IDC Working Group Update

1. IDC Working Group Update Q2 2016 IEEE 11073 meeting 20-Sep-2016

2. PAR Status (11073-10101c) Original dates: Expected date of submission of draft for in initial ballot: May 2017 Projected completion date: Oct 2017 The project is behind schedule and not expected to complete on the original schedule. The projected date of submission/completion is unknown.

3. Current work • May 2016 meeting with clinicians at the Heart Rhythm Society's 37th Annual Scientific Sessions • Feedback gathered from clinician input • Discussion of individual data elements and wants/needs

4. IDCO and ISO/IEEE 11073-10103 Implantable Devices - Cardiac - (IDC) Nomenclature Face-to-Face meeting at theHeart Rhythm Society's 37th Annual Scientific SessionsSan Francisco, May 6-7, 2016Participants*: • Dr. David Slotwiner, MDPresbyterian Hospital, New York • Dr. Jerry Serwer, MDC.S. Mott Children's Hospital, Ann Arbor • Dr. Manish Wadhwa, MDSharp Hospital, Geneva Healthcare, San Diego • Dr. GilanthonyUngab, MDGeneva Healthcare, San Diego, CA • Dr. Fred Kusumoto, MDMayo Clinic, Jacksonville, FL • Dr. Michael Mirro, MDParkview Regional Medical Center, Fort Wayne, IN • Dr. Arnaud Rosier, MDImplicity, Hopital Privé Jacques Cartier, Rennes, FR • Greg Bevan, Eileen OngSt. Jude Medical • Kate Crandall, Steven Glinski,Joe Green, Fadwa Elamin Medtronic • Dr. Alexander KrausBiotronik • Todd ButkaMURJ • Nicholas GawritHeartbase • Isabelle Le Blanc, Laura BlumHRS • Jeff Marchese, Yuri SudhakarGeneva *Some participants did only join on one of the meeting days

5. MAX MIN MEDIAN IDC Nomenclature (ISO/IEEE 11073-10103)development status based on the parameter survey from 2012 with HRS clinicians LOW Importance 2012 HIGH Recent device programming date/time and/or program counter Mean ventricular heart rate at atrial burden Lead/Device recall information Multisite Left Ventricular Pacing parameters Counters for shocks started/successful and ATPs successful Number and energy of shocks applied per episode (machine readable) Number of ATPs applied per episode (machine readable) Message triggers / alert summary (urgency) => Notifications RV pacing avoidance algorithm name and status Message trigger categories MRI parameters Patient Pacemaker Dependant? (YES/NO) Message triggers / alert summary (compact) Shock waveform parameters PVARP Patient activity Message triggers / alert summary (long) RA/RV/LV sensing configuration More vendor specific entries in lists of episode types, brady modesThoracic impedance Definition nearly done Definition is done not done yet skipped

6. MAX MIN MEDIAN IDC Nomenclature (ISO/IEEE 11073-10103)development status based on the parameter survey from 2012 with HRS clinicians LOW Importance 2012 HIGH Mean A/V heart rate at rest/night AF Suppression algorithm info (ON/OFF) PVARP after PVC/PAC PVAB / Far-field protection window after Pace PVAB / Far-field protection window after Sense Patient comments if stored in device / system (medication, indication,…) Date of the next scheduled in clinic / remote follow-up(s) Rate adaptation settings (for brady pacing) LVPP / TWPP (ON/OFF) Post shock pacing settings (brady mode, basic rate, ...) RVB LVB RARP (ARP) RABP RVRP (VRP) LVRP Rate adaptation sensor type (coded and machine readable) IVRP LVPP / TWPP Respiratory Rate Heart Rate Variability (HRV) Machine readable EGMsEGMs via PDFalready available since V1.0 Definition nearly done Definition is done not done yet skipped

7. IDC Nomenclature (ISO/IEEE 11073-10103)Additional content identified after the survey 2012 LOW Importance 2016 HIGH Nomenclature versioning DFT test parameters Heart rates for AV-delay ranges Universal Device Identifier (UDI) Trend data 24h Trend data last weeks/months New Device Types Parameters related to subcutaneous ICD Parameters related to leadless pacemakers … Rating Dr. Rosier Anything else required or missing urgently? No.Can you agree to the ones which have not been done or skipped? Yes. Dr. Kusumoto: Trends would be useful! Definition nearly done Definition is done not done yet skipped

8. Ongoing Work • The group is currently: • Incorporating clinician feedback • Adding content to finalize version 1.1 • Refining details of version 1.1 to ready for submisstion and publication

9. 2016 ACC/ASE/ASNC/HRS/SCAI Health Policy Statement on Integrating the Healthcare Enterprise 4.12. Implantable Device Cardiac Observations The Implantable Device Cardiac Observations (IDCO) content profile describes a means of transferring data (including model and serial number as well as any clinical data) from any implantable cardiac implantable electronic device (CIED) (e.g., pacemakers, implantable cardioverterdefibrillators, cardiac resynchronization therapy devices, and cardiac monitor devices) to any information management system (e.g., cardiovascular information system, electrophysiological device management system, EHR, and so on) (24). The nomenclature was developed through collaboration between the Heart Rhythm Society and device manufacturers.http://content.onlinejacc.org/article.aspx?articleID=2544492 Just published today (September 20, 2016) – congratulations to IDCO! [citation provided by Alexander Kraus]