TED External Home Defibrillator for Home Consumer innovation

1. TED-‐Time and life-‐saving External Deﬁbrillator: a Home AED Inventors and patent holders: Prof. A. Teddy Weiss & team at Hadassah Hospital, Jerusalem, Israel atweiss@hadassah.org.il

2. 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.

3. 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

4. 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

5. 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).

6. Current Solutions AED •  MAINTENANCE COST IS HIGH-‐2363$/YEAR •  AS REPORTED BY ZOLL

7. 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

8. A Typical Monophasic Waveform Basic Output Waveform Classic Style 0 5 10 15 20 25 Time (msec) 30 35 40 45 50

9. 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

10. 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

11. Leading to … •  Lower cost per unit •  Maintenance Free •  Reliable Therefore ideal for Use at Home Preferable to existing AEDs

12. 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...

13. 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

14. 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.

15. 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

16. First Animal Study: Deﬁbrilla<on 49 J AC Successful Deﬁbrilla<on

17. Successful Deﬁbrilla<on 50 J DC

18. An Advanced Biphasic Waveform Advanced Biphasic Output Waveform 0 5 10 15 20 25 Time (msec) 30 35 40 45 50

19. Comparison of AC and DC DFT in each pig a b

20. First Animal Study: Deﬁbrilla<on DFT with MAC versus DC Shocks

21. First Animal Study: Deﬁbrilla<on Rescue Shock-‐18 sec aoer ﬁrst shock

22. 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

23. Second Animal Study: External pacing Pacing 8 Volts Threshold Sinus

24. 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

25. 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)

26. Thank you