1. Jens Eldrup-Jorgensen, MD SVS PSO Medical Director
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. 570 centers in North America
Enrollment as of May 31, 2019
Number of Participating Centers
Location of VQI Participating Centers
VQI
571 VQI Centers
570 centers in North America
1 center in Singapore

3. 18 Regional Quality Groups

4. Case Volume as of May 31, 2019 VQI Total Procedure Volume
Total Procedure Volume tab reflects net procedures added to the registry for the month

5. Medicine Registry To be launched in Q3 2019
Registry to focus on non-operative medical management of these conditions
Medication details and dosages, along with lifestyle modifications and counseling will be the emphasis of this registry
Identify patterns/variation of treatment and pre-intervention management
Identify QI initiatives
Opportunities in comparative effectiveness research

6. Medicine Registry Multi-disciplinary input, including AHA and SVM
SVS PSO is excited to announce a formal relationship with AHA
Please welcome Terri Wiggins, Vice President Patient Engagement & Vascular Health, from the AHA to comment

7. Venous Stent Registry To be launched in Q3 2019
Registry to focus on utilization of stents for venous obstructive disease
Venous stents FDA-approved in 2019
Collaboration with AVF and Industry
Support from Industry
Will help answer questions on best management of venous thrombosis and stenosis

8. 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

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

10. Discharge Meds

11. LTFU

12. EVAR follow up

13. EVAR Imaging LTFU
We used to exclude Lost to follow up; we include them now in the denominator

15. EVAR Imaging LTFU

16. EVAR LTFU LTFU imaging after EVAR is mandatory
EVAR is a non-curative treatment of AAA
Life-long risk of device related failure - endoleak in 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

17. Audits Pilot of IRR Audit last year
Statistical Out-of-Range Audits are in progress
Source Data Audits – Work has commenced at will roll out in the 2nd half of this year

18. 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
Whitepaper will be distributed in the second half of 2019

19. Conflict of Interest Policies
Policies updated for all PSO Committees
Modelled after SVS Policies
Ensure Industry Committee work is free from conflict
SVS Ethics Committee provides ultimate oversight

20. VQI Projects RAPID - Drs. Bertges and Eldrup-Jorgensen
Paclitaxel – Drs. Bertges, Eldrup-Jorgensen and Weaver
ICVR - Drs. Kraiss, Bertges, Beck, Wang
Medicare Matching – yielded 3-5 year data for EVAR
Clinical Guidelines - Drs. Forbes, Kraiss, Chaikoff, Eldrup-Jorgensen, Weaver, Malas and Conte

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

22. Professional Societies/Registries
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)

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

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

25. 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

26. Paclitaxel Committee Meta-analysis by Katsanos
SVS VQI Retrospective propensity matched analysis by Dr. Bertges
Establishment of SVS Committee – Drs. Hodgson, Eldrup-Jorgensen, Kraiss, Conte, Bertges, Farber, Weaver and Forbes
Upcoming FDA Panel
Additional Analyses proposed by SVS VQI

27. 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

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

29. 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

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

31. SVS Guidelines & VQI
OAAA and EVAR
Claudication

32. Please Thank Our Industry Partners
The SVS PSO thanks the following companies
for their generous support of the Vascular Quality Initiative
QUALITY CHAMPIONS
QUALITY PARTNER
Quality Associate

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

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

35. 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

36. TCAR Real world evidence Over 220 centers and 5200 cases entered
Multiple presentations at
Additional presentations at VAM

37. VQI