e-poster11 patel aimradial20170922 pedal radial femoropopliteal cto
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Transpedal versus Dual Transpedal –
Transradial Access Approach for
Endovascular Intervention of
Femoropopliteal Artery Chronic Total
Occlusion
Apurva Patel,MD; Wah Wah Htun, MD; Roosha Parikh, MD; Justin Ratcliffe,
MD; Joseph A. Puma, DO; Tak W. Kwan, MD
Disclosure Information
Wah Wah Htun and co-authors
FINANCIAL DISCLOSURES:
None
UNLABELED/UNAPPROVED USES
DISCLOSURE:
None
• ~ 50% PAD = CTO
• Emerging Pedal (TP)/Radial (TR)
access
- Improved technique and
equipment
- Patient comfort, vascular
complication
- Paucity of outcomes
Study Design-Methods
• Prospective Study
• Endovascular intervention of FP CTO for
symptomatic PAD
• Primary pedal (TP) or dual pedal-radial (TP-TR)
approach
• January 2017 to July 2017
• Mean follow up – 3 months (censor – 7/31/17)
• As-treated analysis
Pedal vs Dual Pedal-Radial – FP CTO
• Outcomes
- Crossing success rate
- Procedural success rate
• Primary endpoint
- 3 month major adverse event (death, TVR,
amputation)
• Secondary endpoint
- Access site complication/patency at 30 days
Outcomes
Baseline Characteristics N = 68 patients
Age (years) 77.2 ± 10.1
Male, % 63.2 (43)
H/o Hypertension, % 88.2 (60)
H/o Hyperlipidemia, % 83.8 (57)
H/o Tobacco use, % 67.6 (46)
H/o Coronary artery disease, % 77.9 (53)
H/o Cerebrovascular accident, % 5.9 (4)
H/o Diabetes mellitus, % 58.8 (40)
H/o Prior PVD intervention, % 51.5 (35)
Rutherford classification, %
III - VI 100 (68)
Results
Results
Lesion Characteristics
TP
(Wire + Catheter)
(N=55)
Dual TR-TP
(CART*/Re-entry
Device**)
(N=29)
P-value
Location – FP CTO, % 0.45
SFA 56.4 (31) 48.3 (14)
Popliteal 21.8 (12) 17.2 (5)
SFA-Popliteal 21.8 (12) 34.5 (10)
Ostial SFA involvement, % 20.0 (11) 24.1 (7) 0.78
SFA ISR, % 14.5 (8) 3.4 (1) 0.15
CTO length, % 0.34
> 200mm 56.4 (31) 69.0 (20)
< 200mm 43.6 (24) 31.0 (9)
FP: Femoropopliteal; CTO: chronic total occlusion; ISR: in-stent restenosis;
CART: Controlled antegrade and retrograde tracking
**Outback® LTD® Re-Entry Device
Results TP
(Wire +
Catheter)
(N=55)
Dual TR-TP
(CART/Re-entry
Device*)
(N=29)
P-value
Procedural Details
Total contrast (ml) 42.9 ± 9.6 49.7 ± 8.9 0.002
Fluoroscopy time (sec) 1222.1 ± 964.2 2091.4 ± 884.0 <0.001
Radiation dose (mGy) 129.0 ± 119.5 235.3 ± 103.3 <0.001
Interventional Details
Atherectomy + PTA, % 100.0 (55) 100 (29) --
DCB PTA, % 5.5 (3) 3.5 (1) 0.68
Stent, % 11.0 (6) 3.5 (1) 0.44
Concomitant tibial artery (outflow
disease) PTA, %92.7 (51) 96.6 (28) 0.71
PTA: Percutaneous transluminal angioplasty; DCB: Drug coated balloon;
CART: Controlled antegrade and retrograde tracking
**Outback® LTD® Re-Entry Device
TP (Wire + Catheter)
Dual TP-TR
(CART/Re-entry
Device**)
P-value
Primary endpoint
Clinical events – 3 months, % 0 0 -
Death, % 0 0
Amputation, % 0 0
TVR, % 2.0 (1) 10.3 (3) 0.1
Secondary endpoint
Access site complications at
30 days, %0 0
Access site patency at 30
days, %100 100
Results
TVR: Target vessel revascularization; CART: Controlled antegrade and retrograde tracking
*Mean follow up of 3 months
**Outback® LTD® Re-Entry Device
Figure:Crossing and Procedural Success Rates
for Primary Transpedal (TP) versus Dual TP-
Transradial (TR) (CART/Re-entry* device)
Approach for Treatment of Femoropopliteal (FP)
Chronic Total cclusion (CTO), p=0.006.
CART: Controlled antegrade and retrograde
tracking, *Outback® LTD® Re-Entry Device
Results
• FP-CTO intervention is feasible and safe using TP, dual
TP-TR
- Early ambulation/discharge
- Better QOL
- Less vascular complications
- Avoid femoral access
Conclusion