1. Peripheral Vascular Intervention (PVI) Device Utilization and Patient Outcomes
Lillian Camino, RPVI, RVT;
Melissa Easterday BS;
Gary Lemmon, MD
Indiana University Health Methodist Hospital Indianapolis, 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: /j.jacc
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
In 2019 FDA released a series or letters to Health Care Providers regarding Paclitaxel Coated balloons and stents in PVI

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),
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: Timeframe: 2012-2018
VQI PVI Registry Database
Microsoft Excel
Timeframe:
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 R ≈ L 1108 segments 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 45.3% 3.4% 12.1% 6.9% Unchanged Symptoms
(281/620)
84.3% NCLI (237/281)
15.7% CLI (44/281)
Worsening of Symptoms
3.4%
(21/620)
100% NCLI (21/21)
TLR
12.1%
(75/620)
37.3% NCLI (28/75)
61.3% CLI (46/75)
Major Amputation
6.9%
(43/620)
14.0% NCLI (6/43)
86.0% CLI (37/43)
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. Target Lesion Revascularization
Cumulative Outcomes Summary ytd
On PVI device at index and at LTFU
9% (15/73) Stent
7% (4/58) Specialty balloon
3% (2/59) Stentgraft
1% (1/104) Atherectomy
Major Amputation
at LTFU
17% (10/59) Stentgraft
16% (28/73) Stent
10% (6/58) Specialty Balloon
9% (9/104) Atherectomy
Target Lesion Revascularization
26% (45/173) Stent
22% (13/59) Stentgraft
20% (13/59) Specialty Balloon
15% (15/104) Atherectomy
Worsening Outcomes1
66% (38/58) Specialty Balloons
65% (67/104) Atherectomy
54% (94/173) Stent
49% (29/59) Stentgraft
Better Outcomes
60% (372) No TLR or Major Amputation
12% (75) Target Lesion Revascularization
7% (43) Major Amputation
Overall outcomes
N=620
95% with <=30% residual stenosis
1% of cases with >30% stenosis or 10mm gradient
3% Failure to treat/Abort
Procedural
Rate of Success
N=1108
36% PTA
31% Stents
15% Atherectomy
15% Specialty Balloon
9% Stentgraft
Device Used
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
Only 3 devices captured
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.
Needs major editing
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