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2013session2 3

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  • 1. COMPLEX SFA INTERVENTIONS:Gilles Soulez, MD, MScProfessor of RadiologyAcademic Chair dpt of Radiology, Nuclear Medicineand Radiation OncologyCHUM-University of Montreal
  • 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. NITINOL STENTS
  • 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. 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. Primary versus optional stentingSchillinger, Meet 2008
  • 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. 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. SUPERA Stent (IDEV)• Nitinol woven design• High radial strength (4X) (especially if Ca++)• High flexibility (kink resistant)• High resistance to fractures
  • 10. Proper delivery- interwovensegmentsImproper delivery- interwovensegmentsAgresssive predilatation & stent at nominal vessel size
  • 11. CLI 85 YO Female
  • 12. Outback
  • 13. Post PTA
  • 14. Supera
  • 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. JVS 2010
  • 17. 59%
  • 18. • M 65 Y-0• CLI left lower limb• Venous femoro-popliteal bypass• Recurrent stenosis on distal anastamosis– Conventional angioplasty– Cutting balloon
  • 19. Bypass thrombosis (1 Y)
  • 20. Endoluminal recanalisation
  • 21. Run-off
  • 22. Recurrence (6mths)
  • 23. Dilatation
  • 24. Recurrence 4months
  • 25. Recurrence 4 monthsCovered stent
  • 26. Thrombosis 3 weeks !
  • 27. Burkett MW TCT 2011
  • 28. Burkett MW TCT 2011
  • 29. Burkett MW TCT 2011
  • 30. Long lesions• Subset long lesions– 226±44mm (135 pts, registry)Bosiers M et al. J Cardiovasc Surg 2013
  • 31. ISR• Subset ISR– 127±9mm (143 patients, registry)Scheinert et al, Leipzig 2011
  • 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. 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. 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. DEB• Paclitaxel combined with acarrier– Iopromide, Ultravist, BTHC, urea• Drug remains in arterial wall forweeks• Effectively inhibits neointimalproliferation
  • 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. F 72 CLI
  • 38. Long stenting
  • 39. 9 months later
  • 40. Femoral bifurcation stenting
  • 41. 6 months laterPTA again
  • 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. 14-04-20111 month post FP bypass thrombosisProximal poplitealstenting
  • 44. DEB
  • 45. 26-08-2011
  • 46. DEB
  • 47. 08-02-2012
  • 48. DEB
  • 49. DEB & ISR SFA• Single arm study(12 months FU)– 39 patients withISR• Primary patency92%• All patientsasymptomaticStabile E et al. JACC 2012
  • 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