Journal of electrocardiology
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Although there are rising public expectations about the prospects for new therapies based on advances in biomedical discoveries, the rate of new product submissions to the Food and Drug Administration (FDA) has not been increasing. Alarmingly, over the past 6 years, there has been a 30% decline in submissions. The reasons for this are multifactorial and include new science not at its full potential, mergers/business arrangements have decreased candidates, chronic disease is harder to study, the failure rate has not improved, and rapidly escalating costs and complexity. ⋯ The partnership is designed to expand product opportunities by sharing existing knowledge and data, allowing the development of enabling standards, to improve drug development and approval. A central tenant of Critical Path is a focus on the evaluative science of the drug approval process, including both efficacy and safety measures. The FDA Electrocardiogram Warehouse is 1 example where a government resource could be used by a confluence of groups to improve the science surrounding important components of the drug approval process such as cardiac safety evaluation.
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In patients with ST-elevation myocardial infarction, fast initiation of reperfusion therapy is mandatory. It is well established that prehospital diagnosis results in earlier initiation of fibrinolysis, but there is limited evidence concerning the value of prehospital evaluation in patients treated with primary percutaneous coronary intervention (PCI). ⋯ In this setting, continuous real-time 1-lead ECG transmission from ambulance to hospital may allow physicians to support ambulance personnel in the treatment of arrhythmias during transportation; and (4) equipment used for prehospital ECG acquisition and transmission has built-in features for continuous ST-segment monitoring. It is hypothesized that continuous ST-segment monitoring performed in the prehospital phase and during primary PCI may provide important prognostic information, with the potential of triaging future pharmacological and interventional treatment at time of PCI.
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Use of intravenous fibrinolytic agents and percutaneous coronary interventions produce the greatest benefit when they are implemented in the first 2 hours after symptom onset. Further delays in the time to treatment typically lead to reduced benefits and poorer outcomes. ⋯ The examples included in this article illustrate that the system and technology can work if applied in a coordinated fashion using multiple disciplines including emergency medical service, cardiologists, ED personnel, and the hospital cardiac care team, which includes the catheterization laboratory call team, acute coronary care nurses, and clerical support staff.
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In keeping with its mandate to provide the least burdensome means of product regulation, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health uses many different standards to facilitate the review of premarket submissions of medical devices. The benefits of using standards in this manner include providing a set of common requirements and test protocols to the device manufacturer, thus reducing the manufacturer's need to "reinvent the wheel" for each new bench test to ensure safety and effectiveness of the device. With the current trend toward international harmonization of standards, tests performed in accordance with an international standard may be acceptable to several countries. ⋯ One approach begins with the recognition of only some provisions of a standard, or more commonly, excluding those parts of a standard that are unacceptable to the FDA for regulatory or scientific validity reasons. Other approaches include working with the standards development organizations to revise the standard to include language more agreeable to all parties involved. Specific examples will be presented on medical devices, such as electrocardiogram cables and connectors, and noninvasive blood pressure monitors.
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We report a case of 54-year-old man who presented to hospital with severe prolonged retrosternal chest pain of anginal nature. Electrocardiogram taken by his general practitioner showed minimal ST elevation in chest leads V1 and V2; there was also marked right axis deviation of P wave (negative in lead I and aVL) and of QRS complexes, together with low voltage in precordial leads V4 through V6 suggestive of dextrocardia. ⋯ The extent of MI in such patients may be underestimated unless dextrocardia is timely recognized and leads reversed. We recommend that for patients with dextrocardia and situs inversus presenting with MI, both chest and limb leads be reversed to reveal the true extent of the infracted area.