Current cardiology reports
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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.
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Platelet inhibition is the main goal of ancillary pharmacologic therapy during percutaneous coronary interventions (PCI). Thienopyridines and ticagrelor are oral drugs developed for this purpose. Cangrelor is an intravenous, non-thienopyridine antagonist of the P2Y12 receptor with a rapid, potent, predictable, and quickly reversible effect. ⋯ In a third trial that implemented the universal definition of MI, CHAMPION PHOENIX, a reduction of thrombotic events, including stent thrombosis, was observed. In the BRIDGE trial cangrelor has been studied in patients who had to prematurely interrupt antiplatelet therapy for surgery. Cangrelor appears a promising agent in patients who require PCI or when a rapid reversal is needed.
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Commotio cordis is increasing described and it is now clear that this phenomenon is an important cause of sudden cardiac death on the playing field. Victims are predominantly young, male, and struck in the left chest with a ball. An animal model has been developed and utilized to explore the important variables and mechanism of commotio cordis. ⋯ In the setting of altered repolarization a trigger of ventricular depolarization (premature ventricular depolarization caused directly by the chest blow) initiates a spiral wave that quickly breaks down into ventricular fibrillation. Prevention of commotio cordis is possible. Improved recognition and resuscitation have led to an improvement in outcome.