American heart journal
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American heart journal · Sep 2011
Multicenter Study Comparative Study Clinical TrialBerlin Heart EXCOR Pediatric ventricular assist device Investigational Device Exemption study: study design and rationale.
Currently, there are no Food and Drug Administration-approved devices available that can provide long-term mechanical circulatory support to smaller children with severe heart failure as a bridge to heart transplant (HT). In recent years, the Berlin Heart EXCOR Pediatric ventricular assist device (VAD) has emerged as a potential treatment option. Systematic data on the safety and efficacy of the EXCOR are limited. ⋯ The Berlin Heart IDE clinical study will be the first bridge-to-HT VAD study designed exclusively for children. It is anticipated that the study will provide important information on the safety and efficacy of the Berlin Heart EXCOR Pediatric in children while providing valuable lessons into the design and conduct of future VAD studies in children.
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American heart journal · Sep 2011
Randomized Controlled Trial Multicenter Study Comparative StudyColchicine prevents early postoperative pericardial and pleural effusions.
No preventive pharmacologic strategies have been proven efficacious for the prevention of postoperative effusions after cardiac surgery. Colchicine is safe and efficacious for the prevention of pericarditis. On this basis, we realized a substudy of the COPPS trial to assess the efficacy and safety of colchicine for the prevention of postoperative pericardial and pleural effusions. ⋯ Colchicine is safe and efficacious for the primary prevention of postoperative effusions after cardiac surgery.
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American heart journal · Sep 2011
Multicenter Study Comparative StudyThe CHADS2 score predicts ischemic stroke in the absence of atrial fibrillation among subjects with coronary heart disease: data from the Heart and Soul Study.
We sought to evaluate the prognostic performance of the CHADS(2) score for prediction of ischemic stroke/transient ischemic attack (TIA) in subjects with coronary heart disease (CHD) without atrial fibrillation (AF). ⋯ The CHADS(2) score predicts ischemic stroke/TIA in subjects with stable CHD and no baseline AF. The event rate in non-AF subjects with high CHADS(2) scores (5-6) was comparable with published rates in AF patients with moderate CHADS(2) scores (1-2), a population known to derive benefit from stroke prevention therapies. These findings should inform efforts to determine whether stroke prevention therapies or screening for silent AF may benefit subjects with stable CHD and high CHADS(2) scores.
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American heart journal · Aug 2011
Randomized Controlled Trial Multicenter Study Comparative StudyTemporal changes in the management and outcome of Canadian diabetic patients hospitalized for non-ST-elevation acute coronary syndromes.
There are limited data on the contemporary management and outcomes of non-ST-elevation acute coronary syndrome (NSTE-ACS) patients with diabetes in the "real world." We sought to evaluate (1) the temporal changes in the medical and invasive management and (2) in-hospital outcome of NSTE-ACS patients with and without diabetes. ⋯ Over the last decade, NSTE-ACS patients with diabetes continue to be treated more conservatively, despite evidence that they would derive similar or even greater benefits from aggressive treatment. This underutilization of evidence-based therapies among diabetic patients with NSTE-ACS in the "real world" may partly explain their worse outcome.
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American heart journal · Aug 2011
Randomized Controlled Trial Multicenter Study Comparative StudyA multicenter comparison of established and emerging cardiac biomarkers for the diagnostic evaluation of chest pain in the emergency department.
The aim of this study is to assess the role of novel biomarkers for the diagnostic evaluation of acute coronary syndrome (ACS). ⋯ Among emergency department patients with symptoms suggestive of ACS, neither ischemia modified albumin nor heart fatty acid binding protein detected or excluded ACS, whereas NT-proBNP, hsTnI, or FFAu added diagnostic information to cTnT. In the context of hsTnI results, FFAu measurement significantly reclassified both false negatives and false positives at baseline and in serial samples.