1. Redefining the Next Generation of AEDs Comilla Sasson, MD, MS Assistant Professor, Dept of EM University of Colorado Denver comilla.sasson@ucdenver.edu FDA External Defibrillator Initiative: Silver Springs, MD Dec. 15 th -16 th, 2010

2. Overview Background on out-of-hospital cardiac arrest −What we know −What we don’t know PAD Summit July 2010 AED Wishlist

3. What we know: 1.No change in survival in 30 years

4. Temporal Trends on OHCA Survival Sasson, C. et. al. Circulation Cardiovascular Quality and Outcomes, 2009

5. What we know: 1.No change in survival in 30 years 2.Huge variation in OHCA survival -0.3% in Detroit 1 to 20.4% in Seattle 2 -Denver 3 - 8.0% 1.Dunne et. al. Resuscitation 2007 2.Nichols et. al. JAMA 2008 3.Haukoos et. al. Annals of Emergency Medicine 2009

6. What we know: 1.No change in survival in 30 years 2.Huge variation in OHCA survival by city 3.AEDs are not being widely used

7. AED Data from CARES Oct. 1 st, 2005 - Dec. 31 st, 2009 Catchment area of 22 million people 20,018 Arrests Total 20% (n=4,010) Arrests in Public Location -11.5% (n=461) of Public Arrests had a Bystander Apply an AED

8. AED Used (n=428) AED Not Used (n=39) AED Present not Used (n=8) AED Mal- function (n=2) Public Building (n=107)106010 Street/Highwa y (n=9)9000 Physician's Office/Medical Building (n=113)981410 Recreation/Sp orts Facility (n=47)47000 Residence/Ins titution (n=22)21100

9. AED Used (n=428) AED Not Used (n=39) AED Present not Used (n=8) AED Mal- function (n=2) Public Building (n=107)106010 Street/Highwa y (n=9)9000 Physician's Office/Medical Building (n=113)981410 Recreation/Sp orts Facility (n=47)47000 Residence/Ins titution (n=22)21100

10. AED Used (n=428) AED Not Used (n=39) AED Present not Used (n=8) AED Mal- function (n=2) Industry (n=17)16100 Jail (n=40)36211 Airport (n=40)40000 Hospital (n=25)151000 Educational Inst (n=12)12000 Other (n=29)28010

11. AED Used (n=428) AED Not Used (n=39) AED Present not Used (n=8) AED Mal- function (n=2) Industry (n=17)16100 Jail (n=40)36211 Airport (n=40)40000 Hospital (n=25)151000 Educational Inst (n=12)12000 Other (n=29)28010

12. CARES Dataset 19.1% of total sample survived to hospital d/c 22.5% of patients with AED used survived to hospital d/c Patients who were 18-34 years old ([OR] 1.59 95% [CI] 1.12-2.25) and male (OR 1.19; 95% CI 1.01-1.39) were more likely to have an AED used during an OHCA event Patients who lived in the western region were least likely of the 4 regions to have an AED used (OR 0.36; 95% CI 0.17-0.77)

13. What we don’t know: 1.How can we create the Next Gen AEDs to increase AED utilization? 2.Can we build consensus on how this process can be done and what milestones must be met in order for this to occur?

14. PAD Summit July 2010 Called for by the University of Colorado and Sudden Cardiac Arrest Association Held in Washington D.C. July, 2010 Attendees: FDA, Defibrillator manufacturers (5), APCO, NENA, NAEMT, NASEMSO, Office of EMS (NHTSA), AHA, OnStar, AED Advocacy Groups

15. Goals of the Summit: Sit in the Same Room Together Introduce New Technology (including NextGen 911) Identify Major Barriers and Facilitators to creating the Next Gen of AEDs Create an Action Plan with Major Milestones Identified

16. After 6 Hours of Negotiating… 1) Create AED Wishlist of core functionality that medical community and public would want for the next generation of AEDs 2) Development of a Pilot AED Registry

17. OtherAED FunctionalityDevice Components NEXT GENERATION AEDs

18. OtherAED FunctionalityDevice Components NEXT GENERATION AEDs

19. Device Components Universal electrodes and wiring system Batteries – longer life; rechargeable Servicing reminders sent automatically by email AED case latches Diagnostics designed so service provider can understand Cabinet design – linking to 911 Global positioning software capability

20. OtherAED FunctionalityDevice Components NEXT GENERATION AEDs

21. AED Functionality Wireless data export of GPS or patient- monitored data. Remote updating of software to accommodate AHA guideline changes. Integrated CPR coaching with feedback Predictive wave-analysis software: –Make better internal algorithms for classifying rhythms adjustable. –Be able to have rhythm analysis during CPR.

22. OtherAED FunctionalityDevice Components NEXT GENERATION AEDs

23. Other Develop less costly units to increase availability and access Adult vs. pediatric modes Multilingual support and visual impaired Mobile handheld device; smaller units Integration into PSAP / Emergency Medical Dispatch Integration into Next Gen 9-1-1

24. Acknowledgements Key stakeholder groups and their wishlist items: APCO, NENA, EMD, ACEP, NAEMSP, NAEMT, NASEMSO, State of Washington University of Colorado Food and Drug Administration Centers for Disease Control and Prevention Sudden Cardiac Arrest Association AED Working Group Members Emory University- Dr. Bryan McNally