Circulation, Volume 146, Issue Suppl_1, Page A12361-A12361, November 8, 2022. Introduction:The efficacy and safety of non-vitamin K oral anticoagulants (NOACs) in patients with atrial fibrillation (AF) at the extremes of body mass index (BMI) and body weight (BW) remains uncertain, leading to concerns regarding use in these populations across clinical practice guidelines.Methods:This analysis of the COMBINE-AF database pools individual patient-level data from the 4 pivotal RCTs of NOAC vs. warfarin in AF: RE-LY, ROCKET-AF, ARISTOTLE, and ENGAGE AF-TIMI 48. Pts randomized to low-dose NOACs not globally approved for clinical use were excluded. The primary efficacy and safety outcome was stroke/systemic embolic event (S/SEE) and major bleeding, respectively, with intracranial hemorrhage (ICH) being a secondary outcome. Outcomes were assessed across BMI and BW using a Cox model stratified by trial, with interaction testing for NOAC vs. warfarin. Restricted cubic splines were used to display the hazard ratio of NOAC vs. warfarin for each outcome across BMI.Results:For 58,464 pts, the median BMI was 28 (25th-75th%ile: 25-32) kg/m2,with the top 5% (n=2,924) having a BMI ≥ 40 kg/m2. For patients randomized to warfarin, the risk of each outcome was lower with increasing BMI (HR per 5 kg/m2increase: S/SEE 0.79 [95% CI 0.75-0.84]; major bleeding 0.91 [95% CI 0.87-0.95]; ICH 0.72 [95% CI 0.66-0.80]; p
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Abstract 9874: Correlation of Left Ventricular Strain Derived From Rb-82 ECG-Gated PET Myocardial Perfusion Imaging vs 2D Echocardiography
Circulation, Volume 146, Issue Suppl_1, Page A9874-A9874, November 8, 2022. Introduction:Global longitudinal strain (GLS) by two-dimensional (2D) transthoracic echocardiography (TTE) is a robust index for identifying early left ventricular (LV) myocardial dysfunction. Positron emission tomography (PET) myocardial perfusion imaging (MPI) is widely used in the assessment of ischemic heart disease (IHD) but has not been used for strain analysis.Hypothesis:Longitudinal, radial, and circumferential myocardial strain measures at rest and at pharmacologic stress by Rb-82 ECG-gated PET MPI are correlated to those measured by resting 2D TTE.Methods:We developed a novel PET MPI method to track the LV myocardium throughout the cardiac cycle processed in the Emory Cardiac Toolbox, to measure LV strain from longitudinal, radial, and circumferential direction at regadenoson-stress and at rest. We retrospectively identified 80 patients who underwent Rb-82 PET MPI and also had TTE with strain analysis within 3 months. The agreement between LV strain and LVEF derived from PET MPI and resting TTE was assessed with Bland-Altman analysis, Pearson’s correlation, and the concordance correlation coefficient (CCC).Results:PET MPI derived measurements of longitudinal (Figure 1A-1B: Bland-Altman analysis; 1C-1D: Pearson’s correlations), circumferential (Figure 1E-1F: Pearson’s correlations) and radial (Figure 1G-1H: Pearson’s correlations) strain measures at rest and stress were strongly correlated to resting TTE derived GLS (p
Abstract 9859: Randomized Comparison of Bare Metal Stents Plus Colchicine vs Drug Eluting Stents: Preliminary Analysis of the Orca Trial (Oral Colchicine in Argentina)
Circulation, Volume 146, Issue Suppl_1, Page A9859-A9859, November 8, 2022. Background:The use of colchicine has been associated with reduction of adverse cardiac events in patients with coronary artery disease (CAD). The role of this drug after percutaneous coronary intervention (PCI) with bare metal stents (BMS) has not been evaluated against isolated PCI with drug eluting stents (DES).Aim:The study was designed to test an improved cost-effectiveness with BMS plus colchicine (group BMS+C) compared to DES alone (group DES), provided its noninferiority in terms of major adverse cardiac events (MACE) at 1 year.Methods:This is a prospective, multicenter, randomized controlled trial performed in 4 centers. The trial has been registered at clinicaltrials.gov (NCT04382443). Study protocol and informed consent have been approved by an Independent Ethical and Review Board Committee and were presented to Argentina National regulatory authorities for Health, Technology and Medications. Patients in the BMS+C group received 0.5mg oral doses twice a day of colchicine for 3 months. Outpatient visits were scheduled at 1, 3, 6 and 12 months as well as at 3 and 5 years. Primary endpoints were to compare cost-effectiveness and MACE defined as composite of death, myocardial infarction (MI), cerebrovascular accident and ischemia-driven target vessel revascularization.Results:During February 2020 to April 2022, 412 patients with clinically indicated PCI were randomized in the study. Because 2 patients with COVID 19 at the time of randomization were excluded, the final study population was composed of 410 patients (205 patients in each group). Baseline demographic and angiographic characteristics were well balanced diabetes 19.5% vs 21.4%, Acute Coronary Syndromes 78% vs 75%, ST elevation MI 23% vs 21% multiple vessel CAD 44% vs 46%, culprit left anterior descending artery 58% vs 57.8%, peripheral vascular disease 3.4% in BMS+C and DES groups respectively.2.9% of patients in BMS+C didn’t complete the treatment for side effects (diarrhea). Presently, patients were follow at mean of 381 days ( range 45 to 839),1 -year follow-up was completed in 61%.Conclusion:A 3-month treatment with colchicine after PCI with BMS was feasible and safe. Final 1-year clinical outcomes and cost-effectiveness results will be available at the time of presentation.
Abstract 11239: Gender Disparities in the Utilization of Catheter-Directed Thrombolytic Therapy vs. Systemic Thrombolytic Therapy in Patients With Acute Pulmonary Embolism
Circulation, Volume 146, Issue Suppl_1, Page A11239-A11239, November 8, 2022. Introduction:Gender disparities in the utilization of catheter-directed thrombolytic (CDT) therapy vs. systemic thrombolytic (ST) therapy in patients with acute pulmonary embolism (PE) have not been studied before.Methods:Using the National Inpatient Sample database from 2012 to 2018, we identified all adult patients with acute PE who received any thrombolytic therapy. The primary outcome was the utilization of CDT vs. ST therapy in females compared to males. The secondary outcome was the mortality in females compared to males in all patients of acute PE who received any thrombolytic therapy.Results:We identified 45,950 patients who received CDT or ST therapy. The mean age was 59.7 years in females vs. 59 in males (p-value – .03). Males were more likely to have saddle PE (33% vs. 29%, p-value < .01) and less likely to have vasopressor use (3% vs. 5%, p-value < .01). Baseline characteristics are shown inTable 1.Females were less likely to have CDT vs. ST therapy on adjusted analysis (AOR - 0.85, p-value < .01), as shown inTable 2.Females also had 27% higher in-hospital mortality than males in the entire cohort who received any thrombolytic therapy even after adjustment for age, race, comorbidities, and hospital factors (AOR - 1.27, p-value < .01). CDT was associated with a 58% lower risk of in-hospital mortality than systemic thrombolytic therapy in the adjusted model (AOR - 0.42, p-value < .01).Conclusion:Gender disparities exist in the utilization of CDT in patients of acute PE who receive thrombolytic therapy, with lower utilization in females than males, despite significantly reduced in-hospital mortality associated with CDT vs. ST therapy.
Abstract 12210: Safety and Efficacy of Transcatheter Aortic Valve Replacement With Continuation vs Interruption of Peri-Procedural Anticoagulation: A Meta-Analysis
Circulation, Volume 146, Issue Suppl_1, Page A12210-A12210, November 8, 2022. Introduction:Approximately 33% of patients undergoing transcatheter aortic valve replacement (TAVR) have an indication for long-term anticoagulation. In clinical routine, anticoagulation is often discontinued 2 to 4 days before TAVR. The purpose of this meta-analysis was to compare the safety and efficacy of TAVR in patients with per-procedural continuation vs interruption of anticoagulation.Methods:An electronic search was performed using PubMed and Ovid Medline from inception to May 2022. The primary outcome of interest was life-threatening or major bleeding. The secondary outcomes were all-cause mortality, stroke, vascular complications, need for blood transfusion, and closure device failure.Results:Three observational studies were included in our final analysis which consisted of 2,286 patients, with anticoagulation being continued in 1,069 patients and interrupted in 1,217 patients. Although, there was no significant difference in our primary outcome of life-threatening or major bleeding between both groups, there was a trend toward decreased risk of bleeding in patients who were continued on anticoagulation (RR: 0.81; CI: 0.65 to 1.0; I2: 0%, p=0.05). There was a significantly lower risk of stroke (RR: 0.55; CI: 0.35 to 0.88; I2: 0%, p=0.01) and need for blood transfusion (RR: 0.72; CI: 0.59 to 0.87; I2: 0%, p
Abstract 13583: Conduction System Pacing Experience: His Bundle vs. Left Bundle Branch Area Pacing at Columbia University
Circulation, Volume 146, Issue Suppl_1, Page A13583-A13583, November 8, 2022. Introduction:Conduction system pacing (CSP) with His bundle pacing (HBP) and left bundle branch area pacing (LBBAP) are utilized as alternatives to RV endocardial and biventricular pacing. Which patients gain the most benefit from CSP remains an area of active investigation.Objective:To report on the early experience with HBP and LBBAP conduction system pacing at an academic medical center.Methods:All patients with a Medtronic 3830 SelectSecure lead implanted from 3/2016 to 5/2022 at Columbia University were selected for chart review. Patients were excluded if follow up interrogation or clinical data were unavailable for review.Results:A total of 36 patients were included and 3 were excluded for lack of follow up. 25 patients had HBP and 11 patients had LBBAP (Table 1). Average time from implant to most recent interrogation for HBP was 530.8 ± 506.2 days, range 22 – 1589, compared to 113.6 ± 149.6 days, range 10 – 397, for LBBAP. The implant threshold was significantly higher in HBP compared to LBBAP (1.58 ± 1.06 V vs. 0.57 ± 0.19 V, p=0.004) (Table 1). There were increased threshold in both groups at follow up compared to initial implant HBP (1.81 ± 1.19 V vs 1.58 ± 1.06, p=0.17) and LLBAP (< 30 days of follow up [n=4], 0.84 ± 0.66 V vs 0.58 ± 0.22 V,p=0.46; >30 days of follow up [n = 7], 1.34 ± 1.40 vs 0.57 ± 0.19, p=0.18) although it was not significant. Complication rates were low, one HBP lead was deactivated due to high threshold, two LBBAP patients required lead revision, one for dislodgement and one for pocket infection.Conclusions:CSP is a feasible and safe procedure. Higher thresholds were observed in the HBP group at implant compared to the LBBAP group. There was a trend of an increased threshold over time in both groups. Ongoing monitoring of the LBBAP is crucial for long term feasibility.
Ketamine vs. ECT for Resistant Depression: A Meta-Analysis
Electroconvulsive therapy was superior, but outcomes with ketamine were better than expected for this difficult-to-treat population.
MRI-Guided Fibrosis Ablation vs Conventional Catheter Ablation for Patients With Persistent Atrial Fibrillation—Reply
In Reply The presence and role of atrial fibrosis in the arrhythmogenesis of AF has been extensively studied and is considered a key component of the arrhythmic substrate in patients with AF. Delayed-enhancement MRI provides a well-validated noninvasive method of assessing the burden of atrial disease and has been shown to have an important clinical role in predicting response to catheter ablation therapy.
Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19
This randomized clinical trial compares the efficacy of ivermectin vs placebo in shortening symptom duration among adult outpatients in the US with symptomatic mild to moderate COVID-19.
MRI-Guided Fibrosis Ablation vs Conventional Catheter Ablation for Patients With Persistent Atrial Fibrillation
To the Editor The emergence of delayed-enhancement magnetic resonance imaging (MRI) has set the stage for advancements in visualization and quantification of left atrial fibrosis. Among patients with atrial fibrillation (AF) undergoing catheter ablation, the DECAAF I trial showed an association between the extent of atrial fibrosis and the likelihood of arrhythmia recurrence. Consequently, atrial fibrotic burden gained clinical importance and became a potential target to improve procedural outcomes.
Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients After Lumbar Spine Surgery
This placebo-controlled, crossover randomized clinical trial compares the effects of spinal cord burst stimulation vs placebo stimulation in patients with chronic radiculopathy after surgery for degenerative lumbar spine disorders.
Odds of Hospitalization for COVID-19 After 3 vs 2 Doses of mRNA COVID-19 Vaccine by Time Since Booster Dose
This study assesses the association between COVID-19 mRNA booster immunization compared with vaccination with the primary mRNA vaccination series alone and odds of hospitalization for COVID-19.
Effect of Paroxetine or Quetiapine With Oxycodone vs Oxycodone Alone on Ventilation During Hypercapnia
This clinical trial assesses whether paroxetine plus oxycodone or quetiapine plus oxycodone combinations decreased the ventilatory response to hypercapnia compared with oxycodone alone.
In patients with high bleeding risk, 1 vs. ≥3 mo of DAPT after complex or noncomplex PCI did not differ for clinical events
Annals of Internal Medicine, Volume 175, Issue 10, Page JC112, October 2022.
In adults hospitalized with COVID-19, adding baricitinib vs. dexamethasone to remdesivir did not differ for MV-free survival
Annals of Internal Medicine, Volume 175, Issue 10, Page JC115, October 2022.
Effect of Opioid-Sparing Protocol vs Standard Prescribing on Opioid Consumption After Knee or Shoulder Arthroscopy
This clinical trial compares the amount of opioids used by patients who underwent arthroscopic knee or shoulder surgery randomized to a pain management protocol involving patient education, nonsteroidal anti-inflammatories, and acetaminophen or to the current pain management care.