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

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

18 Regional Quality Groups

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

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

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

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

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

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

Discharge Meds

LTFU

EVAR follow up

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

EVAR Imaging LTFU

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

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

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

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

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

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

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)

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

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

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

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

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

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

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

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

SVS Guidelines & VQI OAAA and EVAR Claudication

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

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

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

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

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

VQI