Case Review Session: Limb Salvage Interventions in Diabetic Patients: The Diabetic Foot L. Graziani M.D. Servizio di Emodinamica Istituto Clinico “Città di Brescia” Brescia (Italy) www.extrem-es-angioplasty.it

Diabetic Arteriopathy In diabetic population the incidence of arteriopathy is 14% after 2 years of diabetes, 15% after 10 years and 45% after 20 years.(#) In diabetic population the risk of developing lower limb critical ischemia is 5 times greater than in normal population. In particular ischemic ulcers and gangrene are present in about 10% of old diabetic people: this condition is commonly defined “Ischaemic Diabetic Foot”. (§) # Melton LJ, Macken KM, et al. Diabetes Care 1980,3:650-654. § Krolewski AS, Warren JH, in: Joslin's Diabetes Mellitus (ed. 12). Philadelphia, Pa, Lea & Febiger, pp 12-42. www.extrem-es-angioplasty.it

Characteristics of diabetic arteriopathy “In addition to atherosclerotic changes, the vessels of diabetic patients are characterized by increased amounts of connective tissue, such as fibronectin, collagen, and glycoproteins, as well as increased amounts of calcium in the medial layer of the arterial wall, a constellation named diabetic macroangiopathy. These changes lead to a loss of elasticity of the arterial wall”. International Textbook of Diabetes Mellitus. Chichester, England: John Wiley & Sons Ltd; 1992:1435-1446. www.extrem-es-angioplasty.it

Massive medial calcifications Case 1 Result Before PTA www.extrem-es-angioplasty.it

ISCHAEMIC DIABETIC FOOT : INDICATIONS FOR REVASCULARIZATION RISK OF AMPUTATION - TO REDUCE THE LEVEL CRITICAL LIMB ISCHAEMIA PAIN AT REST (BUT PRESENT ONLY IN ABOUT 50% OF ISCHAEMIC ULCERS !) (#) ULCERATIONS (OFTEN AT THE ONSET !), EVEN HEALED SYMPTOMATIC CLAUDICATION (OFTEN ABSENT→ NEUROPATHY !) (§) DECREASED TRANSCUTANEOUS OXYGEN TENSION (TcPO2 < 50mmHg) (‡) # J Diabetes Complications. 1998;12:96-102, § Diabetes Care. 2001; 24:78-83, ‡ J Vasc Surg 31, 1, 2000 www.extrem-es-angioplasty.it

Diabetic foot: Revascularization Procedure Antegrade approach Low-profile (coronary type) wires and catheters Long (8-10 cm) balloons, if needed Prolonged inflations (3-8 min !!) using low-compliant balloons at high pressure (13-18 Atm) Accurate choice of suitable balloon size Rotablator® for some short recurrences Avoid using Stents, particularly below the knee! Effective antiplatelet therapy (clopidogrel, ticlopidine) www.extrem-es-angioplasty.it

Case 2 STENTING 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. www.extrem-es-angioplasty.it

Diabetic foot: Treatment strategy Diabetic patients can develop ischaemic foot ulcer (TcPo2 <50mmHg) even for occlusion of a single leg artery due to lack of collaterals In these subjects collaterals are usually and typically poor, particularly from Peroneal to Tibials, therefore… …optimal revascularization procedure aims to obtain direct flow up to the foot preferably through the Pedal (anterior Tibial) or Plantar (posterior Tibial) artery In presence of ischaemic foot ulcer, Extensive Angioplasty (to recanalize as many arteries as possible) is always preferable (J Intern Med 2002;252:225-232) Lesion site influences the choice of the tibial artery to be recanalized (calcanear→ post. Tibial; forefoot→ ant. Tibial) In some cases stenotic collaterals (i.e. from Peroneal to Pedal/Plantar) can be successfully dilated www.extrem-es-angioplasty.it

Male, 70 yrs. NIDDM, TcPO2 = 32 mmHg 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 Result Case 3 www.extrem-es-angioplasty.it

Same ulcer 2 months Post-PTA. SAME CASE Mid-foot ulcer (Grade IV of Wagner Classification), before PTA. TcPO2 = 35mmHg Same ulcer 2 months Post-PTA. TcPO2 significantly improves: 65mmHg www.extrem-es-angioplasty.it

Diabetic foot: Treatment strategy Diabetic patients can develop ischaemic foot ulcer (TcPo2 <50mmHg) even for occlusion of a single leg artery due to lack of collaterals In these subjects collaterals are usually and typically poor, particularly from Peroneal to Tibials… … therefore optimal revascularization procedure aims to obtain direct flow up to the foot preferably through the Pedal (anterior Tibial) or Plantar (posterior Tibial) artery In presence of ischaemic foot ulcer, Extensive Angioplasty (to recanalize as many arteries as possible) is always preferable (J Intern Med 2002;252:225-232) Lesion site influences the choice of the tibial artery to be recanalized (calcanear→ post. Tibial; forefoot→ ant. Tibial) In some cases stenotic collaterals (i.e. from Peroneal to Pedal/Plantar) can be successfully dilated www.extrem-es-angioplasty.it

Before PTA Result Case 4 Poor collaterals www.extrem-es-angioplasty.it

Diabetic foot: Treatment strategy Diabetic patients can develop ischaemic foot ulcer (TcPo2 <50mmHg) even for occlusion of a single leg artery due to lack of collaterals In these subjects collaterals are usually and typically poor, particularly from Peroneal to Tibials… … therefore optimal revascularization procedure aims to obtain direct flow up to the foot preferably through the Pedal (anterior Tibial) or Plantar (posterior Tibial) artery In presence of ischaemic foot ulcer, Extensive Angioplasty (to recanalize as many arteries as possible) is always preferable (J Intern Med 2002;252:225-232) Lesion site influences the choice of the tibial artery to be recanalized (calcanear→ post. Tibial; forefoot→ ant. Tibial) In some cases stenotic collaterals (i.e. from Peroneal to Pedal/Plantar) can be successfully dilated www.extrem-es-angioplasty.it

Case 5 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 www.extrem-es-angioplasty.it

Before PTA Result Another case… Case 6 Plantar www.extrem-es-angioplasty.it

Diabetic foot: Treatment strategy Diabetic patients can develop ischaemic foot ulcer (TcPo2 <50mmHg) even for occlusion of a single leg artery due to lack of collaterals In these subjects collaterals are usually and typically poor, particularly from Peroneal to Tibials… … therefore optimal revascularization procedure aims to obtain direct flow up to the foot preferably through the Pedal (anterior Tibial) or Plantar (posterior Tibial) artery In presence of ischaemic foot ulcer, Extensive Angioplasty (to recanalize as many arteries as possible) is always preferable (J Intern Med 2002;252:225-232) Lesion site influences the choice of the tibial artery to be recanalized (calcanear→ post. Tibial; forefoot→ ant. Tibial) In some cases stenotic collaterals (i.e. from Peroneal to Pedal/Plantar) can be successfully dilated www.extrem-es-angioplasty.it

Before PTA Case 7 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. Case 7 www.extrem-es-angioplasty.it

Result 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. www.extrem-es-angioplasty.it

Before PTA 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. Case 8 www.extrem-es-angioplasty.it

Result 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. www.extrem-es-angioplasty.it

Diabetic foot: Treatment strategy Diabetic patients can develop ischaemic foot ulcer (TcPo2 <50mmHg) even for occlusion of a single leg artery due to lack of collaterals In these subjects collaterals are usually and typically poor, particularly from Peroneal to Tibials… … therefore optimal revascularization procedure aims to obtain direct flow up to the foot preferably through the Pedal (anterior Tibial) or Plantar (posterior Tibial) artery In presence of ischaemic foot ulcer, Extensive Angioplasty (to recanalize as many arteries as possible) is always preferable (J Intern Med 2002;252:225-232) Lesion site influences the choice of the tibial artery to be recanalized (calcanear→ post. Tibial; forefoot→ ant. Tibial) In some cases stenotic collaterals (i.e. from Peroneal to Pedal/Plantar) can be successfully dilated www.extrem-es-angioplasty.it

Diabetic foot: Treatment strategy Diabetic patients can develop ischaemic foot ulcer (TcPo2 <50mmHg) even for occlusion of a single leg artery due to lack of collaterals In these subjects collaterals are usually and typically poor, particularly from Peroneal to Tibials… … therefore optimal revascularization procedure aims to obtain direct flow up to the foot preferably through the Pedal (anterior Tibial) or Plantar (posterior Tibial) artery In presence of ischaemic foot ulcer, Extensive Angioplasty (to recanalize as many arteries as possible) is always preferable (J Intern Med 2002;252:225-232) Lesion site influences the choice of the tibial artery to be recanalized (calcanear→ post. Tibial; forefoot→ ant. Tibial) In some cases stenotic collaterals (i.e. from Peroneal to Pedal/Plantar) can be successfully dilated www.extrem-es-angioplasty.it

Before PTA Case 9 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. www.extrem-es-angioplasty.it

Result 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.

Before PTA Result Another case… Case 10 2x100mm balloon www.extrem-es-angioplasty.it

Conclusions 1 From: Rosenfield, Vale, Isner, in: Topol, Textbook of Cardiovascular Medicine, 2nd Ed. Lippincott Williams & Wilkins, 2002 “In patients with rest pain or ischemic ulceration, restoration of uninterrupted patency of at least one of the three major infrapopliteal arteries is generally required . In this group of patients, aggressive application of percutaneous revascularization may achieve extremely gratifying results, even in patients with calcified and/or lengthy total occlusions”. www.extrem-es-angioplasty.it

Conclusions 2 From: Rosenfield, Vale, Isner, in: Topol, Textbook of Cardiovascular Medicine, 2nd Ed. Lippincott Williams & Wilkins, 2002 “…the incidence of restenosis—which remains high—should not be a factor in the decision to use a percutaneous approach for what is, in many of these patients, a short-term problem. If uninterrupted patency of even one vessel can be achieved, the improvement in antegrade nutrient flow is typically adequate to facilitate limb salvage. Once healed, most patients will do satisfactorily, even in the face of documented reocclusion or restenosis”. www.extrem-es-angioplasty.it