Abstract
Sudden Cardiac Death — SCD — is a major unmet health problem that needs urgent and prompt solution. AICDs are very expensive, risky and indicated for a small group of patients, at the highest risk. AEDs — Automatic External Defibrillators — are designed for public places and although safe, cannot enter the home-market due to their cost and need for constant, high-cost maintenance. We developed TED, a low-cost AED that derives its energy off the mains, designed for home-use, to save SCD victims’ lives.
Sudden cardiac death (SCD) – caused by ventricular fibrillation (VF) or standstill – occurs in about 350,000 persons every year in the US alone and in about 3 million worldwide and the majority of them occur in the low-risk group at relatively younger age, in their best years of life, usually witnessed — at home or office. Since survival drops by 10% for every minute delay, no ambulance in the world will be quick enough to save them or leave them without neurological damage that will put them in a nursing home, at a huge cost for family or society. Since SCD may occur in apparently healthy people, without any preceding symptoms, all people, especially above age 40 or at risk for myocardial infarction, are at risk.
Therefore every home or office should have a defibrillator device, exactly like they have fire-extinguishers, but isn’t our life more precious than our home? Of course the first group in urgent need for such a device is the high risk group for sudden death: those with reduced heart function after heart attacks; part of them will get automatic implantable defibrillators (AICDs) at a cost of approximately $20,000 each, but those uninsured or not eligible due to co morbidities or high age or during the first month after acute MI or CABG and the big rest of the world (developing countries)-no economy there can afford AICD implantation to all who need it-and it will be recommended by physicians to have at least a low-cost automatic external defibrillator(AED). AICDs require surgical implantation and may deliver inappropriate shocks and thus are risky. These devices can also cause grave psychological effects, especially to the young and elderly, with end-of-life dilemmas. Patients with AICDs need constant care, follow-up in dedicated centers and replacement.
The existing AEDs, which are now distributed in public places such as in airports, airplanes and schools and are purchased more and more – although approved by FDA for home use several years ago – are not a good solution for home-use, due to their high cost (about $1000–$2000 each) for battery and capacitor not needed in TED and their big maintenance problem; such a device that lies for years in the office or home and not in use may not work in the instance you urgently need it due to battery or capacitor failure. They do not have pacing capabilities due to their limited energy source and only 7% of SCD victims were relatively close (within 4 min distance to an AED).
Our TED device, modifies by computer the sinusoidal alternating electrical current from the mains to a biphasic defibrillatory wave, similar to that of standard AED (see Figure ). Since it derives its energy from the mains, it will always be operational as long as it will be plugged in via a running cord to the mains outlet and its cost is affordable to every household — about 300$ only and even less if mass production (as expected) will be used. In addition since there is no need to charge the capacitor it may deliver immediately repeated shocks in case of failed shocks, at a higher energy and to externally pace the heart in case bradycardia or standstill caused SCD or it occurred after the electric shock. It may also use rapid pacing to stop ventricular tachycardia instead of shock—all these features cannot be delivered by existing AEDs. Our device will drastically reduce the huge number of sudden cardiac deaths as well as may be reimbursed by insurance companies or HMOs since this will solve a huge unmet need with an unlimited market.
