Case Presentation - SUNY Downstate Medical Center Presentation • Medical History –HTN – IDDM...
Transcript of Case Presentation - SUNY Downstate Medical Center Presentation • Medical History –HTN – IDDM...
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Case Presentation
ALIREZA SADEGHI MD
Brooklyn VA Medical Center
SUNY Downstate Medical Center
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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
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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
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Case Presentation
• Medications– Coreg– Lisinopril– Lasix– Spirinolactone– Zocor– Fosamax– Calcium Carbonate– Albuterol MDI– Ipratropium MDI
– Insulin (NPH/Regular)– Prednisone– Sulfasalazine– Terazosin– ASA– Multivitamins
• NKDA
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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
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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.
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PVR
Severe Multi-level Occlusive Disease
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Angiogram
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Angiogram
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Operating Room• Percutaneous
Entry Technique:
– Contralateral Femoral Artery Cannulation
– Cross-Over Sheath Placed
– 0.014’ wire passed through the lesions
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SilverHawk Plaque Excision System
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Intra-Operative Angiogram
Before After
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Intra-Operative Angiogram
Before After
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Specimen
Atheromatous Plaque
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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
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Treatment of Peripheral Arterial Disease
The Endovascular Era
ALIREZA SADEGHI MD
SUNY Downstate Medical Center
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Vascular Anatomy
• Femoral Artery:
– Common– Superficial– Deep (Profunda)
• Perforators
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Vascular Anatomy
• Popliteal Artery:– Above Knee– Below Knee
• Tibioperoneal Trunk:– Anterior Tibial– Posterior Tibial– Peroneal
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• 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
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Ankle Brachial Index
Ouriel K. Peripheral Arterial Disease. The Lancet. 2001; 358:1257-1263
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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
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Peripheral Arterial Disease
Ouriel K. Peripheral Arterial Disease. The Lancet. 2001; 358:1257-1263
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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
Ouriel K. Peripheral Arterial Disease. The Lancet. 2001; 358:1257-1263
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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
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SFA Contour
Drisko K .Characterizing the unique features of the SFA. Endovascular Today. Oct 2004; 6-8
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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
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Risk Factors
Ouriel K. Peripheral Arterial Disease. The Lancet. 2001; 358:1257-1263
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Limb Ischemia Classification
Ouriel K. Peripheral Arterial Disease. The Lancet. 2001; 358:1257-1263
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Limb Ischemia Classification
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Diagnosis
• Non invasive– PVR– ABI– Arterial Duplex– MRA– CTA
• Invasive– Angiogram
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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
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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.
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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
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Surgical Therapy
• Open surgical techniques: “Gold Standard”– Amputation, Endarterectomy vs. Bypass
• Catheter Mediated / Endovascular techniques
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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.
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History of Endovascular Interventions
Charles Dotter MD
Pioneer VIR
First Peripheral Angioplasty 1964
“So much for the future!!!”
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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
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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
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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
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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
Davis MG et al .Comprehensive Endovascular Therapy for Femoropopliteal Arterial AtherescleroticOcclusive Disease. JACS. 2005; 1-22
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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)
Davis MG et al .Comprehensive Endovascular Therapy for Femoropopliteal Arterial AtherescleroticOcclusive Disease. JACS. 2005; 1-22
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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.
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Subintimal Angioplasty
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Subintimal Angioplasty
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• Controlled plaque freezing by inflation of the balloon with Liquid Nitrogen.
Cryoplasty Therapy
Tatsutani K. Cryoplasty Procedure: Proposed Mechanism of Action. Cyrovascular Systems Inc.
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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
Tatsutani K. Cryoplasty Procedure: Proposed Mechanism of Action. Cyrovascular Systems Inc.
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Cryoplasty Therapy
Tatsutani K. Cryoplasty Procedure: Proposed Mechanism of Action. Cyrovascular Systems Inc.
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Cryoplasty Therapy
Tatsutani K. Cryoplasty Procedure: Proposed Mechanism of Action. Cyrovascular Systems Inc.
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Cryoplasty Therapy
Laird J. Cryoplasty Procedure: IDE Study Review of Final Results. Cyrovascular Systems Inc.
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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.
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Cutting Balloon• The cutting force is magnified to precise points on the vessel
wall
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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
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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
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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
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Stents
• Dissatisfaction with poor results of conventional PTA & its derivatives
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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
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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
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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%
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SIROCCO I &II
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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%
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Covered PTFE Stent
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aSpire Stent
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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.
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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%
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PELA
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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
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SilverHawk Plaque Excision System
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Advantages of Atherectomy
PTA
Stenting
Plaque Excision
Restenosis
Barotrauma
In-Stent Restenosis
Stent Fracture / Migration in SFA
Avoids Barotrauma
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SilverHawk Plaque Excision System
FDA approved for all Peripheral Lesions
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SilverHawk Carbide Blade
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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!!!
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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
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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%
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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
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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
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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%
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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
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Open Surgery vs. Endovascular Surgery ??
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Open vs Endovascular
Ouriel K. Peripheral Arterial Disease. The Lancet. 2001; 358:1257-1263
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• Simpler Procedures• MAC vs GETA• Patient Preference &
Selection (Co-morbidities)• Re-interventions are possible
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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