L. Graziani M.D

Servizio di Emodinamica Istituto Clinico “Città di Brescia”

Istituto Clinico “Sant’Anna” Brescia

Devices and Techniques for Devices and Techniques for

Extreme Interventions Below Extreme Interventions Below

the Kneethe Knee

Pathology Specific Intervention ConsiderationsIntervention Considerations

Indications: Indications: Chronic Critical Limb Ischaemia Chronic Critical Limb Ischaemia with or withoutwith or without ischaemic or septic ulcer or risk of ischaemic or septic ulcer or risk of amputation.amputation.

Population: Population: The large majority of patients are The large majority of patients are Diabetics.Diabetics.

Pathology: Pathology: Diabetic Macroangiopathy substantially Diabetic Macroangiopathy substantially differs from Atherosclerosis.differs from Atherosclerosis.

Devices and Techniques for Devices and Techniques for Extreme Interventions Below the KneeExtreme Interventions Below the Knee

Characteristics of Characteristics of Diabetic Arteriopathy Diabetic Arteriopathy ((11))

Vascular calcificationVascular calcification:: It occurs at 2 anatomic It occurs at 2 anatomic sites: in sites: in (a)(a) the the intimaintima, where it is invariably , where it is invariably associated with advanced state of associated with advanced state of atherosclerosis and atherosclerosis and (b)(b) in the in the tunica mediatunica media..

(b): (b): Human medial calcificationHuman medial calcification (Mönckeberg’s Sclerosis = M.S.): (Mönckeberg’s Sclerosis = M.S.): itit is common is common in Diabetics and occurs independently of in Diabetics and occurs independently of atherosclerosis, implying different etiological atherosclerosis, implying different etiological mechanisms as long duration of Diabetes. mechanisms as long duration of Diabetes. (It (It is rarely seen in the coronary tree !!!)is rarely seen in the coronary tree !!!)

Shanahan, Cary, Salisbury, Proudfoot, Weissberg, Edmonds Circulation.1999;100:2168-2176Shanahan, Cary, Salisbury, Proudfoot, Weissberg, Edmonds Circulation.1999;100:2168-2176

Characteristics of Characteristics of Diabetic Arteriopathy Diabetic Arteriopathy ((22))

““In addition and independently of In addition and independently of atherosclerotic changes, the arteries of atherosclerotic changes, the arteries of Diabetic patients are characterized by Diabetic patients are characterized by increased amounts of connective tissueincreased amounts of connective tissue, such , such as fibronectin, collagen, and glycoproteins, as as fibronectin, collagen, and glycoproteins, as well as well as increased amounts of calcium in the increased amounts of calcium in the medial layermedial layer (M.S.), a constellation named (M.S.), a constellation named “DIABETIC MACROANGIOPATHY”. “DIABETIC MACROANGIOPATHY”. (Rarely seen (Rarely seen in the coronary tree !!!)in the coronary tree !!!) These changes These changes lead to a loss of compliance and elasticity of lead to a loss of compliance and elasticity of the arterial wall”the arterial wall”. .

International Textbook of Diabetes Mellitus. Chichester, England: John Wiley & Sons International Textbook of Diabetes Mellitus. Chichester, England: John Wiley & Sons Ltd; 1992:1435-1446. Ltd; 1992:1435-1446.

General morphological General morphological differences and mechanical differences and mechanical propertiesproperties

Atherosclerotic lesionsAtherosclerotic lesions: asymmetric plaque : asymmetric plaque distribution and extension, with focal-distribution and extension, with focal-eccentric subintimal and medial eccentric subintimal and medial atheromasic degenerationatheromasic degeneration→→irregularirregular loss loss of elasticityof elasticity. . (This is the Most Common (This is the Most Common condition present in the Coronary tree !!)condition present in the Coronary tree !!)

Diabetic arteriopathyDiabetic arteriopathy: diffuse vessel wall : diffuse vessel wall thickening due to connective (inelastic) thickening due to connective (inelastic) degeneration and medial calcificationdegeneration and medial calcification→→ diffuse diffuse andand regular regular loss of elasticity loss of elasticity. .

LAD or … LAD or … Tibial ?Tibial ?

Specific morphological Specific morphological differencesdifferences

Atherosclerotic lesionsAtherosclerotic lesions: intimal calcification occurs in : intimal calcification occurs in macrophage and lipid-rich atherosclerotic lesions. macrophage and lipid-rich atherosclerotic lesions.

Diabetic arteriopathyDiabetic arteriopathy: the media is filled with : the media is filled with circumferential rings of calcium, and at later stages, circumferential rings of calcium, and at later stages, osteocytes are present within bone trabeculae with osteocytes are present within bone trabeculae with apparent bone marrow formation. apparent bone marrow formation. !!!!!!Calcification in Calcification in the media the media occurs in the absence of macrophages and occurs in the absence of macrophages and lipidlipid !!! !!!

!!!!!! This contrast with the scattered, globular This contrast with the scattered, globular Atherosclerotic calcificationAtherosclerotic calcification of the intimaof the intima, which is , which is invariably associated with lipid and macrophagesinvariably associated with lipid and macrophages !!!!!!Shanahan, Cary, Salisbury, Proudfoot, Weissberg, Edmonds. Shanahan, Cary, Salisbury, Proudfoot, Weissberg, Edmonds. Circulation. 1999;100:2168-2176Circulation. 1999;100:2168-2176

The Crucial Role of Macrophages on The Crucial Role of Macrophages on

RestenosisRestenosis

Macrophage Infiltration Predicts Macrophage Infiltration Predicts Restenosis After Coronary Intervention in Restenosis After Coronary Intervention in Patients With Unstable Angina. Patients With Unstable Angina.

Moreno, Bernardi, Lopez-Cuellar, et al. Moreno, Bernardi, Lopez-Cuellar, et al. Circulation.Circulation. 1996;94:3098- 1996;94:3098-31023102

Macrophage Depletion by Clodronate-Macrophage Depletion by Clodronate-Containing Liposomes Reduces Neointimal Containing Liposomes Reduces Neointimal Formation After Balloon Injury in Rats and Formation After Balloon Injury in Rats and Rabbits. Rabbits. Danenberg, Fishbein, Gao, et al. Danenberg, Fishbein, Gao, et al. Circulation.Circulation. 2002;106:599 2002;106:599

The Angioplasty The Angioplasty Paradox Paradox

Despite the severity and diffusion of peripheral Despite the severity and diffusion of peripheral arterial lesions, these different characteristics of arterial lesions, these different characteristics of Diabetic Arteriopathy could in fact facilitate a very Diabetic Arteriopathy could in fact facilitate a very good immediate angiographic result.good immediate angiographic result.

The “Stent-like appearance after The “Stent-like appearance after PPlain lain OOld ld (Optimal) (Optimal) BBalloon alloon AAngioplasty (ngioplasty (POBAPOBA) could be ) could be frequently achieved even dilating long calcified frequently achieved even dilating long calcified tibial stenoses and occlusions in Diabetic subjects.tibial stenoses and occlusions in Diabetic subjects.

Long-term Clinical result could be favorable, Long-term Clinical result could be favorable, performing extensive-extreme interventions, performing extensive-extreme interventions, including leg and foot arteries revascularizationincluding leg and foot arteries revascularization..

……however the most challenging problem remains however the most challenging problem remains how how to cross long calcified tibial occlusions !!!to cross long calcified tibial occlusions !!!

TYPE AND DISTRIBUTION OF TYPE AND DISTRIBUTION OF 2,8932,893 LESIONS in LESIONS in 417417 Consecutive Consecutive Diabetic Subjects with Ischaemic Foot Ulcer: Diabetic Subjects with Ischaemic Foot Ulcer: (Graziani et al. (Graziani et al. UnpublishedUnpublished data) data)

0

100

200

300

400

500

600

700

Iliac Femoral Popliteal Peroneal Post.Tib. Ant.Tib.

Stenoses

Occlusions

TYPE AND DISTRIBUTION OF TYPE AND DISTRIBUTION OF 2,8932,893 LESIONS in LESIONS in 417417 Consecutive Consecutive Diabetic Subjects with Ischaemic Foot Ulcer: Diabetic Subjects with Ischaemic Foot Ulcer: OcclusionsOcclusions (Graziani et al. (Graziani et al. Unpublished data)Unpublished data)

0

100

200

300

400

500

600

Iliac Femoral Popliteal Peroneal Post.Tib. Ant.Tib.

Occl. 0-5cm

Occl. 5-10cm

Occl. >10cm

WHYWHY SHOULD BALLOON SHOULD BALLOON ANGIOPLASTY BE ANGIOPLASTY BE OPTIMIZED ?OPTIMIZED ?

BECAUSE LESIONS ARE MULTIPLE AND BECAUSE LESIONS ARE MULTIPLE AND DIFFUSEDIFFUSE

BECAUSE LESIONS ARE OFTEN CALCIFIEDBECAUSE LESIONS ARE OFTEN CALCIFIED BECAUSE STENT DEPLOYEMENT IN POPLITEAL BECAUSE STENT DEPLOYEMENT IN POPLITEAL

AND LEG ARTERIES IS RARELY EFFECTIVEAND LEG ARTERIES IS RARELY EFFECTIVE BECAUSE IN-STENT RESTENOSIS IS DIFFICULT BECAUSE IN-STENT RESTENOSIS IS DIFFICULT

TO MANAGETO MANAGE BECAUSE BALLOON ANGIOPLASTY IS EASILY BECAUSE BALLOON ANGIOPLASTY IS EASILY

REPEATABLEREPEATABLE

““OPTIMAL BALLOON ANGIOPLASTY”OPTIMAL BALLOON ANGIOPLASTY” IS THE IS THE GOAL IN TREATING DIFFUSE AND CALCIFIED GOAL IN TREATING DIFFUSE AND CALCIFIED LESIONS IN MEDIUM-SIZE AND SMALL LESIONS IN MEDIUM-SIZE AND SMALL PERIPHERAL ARTERIESPERIPHERAL ARTERIES

OPTIMAL BALLOON ANGIOPLASTY IS A OPTIMAL BALLOON ANGIOPLASTY IS A ““STENT-LIKE”STENT-LIKE”

FINAL ANGIOGRAPHIC RESULTFINAL ANGIOGRAPHIC RESULT

Transluminal balloon angioplasty Transluminal balloon angioplasty remains the most effective procedure remains the most effective procedure to promptly restore flow, with an to promptly restore flow, with an acceptable patency rate over timeacceptable patency rate over time

The performance of the procedure The performance of the procedure largely influences the needs of using largely influences the needs of using Stents and also the clinical resultStents and also the clinical result

OPTIMIZING THE ACUTE RESULT OF OPTIMIZING THE ACUTE RESULT OF

BALLOON ANGIOPLASTY (BALLOON ANGIOPLASTY (11):): Why should a Why should a prolonged (>180 sec) balloon prolonged (>180 sec) balloon inflationinflation be performed ? be performed ?

Prolonged balloon inflation improves the Prolonged balloon inflation improves the immediate results of PTA and PTCA.immediate results of PTA and PTCA.

Significantly fewer major dissections with a Significantly fewer major dissections with a modest reduction of residual stenosis, reducing modest reduction of residual stenosis, reducing the requirement of costly and time consuming the requirement of costly and time consuming further interventions.further interventions.

Causes less arterial trauma (reduction of shear Causes less arterial trauma (reduction of shear stress-related vessel wall injury) with a little stress-related vessel wall injury) with a little advantage in lumen gain.advantage in lumen gain.

But this reduced shear stress-induced vessel But this reduced shear stress-induced vessel wall injury causes only little advantage on wall injury causes only little advantage on restenosis rate and clinical adverse events restenosis rate and clinical adverse events during follow-up. during follow-up. Circulation, 1994, Vol 89, 1118-1125; Am J Cardiol. 1996 May 15;77(12):1062-6 Am Heart J. 1998 Apr;135(4):709-13; J Vasc Interv Radiol 2002, 13:355-359

J Vasc Interv Radiol 2002 Apr;13(4):361-9

OPTIMIZING THE ACUTE RESULT OF OPTIMIZING THE ACUTE RESULT OF

BALLOON ANGIOPLASTY (BALLOON ANGIOPLASTY (22):): Why should a Why should a gradual high-gradual high-pressure balloon dilatationpressure balloon dilatation be be performed ?performed ?

A gradual, compared to rapid, coronary A gradual, compared to rapid, coronary angioplasty balloon inflation protocol reduces angioplasty balloon inflation protocol reduces the frequency of dissection despite similar the frequency of dissection despite similar inflation pressure and balloon/vessel diameter inflation pressure and balloon/vessel diameter ratio. ratio. Gradual Gradual inflations may reduce the frequency of inflations may reduce the frequency of procedure-related complications. procedure-related complications.

Cathet Cardiovasc Diagn. 1993 Jul;29(3):199-202Cathet Cardiovasc Diagn. 1993 Jul;29(3):199-202

High inflation pressure improves the result High inflation pressure improves the result after PTCA because of a greater acute luminal after PTCA because of a greater acute luminal gaingain. . Z Kardiol,1996 Apr;85(4):273-80; Circulation. 1989,Vol Z Kardiol,1996 Apr;85(4):273-80; Circulation. 1989,Vol 80, 1029-104080, 1029-1040

OPTIMIZING THE ACUTE RESULT OPTIMIZING THE ACUTE RESULT OF BALLOON ANGIOPLASTY OF BALLOON ANGIOPLASTY ((33):):Why should dilatation be Why should dilatation be performed using a performed using a correct correct balloon size ?balloon size ?

Selection of a balloon that approximates or Selection of a balloon that approximates or slightly exceeds the diameter of the slightly exceeds the diameter of the normal arterial diameter, normal arterial diameter, yields optimal yields optimal angiographic results with minimal angiographic results with minimal dissections and minimal residual stenosis.dissections and minimal residual stenosis. ((slightly slightly bigger is better)bigger is better)

J Am Coll Cardiol. 1989 Apr;13(5):1094-100; J Am Coll Cardiol. 1989 Apr;13(5):1094-100; Am Heart J. 1996 May;131(5):884-91Am Heart J. 1996 May;131(5):884-91

!!!! In Diabetic Patients, Collaterals In Diabetic Patients, Collaterals Development is Decreased or Development is Decreased or

Absent Absent !!!! … … our findings suggest that Coronary Collaterals our findings suggest that Coronary Collaterals

development is poorer in patients with, than in patients development is poorer in patients with, than in patients without Diabetes. Thus, we can speculate that Diabetes without Diabetes. Thus, we can speculate that Diabetes is an important factor affecting Collaterals is an important factor affecting Collaterals development. development. CirculationCirculation. 1999;99:2239-2242. 1999;99:2239-2242

… … the ability of Monocytes (Collaterals progenitors) to the ability of Monocytes (Collaterals progenitors) to migrate towards a gradient of VEGF-A is severely migrate towards a gradient of VEGF-A is severely impaired in Diabetic individuals.impaired in Diabetic individuals. Cardiovasc Res.Cardiovasc Res. 2001 Feb 16;49(3):554-60 2001 Feb 16;49(3):554-60

… … chronic hyperglycemia abolishes development of chronic hyperglycemia abolishes development of Coronary Collateral vessels by increasing MMP-9 Coronary Collateral vessels by increasing MMP-9 activity and Angiostatin expression in dogs. activity and Angiostatin expression in dogs. CirculationCirculation. 2004;109:2343-2348. 2004;109:2343-2348

Revascularization Revascularization strategy:strategy: our experienceour experience

Obtaining Obtaining direct flowdirect flow to the foot through a to the foot through a Tibial artery is generally required for Tibial artery is generally required for diabetic ischaemic ulcer healing.diabetic ischaemic ulcer healing.

Recanalization of an isolated Peroneal Recanalization of an isolated Peroneal artery, may determine only limited artery, may determine only limited improvement of TcPo2 values improvement of TcPo2 values (non-direct (non-direct flow)flow), depending on collaterals efficiency. , depending on collaterals efficiency.

But due to extreme diffusion of below-the-But due to extreme diffusion of below-the-knee stenosis and occlusions, direct flow knee stenosis and occlusions, direct flow to the Pedal or Plantar (Tibial) arteries can to the Pedal or Plantar (Tibial) arteries can be achieved in no more than be achieved in no more than 63%63% of the of the treated cases, using Catheter-Based-treated cases, using Catheter-Based-Techniques.Techniques.

P.O.B.A.P.O.B.A.BASELINEBASELINE

P.O.B.A.P.O.B.A.BASELINEBASELINE

P.O.B.A.P.O.B.A.BASELINEBASELINE

P.O.B.A.P.O.B.A.BASELINEBASELINE

BASELINEBASELINE

P.O.B.A.P.O.B.A.

BASELINEBASELINE

P.O.B.A.Through the Posterior Perforating Branch…

BUT RESTENOSIS BUT RESTENOSIS ISIS NOTNOT THE THE MOST IMPORTANT PROBLEM TO MOST IMPORTANT PROBLEM TO MANAGE !MANAGE !

The healing process of ischaemic foot lesions The healing process of ischaemic foot lesions could be very quick when combining could be very quick when combining revascularization and proper surgical foot carerevascularization and proper surgical foot care

After healing, lesion and symptoms may not After healing, lesion and symptoms may not recur, even in cases of significant restenosisrecur, even in cases of significant restenosis

The goal remains: pain relief, ulcer healing, The goal remains: pain relief, ulcer healing, major amputation avoidance and limb salvage !major amputation avoidance and limb salvage !

!!!! Major amputation dramatically increases the Major amputation dramatically increases the mortality rate and decreases life quality and mortality rate and decreases life quality and expectation over the timeexpectation over the time !! !! J Vasc Surg. 2000;31(suppl):S1-J Vasc Surg. 2000;31(suppl):S1-S296S296. .

Rosenfield, Vale, Isner, in: Topol, Textbook of Cardiovascular Medicine, 2nd Ed. Chapter 111: Disease of Peripheral Vessels. Lippincott Williams & Wilkins, 2002

FOOT SURGERY to manage ischaemic

& septic complications like abscesses and necrosis

Revascularization usually Revascularization usually precedes surgical foot precedes surgical foot carecare

Endovascular Treatment Endovascular Treatment of C.L.I.: of C.L.I.: common common approachapproach

Antegrade puncture and catheterization ! (95% of Antegrade puncture and catheterization ! (95% of cases)cases)

Crossing stenosisCrossing stenosis: steerable wires: steerable wires Crossing occlusionsCrossing occlusions: suitable catheter-wire system : suitable catheter-wire system

(angled wire (angled wire + + straight cath or angled cath straight cath or angled cath + + straight wire)straight wire) Crossing heavily calcified lesionsCrossing heavily calcified lesions: stiff .014 - .035 : stiff .014 - .035

wires with hydrophilic coating and preformable stiff tipwires with hydrophilic coating and preformable stiff tip Balloon dilatationBalloon dilatation: new generation of low profile, very : new generation of low profile, very

long, high pressure, 1.5-6.0 mm Ø balloon catheterlong, high pressure, 1.5-6.0 mm Ø balloon catheter StentingStenting: Provisional : Provisional (mostly self-expandable)(mostly self-expandable) Cutting Balloon and RotablatorCutting Balloon and Rotablator: in 2-3% of procedures: in 2-3% of procedures Aspiration ThrombectomyAspiration Thrombectomy or Embolectomy if or Embolectomy if

necessarynecessary New-generation of Atherectomy-cathetersNew-generation of Atherectomy-catheters: for long in-: for long in-

Stent restenosis Stent restenosis

How to reopen a chronically occluded tibial artery

““different solutions for the same problem”different solutions for the same problem”

3Fr OTW 3Fr OTW balloonballoon

4Fr cath4Fr cath

.035 GW.035 GW

FINAL RESULT

.035 gw in the .035 gw in the Pedal ArteryPedal Artery

Ideal Device CharacteristicsIdeal Device Characteristics forfor Optimal BTK Balloon Optimal BTK Balloon AngioplastyAngioplasty

Low profileLow profile: able to cross occlusions without predilatation: able to cross occlusions without predilatation Low complianceLow compliance: minimal Ø: minimal Ø increments at high pressureincrements at high pressure High resistanceHigh resistance to abrasion: to avoid balloon damage to abrasion: to avoid balloon damage

when crossing heavily calcified occlusionswhen crossing heavily calcified occlusions Suitable balloon length and diameterSuitable balloon length and diameter Tapered to .014Tapered to .014 guide wire: to be used with all brands of guide wire: to be used with all brands of

specialized coronary wiresspecialized coronary wires Over-The-Wire structureOver-The-Wire structure: is superior to : is superior to rapid exchangerapid exchange in in

crossability and pushability, and even allows selective crossability and pushability, and even allows selective injections of contrast media or drugs injections of contrast media or drugs

New balloon catheter New balloon catheter generation for complex & generation for complex & diffuse BTK lesionsdiffuse BTK lesions

•Up to 120 mm long balloonsUp to 120 mm long balloons

•Very low profileVery low profile

•Scratch resistantScratch resistant

•Low complianceLow compliance

•High RBP: 16 bar High RBP: 16 bar (max 20 Atm)(max 20 Atm)

•Over the wire coaxial designOver the wire coaxial design

Interventions in CLI and Interventions in CLI and prevalent BTK lesions: prevalent BTK lesions: Device Device ComsumptionComsumption

Study performed on Study performed on 376376 consecutive CLI patients, 90% diabetics consecutive CLI patients, 90% diabetics

• 5 Fr Balloons: 0.7 (35%)5 Fr Balloons: 0.7 (35%)

• 3.5 Fr Small Vessel Balloons: 1.13 (56%)3.5 Fr Small Vessel Balloons: 1.13 (56%)

• Coronary Balloons: 0.17 (9%)Coronary Balloons: 0.17 (9%)

• Stent: 0.18 (17.9%), 90% Self ExpandableStent: 0.18 (17.9%), 90% Self Expandable

EVERY PROCEDURE REQUIRED 2.0 BALLOONS AND 0.18 STENTSEVERY PROCEDURE REQUIRED 2.0 BALLOONS AND 0.18 STENTS

STENT IMPLANTATION WAS NECESSARY IN NO MORE THAN 18% STENT IMPLANTATION WAS NECESSARY IN NO MORE THAN 18% OF CASESOF CASES

IN 2% OF CASES CATHETER IN 2% OF CASES CATHETER FIBRINOLYSISFIBRINOLYSIS OR OR ASPIRATIONASPIRATION THROMBECTOMYTHROMBECTOMY WAS EMPLOYED WAS EMPLOYED

RARELY RARELY ROTABLATORROTABLATOR, , CUTTING BALLOONCUTTING BALLOON or OTHER DEVICES or OTHER DEVICES WERE USEDWERE USED

!!! !!! ANTEGRADE APPROACHANTEGRADE APPROACH PERFORMANCE IN 95% OF CASES !!! PERFORMANCE IN 95% OF CASES !!!

= 2.0 Balloons per patient

= = One Stent every 4.5 patients

The Stent DilemmaThe Stent Dilemma (To Stent or Not To Stent, That (To Stent or Not To Stent, That is the Question…)is the Question…) (Our Strategy, for CLI and BTK Lesions):(Our Strategy, for CLI and BTK Lesions):

Extensive use of Optimal Balloon Angioplasty Extensive use of Optimal Balloon Angioplasty (P.O.B.A.) !!(P.O.B.A.) !!

Provisional StentingProvisional Stenting in a few selected cases: Localized in a few selected cases: Localized True Biforcating Lesion with Plaque Shifting, Persistent True Biforcating Lesion with Plaque Shifting, Persistent Recoil, non-Removable Thrombus, Obstructive and Recoil, non-Removable Thrombus, Obstructive and localized Dissectionlocalized Dissection

Elective StentingElective Stenting in Stenosis of By-pass Graft in Stenosis of By-pass Graft AnastomosisAnastomosis

Self-Expandable StentsSelf-Expandable Stents preferable in many cases preferable in many cases Avoid Avoid putting Stents in the middle Popliteal and putting Stents in the middle Popliteal and

medium-distal Tibialsmedium-distal Tibials No StentsNo Stents in the Foot Arteries ! in the Foot Arteries ! NB: Actually Crural Stenting (mostly using coronary NB: Actually Crural Stenting (mostly using coronary

Stents) accounts for about 2% of our BTK procedures.Stents) accounts for about 2% of our BTK procedures.

Do we have to Do we have to avoid using avoid using

Balloon-Balloon-Expandable Stents Expandable Stents

in some specific in some specific BTK segments ?BTK segments ?

Risk of Stent crushing during routine manual pulse palpation attempt !

Risk of Stent crushing by the Cuff during routine ABI measurement !

No Stent here !

Joint !!!

F.A.Q.F.A.Q. about about EExtreme xtreme VVascularascular IInterventionsnterventions

Is it feasible in most patients?Is it feasible in most patients? How long does the benefit last?How long does the benefit last? Is PTA intervention really effective in Is PTA intervention really effective in

reducing amputation rate?reducing amputation rate? How often does intervention need to How often does intervention need to

be repeated?be repeated? Evidence on Below The Knee Evidence on Below The Knee

interventions: what is it proved?interventions: what is it proved?

Peripheral angioplasty as the first-choice Peripheral angioplasty as the first-choice revascularization procedure in diabetic patients with revascularization procedure in diabetic patients with

critical limb ischemia with or without foot ulcer: critical limb ischemia with or without foot ulcer: prospective study of prospective study of 1,1881,188 consecutive consecutive patients patients

hospitalized and followed between 1999 and 2003. hospitalized and followed between 1999 and 2003.

European Journal of Vascular and Endovascular Surgery

(manuscript number EJVES2363),

Recommended for publication, October 6th, 2004.

Ezio Faglia, MD; Luca Dalla Paola, MD; Lanfroi Graziani, MD; Jacques Clerissi, MD; Massimiliano Fusaro, MD; Giacomo Clerici, MD; Livio Gabrielli, MD; Sergio

Losa, MD; Andrea Stella, MD; Mauro Gargiulo, MD; Manuela Mantero, MD; Maurizio Caminiti, MD; Sasa Ninkovic, MD; Vincenzo Curci, MD; Alberto

Morabito, PhD.

THE ANSWERTHE ANSWER

The cumulative rate of major amputation in PTA-revascularized patients was 4.0%.

157 patients (13.2%) underwent surgical revascularization. In this group 8.3% underwent major amputation.

Out of the 47 subjects not revascularized (5 anesthesiology risk, 4 patient refusal, 38 not considered by the Vascular Surgeon as candidates for By-Pass Surgery ), 34.0% underwent major amputation.

Clinical recurrence rate was 12,5%, with an incidence of 7.1% per year.

In 85.4% of clinical recurrences, a second PTA was successfully performed.

Peripheral angioplasty and limb salvage in 1,188 consecutive diabetic patients

Thanks For Your

Attention

END OF THE PRESENTATION

arteryartery stenosesstenoses multiple or multiple or length > 4 length > 4

cmcm

successful successful PTAPTA

occlusionsocclusions multiple or multiple or length > 2 length > 2

cmcm

successful successful PTAPTA

iliac trunkiliac trunk 6565 29 (44.6%)29 (44.6%) 65 (100%)65 (100%) 66 3 (50.0%)3 (50.0%) 6 (100%)6 (100%)

profunda femoralprofunda femoral 3131 16 (51.6%)16 (51.6%) 25 (80.6%)25 (80.6%) 66 1 (16.7%)1 (16.7%) 5 (83.3%)5 (83.3%)

superficial superficial femoralfemoral

343343 266 (77.6%)266 (77.6%) 341 341 (99.4%)(99.4%)

185185 123 (66.5%)123 (66.5%) 142 142 (76.8%)(76.8%)

popliteal popliteal 221221 92 (41.6%)92 (41.6%) 215 215 (97.3%)(97.3%)

8686 47 (54.7%)47 (54.7%) 77 (89.5%)77 (89.5%)

anterior tibialanterior tibial 235235 188 (80.0%)188 (80.0%) 215 215 (91.5%)(91.5%)

589589 530 (90.0%)530 (90.0%) 142 142 (24.1%)(24.1%)

posterior tibialposterior tibial 218218 164 (75.2)164 (75.2) 185 185 (84.7%)(84.7%)

725725 679 (93.7%)679 (93.7%) 83 (11.4%)83 (11.4%)

peronealperoneal 337337 241 (71.5%)241 (71.5%) 284 284 (84.3%)(84.3%)

342342 257 (75.1%)257 (75.1%) 88 (25.7%)88 (25.7%)

Stenoses (number of, >4 cm of length or multiple) and Occlusions (number of, >2 cm of length or multiple) in every artery of the

ischemic limb and successful PTA procedures performed

Peripheral angioplasty and limb salvage in 1,188 consecutive diabetic patients

Follow-upFollow-up

1,1691,169 (98.4%) patients were (98.4%) patients were followed over a period of followed over a period of 5 5 yearsyears. .

The mean follow-up was 20 The mean follow-up was 20 15 months, range 0 - 60 15 months, range 0 - 60 months, median 17 months.months, median 17 months.

Peripheral angioplasty and limb salvage in 1,188 consecutive diabetic patients

CLINICAL RECURRENCECLINICAL RECURRENCE

Pain, Ulcer Worsening or its RecurrencePain, Ulcer Worsening or its Recurrence

ABI and TcPOABI and TcPO2 2 values were values were assessed assessed beforehand, 3-6 days after PTA and every beforehand, 3-6 days after PTA and every 3-6 months after ulcer healing 3-6 months after ulcer healing and if and if worse (<15% of the post PTA) Duplex worse (<15% of the post PTA) Duplex Scanning was used for confirmation. Scanning was used for confirmation.

If positive, a new PTA was scheduled.If positive, a new PTA was scheduled.

Peripheral angioplasty and limb salvage in 1,188 consecutive diabetic patients

0

100

200

300

400

500

600

pat

ien

ts

< 10 11-20 21-30 31-40 41-50 > 50

mmHg

before PTA after PTA

TcPO2 values distribution by 10 mmHg classes before (N = 993) and after (N = 937) PTA in study population

Peripheral angioplasty and limb salvage in 1,188 consecutive diabetic patients

487

328

10276 10162

495

326

0

100

200

300

400

500

600

no obstructions 1 obstructedartery

2 obstructedarteries

3 obstructedarteries

before PTA after PTA

Number of patients with obstructions in the infrapopliteal arteries before and after PTA (N =

993)

Peripheral angioplasty and limb salvage in 1,188 consecutive diabetic patients

Years Patients Primary Clinical Patency

95% Confidence Interval

0 993 100% -

1 606 91% 0.89-0.93

2 320 89% 0.87-0.91

3 150 87% 0.84-0.90

4 57 86% 0.82-0.89

5 4 86% 0.82-0.89

Primary patency at clinical exam over 5 years (%). The mean follow-up was 20.2 15.1 months, range 0.6 - 60 months, average 16.9 months.

Peripheral angioplasty and limb salvage in 1,188 consecutive diabetic patients: Peripheral angioplasty and limb salvage in 1,188 consecutive diabetic patients: Primary Clinical Patency

Eur J Vasc Endovasc Surg (manuscript number EJVES2363)

Complication Complication NN TreatmentTreatment

Sudden death following PTASudden death following PTA 11 --

Myocardial infarction Myocardial infarction 22 intensive care unit intensive care unit

AnginaAngina 22 medical treatmentmedical treatment

Cardiac arrhythmiaCardiac arrhythmia 11 intensive care unitintensive care unit

Chest painChest pain 11 investigation, no treatmentinvestigation, no treatment

Left ventricular failureLeft ventricular failure 11 medical treatment.medical treatment.

Acute renal failureAcute renal failure 11 medical treatment without medical treatment without dialysisdialysis

HaematomaHaematoma 3 3 11

transfusion transfusion investigation, no treatmentinvestigation, no treatment

Access site pseudoaneurysmsAccess site pseudoaneurysms 5 5 33

surgical treatment surgical treatment surgical treatment plus surgical treatment plus transfusiontransfusion

Distal thrombosis Distal thrombosis 7 7 3 3

1 1

thrombolysis effectiveness thrombolysis effectiveness by-pass graft by-pass graft above the knee above the knee amputationamputation

Cholesterol embolismCholesterol embolism 11 medical therapymedical therapy

Complications and their treatment in the PTA group patients (N = 993).