SUDDEN: Out of Hospital Sudden Unexpected Death Project

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SUDDEN: Out of Hospital Sudden Unexpected Death Project Center for Heart and Vascular Care Division of Cardiology, Cardiac Electrophysiology Section Ross J Simpson, Jr, MD, PhD, Project Leader Irion W Pursell, Jr., RN, Co Project Leader Carter Devlin, BS, Post-Graduate Intern Paul Mounsey, MD, Chair, Steering Committee February, 2008

Conclusions 1. Out of hospital sudden unexpected death (OHSUD) is underreported 2. The majority of OHSUD victims are not candidates for resuscitation and for those that are, resuscitation is almost always futile 3. Prevention is the only strategy that will lower the incidence of OHSUD

Why SUDDEN? Institute of Medicine Report (July, 2015) Strategies to Improve Cardiac Arrest Survival: A Time to Act Identifies Out of Hospital Death as a critical need for study Confirms the need for a OHSUD registry

Mummy CT scans show hunter-gatherers had clogged arteries Lancet 2013

Prevalence of CVD: NHNES Go AS Circulation 2013 10/25/2015 5

What is SUDDEN? A teaching and research platform focused on the epidemiology and prevention of out of hospital sudden unexpected death (OHSUD).

What is Sudden Unexpected Death? It s not just sudden cardiac arrest

What is Sudden Unexpected Death? It s not just sudden cardiac arrest Sudden Unexpected Death Acute Myocardial Infarction Arrhythmia Intracranial Emergencies Pulmonary Embolism Aortic Catastrophe Slovis, C., et al. Five Common Causes of Sudden Unexpected Death. Patient Care. January 21, 2015

Sudden Unexpected Death Survival rate for out of hospital, potential sudden death event 3 to 10 % Rates depend on how you select entry criteria The focus needs to shift to.. Risk stratification Prevention Cost effective use of current modalities

Sudden Unexpected Death Obstacles to understanding OHSUD: No uniform description of OHSUD Magnitude in general population is unclear Occurrence in African Americans is underreported Death certificate data has limitations

SUDDEN Process Flow Electronic Death Certificate Procurement Out of hospital, non-homicide/suicide deaths, 18-64 years old EMS Referral Matching Dead on Scene/Non Transported Cases Record Procurement Medical Records, Medical Examiner Reports, Death Certificate Data Inclusion Screening Free-living, natural, unexpected death in county of residence SUDDEN Cohort

SUDDEN Design Use a prospective, community based data collection process to establish the epidemiology of OHSUD Objectives Establish a baseline description of OHSUD Determine incidence rate of OHSUD Determine variation by race, gender, and socioeconomic class Establish geographic and personal risk models for OHSUD with a view to targeted prevention strategies

SUDDEN Registry Management Steering Committee Coordinates all study activities, provides oversight and is responsible for all issues related to data security and compliance Ethics Committee Deals with study protocol and ethical issues Writing Committee Responsible for all research output.

SUDDEN - Approval and Compliance Status Institutional Review Board Exempt from IRB approval because submission does not constitute human subjects research as defined under federal regulations [45 CFR 46.102 (d or f) and 21 CFR 56.102(c)(e)(l)] HIPAA Registry designated HIPAA Compliant Steering Committee responsible for ongoing oversight and compliance Medical Records procured for screened subjects only and de-identified Legal Business Associate Agreement Data Use Agreement Registry protocol reviewed and approved by UNC Compliance Officer

SUDDEN Facilitators Center for Disease Control Mary G. George MD, MSPH, FACS, FAHA The Honorable Richard Burr Margaret Coulter, Health Policy Assistant NC Vital Statistics Eleanor Howell Justus Warren Heart Disease and Stroke Prevention Task Force Anita Holmes, JD Strengthening The Black Family Association Melvin Jackson, Director Office of the NC Chief Medical Examiner Deborah Radisch, MD, MPH NC Office of Emergency Medical Services Antonio Fernandez, PhD NC Department of Health and Human Services Chris Hoke, JD

SUDDEN Center for Disease Control and Prevention Presentation February 22, 2015 24 Epidemiologist and Physicians Validation of methods Expansion mandate US and Internationally

SUDDEN McAllister Heart Institute NC Office of the Chief Medical Examiner UNC Gillings School of Public Health UNC School of Family Medicine UNC School of Social Work Eshelman School of Pharmacy North American SUDEP Registry (Epilepsy) Medical University of South Carolina Environmental Protection Agency (EPA) International Society for Traumatic Stress Studies (PTSD)

Sudden Referrals

SUDDEN Referrals FY2013 FY2014 FY2015(EST) Total Referrals 1680 2409 4762 Probable Cases 336 482 952 of OHSUD

SUDDEN Referrals Current EMS Counties Actively Sending Data Wake Mecklenburg Guilford Onslow Surry New Hanover Lincoln Charleston (SC) Agreed to Participate Forsyth Franklin Orange Johnston Randolph Robeson Rowan Pending EMS Counties Bertie Brunswick Catawba Cumberland Pender Pitt Warren Wilkes Berkeley (SC) Dorchester (SC)

SUDDEN Referrals

The study is not possible without EMS participation

SUDDEN What we need from EMS: Query of EMS clinical software for out of hospital deaths Monthly referrals transmitted by secure email The referral process is very low maintenance and critically important to the project

SUDDEN What we provide to EMS: Access to information Three standardized, geocoded reports sent to EMS quarterly OHSUD Victim Profile Resuscitation Analysis for OHSUD Victims Comorbidities and Risk Factors for OHSUD Victims

OHSUD Victim Profile from Wake Pilot Data

Resuscitation Comparison for Wake County Pilot Data

SUDDEN Update Recently closed 2 nd year of Wake County Pilot Data 409 OHSUD over two years in Wake County New data collection process implemented Actively processing data in Wake, Guilford, Mecklenburg, Lincoln, Surry, Onslow, New Hanover, and Charleston (SC) Expanding within NC and into SC

Percent of Group SUDDEN Race and Gender 70% 60% Male/White 50% Male/African American 40% Female/White 30% Female/African American 20% 10% 0% <=35 36-45 46-55 >55 Age Lewis, Mary Elizabeth, Feng-Chang Lin, Parin Nanavati, Neil Mehta, Louisa Mounsey, Anthony Nwosu, Irion Pursell, Eugene Chung, J.P. Mounsey, and Ross J. Simpson, Jr. Sudden Unexpected Death in Women. Heart (submitted)

OHSUD Victim Profile from Wake Pilot Data

EMS Public Health Survey

SUDDEN Prevention: EMS Survey Justification We believe county EMS is a integral partner in OHSUD prevention EMS has the potential to become leaders in public health Purpose To gauge interest and motivation in becoming public health leaders To learn about what factors have prevented EMS participation in public health education in the past

SUDDEN Prevention: EMS Survey Sudden cardiac arrest rates will likely change with intervention Agree 71% Disagree 11 Unsure 17

SUDDEN Prevention: EMS Survey If given more information about OHSUD in my region, my participation in public health education would increase Agree 73% Disagree 2 Unsure 25

SUDDEN Prevention: EMS Survey I have the resources (funds) necessary to participate in public health education Agree 9% Disagree 74 Unsure 17

Intervention Plan Collaborate with EMS and hospitals for preemptive case management Use EMS geo-coded data to identify atrisk areas and deliver focused, preventative messages

Conclusions 1. OHSUD is underreported 2. The majority of OHSUD victims are not candidates for resuscitation and for those that are, resuscitation is futile 3. Prevention is the only strategy that will lower the incidence of OHSUD