Incidence Of Adverse Clinical Events Research Articles

New Score Models for Predicting Bleeding and Ischemic of Ticagrelor Therapy in Patients with Diabetes Mellitus.

Ticagrelor is an antiplatelet drug, and its use increases the risk of bleeding. Coronary artery disease is significantly influenced by the widespread occurrence of diabetes mellitus. In order to decrease the incidence of clinical adverse events, a novel bleeding and thrombosis score is developed in this research. We conducted a retrospective analysis of patient data from two medical centers who were diagnosed with diabetes mellitus and treated with ticagrelor. We gathered information on every patient from the electronic database of the hospital and follow-up. The collected data were statistically analyzed to obtain risk factors for bleeding and ischemic events. A total of 851 patients with diabetes mellitus who have been administered ticagrelor are included in our investigation. A total of 76 patients have bleeding events and 80 patients have ischemic events. The analysis of multiple variables indicates that characteristics like the age of >65, having a previous occurrence of bleeding, experiencing anemia, using aspirin, and taking atorvastatin are linked to a higher likelihood of bleeding. Additionally, the age of >65, smoking, having a history of blood clots, and having a BMI ≥ 30 are found to increase the risk of ischemia. The A4B score established in this study was better than the HAS-BLED score，and the same is true for the ABST score to the CHA2DS-VASc score. This new risk assessment model can potentially detect patients who are at high risk for bleeding and ischemic events. For high-risk patients, the dose of ticagrelor can be adjusted appropriately or the medication can be adjusted.(2023-09-11, ChiCTR2300075627).

Global incidence of adverse clinical events in non-alcoholic fatty liver disease: A systematic review and meta-analysis.

Nonalcoholic fatty liver disease (NAFLD) is associated with a multitude of adverse outcomes. We aimed to estimate the pooled incidence of NAFLD-related adverse events. We performed a systematic review and meta-analysis of cohort studies of adults with NAFLD to evaluate the pooled incidence of adverse events. 19,406 articles were screened, 409 full-text articles reviewed, and 79 eligible studies (1,377,466 persons) were included. Mean age was 51.47 years and body mass index 28.90 kg/m2. Baseline comorbidities included metabolic syndrome (41.73%), cardiovascular disease (CVD) (16.83%), cirrhosis (21.97%), and nonalcoholic steatohepatitis (NASH) (58.85%). Incidence rate per 1,000 person-years for mortality included: all-cause (14.6), CVD-related (4.53), non-liver cancer-related (4.53), and liver-related (3.10). Incidence for liver-related events included overall (24.3), fibrosis progression (49.0), cirrhosis (10.9), liver transplant (12.0), and hepatocellular carcinoma (HCC) (3.39). Incidence for non-liver events included metabolic syndrome (25.4), hypertension (25.8), dyslipidemia (26.4), diabetes (19.0), CVD (24.77), renal impairment (30.3), depression/anxiety (29.1), and non-liver cancer (10.5). Biopsy-proven NASH had higher incidence of HCC (P=0.043) compared to non-NASH. Higher rates of CVD and mortality were observed in North America and Europe, hypertension and non-liver cancer in North America, and HCC in Western Pacific/Southeast Asia (P<0.05). No significant differences were observed by sex. Time-period analyses showed decreasing rates of cardiovascular and non-liver cancer mortality and increasing rates of decompensated cirrhosis (P<0.05). People with NAFLD have high incidence of liver and non-liver adverse clinical events, varying by NASH, geographic region, and time-period, but not sex.

Neighborhood Disadvantage Increases Risk of Adverse Clinical Events in Children with Sickle Cell Disease

Background: Hydroxyurea is the most widely used pharmacologic agent to treat patients with sickle cell disease (SCD). Hydroxyurea treatment has well established effects of inducing expression of fetal hemoglobin (HbF) and a beneficial impact on clinical outcomes such as reduced number of vaso-occlusive (VOC) events, transfusions, and hospitalizations. In non-SCD populations, living in socio-economic disadvantage is a well-established factor for poor health outcomes. However, there is a paucity of data to describe how social stressors impact children with SCD. We hypothesized that socio-economic disadvantage impacts risk of adverse clinical outcomes in pediatric SCD patients even while on hydroxyurea therapy. Methods: We performed a retrospective chart review on 121 pediatric patients with severe SCD genotypes (homozygous HbS and sickle-beta 0 thalassemia) seen at Texas Children's Hospital (TCH) between 2010-2021. All patients were treated with hydroxyurea for a minimum of five years. Adherence to hydroxyurea was assessed through lab markers including absolute neutrophil count and reticulocyte counts. Patients not adherent were excluded from analysis. We examined the incidence of all clinical events for a total of 1026 patient years, including the number of office visits, ER visits, hospitalizations, transfusions, VOC, acute chest syndrome episodes (ACS), acute splenic sequestration (ASS), and febrile illness. We collected laboratory data including absolute neutrophil count, hemoglobin level, and HbF levels for each patient per year they were on hydroxyurea. We used the area deprivation index (ADI) to determine a score of neighborhood disadvantage amongst our cohort of patients. The ADI is a factor-based index which uses 17 US Census variables including poverty, education, and employment. We used individual residential addresses during our observation period to assign a geocode specific to each individual and obtain an ADI score. The ADI scores are ranked from 1-10, with higher ADI rankings reflecting a higher level of disadvantage. Results: All individuals with SCD had a robust response to hydroxyurea within their first year of initiating the drug (&amp;gt;20% HbF). We stratified our cohort based on their ADI scores into low ADI (1-3; n=42); medium ADI (4-6; n=42); and high ADI groups (7-10; n=37), where high ADI is the group with highest levels of disadvantage. All three groups had a similar average duration of hydroxyurea treatment. There were no significant differences in age, sex, or reason given for starting hydroxyurea between the ADI groups. When we examined hydroxyurea response, there was no significant difference in HbF levels at 1 year (23.8 vs. 24.06 %HbF in the low vs. high ADI groups) or after 5 years (19.6 vs. 18.6 % HbF in the low and high ADI groups). Individuals with high ADI did started hydroxyurea at a younger age (2.9 years vs. 4.9 years, p=0.02). We found that any individual living in an area with higher ADI had an increased incidence of adverse clinical events. We calculated the incidence of each clinical event per 100 patient years in our 3 ADI groups and used a conditional maximum likelihood estimate of rate ratio method to compare incidences (Table 1). We found that among individuals living in an area with a higher ADI (more deprived region), there was increased frequency of ER visits, hospitalizations, transfusions, VOC, and ASS. In particular, patients with the highest ADI had a 3 and 5 times higher rate of VOC and ASS, respectively (Table 1). Discussion: While we did not observe an association between ADI and HbF expression, our results show that higher neighborhood disadvantage is associated with poorer clinical outcomes among hydroxyurea-adherent pediatric patients with SCD who maintained a robust response to the drug (&amp;gt;20% HbF). All individuals in our study had a similar number of routine office visits at our clinic but any patient living in an area of high ADI had significantly more ER visits and hospitalizations for VOC and ASS events. While hydroxyurea is shown to reduce hospitalizations and VOC events in pediatric sickle cell patients, we show that neighborhood disadvantage can influence clinical outcomes even among patients who respond to hydroxyurea. More analysis remains in order to better characterize this association, and to understand additional strategies that can be used to reduce clinical events in pediatric patients of lower socioeconomic status.

Increased Left Ventricular End-Diastolic Volume Index Is Associated With Increased Adverse Events After MitraClip Implantation

This study investigated the association between the left ventricular end-diastolic volume index (LVEDVI) and the incidence of adverse clinical events in patients after MitraClip implantation. In this retrospective, observational study, 123 patients who underwent the MitraClip procedure were enrolled. Participants were divided into 2 groups according to the LVEDVI cut-off level, calculated using receiver operating characteristic curve analysis, to predict the primary end point and the occurrence of cardiovascular events was compared between the groups. The primary end point was all-cause mortality and hospitalization because of heart failure. The receiver operating characteristic curve analysis for the composite primary end point revealed an LVEDVI cut-off point of 118ml/m2. Based on this threshold, 61 patients (49.6%) were categorized into the LVEDVI <118 ml/m2 group, whereas 62 (50.4%) fell into the LVEDVI ≥118 ml/m2 group. Over a median follow-up period of 336days (interquartile range 80 to 667), the primary end points occurred in 15 and 26 patients in the LVEDVI <118 and LVEDVI ≥118 ml/m2 groups, corresponding to incidence rates of 24.6% and 41.9%, respectively. Patients in the LVEDVI ≥118ml/m2 group demonstrated a significantly higher risk of adverse clinical events than those in the LVEDVI <118ml/m2 group (hazard ratio 2.24, 95% confidence interval 1.17 to 4.28, p=0.01). This trend persisted even after adjusting for several confounders (p=0.02). In conclusion, increased LVEDVI values were associated with increased adverse clinical events after MitraClip implantation in patients with severe mitral valve regurgitation.

Effects of NBP injection on the inflammatory response, oxidative stress response and vascular endothelial function in patients with ACI: A systematic review and meta-analysis.

Acute cerebral infarction (ACI) is a common medical emergency. This study is the first systematic review of the use of Dl-3-n-butylphthalide (NBP) injection in the treatment of ACI. The purpose of this study was to systematically evaluate the effects of NBP injection on the inflammatory response, oxidative stress response and vascular endothelial function in patients with acute ACI. The objective is to provide reference for clinical application. From the establishment of the database until August 2022, we systematically searched EMbase, PubMed, Cochrane Library, Web of Science, CNKI, VIP, and Wanfang Database. RCTs and retrospective studies were included in this study, and the results that qualified for inclusion were screened by 2 researchers and cross-checked. After the relevant data were extracted, a meta-analysis was performed using RevMan5.3 software. A total of 3307 patients with ACI from 34 studies were analyzed. The meta-analysis showed that the C-reactive protein levels in the NBP combined group were effectively reduced compared with those in the control group (MD = -3.75, 95% confidence intervals [95% CI] [-4.95, -2.56], P < .00001). Based on comparison with the control group, it is evident that combination treatment with NBP is more effective than control group in reducing the oxidative stress response of ACI (MD[superoxide dismutase levels] = 22.16, 95% CI [14.20,30.11], P < .00001; MD[malondialdehyde levels] = -1.97, 95% CI [-2.62, -1.32], P < .00001). Comparison with the control group shows that combination treatment with NBP is more effective in improving vascular endothelial function in ACI patients (MD[vascular endothelial growth factor levels] = 71.44, 95% CI [41.22, 101.66], P < .00001; MD[endothelin-1 levels] = -11.47, 95% CI [-17.39, -5.55], P = .0001; MD[nitric oxide levels] = 9.54, 95% CI [8.39, 10.68], P < .00001) than control group. The NBP combined group also showed a greater reduction in cerebral infarct volume (CIV) and cerebral infarct size (CIS) of ACI (MD[CIV] = -1.52, 95% CI [-2.23, -0.81], P < .0001; MD[CIS] = -2.79, 95% CI [-3.65, -1.94], P < .00001). The NBP combined group did not show an increase in the incidence of adverse reactions compared with the control group (odds ratio = 1.06, 95% CI [0.73, 1.53], P = .77). In summary, the use of NBP in combination with control group for ACI can reduce the degree of nerve damage, reduce inflammation and oxidative stress, improve vascular endothelial function, and reduce CIS and CIV in ACI patients, without increasing the incidence of clinical adverse events.

Staged endovascular recanalization for symptomatic atherosclerotic non-acutely occluded internal carotid artery

Symptomatic "non-acutely" occluded internal carotid artery (NAOICA) results in stroke, cognitive impairment, and hemicerebral atrophy through cerebral hypoperfusion and artery-to-artery embolism. Atherosclerosis is the main cause of NAOICA. Conventional one-stage endovascular recanalization showed effectiveness but was plagued by many challenges. This retrospective analysis reports the technical feasibility and outcomes of the staged endovascular recanalization in patients with NAOICA. Eight consecutive patients with atherosclerotic NAOICA and ipsilateral ischemic stroke within 3 months between January 2019 and March 2022 were retrospectively reviewed. The patients (all males, with a mean age of 64.6 years) underwent staged endovascular recanalization 13 to 56 days after documented occlusion by imaging techniques (mean 28.8 days); the mean follow-up period was 20 months (range: 6-28). The approach of the staged intervention was as follows. In the first stage, the occluded ICA was successfully recanalized using the simple small balloon dilation technique. In the second stage, angioplasty with a stent implant was performed with >50% residual stenosis in the initial segment or ≥70% residual stenosis in the C2-C5 segment. The technical success rate, the incidence of clinical adverse events (any stroke, death, cerebral hyperperfusion), and long-term in-stent stenosis (ISR) and reocclusion rates were evaluated. Technical success was achieved in seven patients, with early reocclusion occurring in one patient after the first-stage intervention. There were no adverse events observed within 30 days (0%), and long-term reocclusion and long-term ISR rates were both 14% (1/7). However, all patients developed iatrogenic arterial dissections during the first stage, indicating the challenge of reaching the true lumen through the occlusion site without damaging the intima. Based on the National Heart, Lung and Blood Institute (NHLBI) classification, there were two type A, four type B, three type C, and two type D dissections. The mean time interval between the two stages was 46.1 days (21-152 days). All type A and B dissections resolved spontaneously after ≥3 weeks of dual antiplatelet therapy, whereas most type C and all type D dissections did not heal spontaneously before the second stage. Also, one type C dissection led to reocclusion. This observation suggested that occlusions without flow limit and persistent vessel staining or extravasation could be clinically observed, while severe dissections (characterized as type C or greater) required prompt stenting rather than conservative treatment. Performing high-resolution MRI preoperatively to exclude fresh thrombus in the occluded vessel segment is indispensable in selecting appropriate candidates for endovascular recanalization. This could avoid downstream embolism during the interventional procedure. This retrospective study found that staged endovascular recanalization for symptomatic atherosclerotic NAOICA may be feasible with an acceptable technical success rate and a low complication rate in the selected candidates.

Clinical study on the classification of renal artery involvement and comparison of renal function and prognosis of Stanford type B aortic dissection after thoracic aortic endovascular repair

Objective: To investigate the different types of renal artery involvement in Stanford type B aortic dissection (TBAD) and the comparison of clinical effecacy after thoracic endovascular aortic repair (TEVAR). Methods: This is a retrospective cohort study included 330 patients with TBAD and renal artery involvement treated with TEVAR from June 2002 to September 2021 in General Hospital of Northern Theater Command of the PLA. According to aortic CTA image, unilateral renal artery involvement conditions were divided into 5 types: the true lumen type (renal artery opening completely from the true lumen), false lumen type (renal artery opening completely from the false lumen), double lumen type (renal artery opening from the true and false double lumen), compression type (renal artery opening connected with the true lumen, but the renal artery opening was extremely squeezed by the inner membrane), open type (renal artery opening with intimal tear). There were seven types of bilateral renal artery involvement: true-true type (true lumen-true lumen type), true and false type (true lumen-false lumen type), true-double type (true lumen-double lumen type), true-opening type (true lumen-opening type), false-false type (false lumen-false lumen type), false-compression type (false lumen-compression type), double-double type (double lumen-double lumen type). The primary observation index of this study was the comparison of postoperative renal function and the incidence of clinical adverse events of different types of renal artery involvement. One-way ANOVA test, Kruskal-Wallis H test and paired sample rank sum test were used to compare postoperative renal function between different types of bilateral renal artery involvement. The Chi-square test or Fisher's exact probability test were used to compare the near and long term adverse events between different types of bilateral renal artery involvement. Kaplan-Meier method was used to compare the all-cause mortality of patients with severe renal functional injury and non-severe renal functional injury before surgery. Results: The average age of the patients included in this study was (53±11) years, including 276 males (83.6%) and 54 females (16.4%). There were statistical difference in the level of serum creatinine (preoperative:H=18.686, P=0.005, postoperative:H=18.101, P=0.006) and cystatin C (preoperative:H=17.566, P=0.007, postoperative:H=10.433, P=0.016), pre-and post-operative, between the seven groups of TBAD patients with different renal artery involvement types (P<0.05), and the false-false type group shown the worst kidney function. However, no statistically significant differences were shown when comparing their pre- and post-operative change values (P>0.05). The 30-day follow-up result showed that there were statistically significant differences in the incidence of postoperative acute kidney injury (χ2=15.623, P=0.007), aorta-related adverse events (χ2=15.523, P=0.010), and intraoperative endoleak (χ2=17.935, P=0.004) among the seven groups, and the false-false group was the highest (2/9, 5/9 and 5/9, respectively). In terms of long-term follow-up results, there were statistically significant differences in all-cause death (χ2=14.772, P=0.011) and non-aortic death (χ2=15.589,P=0.008) among the seven groups. Kaplan-Meier survival analysis showed that patients with worse pre-operative renal function showed higher long-term all cause death (17.7% vs. 4.8%, P=0.009). Conclusions: For TBAD patients with renal artery involvement, there were differences in renal function among different types, and TEVAR showed no significant effect on renal function in TBAD patients. The long-term all cause death was higher in patients with worse renal function pre-operative.

Early-Stage Vasoactive-Inotropic Score and Left Ventricular Ejection Fraction Following Cardiac Surgery: A Comparison of Two Non-invasive Heart Function Monitoring Technologies in the Prognosis of Infants

Objectives: This study aimed to compare the efficiencies of the vasoactive-inotropic score (VIS) and left ventricular ejection fraction (LVEF) in predicting the condition and prognosis of children with congenital heart disease (CHD). Methods: We retrospectively reviewed the medical charts of 104 infants aged &lt; 1 year who underwent cardiac surgery with cardiopulmonary bypass. The maximum and mean postoperative VIS in the first and second 24 hours [VIS (24MAX), VIS (24MEA), VIS (48MAX), and VIS (48MEA)] were recorded. Similarly, LVEF within 24 hours following surgery was monitored. Receiver operator curve (ROC), regression analysis, chi-square test, and t-test were used to analyze both heart function monitoring technologies Results: Receiver operating characteristic analysis revealed that VIS was strongly associated with adverse events and death [area under ROC (AUROC) &gt; 0.90, P = 0.00], with the two most representative scores being VIS (24MEA) and VIS (48MAX), with cut-off points of 19.42 (sensitivity = 100%; specificity = 93.90%) and 22 (sensitivity = 100%; specificity = 93.90%), respectively for death, and 18.02 (sensitivity = 91.70%; specificity = 89.10%) and 17.75 (sensitivity = 91.70%; specificity = 90.20%), respectively for adverse events. Infants with higher VIS had significantly higher mortality, higher incidence of clinical adverse events, higher lactic acid value, and longer mechanical ventilation and ICU stay (P &lt; 0.05). However, LVEF within 24 hours following surgery was not associated with death (AUROC = 0.65, P = 0.33) or adverse events (AUROC = 0.53, P = 0.81). Moreover, there was no significant change in the length of ICU stay, duration of mechanical ventilation, and lactate value (P &gt; 0.05). Conclusions: Vasoactive-inotropic score at an early stage following surgery was significantly associated with the condition and prognosis of infants with congenital heart disease; however, the predictive value of LVEF within 24 hours following surgery was lower.

Evaluation of ROTARIX® Booster Dose Vaccination at 9 Months for Safety and Enhanced Anti-Rotavirus Immunity in Zambian Children: A Randomised Controlled Trial.

Oral rotavirus vaccines show diminished immunogenicity in low-resource settings where rotavirus burden is highest. This study assessed the safety and immune boosting effect of a third dose of oral ROTARIX® (GlaxoSmithKline) vaccine administered at 9 months of age. A total of 214 infants aged 6 to 12 weeks were randomised to receive two doses of ROTARIX® as per standard schedule with other routine vaccinations or an additional third dose of ROTARIX® administered at 9 months old concomitantly with measles/rubella vaccination. Plasma collected pre-vaccination, 1 month after first- and second-dose vaccination, at 9 months old before receipt of third ROTARIX® dose and/or measles/rubella vaccination, and at 12 months old were assayed for rotavirus-specific IgA (RV-IgA). Geometric mean RV-IgA at 12 months of age and the incidence of clinical adverse events 1 month following administration of the third dose of ROTARIX® among infants in the intervention arm were compared between infants in the two arms. We found no significant difference in RV-IgA titres at 12 months between the two arms. Our findings showed that rotavirus vaccines are immunogenic in Zambian infants but with modest vaccine seroconversion rates in low-income settings. Importantly, however, a third dose of oral ROTARIX® vaccine was shown to be safe when administered concomitantly with measles/rubella vaccine at 9 months of age in Zambia. This speaks to opportunities for enhancing rotavirus vaccine immunity within feasible schedules in the national immunization program.

Adverse events after repair of tetralogy of Fallot: prediction models by machine learning of a retrospective cohort study in western China.

The incidence of clinical adverse events after tetralogy of Fallot (TOF) repair remains high. This study was performed to explore risk factors for adverse events and develop a prediction model through machine learning (ML) to forecast the incidence of clinical adverse events after TOF repair. A total of 281 participants who were treated with cardiopulmonary bypass (CPB) at our hospital from January 2002 to January 2022 were included in the study. Risk factors for adverse events were explored by composite and comprehensive analyses. Five artificial intelligence (AI) models were used for ML to build prediction models and screen out the model with the best performance in predicting adverse events. CPB time, differential pressure of the right ventricular outflow tract (RVOTDP or DP), and transannular patch repair were identified as the main risk factors for adverse events. The reference point for CPB time was 116.5 minutes and that for right ventricular (RV) outflow tract differential pressure was 70 mmHg. SPO2 was a protective factor, with a reference point of 88%. By integrating the results for the training and validation cohorts, we confirmed that, among all models, the logistic regression (LR) model and Gaussian Naive Bayes (GNB) model were stable, showing good discrimination, calibration and clinical practicability. The dynamic nomogram can be used as a predictive tool for clinical application. Differential pressure of the RV outflow tract, CPB time, and transannular patch repair are risk factors, and SPO2 is a protective factor for adverse events after complete TOF repair. In this study, models developed by ML were established to predict the incidence of adverse events.

Mid-term results of open transaortic implantation of the «MedLab-CT» prosthesis: prospective clinical study

Aim. To evaluate the mid-term clinical and hemodynamic results of open transaortic implantation of the balloon-expandable prosthesis MedLab-CT in patients with high surgical risk.&#x0D; Material and methods. The study included 41 patients (mean age 65.711.7 years) who underwent open implantation of the MedLab-CT (MedInzh, Russia) aortic valve (AV) prosthesis under cardiopulmonary bypass and cardioplegia, belonging to the cohort of high surgical risk according to the data EuroSCORE II scale, with critical symptomatic aortic stenosis, high functional class according to the classification of the New York Heart Association (NYHA). All studied patients had clinical indications for transcatheter AV replacement, however, given the concomitant surgical pathology of the heart (critical multivessel coronary artery disease unsuitable for endovascular treatment and/or damage to other valves), as well as the morphological features of the aortic root (low location coronary artery ostia relative to the annulus fibrosus of the AV, large calcifications of the coronary cusps according to computed tomography, with a high risk of ostium occlusion), they were denied a minimally invasive procedure. The incidence of adverse clinical events and hemodynamic parameters of the AV prosthesis in the medium-term period were assessed.&#x0D; Results. The average follow-up period was 13.1 months, the maximum was 3 years. Mortality 2.4% (n=1), there were no cases of stroke. The average gradient in the long-term period on AK MedLab-CT is 8.53.1 mm Hg. Paravalvular regurgitation above grade 2 and transvalvular regurgitation were not detected. Thus, no cases of dysfunction of the aortic prosthesis were noted.&#x0D; Conclusion. In the medium term, satisfactory clinical and hemodynamic results of open implantation of the MedLab-CT balloon-expandable prosthesis were obtained in high surgical risk patients.

Comparison of Sequential POT-Side-POT and Kissing Balloon Techniquesin Patientswith Coronary Bifurcation Lesions Treatedwith Single-Stent Strategy; Which One is Simple and Safe? Propensity Score Analysis.

Background:It is unknown whether the novel POT-side-POT technique is more useful than the commonly preferred kissing balloon inflation in patients with non-complex coronary bifurcation lesions treated with a single-stent strategy. The aim of this study was to compare the efficacy of POT-side-POT and kissing balloon inflation techniques in one-stent strategy for non-complex coronary bifurcation lesions.Methods:In this study, 283 patients were retrospectively analyzed (POT-side-POT group, n = 149; KBI group, n = 134). Primary endpoints of the study were defined as follows: in-hospital and 30-day mortality, contrast-induced acute kidney injury, stent thrombosis, side branch dissection, and need for side-branch stenting. Characteristics of patients at baseline were balanced by using propensity score inverse probability weighting.Results:Procedure time (minute, 30.6 ± 8.5 vs. 34.3 ± 11.6; P = .003) and contrast volume (milliliter, 153.7 ± 42.4 vs. 171.1 ± 58.2; P = .004) were significantly lower in POT-side-POT group. Besides, side branch residual stenosis and number of patients with >50% side branch residual stenosis remained significantly higher in POT-side-POT group both in general and true bifurcation subgroup analysis (20.3 ± 19.8% vs. 16.5 ± 16.4%, P = .022; 11.9% vs. 5.7%, P = .013 and 24.1 ± 23.2% vs. 18.8 ± 18.7%, P = .033; 17.6% vs. 6.6%, P = .005; respectively). Combined clinical adverse outcomes were similar between groups. Side branch dissection (10.2% vs. 20.1%, P = .001) and need for side branch stenting (12.6% vs. 19%, P = .040) reached statistically significance in kissing balloon inflation group after adjustment.Conclusion:POT-side-POT may be a simple and safe technique with a shorter procedure time and lower incidence of adverse clinical events in non-complex coronary bifurcation lesions treated with single-stent strategy.

Impact of prolonging dual antiplatelet therapy on long-term prognosis of elderly patients with coronary heart disease complicated with diabetes mellitus undergoing drug-eluting stent implantation

Objective: To explore and compare the effect of standard or prolonged dual antiplatelet therapy (DAPT) on the long-term prognosis of elderly patients with coronary heart disease complicated with diabetes mellitus after drug-eluting stent (DES) implantation. Methods: Consecutive patients with diabetes mellitus, ≥65 years old, underwent DES implantation, and had no adverse events within 1 year after operation underwent percutaneous coronary intervention (PCI) from January to December 2013 in Fuwai Hospital were enrolled in this prospective cohort study. These patients were divided into three groups according to DAPT duration: standard DAPT duration group (11 ≤ DAPT duration≤ 13 months) and prolonged DAPT duration group (13<DAPT duration≤ 24 months; DAPT duration>24 months). All the patients were followed up at 1, 6 months, 1, 2 and 5 years in order to collect the incidence of major adverse cardiovascular and cerebrovascular events (MACCE), and type 2 to 5 bleeding events defined by the Federation of Bleeding Academic Research (BARC). MACCE were consisted of all cause death, myocardial infarction, target vessel revascularization or stroke. The incidence of clinical adverse events were compared among 3 different DAPT duration groups, and Cox regression model were used to analyze the effect of different DAPT duration on 5-year long-term prognosis. Results: A total of 1 562 patients were enrolled, aged (70.8±4.5) years, with 398 female (25.5%). There were 467 cases in standard DAPT duration group, 684 cases in 13<DAPT duration≤ 24 months group and 411 cases in DAPT duration>24 months group. The patients in standard DAPT duration group and the prolonged DAPT duration groups accounted for 29.9% (467/1 562) and 70.1% (1 095/1 562), respectively. The 5-year follow-up results showed that the incidence of all-cause death in 13<DAPT duration≤ 24 months group (4.8%(33/684) vs. 8.6%(40/467),P=0.011) and DAPT duration>24 month group(4.1%(17/411) vs. 8.6%(40/467),P=0.008) were significantly lower than in standard DAPT group. The incidence of myocardial infarction in 13<DAPT duration≤ 24 months group was lower than in standard DAPT duration group (1.9%(13/684) vs. 5.1%(24/467),P=0.002). The incidence of MACCE in 13<DAPT duration≤ 24 months group was the lowest (standard DAPT duration group, 13<DAPT duration≤ 24 months group and DAPT duration>24 month group were 19.3% (90/467), 12.3% (84/684), 20.2% (83/411), respectively, P<0.001). There was no significant difference in the incidence of stroke and bleeding events among the three groups (all P>0.05). Multivariate Cox analysis showed that compared with the standard DAPT group, prolonged DAPT to 13-24 months was negatively correlated with MACCE (HR=0.601, 95%CI 0.446-0.811, P=0.001), all-cause death (HR=0.568, 95%CI 0.357-0.903, P=0.017) and myocardial infarction (HR=0.353, 95%CI 0.179-0.695, P=0.003). DAPT>24 months was negatively correlated with all-cause death (HR=0.687, 95%CI 0.516-0.913, P=0.010) and positively correlated with revascularization (HR=1.404, 95%CI 1.116-1.765, P=0.004). There was no correlation between prolonged DAPT and bleeding events. Conclusions: For elderly patients with coronary heart disease complicated with diabetes mellitus underwent DES implantation, and had no MACCE and bleeding events within 1 year after operation, appropriately prolonging of the DAPT duration is related to the reduction of the risk of cardiovascular adverse events. Patients may benefit the most from the DAPT between 13 to 24 months. In addition, prolonging DAPT duration does not increase the incidence of bleeding events in this patient cohort.

Impact of Atrial Tachyarrhythmia Recurrence on the Development of Long-Term Adverse Clinical Events Following Catheter Ablation in Patients With Atrial Fibrillation With Systolic Impairment: A Single-Center Observational Study.

BackgroundCatheter ablation can improve long‐term prognosis of patients with atrial fibrillation with systolic impairment. However, atrial tachyarrhythmia (ATA) recurrence increases during long‐term follow‐up. We aimed to investigate the impact of ATA recurrence on the development of long‐term adverse clinical events following catheter ablation for atrial fibrillation and to identify predictors for the development of adverse clinical events.Methods and ResultsThis single‐center observational study included 75 patients with systolic impairment (left ventricular ejection fraction <50%) who underwent the first catheter ablation procedure for atrial fibrillation at our institution (median follow‐up period: 3.5 [range: 2.4–4.7] years). We compared the cumulative incidence of adverse clinical events (all‐cause death, heart failure hospitalization, stroke, or acute myocardial infarction) between the groups with and without ATA recurrence following the first and last procedures. Multivariable analyses were performed to identify predictors for developing adverse clinical events. Twenty‐one patients (28%) developed adverse clinical events at a median of 2.2 (range: 0.64–2.8) years following the first procedure. The proportion of freedom from adverse clinical events following the first procedure was significantly lower in the ATA recurrence group than in the nonrecurrence group (41% [n=40] versus 95% [n=35], P<0.0005); the proportion following the last procedure also showed a similar tendency (35% [n=26] versus 57% [n=49], P<0.0001). ATA recurrence emerged as an independent predictor for adverse clinical events following both procedures after multivariable adjustment.ConclusionsATA recurrence following catheter ablation procedure could predict adverse clinical events in patients with atrial fibrillation with systolic impairment.

Prospective real-time evaluation of the QTc interval variation after low-dose droperidol among emergency department patients.

To assess the QTc interval variation after low-dose droperidol in a population of undifferentiated, stable, and non-agitated patients receiving droperidol in the emergency department. Prospective cohort study of patients aged ≥12years of age who received low-dose droperidol (≤ 2.5mg) for indications other than acute behavioral disturbances. QTc intervals were monitored in real-time during pre-specified observation periods in the ED. Primary outcome was variation of QTc interval after droperidol administration, defined as the maximum delta (change) of QTc interval. Other outcomes included proportion of patients with a QTc≥500ms after droperidol, delta≥+60ms, and incidence of clinical adverse events. Patients were monitored up to 30min after IV bolus and up to 46min after infusion. A total of 68 patients were included (mean age 42.1years, 66.2% females). The median dose of droperidol was 1.875mg (range 0.625mg, 2.5mg) and 94.1% received droperidol for headache management. Most patients received droperidol as a 2-min bolus (n=41, 60.3%). The mean maximum delta of QTc interval after droperidol across all 68 patients was +29.9ms (SD 15). A total of 12 patients (17.6%) experienced a QTc interval≥500ms during the observation period after droperidol, and 3 patients (4.4%) had a delta QTc≥+60ms. There were no serious arrhythmias, such as TdP, or deaths among the 68 participants in this study (0/68). However, 13.2% (n=9) had at least one non-serious adverse event including restlessness and/or anxiety. The QTc interval slightly increased after droperidol administration, but these prolongations were brief, mostly below 500msec and did not lead to serious arrhythmias. The yield of continuous cardiac monitoring in patients receiving low doses of droperidol is likely low.

Minimally invasive microsurgical decompression in patients with monosegmental lumbar spinal stenosis

To analyze the results of minimally invasive microsurgical decompression (MI-MD) in patients with monosegmental lumbar spinal stenosis. A retrospective observational cohort study was performed. We analyzed medical records of patients who underwent MI-MD for monosegmental degenerative lumbar spinal stenosis. Clinical and objective results of MI-MD, as well as the types and prevalence of adverse clinical events were studied. The study included 96 medical records (50 (52%) males and 46 (48%) females aged 18-84 years). Analysis of pain in lower back and lower extremities in 3, 6, 9, 12 and 24 months after MI-MD showed a significant decrease of this indicator (p<0.001). There was significant improvement of capacity according to ODI score up to 5-12% in 72.9% of patients in early postoperative period (p=0.055). In delayed postoperative period, we also observed significant improvement of working capacity according to ODI score and gradual decrease in disability index (p<0.001). Adverse clinical events occurred in 6 (6.2%) patients. MI-MD is a highly effective surgical method for monosegmental lumbar spinal stenosis with minimal incidence of adverse clinical events.

Optimal Antithrombotic Therapy after Implantation of a Transcatheter Aortic Valve: Warfarin, Aspirin, or Non-Vitamin K Antagonist Oral Anticoagulants? A Systematic Review and Meta-Analysis

Abstract Objective: Diverse antithrombotic strategies were applied to patients undergoing aortic valve replacement. However, the optimal therapeutic regimen for patients undergoing transcatheter aortic valve implantation/replacement (TAVI/TAVR) remains unclear. The purpose of this study was to compare the efficacy and safety of various antithrombotic therapies following TAVI/TAVR. Methods: Relevant clinical trials evaluating the effect of anticoagulation or antiplatelet regimens on patients after TAVI/TAVR from inception to September 2020 were identified using the PubMed, EMBASE, and the Cochrane Library databases. The inclusion criteria including (1) all patients underwent TAVI/TAVR; (2) the interventions were antithrombotic strategies that prevent the occurrence of thrombotic events in patients; (3) randomized controlled trials or prospective observational studies; and (4) investigation of at least 1 outcome with a follow-up period of ≥3 months. The exclusion criteria including (1) research content was identical or irrelevant to the purpose of the present study; (2) lack of the required outcome index or availability of fragmentary original information; and (3) the full text is not available. The major outcomes were all-cause mortality, thromboembolic complications, and bleeding events. The Cochrane Collaboration's tool and the Newcastle-Ottawa Scale were used for assessing the risk of bias in included studies. Results: Thirteen studies (3 randomized controlled trials and 10 non-randomized studies) were identified, with a total of 23,497 patients. Four studies compared direct oral anticoagulants (DOACs) with warfarin, 1 study compared aspirin with warfarin, 6 studies compared aspirin plus clopidogrel (dual antiplatelet therapy (DAPT)) with aspirin monotherapy, and 2 studies compared DAPT and aspirin monotherapy with warfarin concurrently. There were no significant differences found between the DOAC and warfarin groups regarding all-cause mortality (risk ratio (RR): 1.03; 95% confidence interval (CI): 0.65–1.64; P = 0.909; P het = 0.105), clinical adverse events (RR: 1.59; 95% CI: 0.99–2.58; P = 0.057; P het = 0.738), or bleeding events (RR: 0.93; 95% CI: 0.78–1.11; P = 0.437; P het = 0.338). The rates of all-cause mortality (RR: 0.71; 95% CI: 0.54–0.93; P = 0.012; P het = 0.845) and bleeding events (RR: 0.43; 95% CI: 0.22–0.83; P = 0.012; P het = 0.569) were lower in the aspirin group versus the warfarin group; however, there was no difference in the rate of clinical adverse events (RR: 0.38; 95% CI: 0.14–1.07; P = 0.068; P het = 0.593). The DAPT group had an advantage versus the aspirin group in all-cause mortality (RR: 0.89; 95% CI: 0.82–0.98; P = 0.013; P het = 0.299); however, the incidence of bleeding events (RR: 2.06; 95% CI: 1.39–3.07; P &lt; 0.001; P het = 0.001) exhibited an increasing trend. Notably, there was a slight decrease in the incidence of clinical adverse events (RR: 1.09; 95% CI: 0.94–1.26; P = 0.268; P het = 0.554). Conclusion: The present meta-analysis integrates the latest published results on antithrombotic strategies in patients after TAVI/TAVR. Aspirin showed a favorable risk-benefit profile versus warfarin, with lower rates of all-cause mortality and bleeding events. Although DAPT was also associated with a significantly lower rate of all-cause mortality, it was linked to a higher incidence of bleeding events. The DOACs did not show significant benefits compared with warfarin. Some certain limitations should be noted, such as different types of trails produce heterogeneity and finite inclusion of TAVI/TAVR patients increased selection bias.

Clinical Profile, Mortality, and Short-term Outcome in Asphyxiated Neonates Receiving Therapeutic Hypothermia in a Limited Resource Setting: A Cohort Study

Objective :To evaluate the effectiveness of therapeutic hypothermia(TH) among asphyxiated newborns for reducing mortality, adverse clinical events, and short-term outcomes in comparison to asphyxiated newborns treated with standard therapy. Material and method: Non-randomised cohort study at the tertiary care center. Study population: Asphyxiated newborns admitted in NICU within 24 hrs of life meeting the lab and/or clinical criteria of Severe Birth Asphyxia. Eligible newborns who received TH were labeled as recipients and newborns who received standard care were labeled as non-recipient. Results: Out of 176 infants studied, 89 newborns received TH, and 87 newborns received standard care. Recipients of TH had 15.3% lower mortality than non-recipients (P<0.05). The incidence of adverse clinical events was similar among both groups. At discharge 73.2% among recipients vs 56.8% non recipients were neurologically normal( p=0.01). 92.6% among recipients vs 70.1% non recipients were able to breast feed (p<0.05), 30.4% of recipients vs 46.2% non-recipients required anti-epileptics(p<0.05). Conclusion: TH is effective and feasible with a decrease in the rate of death, better neurological status at discharge, and less need for anti-epileptics without increasing adverse clinical events at limited-resource settings using low-cost devices.

Valor pronóstico de un nuevo modelo de evaluación clínica de pacientes ambulatorios con insuficiencia cardiaca

Introduction and objectivesTo assess the prognostic value of a 5-item clinical model based in the IC-BERG recommendations to evaluate ambulatory patients with heart failure (HF) in the clinic. MethodsObservational study based on the historical cohort of patients with HF referred to a specific facility since 2010 to 2019. The presence of 5 clinical ítems was evaluated: NYHA III-IV class, signs of congestion, admission due to decompensation in the previous year, daily dose≥40mg furosemide or equivalent, and NT-proBNP≥1,000pg/ml. The incidence of adverse clinical events was assessed by means of the Kaplan-Meier method and multivariable Cox's regression. ResultsWe studied 1909 patients, whose mean number of clinical ítems indicating risk was 2.29. Kaplan-Meier survival analysis showed an incremental trend between an increasing number of clinical ítems of risk and the combined event death or admission due to HF, overall mortality, and cardiovascular mortality (P<.001). Adjusted hazard-ratio for the combined end-point death or admission due to HF, as estimated by means of multivariable Cox's regression, were 1.47 (95%CI, 1–2.15), 2.03 (95%CI, 1.41–2.92), 2.98 (95%CI, 2.08–4.28), 5.07 (95%C,: 3.51–7.32), and 7.73 (95%CI, 5.21–11.45) for patients who showed 1, 2, 3, 4, or 5 clinical ítems indicating risk, respectively. The proportional weight of cardiovascular causes of risk, especially refractory HF, was higher in patients with a higher number of clinical ítems of risk. ConclusionsThis study supports the prognostic value of a 5-item clinical model based on IC-BERG recommendations in ambulatory patients with HF.

Adverse events in the treatment of motorcycle-related isolated limb injuries at a regional hospital in Uganda: a prospective clinical analysis.

Although motorcycle accidents are a leading cause of limb injury in Uganda, little is known about injury care quality at regional hospitals. This study measured the incidence of clinical adverse events (CAEs) and identified associated treatment barriers surrounding motorcycle-related isolated limb injuries at a regional hospital. A prospective descriptive study was conducted among patients with motorcycle-related isolated limb injuries at a Ugandan regional hospital between September 2017 and February 2018. Patients were surveyed upon admission and monitored throughout their course of treatment. Weight-bearing status and quality of life measures (EQ-5D) were assessed at four and 12weeks. One hundred twenty-four participants enrolled. Of the total participants, 12% refused definitive treatment. Among 108 treated patients, six experienced CAEs: four wound infections, one amputation, and one death. At 12weeks follow-up, the majority of patients had no difficulty with mobility, pain/discomfort, or self-care, but 51% endorsed challenges completing certain daily chores, and 40% of patients could ambulate without an assistive device with restoration of pre-fracture gait. Both longer hospital stays and poorer 12-week functional recovery were seen among patients sustaining open fracture (p < 0.001). Treatment of isolated limb injuries at a Ugandan Regional Hospital was associated with minimal short-term CAEs. However, patients with more severe injuries may be at risk for delayed post-operative recovery. Future studies measuring long-term functional outcomes should be performed to better understand and optimize injury care in this population.