COMPLEX SFA INTERVENTIONS:Gilles Soulez, MD, MScProfessor of RadiologyAcademic Chair dpt of Radiology, Nuclear Medicineand...
Introduction• Lot of technological evolution in theendovascular management of SFA disease– 3rd and 4th generation of nitin...
NITINOL STENTS
SFA Patency vs. Mean Lesion Length• Historically, there’s been a direct relationship between lesion lengthand patency rate...
Long-term clinical impact ?• RESILIENT 36 MONTHS– Survival• 90% vs. 91.7%, p = 0.71– Major adverse events• 75.2% vs. 75.2%...
Primary versus optional stentingSchillinger, Meet 2008
When shoud we perform primarystenting?• Our practice– More than 90% stenting overall !– Primary stenting• Lesion length mo...
Stent Fractures – what we know today• Major stent fractures (types 3 and 4) areclearly linked to reocclusion• Different ni...
SUPERA Stent (IDEV)• Nitinol woven design• High radial strength (4X) (especially if Ca++)• High flexibility (kink resistan...
Proper delivery- interwovensegmentsImproper delivery- interwovensegmentsAgresssive predilatation & stent at nominal vessel...
CLI 85 YO Female
Outback
Post PTA
Supera
Covered stent• Patency not different fromabove the knee syntheticbypass• Potential indications– No venous conduit– Long le...
JVS 2010
59%
• M 65 Y-0• CLI left lower limb• Venous femoro-popliteal bypass• Recurrent stenosis on distal anastamosis– Conventional an...
Bypass thrombosis (1 Y)
Endoluminal recanalisation
Run-off
Recurrence (6mths)
Dilatation
Recurrence 4months
Recurrence 4 monthsCovered 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 ...
Indication of DES ?• ISR (drug coated balloon is an alternative)• Patient at high risk for restenosis by IH– Small arterie...
Drug eluting balloon• Potential advantage– Stent can be optional– Significant drug transfer to the wall and drugeffect– IS...
DEB• Paclitaxel combined with acarrier– Iopromide, Ultravist, BTHC, urea• Drug remains in arterial wall forweeks• Effectiv...
Supportive data6m LateLumen Loss6m angiographicrestenosis6m TLR 18-24mTLRTrial Size LL [mm] n (%) TLR TLRFemPac DEBn=450.5...
F 72 CLI
Long stenting
9 months later
Femoral bifurcation stenting
6 months laterPTA 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...
14-04-20111 month post FP bypass thrombosisProximal poplitealstenting
DEB
26-08-2011
DEB
08-02-2012
DEB
DEB & ISR SFA• Single arm study(12 months FU)– 39 patients withISR• Primary patency92%• All patientsasymptomaticStabile E ...
Conclusion• Complex lesion 5-15 cm– Calcification = 4th generation stent– ISR= DEB• Longer lesion– 4th generation stent ?–...
2013session2 3
2013session2 3
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2013session2 3

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2013session2 3

  1. 1. COMPLEX SFA INTERVENTIONS:Gilles Soulez, MD, MScProfessor of RadiologyAcademic Chair dpt of Radiology, Nuclear Medicineand Radiation OncologyCHUM-University of Montreal
  2. 2. Introduction• Lot of technological evolution in theendovascular 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
  3. 3. NITINOL STENTS
  4. 4. SFA Patency vs. Mean Lesion Length• Historically, there’s been a direct relationship between lesion lengthand patency rate in SFA trialsFAST(Luminexx)FACT(Conformexx)RESILIENT(LifeStent)Astron(Biotronik)DURABILITY(Everflex)Vienna(Absolute)Super SL(SMART)VIBRANT(BMS arm)01020304050607080901000.00 5.00 10.00 15.00 20.00 25.00 30.00PatencyRate(12mo)Mean Lesion Length (cm)DURABILITY 200(Everflex)Leipzig SFA Registry(SUPERA)CWZ(SUPERA)
  5. 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-8questionnaire and WIQ.– Significant improvement in quality of life for both treatmentgroups compared to baseline at all study time intervals.Laird et al JEVT 2012
  6. 6. Primary versus optional stentingSchillinger, Meet 2008
  7. 7. When shoud we perform primarystenting?• 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. 8. Stent Fractures – what we know today• Major stent fractures (types 3 and 4) areclearly linked to reocclusion• Different nitinol stent designs havedifferent fracture rates and types• Fractures ↑ with Length of lesion andnumber of overlapping stents• Elongation of the stent during deploymentpredisposes to severe stent fracture
  9. 9. SUPERA Stent (IDEV)• Nitinol woven design• High radial strength (4X) (especially if Ca++)• High flexibility (kink resistant)• High resistance to fractures
  10. 10. Proper delivery- interwovensegmentsImproper delivery- interwovensegmentsAgresssive predilatation & stent at nominal vessel size
  11. 11. CLI 85 YO Female
  12. 12. Outback
  13. 13. Post PTA
  14. 14. Supera
  15. 15. Covered stent• Patency not different fromabove the knee syntheticbypass• 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
  16. 16. JVS 2010
  17. 17. 59%
  18. 18. • M 65 Y-0• CLI left lower limb• Venous femoro-popliteal bypass• Recurrent stenosis on distal anastamosis– Conventional angioplasty– Cutting balloon
  19. 19. Bypass thrombosis (1 Y)
  20. 20. Endoluminal recanalisation
  21. 21. Run-off
  22. 22. Recurrence (6mths)
  23. 23. Dilatation
  24. 24. Recurrence 4months
  25. 25. Recurrence 4 monthsCovered stent
  26. 26. Thrombosis 3 weeks !
  27. 27. Burkett MW TCT 2011
  28. 28. Burkett MW TCT 2011
  29. 29. Burkett MW TCT 2011
  30. 30. Long lesions• Subset long lesions– 226±44mm (135 pts, registry)Bosiers M et al. J Cardiovasc Surg 2013
  31. 31. ISR• Subset ISR– 127±9mm (143 patients, registry)Scheinert et al, Leipzig 2011
  32. 32. Limitations• Short stent 8cm• Need to overlap several stents for long lesions• Cost• Positive clinical impact required to justify thecost• DEB for ISR good alternative ?
  33. 33. 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 ?
  34. 34. Drug eluting balloon• Potential advantage– Stent can be optional– Significant drug transfer to the wall and drugeffect– ISR• Potential limitation– No stent or vascular scaffold
  35. 35. DEB• Paclitaxel combined with acarrier– Iopromide, Ultravist, BTHC, urea• Drug remains in arterial wall forweeks• Effectively inhibits neointimalproliferation
  36. 36. Supportive data6m LateLumen Loss6m angiographicrestenosis6m TLR 18-24mTLRTrial Size LL [mm] n (%) TLR TLRFemPac DEBn=450.5 1.1 6/31 (19) 9% 20%PTAn=421.0 1.1 16/34 (47) 33% 48%Thunder DEBn=480.4 1.2 7/41 (17) 4% 15%PTAn=541.7 1.8 21/48 (44) 37% 52%
  37. 37. F 72 CLI
  38. 38. Long stenting
  39. 39. 9 months later
  40. 40. Femoral bifurcation stenting
  41. 41. 6 months laterPTA again
  42. 42. 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-popbypass• 15-03-2011:fem-pop bypass thrombosis
  43. 43. 14-04-20111 month post FP bypass thrombosisProximal poplitealstenting
  44. 44. DEB
  45. 45. 26-08-2011
  46. 46. DEB
  47. 47. 08-02-2012
  48. 48. DEB
  49. 49. DEB & ISR SFA• Single arm study(12 months FU)– 39 patients withISR• Primary patency92%• All patientsasymptomaticStabile E et al. JACC 2012
  50. 50. 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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