American heart journal
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Hospices provide end-of-life care for heart failure (HF) patients, but hospice is underused for these patients, and its use has not been well described. ⋯ Our study provides detailed estimates of hospice use and identifies potential areas of hospice care that are unique to HF patients. Our findings generate hypotheses about the Medicare Hospice Benefit, specifically whether changes to the 6-month prognosis criterion for hospice eligibility would result in increased hospice use for HF patients. We hope that our results will stimulate additional studies to elucidate differences in hospice use between HF and cancer patients, including patient perspectives of hospice care and clinician referral patterns.
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American heart journal · Jul 2009
Randomized Controlled Trial Comparative StudyBone marrow mobilization with granulocyte macrophage colony-stimulating factor improves endothelial dysfunction and exercise capacity in patients with peripheral arterial disease.
We hypothesized that granulocyte macrophage colony-stimulating factor (GM-CSF) administration will be safe and will improve endothelial dysfunction and exercise capacity by mobilizing progenitor cells in patients with peripheral arterial disease (PAD). ⋯ Granulocyte macrophage colony-stimulating factor therapy in patients with PAD was associated with mobilization of progenitor cells, improvement of endothelial dysfunction, and exercise capacity. The efficacy of strategies designed to mobilize bone marrow progenitors warrants further study in patients with PAD.
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American heart journal · Jul 2009
Delayed improvement of right ventricular diastolic function and regression of right ventricular mass after percutaneous pulmonary valve implantation in patients with congenital heart disease.
Percutaneous pulmonary valve implantation (PPVI) has been introduced as therapy for right ventricular (RV) to pulmonary artery conduit dysfunction in patients with congenital heart disease. It has been shown that RV systolic function improved early after PPVI. The effects of PPVI on RV diastolic function and RV hypertrophy have not yet been studied. ⋯ After PPVI, in contrast to rapid improvement of RV systolic function, the improvement of RV diastolic function is delayed. The reduction of RV mass appears to be the underlying mechanism for improvement of RV diastolic function. Long follow-up for patients with PPVI is recommended.
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American heart journal · Jun 2009
Regulatory and ethical considerations for linking clinical and administrative databases.
Clinical data registries are valuable tools that support evidence development, performance assessment, comparative effectiveness studies, and the adoption of new treatments into routine clinical practice. Although these registries do not have important information on long-term therapies or clinical events, administrative claims databases offer a potentially valuable complement. This article focuses on the regulatory and ethical considerations that arise from the use of registry data for research, including linkage of clinical and administrative data sets. (1) Are such activities primarily designed for quality assessment and improvement, research, or both, as this determines the appropriate ethical and regulatory standards? (2) Does the submission of data to a central registry, which may subsequently be linked to other data sources, require review by the institutional review board (IRB) of each participating organization? (3) What levels and mechanisms of IRB oversight are appropriate for the existence of a linked central data repository and the specific studies that may subsequently be developed using it? (4) Under what circumstances are waivers of informed consent and Health Insurance Portability and Accountability Act authorization required? (5) What are the requirements for a limited data set that would qualify a research activity as not involving human subjects and thus not subject to further IRB review? The approaches outlined in this article represent a local interpretation of the regulations in the context of several clinical data registry projects and focuses on a specific case study of the Society of Thoracic Surgeons National Database.
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American heart journal · Jun 2009
The impact of dyspnea on health-related quality of life in patients with coronary artery disease: results from the PREMIER registry.
Both angina and dyspnea are prevalent symptoms among post-myocardial infarction (MI) patients. Given their frequent overlap, little is known about the degree to which these symptoms provide independent information in this population. ⋯ Among post-MI patients, dyspnea is common and strongly associated with impaired QOL, more frequent rehospitalization, and reduced survival--independent of both clinical factors and angina. These findings suggest that dyspnea is an important component of disease-specific health status for post-MI patients, and its assessment should be strongly considered in both research studies and clinical practice.