This document discusses the debate around whether endovascular or surgical interventions should be the first option for treating critical limb ischemia in the lower extremities. It presents data on patency rates from studies comparing percutaneous angioplasty and stenting to femoral-popliteal bypass. It also summarizes studies reporting outcomes of endovascular and surgical procedures for various levels of the leg vasculature. The overall conclusion is that an endovascular-first approach is reasonable for appropriately selected patients, as it is not associated with worse outcomes compared to initial surgery.

1. DebateDebate
Ischemie critique aux membres inferieurs:Ischemie critique aux membres inferieurs:
L’option premiere est endovasculaireL’option premiere est endovasculaire
Daniel I Obrand, MDDaniel I Obrand, MD
SMBD Jewish General Hospital,SMBD Jewish General Hospital,
McGill University, Montreal, QuebecMcGill University, Montreal, Quebec

2. DisclosuresDisclosures
 Paid consultant GorePaid consultant Gore

3. J’exécute régulièrement un pontageJ’exécute régulièrement un pontage
fémoro-poplité pour les patients avecfémoro-poplité pour les patients avec
demi bloc claudication chez lesdemi bloc claudication chez les
patients médicalement acceptables ?patients médicalement acceptables ?
1. 2.
62%
38%1.1. OuiOui
2.2. NonNon

4. J’exécute régulièrement angioplastieJ’exécute régulièrement angioplastie
fémoro pour les patients avec demifémoro pour les patients avec demi
bloc claudication chez les patientsbloc claudication chez les patients
médicalement acceptablesmédicalement acceptables
1. 2.
21%
79%
1.1. OuiOui
2.2. NonNon

5. J’exécute un pontage tibial pourJ’exécute un pontage tibial pour
claudicationclaudication
1. 2.
87%
13%
1.1. OuiOui
2.2. NonNon

6. J’exécute mes propres angioplastiesJ’exécute mes propres angioplasties
1. 2.
44%
56%
1.1. OuiOui
2.2. NonNon

7. POURPOUR
Ischemie critique aux membres inferieurs:Ischemie critique aux membres inferieurs:
L’option premiere est endovasculaireL’option premiere est endovasculaire

8. QuestionQuestion
 Why not Endovascular firstWhy not Endovascular first
Myths:Myths:
 Bypass patency is betterBypass patency is better
 ReinterventionReintervention
 Make it worseMake it worse

9. QuestionQuestion
 Why not Endovascular firstWhy not Endovascular first
Myths:Myths:
 Bypass patency is betterBypass patency is better Patency RatesPatency Rates
 ReinterventionReintervention Is it importantIs it important
 Make it worseMake it worse Bypass after plastyBypass after plasty

10. Rutherford
 Catégorie 0: asymptomatique
 Catégorie 1: claudication légère
 Catégorie 2: claudication modérée
 Catégorie 3: claudication sévère
 Catégorie 4: Reste la douleur
 Catégorie 5: perte de tissu mineure; Ulcération
ischémique ne dépassant pas ulcère des chiffres du
pied
 Catégorie 6: la perte de tissu Major; Ulcères
ischémiques sévères ou gangrène franc

11. TASC I-IITASC I-II
TASC ITASC I TASC IITASC II
 AA single stenosis <3cmsingle stenosis <3cm Single stenosis<10 cmSingle stenosis<10 cm
 BB single stenosis 3-10 cmsingle stenosis 3-10 cm Single stenosis/occlusion <15cmSingle stenosis/occlusion <15cm
 CC Single stenosis/occlusion Multiple stenosis/occlusions >15 cmSingle stenosis/occlusion Multiple stenosis/occlusions >15 cm
>5 cm>5 cm
 DD Complete CFA/SFA/pop Chronic total occlusion > 20 cm involvingComplete CFA/SFA/pop Chronic total occlusion > 20 cm involving
or trifurcation occlusion CFA/SFA/popliteal or trifurcationor trifurcation occlusion CFA/SFA/popliteal or trifurcation

12. TASC

13. TASC IITASC II
 Type A EndovascularType A Endovascular
 Type BType B ??
 Type CType C ??
 Type DType D SurgerySurgery

18. Patency Fem Pop bypass

19. Patency fem tib bypassPatency fem tib bypass

20. Patency bypassPatency bypass
 314 patients314 patients
 Infrapopliteal 60%Infrapopliteal 60%
 30 day mortality 3.5%30 day mortality 3.5%
 Primary patency 1 year 61%Primary patency 1 year 61%
 Reintervention rate 23% 1 yearReintervention rate 23% 1 year
Santo et al JVS Mar 2014Santo et al JVS Mar 2014

21. Independence and mobility afterIndependence and mobility after
infrainguinal lower limb bypass surgery forinfrainguinal lower limb bypass surgery for
critical limb ischemiacritical limb ischemia
 93 patients undergoing lower limb bypass93 patients undergoing lower limb bypass
 12 month patency 75%12 month patency 75%
 12 month major amputation 9%12 month major amputation 9%
 12 month mortality 6%12 month mortality 6%
 Median length of stay 11 daysMedian length of stay 11 days
 Rate of dependence 5% - 21%Rate of dependence 5% - 21%
Ambler G, Dapaah A, Zuhir N et al JVS,59:4 Apr 2014Ambler G, Dapaah A, Zuhir N et al JVS,59:4 Apr 2014

22. 30 day Graft Failure30 day Graft Failure
InfrapoplitealInfrapopliteal
 5375 infrapopliteal bypass 2005-20105375 infrapopliteal bypass 2005-2010
 NSQIPNSQIP
 GSV 75%GSV 75%
 Prosthetic 17%Prosthetic 17%
 Spliced, arm,compositeSpliced, arm,composite
Nguyen et al JVS 2013Nguyen et al JVS 2013

23. 30 day Graft Failure30 day Graft Failure
InfrapoplitealInfrapopliteal
 GSV 7.5%GSV 7.5%
 Composite 15%Composite 15%
 Prosthetics 10.5%Prosthetics 10.5%

24. Patency Femoral Endovascular
 Plain Old Balloon AngioplastyPlain Old Balloon Angioplasty
 Drug Eluting BalloonsDrug Eluting Balloons
 StentsStents

25. Percutaneous angioplasty and stenting of
the superficial femoral artery.
 380 procedures
 claudication 66%, rest pain in 16%, and tissue loss in 18%.
 TASC lesion grades were A (48%), B (18%), C (22%), and D (12%).
 Primary treatment failure (inability to cross lesion) was seen in 7% of patients.
 There was one periprocedural death.
 Primary patency rates were 86% at 3 months, 80% at 6 months, 75% at 12
months, 66% at 24 months, 60% at 36 months, 58% at 48 months, and 52%
at 60 months. Assisted primary patency rates were slightly higher ( P = not
significant)..
 Subgroup analysis revealed that primary patency rates are highly dependent
on lesion type (A > B > C > D, P < .0001).
 PTA/S patency for TASC A and B lesions compared favorably to prosthetic
and venous femoropopliteal bypass.
 Surgical bypass was superior to PTA/S for TASC C and D lesions
J Vasc Surg. 2005 Feb;41(2):269-78.

26. Endo v Bypass
 104 symptomatic patients PTA/S SFA or femoral-popliteal bypass
 Both treatment groups had similar risk factors.
 77% of patients with TASC II A and B lesions underwent angioplasty and
stenting,
 73% of patients with TASC C and D lesions underwent bypass (P < .01).
 24 month primary patency stent group 67% (95% confidence interval [CI],
0.52-0.78)
 24 month Primary patency bypass group 49% (95% CI, 0.32-0.64; P = .05).
 The rate of reintervention within the 2-year period was higher in the bypass
group compared with the stent group (54% vs 31%; P = .02)
 M. Malas, et al. Comparison of surgical bypass with angioplasty and stenting of
superficial femoral artery disease;JVS 2014;59

27. DEB vs POBA
 Primary patency at one year 89.8% for the drug-eluting
balloon group and 66.8% for the angioplasty group.
IN.PACT SFA trial – Charing Cross Symposium Apr 5-8 2014

28. BasilBasil
 452 patients Rutherford 4-6452 patients Rutherford 4-6
 Amputation free survival one yearAmputation free survival one year
 PTAPTA 71%71%
 SurgerySurgery 68%68%
 Amputation free survival three yearAmputation free survival three year
 PTAPTA 52%52%
 SurgerySurgery 57%57%

29. BasilBasil
 5 year mortality 37%5 year mortality 37%
 Higher costs for surgeryHigher costs for surgery
 Trend toward benefit for bypass if greater than 2Trend toward benefit for bypass if greater than 2
year survivalyear survival

30. BasilBasil
 In patients presenting with severe limb ischaemia
due to infra-inguinal disease and who are suitable
for surgery and angioplasty, a bypass-surgery-first
and a balloon-angioplasty-first strategy are
associated with broadly similar outcomes in terms of
amputation-free survival, and in the short-term,
surgery is more expensive than angioplasty

31. Patency PTAPatency PTA
 221 Patients BK Pop221 Patients BK Pop
 78% CLI78% CLI
 45% total occlusions45% total occlusions
 Restenosis 1 year 35%Restenosis 1 year 35%
 Primary assisted/Secondary Patency - 1 yrPrimary assisted/Secondary Patency - 1 yr
95%/85%95%/85%
Siracuse et al. Endovascular Treatment of lesion in the below-knee popliteal artery . JVSSiracuse et al. Endovascular Treatment of lesion in the below-knee popliteal artery . JVS
Mar 2014Mar 2014

32. Endovascular recanalization of infrapoplitealEndovascular recanalization of infrapopliteal
occlusion in patients with critical limbocclusion in patients with critical limb
ischemiaischemia
 187 patients 2006-2012187 patients 2006-2012
 77 (41%) occlusion77 (41%) occlusion
 Procedural success 79%Procedural success 79%
 1 year limb salvage 92% stenosis 75% occlusion1 year limb salvage 92% stenosis 75% occlusion
Singh G, Armstrong E, Yeo K et al JVS 59:5 May 2014Singh G, Armstrong E, Yeo K et al JVS 59:5 May 2014

33. Primary PTA Below kneePrimary PTA Below knee
 459 limbs
 Technical success 93%
 TASC A 16% B 22% C 27% D 34%
 5 year survival 49%
 1 and 5 year primary patency 57 and 38%
 Limb salvage 84 and 81%
 Ruby et al. Outcomes following infrapopliteal angioplasty for critical limb ischemia.
JVS 57:6 June 2012

34. Meta-analysis of infrapopliteal angioplasty
for chronic critical limb ischemia
 30 articles 1990 – 200630 articles 1990 – 2006
30 day 3 year
 Primary patency 77% 48%
 Secondary Patency 83% 62%
 Limb salvage 93% 82%
 Patient Survival 98% 68%
Romiti et al; Journal of Vascular Surgery 47;5 May 2008

35. PTA versus primary stenting in infrapoplitealPTA versus primary stenting in infrapopliteal
arterial disease:arterial disease:
A meta-analysis of randomized trialsA meta-analysis of randomized trials
 Primary Patency 1 yr 57-65%Primary Patency 1 yr 57-65%
 Secondary patency 73-57%Secondary patency 73-57%
 Limb salvage 82-87%Limb salvage 82-87%
 Wu et al. JVS 2014;59Wu et al. JVS 2014;59

36. Endovascular-first approach is not associated with worse
amputation-free survival in appropriately selected patients
with critical limb ischemia
 Endo firstEndo first
 5-7 cm crural vessel occlusion/stenosis5-7 cm crural vessel occlusion/stenosis
 SFA TASC II A-CSFA TASC II A-C
 Endo first 187(62%)Endo first 187(62%)
 Open first 105(35%)Open first 105(35%)
 Garg K, Kaszubski P, Moridzadeh B et al JVS Feb 2014Garg K, Kaszubski P, Moridzadeh B et al JVS Feb 2014

37. Endovascular-first approach is not associated with worseEndovascular-first approach is not associated with worse
amputation-free survival in appropriately selected patientsamputation-free survival in appropriately selected patients
with critical limb ischemiawith critical limb ischemia
Endo Open PEndo Open P
 5 year mortality5 year mortality 42%42% 48% .10748% .107
 Secondary ProceduresSecondary Procedures 55%55% 68% .02968% .029
 5 year Limb salvage5 year Limb salvage 85%85% 83%83% .586.586
 Amp free survivalAmp free survival 45%45% 50%50% .785.785
 Garg K et al. Journal Vasc Surg 2014 feb(59)2Garg K et al. Journal Vasc Surg 2014 feb(59)2

38. Prior PTAPrior PTA
 19 iliac stents, 29 femoral, 13 popliteal, 9 crural19 iliac stents, 29 femoral, 13 popliteal, 9 crural
 1 year patency 62% NPEI v 59% PEI p=NS1 year patency 62% NPEI v 59% PEI p=NS
 3 yr limb salvage 59% NPEI v 52% PEI p=NS3 yr limb salvage 59% NPEI v 52% PEI p=NS
 No effectNo effect
Santo V, Moneta G et al JVS 2014 JanSanto V, Moneta G et al JVS 2014 Jan

39. Prior PTAPrior PTA
 75 pedal bypasses 2008-201275 pedal bypasses 2008-2012
 36 previous percutaneous endo interventions (PEI)36 previous percutaneous endo interventions (PEI)
 39 bypass first (BPF)39 bypass first (BPF)
 1 year primary patency 67%(PEI) v 48% (BPF)1 year primary patency 67%(PEI) v 48% (BPF)
Limb salvage 82% v 71% NSLimb salvage 82% v 71% NS
Survival 79% v 81% NSSurvival 79% v 81% NS
 Uhl et al Pedal bypass surgery after crural endovascular intervention JVS 2014;59Uhl et al Pedal bypass surgery after crural endovascular intervention JVS 2014;59

40. TASC IITASC II
 Treatment of femoral popliteal lesionsTreatment of femoral popliteal lesions
 Endovascular therapy is the treatment of choiceEndovascular therapy is the treatment of choice
for type A lesions, and…for type A lesions, and…
 Endovascular treatment is the preferredEndovascular treatment is the preferred
treatment for type B lesionstreatment for type B lesions
 Type A: single occlusion ≤ 5cmType A: single occlusion ≤ 5cm
 Type B: occlusion ≤15cmType B: occlusion ≤15cm

41. ConclusionConclusion
 For Critical Ischemia the first option isFor Critical Ischemia the first option is
endovascularendovascular
 TASC A and BTASC A and B
 TASC C ?TASC C ?
 Does not preclude bypass surgery in the futureDoes not preclude bypass surgery in the future
 Patency rates are approaching equivalancePatency rates are approaching equivalance
 Nothing wrong with reinterventionNothing wrong with reintervention

42. ConclusionConclusion
Think limb Salvage Not PatencyThink limb Salvage Not Patency
Does operator specialty make a differenceDoes operator specialty make a difference

43. MerciMerci

45. You never knowYou never know