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CSRC Think Tank 2017

CSRC Think Tank 2017

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CSRC Think Tank 2017

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  1. CSRC Think Tank 2017 FDA February 2017

  2. Think Tank Survey Monkey 2016 Follow-up Survey 39 questions

  3. Survey Monkey 2016 • Survey sent to organizations that are involved with screening for risk factors for SCA • Screening includes H and P, ECG, echocardiography and all combinations • Included organizations polled in the previous survey and then some • United States and International • 72 organizations received survey; 40 responses (55.5%); last year 50%

  4. Themes of the Narrative Responses • Frustration that everyone, especially physicians and the AHA, has not embraced ECG screening • Desire to own the equipment • More consensus on abnormal findings and what would require follow-up; UNDERSTANDING WHAT IS NORMAL • Getting more physicians (cardiologists) involved

  5. Themes of the Narrative Responses • Digital storage capabilities on a more uniform basis • More volunteers from the medical profession, not only physicians. ECG techs, echo techs, nurses, etc.

  6. SUMMARY 2016 • The highest screened population are high school students. • There is a variation in number screened per organization; a few with 30-40K screened. • Variables screened are multi-fold. • 55% of organizations do it for free; 15% charge a fee. • Screenings are done mostly at schools but not exclusively so.

  7. SUMMARY • The ECGs are interpreted mostly by pediatric cardiologists. • 70% of the H and P data is stored but by various mechanisms: paper, electronic, etc. • 70% of the ECG data is stored but by various mechanisms: paper, electronic, etc. • 70% of the echo data is stored but by various mechanisms: paper, electronic, etc. • Who gets an echo is also variable but mostly as a result of an abnormal ECG (onsite eval).

  8. SUMMARY • Echoes interpreted by cardiologists: both pediatric and adult. • 90% have follow-up after screening mostly via an e-mail or phone call. • Almost 70% assure that follow-up does occur after a positive test but 35% do not. • There is overwhelming support for the development of a national health care resource and would be willing to participate by contributing their data = 95%

  9. GOAL IN GOING FORWARD 2016“THE DELIVERABLES” Define the “uniform data set” The core set of info Ultimately: can we define “normal”?

  10. Guiding Principles • Identification of individuals who may be at risk for SCA is valuable: measures may prevent SCA and SCD • Cardiac screening is occurring in a manner that does allow us to determine efficacy, coordination of approach or widespread QI • Uniform data of the highest quality must be obtained in order to reduce intergroup variability and allow prospective research

  11. Guiding Principles • High quality ECG data must be obtained across the diverse population to enable the determination of population-specific normal values and promote research to improve ECG screening • A warehouse of screening data collected across the US population will be developed as an indispensable and and sustainable national resource • While the overall goal is to reduce SCA/SCD, it is recognized that stakeholders may have separate expectations, goals and purposes that their commitment to the success of this program.

  12. Next Steps after February 2016 • Regroup and reorganize our subcommittees to explore and redefine important questions • “Committee 1” divided into three subcommittees with role and goals - define the uniform data set for: • History and physical examination • ECG • Echocardiogram

  13. H and P Uniformity Vickie Vetter

  14. Uniform Data Set for H and P • There are fairly complete Participant Heart Health Screening Forms • Multiple organizations have done this well – AAP, etc. • Important to incorporate the AHA “14 elements” as a minimum • See the 4-page form that we have come up with

  15. AHA elements H and P • Chest pain with exertion • Fatigue with exercise • Syncope • Hypertension • Relative death prior to 50 y.o. • Close relative < 50 y.o. with disability from heart disease • FH LQTS, Marfan, HCM • Heart murmur • Femoral pulse exam • Physical appearance of Marfan • Brachial BP • Restricted from exercise in past? • Had prior testing for heart disease?

  16. ECG UniformityKim Harmon Uniformity and consistency in how the data is collected Uniform consistency in how the data is interpreted

  17. Uniform Data Set for ECG - Collection • High fidelity ECG • Proper and uniform lead placement • Local experts should do the interpretation • Long-term follow-up must be optimized • Consistent “system” to disseminate info to the child/adolescent and family

  18. Uniform Data Set for ECG - Interpretation • Youth over 14 years of age – Recommend the Seattle criteria (note that these criteria were developed for those active for more that 4 hours per week) • In many settings this is also used for sedentary youth • Ongoing development for criteria for interpretation • International criteria for children < 12 y.o.

  19. Echocardiography UniformityNancy Cutler Technical uniformity Data (image) collection uniformity

  20. Uniform Data Set for Echocardiogram - Technical • DICOM format • Machine type • Demographics • Age -Sports? • Gender -Medications • Height, weight, BSA • BP • Ethnicity

  21. Uniform Data Set for Echocardiogram - Data M-mode (PSAX/PLAX) 2D Parasternal long axis with and without color Doppler +/- SAM ant mitral leaflet Parasternal short axis Aortic view to show cor a. origins 4-chamber and 5-chamber with and without color Doppler Ao valve annulus dimension Sinuses of valsalva dimension • IVSd • LVIDD • IVSs • LVIDSLVPWs • Ao/LA • LV mass

  22. Summary • As a follow-up to Think Tank 2016 the subcommittees to group 1 have come up with uniform data recommendations for • H and P • ECG • Echocardiography • We are excited about pilot “next steps” that will come of CSRC February 2017