Early Longitudinal Change in Heart Failure Health Status Following Initiation of Canagliflozin.

Background: Sodium glucose co-transporter 2 inhibitor (SGLT2i) therapy improves health status in heart failure (HF). There is insufficient description regarding the timing, rate, and extent of the health status changes in heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF) after initiation of SGLT2is.

Objectives: The authors sought to model the association of canagliflozin treatment with rates of change in HF symptom status in HFpEF and HFrEF.

Association Between Wearable Device Measured Activity and Patient-Reported Outcomes for Heart Failure.

Background: Wearable devices are increasingly used in research and clinical care though the relevance of their data in the context of validated outcomes remains unknown.

Objectives: The purpose of this study was to characterize the relationship between smartwatch activity and patient-centered outcomes in patients with heart failure.

Methods: CHIEF-HF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure) was a randomized-controlled clinical trial that enrolled participants with heart failure and a compatible smartphone.

Racial Differences in Quality of Life in Patients With Heart Failure Treated With Sodium-Glucose Cotransporter 2 Inhibitors: A Patient-Level Meta-Analysis of the CHIEF-HF, DEFINE-HF, and PRESERVED-HF Trials.

Background: Health status outcomes, including symptoms, function, and quality of life, are worse for Black compared with White patients with heart failure. Sodium-glucose cotransporter 2 inhibitors (SGLT2is) reduce cardiovascular mortality and improve health status in patients with heart failure, but whether the health status benefit of SGLT2is is similar across races is not established. The objective of this study was to compare the treatment effect of SGLT2is (versus placebo) on health status for Black compared with White patients with heart failure.

Recruitment Strategies of a Decentralized Randomized Placebo Controlled Clinical Trial: The Canagliflozin Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) Trial.

Background: There has been growing Interest in patient-centered clinical trials using mobile technologies to reduce the need for in-person visits. The CHIEF-HF (Canagliflozin Impact on Health Status, Quality of Life and Functional Status in Heart Failure) trial was designed as a double-blind, randomized, fully decentralized clinical trial (DCT) that identified, consented, treated, and followed participants without any in-person visits. Patient-reported questionnaires were the primary outcome, which were collected by a mobile application.

The SGLT2 inhibitor canagliflozin in heart failure: the CHIEF-HF remote, patient-centered randomized trial.

Large traditional clinical trials suggest that sodium-glucose co-transporter 2 inhibitors improve symptoms in patients with heart failure and reduced ejection fraction (HFrEF) and in patients with heart failure and preserved ejection fraction (HFpEF). In the midst of the Coronavirus Disease 2019 pandemic, we sought to confirm these benefits in a new type of trial that was patient centered and conducted in a completely remote fashion. In the CHIEF-HF trial ( NCT04252287 ), 476 participants with HF, regardless of EF or diabetes status, were randomized to 100 mg of canagliflozin or placebo.

Association of Recent Use of Non-Vitamin K Antagonist Oral Anticoagulants With Intracranial Hemorrhage Among Patients With Acute Ischemic Stroke Treated With Alteplase.

Importance: Current guidelines recommend against use of intravenous alteplase in patients with acute ischemic stroke who are taking non-vitamin K antagonist oral anticoagulants (NOACs).

Objective: To evaluate the safety and functional outcomes of intravenous alteplase among patients who were taking NOACs prior to stroke and compare outcomes with patients who were not taking long-term anticoagulants.

Design, Setting, And Participants: A retrospective cohort study of 163 038 patients with acute ischemic stroke either taking NOACs or not taking anticoagulants prior to stroke and treated with intravenous alteplase within 4.

Novel Trial Design: CHIEF-HF.

Background: The expense of clinical trials mandates new strategies to efficiently generate evidence and test novel therapies. In this context, we designed a decentralized, patient-centered randomized clinical trial leveraging mobile technologies, rather than in-person site visits, to test the efficacy of 12 weeks of canagliflozin for the treatment of heart failure, regardless of ejection fraction or diabetes status, on the reduction of heart failure symptoms.

Methods: One thousand nine hundred patients will be enrolled with a medical record-confirmed diagnosis of heart failure, stratified by reduced (≤40%) or preserved (>40%) ejection fraction and randomized 1:1 to 100 mg daily of canagliflozin or matching placebo.

Efficacy of a centralized, blended electronic, and human intervention to improve direct oral anticoagulant adherence: Smartphones to improve rivaroxaban ADHEREnce in atrial fibrillation (SmartADHERE) a randomized clinical trial.

Background: Improving adherence to direct oral anticoagulants (DOAC) is challenging, and simple text messaging reminders have not been effective.

Methods: SmartADHERE was a randomized trial that tested a personalized digital and human direct oral anticoagulant adherence intervention compared to usual care. Eligibility required age ≥ 18, newly-prescribed (≤90 days) rivaroxaban for atrial fibrillation (AF), 1 of 4 at-risk criteria for nonadherence, and a smartphone.

Infective Endocarditis of the Aortic Valve Complicated by Aorta-To-Pulmonary Artery Fistula.

• Aortopulmonary fistulas in IE are a cause of aorta–to–pulmonary connections. • Other causes include PDA and ruptured sinus of Valsalva aneurysm. • Continuous flow is seen in modified views of the pulmonary artery.

Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI.

Background: In patients with atrial fibrillation undergoing percutaneous coronary intervention (PCI) with placement of stents, standard anticoagulation with a vitamin K antagonist plus dual antiplatelet therapy (DAPT) with a P2Y inhibitor and aspirin reduces the risk of thrombosis and stroke but increases the risk of bleeding. The effectiveness and safety of anticoagulation with rivaroxaban plus either one or two antiplatelet agents are uncertain.

Methods: We randomly assigned 2124 participants with nonvalvular atrial fibrillation who had undergone PCI with stenting to receive, in a 1:1:1 ratio, low-dose rivaroxaban (15 mg once daily) plus a P2Y inhibitor for 12 months (group 1), very-low-dose rivaroxaban (2.

Screening for postpartum depression in a pediatric emergency department.

Objective: The objective was to determine whether a 3-question version of the Edinburgh Postpartum Depression Scale (EPDS) performs as well as the full EPDS in screening for postpartum depression in a pediatric emergency department (PED).

Methods: Mothers of infants younger than 6 months presenting to an urban PED were enrolled. After the PED encounter, mothers were asked about demographics, health problems, insurance status, social support, food and housing security, and 3 questions from the EPDS.

Neck pain and stiffness in a toddler with history of button battery ingestion.

Background: Button batteries within the gastrointestinal system are dangerous and must be suspected after any foreign body ingestion. Common complications include esophageal perforation, fistula formation, and esophageal scarring.

Objectives: Spondylodiscitis resulting from button battery ingestion is extremely rare and, to our knowledge, has been described in the literature only once to date.

Pharmacodynamics of vancomycin and other antimicrobials in patients with Staphylococcus aureus lower respiratory tract infections.

Background: Vancomycin is commonly used to treat staphylococcal infections, but there has not been a definitive analysis of the pharmacokinetics of this antibacterial in relation to minimum inhibitory concentration (MIC) that could be used to determine a target pharmacodynamic index for treatment optimisation.

Objective: To clarify relationships between vancomycin dosage, serum concentration, MIC and antimicrobial activity by using data gathered from a therapeutic monitoring environment that observes failures in some cases.

Methods: We investigated all patients with a Staphylococcus aureus lower respiratory tract infection at a 300-bed teaching hospital in the US during a 1-year period.

Clinical pharmacodynamics of linezolid in seriously ill patients treated in a compassionate use programme.

Objective: To characterise the pharmacokinetic-pharmacodynamic relationships for linezolid efficacy.

Design And Study Population: Retrospective nonblinded analysis of severely debilitated adult patients with numerous comorbid conditions and complicated infections enrolled under the manufacturer's compassionate use programme.

Methods: Patients received intravenous or oral linezolid 600 mg every 12 hours.

Population pharmacokinetics of linezolid in patients treated in a compassionate-use program.

Data obtained from 318 adult patients treated under the linezolid compassionate-use protocol were used to develop a population model of the pharmacokinetics of intravenous and oral linezolid. All of the patients received 600 mg of linezolid every 12 h, intravenously and/or orally. Blood samples (2 to 10 per patient; median, 4) were obtained and assayed for linezolid by high-performance liquid chromatography.

Clinical experience with linezolid for the treatment of nocardia infection.

Linezolid is an oxazolidinone that has activity against most gram-positive bacteria, including in vitro activity against all Nocardia species and strains. We describe 6 clinical cases of nocardiosis that were successfully treated with linezolid. Two patients had underlying X-linked chronic granulomatous disease, and 2 patients were receiving chronic corticosteroid therapy.

Linezolid for the treatment of multidrug-resistant, gram-positive infections: experience from a compassionate-use program.

Linezolid was provided for treatment of multidrug-resistant, gram-positive infections through a compassionate-use program. Patients (n=796) received 600 mg of linezolid intravenously or orally every 12 h (828 treatment courses). Bacteremia was present in 46% of infections, endocarditis was present in 10.

The efficacy and safety of linezolid as treatment for Staphylococcus aureus infections in compassionate use patients who are intolerant of, or who have failed to respond to, vancomycin.

Objective: The incidence of infections caused by methicillin-resistant Staphylococcus aureus continues to increase annually. Unfortunately, only a few therapeutic agents are available for the treatment of patients with such infections and all of the existing drugs have limitations. A pressing need exists, therefore, to identify new antibiotics for use in this clinical setting.