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Case Presentation

ALIREZA SADEGHI MD

Brooklyn VA Medical Center

SUNY Downstate Medical Center

Case Presentation

• xx Year Old African-American Male • Referral: Podiatry • Chief Complaint:

– History of ½ Block Claudication (RLE)– New Onset Rest Pain:

• Right Lower Extremity x 3 months– Tissue Loss: Non Healing Ischemic Ulcer x 2

months • Plantar Surface Right 1st Toe

Case Presentation

• Medical History– HTN– IDDM– CAD– MI x 2– CHF– COPD – Hyperlipidemia– Rheumatoid Arthritis– Osteoporosis

– BPH– EtOH Abuse– Tobacco Use

• Current: xx Pack Yrs

– Glaucoma– Obesity

• Surgical History– Appendectomy xx years

prior

Case Presentation

• Medications– Coreg– Lisinopril– Lasix– Spirinolactone– Zocor– Fosamax– Calcium Carbonate– Albuterol MDI– Ipratropium MDI

– Insulin (NPH/Regular)– Prednisone– Sulfasalazine– Terazosin– ASA– Multivitamins

• NKDA

Case Presentation

• Laboratory Values:

• WBC: 7.0• HGB: 13.3• HCT: 41.7• PLT: 206

• PT: 13.7• PTT: 28.1• INR: 1.1

• Na: 142

• K: 4.4

• Cl: 107

• CO2: 28

• BUN: 10.0

• Creat: 1.0

• Gluc: 72

• Ca: 8.2

• LDL: 207

Physical Examination• Vital Signs

– Temp: 98.6 F– BP: 127/64– HR: 75– RR: 18– O2 Sat: 95% RA

• Physical Exam– A & O x 3– No carotid bruit– CTA B/L; RRR– + JVD at 30 Degrees– Abd: No pulsatile mass– Extremities:

• Pulses:– 2+ Femoral B/L– Nonpalpable Pop/DP/PT

B/L• 2 x 2 cm non healing ischemic

ulcer on R 1st toe.

PVR

Severe Multi-level Occlusive Disease

Angiogram

Operating Room• Percutaneous

Entry Technique:

– Contralateral Femoral Artery Cannulation

– Cross-Over Sheath Placed

– 0.014’ wire passed through the lesions

SilverHawk Plaque Excision System

Intra-Operative Angiogram

Before After

Specimen

Atheromatous Plaque

Postoperative Course

• OR: Subjective relief of Rest Pain• POD#1: Discharged home

• 30 Day follow up:– Healing ulcer– No Rest Pain– Improved Claudication & Exercise Capacity

Treatment of Peripheral Arterial Disease

The Endovascular Era

ALIREZA SADEGHI MD

SUNY Downstate Medical Center

Vascular Anatomy

• Femoral Artery:

– Common– Superficial– Deep (Profunda)

• Perforators

Vascular Anatomy

• Popliteal Artery:– Above Knee– Below Knee

• Tibioperoneal Trunk:– Anterior Tibial– Posterior Tibial– Peroneal

• Chronic occlusive disease of lower extremities• Strong surrogate marker for atherosclerotic disease in

the heart, kidneys & brain• Intermittent Claudication

– Most common symptom caused by atherosclerotic occlusive disease.

– Latin caludicatio: To Limp• Pain in a muscle upon exercise that resolves with rest.

– Symptoms range from mild life-style limiting IC to severe limb threatening ischemia

Peripheral Arterial Disease

Ankle Brachial Index

Ouriel K. Peripheral Arterial Disease. The Lancet. 2001; 358:1257-1263

Statistics

• Peripheral Arterial Disease:– Associated with a 60% incidence of coronary &

cerebrovascular disease– About 90% of patients with symptomatic PAD have

coronary disease.– Mortality from PAD:

• 30% in 5 years• 50% in 10 years• 75% in 15 years

Murdock, BS. Literature Review of LE PAD & Percutaneous Techniques. Env Health Comm. 2004:1-32

Peripheral Arterial Disease


Demographics

• Peripheral Artery Disease– 20% incidence in patients older than 75

• 30-50% of these patients become symptomatic– 4-6 million of the US population

• Up to 30% will progress to Critical Limb Ischemia– Associated with poor prognosis– 50% mortality at one year without major amputation

– Nearly 70% of the arterial lesions are in the Femorotibial tract

• 85% in the SFA/Popliteal• 15% in the Tibioperoneal Vessels


SFA Disease

• Superficial Femoral Artery:– Most commonly diseased artery in the

peripheral vasculature:• More than 50% of all PAD involves SFA

– One of the longest vessels in the body– Few collaterals promoting diffuse disease– Occlusive lesions outweigh stenosis– Adductor Canal has Nonlaminar flow dynamics

» More calcification & elastic recoil » Higher rates of recurrence after

surgical/endovascular interventions– Multiple forces exert significant stress on the SFA

» Challenges for Endovascular devices

Ansel G. Tips & Techniques for Stenting the SFA. Endovascular Today. Oct 2004; 13-15

SFA Contour

Drisko K .Characterizing the unique features of the SFA. Endovascular Today. Oct 2004; 6-8

SFA Disease

Extension / Contraction1.

Torsion

2.

Compression

3. Flexion 4.

Drisko K .Characterizing the unique features of the SFA. Endovascular Today. Oct 2004; 6-8

Risk Factors


Limb Ischemia Classification


Diagnosis

• Non invasive– PVR– ABI– Arterial Duplex– MRA– CTA

• Invasive– Angiogram

Therapy

• Main Goals of PAD Treatment:– Improve functional status & quality of life– Limb Preservation/Salvage

• Surgical approach (Open vs. Endovascular)• Restoring Straight-Line & Pulsatile blood flow from the

heart to the ankle– Relieve claudication/rest pain & achieve wound healing

– Identify and treat systemic atherosclerosis– Prevent progression of atherosclerosis

Indication for Intervention

• Limb Threatening Ischemia– Rest Pain– Non Healing Ulcer– Gangrene

• Lifestyle limiting claudication– Not controlled by risk factor modification, Exercise

Therapy and/or Pharmacotherapy.

Medical Therapy• Life Style Modification

• Smoking cessation• Exercise therapy• Blood pressure reduction• Diabetes optimization

• Pharmacologic Therapy• Antiplatelet Therapy• Lipid Lowering Therapy• ACE Inhibitors• Pentoxifyline/Cilostazol

– Phosphodiesterase Inhibition• Naftidrofuryl/Blufomedil

– Serotonin Antagonism– Alpha adrenolytic agents

Surgical Therapy

• Open surgical techniques: “Gold Standard”– Amputation, Endarterectomy vs. Bypass

• Catheter Mediated / Endovascular techniques

Therapy

• Many patients have many other severe co-morbidities and are not favorable candidate for surgery

• Require customized treatment strategy for each “individual patient”.

• Endovascular approaches especially valuable for patients who are too high risk for the standard surgical treatments.

History of Endovascular Interventions

Charles Dotter MD

Pioneer VIR

First Peripheral Angioplasty 1964

“So much for the future!!!”

Endovascular Options in the SFA

• Percutaneous Transluminal Angioplasty– Subintimal Angioplasty– Cutting Balloon Angioplasty– Cryoplasty

• Stent– Metallic (Balloon vs. Self Expanding)– Drug-Eluting Stents

• Atherectomy– Laser Debulking Atherectomy– Plaque Excision Devices

Percutaneous Transluminal Angioplasty

• In order to classify lesions and the subsequent interventions in the SFA & Popliteal arteries, The TransAtlantic Inter-Society Consensus (TASC) Working Group formulated a classification system for the Lower Extremity Arteries

• Endovascular techniques can be applied to this classification system

Conventional PTA

• Controlled injury to the vessel wall by direct dilation• Induces apoptosis of the medial smooth muscle cells• Studies show that 20% of the vascular wall DNA is lost

within 4 hours from the medial smooth muscle cells• Restenosis after PTA is common, secondary to medial

and intimal reaction to this injury – Presents 3-6 months after the initial angioplasty depending

on the location and size of the blood vessel.

• High incidence of Barotrauma/Dissection/Perforation

Davis MG et al .Comprehensive Endovascular Therapy for Femoropopliteal Arterial AtherescleroticOcclusive Disease. JACS. 2005; 1-22

Good Outcomes

• Factors affecting Primary & Long-Term Patency of PTA:– Short segment disease– Large vessel involvement (Iliac>SFA>TPT)– Stenosis rather than Occlusion– Good peripheral run-off– Claudication rather than rest pain– Minimal Coronary Disease with good renal function– Absence of Diabetes Mellitus


Conventional PTA Outcomes

• Iliac Arteries (IC)• 1 year: 68%• 3 year: 60%

• Femoropopliteal (IC)• 1 year: 79%• 3 years: 59%• 5 years: 51%

• Infrapopliteal (Limb Salvage)• 2 year: 25-50% (Lesion dependent)


Subintimal Angioplasty

• Developed accidentally in 1987 in the course of the treatment of a 15 cm popliteal occlusion.

• A Subintimal channel was created and the artery remained patent for 9 years to follow in that patient.

Subintimal Angioplasty

• Controlled plaque freezing by inflation of the balloon with Liquid Nitrogen.

Cryoplasty Therapy

Tatsutani K. Cryoplasty Procedure: Proposed Mechanism of Action. Cyrovascular Systems Inc.

Cryoplasty Therapy

• As temperature cools, interstitial saline freezes.• Plaque become more distensible as it freezes• Application of cold to vessel wall temporarily alters the biomechanics of the

fibrin and elastin fibers: Less elastic recoil• More uniform apoptosis of the medial smooth muscle cells with a non-

inflammatory mechanism: reduces neointimal hyperplasia• Less wall stress on the vessel wall


Cryoplasty Therapy


Cryoplasty Therapy

Laird J. Cryoplasty Procedure: IDE Study Review of Final Results. Cyrovascular Systems Inc.

Cutting Balloon

• Noncompliant balloon with 3 or 4 atherotomes mounted on the surface

• When balloon is inflated the atherotomes, score and displace the plaque or fibrotic tissue.

Cutting Balloon• The cutting force is magnified to precise points on the vessel

wall

Indications for Cutting Balloon

• Native arterial vessel stenosis with/without conventional PTA

• Anastomosis stenosis of Bypass grafts (neointimal hyperplasia )

• In-Stent restenosis• Venous fibrotic lesions ( AVF)

Settaci C et al. The Cutting Balloon experience in the lower limbs. TCT Presentation. MEET 2004

Cutting Balloon

Above Knee Femoropopliteal Bypass: Distal Anastomosis Stenosis

Engelke C et al. Cutting balloon percutaneous transluminal angioplasty for salvage of lower limbs: Arterial Bypass Grafts: Feasibility. Radiology Apr 2002.106-114

Outcomes

• Cutting Balloon for neointimal hyperplasia for arterial bypass grafts

– Primary Patency:• 6 Months: 84%• 12 Months: 67%• 18 Months: 63%

Engelke C et al. Cutting balloon percutaneous transluminal angioplasty for salvage of lower limbs: Arterial Bypass Grafts: Feasibility. Radiology Apr 2002.106-114

Stents

• Dissatisfaction with poor results of conventional PTA & its derivatives

Stents

• Multiple varieties of Stents out in the Market

• FDA approved for the SFA:– Stainless Steel Stents

• Intracoil: 9 month 80%• Wallstent: 6 month 60%

– Unsatisfactory

– Nitinol Stent• SMART stent

Other Stents

• Nitinol Stents

– Coiled stent vs. Mesh stent (Bare/ePTFE covered)– Recently FDA approved (Cordis SMART stent)– An alloy of Nickel and Titanium which can be

annealed so that expansion occurs when the stent is at body temperature

– Also used in biliary interventions

Other Stents• Nitinol Mesh Stents

– Cordis SMART Stent– Accommodates longer lesions– Similar patency Coiled vs. Mesh– Patency

• 6 months: 80%• 1 year: 76%

• Drug Eluting Stent– Sirolimus coated SMART

Nitinol Stent• Not FDA Approved• SIROCCO I & II trials:

– 6,12,18 & 24 months– No significant

difference in bare nitinol vs. DES

– BLASTER trial:• Reopro (Abciximab)• One year patency: 83%

SIROCCO I &II

Other Stents

• Covered Stents:– Expanded PTFE over a

nitinol skeleton – “Internal Bypass Graft”– Limits tissue in growth– FDA-approved clinical

trials for Iliac & SFA– aSpire Stent (Vascular

Architects)– One year patency: 80%

Covered PTFE Stent

aSpire Stent

PTA vs PTA & Stenting

Four randomized studies comparing PTA vs PTA+Stent have failed to demonstrate a benefit it terms of long term patency and symptom relief.

Excimer Laser Atherectomy

• Laser Debulking Atherectomy– Peripheral debulking for long

lesions occlusions/stenosis– Evaporates plaque without

damage to vessel wall– Allows optional PTA/Stenting– 12 month Duplex results:

• Patency from PELA trial– Laser: 78%– PTA: 82%

Atherectomy

• Two Categories:– Extirpative

• AKA Directional Atherectomy• Removal plaque and delivering it

outside• Simpson device/SilverHawk device

– Ablative• AKA Rotational Atherectomy• Fragmenting plaque into small particles

that enter the reticuloendothelial system• Rotablator device

Advantages of Atherectomy

PTA

Stenting

Plaque Excision

Restenosis

Barotrauma

In-Stent Restenosis

Stent Fracture / Migration in SFA

Avoids Barotrauma


FDA approved for all Peripheral Lesions

SilverHawk Carbide Blade

SilverHawk Benefits

• The operator dependent

• determines cut length

• Continuous longitudinal plaque shaving enables efficient treatment of long lesions

• Single device can be used to treat multi-focal and multi-vessel disease

• Time Consuming Procedure!!!

LS and LX: Femoral-Popliteal • Varying tip collection capacity • Treat vessels greater than 4 mm

through a 7F sheath

SX, SS and ES: Tibial-Peroneal • Different crossing profiles• Varying Tip capacity• 6 and 7F Sheaths• Treat 2.0 mm-3.5 mm lesions

SilverHawk Catheters

SilverHawk Outcomes

• 506 pts/1099 lesions• 32 % with CLI• Average Fem-Pop Lesion

length 7.5 cm• 49% with multiple lesions• Immediate Success: 99%• 6 Month Patency: 89%• Complication rate

– Dissection/Perf: 2.2%

SilverHawk Outcomes

• Real World SFA Disease – CIS• Cardiovascular Institute of the South (CIS): Louisiana• Single institute: 10 month experience• Total of 133 Lesions• TASC B: 45% TASC C: 26%• Mean Lesion Length: 16.2 cm• Procedural Success: 98% with 90% SH alone• ABI: Pre (0.61) Post (0.79)• 6 month patency: 91.4%• No Complications

SilverHawk Outcomes

• Arizona Heart Hospital• 12 Month Follow Up• 104 Patients• TASC B,C,D 77%• Rest Pain & Tissue Loss 38%• One year Patency 86%• Minor complications: 4%

– Groin hematoma/pseudoaneursym– ARF

SilverHawk Outcomes

• Limb Salvage with SilverHawk– Duke Clinical Research Inst & Austin Heart

Hospital• 16 Patients, 34 Lesions• History Treatment• Diabetes 69% Standalone SH 56%• Claudication 92% SH + PTA 29%• Prev MI, CABG 61% SH + PTA + Stent 15%• Prev Perp Intrv 17%• Smokers 56%• Rutherford-Becker ≥ 5 100%

SilverHawk Outcomes• Complications

– 0 MI • 0 Emergent Surgery • 0 Embolization – 0 Stroke • 0 Perforations • 0 Thrombosis

• Results– Procedural success 16/16 patients (100%)– Mean follow up of 6 weeks

• 14 of 16 patients required NO amputations• 2 of 16 required less extensive amputations than scheduled

• Conclusions– 14 of 16 Limbs salvaged– 2 of 16 required less extensive amputations

• Complications– 0 MI • 0 Emergent Surgery • 0 Embolization – 0 Stroke • 0 Perforations • 0 Thrombosis

• Results– Procedural success 16/16 patients (100%)– Mean follow up of 6 weeks

• 14 of 16 patients required NO amputations• 2 of 16 required less extensive amputations than scheduled

• Conclusions– 14 of 16 Limbs salvaged– 2 of 16 required less extensive amputations

Open Surgery vs. Endovascular Surgery ??

Open vs Endovascular


• Simpler Procedures• MAC vs GETA• Patient Preference &

Selection (Co-morbidities)• Re-interventions are possible

Conclusion

• There is a repertoire of endovascular techniques in the management of Femoropopliteal atherosclerotic disease

• Most devices have excellent initial success rates, given that they are used at the proper location and for the proper lesion

• Re-interventions with Endovascular catheters are possible with combined modalities

• Open Surgical methods are always available with failed endovascular modalities

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