U.S. Mortality by Death Certificates Redefining Sudden Cardiac Death: Insights from the 500,000 San Francisco POstmortem 400,000 Systematic invesTigation of # deaths/year 300,000 Sudden Cardiac Death Study 200,000 100,000 17 December 2016 33 rd Annual Advances in Heart Disease 0 AIDS Breast Lung Stroke SCD Park Central Hotel, San Francisco Cancer Cancer Zian H. Tseng, M.D., M.A.S. 1 U.S. Census Bureau, Statistical Abstract of the United States : 2001. Associate Professor of Medicine in Residence 2 American Cancer Society, Inc., Surveillance Research, Cancer Facts and Figures 2001. Murray Davis Endowed Professor 3 2002 Heart and Stroke Statistical Update , American Heart Association. Cardiac Electrophysiology Section 4 Circulation . 2001;104:2158-2163. University of California, San Francisco RCTs, Registries: Sudden Cardiac Death Etiology of Sudden Cardiac Death • VALIANT trial: Valsartan after acute MI and HF – “The cause of death was considered as SCD if death occurred suddenly and unexpectedly in a patient in otherwise stable condition, with no premonitory HF, MI, or another clear cause of death. These could have been witnessed deaths (with or without documentation of arrhythmias) or unwitnessed deaths if the patient had been seen within 24 h before death.” • MERIT-HF trial: Metoprolol for Heart Failure – “Witnessed instantaneous death in the absence of progressive circulatory failure lasting for 60 min or more, unwitnessed death in the absence of pre-existence progressive circulatory failure or other causes of death” • Hinkle-Thaler, 1982: – “No evidence of circulatory impairment until they collapsed and the pulse disappeared” • SCD-HeFT and MADIT 2 – No definition of SCD Huikuri et al. N Engl J Med , Vol. 345 2001 1
EMS: Out of Hospital Cardiac Arrest ACC/AHA/HRS: Sudden Cardiac Death ACC/AHA/HRS, 2006: 2004: CDC established Cardiac Arrest Registry to Enhance Survival (CARES) to precisely define OHCA “ SCA is the sudden cessation of cardiac activity so that the outcomes in the continuum of emergency cardiac care: victim becomes unresponsive, with no normal breathing and no 911 dispatch centers, EMS providers, and receiving signs of circulation. If corrective measures are not taken rapidly, this condition progresses to sudden cardiac death. ” hospitals “OHCA is a cardiac arrest that occurred in the pre- hospital setting, had a presumed cardiac etiology, and involved a person who received resuscitative efforts, including CPR or defibrillation.” Methodological Issues in Population Studies of SCD Sudden Cardiac Death: Definition § US incidence estimates: 184,000 - 450,000 annually (2.5-fold range) World Health Organization (WHO), 1969: – Unexpected death within 1 h of symptom onset if witnessed – Unexpected death within 24 h of having been observed alive and § Where does the data come from? sx-free if unwitnessed § Death certificate review of listed COD • Out-of-hospital § Retrospective review of paramedic/ER narratives § Incomplete medical records • Absence of obvious noncardiac condition • Presumed sudden pulseless condition § Which definition should we use for SCD? § WHO (Hinkle-Thaler) criteria? § Documented VF? § CARES? § Witnessed cases only? 2
Emperor’s New Clothes? • ~ 90% of SCDs occur out of hospital (OOH) 1 in jurisdiction of coroner or medical examiner (ME) 14 February 2016 • Investigation after such natural deaths is not routine ME practice. Autopsy rates: • OOH deaths: ~10% (U.S.), 2 23% (Finland) 3 • Hinkle-Thaler: 27% 4 • Exemplar autopsy studies demonstrating CAD as cause of > 80% of SCDs 5,6 therefore limited by referral bias 1. Nichol JAMA 2008 2. Shojania NEJM 2008 3. Lunetta Inj Prev 2007 4. Hinkle, Thaler Circulation 65,1982. 5. Davies Circulation 85, 1992 6. Burke….Virmani NEJM 1997 Comprehensive Surveillance of SCD Comprehensive Surveillance of SCD § Oregon–SUDS (Chugh, JACC , 2004) § Oregon–SUDS (Chugh, JACC , 2004) § WHO criteria § WHO criteria § Portland, OR: population 1,000,000 § Portland, OR: population 1,000,000 § Track dozens of ambulance companies and area § Track dozens of ambulance companies and area hospitals hospitals § Review of all available records § Review of all available records § SCA+SCD: 53/100,000 § SCA+SCD: 53/100,000 Autopsy rate: 11% Chugh SS et al J ACC 2004 Chugh SS et al J ACC 2004 3
Sudden Cardiac Arrest vs. Sudden Cardiac Arrest vs. Sudden Cardiac Death Sudden Cardiac Death SCA SCA SCD SCD? Sudden “Cardiac” Death Sudden Arrhythmic Death SCA SCA CAD CAD Tamponade Tamponade Valvular Valvular Neurologic Neurologic DCM DCM HCM HCM Hemorrhage Ao Dissection Hemorrhage Ao Dissection 1 o electrical disease 1 o electrical disease 4
San Francisco POST SCD Study PO stmortem S ystematic Inves T igation of S udden C ardiac D eath San Francisco County • Single ME Office serving 49 mi 2 , pop 864,000 (~1.5M business hrs) • Racially/Ethnically diverse: 33% Asian, 6.1% Black, 15% Hispanic, 48% White All out of hospital and ER deaths reported • 8 Hospitals, 3 ambulance companies by law to ME (SFFD responds to ~85% of 911 calls) Every Incident SCD • By CA state law, all OOH or ER 2011- deaths are reported to the ME UC SF Medical Examiner SF Cardiology Case Adjudication Methods Data reviewed at adjudication - PMH (active problems, prescriptions, recent visits) • Daily AM review of all OOH deaths reported to ME - Medications (Rx, QT-prolonging, methadone) to determine WHO SCDs ages 18-90 y for full - EMS runsheets and rhythms autopsy, histology, tox - Witness/family interviews - Autopsy, tox, histology findings • All county death certificates retrieved and reviewed Adjudication panel quarterly from DPH to cross-check for missed SCDs • IRBs with all county hospitals and ambulance companies • Outside medical records obtainable via ME medicolegal authority Dr. Phil Ursell Dr. Ellen Moffatt Dr. Zian H. Tseng Dr. Jeff Olgin Dr. Anthony Kim Chief Cardiac Medical Examiner, Study PI Chief of Cardiology, Neurologist Director of UCSF Pathologist City and County of Cardiac UCSF Stroke Center UCSF San Francisco Electrophysiologist, UCSF 5
PO stmortem S ystematic Inves T igation of S udden C ardiac D eath…….. POST SCD Demographics February 1, 2011 – March 1, 2014 SCD Criteria Deaths in San Francisco Key for Case Review: Witnessed: Symptoms <1 hour of death 2/1/2011-3/1/2014 p* SCD with Death Certif. (DC) Only SF Adult N=20441 Unwitnessed: Observed well within 24 hours of death SCD with SCD without Autopsy vs. US Adult Population Not Reported to ME EMS + Initial ME Investig. Excluded: Known metastatic CA, ESRD on HD, Population N= 7769 Autopsy Autopsy without 2011 All Records (all medical Hospice, Hospitalization <1 mo 2011 (See Table 1A) Deaths Reported to ME: Autopsy records, EMS run sheets and all ER, OOH, Unexpected ME records) N 525 105 - 690,689 232,556,019 Inpatient Death Adjudication Age, mean ± SD 62.8 ± 14.5 73.1 ± 11.6 0 - - N= 12672 Non-Natural Deaths Accidental OD Deaths 18-90 37-89 - - - N= 2021 N=815 Natural Deaths Excluded- Age <18 or >90 350,179 112,848,136 (See Table 1B) Male, n (%) 362 (69%) 74 (70%) 0.82 N= 10651 N= 1998 (51%) (49%) Race (%) Excluded- Inpatient/Hospice OOH Natural Deaths, 18- Under MD Care < 3 weeks 290,089 149,300,964 N= 3843 90 yo, N= 4810 White 279 (53%) 44 (42%) Signed Death Certificate, (See Table 1C) (42%) (64%) Ineligible for Autopsy 40,751 28,371,834 OOH Deaths, Eligible for Black 81 (15%) 8 (8%) N= 1120 (6%) (12%) Autopsy 102,913 37,441,519 N= 3690 Excluded at Initial Presentation Hispanic 40 (8%) 8 (8%) 0.001 (15%) (16%) (Non-Sudden or Ineligible) WHO SCD w/o Autopsy Non-Sudden Deaths N= 2776 232762 11,395,245 SCD by EMS N= 89 N= 1031 Asian 110 (21%) 37 (35%) (See Table 1C) referred for autopsy (34%) (5%) (See Table 1C) N= 914 EMS SCD 24,174 6,046,457 Other 15 (3%) 8 (8%) Refused Autopsy (3%) (3%) N= 16 Autopsied EMS SCDs Median Income Excluded after comprehensive N= 898 184,288,905 records review 248 (50%) 43 (45%) 266,642 (39%) Tertile 1 (79%) (Non-Sudden Death) Adjudicated Autopsied N= 268 16,631,720 82 (16%) 14 (13%) 230,900 (33%) 0.3446 Potential SCDs (See Table 1C and 2A) Tertile 2 (7%) ME POST SCD Autopsy Rate = 97% Excluded at Adjudication N= 630 31,635,394 (Non-Sudden Death) 171 (34%) 43 (42%) 193,147 (28%) Overall WHO SCD Autopsy Rate = 83% Tertile 3 (14%) N= 105 Adjudicated Autopsied • for age, t-test assuming unequal variance; for categorical, Fisher's exact test (See Table 1C and 2B) WHO SCDs • Population data from American Community Survey 2011 N= 525 Tseng, ZH….Moffatt E . AHA Late-breaking 2016 Tseng, ZH….Moffatt E . AHA Late-breaking 2016 SCD Case Study #1 SCD Case Study #1 • 74 yo Filipino gentleman • Recommended uptitration of ß blocker, ICD implant as an outpatient after completing – 4 V CABG 2002 – EF 22%, fixed defect anterior, inferior walls antibiotic treatment – Diabetes • ICD scheduled for 1 month after discharge • Admitted for fever and bronchitis, receiving IV • 2 weeks later patient found dead in the antibiotics morning by wife • Troponin negative, slightly fluid overloaded • Pt had returned to usual state of health, no • Called to consult on several asymptomatic complaints the night before runs of NSVT (5-7 beats) and to consider primary prevention ICD 6
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