Published on March 8, 2014
TED-‐Time and life-‐saving External Deﬁbrillator: a Home AED Inventors and patent holders: Prof. A. Teddy Weiss & team at Hadassah Hospital, Jerusalem, Israel firstname.lastname@example.org
Sudden Cardiac Arrest The Need • Sudden Cardiac Arrest (SCA)-‐ventricular ﬁbrilla<on (VF)-‐ kills 350000 people in the US alone, each year, about 3 million worldwide, at the prime-‐<me of their life, mostly witnessed and at home /oﬃce. • Deﬁbrilla<on procedure must be performed as soon as possible: survival decreases by 10% for every minute of delay-‐therefore ambulance help at home-‐ too late! At present, only very few of SCA vic<ms at home survive and many-‐ in coma, in nursing homes. • TED is a home consumer solu<on that is much more aﬀordable and reliable. The novelty in our deﬁbrillator device is based on a computerized modiﬁca<on of the alterna<ng current, from the mains , exis<ng in every home, to the FDA-‐ approved biphasic deﬁbrillatory wave.
Sudden Cardiac Arrest The Evolu<on • External Deﬁbrillators-‐ used in hospitals, since 1960s • AICD-‐for the very high risk pts-‐since 1980s • AED used by trained emergency personnel have become an essen<al link in the “Chain of Survival”(CPR), since 1980s • The logical extension of the AED concept is the Public Access Deﬁbrillator (in airplanes, airport, casino)-‐infrequent use, by laymen and since safe-‐ FDA approved its use at home-‐2000 • A further logical extension of the Public Access Deﬁbrillator is our TED -‐ Personal Deﬁbrillator to be used at home/oﬃce
Current Solu<ons AICD • • • • • • VERY HIGH COST (20,000$) NEEDS OPERATIVE PROCEDURE (RISKY) MAY DELIVER INAPROPRIATE SHOCKS NEEDS CARE AND REPLACEMENT PSYCHOLOGIC BURDEN END-‐OF-‐LIFE PROBLEMS
Current Solu<ons AEDs-‐ in public places • HIGH COST PER UNIT (1000-‐2000$) • HIGH COST FOR MAINTENANCE (about 2000$ PER YEAR). -‐-‐ SINCE INTENDED FOR LONG STORAGE-‐ MAY NEVER BE USED OR CHECKED -‐-‐WHEN NEEDED IN EMERGENCY-‐MAY NOT WORK: BATTERY OR CAPACITOR FAILURE • NO PACING CAPABILITIES IN CASE OF VERY SLOW HEART RATE OR ASYSTOLE • NOT CLOSE ENOUGH TO SCA VICTIMS (ONLY 7% OF SCA-‐WERE IN 4 MINUTE DISTANCES FROM AEDs LOCATED IN PUBLIC PLACES).
Current Solutions AED • MAINTENANCE COST IS HIGH-‐2363$/YEAR • AS REPORTED BY ZOLL
TED Solu<on Main ideas • Use the AC mains as source of energy • Shape by computer the sinusoidal waveform-‐to a similar deﬁbrilla<on wave as that of a standard AED • Maximum ﬂexibility in future waveform genera<on achieving bener results with less Energy • Use a High Voltage Step Up Transformer
A Typical Monophasic Waveform Basic Output Waveform Classic Style 0 5 10 15 20 25 Time (msec) 30 35 40 45 50
TED Solu<on A Typical AC-‐derived Biphasic Waveform Basic Biphasic Output Waveform Classic Style 0 5 10 15 20 25 Time (msec) 30 35 40 45 50
TED Solu<on Advantages • Immediately opera<onal • No delay in repeated opera<on allowing: – Repeated deﬁbrilla<on , no need to recharge – Pacing in case of Cardiac Stands<ll or Bradycardia – Pacing override for VT termina<on • No Need for baneries and capacitor • Lower cost , more reliable than AEDs Therefore-‐ideal for home-‐use
Leading to … • Lower cost per unit • Maintenance Free • Reliable Therefore ideal for Use at Home Preferable to existing AEDs
Sudden Cardiac Arrest The market • It should be recommended by physicians to pa<ents at increased risk of SCA-‐following myocardial infarc<on(MI), hypertrophic or dilated cardiomyopathy or gene<c inclina<on for ventricular arrhythmias • It could be an alterna<ve treatment for pa<ents who are candidates for surgically implanted deﬁbrillator-‐ AICDs: poor Leo Ventricular Func<on-‐in US alone, A. Moss es<mates about 10 million pts=200 billion $-‐NO state economy can aﬀord it! Its use in developing countries-‐limited • Pa<ents post MI, or at risk for MI, or with heart failure • 50% of men and 63% of women SCA vic<ms previously reported no CHD symptoms,-‐it may aﬄict anyone, any<me...
Sudden Cardiac Arrest AICD Automa<c Internal Cardiac Deﬁbrilla<on (X20) LVD Leo Ventricular Dysfunc<on (X10) CHF Conges<ve Heart Failure (X8) MI Myocardial Infarc<on (X5) The market TED targets by risk group AICD candidates LVD-‐CHF Post MI Good LV High risk for MI Age> 40
Sudden Cardiac Arrest The market Ideally a personal AED should be present in every home exactly like ﬁre ex<nguishing equipment. Lower Cost will lead to an almost unlimited market.
First Animal Study: Deﬁbrilla<on 5 small pigs (30-‐40 Kg body weight) General anesthesia with ketamin and isoﬂuoran A single quadripolar pacing catheter was inserted percutaneously through one of the femoral veins or jugular vein VF was induced with rapid ventricular burst pacing or T wave shock Deﬁbrilla<on of stable VF aoer 15 seconds If failed , immediate rescue shock with a higher energy or DC shock DFT determined with AC shock, than again with DC shock delivered with a commercial external deﬁbrillator (Zoll) using a step-‐down protocol Comparison of DFT between modiﬁed AC and standard DC shock
First Animal Study: Deﬁbrilla<on 49 J AC Successful Deﬁbrilla<on
Successful Deﬁbrilla<on 50 J DC
An Advanced Biphasic Waveform Advanced Biphasic Output Waveform 0 5 10 15 20 25 Time (msec) 30 35 40 45 50
Comparison of AC and DC DFT in each pig a b
First Animal Study: Deﬁbrilla<on DFT with MAC versus DC Shocks
First Animal Study: Deﬁbrilla<on Rescue Shock-‐18 sec aoer ﬁrst shock
Second Animal Study • • • • • • Six rats Mean weight 491.7±123.7 grams mid LAD was occluded at 3 moths age 3-‐6 months for complete recovery MAC deﬁbrilla<on-‐successful in all External pacing-‐at a rate above sinus rhythm-‐ successful in all
Second Animal Study: External pacing Pacing 8 Volts Threshold Sinus
Conclusions • Modiﬁed AC Shock Deﬁbrilla<on is feasible and as eﬀec<ve as the standard biphasic DC Deﬁbrilla<on • Repeated higher energy shocks are quickly available • External Pacing is feasible and durable due to unlimited energy We suggest this type of deﬁbrilla<on shock to be implemented in Automa<c External Home Deﬁbrillators This low-‐cost new technology should be used to treat sudden cardiac arrest occurring at home/oﬃce and to save lives
Publica<ons Europace Shimon Rosenheck, Shraga Gorni, Ioni Katz, Asaf Rabin, Uri Shpoliansky, Mendel Mandelbaum, and Abraham Teddy Weiss (2009) Modiﬁed alterna2ng current deﬁbrilla2on: a new deﬁbrilla2on technique, Europace 11, 239–244. Awards: Neufeld prize for the best paper from the Israeli Heart Society (2010)
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