Current cardiology reports
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Obesity and diabetes are chronic diseases frequently linked together. Durable weight loss is uncommon with medical/behavioral approaches. For severe obesity, bariatric surgery is the only treatment resulting in sustained weight loss. ⋯ Bariatric surgery reduces the incidence of diabetes in overweight insulin-resistant subjects and is associated with remission of diabetes in a large proportion of patients. In considering the usefulness of bariatric surgery, it is also important to recognize that long-term follow-up is required before assigning a beneficial therapeutic effect in patients with diabetes because of the potential for weight regain that has been observed. As diabetes is a lifelong disease, it is important to emphasize that a certain percentage of patients will suffer from relapse of their diabetes.
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Most secundum atrial septal defects (ASD) are amenable to device closure. Three- dimensional transesophageal echocardiography (3DTEE) can be used to obtain an en face view of the ASD and important surrounding structures which provides for analysis of the type, size, shape, orientation, number and position of orifices, ASD rims and important surrounding structures in a single live 3D echo view. ⋯ The respective 3D TEE modalities, imaging protocols, advantages and limitations will be discussed. Because it is useful, accurate and fairly simple to use, we have adopted 3D TEE for routine clinical use during ASD device closure.
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Increasing barriers to medical device innovation in the United States including constrained financial resources and rising research costs require that physicians take on greater involvement in medical device development, evaluation, and regulatory processes. Such involvement requires that physicians understand basic aspects of the regulatory process for medical devices and recognize the myriad opportunities for involvement in these activities.
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Transcatheter aortic valve replacement (TAVR) has recently emerged as an alternative to surgical aortic valve replacement for patients with severe aortic stenosis who are at "high risk" or deemed inoperable. Careful pre-procedural preparation requires multi-modality imaging. Intra-procedural imaging frequently relies on transesophageal echocardiography (TEE). This review will discuss the role of TEE in pre-implantation assessment, intra-procedural guidance, and post-implantation evaluation.
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Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls-most notably related to underperforming ICD leads-have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. ⋯ Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative.