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COMPLEX SFA INTERVENTIONS:
Gilles Soulez, MD, MSc
Professor of Radiology
Academic Chair dpt of Radiology, Nuclear Medicine
and Radiation Oncology
CHUM-University of Montreal
Introduction
• Lot of technological evolution in the
endovascular management of SFA disease
– 3rd and 4th generation of nitinol stents
– Covered and DE stents
– DEB
– Atherectomy
– Re-entry devices
– Bioabsorbable vascular scaffold
• Need first to focus on the clinical indication
NITINOL STENTS
SFA Patency vs. Mean Lesion Length
• Historically, there’s been a direct relationship between lesion length
and patency rate in SFA trials
FAST
(Luminexx)
FACT
(Conformexx)
RESILIENT
(LifeStent)
Astron
(Biotronik)
DURABILITY
(Everflex)
Vienna
(Absolute)
Super SL
(SMART)
VIBRANT
(BMS arm)
0
10
20
30
40
50
60
70
80
90
100
0.00 5.00 10.00 15.00 20.00 25.00 30.00
PatencyRate(12mo)
Mean Lesion Length (cm)
DURABILITY 200
(Everflex)
Leipzig SFA Registry
(SUPERA)
CWZ
(SUPERA)
Long-term clinical impact ?
• RESILIENT 36 MONTHS
– Survival
• 90% vs. 91.7%, p = 0.71
– Major adverse events
• 75.2% vs. 75.2%, p = 0.98
– target lesion revascularization
• stent group (75.5%)
• angioplasty group (41.8%), p<0.0001.
– No difference in QOL at 2 and 3 years based upon the SF-8
questionnaire and WIQ.
– Significant improvement in quality of life for both treatment
groups compared to baseline at all study time intervals.
Laird et al JEVT 2012
Primary versus optional stenting
Schillinger, Meet 2008
When shoud we perform primary
stenting?
• Our practice
– More than 90% stenting overall !
– Primary stenting
• Lesion length more than 4cm
• CTO
• Recurrence post angioplasty
– Provisional
• Single stenosis less than 4 cm
Stent Fractures – what we know today
• Major stent fractures (types 3 and 4) are
clearly linked to reocclusion
• Different nitinol stent designs have
different fracture rates and types
• Fractures ↑ with Length of lesion and
number of overlapping stents
• Elongation of the stent during deployment
predisposes to severe stent fracture
SUPERA Stent (IDEV)
• Nitinol woven design
• High radial strength (4X) (especially if Ca++)
• High flexibility (kink resistant)
• High resistance to fractures
Proper delivery- interwoven
segments
Improper delivery- interwoven
segments
Agresssive predilatation & stent at nominal vessel size
CLI 85 YO Female
Outback
Post PTA
Supera
Covered stent
• Patency not different from
above the knee synthetic
bypass
• Potential indications
– No venous conduit
– Long lesion > 20cm
– Large arteries 6mm and more
– Not too calcified
– In stent stenosis ?
Mc Quade K et al. J Vasc Surg 2010;53:584-90
JVS 2010
59%
• M 65 Y-0
• CLI left lower limb
• Venous femoro-popliteal bypass
• Recurrent stenosis on distal anastamosis
– Conventional angioplasty
– Cutting balloon
Bypass thrombosis (1 Y)
Endoluminal recanalisation
Run-off
Recurrence (6mths)
Dilatation
Recurrence 4months
Recurrence 4 months
Covered stent
Thrombosis 3 weeks !
Burkett MW TCT 2011
Burkett MW TCT 2011
Burkett MW TCT 2011
Long lesions
• Subset long lesions
– 226±44mm (135 pts, registry)
Bosiers M et al. J Cardiovasc Surg 2013
ISR
• Subset ISR
– 127±9mm (143 patients, registry)
Scheinert et al, Leipzig 2011
Limitations
• Short stent 8cm
• Need to overlap several stents for long lesions
• Cost
• Positive clinical impact required to justify the
cost
• DEB for ISR good alternative ?
Indication of DES ?
• ISR (drug coated balloon is an alternative)
• Patient at high risk for restenosis by IH
– Small arteries
– Poor run-off
– History of IH
– Recurrence post-angioplasty
– Long lesions
• Calcified lesions ?
Drug eluting balloon
• Potential advantage
– Stent can be optional
– Significant drug transfer to the wall and drug
effect
– ISR
• Potential limitation
– No stent or vascular scaffold
DEB
• Paclitaxel combined with a
carrier
– Iopromide, Ultravist, BTHC, urea
• Drug remains in arterial wall for
weeks
• Effectively inhibits neointimal
proliferation
Supportive data
6m Late
Lumen Loss
6m angiographic
restenosis
6m TLR 18-24m
TLR
Trial Size LL [mm] n (%) TLR TLR
FemPac DEB
n=45
0.5 1.1 6/31 (19) 9% 20%
PTA
n=42
1.0 1.1 16/34 (47) 33% 48%
Thunder DEB
n=48
0.4 1.2 7/41 (17) 4% 15%
PTA
n=54
1.7 1.8 21/48 (44) 37% 52%
F 72 CLI
Long stenting
9 months later
Femoral bifurcation stenting
6 months later
PTA again
Clinical evolution
• 25-09-2008: PTA-stenting
• 30-06-2009: ISR PTA and PFA stenting
• 16-12-2009: PTA-ISR
• 26-02-2010: stent thrombosis and fem-pop
bypass
• 15-03-2011:fem-pop bypass thrombosis
14-04-2011
1 month post FP bypass thrombosis
Proximal popliteal
stenting
DEB
26-08-2011
DEB
08-02-2012
DEB
DEB & ISR SFA
• Single arm study
(12 months FU)
– 39 patients with
ISR
• Primary patency
92%
• All patients
asymptomatic
Stabile E et al. JACC 2012
Conclusion
• Complex lesion 5-15 cm
– Calcification = 4th generation stent
– ISR= DEB
• Longer lesion
– 4th generation stent ?
– 4th generation stent + DEB ?
– Bioabsorbable vascular scaffold ?
– Covered stent-graft

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2013session2 3

  • 1. COMPLEX SFA INTERVENTIONS: Gilles Soulez, MD, MSc Professor of Radiology Academic Chair dpt of Radiology, Nuclear Medicine and Radiation Oncology CHUM-University of Montreal
  • 2. Introduction • Lot of technological evolution in the endovascular management of SFA disease – 3rd and 4th generation of nitinol stents – Covered and DE stents – DEB – Atherectomy – Re-entry devices – Bioabsorbable vascular scaffold • Need first to focus on the clinical indication
  • 4. SFA Patency vs. Mean Lesion Length • Historically, there’s been a direct relationship between lesion length and patency rate in SFA trials FAST (Luminexx) FACT (Conformexx) RESILIENT (LifeStent) Astron (Biotronik) DURABILITY (Everflex) Vienna (Absolute) Super SL (SMART) VIBRANT (BMS arm) 0 10 20 30 40 50 60 70 80 90 100 0.00 5.00 10.00 15.00 20.00 25.00 30.00 PatencyRate(12mo) Mean Lesion Length (cm) DURABILITY 200 (Everflex) Leipzig SFA Registry (SUPERA) CWZ (SUPERA)
  • 5. Long-term clinical impact ? • RESILIENT 36 MONTHS – Survival • 90% vs. 91.7%, p = 0.71 – Major adverse events • 75.2% vs. 75.2%, p = 0.98 – target lesion revascularization • stent group (75.5%) • angioplasty group (41.8%), p<0.0001. – No difference in QOL at 2 and 3 years based upon the SF-8 questionnaire and WIQ. – Significant improvement in quality of life for both treatment groups compared to baseline at all study time intervals. Laird et al JEVT 2012
  • 6. Primary versus optional stenting Schillinger, Meet 2008
  • 7. When shoud we perform primary stenting? • Our practice – More than 90% stenting overall ! – Primary stenting • Lesion length more than 4cm • CTO • Recurrence post angioplasty – Provisional • Single stenosis less than 4 cm
  • 8. Stent Fractures – what we know today • Major stent fractures (types 3 and 4) are clearly linked to reocclusion • Different nitinol stent designs have different fracture rates and types • Fractures ↑ with Length of lesion and number of overlapping stents • Elongation of the stent during deployment predisposes to severe stent fracture
  • 9. SUPERA Stent (IDEV) • Nitinol woven design • High radial strength (4X) (especially if Ca++) • High flexibility (kink resistant) • High resistance to fractures
  • 10. Proper delivery- interwoven segments Improper delivery- interwoven segments Agresssive predilatation & stent at nominal vessel size
  • 11. CLI 85 YO Female
  • 15. Covered stent • Patency not different from above the knee synthetic bypass • Potential indications – No venous conduit – Long lesion > 20cm – Large arteries 6mm and more – Not too calcified – In stent stenosis ? Mc Quade K et al. J Vasc Surg 2010;53:584-90
  • 17. 59%
  • 18.
  • 19. • M 65 Y-0 • CLI left lower limb • Venous femoro-popliteal bypass • Recurrent stenosis on distal anastamosis – Conventional angioplasty – Cutting balloon
  • 28.
  • 32. Long lesions • Subset long lesions – 226±44mm (135 pts, registry) Bosiers M et al. J Cardiovasc Surg 2013
  • 33. ISR • Subset ISR – 127±9mm (143 patients, registry) Scheinert et al, Leipzig 2011
  • 34. Limitations • Short stent 8cm • Need to overlap several stents for long lesions • Cost • Positive clinical impact required to justify the cost • DEB for ISR good alternative ?
  • 35. Indication of DES ? • ISR (drug coated balloon is an alternative) • Patient at high risk for restenosis by IH – Small arteries – Poor run-off – History of IH – Recurrence post-angioplasty – Long lesions • Calcified lesions ?
  • 36. Drug eluting balloon • Potential advantage – Stent can be optional – Significant drug transfer to the wall and drug effect – ISR • Potential limitation – No stent or vascular scaffold
  • 37. DEB • Paclitaxel combined with a carrier – Iopromide, Ultravist, BTHC, urea • Drug remains in arterial wall for weeks • Effectively inhibits neointimal proliferation
  • 38. Supportive data 6m Late Lumen Loss 6m angiographic restenosis 6m TLR 18-24m TLR Trial Size LL [mm] n (%) TLR TLR FemPac DEB n=45 0.5 1.1 6/31 (19) 9% 20% PTA n=42 1.0 1.1 16/34 (47) 33% 48% Thunder DEB n=48 0.4 1.2 7/41 (17) 4% 15% PTA n=54 1.7 1.8 21/48 (44) 37% 52%
  • 44. Clinical evolution • 25-09-2008: PTA-stenting • 30-06-2009: ISR PTA and PFA stenting • 16-12-2009: PTA-ISR • 26-02-2010: stent thrombosis and fem-pop bypass • 15-03-2011:fem-pop bypass thrombosis
  • 45. 14-04-2011 1 month post FP bypass thrombosis Proximal popliteal stenting
  • 46. DEB
  • 48. DEB
  • 50. DEB
  • 51. DEB & ISR SFA • Single arm study (12 months FU) – 39 patients with ISR • Primary patency 92% • All patients asymptomatic Stabile E et al. JACC 2012
  • 52. Conclusion • Complex lesion 5-15 cm – Calcification = 4th generation stent – ISR= DEB • Longer lesion – 4th generation stent ? – 4th generation stent + DEB ? – Bioabsorbable vascular scaffold ? – Covered stent-graft