American heart journal
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American heart journal · Apr 2020
Randomized Controlled Trial Multicenter StudyOutcome impact of different tranexamic acid regimens in cardiac surgery with cardiopulmonary bypass (OPTIMAL): Rationale, design, and study protocol of a multicenter randomized controlled trial.
This large-scale, double-blind, randomized controlled trial with a 1-year follow-up enrolls patients undergoing elective cardiac surgery with cardiopulmonary bypass. Patients are randomly assigned 1:1 into either the high-dose TxA group (intravenous bolus [30 mg/kg] after anesthesia followed by intravenous maintenance [16 mg/kg/h] throughout the operation, and a pump prime dose of 2 mg/kg) or the low-dose TxA group (intravenous bolus and maintenance are 10 mg/kg and 2 mg/kg/h, respectively, and a pump prime dose of 1 mg/kg). The primary efficacy end point is the rate of perioperative allogeneic red blood cell (RBC) transfusion defined as the number (%) of patients who will receive at least 1 RBC unit from operation day to discharge. The primary safety end point is the 30-day rate of the composite of perioperative seizures, renal dysfunction, myocardial infarction, ischemic stroke, deep vein thrombosis, pulmonary embolism, and all-cause mortality. The secondary end points are perioperative allogeneic RBC transfusion volume, the non-RBC blood transfusion rate, postoperative bleeding, reoperation rate, mechanical ventilation duration, intensive care unit stay, hospital length of stay, total hospitalization cost, each component of composite primary safety end point, and the 6-month/1-year follow-up mortality and morbidity. We estimated a sample size of 3,008 participants. ⋯ The study is designed to identify a TxA dose with maximal efficacy and minimal complications. We hypothesize that the high dose has superior efficacy and noninferior safety to the low dose.
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American heart journal · Feb 2020
Multicenter StudyPatterns of amiodarone use and outcomes in clinical practice for atrial fibrillation.
Amiodarone is the most effective antiarrhythmic drug (AAD) for atrial fibrillation (AF), but it has a high incidence of adverse effects. ⋯ Use of amiodarone among AF patients in community practice is highly variable. More than 2 out of 3 patients treated with amiodarone appeared to be eligible for a different AAD.
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American heart journal · Dec 2019
Randomized Controlled Trial Multicenter StudyThe effect of low-dose colchicine in patients with stable coronary artery disease: The LoDoCo2 trial rationale, design, and baseline characteristics.
Because patients with stable coronary artery disease are at continued risk of major atherosclerotic events despite effective secondary prevention strategies, there is a need to continue to develop additional safe, effective and well-tolerated therapies for secondary prevention of cardiovascular disease. RATIONALE AND DESIGN: The LoDoCo (Low Dose Colchicine) pilot trial showed that the anti-inflammatory drug colchicine 0.5 mg once daily appears safe and effective for secondary prevention of cardiovascular disease. Colchicine's low cost and long-term safety suggest that if its efficacy can be confirmed in a rigorous trial, repurposing it for secondary prevention of cardiovascular disease would have the potential to impact the global burden of cardiovascular disease. ⋯ The study will have 90% power to detect a 30% reduction in the composite primary endpoint: cardiovascular death, myocardial infarction, ischemic stroke and ischemia-driven coronary revascularization. Adverse events potentially related to the use of colchicine will also be collected, including late gastrointestinal intolerance, neuropathy, myopathy, myositis, and neutropenia. The LoDoCo2 Trial will provide information on the efficacy and safety of low-dose colchicine for secondary prevention in patients with stable coronary artery disease.
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American heart journal · Aug 2019
Multicenter Study Observational StudyRisk factors and prognostic impact of left ventricular assist device-associated infections.
Left ventricular assist device (LVAD)-associated infections may be life-threatening and impact patients' outcome. We aimed to identify the characteristics, risk factors, and prognosis of LVAD-associated infections. ⋯ Left ventricular assist device-associated infections affect one-third of LVAD recipients, mostly related to skin pathogens and gram-negative bacilli, with increased risk with HeartMate II as compared with HeartWare, and in patients who required ICD-related procedures post-LVAD. This is a plea to better select patients needing ICD implantation/replacement after LVAD implantation.
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American heart journal · Jul 2019
Multicenter Study Observational StudyFactors for modifying the termination of resuscitation rule in out-of-hospital cardiac arrest.
False positive rate (FPR) of the current basic life support (BLS) termination of resuscitation (TOR) rule in out-of-hospital cardiac arrest (OHCA) patients (not witnessed; no return of spontaneous circulation prior to transport; and no shocks were delivered) has been ethically challenging. We validated the current BLS TOR rule with using nationwide Korean Cardiac Arrest Research Consortium (KoCARC) registry and identified the factors for modifying the rules. ⋯ In this recent nationwide cohort, the current BLS TOR rule showed high FPR (5.9%) for predicting poor neurologic outcome. We anticipate that our new KoCARC TOR rules, application of 2 new factors (asystole as initial rhythm and age > 60 years) with BLS TOR rule, could reduce unwarranted death.