1. Division of Endovascular Interventions Mount Sinai Hospital New York 04/22/2019

2. Patient history Female, 71 y/o
Complains of bilateral LE claudication which progressed to resting pain (Rutherford 4)
PMH: Hypertension, DM (insulin therapy), Hyperlipidemia, Smoking. PAD s/p RSFA intervention using DES (Eluvia)
Medication: Lipitor, Insulin, Lisinopril, Lopressor, HCTZ, Aspirin, Clopidogrel, Glucophage.
ABI: R 0.82 and Left 0.64

3. Non-invasive Imaging Post RSFA intervention
Right:
Superficial Femoral Artery:
B-mode and spectral analysis is consistent with a 20-50% stenosis in the superficial femoral artery (proximal).
The distal external iliac artery, common femoral artery and proximal profunda femoral artery appear patent by B-mode, color and spectral analysis without significant stenosis.
Left:
The superficial femoral artery (proximal) is occluded.

4. Previous angiogram
ATK
BTK

5. CTO of femoropopliteal arteries
PCTOs are encountered in 40%-50% of patients presenting intermittent claudication or CLI
These patients often have coexistent cardiovascular and cerebrovascular disease which increases the 5-year mortality rate by:
50% in patients with intermittent claudication
60%-70% in patients with CLI (critical limb ischemia)

6. Problem during PTA of Femoropopliteal Chronic Total Occlusions
Unsuccessful procedure in ~ 20 %, due to inability to reenter distal

7. Approach To FP/Tibial CTO
1. Define lesion
2. Define approach
3. Define device
4. Define Rx strategy
Imaging, image analysis, CTO Classification
Antegrade, retrograde, hybrid
Wire-catheter, CTO crossing device
Stent, non-stent
Banerjee TCT 2017

8. Approach for endovascular treatment of femoropopliteal CTO
J INVASIVE CARDIOL 2019;31(4):

9. Classification of CTO based on morphology
J INVASIVE CARDIOL 2019;31(4):

10. Anticipated access Antegrade ipsilateral/ contralateral CFA
Retrograde via pedal arteries

11. FP CTO Classification & Initial Crossing Approach
J INVASIVE CARDIOL 2019;31(4):

12. Patient selection for tibiopedal access
Advanced PAD or CLI
Inability to lie flat for prolonged periods of time (severe osteoarthritis, lower back pain, CHF, COPD)
Hostile groins: morbid obesity, infected groins, severely scarred/ fibrotic groins.
Flush occlusion of the ostium of the SFA
The proximal CTO cap has an antegrade convex morphology.
Long suprapopliteal CTO

13. Crossing techniques and success definition
J INVASIVE CARDIOL 2019;31(4):

14. Wire diameter selection
ILIAC
SFA
BTK
0.035" PLATFORM
Designed to provide highest support and stability
Compatible with iliac treatment platforms
0.035" PLATFORM
Designed to provide highest support & stability
Compatible with most SFA balloons/stents
0.018" PLATFORM
Less traumatic
Well suited to distal SFA/popliteal
More steerable and flexible
Supports lower profile devices
0.014" PLATFORM
Least traumatic
Least support
May be useful in some situations e.g., re-entry
0.014" PLATFORM
Most suitable for small vessels
Compatible with lowest profile balloons
0.018" PLATFORM
Specific feature needed, i.e., high support, good device crossing
Abbott 2017

15. Wire selection

16. Crossing devices (true lumen)
TruePath
Front Runner
Crosser
WildCat
Crossing devices
Gentle forward pressure
Let device do the work
Exploit micro-channels
Mechanical or vibrational energy to break up calcium

17. Sub-Intimal Dissection with Re-Entry
Enteer
Off-Road
Pioneer
Outback
Re-entry often occurs at transition to healthy vessel
Re-entry devices can assist this process:
Outback (Cordis)
Enteer (Medtronic)
Off-Road (Boston Scientific)
Pioneer (Volcano)

18. The Constellation of FP Technologies:
Nitinol Stents
PTA
FPA
Exercise
Rehab
Stent Grafts
Atherectomy
‘Vessel Prep’ +/- DCB
DES

19. Algorithmic Approach to FP Intervention:
FP PAD
Claudicant/CLI
Long Lesions
Ostial SFA
P2-P3
DCB
CTO
≤200 mm
>200 mm
Limited Stenting
Heavy calcification
DAART
ISR
≤100 mm
>100 mm
DAART: Directional Atherectomy and Anti-Restenotic Therapy
S. Banerjee TCT 2016

20. FDA alert:

21. Bare metal stents: Supera stent studies Nitinol stent studies
Vascular Health and Risk Management 2015:11

22. Supera stent (BMS):
Source: US Supera Peripheral Stent System Instructions for US
Post-hoc analysis

23. Strongest predictor for poor patency rate: Calcium and lesion length
12 Month Primary Patency
Patency
Data derived from a DCB study, but they apply to all interventional treatments
Ansel, G. VIBRANT 1 year results. LINC 2010.
Dake, M. D., et al. (2016). Zilver PTX 5 year results. Circ.
Innova IFU.
Rocha-Singh, K. J., et al. (2015). Durability II 3 year data. CCI 86(1):
Garcia, L., et al. (2015). SUPERB 1 year results. Circ-CI 8(5).
Bosiers, M., et al. (2011). DURABILITY J VS 54(4):
Ohki, T., et al. (2016). OSPREY 1 year results. JVS 63(2): e371.
Gray, W. A., et al. (2015). STROLL 1 year results. JVIR 26(1):
Lammer, J., et al. (2011). STRIDES 1 year results. JVS 54(2):
Laird, J. R., et al. (2012). RESILIENT 3 year results. JEVT 19(1): 1-9.
Jaff, M. STROLL 3 year results. ISET 2014.
Geraghty, P. J., et al. (2013). VIBRANT 3 year results. JVS 58(2): e384.
Minimal Calcificationa
High Calcification
aCalcium burden quantified with computed tomography angiography (CTA), digital subtraction angiography (DSA), and intravascular ultrasound (IVUS).
Fanelli F, et al. Cardiovasc Intervent Radiol ;37(4):

24. Tools for Vessel Preparation
Balloons
Plain Balloons
Cutting Balloons
Scoring Balloons
Other Specialty Balloons (e.g. Chocolate™* PTA balloon catheter)
Atherectomy
Directional
Orbital
Rotational
Laser

25. Atherectomy devices for peripheral arteries with published data
Circulation. 2016;134:2008–2027.

26. Compliance 360 (Superficial Femoral Artery)
Diamondback 360°
Balloon Angioplasty
Average maximum balloon pressures
4.0 atms (p<0.001)
9.1 atms
≤30% residual stenosis without stenting
86.8%
(p<0.001)
18.5%
Dissections
15.8%
(p=0.02)
48.1%
Bail-out stenting (for residual over 30%)
5.3%
(P<0.001)
77.8%
Freedom from revascularization (1 yr)
81.2%
(P=NS)
78.3%
 orbital atherectomy (OA) vs balloon angioplasty (BA) for calcified femoropopliteal (FP) disease.
followed for 12 months. The primary endpoint was freedom from target lesion revascularization (TLR), including adjunctive stenting, or restenosis as evidenced by duplex ultrasound at 6 months.
J Invasive Cardiol Aug;26(8):355-60

27. Thank you very much