Risk Factors For Clinical Outcomes Research Articles

Investigating the Trajectory and Associated Risk Factors of Clinical Outcomes for Early Childhood Disruptive Behavior Disorders Using Real World Data.

Disruptive behavior disorders (DBDs) are common mental health problems among early childhood American youth that, if poorly managed, pose costly psychological and societal burdens. There is limited real world evidence on how parent management training (PMT) - the evidence-based treatment model of choice - implemented in common practice settings within the United States influences the behavioral progress of early childhood DBDs, and the risk factors associated with poor outcomes. This study used data from a measurement feedback system implemented within a U.S.-based private practice to study how behavioral outcomes change as a function of PMT treatment engagement and associated risk factors for 4-7 year-old children diagnosed with DBDs. Over 50% of patients reached optimal outcomes after 10 appointments. Attending 24-29 appointments provided maximum treatment effect - namely, 75% of patients reaching optimal outcomes by end of treatment. Outcomes attenuate after reaching the maximum effect. Patients also had higher odds of reaching optimal outcomes if they had consistent attendance throughout the treatment course. Notable risk factors associated with lower odds of reaching optimal outcomes included Medicaid insurance-type, greater clinical complexity, and having siblings concurrently in treatment. Increased implementation of systems that monitor and provide feedback on treatment outcomes in U.S.-based practice settings and similar investigations using its data can further enhance 'real world' management of early childhood DBDs among American youth.

OpenSAFELY: Measuring BMI in 22 million patients in England

Background Body mass index (BMI) has been identified as a risk factor for clinical outcomes in patients with COVID-19. Studies identifying this risk have used electronic health record (EHR) platforms in which clinical conditions must be properly identified. We set out to define and evaluate various methods of deriving BMI measurements in OpenSAFELY-TPP, an EHR platform that has been used in many studies relating to the COVID-19 pandemic. Methods With the approval of NHS England, we use routine clinical data from >22 million patients in England to define four derivations of BMI. We compare the number of patients with each type of BMI measurement and the number of measurements themselves. We also examine the plausibility of each derivation by looking at the distribution of measurements and counting values out of the expected range. To evaluate how frequently the BMI derivations are recorded, we track the number of new measurements recorded over time and the average time between updates in patients with multiple measurements. Results Primary constraints in creating the optimal BMI derivation is coverage, accuracy, and computational complexity. BMI derivations calculated from height and weight contain a few extreme outliers that affect aggregated statistics. SNOMED-recorded BMI records are more accurate on average and offer better coverage across the population. The canonical OpenSAFELY definition – which uses calculated BMI as a first instance and SNOMED-recorded BMI if missing – offers the best coverage, but contains the same extreme outliers found in calculated BMI and is the most computationally expensive of all methods. Conclusions Across all derivations, some cleaning should be performed to drop implausible outliers. Using calculated BMI on its own does not offer the best coverage or accuracy. In choosing between SNOMED-recorded BMI and the current OpenSAFELY implementation, users should decide whether they would like to maximise computational efficiency or coverage.

Compromised dynamic cerebral autoregulation is a hemodynamic marker for predicting poor prognosis even with good recanalization after endovascular thrombectomy.

In patients undergoing endovascular thrombectomy (EVT) with acute ischemic stroke (AIS), dynamic cerebral autoregulation (dCA) may minimize neurological injury from blood pressure fluctuations. This study set out to investigate the function of dCA in predicting clinical outcomes following EVT. 43 AIS of the middle cerebral or internal carotid artery patients underwent with EVT, and 43 healthy individuals (controls) were enrolled in this case control research. The dCA was evaluated using transcranial Doppler 12 h and five days after EVT. The transfer function analysis was used to derive the dCA parameters, such as phase, gain, and coherence. The modified Rankin scale (mRS) at 3 months after EVT was used to assess the clinical outcomes. Thefavorable outcome group was defined with mRS ≤2 and the unfavorable outcome group was defined with mRS score of 3-6. Logistic regression analysis was performed to determine the risk factors of clinical outcomes. A significant impairment in dCA was observed on the ipsilateral side after EVT, particularly in patients with unfavorable outcomes. After 5 days, the ipsilateral phase was associated with poor functional outcomes (adjusted odds ratio [OR] = 0.911, 95% confidence interval [CI]: 0.854-0.972; P = 0.005) and the area under the curve (AUC) (AUC, 0.878, [95% CI: 0.756-1.000] P < 0.001) (optimal cutoff, 35.0°). Phase change was an independent predictor of clinical outcomes from 12 h to 5 days after EVT (adjusted OR = 1.061, 95% CI: 1.016-1.109, P = 0.008). dCA is impaired in patients with AIS after EVT. Change in dCA could be an independent factor related to the clinical outcomes.

Efficacy of high-dose-rate brachytherapy with different radiation source activities among cervical cancer patients and risk factors for long-term outcomes: A 6-year retrospective study

PURPOSEThis study aimed to assess the impact of dose rates due to natural decay of Iridium-192 sources and the risk factors of clinical outcomes for cervical cancer patients treated with high-dose-rate (HDR) brachytherapy. METHODS AND MATERIALSFour ninety-four patients were divided into relatively-high-radioactive (rHR), relatively-medium-radioactive (rMR), and relatively-low-radioactive (rLR) groups for retrospective treatment response comparison. The short-term outcomes were evaluated using the 1-month /3-month follow-up results based on RECIST 1.1. Local recurrence-free survival (LRFS) and metastatic recurrence-free survival (MRFS) were selected as long-term outcomes. A class of transformation models with adaptive lasso was applied to assess the risk factors of long-term outcomes. RESULTSNo significant difference was identified in short- or long-term outcomes of different radioactive groups. Subgroup analyses demonstrated similar findings. In multivariate factor analysis, advanced stage was significantly associated with higher risk of local recurrence and metastatic recurrence (HR = 1.66, 95%confidence interval [CI] = 1.14–2.43, p = 0.008; HR = 1.57, 95%CI = 1.23–2.00, p < 0.001). Significant associations were observed between local recurrence and pathology, and between metastatic recurrence and pre-treatment serum indices, respectively (HR = 8.62, 95%CI = 2.28–32.60, p = 0.002; HR = 1.98, 95%CI=1.20–2.26, p = 0.008). CONCLUSIONSOverall, there was no significant difference in long- or short-term efficacy of the HDR brachytherapy among the groups with different levels of activity of radiation sources. Stage, pathology, and pretreatment serum indices were crucial factors that affected the long-term outcomes.

Disseminated Intravascular Coagulation as a Risk Factor for Clinical Outcome After Liver Transplantation in Pediatric Patients With Kasai Portoenterostomy Failure

Disseminated intravascular coagulation (DIC) is a serious complication in critically ill pediatric patients. This study aimed to evaluate the association between pretransplant DIC and perioperative clinical outcomes of liver transplantation (LT) in pediatric patients with Kasai portoenterostomy (KPE) failure. We enrolled pediatric patients who received LT after KPE failure between January 2005 and April 2021. We retrospectively reviewed the electronic medical records of included patients and evaluated the presence of DIC using the International Society on Thrombosis and Hemostasis (ISTH) criteria and association with perioperative clinical outcome. The study included 106 patients. Their median age and body weight at the time of pediatric intensive care unit (PICU) admission were 28.7 months and 9.25 kg, respectively. Of these patients, 23 had undergone pretransplant DIC (22%). Patients with pretransplant DIC required significantly more blood transfusions during operation. They had significantly higher serum lactate levels, pediatric end-stage liver disease scores, pediatric risk for mortality III (PRISM III) scores, longer durations of mechanical ventilator support, and longer PICU stays (all P < .05). The presence of pretransplant DIC in pediatric patients requiring LT after KPE failure was associated with poor clinical outcomes, which required more intensive and meticulous supportive management in the perioperative period of LT. DIC would be a promising prognostic factor in these patients.

FRI-542 - Different risk factors of clinical outcomes between variceal bleeding and non-variceal gastrointestinal bleeding in acutely decompensated cirrhosis

FRI-542 - Different risk factors of clinical outcomes between variceal bleeding and non-variceal gastrointestinal bleeding in acutely decompensated cirrhosis

Endoscope-assisted microsurgical clipping and reduction of post-clipping cerebral infarction: historical comparison using diffusion-weighted images

Endoscopic assistance for aneurysm clipping and its possible benefits have been suggested in previous studies, but its clinical significance has not been fully elucidated. This study aimed to present the efficacy of endoscopy-assisted clipping in reducing post-clipping cerebral infarction (PCI) and clinical outcomes via a historical comparison of patients in our institution from January 2020 to March 2022. A total of 348 patients were included, 189 of whom underwent endoscope-assisted clipping. The overall incidence of PCI was 10.9% (n = 38); it was 15.7% (n = 25) before applying endoscopic assistance and decreased to 6.9% (n = 13) after endoscope application (p = 0.010). The application of a temporary clip (odds ratio [OR]: 2.673, 95% confidence interval [CI]: 1.291-5.536), history of hypertension (OR: 2.176, 95% CI: 0.897-5.279), history of diabetes mellitus (OR: 2.530, 95% CI: 1.079-5.932), and current smoker (OR: 3.553, 95% CI: 1.288-9.802) were independent risk factors of PCI, whereas endoscopic assistance was an independent inverse risk factor (OR: 0.387, 95% CI: 0.182-0.823). Compared to the location of the unruptured intracranial aneurysms, internal carotid artery aneurysms showed a significant decrease in the incidence of PCI (5.8% vs. 22.9%, p = 0.019). In terms of clinical outcomes, PCI was a significant risk factor for longer admission duration, intensive care unit stay, and poor clinical outcomes. However, endoscopic assistance itself was not a significant risk factor for clinical outcomes on the 45-day modified Rankin Scale. In this study, we noted the clinical significance of endoscope-assisted clipping in preventing PCI. These findings could reduce the incidence of PCI and improve the understanding of its mechanisms of action. However, a larger and longer-term study is required to evaluate the benefits of endoscopy on clinical outcomes.

Impact of Arterial Calcification of the Lower Limbs on Long-Term Clinical Outcomes in Patients on Hemodialysis

Lower limbs' arterial calcification is significantly associated with the clinical severity of lower extremity artery disease (LEAD) in patients undergoing hemodialysis (HD). However, the association between arterial calcification of the lower limbs and long-term clinical outcomes in patients on HD has not been elucidated. Calcification scores of the superficial femoral artery (SFACS) and below-knee arteries (BKACS) were quantitatively evaluated in 97 HD patients who were followed for 10 years. Clinical outcomes, including all-cause and cardiovascular mortality, cardiovascular events, and limb amputation were evaluated. Risk factors for clinical outcomes were evaluated using univariate and multivariate Cox proportional hazard analyses. Furthermore, SFACS and BKACS were divided into three groups (low, middle, and high), and their associations with clinical outcomes were evaluated using Kaplan-Meier analysis. SFACS, BKACS, C-reactive protein, serum albumin, age, diabetes, presence of ischemic heart disease, and critical limb-threatening ischemia were significantly associated with 3-year and 10-year clinical outcomes in the univariate analysis. Multivariate analysis showed that SFACS was an independent factor associated with 10-year cardiovascular events and limb amputations. Kaplan-Meier life table analysis showed that higher SFACS and BKACS levels were significantly associated with cardiovascular events and mortality. In conclusion, long-term clinical outcomes and the risk factors in patients undergoing HD were evaluated. Arterial calcification of the lower limbs was strongly associated with 10-year cardiovascular events and mortality in patients undergoing HD.

Meniscal and Articular Cartilage Predictors of Outcome After Revision ACL Reconstruction: A 6-Year Follow-up Cohort Study

Background: Meniscal and chondral damage is common in the patient undergoing revision anterior cruciate ligament (ACL) reconstruction. Purpose: To determine if meniscal and/or articular cartilage pathology at the time of revision ACL surgery significantly influences a patient’s outcome at 6-year follow-up. Study Design: Cohort study; Level of evidence, 3. Methods: Patients undergoing revision ACL reconstruction were prospectively enrolled between 2006 and 2011. Data collection included baseline demographics, surgical technique, pathology, treatment, and scores from 4 validated patient-reported outcome instruments: International Knee Documentation Committee (IKDC), Knee injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Marx Activity Rating Scale. Patients were followed up at 6 years and asked to complete the identical set of outcome instruments. Regression analysis assessed the meniscal and articular cartilage pathology risk factors for clinical outcomes 6 years after revision ACL reconstruction. Results: An overall 1234 patients were enrolled (716 males, 58%; median age, 26 years). Surgeons reported the pathology at the time of revision surgery in the medial meniscus (45%), lateral meniscus (36%), medial femoral condyle (43%), lateral femoral condyle (29%), medial tibial plateau (11%), lateral tibial plateau (17%), patella (30%), and trochlea (21%). Six-year follow-up was obtained on 79% of the sample (980/1234). Meniscal pathology and articular cartilage pathology (medial femoral condyle, lateral femoral condyle, lateral tibial plateau, trochlea, and patella) were significant drivers of poorer patient-reported outcomes at 6 years (IKDC, KOOS, WOMAC, and Marx). The most consistent factors driving outcomes were having a medial meniscal excision (either before or at the time of revision surgery) and patellofemoral articular cartilage pathology. Six-year Marx activity levels were negatively affected by having either a repair/excision of the medial meniscus (odds ratio range, 1.45-1.72; P≤ .04) or grade 3-4 patellar chondrosis (odds ratio, 1.72; P = .04). Meniscal pathology occurring before the index revision surgery negatively affected scores on all KOOS subscales except for sports/recreation (P < .05). Articular cartilage pathology significantly impaired all KOOS subscale scores (P < .05). Lower baseline outcome scores, higher body mass index, being a smoker, and incurring subsequent surgery all significantly increased the odds of reporting poorer clinical outcomes at 6 years. Conclusion: Meniscal and chondral pathology at the time of revision ACL reconstruction has continued significant detrimental effects on patient-reported outcomes at 6 years after revision surgery.

Anti-cancer treatment within two weeks serves as a risk factor for clinical outcomes among cancer patients with COVID-19.

The coronavirus disease 2019 (COVID-19) pandemic has resulted in infections among patients with cancer. Our study aimed to investigate the potential adverse impact of anti-cancer treatments within 2 weeks of COVID-19 infection on clinical outcomes in patients with cancer. This retrospective cohort study analyzed 70 cancer patients with COVID-19 infection from the First Hospital of Jilin University in Changchun City, Jilin Province, between March and June 2022. Data on demographic characteristics, vaccination status, COVID-19 clinical classification, symptoms, complications, tumor-related characteristics, laboratory examinations and medical interventions were extracted from electronic medical record. The primary outcome of our study was Intensive Care Unit (ICU) admission. Logistic regression model was performed to investigate the association between anti-cancer treatments within 2 weeks after COVID-19 infection and the risk of ICU admission. Of the 70 patients enrolled in this study, 37 received anti-cancer treatments within 2 weeks after COVID-19 infection. Patients receiving anti-cancer treatment were more likely to experience non-mild COVID-19, require oxygen therapy, develop acute respiratory distress syndrome (ARDS) and exhibit elevated inflammatory levels. The risk of ICU admission (P<0.001) and 30-day mortality after reverse transcriptase polymerase chain reaction (RT-PCR) negative conversion (P=0.007) was significantly higher in patients receiving anti-cancer treatments. In multivariate Logistic regression analysis, non-mild classification of COVID-19, anti-cancer treatments within 2 weeks and ECOG > 1were all independently associated with ICU admission after adjusting for confounder factors. The risk of ICU admission rose to 43.63 times (95% confidence interval=1.31-1452.94, P=0.035) in patients receiving anti-cancer treatments within 2 weeks. Anti-cancer treatments within 2 weeks of COVID-19 infection increase the risk of ICU admission and 30-day mortality after RT-PCR negative conversion in patients with cancer. It may be recommended to postpone cancer-related treatments for more than 2 weeks in cancer patients with COVID-19 infection.

Comorbidities as risk factors for clinical outcomes in pediatric patients with COVID-19: a comprehensive literature review

Comorbidities as risk factors for clinical outcomes in pediatric patients with COVID-19: a comprehensive literature review

Safety and effectiveness of double microcatheter technique in the treatment of ruptured aneurysms of anterior cerebral circulation.

To evaluate the safety and effectiveness of the double microcatheter technique in the treatment of ruptured aneurysms of the anterior cerebral circulation. Between 2012 and 2019, 113 patients with ruptured aneurysms of the anterior cerebral circulation were treated using the double microcatheter technique. Clinical records, angiographic results, and procedure-related complications were reviewed. Clinical and angiographic follow-up was performed. Complete occlusion, neck remnant, and partial occlusion were, respectively, recorded in 56.6, 38.9, and 4.4% of the total cases. For all patients, the incidence of intraoperative complications was 5.3% (6/113), and the overall rate of morbidity was 10.6% (12/113). Before discharge, three patients (2.7%) died. There was no procedure-related mortality. At discharge, favorable outcomes were observed in 79.6% (90/113) of the patients. High Hunt-Hess grades and receiving a craniotomy or external ventricular drainage were risk factors for clinical outcomes at discharge. Clinical follow-up was performed in 91 patients at a mean interval of 14.07 ± 11.68 months. At follow-up, favorable outcomes were observed in 92.3% (84/91) of the patients. Angiographic follow-up was performed in 66 patients at an average of 11.53 ± 11.13 months. The recurrence rate was 37.9%. Of these patients, 13 (19.7%) received retreatment. The double microcatheter technique can be performed in ruptured aneurysms with high technical success and low morbidity/mortality. However, recurrence remains a problem, and patients should be followed up regularly.

Mental health risk factors during the first wave of the COVID-19 pandemic.

During the first wave of the COVID-19 pandemic, distancing measures were enforced to reduce virus spread, which likely had an impact on the overall mental health of the population. To investigate the prevalence of mental health outcomes (depression, anxiety and insomnia), and associated risk factors, during a physical distancing period imposed in the first wave of COVID-19. During the first month of Portugal's state of emergency, an online survey was created and disseminated through social media channels. Sociodemographic and clinical variables were assessed via self-reported questionnaires. Univariate linear regressions were used to identify associations between the collected variables and mental health outcomes. Multivariate regression analyses were performed to identify independent risk factors for clinical outcomes, with adjustment for potential confounders. We analysed data from 1626 participants: a significant proportion showed depression (30.2%), anxiety (53.1%) and insomnia (36.3%) symptoms. Multivariate regression models showed that being male and working from home were protective for all mental health outcomes analysed, whereas the perception of infection, being under psychiatric care and taking medication were risk factors (P < 0.05). Days in isolation and being unemployed were risk factors for depression and insomnia (P < 0.05). Younger age and being a student were risk factors for depression, whereas being a healthcare professional was protective (P < 0.05). Indirect contact with COVID-19 was a risk factor for anxiety (P < 0.05). COVID-19-related distancing measures were associated with high levels of adverse mental health symptoms. Several risk factors were associated with these symptoms, which highlight the importance of identifying vulnerable groups during physical distancing periods.

Treatment profiles and risk factors for clinical outcomes of confirmed COVID-19 and pneumonia patients at fatmawati general hospital Jakarta

Objectives: This study aimed to investigate the treatment profiles and the risk factor for clinical outcomes of confirmed coronavirus disease-19 (COVID-19) and pneumonia patients at Fatmawati General Hospital Jakarta. Methods: This research was conducted using a cross-sectional design at Fatmawati General Hospital Jakarta. A total of 72 adults COVID-19 confirmed patients with pneumonia diagnosis from March to December 2020 were included in our study. Data were collected retrospectively by the patients' medical record. Results: The percentage of critical or severe confirmed COVID-19 with pneumonia inpatients (66.7%) was higher than those who were having non-severe diseases (33.3%). 36 (50%) death were reported in our patient population. Patients received antiviral, antibiotics, and steroids during a treatment period. The most common antibiotic regimens were levofloxacin intravenous (IV) (18.8%) and azithromycin per oral (PO) (13.9%). Oseltamivir (83.3%) was the most frequently prescribed antiviral for the patients. A total of 41.7% of patients used steroids. In multivariable logistic regression analyses, the severity of COVID-19 disease was the only predictive factor of death in COVID-19 and pneumonia patients (p<0.001, OR=26.714, 95% confidence intervals: 5.526-129.135). Conclusion: Some drugs (antiviral, antibiotics, and steroids) have been prescribed to the confirmed COVID-19 with pneumonia patients. Oseltamivir and levofloxacin were the widely used antiviral and antibiotic agents in this study. The analysis showed that the disease severity was statistically associated with patient's clinical outcomes. COVID-19 patients with the severe illness have a greater risk of death.

TREATMENT PROFILES AND RISK FACTORS FOR CLINICAL OUTCOMES OF CONFIRMED COVID-19 AND PNEUMONIA PATIENTS AT FATMAWATI GENERAL HOSPITAL JAKARTA

Objectives: This study aimed to investigate the treatment profiles and the risk factor for clinical outcomes of confirmed coronavirus disease-19 (COVID-19) and pneumonia patients at Fatmawati General Hospital Jakarta. Methods: This research was conducted using a cross-sectional design at Fatmawati General Hospital Jakarta. A total of 72 adults COVID-19 confirmed patients with pneumonia diagnosis from March to December 2020 were included in our study. Data were collected retrospectively by the patients’ medical record. Results: The percentage of critical or severe confirmed COVID-19 with pneumonia inpatients (66.7%) was higher than those who were having non-severe diseases (33.3%). 36 (50%) death were reported in our patient population. Patients received antiviral, antibiotics, and steroids during a treatment period. The most common antibiotic regimens were levofloxacin intravenous (IV) (18.8%) and azithromycin per oral (PO) (13.9%). Oseltamivir (83.3%) was the most frequently prescribed antiviral for the patients. A total of 41.7% of patients used steroids. In multivariable logistic regression analyses, the severity of COVID-19 disease was the only predictive factor of death in COVID-19 and pneumonia patients (p&lt;0.001, OR=26.714, 95% confidence intervals: 5.526–129.135). Conclusion: Some drugs (antiviral, antibiotics, and steroids) have been prescribed to the confirmed COVID-19 with pneumonia patients. Oseltamivir and levofloxacin were the widely used antiviral and antibiotic agents in this study. The analysis showed that the disease severity was statistically associated with patient’s clinical outcomes. COVID-19 patients with the severe illness have a greater risk of death.

Early Fever Is Associated With Clinical Outcomes in Patients With Coronavirus Disease.

Fever is one of the typical symptoms of coronavirus disease (COVID-19). We aimed to investigate the association between early fever (EF) and clinical outcomes in COVID-19 patients. A total of 1,014 COVID-19 patients at the Leishenshan Hospital were enrolled and classified into the EF and non-EF groups based on whether they had fever within 5 days of symptom onset. Risk factors for clinical outcomes in patients with different levels of disease severity were analyzed using multivariable analyses. Time from symptom onset to symptom alleviation, CT image improvement, and discharge were longer for patients with moderate and severe disease in the EF group than in the non-EF group. Multivariable analysis showed that sex, EF, eosinophil number, C-reactive protein, and IL-6 levels were positively correlated with the time from symptom onset to hospital discharge in moderate cases. The EF patients showed no significant differences in the development of acute respiratory distress syndrome, compared with the non-EF patients. The Kaplan–Meier curve showed no obvious differences in survival between the EF and non-EF patients. However, EF patients with increased temperature showed markedly lower survival than the non-EF patients with increased temperature. EF had no significant impact on the survival of critically ill patients, while an increase in temperature was identified as an independent risk factor. EF appears to be a predictor of longer recovery time in moderate/severe COVID-19 infections. However, its value in predicting mortality needs to be considered for critically ill patients with EF showing increasing temperature.

Extended dual antiplatelet therapy with ticagrelor 60 mg in patients with prior myocardial infarction: The design of ALETHEIA, a multi-country observational study.

IntroductionClinical guidelines recommend extended treatment with dual antiplatelet therapy (DAPT) with ticagrelor 60 mg (twice daily) beyond 12 months in high‐risk patients with a history of myocardial infarction (MI) who have previously tolerated DAPT and are not at heightened bleeding risk. However, evidence on patterns of use and associated clinical outcomes in routine clinical practice is limited.MethodsALETHEIA is an observational, multi‐country study, designed to describe characteristics, treatment persistence, and bleeding and cardiovascular (CV) outcomes in post‐MI patients who initiate ticagrelor 60 mg in routine clinical practice (NCT04568083). The study will include electronic health data in the United States (US; Medicare, commercial claims) and Europe (Sweden, Italy, United Kingdom, Germany). Characteristics will be described among patients with and without ticagrelor 60 mg ≥1 year post‐MI. Assuming an a priori threshold of 5000 person‐years on‐treatment is met, to ensure sufficient precision, clinical outcomes (bleeding and CV events) among patients treated with ticagrelor 60 mg will be assessed. Risk factors for clinical outcomes and treatment discontinuation will be assessed in patients with ticagrelor 60 mg and meta‐analysis used to combine estimates across databases. Cohort selection will initiate from the ticagrelor 60 mg US and European approval dates and end February 2020. An estimated total of 7250 patients prescribed ticagrelor 60 mg are expected to be included.DiscussionAn increased understanding of patterns of ticagrelor 60 mg use and associated clinical outcomes among high‐risk patients with a prior MI is needed. The a priori specified stepwise approach adapted in this observational study is expected to generate useful evidence for clinical decision‐making and treatment optimization.

Surgical Predictors of Clinical Outcome Six Years following Revision ACL Reconstruction

Objectives:Revision ACL reconstruction has been documented to have inferior outcomes compared with primary ACL reconstructions. The reasons why remain unknown. The purpose of this study was to determine if surgical factors performed at the time of revision ACL reconstruction have the ability to influence a patient’s outcome at 6-year follow-up.Methods:Revision ACL reconstruction patients were identified and prospectively enrolled between 2006 and 2011. Data collected included baseline demographics, surgical technique and pathology, and a series of validated patient-reported outcome instruments (IKDC, KOOS, WOMAC, and Marx activity rating score). Patients were followed up for 6 years and asked to complete the identical set of outcome instruments. Regression analysis was used to control for age, gender, BMI, activity level, baseline outcome scores, revision number, time since last ACL reconstruction, and a variety of surgical variables, in order to assess the surgical risk factors for clinical outcomes 6 years after revision ACL reconstruction.Results:1234 patients met the inclusion criteria and were successfully enrolled. 716 (58%) were males, with a median cohort age of 26 years. The median time since their last ACL reconstruction was 3.3 years. At 6 years, follow-up was obtained on 77% (949/1234). Several surgical factors at the time of revision surgery were found to be significant drivers of poorer outcomes at 6 years. The most consistent surgical variables driving outcome in revision patients were related to femoral and tibial fixation. Using an interference screw for femoral fixation compared with a cross-pin resulted in significantly better outcomes in 6-year IKDC scores (OR=2.2; 95% CI=1.2, 3.8; p=0.008), KOOS sports/rec and KOOS QOL subscales (OR range = 2.2-2.7; 95% CI=1.2, 3.8; p<0.001). Using an interference screw compared with a cross-pin also resulted in 2.6 times less likely to have a subsequent surgery within the 6 years. Using an interference screw for tibial fixation compared to any combination of tibial fixation techniques also resulted in significantly improved IKDC (OR=2.0; 95% CI=1.3, 2.9; p=0.001), KOOS pain, ADL, sports/rec (OR range=1.5-1.6; 95% CI=1.0, 2.4; p<0.05) and WOMAC pain and stiffness subscales (OR range=1.5-1.8; 95% CI=1.0, 2.9; p<0.05). Using a transtibial surgical approach compared to an anteromedial portal approach resulted in significantly improved KOOS pain and QOL subscales at 6 years (OR=1.5; 95% CI=1.02, 2.2; p<0.04). Avoiding a notchplasty significantly improved 2 year outcomes of the IKDC (OR=1.5; 95% CI=1.1, 2.0; p=0.013), KOOS ADL and QOL subscales (OR range= 1.4; 95% CI=1.0, 1.9; p<0.04), and the WOMAC stiffness and ADL subscales (OR range = 1.4-1.5; 95% CI=1.0, 2.1; p<0.04). Regarding tunnel position at the time of the revision surgery, surgeons who noted that the tibial tunnel aperture position was in the ‘optimum position’ fared significantly worse in 6-year IKDC scores (OR=0.6; 95% CI=0.4, 0.8; p=0.003), Marx activity levels (OR=0.20; 95% CI=0.07, 0.6; p=0.005), KOOS symptoms, pain, sports/rec, and QOL subscales (OR range=0.56-0.68; 95% CI=0.38, 0.47; p<0.05), compared with surgeons who opted for either a blended new tunnel or noted that the previous tunnel had the same tunnel aperture, but ‘compromised position’. Lower baseline outcome scores, lower baseline activity level, being a smoker at the time of the revision, higher BMI, female gender, shorter time since the patient’s last ACL reconstruction, and having a previous ACL reconstruction on the contralateral side all significantly increased the odds of reporting poorer clinical outcomes at 6 years. Knee flexion angle at the time of graft fixation and biologic enhancement (i.e. PRP) did not influence 6-year outcomes in this revision cohort.Conclusions:There are surgical variables that the physician can control at the time of an ACL revision which have the ability to modify clinical outcomes. Based on outcomes at 6 years, opting for a transtibial surgical approach, choosing an inference screw for femoral and tibial fixation, and not performing a notchplasty will improve the patient’s odds of having a significantly better 6-year clinical outcome.

Supraventricular tachycardias in neonates and infants: factors associated with fatal or near-fatal outcome.

Prognosis of supraventricular tachycardias in neonates and infants is thought to be excellent with rare fatal outcomes. Nevertheless, initial management can be challenging. The aim of this study was to perform a retrospective analysis in neonates/infants with non-pos-toperative supraventricular tachycardias regarding risk factors for clinical outcome and type of antiarrhythmic drug therapy. The data of 157 patients aged < 1 year who presented between 2000 and 2015 with symptomatic tachycardias were retrospectively reviewed. Pharmacological therapy was successful in 151 patients (96%); 1 patient (1%) required catheter ablation and 5 patients (3%) died (1 death linked to hemodynamical reasons after effective arrhythmia control). Serious complications following acute medical therapy occurred in 4 patients of survivors. Patients with complications or death had a lower bodyweight, more frequent intrauterine tachycardia, transplacental therapy, urgent caesarian section, higher PRISM II score, longer period to control tachycardia, more frequent proarrhythmia, and major adverse event-defined as life-threatening event without a documented new arrhythmia-compared to the group without complications. There was no significant difference between the groups regarding prematurity, structural heart disease, and type of tachycardia. Proarrhythmia occurred in 6 cases and was related to intravenous drug use with class IC antiarrhythmics in 3/6 cases, digoxin in 2/6 cases, and amiodarone in 1/6 cases. ECG signs of impending proarrhythmia without new-onset arrhythmia requiring cessation of therapy were detected in 6 patients.Conclusion: Although rare, non-post-operative supraventricular tachycardia in neonates and infants might be a serious disease. Acute intravenous pharmacological treatment to control tachycardia might pose a risk for fatal or near-fatal outcome. Detection of proarrhythmia related to class IC antiarrhythmics in neonates might be especially difficult and requires alertness. What is Known • Prognosis of supraventricular tachycardias in children are thought to be excellent with fatal outcomes being rare. • Mortality is increased in the very young and in those with structural heart disease. What is New • Complicated outcome of non-post-operative supraventricular tachycardias in neonates is associated with lower bodyweight, age, prenatal tachycardia, higher PRISM II score, longer period to control tachycardia, and proarrhythmia. • Detection of class IC proarrhythmic effect is especially difficult in neonates because of their narrow QRS and warrants alertness.

MO862COVID-19 INFECTION IN HEMODIALYSIS PATIENTS:FINDINGS-EXPERIENCE-OUTCOME

Background and AimsOur Nephrology Department during spring period on the first wave of COVID-19 was the referral Dialysis Unit for Covid-19 positive HD patients in the district area of Athens, Greece. The aims of this study are to report characteristics, rates and outcomes of all patients affected by infection with SARS-CoV-2 undergoing HD and treated under our careMethodThis is an observational study. Our Dialysis Unit has been assigned as a referral unit for Covid-19 positive HD patients. We registered all the data regarding the clinical course of our patients population. Age, primary cause of end stage renal disease, weight, clinical presentation, HD history, outcome, days of hospitalization.Results22 Covid-19 positive HD patients were treated under the care of our facility during the period 8 April 2020-17 June 2020. 16 patients were symptomatic at admission and 13 patients admitted with or developed during their stay pleural effusions. 12 patients (8 male) of our group died during their hospitalization. 3 out of 12 were admitted to Intensive Care Unit (ICU). 6 patients were septic, 4 had respiratory failure and 2 developed cardiovascular events. 14.5 days were the mean hospitalization days (range: 1-38 days) for the diceased ones.2 out of 3 patients that admitted to ICU had quick deterioration, incubated and stayed in ICU for 48 hours. The third one with severe cormobidities (multiple myeloma, cancer of bladder) developed respiratory failure after 8 days of hospitalization, incubated, became septic and died after 20 days in ICU.Mean age of our patients was 74.5 years. It has to be pointed out that 13 patients were over 75 years old. Mean age was higher in those who died compared with those who were discharged with double negative Covid-19 tests (79 vs 74,5 years old respectively). Median dialysis vintage for our patients was 63 months and for the diceased ones was 89 months. Average weight of our patients was 69 kgrs. Weight of diceased patients was 63 kgrs. 11 out of 22 patients and 5 out of 12 diceased patients were diabetic. 14 patients were hypertensive and 16 had official cardiovascular backround. 10 out of total 22 patients under our care discharged after 43 days of hospitalization (range:35-56 days).ConclusionAs a conclusion our data provide clues regarding out experience of caring HD patients with COVID-19. Mortality was high. It seems that despite the fact that immune response of this population has not been clearly clarified, age, cormobidities and above all end-stage renal disease by its self is a significant and unpredictable risk factor for clinical outcome of HD patients with COVID-19 infection.