1. CSRC Think Tank 2017
FDA
February 2017

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

4. 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%

5. 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

6. 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.

7. 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.

8. 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).

9. SUMMARY Echoes interpreted by cardiologists: both pediatric and adult.
90% have follow-up after screening mostly via an 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%

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

11. 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

12. 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.

13. 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

14. H and P Uniformity
Vickie Vetter

15. 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

16. 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?

17. ECG Uniformity Kim Harmon
Uniformity and consistency in how the data is collected
Uniform consistency in how the data is interpreted

18. 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

19. 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.

20. Echocardiography Uniformity Nancy Cutler
Technical uniformity
Data (image) collection uniformity

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

22. Uniform Data Set for Echocardiogram - Data
M-mode (PSAX/PLAX) 2D
IVSd
LVIDD
IVSs
LVIDS LVPWs
Ao/LA
LV mass
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

23. 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