Statistical Differences In Clinical Outcomes Research Articles

Functional Outcomes and a Review of Management Options for Revision Shoulder Arthroplasty.

Increase in the number of primary shoulder arthroplasty has led to an increase in the number of revisions which presents many complex challenges and often has inferior outcomes. Data was collected retrospectively, and patients were classified using Dines classification. Comprehensive case reviews were done to identify preoperative and intra-operative challenges. The primary outcome measure was Oxford shoulder score (OSS). The secondary measures were range of motion (ROM) and patient satisfaction (very satisfied, satisfied, not satisfied or worse). A total of 32 patients were identified with a mean age of 67.64 years and the most common cause of revision was a combination of bone and soft tissue failure (39.3%). All patients (n=8) with hemiarthroplasty had rotator cuff deficiency while patients with resurfacing had both rotator cuff failure and bony erosion. Four patients needed a proximal humeral osteotomy and six patients needed allograft reconstruction of the glenoid for bone loss. Twenty-one shoulders were revised to reverse total shoulder arthroplasty (TSA), 2 to anatomical TSA and 5 were left with cement spacer in situ. Mean duration of follow-up was 41.6 months. Mean OSS at the last follow-up was 26.88 with statistically significant improvement in ROM. There was no statistical difference in clinical outcomes (p>0.05) based on the type of primary prosthesis or cause of revision. A total of 70% patients were pain free. Patients with infection had inferior outcomes with a mean OSS of 17. Management of patients with failed shoulder arthroplasty is often challenging but has good clinical outcome except in infections.

Analysis of injected cement volume and clinical outcomes following balloon-assisted kyphoplasty in a series of 368 patients

ObjectiveBalloon-assisted kyphoplasty (BAK) is a modified vertebroplasty technique developed to treat vertebral compression fractures (VCFs) secondary to osteoporosis. This study investigates the association between injected cement volume and the development of subsequent VCFs after BAK. MethodsA retrospective analysis of 368 patients who underwent BAK at a single institution was performed from 2001 to 2021. Inclusion was defined by at least 2 years of follow-up. Clinical characteristics and outcomes following BAK, including subsequent fractures at adjacent and remote levels, were identified. Patients that underwent a thoracic BAK were stratified by injected cement volume: below or equal to the median (≤ 6.0 mL, 265 vertebrae) or above the median (> 6.0 mL, 144 vertebrae). Patients that underwent a lumbar BAK were similarly stratified: below or equal to the median (≤ 8.0 mL, 233 vertebrae) or above the median (>8.0 mL, 160 vertebrae). ResultsA total of 802 vertebrae were treated. The average volume of cement was recorded in the thoracic (6.2 ± 1.9 mL) and lumbar (7.8 ± 1.8 mL) vertebrae. In the thoracic spine, vertebrae that were injected with > 6.0 mL of cement underwent a greater change in local kyphotic angle (P = 0.0001) and were more likely to develop adjacent-level VCFs (P = 0.032) after kyphoplasty. Univariate analysis did not elucidate any additional risk factors. There were no statistical differences in clinical outcomes between the three groups of lumbar vertebrae. ConclusionsLarger volumes of injected cement were associated with a greater change in local kyphosis and subsequent adjacent-level fractures after BAK in the thoracic spine. This association was not found in the lumbar spine. Close attention to injected cement volumes must be made in the thoracic spine and patients who undergo significant kyphotic correction should be carefully observed postoperatively.

Prospective randomized pilot trial comparing prophylactic and therapeutic cerebrospinal fluid drainage during complex endovascular thoracoabdominal aortic aneurysm repair

BackgroundEndovascular techniques have transformed the management of thoracoabdominal aortic aneurysms (TAAAs). However, spinal cord ischemia (SCI) remains a prevalent and devastating complication. Prophylactic drainage of cerebrospinal fluid (CSF) is among the proposed strategies for prevention of SCI. Although prophylactic CSF drainage is widely used and conceptually attractive, prophylactic CSF drains have not been demonstrated to definitively prevent the occurrence nor mitigate the severity of SCI in endovascular TAAA repair. Whether or not outcomes of prophylactic drains are superior to therapeutic drains remains unknown. This pilot study was performed to determine the feasibility of a randomized clinical trial designed to investigate the role of prophylactic vs therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair using branched and fenestrated endovascular aortic repair (FBEVAR). MethodsThis was a prospective multicenter randomized pilot clinical trial conducted at The University of Alabama at Birmingham and The University of Massachusetts. Twenty patients were enrolled and randomized to either the prophylactic drainage or therapeutic drainage groups, prior to undergoing FBEVAR for extensive TAAAs and arch aortic aneurysms. This was a pilot feasibility study that was not powered to detect statistical differences in clinical outcomes. The primary outcome was feasibility of randomization and compliance with a shared lumbar drain protocol. Secondary outcomes included rate of drain complications and SCI. ResultsTwenty patients were enrolled and successfully randomized, without any crossovers, to either the control cohort (n = 10), without prophylactic drains, or the experimental cohort (n = 10), with prophylactic drains. There were no differences in age, comorbidities, or history of prior aortic surgery across the cohorts. All patients were treated with FBEVAR. Aneurysm classifications were as follows: Extent I (10%), Extent II (50%), Extent III (35%), and Extent IV (5%). The average length of aortic coverage was 207 ± 21.6 mm. The length of aortic coverage did not vary across cohorts, nor did procedural times or blood loss volume. Compliance with the SCI prevention protocol was 100% across both groups. Within the prophylactic drain cohort, one patient experienced an adverse event related to lumbar drain placement, manifested as an epidural hematoma requiring laminectomy, without neurologic deficit (n = 1/10; 10%). There was one SCI event (n = 1/20; 5%), which occurred in the prophylactic drain cohort on postoperative day 9 following an episode of hypotension related to a gastrointestinal bleed. ConclusionsThe role of prophylactic CSF drains for the prevention of SCI following endovascular TAAA repair is a topic of ongoing research, with many current practices based on expert opinion and experience, rather than rigorous scientific data. This study demonstrates the feasibility of a multicenter randomized clinical trial to evaluate the role of prophylactic vs therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair.

Learning curve for biportal endoscopic posterior cervical foraminotomy determined using the cumulative summation test

BackgroundLearning curves describe the rate of performance improvements corresponding to the surgeon’s caseload, followed by a plateau where limited further improvements are observed. This study aimed to determine the learning curve for biportal full-endoscopic posterior cervical foraminotomy (BE-PCF) for the unilateral cervical foraminal disc.MethodsThe learning curve was evaluated using a learning curve cumulative summation test (LC-CUSUM). The goal for the operation time was set to 78 min, which is the mean operation time (mOT) of percutaneous full-endoscopic posterior cervical foraminotomy (PE-PCF) performed by a senior surgeon. Moreover, clinical outcomes and post-operative complications were compared between the early and late learning periods 1 year post-operatively.ResultsThis study enrolled the first 50 patients who underwent single-level BE-PCF, performed by a single surgeon. The LC-CUSUM signalled competency for surgery at the 20th operation, indicating that sufficient evidence was obtained to prove that the surgeon was competent. The mOT was 71.29 ± 11.69 min in BE-PCF, 71.84 ± 12.61 min in the early learning period, and 67.83 ± 10.31 min in the late learning period (p = 0.254). There was no statistical difference in clinical outcomes, visual analogue scale scores, and neck disability index between both periods (p > 0.05). Four complications were recorded throughout the whole period, with three in the early period and one in the late period (p = 0.285).ConclusionOur study shows that BE-PCF has a learning curve of 20 caseloads to achieve 90% proficiency, and it significantly reduces the operation time based on the performance of a senior surgeon proficient in PE-PCF.

1815. Assessment of Therapy Duration for Non-Staphylococcal Gram-Positive Bloodstream Infections

Abstract Background The optimal duration of antimicrobial therapy for non-staphylococcal Gram-positive (GP) bloodstream infections (BSIs) remains unknown. The purpose of this study was to evaluate clinical outcomes in patients with short (6-10 days) vs. long (11-21 days) duration of therapy (DOT) for non-staphylococcal GP BSIs. Methods Adult patients with BSI due to Streptococcus or Enterococcus spp. admitted to a community health system from January 2016 to December 2021 were included in this retrospective chart review. Patients were excluded for polymicrobial BSI, positive culture deemed contamination, infectious source requiring prolonged treatment, DOT < 6 or > 21 days, or transfer, hospice, or death prior to therapy completion. The primary endpoint was 90-day all-cause mortality. Descriptive statistics, chi-square or Fisher’s exact test, and the student t-test were used for data analysis. Results Of 3,544 patients identified, 384 were screened and 86 included. There were 71 patients in the long DOT group and 15 patients in the short DOT group. All included patients were on active therapy for the entire DOT. Baseline characteristics were similar except patients in the long DOT group were more likely to have an infectious diseases consultation and a non-pulmonary source of infection (Table 1). All-cause mortality at 90 days was similar between short vs. long DOT groups (0% vs. 3%, p=0.51) (Table 2). The secondary endpoints of 30-day all-cause mortality, 30-day and 90-day BSI recurrence due to the same organism, 30-day readmission, and hospital length of stay were not statistically different between groups (Table 2). The most common pathogen identified in the short DOT group was Streptococcus pneumoniae (n=8), and the most common identified pathogens identified in the long DOT group was Streptococcus agalactiae (n=22), Enterococcus faecalis (n=14), and S. pneumoniae (n=13) (Table 3). Conclusion In this retrospective review of non-staphylococcal GP BSIs, there was no statistical difference in clinical outcomes between the short and long DOT arms. Additional research is needed to identify the optimal duration of antimicrobial therapy for non-staphylococcal GP BSIs. Disclosures All Authors: No reported disclosures.

UGT2B7 gene polymorphism and linkage disequilibrium in pediatric epileptic patients and their influence on sodium valproate monotherapy: A cohort study.

Background: Uridine 5′-diphospho glucuronosyl transferase (UGT) is the main enzyme responsible for the glucuronide conjugation, the principal metabolic pathway of sodium valproate. The objective of the study was to explore if there was an association between the UGT2B7 genetic polymorphism and clinical efficacy and safety in paediatric epileptic patients on sodium valproate monotherapy. Methods and materials: The cohort study included 100 pediatric epileptic patients aged 2–18 years who had been on sodium valproate monotherapy for at least 1 month. PCR-RFLP was carried out to assess the genetic polymorphism patterns of UGT2B7 (C161T, A268G, G211T). Based on the extent of seizure control throughout the 1-year follow-up, clinical outcome was assessed in terms of responders and non-responders. Hepatic, renal, and other lab parameters were assayed to determine safety. The SNPstat web software was used to calculate linkage disequilibrium. Results: Out of 100 patients, CC (38%), CT (43%), TT (19%) pattern was observed in UGT2B7 (C161T) gene, AA (15%), AG (39%), GG (46%) in (A268G) gene and GG (80%), GT (18%), TT (02%) in (G211T) gene. There was no statistical difference in clinical outcome with distinct UGT2B7 genetic polymorphism patterns, according to the findings. With low D′ and R2 values, linkage disequilibrium between alleles was statistically insignificant. However, the associations of C161T and G211T with treatment response were significant (p = 0.014) in determining treatment response. Conclusion: Our findings show that the genetic variation of UGT2B7 had no bearing on the clinical outcome of epilepsy. Gene interactions, on the other hand, had an impact on treatment response.

Early Experience With Interleukin-6 Receptor Antagonists in Patients With COVID-19 Admitted to a Community Hospital.

Background/objective: The efficacy of interleukin-6 (IL-6) inhibitors in hospitalized patients with severe coronavirus disease 2019 (COVID-19) pneumonitis is unclear. Method: This retrospective, observational cohort study included patients hospitalized at a community hospital with COVID-19 pneumonia from March 2020 to May 2020. All patients were treated with standard of care (SOC), and a nonrandomly selected subset of patients also received an IL-6 inhibitor. The primary outcome was clinical response, defined as an improvement of at least 2 categories relative to baseline on a 7-category ordinal scale up to hospital discharge or 30 days. In adjusted analyses, logistic and linear regression models were conducted, controlling for covariates of hospital length of stay (LOS), intensive care unit (ICU) care, ICU LOS, gender, age, race, and Charlson Comorbidity Index. Results: A total of 133 patients met inclusion criteria. In all, 30 patients received an IL-6 inhibitor plus SOC. There was no statistical difference in clinical outcome between groups as 76.7% in the SOC alone group and 70.0% in the IL-6 inhibitor group met the defined endpoints for clinical response (P = 0.477). In the adjusted analysis, patients treated with IL-6 inhibitors were approximately 4 times more likely to meet the primary endpoint compared with patients with SOC alone (adj. odds ratio = 4.325; P = 0.038, 95% confidence interval = [1.09-17.18]). Conclusions: Compared with SOC alone, IL-6 inhibitors were not associated with a significant clinical response. However, after adjusting for covariates, this study suggests that the initiation of IL-6 inhibitors in patients with early COVID-19 pneumonitis before progression to the ICU may be associated with improved clinical status.

Head and neck arteriovenous malformations: University of Tennessee experience, 2012–2022

Head and neck arteriovenous malformations (AVMs) are complex lesions that represent a subset of vascular anomalies (VAs). The authors present an analysis of their institutional experience managing these lesions as a multidisciplinary team. A retrospective chart review was performed of head and neck AVM patients treated at the authors' institution from 2012 to 2022. Recorded data included patient demographic characteristics, details of clinical presentation, Schöbinger clinical scale and Yakes AVM classification results, and details of all endovascular and surgical treatments. The primary outcome of the study was clinical response to treatment. Angiographic occlusion and complication rates were reported. Chi-square tests were used for comparative statistics. Sixteen patients (9 female, 56%) with AVMs of the head and neck presented from age 3 to 77 years. The Schöbinger stage was stage II in 56% of patients (n = 9) and stage III in 44% of patients (n = 7). The Yakes AVM classification was nidus type (2a, 2b, or 4) in 7 patients (43%) and fistula type (1, 3a, or 3b) in 9 patients (57%). The majority of patients (n = 11, 69.0%) were managed with embolization as the only treatment modality, with an average of 1.5 embolizations/patient (range 1-3). Surgical resection was employed in 5 patients (4 in combination with embolization). Symptom resolution and symptom control were achieved in 69% and 31% of patients, respectively, in the entire cohort. A radiographic cure was demonstrated in 50% of patients. There were no statistical differences in clinical outcomes or radiographic cure rates between patients treated with different modalities. Head and neck AVMs can be treated successfully with a primarily endovascular management strategy by a multidisciplinary team with the goal of symptomatic control.

Impact of Atrial Fibrillation on Cardiovascular and Economic Outcomes in Patients with Chronic Lymphocytic Leukemia

Introduction: Chronic lymphocytic leukemia (CLL) is the most frequently diagnosed hematologic cancer, with many patients diagnosed at a later stage in life and typically with comorbidities that often complicate CLL management. Atrial fibrillation (AF) is the most common arrhythmia in the United States and is associated with high hospitalization and mortality rates. While the relationship between CLL and AF has been reported, there is limited real-world evidence on the clinical and economic impact of AF in CLL patients. The objectives of this study were to examine the impact of AF on cardiovascular (stroke, bleeding events, heart failure) and economic (costs and healthcare resource utilization [HRU]) outcomes among patients with CLL.Methods: This retrospective observational study used the IBM MarketScan Research Databases in Treatment Pathways that includes at least a 10-million sample of the commercial and Medicare supplemental claims database. Patients who were at least 18 years, diagnosed with CLL (identified by ICD-9/ICD-10) and continuously enrolled from January 2009 to July 2020 were included. CLL patients were followed up for one year after their first CLL diagnosis date to examine the incidence of AF. Cardiovascular outcomes were evaluated as the incidence of stroke, bleeding events, and heart failure among the CLL patients with and without AF. Costs and HRU were assessed following up until 1 year after the first date of AF, stroke, bleeding events, and heart failure. HRU was evaluated for outpatient, emergency room (ER), inpatient, and pharmacy visits, and by length of stay (LOS) for hospitalizations. Costs were evaluated in overall population and by HRU type. Statistical differences in clinical outcomes between patients with and without AF were compared using chi-square tests. The Mann Whitney Wilcoxon test was used to compare the medians for the HRU and cost outcomes. The associations between AF and hospitalizations as well as costs were evaluated by multivariable logistic regression and generalized linear model, respectively. Statistical significance was determined at a P-value of less than 0.05.Results: Among the total of 23,756 newly diagnosed CLL patients (median age 68 years, 57.83% male) included in the study, 11% had AF within 1 year of the CLL diagnosis. CLL patients who had AF were significantly older (median age: 67 vs 82 years) and had more male patients (56.9% vs 65.1%) compared to CLL patients without AF. Significantly higher rates of stroke (12.67% vs. 4.97%), bleeding events (17.45% vs. 8.53%), and heart failure (31.14% vs. 4.70%) were observed in CLL patients with AF than those without (Figure 1). Compared to the CLL cohort without AF, adjusted regression analysis indicated that overall, CLL cohort with AF was twice as likely to be hospitalized (odds ratio [OR]=2.03) and incurred 44% higher total costs (cost ratio [CR]=1.44). Further examining the impact of AF-related cardiovascular outcomes, we observed that CLL patients with AF who developed stroke, bleeding events, and heart failure had statistically significant higher HRU (outpatient, ER, inpatient, and pharmacy visits), longer LOS, and costs (total, outpatient, pharmacy) than CLL patients without AF. After adjusting for demographic and clinical confounders, significantly higher hospitalization rates and costs were also reported in the CLL cohort who had AF with further stroke (OR=2.59; CR=1.36), bleeding events (OR=3.27; CR=2.03), and heart failure (OR=5.47; CR=2.07) compared to the CLL cohort without AF.Conclusions: The findings of this real-world study demonstrated significantly higher hospitalizations, cardiovascular events, and economic burden incurred by CLL patients who had AF than those without. The presence of stroke, bleeding events, heart failure among CLL patients with AF further increased the HRU and costs. This study highlighted the importance of better disease management, more intentional monitoring for AF and improved CLL therapeutics with a lower risk of AF or cardiovascular toxicity to prevent or minimize the incidence of AF in CLL patients. [Display omitted] DisclosuresMohan: BeiGene, Ltd.: Current Employment. Yang: BeiGene, Ltd.: Current Employment. Liu: BeiGene, Ltd.: Current Employment. Dick: IBM Watson Health: Current Employment. Tang: BeiGene, Ltd.: Current Employment. Chanan-Khan: Ascentage: Research Funding; Alpha2 Pharmaceuticals, NonoDev, Starton: Current holder of stock options in a privately-held company; Cellectar: Current equity holder in publicly-traded company; Alpha2 Pharmaceuticals: Patents & Royalties: Tabi; Ascentage, Starton, Cellectar, NonoDev, Alpha2 Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; BeiGene, Jansen, Ascentage: Honoraria; BieGene, Jansen, Ascentage: Consultancy.

Obese people benefit from lumbar spinal stenosis surgery as much as people of normal weight

BackgroundLumbar spinal stenosis (LSS) is a common degenerative condition of the spine that causes back pain radiating to the lower extremity. Surgical treatment is indicated to treat progressive radical symptoms. Obesity has been associated with inferior results in the domains of quality of life (QoL) following an LSS operation, but the research findings have been limited. This paper aims to identify whether obesity affects QoL due to back pain among patients who underwent an operation for LSS.MethodsThis study is based on a series of patients operated on for LSS between 2012 and 2018. Operated patients who returned for follow-up forms within the first or second years were included. A total of 359 patients were selected, 163 males (45%) and 196 females (55%). The mean age was 68.9 years. The EuroQol five-dimension scale (EQ-5D) questionnaire was chosen to measure QoL and the Oswestry Disability Index (ODI) for functional disability.ResultsQoL, as measured by EQ-5D, was preoperatively lower in those patients with a BMI ≥ 30. One year after the operation, all groups had a similar trend of improved QoL. At the second year, the results in all groups levelled off even though there was no statistical difference in clinical outcomes (p = 0.92).The ODI was preoperatively statistically higher in patients with a BMI ≥ 30 (p < 0.001). Two years after the surgery, all groups had improved ODI scores, but there was no statistical difference in ODI between the BMI groups (p = 0.54).ConclusionSurgical intervention for debilitating or longstanding symptoms of LSS should be considered as a treatment option for suitable patients in spite of an elevated BMI.

Arthroscopic Correction of Femoroacetabular Impingement for Concomitant Inguinal Disruption in Athletes With Dual Pathology

Background: Inguinal disruption and femoroacetabular impingement (FAI) are well-recognized sources of groin pain in athletes; however, the relationship between inguinal disruption and FAI remains unclear. In cases of dual pathology, where both entities coexist, there is no definitive consensus regarding which pathology should be prioritized for treatment in the first instance. Purpose: (1) To examine the 2-year effectiveness and clinical outcome in athletes presenting with dual pathology in which the FAI component alone was treated with arthroscopic deformity correction. (2) To compare 2-year patient-reported outcome measures between athletes undergoing only hip arthroscopy (HA) and athletes undergoing groin repair and HA. Study Design: Cohort study; Level of evidence, 3. Methods: All patients undergoing HA for the treatment of FAI with concomitant clinical signs of inguinal disruption at initial consultation were between 2010 and 2016 were included in this study. Inclusion criteria were male sex, age <40 years, and involvement in competitive sporting activity. Athletes with previous HA on the symptomatic side, Tönnis grade >1, or lateral center-edge angle <25° were excluded. Revision HA or subsequent groin surgery was documented. Outcome evaluation consisted of validated patient-reported outcome measures (modified Harris Hip Score; University of California, Los Angeles Activity Scale; 36-Item Short Form Health Survey; Western Ontario and McMaster Universities Osteoarthritis Index) completed preoperatively and a minimum 2 years postoperatively. The minimal clinically important difference was assessed by using a distribution-based technique (SD, 0.5) and an anchor-based technique (percentage of possible improvement). Level of satisfaction and return to play were assessed. Results: A total of 113 cases of dual pathology were included in 91 patients with a mean ± SD age of 26.3 ± 5.1 years. The index surgical procedure was HA for 104 cases (92%) and groin repair for 9 (8%). For patients undergoing HA as the index procedure, 98.1% (102/104 cases) were successfully followed up to establish survivorship. In 89.2% (91/102 cases), no additional groin surgery was required. In 11 cases (10.8%), additional groin surgery was required for persisting inguinal-related groin pain. At 2 years after the operation, there was no difference for any patient-reported outcome measure (P > .099), improvement from baseline (P > .070), or proportion of cases achieving the minimal clinically important difference (P > .120) between the HA-only group and the group undergoing HA and groin repair at any stage. There was also no difference between groups in terms of return-to-play rate (P = .509) or levels of satisfaction (pain, P = .204; performance, P = .345). Conclusion: In patients with dual pathology, treatment of the FAI component alone using arthroscopic hip surgery results in a successful outcome without need for groin repair in 89.2% of cases. No statistical difference in clinical outcome 2 years after surgery was observed between athletes undergoing 1 procedure (HA alone) and those undergoing 2 procedures (HA and groin repair at any stage).

Association of UGT1A6 gene polymorphism with clinical outcome in pediatric epileptic patients on sodium valproate monotherapy.

Pediatric epilepsy comprises chronic neurological disorders characterized by recurrent seizures. Sodium valproate is one of the common antiseizure medications used for treatment. Glucuronide conjugation is the major metabolic pathway of sodium valproate, carried out by the enzyme uridine 5′-diphosphate (UDP) glucuronosyl transferase (UGT) whose gene polymorphisms may alter the clinical outcome. The objective of this study was to assess the association between UGT1A6 genetic polymorphism and clinical outcome in terms of efficacy and tolerability in pediatric epileptic patients on sodium valproate monotherapy. Pediatric epileptic patients (n=65) aged 2-18 years receiving sodium valproate monotherapy for the past one month were included. Genetic polymorphism patterns of UGT1A6 (T19G, A541G, A552C) were evaluated by PCR-RFLP. Clinical outcome was seizure control during the 6 months observation period. Tolerability was measured by estimating the hepatic, renal, and other lab parameters. Out of 65 patients, TT (40%), TG (57%), and GG (3%) patterns were observed in UGT1A6 (T19G) gene, AA (51%), AG (40%), and GG (9%) in (A541G) gene, and AA (43%), AC (43%), and CC (14%) in (A552C) gene. No statistical difference in clinical outcome was found for different UGT1A6 genetic polymorphism patterns. We concluded that different patterns of UGT1A6 genetic polymorphism were not associated with the clinical outcome of sodium valproate in terms of efficacy and tolerability. Sodium valproate was well-tolerated among pediatric patients with epilepsy and can be used as an effective antiseizure medication.

Effect of UGT2B7 Gene Polymorphism with Clinical Pediatric Epileptic patients on Sodium Valproate Monotherapy

Background: Pediatric epilepsy comprises of a chronic neurological disorders characterized by recurrent seizure attack. Sodium valproate is one of the common anti-epileptic drugs used in the treatment. Glucuronide conjugation is the major metabolic pathway of sodium valproate, carried out by the enzyme Uridine 5’-diphospho (UDP) glucuronosyl transferase (UGT) whose genetic polymorphisms may alter clinical outcome. Aim: To find the association between UGT2B7 genetic polymorphism and clinical outcome in terms of efficacy and tolerability in pediatric epileptic patients on sodium valproate monotherapy. Methods and Materials: In this cohort study, 75 pediatric epileptic patients aged 2-18 years receiving sodium valproate monotherapy for past one month were included from Justice K S Hegde Charitable Hospital, Mangalore, India after obtaining informed consent. Genetic polymorphism patterns of UGT2B7 (C161T, A268G, G211T) was evaluated by PCR-RFLP. Clinical outcome was measured in terms of responders and non-responders based on seizure control during the 6 month observation period. Tolerability was measured by estimating the hepatic, renal and other lab parameters. Clinical outcome in different UGT genotypes was compared by Chi square test. P value <0.05 was considered as significant. Results: Out of 75 patients, CC (41.3%), CT (38.7%), TT (20%) pattern was observed in UGT2B7 (C161T) gene, AA(14.7%), AG(42.7%), GG(42.7%) in (A268G) gene and GG(80%), GT(18.7%), TT(1.3%) in (G211T) gene. It was found that there was no statistical difference in clinical outcome with different UGT2B7 genetic polymorphism patterns. Conclusion: We conclude from our study that genetic polymorphism of UGT2B7 doesn’t have any role on the clinical outcome of epilepsy.

Outcomes of optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation: one-year results from the ILUMIEN III: OPTIMIZE PCI trial.

In the ILUMIEN III trial, among 450 randomised patients with non-complex lesions undergoing percutaneous coronary intervention (PCI), optical coherence tomography (OCT) guidance led to greater stent expansion than angiography guidance, similar minimal stent area compared to both intravascular ultrasound (IVUS) guidance and angiography guidance, and lower rates of uncorrected dissection and malapposition than both IVUS guidance and angiography guidance. Whether these differences impact on clinical outcomes is unknown. The aim of the present study was to report the 12-month clinical follow-up data from the ILUMIEN III study. OCT-guided PCI, using an external elastic lamina-based protocol, was compared to operator-directed IVUS-guided or angiography-guided PCI. Target lesion failure (TLF) and major adverse cardiovascular events (MACE) at 12 months were adjudicated by a blinded clinical events committee. There were no significant differences in the rates of TLF (2.0% OCT, 3.7% IVUS, 1.4% angiography), MACE (9.8% OCT, 9.1% IVUS, 7.9% angiography), or any of the individual components of these outcomes among the groups. No independent predictors of 12-month stent-related clinical events were identified from final OCT. In this underpowered study, OCT-guided PCI of non-complex lesions did not show a statistical difference in clinical outcomes at 12 months compared with IVUS or angiography guidance. An appropriately powered trial, including only complex patients and lesions, is underway to substantiate the potential clinical benefit of OCT-guided PCI. NCT02471586.

Is it necessary to place screws in the intervening vertebrae in two-level anterior cervical discectomy with fusion and plating?

ObjectiveThe clinical outcomes, radiological parameters, complication rate and the cost of implants in two-level ACDF with and without screws in the intervening segment were compared. MethodsA retrospective study of 68 patients who underwent 2-level ACDF from January 2014 to June 2016 was performed. The patients were divided into two groups: ACDF with screws in the intervening vertebra and those without screws in the intervening vertebra. Perioperative factors, clinical outcomes, postoperative complications, radiological parameters, and cost of the implants were evaluated in both groups. ResultsNo statistical differences in clinical outcomes, operative blood loss, hospital stay, restoration of cervical lordosis or segment height, postoperative complications, and fusion rate were found between the ACDF (middle vertebra with screw) and ACDF (middle vertebra without screw) groups (P > 0.05). But the operative time of added screw placement and cost of implants in the ACDF (middle vertebra without screw) group were significantly less than the ACDF (middle vertebra with screw) group (P < 0.05). ConclusionTwo kinds of screw placement with ACDF were found to be similar in terms of clinical outcomes. However, ACDF (middle vertebra without screw) was found to be superior to ACDF (middle vertebra with screw) in terms of the screw placement time and cost of implants.

Epidemiological investigation on 1 946 hospitalized pediatric patients with burns

Objective: To investigate the epidemiological characteristics of hospitalized pediatric patients with burns and explore the prevention and treatment strategy of pediatric burns. Methods: Medical records of pediatric burn patients hospitalized in multiple departments of Children's Hospital of Chongqing Medical University from January 2012 to December 2016 were retrospectively analyzed. Data including gender, age, residence, ways of paying, total burn area, burn severity, cause, time, and place of burns, prehospital treatment ways, clinical outcome, length of hospital stay were collected and processed with chi-square test, Kruskal-Wallis H test, and Bonferroni correction. The factors which influence wound healing were processed with multivariate logistic regression analysis. Results: (1) A total of 1 946 pediatric burn patients with complete medical records were hospitalized in Children's Hospital of Chongqing Medical University during the 5 years, with 1 127 boys (57.91%), which were more than 819 girls (42.09%). Pediatric patients≤3 years old were with the highest incidence of burns of 87.15% (1 696/1 946). There was no significantly statistical difference in gender composition ratio among pediatric patients of different ages (χ2=2.294, P= 0.318). (2) The residence of 1 536 pediatric patients (78.93%) were in town, and most of them used urban resident essential medical insurance for medical cost. Most of the pediatric patients living in rural areas paid the medical cost at their own expense. There was significantly statistical difference in way of paying between pediatric patients living in urban and those in rural areas (χ2=658.324, P<0.05). (3) The pediatric patients with total burn surface area≥5% total body surface area (TBSA) and<15% TBSA were the most (1 200 cases, accounting for 61.66%). The pediatric patients with moderate burns were the most (1 225 cases, accounting for 62.95%), followed by mild burns (494 cases, accounting for 25.39%), severe burns (124 cases, accounting for 6.37%), and extremely severe burns (46 cases, accounting for 2.36%). (4) The pediatric patients with scald caused by hot water were the most (1 801 cases, accounting for 92.55%), followed by flame burns (69 cases, accounting for 3.55%), chemical burns (44 cases, accounting for 2.26%), and electrical burns (32 cases, accounting for 1.64%). There was significantly statistical difference in cause of injury among pediatric patients of different ages (χ2=85.471, P<0.05). (5) The incidence of burns of pediatric patients in Spring was 27.95% (544/1 946), which was slightly higher than those in other seasons. There was significantly statistical difference in the burn season among pediatric patients admitted to the hospital in different years (χ2= 23.172, P< 0.05). As to burn place, most of burns of pediatric patients happened at home (1 776 cases, accounting for 91.26%). (6) There was significantly statistical difference in clinical outcome among pediatric patients with different prehospital treatments (H=16.005, P<0.05). There was significantly statistical difference in clinical outcome between pediatric patients with reasonable prehospital treatments and those with unreasonable prehospital treatments (H=-64.990, P<0.05), and between pediatric patients with reasonable prehospital treatments and those without any treatment (H=-74.775, P<0.05). There was no significantly statistical difference in clinical outcome between pediatric patients with unreasonable prehospital treatments and those without any prehospital treatment (H=-9.785, P>0.05). (7) The median of length of hospital stay of pediatric patients was 8 days. The pediatric patients with length of hospital stay≤7 days were the most (834 cases, accounting for 42.86%), and the pediatric patients with length of hospital stay>30 days were the least (39 cases, accounting for 2.00%). (8) The way of prehospital treatment and cause of injury were independent risk factors influencing wound healing (χ2=7.946, 12.977, P<0.05). With no prehospital treatment as benchmark, reasonable prehospital treatments promoted wound healing (odds ratio=1.662, 95% confidence interval=1.129-2.447, P<0.05). With chemical burns as benchmark, electrical burn wounds were harder to heal (odds ratio=0.144, 95% confidence interval=0.028-0.734, P<0.05). Conclusions: Pediatric burn patients hospitalized in Children's Hospital of Chongqing Medical University were mainly boys≤3 years old with moderate scald caused by hot water at home in urban areas. Timely and reasonable prehospital treatments are beneficial to wound healing.

Placement of closed-cell designed venous stents in a mixed cohort of patients with chronic venous outflow obstructions – short-term safety, patency, and clinical outcomes

To evaluate the performance of a closed-cell designed venous stent for the treatment of chronic ilio-femoral venous outflow obstruction (VOO) in the shortterm. Safety, stent patency and clinical outcome after placement of the Vici Venous Stent® in patients with chronic ilio-femoral venous obstruction were assessed retrospectively. Stent patency was evaluated by duplex ultrasound scanning, and clinical outcome was determined using the revised Venous Clinical Severity score (rVCSS). 75 patients (49 % female; median age 57 years; 82 limbs) with symptomatic significant VOO had stents placed in the ilio-femoral veins. Lower limb venous skin changes including ulcers (C-class in CEAP 4-6) were found in 31 patients (41 %). Nonthrombotic iliac vein lesions (NIVLs) and post-thrombotic obstruction (PTO) were found in 40 and 42 limbs, respectively. There were no safety issues. Cumulative primary, assisted-primary, and secondary stent patency in the entire cohort at 12 months were 94 %, 94 % and 96 %, respectively. Five limbs presented with stent occlusion. Two limbs had no intervention, 2/3 remained patent after reintervention. Clinical improvement (a decrease ≥ 2 rVCSS points) was observed in 81 %, 81 %, and 77 % of patients at 1 month, 6 months, and 12 months, respectively. There was a marked drop in the frequency of more marked pain and swelling (VCSS ≥ 2) from 62 % to 5 % and 93 % to 19 %, respectively. Four limbs had venous ulcers, three healed during the follow-up. Cumulative pri- mary stent patency at 12 months was 100 % and 87 % in patients with NIVL and PTO, respectively (p= 0.032). There was no statistical difference in clinical outcome between these subgroups. The Vici Venous Stent® placed in the ilio-femoral vein segment in patients with symptomatic VOO revealed no safety issues, had excellent primary patency and substantial symptom improvement. Long-term studies are needed to evaluate the durability of this stenting procedure.

Monitoring minimal residual disease in canine lymphomas treated with modified L-COP or L-CHOP protocols.

Heteroduplex polymerase chain reaction for antigen receptor rearrangements (hPARR) was developed to monitor minimal residual disease (MRD) in canine B- and T-cell lymphomas treated with the modified L-COP or L-CHOP protocol. Thirty-five dogs were recruited in this study and their neoplastic lineages were determined by immunophenotyping with Pax5 and CD3. Peripheral blood leukocytes were collected prior to and during chemotherapy in weeks 4, 9 and 13 to detect MRD by hPARR. Twenty-eight dogs (80%) had B-cell lymphoma while seven dogs (20%) had T-cell lymphoma. A monoclonal band was detected in 11 cases that showed complete or partial remission before tumour relapse and no response to the current treatment without statistical difference in clinical outcomes; however, the treatment response had an association with the MRD result (P < 0.05). Modified L-CHOP prolonged median progression-free survival as compared to modified L-COP (215 days vs. 93 days; P < 0.05). Substage b had shorter progression-free survival than substage a (90 days vs. 215 days; P < 0.05). Clinical stage III affected median overall survival time when compared to clinical stages IV and V (432, 173 and 118 days, respectively; P < 0.05). hPARR could be used for screening refractory lymphoma together with lymph node measurement in routine clinical cases.

Fish Oil-Containing Lipid Emulsions in Adult Parenteral Nutrition: A Review of the Evidence.

There is evidence from laboratory and animal studies that fish oil-containing intravenous lipid emulsions (FOC-IVLEs) have a beneficial effect on inflammation and the immune response, suggesting a possible clinical benefit. Clinical studies of FOC-IVLEs have reported mixed results. The aim of this review is to present findings from recent randomized controlled clinical trials and other quality clinical studies investigating the effects of administering intravenous fish oil alone or as part of a multilipid emulsion and to examine the quality of these studies in an objective, evidence-based manner. Studies comparing FOC-IVLEs with other IVLEs in adults were included. Thirty-four clinical studies were evaluated: 19 investigated levels of inflammatory and immune markers as an endpoint; 13 investigated rates of infection or sepsis; 3 investigated clinical outcomes in septic patients; and 29 investigated general clinical outcomes. There was conflicting evidence for a beneficial effect of fish oil on levels of inflammatory and immune markers and some evidence that fish oil decreased the rate of postoperative atrial fibrillation. Studies generally reported few statistical differences in clinical outcomes and rates of infection and sepsis with FOC-IVLEs as compared with other IVLEs. The quality of reporting was generally poor, and the presented evidence for comparisons between FOC-IVLEs and other IVLEs was inconclusive or weak. There is very little high-quality evidence that FOC-IVLEs have a more beneficial effect than other IVLEs on clinical outcomes in adult patients.

Clinical outcomes in myocardial infarction and multivessel disease after a cardiac rehabilitation programme: Partial versus complete revascularization

Current guideline recommendations encourage culprit vessel only percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. However, recent studies have shown a better clinical outcome in patients who receive multivessel PCI. To measure and compare clinical outcomes between partial revascularization (PR) versus complete revascularization (CR) in patients with STEMI and multivessel disease who underwent a cardiac rehabilitation programme. We retrospectively reviewed the medical records of 282 patients with STEMI and multivessel disease who received PR or CR and were subsequently enrolled in a cardiac rehabilitation programme between July 2006 and November 2013 at La Paz University Hospital. The incidences of cardiovascular events, new PCI, hospital admissions for cardiovascular reasons and mortality were compared between the PR and CR groups. Overall, 143 patients received PR and 139 received CR. Baseline characteristics were similar in both groups, except for mean age (59.3 vs. 56.7 years; P=0.02), diabetes mellitus prevalence (34.3% vs. 20.1%; P=0.01) and number of arteries with stenosis (2.6 vs. 2.3; P=0.001). During the mean follow-up of 48.0±25.9 months, a cardiovascular event occurred in 23 (16.1%) PR patients and 20 (14.4%) CR patients, with no statistically significant differences in the early (hazard ratio: 0.61, 95% confidence interval: 0.19-1.89) or late (hazard ratio: 1.40, 95% confidence interval: 0.62-3.14) follow-up periods. Cox regression, adjusted for age, sex, presence of diabetes mellitus and number of affected coronary vessels, showed no difference in new cardiovascular event risk. There were no statistical differences in clinical outcomes between PR and CR among patients who received cardiac rehabilitation.