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Case Review Case Review Session:Session:Limb SalvageLimb Salvage

Case Review Case Review Session:Session:Limb SalvageLimb Salvage

Interventions in Diabetic Patients: Interventions in Diabetic Patients: The Diabetic Foot The Diabetic Foot

L. Graziani M.D. L. Graziani M.D.

Servizio di Emodinamica Servizio di Emodinamica

Istituto Clinico “Città di Brescia” Istituto Clinico “Città di Brescia” Brescia (Italy)Brescia (Italy)


Diabetic Diabetic ArteriopathyArteriopathyDiabetic Diabetic ArteriopathyArteriopathy

In diabetic population the incidence of In diabetic population the incidence of arteriopathy is 14% after 2 years of diabetes, arteriopathy is 14% after 2 years of diabetes, 15% after 10 years and 45% after 20 years.15% after 10 years and 45% after 20 years.((#)#)

In diabetic population the risk of developing In diabetic population the risk of developing lower limb critical ischemia is 5 times greater lower limb critical ischemia is 5 times greater than in normal population. than in normal population. In particular ischemic ulcers and gangrene In particular ischemic ulcers and gangrene are present in about 10% of old diabetic are present in about 10% of old diabetic people: this condition is commonly defined people: this condition is commonly defined “Ischaemic Diabetic Foot”. “Ischaemic Diabetic Foot”. ((§)§)

## Melton LJ, Macken KM, et al. Diabetes Care 1980,3:650-654.Melton LJ, Macken KM, et al. Diabetes Care 1980,3:650-654. §§ Krolewski AS, Warren JH, in: Joslin's Diabetes Mellitus (ed. 12). Krolewski AS, Warren JH, in: Joslin's Diabetes Mellitus (ed. 12). Philadelphia, Pa, Lea & Febiger, pp 12-42. Philadelphia, Pa, Lea & Febiger, pp 12-42.


Characteristics of Characteristics of diabetic diabetic arteriopathyarteriopathy

Characteristics of Characteristics of diabetic diabetic arteriopathyarteriopathy

““In addition to atherosclerotic changes, the In addition to atherosclerotic changes, the vessels of diabetic patients are characterized vessels of diabetic patients are characterized byby increased amounts of connective tissueincreased amounts of connective tissue, , such as fibronectin, collagen, and such as fibronectin, collagen, and glycoproteins, as well as glycoproteins, as well as increased amounts of increased amounts of calcium in the medial layercalcium in the medial layer of the arterial wall, a of the arterial wall, a constellation named constellation named diabetic macroangiopathydiabetic macroangiopathy. . These changes lead to a loss of elasticity of the These changes lead to a loss of elasticity of the arterial wall”arterial wall”. .

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


Massive medial calcifications

Before PTA ResultResultCase 1


ISCHAEMIC DIABETIC FOOTISCHAEMIC DIABETIC FOOT ::INDICATIONS FOR INDICATIONS FOR REVASCULARIZATIONREVASCULARIZATION

ISCHAEMIC DIABETIC FOOTISCHAEMIC DIABETIC FOOT ::INDICATIONS FOR INDICATIONS FOR REVASCULARIZATIONREVASCULARIZATION

1.1. RISK OF AMPUTATION - TO REDUCE THE LEVELRISK OF AMPUTATION - TO REDUCE THE LEVEL

2.2. CRITICAL LIMB ISCHAEMIACRITICAL LIMB ISCHAEMIA

3.3. PAIN AT RESTPAIN AT REST (BUT PRESENT ONLY IN ABOUT 50% OF ISCHAEMIC (BUT PRESENT ONLY IN ABOUT 50% OF ISCHAEMIC

ULCERS !) ULCERS !) ( (##))

4.4. ULCERATIONSULCERATIONS (OFTEN AT THE ONSET !)(OFTEN AT THE ONSET !), , EVEN HEALEDEVEN HEALED

5.5. SYMPTOMATIC CLAUDICATIONSYMPTOMATIC CLAUDICATION (OFTEN ABSENT(OFTEN ABSENT→→

NEUROPATHY !)NEUROPATHY !) (§ (§))

6.6. DECREASED TRANSCUTANEOUS OXYGEN TENSIONDECREASED TRANSCUTANEOUS OXYGEN TENSION (TcPO2 < 50mmHg) (TcPO2 < 50mmHg) ( (‡‡))

# J Diabetes Complications. 1998;12:96-102, § Diabetes Care. 2001; 24:78-83, ‡ J Vasc Surg 31, 1, 2000


Diabetic foot:Diabetic foot:RevascularizationRevascularization ProcedureProcedure

Diabetic foot:Diabetic foot:RevascularizationRevascularization ProcedureProcedure

Antegrade approachAntegrade approach Low-profile (coronary type) wires and cathetersLow-profile (coronary type) wires and catheters Long Long (8-10 cm)(8-10 cm) balloons, if needed balloons, if needed Prolonged inflations Prolonged inflations (3-8 min !!)(3-8 min !!) using low- using low-

compliant balloons at high pressure compliant balloons at high pressure (13-18 Atm)(13-18 Atm) Accurate choice of suitable balloon sizeAccurate choice of suitable balloon size RotablatorRotablator®® for some short recurrences for some short recurrences Avoid using Stents, particularly below the knee!Avoid using Stents, particularly below the knee! Effective antiplatelet therapy Effective antiplatelet therapy (clopidogrel, ticlopidine)(clopidogrel, ticlopidine)


Male, 69 yrs, IDDM, previous fem-pop by-pass graft, persistence of the right foot ischaemic ulcer.

Procedure: Antegrade approach, ant. Tibial occlusion crossed with an extra support, hydrophilic coronary wire and 3.5mm balloon, Magic Wallstent® deployment. Final balloon dilatation.

STENTING

Case 2


Diabetic foot: Diabetic foot: Treatment Treatment strategystrategyDiabetic foot: Diabetic foot: Treatment Treatment strategystrategy

Diabetic patients can develop ischaemic foot ulcer Diabetic patients can develop ischaemic foot ulcer ((TcPo2 <50mmHg)TcPo2 <50mmHg) even for occlusion of a single leg even for occlusion of a single leg artery due to lack of collateralsartery due to lack of collaterals

In these subjects collaterals are usually and typically In these subjects collaterals are usually and typically poor, particularly from Peroneal to Tibials, therefore…poor, particularly from Peroneal to Tibials, therefore…

……optimal revascularization procedure aims to obtain optimal revascularization procedure aims to obtain direct flow up to the foot preferably through the Pedal direct flow up to the foot preferably through the Pedal (anterior Tibial)(anterior Tibial) or Plantar or Plantar (posterior Tibial)(posterior Tibial) artery artery

In presence of ischaemic foot ulcerIn presence of ischaemic foot ulcer, Extensive, Extensive AngioplastyAngioplasty (to recanalize as many arteries as possible)(to recanalize as many arteries as possible) is is always preferable always preferable (J Intern Med 2002;252:225-232)(J Intern Med 2002;252:225-232)

Lesion site influences the choice of the tibial artery to Lesion site influences the choice of the tibial artery to be recanalized be recanalized (calcanear(calcanear→ post. Tibial; forefoot→ ant. Tibial)→ post. Tibial; forefoot→ ant. Tibial)

In some cases stenotic In some cases stenotic collateralscollaterals (i.e. from Peroneal to (i.e. from Peroneal to Pedal/Plantar)Pedal/Plantar) can be successfully dilated can be successfully dilated


Male, 70 yrs. NIDDM, TcPO2 = 32 mmHg !, previous 4th and 5th ray amputation due to ischaemic necrosis. Recent onset of mid-foot ulcer due to foot malposition. Isolate occlusion of Anterior Tibial. PTA → .014 hydrophilic coronary wire and 2.5mm balloon.

Before PTA ResultCase 3


Mid-foot ulcer (Grade IV of Wagner Classification), before PTA. TcPO2 = 35mmHg

Same ulcer 2 months Post-PTA.

TcPO2 significantly improves: 65mmHg

SAME CASE




In these subjects collaterals are usually and typically In these subjects collaterals are usually and typically poor, particularly from Peroneal to Tibials… poor, particularly from Peroneal to Tibials…

… … therefore optimal revascularization procedure aims therefore optimal revascularization procedure aims to obtain direct flow up to the foot preferably through to obtain direct flow up to the foot preferably through the Pedal the Pedal (anterior Tibial)(anterior Tibial) or Plantar or Plantar (posterior Tibial)(posterior Tibial) artery artery





Before PTA Result

Poor collaterals

Case 4




In these subjects collaterals are usually and typically In these subjects collaterals are usually and typically poor, particularly from Peroneal to Tibials…poor, particularly from Peroneal to Tibials…






Male, 63 yrs, NIDDM, critical leg ischaemia, pain at rest, foot ulcer. Complete occlusion of distal post. Tib. and Plantar. Diffuse stenosis and occlusion of the Pedal, stenosed Peroneal artery

Procedure: Pedal artery obstruction crossed with an .014 coronary extra-support hydrophilic wire, followed by a 2.0 and 2.5Ø balloon catheter dilatation.

Rest pain ceased immediately and major amputation was avoided.

Pedal

Case 5


Before PTA Result

Another case…

Plantar

Case 6




In these subjects collaterals are usually and typically In these subjects collaterals are usually and typically poor, particularly from Peroneal to Tibials… poor, particularly from Peroneal to Tibials…






Female, 70 yrs,

IDDM, rest pain with ischaemic left foot ulcer.

Procedure: occlusions were crossed with a regular 4 Fr/.035 catheter-wire system and a .014 coronary wire. Prolonged inflations with 2.5, 3.5 and 5.0 Ø balloon catheters were performed.

Rest pain ceased, foot ulcer healed and major amputation was avoided.

Before PTACase 7


Considerations:

Revascularization procedure must include as many stenotic segments as possible.

Luckily, long fem-pop and tibial occlusions in diabetic patients are rarely associated with evident thrombosis, unless previous By-Pass surgery was performed.

In fact, most below-the-knee thrombolysis procedures are related to occlusive complications after By-Pass surgery.

Result


Male, 65 yrs, NIDDM, ischaemic left foot ulcer. Severe stenosis of Peroneal, ant. Tibial, Pedal and Plantar arteries.

Procedure: Antegrade approach, .014 hydrophilic “intermediate” coronary wire was advanced along the Pedal and the major branch of the Plantar artery. Stenoses dilatation using 2.5 and 3.0Ø balloon catheter was performed. Balloons were inflated at16 Atm for 4 minutes each time.

Foot ulcer healed in few weeks.

Before PTA

Case 8


Considerations:

Direct flow along the entire length of ONE Tibial artery is usually necessary to promote ulcer healing.

Direct flow along TWO Tibial arteries represents the most favorable condition for ulcer healing.

In the majority of cases, obtaining direct flow along a solitary Peroneal artery, provides little improvement of TcPO2 measurement, due to lack of collaterals to the foot.

Result


















Male, 63 yrs IDDM with ischaemic foot ulcer. Diffuse occlusion of all leg arteries.

Procedure: a .014 wire was advanced along the peroneal up to the plantar, through a collateral. A 2.0 and 2.5 mmØ, 10 cm long balloon was used. 4x3 min inflations at 12-14 Atm, using a semi-compliant balloon.

Case 9

Before PTA


Considerations:

Mönckeberg’s medial calcifications may act as rails to guide the wire while maintaining a correct centroluminal position.

This is particularly useful in case of long occlusion recanalization.

Also collaterals between peroneal and plantar or pedal artery, present diffuse connective thickening of the arterial wall.

In these branches it could represent a protective factor against arterial rupture during balloon inflation.

Result


Before PTA Result

2x100mm balloon

Another case…

Case 10


Conclusions 1Conclusions 1From: Rosenfield, Vale, Isner, in: Topol, Textbook of From: Rosenfield, Vale, Isner, in: Topol, Textbook of Cardiovascular Medicine, 2nd Ed. Lippincott Williams & Cardiovascular Medicine, 2nd Ed. Lippincott Williams & Wilkins, 2002Wilkins, 2002


““In patients with rest pain or ischemic In patients with rest pain or ischemic ulceration, restoration of uninterrupted patency ulceration, restoration of uninterrupted patency of at least one of the three major infrapopliteal of at least one of the three major infrapopliteal arteries is generally required . arteries is generally required .

In this group of patients, aggressive application In this group of patients, aggressive application of percutaneous revascularization may achieve of percutaneous revascularization may achieve extremely gratifying results, even in patients extremely gratifying results, even in patients with calcified and/or lengthy total occlusions”. with calcified and/or lengthy total occlusions”.




“…“…the incidence of restenosis—which remains the incidence of restenosis—which remains high—should not be a factor in the decision to high—should not be a factor in the decision to use a percutaneous approach for what is, in use a percutaneous approach for what is, in many of these patients, a short-term problem. many of these patients, a short-term problem. If uninterrupted patency of even one vessel If uninterrupted patency of even one vessel can be achieved, the improvement in can be achieved, the improvement in antegrade nutrient flow is typically adequate to antegrade nutrient flow is typically adequate to facilitate limb salvage. Once healed, most facilitate limb salvage. Once healed, most patients will do satisfactorily, even in the face patients will do satisfactorily, even in the face of documented reocclusion or restenosis”.of documented reocclusion or restenosis”.

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Www.extrem-es-angioplasty.it Case Review Session: Limb Salvage Interventions in Diabetic Patients: The Diabetic Foot L. Graziani M.D. Servizio di Emodinamica