into adulthood, and this evaluation must include urodynamic testing. Additionally, there is indication that patients who delay care are more likely to have UDS abnormalities that might necessitate changes in management strategies. We advocate follow-up of less than 12 months between adult urology clinics or within one year after pediatric surveillance has terminated.Item Analysis of Association Between Keloids and Other Medical Conditions(2016-01-19) Rutherford, Audrey; Glass, Donald A., IIBACKGROUND: Keloids are an exaggerated response to cutaneous wound healing. Keloids negatively affect patients' quality of life and there is no 100% effective treatment to prevent occurrence or recurrence. Previous results from the Genetic Causes of Keloid Formation Study (GCKFS), an IRB-approved keloid registry, showed that hypertension and obesity may be more prevalent in African-Americans with keloids versus the general African-American population. This suggests that there are possible common mechanisms between keloids and these comorbidities. OBJECTIVE: The aim was to assess for an association between hypertension and/or obesity with keloid-affected patients, and to evaluate various subcategories of keloid-affected patients. METHODS: Seventy-nine GCKFS participants with diagnosed keloids were matched to controls from the Dallas Heart Study (at a 1 GCKFS:7 DHS ratio). Participants were categorized into hypertensive and obese cohorts using objective recorded measurements and calculations made using Fisher's exact test (significance P < 0.05). Sub-analyses were assessed among the GCKFS cohort using number of keloids, location, and number of anatomic sites involved. RESULTS: There were 504 total keloids distributed among six designated anatomical sites (ears, neck up, extremities, trunk, abdomen, other). Thirty (37.97%) GCKFS participants were hypertensive, and thirty-six (45.57%) were obese. The GCKFS participants showed an association with hypertension (p=0.045) but not with obesity (p=0.903). On subanalyses, keloid-affected individuals under age 30 had a higher prevalence of hypertension (p=0.042) and participants with multiple keloid sites had a higher prevalence of obesity (p=0.024). CONCLUSIONS: The results are consistent with hypertensive associations with keloids found in the literature. Data collection will continue by increasing the GCKFS cohort to determine if the trending data will reach statistical significance. Further research is encouraged to delve into the mechanisms between the association between hypertension and/or obesity and keloids.Item Analysis of Free Flap Breast Reconstruction Failures: Are Specific Patient Characteristics Associated with Free Flap Failure?(2013-01-22) Sciano, Natalie M.; Farkas, Jordan; Cortez, Robert; Miller, Travis; Davis, Kathryn; Kenkel, Jeffrey M.PURPOSE: This study was performed to gain insight on the patients who have undergone free flap breast reconstructive surgery. Recognizing certain patient variables, as risk factors for developing free flap failure, is invaluable. This knowledge can provide surgeons the benefit of foresight when assessing patients pre and postoperatively. The goal was to identify specific characteristics that predisposed patients to developing flap failure. METHODS: A retrospective chart review was completed on patients who had received free flap breast reconstructive surgery during January 2008 to January 2012. A cohort of 124 patients receiving free flap reconstruction was identified using the Current Procedural Technology (CPT) code 19364. A number of patient variables which include general characteristics, comorbidities, and surgical characteristics were analyzed to determine their contribution toward a patient's development of free flap failure. Patients were categorized into two groups- those without and those with flap failure. A comparison of the means and proportions was performed to determine statistical significance between the two groups. The level of statistical significance for this univariate analysis was set at a P < 0.05. RESULTS: All of the 124 patients identified were female. The overall flap success rate was 91.94 percent, with only ten patients experiencing flap failure. Of the factors analyzed in this study, there was not an identified patient characteristic that predisposed a patient to developing free flap failure. CONCLUSIONS: Flap failure is an unfortunate risk of reconstructive surgery that needs to be minimized at all costs. No specific patient variables were identified as predisposing risk factors that could contribute to free flap failure. Institutions should strive to educate all breast reconstruction candidates on their options and risks which can help increase the volume of patients acquiring reconstruction. In the future, other investigations with a larger sample size should be done to yield more beneficial information for the physician and patient.Item Anterior Cruciate Ligament Tears: Impact of Delayed Presentation on Intra-Articular Injuries(2016-01-19) Chavez, Audrie; Riepen, Dietrich; Coyner, Katherine J.; Schell, Benjamin; Khazzam, MichaelBACKGROUND: Chronic anterior cruciate ligament (ACL) injury is associated with increased risk for meniscal and chondral injuries. This study aims to establish specifically what meniscal and chondral injuries occur in the setting of chronic ACL deficiency. UTSW and Parkland treat many chronically ACL-deficient patients, thus offering unique insight into the natural history of ACL-deficient knees. METHODS: Retrospective chart review was conducted for all patients who underwent ACL reconstruction at UTSW or Parkland from 1/1/2009 to 5/4/2015. Variables studied were age, gender, BMI, chondroplasty performed, microfracture performed, medial meniscus tear (MMT), lateral meniscus tear (LMT), and injury to the medial femoral condyle (MFC), lateral femoral condyle (LFC), medial tibial plateau (MTP), lateral tibial plateau (LTP), and patellofemoral (PF) joint. RESULTS: Four hundred and ten subjects were included in this study. Average patient age was 27+8.8 years. 58.5% had BMI >25. Males comprised 70.5% of patients. Approximately 27.1% received surgery less than 3 months after injury, 23.4% from 3 to < 6 months, 17.8% from 6 to < 12 months, 23.9% from 12 to < 60 months, and 6.8% 60+ months. Male gender and older age were predictive factors for delayed reconstruction (P<.01). MMTs were correlated with both MFC injury (OR 4.8) and MTP injury (OR 2.6), while LMTs were only correlated with LTP injury (OR 2.0). Frequency of MMT was increased with surgical delay. Compared to delays of 0 to less than 3 months, MMTs were more common in patients with delays of 6 to < 12 months (OR 2.1), 12 to < 60 months (OR 4.2) and 60+ months (OR 6.2). A similar trend characterized MFC injury. Compared to the 0 to < 3 month group, MFC injury was more likely to occur with delays of 6 to < 12 months (OR 2.7), 12 to < 60 months (OR 3.1), and 60+ months (OR 8.3). LTP and LFC injury were only associated with surgical delays of 12 to < 60 months (P<.05) and 60+ months (P<.001). Microfracture and chondroplasty were more likely to be performed in patients with delays of 12 to < 60 months (P<.001). CONCLUSION: Delaying ACL surgery for 6 months or longer is associated with an increased presence of medial meniscus tears and chondral injury (MFC, LFC, and LTP), with increased incidence in longer delays. This data supports not delaying surgery more than 6 months following an ACL tear to prevent the incidence of secondary meniscus tears and articular cartilage injury. In addition, particular attention should be paid to those who are of older age and male gender as they are at increased risk for worse cartilage and meniscus injury.Item Anticoagulant Use is Associated with Improved Biochemical Control of High-Risk Prostate Cancer Patients Treated with Radiation Therapy(2013-01-22) Jacobs, Corbin; Kim, D. Nathan; Choe, Kevin; Yan, Jingsheng; Xie, Xian-Jin; Hannan, Raquibul; Pistenmaa, David; Lotan, Yair; Roehrborn, ClausINTRODUCTION: The coagulation system modulates multiple cancer pathways, including tumor proliferation, angiogenesis, host immunologic defense, and metastasis. Prior studies have reported improved survival and freedom from biochemical failure (FFBF) in prostate cancer (PCa) patients taking aspirin and other anticoagulants (ACs). We reviewed the outcomes of patients with high-risk PCa who received ACs and definitive radiation therapy (RT). METHODS: Patients with nonmetastatic high-risk adenocarinoma of the prostate (stage ≥ T3a, or Gleason score (GS) ≥ 8, or prostate-specific antigen (PSA) ≥ 20) treated with definitive RT between 2005-2008 at UTSW were identified. The AC group consisted of patients who had warfarin, clopidogrel, or aspirin recorded on the medication list at any clinical visit. FFBF of patients was determined using the Phoenix definition. Log-rank test was used to correlate FFBF with the ACs. Univariate and multivariate analysis (MVA) of FFBF to pretreatment PSA, GS, stage, hormone use, total RT dose, and ACs was performed. RESULTS: Among the 76 patients identified, 45 (59.2%) comprised the AC group. Within the AC group, 43 were taking aspirin, 8 were taking warfarin, 8 were taking clopidogrel, and 13 were taking multiple ACs. Median follow up was 61.2 months (range 3.1-89.4) for the AC group and 55.1 months (range 6.5-88.9) for the non-AC group. Patients receiving ACs exhibited significantly improved FFBF compared to the control group (p=0.0018; log-rank test). The estimated 4-year FFBF was 83.7% and 63.2% for the AC and non-AC groups, respectively. Among the patients taking a single AC, only aspirin showed significantly improved FFBF (p=0.0037). The hazard ratio for T-stage was 1.18 (95% CI 0.75, 1.85; p=0.4672) in the AC group and 1.67 (95% CI 1.09, 2.58; p=0.0196) in the non-AC group, implying a benefit from taking the AC. Aspirin use, T-stage, and N-stage remained significantly correlated to FFBF (p=0.0002, p=0.0056, and p=0.0040, respectively). The early and late grade 2 toxicity rates for rectal bleeding were 7.7% in patients on multiple ACs and 0% for patients on a single AC or no AC. No patients experienced grade 3 rectal toxicity. CONCLUSION: Use of ACs in high-risk PCa patients improved the FFBF after definitive RT without increasing rates of rectal bleeding. This suggests that daily use of a single anticoagulant, especially aspirin, in high-risk PCa patients treated with definitive RT decreases biochemical failure and may improve outcome. Large prospective data are needed to validate the findings of this study.Item Apolipoprotein E Isoform Influence on Outcomes after Pediatric Traumatic Brain Injury(2016-01-19) Usala, Claire; Huang, Rong; Hernandez, Ana; Miles, DarrylINTRODUCTION: The ε4 allele of the apolipoprotein E gene (APOε) is associated with poor outcomes in adults with traumatic brain injury (TBI), but its influence on recovery after pediatric TBI is uncertain. The primary aims of this study were to determine if an association exists in the outcome of children after TBI between those with at least one ε4 allele and non ε4 genotypes. Using the Glasgow outcome score (GOS), we examined three outcome variables between the two groups 1) GOS at hospital discharge, 2) GOS at long-term follow-up, and 3) the magnitude of change in GOS from discharge to > 6 month assessment (Δ GOS). METHODS: Data were prospectively collected from 220 children presenting with moderate or severe blunt head trauma between the ages of 0 and 17 years old from 2002-2013. Outcomes were assessed at hospital discharge and 12.7±8.4 months post-injury. Patients in the ε4 and non ε4 groups did not differ in injury mechanism, severity, or demographics; 23.4% had at least one ε4 allele and ε3/ ε3 was the most common genotype (67.4%). Multiple regression model analysis was conducted to determine if associations existed between the genotype combinations and outcome while controlling for age, ER GCS, ICP monitor placement, and whether CPR was performed. For ε4 genotypes analysis, we also stratified patients by admission Glasgow Coma Scale (GCS) into severe (GCS 3-8) versus non-severe (9-15), as well as moderate and severe (3-12) versus mild (13-15) groups. RESULTS: For aim 1, the GOS at discharge did not differ significantly in ε4 versus non- ε4 patients in any injury severity category before or after controlling for cofounding variables. However, after controlling for confounding variables, patients with at least one ε2 allele in the moderate or severe injury category had significantly worse GOS at discharge. For aim 2, after controlling for confounding variables, patients with the ε3/ε3 genotype had significantly better long-term GOS than patients with the genotype ε3/ε2 (p<0.05). However, we did not find a significant difference in long-term outcome between ε4 and non ε4 genotypes in the primary analysis or when stratified by injury severity groups. Finally, between ε4 and non ε4 genotypes, the Δ GOS and neuropsychological scores did not differ significantly between genotypes. DISCUSSION: Overall these results propose that unlike adults, the ε4 allele may not be associated with 12-month outcome or the rate of recovery (ΔGOS) from hospital discharge following pediatric TBI. Our results implicating worse outcomes for the ε2 genotypes suggest that this allele may be a candidate for further study to delineate its role in TBI outcome in children. Unique to this study was our analysis of neuropsychological measures, which were also not affected by the presence of ε4 in a smaller cohort of children. This study adds to current literature suggesting that unlike adults APOε4 may not exert a significant effect on pediatric TBI outcome. However, these results are limited in that any genotypic effect on neurologic repair may not be apparent for much longer time periods in pediatric brain injury as the child continues to develop and grow.Item Application of the "Hybrid Approach" to Chronic Total Occlusions in a Contemporary Multicenter US Registry(2014-02-04) Menon, Rohan; Christopoulos, Georgios; Karmpaliotis, Dimitrios; Alaswad, Khaldoon; Lombardi, William; Grantham, Aaron; Mishoe, Katrina L.; Patel, Vishal G.; Rangan, Bavana V.; Kotsia, Anna P.; Lembo, Nicholas; Kandzari, David; Lee, James; Kalynych, Anna; Carlson, Harold; Garcia, Santiago; Banerjee, Subhash; Thompson, Craig A.; Brilakis, Emmanouil S.BACKGROUND: The "hybrid" approach to coronary chronic total occlusion (CTO) crossing was developed to optimize procedural efficacy, efficiency, and safety. Current strategies of crossing CTOs include antegrade wire escalation, antegrade dissection re-entry, and the retrograde approach. The "hybrid" approach is an algorithm that, based on angiographic characteristics of the lesion, streamlines the selection of the optimal technique for crossing the CTO. The goal of this study was to analyze the impact of the "hybrid" approach to CTO percutaneous coronary intervention on procedural workflow and outcomes at five high-volume US centers. METHODS: We examined the procedural techniques and outcomes of 489 consecutive CTO cases performed using the "hybrid" approach between 2012 and 2013 at 5 US centers from cities including Appleton WI, Atlanta GA, Bellingham WA, Kansas City MO, and Dallas TX. RESULTS: Mean age was 63.8 ± 9.8 years and 86.9% of the patients were men, with high prevalence of diabetes mellitus (41.7%) and prior coronary artery bypass graft surgery (35.7%). Most target CTOs were located in the right coronary artery (61.5%), followed by the left anterior descending artery (20.9%) and left circumflex (16.8%). Dual injection was used in 73.3%. Overall, antegrade wire escalation was used in 62.8%, antegrade dissection re-entry in 38.9% and retrograde in 44.2%. Among successful cases, the final successful crossing technique was antegrade wire escalation in 40.6%, antegrade dissection and re-entry in 27.5%, and retrograde in 31.9%. The initial crossing strategy was successful in 62.0% of the patients, whereas 35.8% required an additional 1 to 4 crossing strategies. Technical success was achieved in 91.6% and major procedural complications occurred in 1.6%. Mean contrast volume, fluoroscopy time, and air kerma radiation exposure were 297.6 ± 154.7 ml, 48.9 ± 31.4 min, 4.4 ± 3.8 Gray, respectively. CONCLUSION: Application of the "hybrid" approach to CTO crossing resulted in high success and low complication rates among a varied operator group and hospital structure, further supporting the value of the "hybrid" approach in crossing these challenging coronary lesions.Item Application of the Caprini Risk Assessment Model in Evaluation of Non-Venous Thromboembolism Complications in Plastic and Reconstructive Surgery Patients(2014-02-04) Jeong, Haneol S.; Miller, Travis J.; Davis, Kathryn; Matthew, Anoop; Lysikowski, Jerzy; Lazcano, Eric; Reed, Gary; Kenkel, Jeffrey M.GOALS/PURPOSE: The Caprini Risk Assessment Model (RAM) is an ordinal scoring tool used to quantify and categorize a patient's risk for venous thromboembolism in the post-surgery setting. However, there has been no similar exploration into predictive associations of this score with the other potential complications of surgical procedures. This is surprising because the full list of variables that comprise an individual Caprini score involve a host of systemic factors that involve multiple organ systems. This study investigates whether Caprini scores can be applied to non-VTE complications. METHODS/TECHNIQUE: Authors undertook a retrospective chart review of 1598 encounters for a series of complex reconstructive and body-contouring operations at an academic medical institution. Input variables included Caprini score components, patient co-morbidities, and prophylactic use. Output variables were postoperative complications. Tests for proportions were performed on percentile data. Non-percentile data was treated with comparison of means (t-test). Odds ratios for complications were calculated for stratified risk groups and compared. RESULTS/COMPLICATIONS: The overall complication rate was 28.03%. DVT incidence was 1.50%. In comparing complication vs. complication-free patients, age, BMI, operation time, hypertension, diabetes, renal disease, and cancer were statistically significant. For DVT versus DVT-free patients, sex, BMI, operation time, smoking status, diabetes, hypertension, and prior DVT were significant. Increasing Caprini scores are associated with increasing odds ratios (OR) for dehiscence (1.73, p = 0.028), infection (2.04, p = 0.0003), seroma (1.52, p = .045), hematoma (2.12, p = 0.050), and necrosis (2.83, p = 0.0004) with a corresponding overall OR increase of 1.69 (p < 0.0001). These odds ratios parallel similar increases in the baseline occurrence rates for the noted complications. CONCLUSIONS: The data demonstrates that Caprini scores can be applied preoperatively to categorize a patient's risk of developing multiple non-VTE complications. Patients in the higher risk categories will be at an increased risk of suffering from wound dehiscence, infection, seroma, hematoma, and necrosis. Considering these potential complications as a single group, a high-risk patient has a 69% increased odds of suffering at least one problem compared with low-risk individuals. Unfortunately, few preoperative steps can be taken to directly address the complications that the Caprini model is predictive for. However, these results can help physicians better understand which complications to keep watch for most rigorously during postoperative monitoring. In addition, the data can guide conservations with patients during initial preoperative consultations.Item Argon Laser Trabeculoplasty (ALT): Predictors of Failure(2013-01-22) Chang, Eric; Markel, Nathan; Kooner, Karanjit; Adams-Huet, Beverley; Li, XilongPURPOSE. ALT is widely used to control intraocular pressure (IOP) in glaucoma. We wished to determine predictive factors for long term success of ALT performed by supervised residents in training on patients at a local VA Hospital in Dallas. METHODS. Charts of patients with primary open angle glaucoma who underwent ALT between 2001 and 2011 were reviewed retrospectively. Those with follow up < 3 months, prior ALT/SLT, filtering procedure or inadequate data were excluded. The dependent variable was time to failure after ALT. Failure was defined as any additional medication, ALT/SLT or glaucoma filtering surgery. All patients were treated with 360 ° ALT. Logistic regression and receiver operating characteristic (ROC) analysis was performed to assess correlation between time to failure after ALT and age, pre-op IOP, C/D ratio, visual field defect, family history, refractive error, hypertension, diabetes, number of medications, laser energy used, central corneal thickness. RESULTS. Evaluable data was obtained on 206 patients; mean age 65, 98% male, and 61% black. 40.8% (84/206) were classified as ALT failures. Failure and non-failure patients had equal follow-up duration of median 2 yr. Pre-ALT LogMar (mean (SD) 0.25 (.3) vs. 0.35 (.3)), no. of glaucoma medications (2.9 (1.0) vs. 3.3 (1.0)), and myopia (46% vs. 61%) differed, respectively, between ALT failures and non-failures (p<0.05). In multivariable logistic regression models, after adjusting for age, hypertension, and diabetes, we found that myopia was protective (odds ratio (OR) =0.39, 95% CI 0.21-0.78, p=0.005) but that higher laser energy ((OR=1.6 for a 20k increase in energy, 95% CI: 1.1-2.4, p=0.005) was associated with increased risk associated for ALT failure; model ROC AUC = 0.70 (95% CI: 0.63-0.78). DISCUSSION. Our VA patients were mainly males but had good ethnical diversity. Better response in myopia may be related to thickness of trabecular meshwork while poorer response to increased laser energy may be from thermal damage. Patients using more than three meds were on systemic carbonic anhydrase inhibitors CONCLUSIONS. ALT results were better in patients who used more than 3 meds, were myopic and required less laser energy.Item Aspiration Pneumonia and Perioperative Antibiotic Use in Transoral Robotic and Laser Microsurgery(2015-01-26) Gajera, Prakash; Sumer, Baran D.INTRODUCTION: Aspiration pneumonia can follow transoral surgery for head and neck cancer due to abnormal swallowing function. While prophylactic post-operative antibiotics may decrease the incidence of this complication, excessive use can be costly, and lead to adverse reactions or antibiotic resistance. The objectives of this study are to 1) determine if the use post-op antibiotics prevent aspiration pneumonia. 2) Identify any complications related to the use of antibiotics. METHODS: A retrospective review of 155 patients who underwent transoral surgery for squamous cell carcinoma (SCCA) between May 2008 and June 2014 was conducted and demographic data was collected. The MD Anderson dysphagia inventory (MDADI) was used to assess swallowing function. RESULTS: Sixteen of 122 patients that received postoperative antibiotics (13.1%) developed pneumonia, compared to 4/32(12.5%) patients who did not receive antibiotics (p=0.925). Average antibiotic course was 39.2 days (median=23). Average time to infection was 290 days (median=217, range=11-979). Univariate analysis did not show a correlation between patients that developed pneumonia and antibiotic use (p=1.00), location (p=.1642), overall stage (p=.1599), comorbidity status (p=.5327), tobacco use (p=.6328), alcohol use (p=.351), and gastrostomy tube dependence (p=.254). Univariate analysis did show a correlation between pneumonia and tracheostomy placement (p=.0316), T stage (p=.0357), and days post-op of PEG placement (p=.0297). Multivariate analysis showed correlation with tracheostomy placement (p=.0236). No patients contracted C. difficile infection. No trend was observed in post-operative MDADI score. DISCUSSION: Routine use of post-operative prophylactic antibiotic does not correlate with a decreased rate of pneumonia or improved functional outcomes. Given that tracheostomies are performed mainly for pulmonary toilet, and a larger T stage results in larger resections, the significant correlation was expected. PEG placement in pneumonia patients was significantly later than patients with no pneumonia. This, and the fact that pneumonia generally developed outside of the 30-day perioperative period, supports the idea that aspiration pneumonia development reflects a chronic worsening swallowing dysfunction. Therefore, dysphagia immediately after surgery is probably not a significant risk factor for developing aspiration pneumonia and routine post-operative antibiotic use for pneumonia prevention is not indicated after transoral surgery.Item Assessing Complications of Epiphysiodesis for Leg Length Discrepancy(2014-02-04) Terrill, Tyler A.; Dunn, Samuel H.; Birch, John; Makarov, MarinaINTRODUCTION: Leg length discrepancy in children and adolescents is a serious orthopedic problem that can cause leg and back problems due to abnormal gait. This condition may be congenital or caused by disease or trauma. One method to correct leg length discrepancies in children is to perform an epiphysiodesis. This surgical procedure removes one or more growth plates from the femur, tibia, or fibula. This operation slows down the growth of the long leg to allow the shorter leg to catch up, or at least prevent the discrepancy from increasing. As there has been no large study of epiphysiodesis patients in the literature, the rates for surgical complications and errors associated with this surgery are not well known. These complications may include infections, nerve damage, and incomplete epiphysiodesis, which often results in an angular deformity. Because of the lack of understanding for rate of complications and characteristics associated with these, we studied a large patient population to gain insight into these aspects of the procedure. METHODS: The patient population at Texas Scottish Rite Hospital for Children undergoing epiphysiodesis for the treatment of leg length discrepancy from 1980 to 2008 was examined by a retrospective review of both charts and radiographs, with a total of 755 patients included in the study. The information recorded in the study included the extent of leg length discrepancy, angular measurements of the joints, method of epiphysiodesis, postoperative development of angular deformities, underlying etiology, length correction prediction, and other clinical features. RESULTS: Of the 755 patients examined, 38 had surgical complications, (5%). Of these patients, 27 had incomplete epiphysiodesis, 6 had neurological problems, 3 had overcorrection of the leg length discrepancy, and 2 had other complications not specific to this procedure. Patients incurring complications had statistically significant risk factors that include greater leg length discrepancies at the time of epiphysiodesis, congenital defects instead of acquired ones, and younger age. There were also trends towards open curettage method, epiphysiodesis involving the femoral growth plate, and male gender as risk factors, though these did not achieve statistical significance. DISCUSSION: It is important that surgeons understand which populations of patients are at greater risk for complications during this procedure, so that extra caution may be taken to prevent harm. Also, parents should be aware that there is a 5% risk of surgical complication, so that they may be fully informed before committing to the procedure.Item Assessing Water Fluoride Levels in Rural Rajasthan, India(2014-02-04) Mehta, Kajal; Sreeramoju, PranaviINTRODUCTION: Skeletal and dental fluorosis are crippling diseases associated with consumption of water with excess fluoride. The diseases manifest with symptoms such as severe staining, pitting, enamel damage and cracking of teeth in dental fluorosis to stiffness, joint pain, crippling, kyphosis, invalidism, and GI complications in skeletal fluorosis. Fluorosis is an endemic public health issue in many developing regions around the world, including areas of India. A study conducted in Rajasthan, India shows the prevalence of dental fluorosis to be 70.6-100% in village children and 68-100% in village adults. Prevalence of skeletal fluorosis was 5.2% among children and ranged from 7.4% to 37.7% in adults. The present study hopes to address the underlying problem of fluorosis in Rajasthan, India by analyzing water quality in the region. METHODS: This study is a retrospective observational study based on water data collected over a ten month period by the Jal Bhagirathi Foundation (JBF) in Jodhpur, India for a European Union funded water monitoring project. The water data are from the nearby Jalore, Barmer and Jaisalmer Districts, with water samples from all drinking water sources including handpumps, deep bore wells, tube wells, government run pipelines, ponds, lakes, and reverse osmosis water purification systems. The water samples were collected by trained JBF staff in sterile 1L containers, and the water quality testing was carried out by the on-site chemistry lab manager. Fluoride levels were tested within 24 hours of water sampling using a benchtop multiparameter meter and a fluoride electrode in 100 mL water. Additional tests for color, odor, turbidity, pH, alkalinity, total dissolved solutes, and presence of fecal bacteria were performed on each sample. RESULTS/OUTCOMES: The data were analyzed for frequency of fluoride levels above the recommended level of 1 parts per million (ppm). Of the water samples tested for fluoride concentration, 57 of 156 samples (36.5%) showed concentrations above 1ppm. The mean fluoride concentration of all tested water samples was .81ppm, with a standard deviation of .73ppm. CONCLUSION: The results demonstrate over one-third of the sampled drinking water is potentially toxic to the health of its consumers. This incidence is particularly alarming in the arid conditions of Rajasthan where rural inhabitants have limited water resources, leading them to rely heavily on these harmful supplies. These results provide an impetus to approach the problem by increasing community education of unsafe drinking water sources and methods of purification, including home systems and community-wide solutions like reserve osmosis plants.Item Association of Statin Therapy with Risk of Epilepsy in Two Propensity Score-Matched Cohorts(2017-01-17) Trivedi, Lakshya; Mansi, IshakINTRODUCTION: In recent years, studies have suggested that statins may have a neuroprotective effect against epilepsy. Additionally, statins may lower risk of epilepsy through lowering the risk of stroke.3 However, evidence from rat models and case reports suggests an opposite effect. Overall data is limited and little is known about the incidence of epilepsy in healthy adults who are taking statins for primary preventions. OBJECTIVES: To examine the association between statin use and epilepsy risk in a general population cohort and a healthy population cohort (individuals with no severe comorbidities). METHODS: Patients were Tricare beneficiaries who were studied between October 2003 to March 2012. Based on patients' characteristics during baseline period (Fiscal Year [FY] 2004-2005), we formed 2 propensity scores (PS) matched cohorts of Statin-users and Non-users 1) a PS-matched General cohort, 2) a PS-matched Healthy cohort Our outcome was defined using a validated ICD-9 code for epilepsy inpatient or outpatient encounters during follow up period (FY 2006 - March 2012) . We calculated odds ratios (OR) and 95% confidence intervals (95% CI) for epilepsy during follow up. RESULTS: PS-matched General cohort matched 6342 Statin- users to 6342 Non-users, OR of epilepsy in this cohort during follow up was 0.91, 95%CI=0.67-1.23; PS-matched Healthy cohort matched 3351 Statin-users to 3351 Non-users. OR in the Healthy cohort during follow up was 1.08; 95%CI= 0.64-1.83. There was an increased prevalence of epilepsy in Non-users (0.6%) vs. Statin-users (0.3%) at baseline in the PS-matched Healthy cohort. (p=0.04) CONCLUSION: This study did not demonstrate a significant beneficial or deleterious effect of statin use on risk of being diagnosed with epilepsy. The increased prevalence of epilepsy in Non-users at baseline in the PS-matched Healthy cohort suggests that physicians might be avoiding statin prescription in patients with epilepsy, which may explain the apparent association of statins with less risk of epilepsy in some previous observational studies.Item Association of Vitamin D Serum Concentration with Infection Outcomes for Children after Surgery(2016-01-19) Aboul-Fettouh, Nader; Williams, Timothy; Ploski, Roxana; Griffin, Allison; Szmuk, PeterVitamin D insufficiency and deficiency has been associated with various disease states and lower health outcomes. In the adult population, higher vitamin D levels correlated with decreased odds of in-hospital morbidity and mortality. However, no study examined the role of Vit D on the perioperative and post-operative outcomes in the pediatric patient population. We hypothesized that vitamin D deficient pediatric patients will have a higher incidence of composite infectious complications. As a secondary outcome we will analyze whether there is a relationship between the patient's vitamin D levels and hospital length of stay. With IRB approval we performed an EPIC search for all Children's Health patients from 2011 to 2015 where at least one 25-hydroxyvitamin D level was determined within the perioperative period (1 month pre- and post-surgery). Patients were included if they were less than 18 years of age and had underwent non-cardiac surgery. Patients were excluded if they did not receive general anesthesia, stayed less than one night in the hospital, had an American Society of Anesthesiologists Physical Status greater than 4, or underwent emergent surgery. Pertinent information including details of the surgery and relevant past medical history were collected for each patient to help analyze the data set and account for confounding factors. In order to have access to a larger number of patients, this project was performed in collaboration with Cleveland Clinic (Cleveland, OH). The EPIC search provided us with 1600 patient charts from CMC or Children's Health-Plano, and 850 were included into the study after being screened using the criteria noted previously. After analyzing the data, The incidence of infection were 5.5%, 5.8%, 4.9%, 5.8%, and 11.7% for patients with vitamin D level ≤13, 14-19, 20-25, 26-34, and ≥35 ng/ml, respectively. The odds of having infection did not differ significantly among the five vitamin D groups. Secondly, no difference was found in the length of hospital stay among the five vitamin D groups (P = 0.55). Vitamin D levels do not seem to be associated with infection or length of hospital stay in pediatric surgical patients. Other baseline and surgical factors have probably a stronger influence on in-hospital infection and length of hospital stay than vitamin D levels.Item Attitudes and Trends in the Treatment of Morphea: A National Study(2013-01-22) Strickland, Nicole; Patel, Gopal; Jacobe, HeidiINTRODUCTION: Morphea, or localized scleroderma, is an inflammatory disorder of both adults and children that can lead to severe cosmetic and functional impairment due to excess collagen deposition in the dermis and subcutaneous tissues. The attitudes of the main specialists caring for these patients, dermatologists and rheumatologists, have not been directly evaluated in regards to evaluation and treatment. Given the multidisciplinary management of this disease and the lack of a national perspective on physicians' current treatment regimens, there is no uniform standard of care for morphea, and the indications for aggressive treatment are not widely accepted among providers. We report here the results of a national cross-sectional survey of both dermatologists and rheumatologists, showing current practice patterns of evaluation and treatment of morphea in the United States. METHODS: A web-based cross-sectional survey was administered to physicians who were randomly selected from the current American Academy of Dermatology, Society of Pediatric Dermatology, and the American College of Rheumatology Membership Directories. RESULTS: Physician approach to evaluation and treatment of morphea is driven by the specialty training of the physician rather than the disease characteristics. For evaluation of morphea, all specialties de-emphasized subtyping morphea, instead strongly relying on the history and physical exam, a modality based on physician training. Over all morphea subtypes, dermatologists tended to utilize external treatments (topical steroids, phototherapy), while rheumatologists preferred systemic treatments (methotrexate, antimalarials/antibiotics, systemic steroids). Both specialties are willing to refer patients to their colleagues in other specialties when evaluation or treatments extend beyond their own training. For some morphea subtypes, each specialty did not have a clear consensus on first and second-line treatment. DISCUSSION: This is the first study to concurrently assess the evaluation and treatment practices of main stakeholders in morphea care. With the lack of standardized guidelines, dermatologists and rheumatologists rely heavily on specialty training for assessing and treating morphea patients. Even within a specialty, there are no clear agreements on treatment choices for individual morphea subtypes. This study 1) provides support for the necessity to develop evidence-based practice guidelines; 2) emphasizes the need for interdisciplinary collaboration that is already in place among these stakeholders; and 3) shows a national perspective on morphea care that can be used as a platform to launch consensus statements on morphea treatment.Item Auditory Navigation in Bilateral Hearing Aid Users(2017-01-17) Chamseddin, Bahir; Shayman, Corey; Lee, Rebecca; Hullar, TimothyINTRODUCTION: Falling is a serious and common problem in the United States and is responsible for the most injuries, fatal and nonfatal, for Americans. Recent data implicates a link between those suffering from hearing loss and increased incidence of falls. Possible reasons include a coexisting reduction in cognitive capacity, reduced vestibular sense, and loss of auditory perception leading to decreased spatial awareness; however, none have been investigated during a walking balance test. This study investigates the ability of hearing aids to reduce veering, a walk that increases risk of falls, in the bilateral hearing aid population. METHODS: Healthy subjects (n=11) with no reported vestibular or auditory pathology and experienced bilateral hearing aid users (n=6) were blindfolded and instructed to walk 8m towards a speaker that emitted broadband white noise. Variables integrated a loud speaker, headphones, and no sound or bilaterally aided, unilaterally aided, and unaided in the healthy and pathologic populations, respectively. Recordings were taken for displacement from the speaker at the end of the runway and distance reached when subjects deviated within 1m from the intended walking path. Users also were instructed to walk normally or heel-to-toe. RESULTS: Using ANOVA analysis, healthy subjects significantly improved navigation during sound trials throughout both walking conditions (P= 0.005 for both tests). Bilateral hearing aid populations benefited from sound during narrow-based walking conditions (P= 0.06), yet during standard walking conditions the final displacement observed between aided and unaided trials were no different (P=0.85). Participants did not report a subjective improvement in balance with maximal sound cues. DISCUSSION: This study suggests that bilateral hearing aid population who do not have excellent familiarity with walking deprived of vision do not benefit from hearing aids to reduce veering during transient low-light conditions, such as getting up at night to use the restroom. The results also suggest differences in localization between normal walking and tandem walking which may have been attributed to sensory compensation, gait velocity, and attention required to keep balance. The reduction in veering with hearing aids in some cases may offer a public-health benefit through avoiding falls in this population. CONCLUSION: Auditory spatial awareness is responsible for the reduction in veering associated with imbalance. This study suggest that bilateral hearing aid population may benefit from hearing aids to walk during conditions in the absence of vision. Additionally, sound beacons can be used to benefit populations outside the blind.