Peripheral Vascular Intervention (PVI) Device Utilization and Patient Outcomes

1. Peripheral Vascular Intervention (PVI) Device Utilization and Patient Outcomes Lillian Camino, RPVI, RVT; Melissa Easterday BS; Gary Lemmon, MD Indiana University Health Methodist HospitalIndianapolis, Indiana

2. Disclosures • We do not have any actual or potential conflict of interest in relation to this presentation.

3. SCAI Consensus Guideline for Device Selection in Femoral-Popliteal Arterial Interventions In 2018, ACC/AHA/SCAI/SIR/SVM released a publication regarding appropriate use criteria for Peripheral Artery Intervention. Journal of the American College of Cardiology Dec 2018, 25614; DOI: 10.1016/j.jacc.2018.10.002 Green: Class 1 strong recommendation These are DES and DCB

4. Paclitaxel‐Coated Balloons and Stents in the Femoropopliteal Artery of the Leg In 2018 JAHA released an article indicating increased risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the lower limbs. In 2018, Risk of Death Following Application of Paclitaxel‐Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta‐Analysis of Randomized Controlled Ie “Konstantinos Katsanos study” Journal of the American Heart Association Dec 18, 2018, Vol 7, Issue 24 https://doi.org/10.1161/JAHA.118.011245 In 2019 FDA released a series or letters to Health Care Providers regarding Paclitaxel Coated balloons and stents in PVI https://www.fda.gov/medical-devices/letters-health-care-providers/update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel-eluting

5. Global Vascular Guidelines (GVG) for patients with critical limb-threatening Recently in 2019 JVS and ESVS copublished Global Vascular Guidelines (GVG) for patients with critical limb-threatening ischemia Representation of Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS), https://doi.org/10.1016/j.jvs.2019.04.469 Just Released

6. Goal • Indiana University Health (IUH) Methodist Hospital (MH) : Review device specific procedural outcomes for LE PVI • Analyze the amount and type of devices used in Femoral-popliteal atherosclerotic disease treatment. • Immediate and long term outcomes of the procedure • Determine efficacy of treatment at follow up timeframes

7. Method • Type: Retrospective analysis • Software: • VQI PVI Registry Database • Microsoft Excel • Timeframe: 2012-2018 • Pathology: Atherosclerotic occlusive disease only (ASO) • Segments (native vessels only): • Superficial Femoral (SFA) • Popliteal (Pop) • “SFA/Pop” • Cases presented are PER Segment AND SIDE treated • If one case has R-SFA and L-Pop, it will count as 2 cases • Symptoms and outcomes adjusted by laterality • right segments were matched only with right sided data (R-segments w R-sided symptoms and R-sided amputations, etc)

8. Method Definitions: • Non-critical limb ischemia (NCLI) : • asymptomatic • claudicant • Critical limb ischemia (CLI): • rest pain • ulcers • non-healing amputations • acute ischemia cases • Target Lesion Revascularization (TLR): • percutaneous PVI* • open bypass graft* *(related to the area treated) • Major Amputations: • above the knee amputation (AKA) • below the knee amputation (BKA) * Ipsilateral to area treated

9. Method • A = Atherectomy • Directional • Orbital • Excisional • Laser • SG = Stentgrafts • Covered stents • ST = Stents • Balloon expanded • Self expanded • Drug eluting stents • SB = Special Balloons • Drug coated balloons • Cryoplasty • Cutting Balloons • PTA = Simple Balloons • Uncoated balloons • Order of entry of devices (when more devices used than registry capacity to collect): • 1st Atherectomies • 2nd Stentgrafts • 3rd Stents • 4th Special Balloons • 5th Plain Balloons

10. Results • We were able to collect and analyze robust amount of data • We will present here the highlights of the data

11. Results • 1012 Patients treated • 1004 Patients with only 1 limb treated • 8 Patients with bilateral limbs treated • R ≈ L • 1108 segments treated • 901 with 1 segment treated • 102 with 2 segments treated • 1 with 3 segments treated • Symptoms at index: • NCLI: 553/1108 • CLI: 540/1108 • Unknown: 15/1108 • PTA Alone was performed on 245/1108 (22% of all cases)

12. Results Outcomes at LTFU • Worsening of Symptoms • 3.4% • (21/620) • 100% NCLI(21/21) • Major Amputation • 6.9% • (43/620) • 14.0% NCLI(6/43) • 86.0% CLI(37/43) • Unchanged Symptoms • 45.3% • (281/620) • 84.3% NCLI(237/281) • 15.7% CLI(44/281) • TLR • 12.1% • (75/620) • 37.3% NCLI(28/75) • 61.3% CLI(46/75) 620 Segments with LTFU data 488 no LTFU IUH-MH averages 64.8% compliance of LTFU for PVI module at the time of study

13. Cumulative Outcomes Summary 2012-2018ytd On PVI device at index and at LTFU 1 includes worsening of Symptoms, TLR and/or Major amp

14. Challenges/Limitations • VQI/Pathways Analytic and Reporting Engine unable to produce this type of analysis (Manual Analysis) • Limitations in amount of devices captured • Only 2 devices captured 2012-2015 • Only 3 devices captured 2016-2018 • Treatment options may require >>3 devices • LTFU void • Incomplete/Missing data • Specialty balloon descriptors not captured at the time • Drug coated balloons • Cryoplasty • Cutting Balloons • Inadequate statistical power • single site • WIFI scoring impact on PVI • Underestimated time needed to complete this review!!!!

15. Conclusions • Deep dive analysis was possible using VQI PVI raw data • We found value in analysis of VQI data • to review internal treatment strategies and patient outcomes. • Preconceived notions/bias of device performance could not be reproduced • all devices performed well when compared to each other. • The review supports the adoption of current practices to align with the recently published SCAI PVI guidelines. • Insights from the initial review will guide future continued tracking • New PVI module update may allow future review of Paclitaxel containing devices data review* • *Registry limited to 3 or less devices

16. Thank you