Wireless, Batteryless Implantable Medical Products
One of the most important applications for this product family is Congestive Heart Failure (CHF) due to its clinical significance and large market. CHF patients have a damaged or overworked heart that cannot pump sufficiently to meet the metabolic demands of the body or can do so only with an elevated ventricular diastolic pressure. Secondary pulmonary edema occurs with the most severe cases of CHF.
Identified by the NIH [link] as the latest epidemic to hit the U.S., CHF is a major health problem worldwide, affecting 4.8 million U.S. patients and accounts for 978,000 or 5-10% of all hospitalizations. Some estimates show 550,000 new cases of CHF diagnosed each year in the U.S. alone. Currently, CHF accounts for 20% of all discharges in the over age 65 category; with the ageing demographic, this statistic is expected to increase significantly. Overall, the cost of treating CHF is very high ($38 billion annually in the U.S., representing 5.4% of total health care costs) and involves many physician visits (at least 11 million ambulatory visits per year). From 1979 to 1999, CHF deaths increased 145% and hospital discharges increased 155%. The fatality rate for CHF is high, with one in five persons dying within 1 year, more than half of the CHF patients dying within 5 years, and sudden death occurring at a rate of six to nine times that of the general population. One in five of all discharged patients age 65 and older had CHF as a primary or secondary diagnosis. A person age 40 or older has a one-in-five chance of developing congestive heart failure, according to a study published in Circulation: Journal of the American Heart Association [link]. Many patients suffering from this progressive, fatal disease tend towards an extremely poor quality of life and become increasingly unable to perform routine daily tasks.
CHF is mostly treated with medication in a very delicate manner to provide a balance between cardiac output (CO) and left ventricular end diastolic pressure (LVEDP). A major problem facing the effective treatment of CHF via ongoing tailored medication is the lack of a safe, low cost, easy method to regularly collect patient's medical data needed to maintain the balance between CO and LVEDP over time.
Currently, the treatment of CHF is mostly monitored to the best of physicians' capabilities through symptom evaluation, observational assessments, and echocardiography. Dr. Achi Ludomirsky, Director of Division of Cardiology, Department of Pediatrics, Washington University School of Medicine, summarizes the current CHF management as the observation of rudimentary parameters: "The physiologic parameters being used today in order to tailor home monitoring and management of CHF are patient weight, heart rate, and blood pressure". Observation of rudimentary physical symptoms (e.g., patient's weight) is low cost and possess no procedural risk; it is, however, medically very ineffective and results in a high risk of wrong dosage."
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