Jens Eldrup-Jorgensen, MD SVS PSO Medical Director Division of Vascular and Endovascular Surgery

1. VQI National Update Jens Eldrup-Jorgensen, MD SVS PSO Medical Director Division of Vascular and Endovascular Surgery Maine Medical Center, Portland, ME Professor of Surgery Tufts University School of Medicine

2. Enrollment as of May 31, 2018 Location of VQI Participating Centers Number of Participating Centers VQI 479 Centers, 46 States + Canada

3. 18 Regional Quality Groups

4. Case Volume as of May 31, 2018 VQI Total Procedure Volume

5. Two National Quality Initiatives • Discharge Medications & EVAR Follow-up • Additional Reporting from PSO • Focus at Regional Meeting • Education and Case Studies • QI Initiatives undertaken • DC Meds - Steady Improvement • EVAR LTFU – Room for Improvement • Added as measure to Participation Awards

6. Changes to Participation Award Program • Still Emphasizes the Importance of LTFU and Regional Meeting Attendance • Added a Quality Domain • Quality component focuses on use VQI data to initiate QI Projects • Additional credit for sharing results of QI Projects • Also recognizes improvement relative to DC Meds and EVAR LTFU

7. Additional Educational Resources QI Project Guide Supplement: Resource Focused on the VQI National Quality Initiatives VQI Member Guide: How to Navigate the VQI

8. National Quality Initiatives

9. DC Meds – By Procedure

10. LTFU Longitudinal Care - Improves Care Monitors outcomes – EVAR, graft patency Secondary prevention – Antiplatelets, statin, tobacco cessation Incidental findings – aneurysm, TIA, chest pain

12. LTFU

13. EVAR follow up

14. EVAR: Rate of Sac Diameter Reporting at Long-Term Follow-Up (Jan. 1, 2015-Dec. 31, 2015) Percentage of those cases in which the patient had a follow-up visit between 9 and 21 months post-surgery at which a sac diameter was recorded. Data for this report include all cases with surgery date between Jan. 1 and Dec. 31, 2015, that had been entered into the VQI as of Jan. 31, 2018

17. EVAR LTFU • EVAR is a non-curative treatment of AAA • Life-long risk of device related failure - endoleakin up to 20% of patients • LTFU imaging after EVAR is mandatory • Obligation of the operating surgeon to obtain life-long imaging follow up • To ensure that patients achieve durable outcomes Salvatore Scali, MD Chair of the EVAR Registry Committee

18. Enhanced Reporting from the PSO 2018 reporting schedule • February: Spring Regional Reports • March: VQI Participation Awards • April: Physician-Level Dashboards (new!) • April: QI Initiative Update (new!) • May: COPI Report: EVAR LOS (new!) • June: Center- and System-Level Dashboards with QI Update (new!)

19. Enhanced Reporting from the PSO 2018 reporting schedule (cont) • July: Fall Regional Reports • July: PilotSystem-Level Fall Reports for Inova and Ohio Health (new!) • August: COPI Report: INFRA LOS (new!) • September: COPI Report: INFRA SSI (new!) • October: QI Initiative Update • November: Cumulative Physician Dashboards (new!)

20. Audits • Completion of the BDS Audit • Pilot of IRR Audit • Planning for Statistical and Random Audits

21. Social Security Numbers • Critical to enhance the value of the registry data • Social Security Death Index Matching • Medicare Claims Data Matching • HIPAA/Hitech Security complaint

22. VQI Projects • Medicare Matching – yielded 3-5 year data for EVAR • ICVR - Drs. Kraiss, Bertges, Beck, Wang • RAPID/SPEED - Drs. Bertges and Eldrup-Jorgensen • Vascular Ultrasound - Dr. Dawson and Moneta • Clinical Guidelines - Drs. Forbes, Kraiss, Chaikoff and Eldrup-Jorgensen

23. RAPID Registry Assessment of Peripheral Interventional Devices (RAPID) Using registries to evaluate and monitor endovascular devices

24. RAPID P3 -Public Private Partnership Professional Societies (ACC, SVS, SIR) Academia Industry Payers – CMS, Private EMR’s Others

25. RAPID Professional Societies/Registries American College of Cardiology (ACC) National Cardiovascular Disease Registry (NCDR) Society of Interventional Radiology (SIR) National Interventional Radiology Quality Registry (NIRQR) Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI)

26. RAPID Government Agencies FDA (CDRH pre- and post-market, and CEDR) Agency for Healthcare Research and Quality (AHRQ) Centers for Medicare and Medicaid Services (CMS) Department of Defense (DOD) Healthcare Resources Office of the National Coordinator (ONC) National Heart, Lung and Blood Institute (NHLBI) National Library of Medicine (NLM) Global Medical Device Nomenclature (GMDN) Agency

27. RAPID Private companies Epic MedStreaming/M2S Healthjump Boston Biomedical Assoc. Novella Clinical, Quintiles

28. RAPIDPeripheral Vascular Device Manufacturers • 4C Medical Technologies • Abbott • Aortic Medical Inc. • BDI Peripheral Intervention • Becton Dickinson • Boston Scientific • Cardiovascular Systems Inc. • Cook Medical • Intact Vascular, Inc. • Medtronic • Mercator MedSystems • WL Gore

29. RAPIDRelated Companies / Organizations • AHRMM • American Uro-GYN Society • Aspire Bariatrics, Inc. • Brooks Medtech, LLC • Cardiac Interventions Today • Cognitive Medical Systems • Cook Research, Inc. • ECRI Institute • Healthjump Inc. • IQVIA • M2S/Medstreaming • National Ctr for Health Research • NEST cc

30. RAPID Infrastructure - Registry based system Assess device performance Monitor safety and efficacy

31. RAPIDPhase 1 - DONE Develop core data elements and definitions (ACC NCDR and SVS VQI) Create unique device identifiers (UDI)

32. RAPID Phase 2 Registry based analysis of device performance Create Objective Performance Criteria for treatment of infrainguinal PVI

33. RAPID FDA - Safer, better, and cheaper Device approval – expensive and time consuming RCT’s – Selected patients, selected centers, selected providers Registry based trials more efficient and provide “real world experience” Faster to market, better surveillance

34. RAPIDFDA Collaborative societies VQI – UDI, one year follow up NCDR SIR

35. RAPID SPEED Superficial Popliteal EvidencEDevelopment Registry based analysis of device performance in the SFA and popliteal artery OPC’s for treatment of SFA/popliteal artery

36. RAPID 1= PTA alone 2= Stenting 3= Atherectomy +/- PTA 4= Atherectomy + stent K-M for SFA by treatment type

37. ICVR International Consortium of Vascular Registries (ICVR) Members Medical Device Epidemiology Network (MDEpiNet) Vascular Quality Initiative Vascunet – Swedvasc, UK NVR, Germanvasc, NORKAR, Australasian, Isvasc, Swissvasc, Italian, Karbase, Dutch, Japan

38. ICVR Advisors/Stakeholders US FDA Medtronic Cook Medical WL Gore

39. ICVR Objectives Development/testing of innovative methodological approaches Forums for discussion Safety studies, surveillance and comparative outcome evaluation Collaboration/peer reviewed articles and white papers

40. ICVR

41. ICVR

42. ICVR

43. ICVR

44. Major Registry Updates - 2018 • Transition to the new CAS forms • IVC Filter Retrieval Reporting & Notifications • Revisions to Hemodialysis • Streamlined PVI and VV forms • 30-day Readmission Measures • Mandatory LTFU fields

45. Corporate Sponsors The SVS PSO thanks the following companies for their generous support of the Vascular Quality Initiative QUALITY CHAMPIONS QUALITY PARTNER

46. Industry Projects • TEVAR Dissection • TCAR • Bard LifeStent Popliteal Artery Stent • Medtronic IN.PACT Admiral DCB ISR • CREST2

47. TCAR TransCarotid Artery Revascularization (TCAR) VQI TCAR Surveillance Project (TSP)

48. TCAR TSP - Collecting real-world outcomes of TCAR compared to CEA in VQI FDA- scientifically valid CMS- approves reimbursement for centers in TSP for high risk patients based on National Coverage Determination

49. TCAR Real world evidence 2 abstracts at VAM TCAR vs CEA TCAR vs TFCAS

50. SVS Guidelines & VQI SVS Guidelines • Are they being followed? • Are they adopted over time? • Do they influence outcomes? • Can VQI help answer these questions?