Superficial Femoral Artery Disease: Simulation Training Curriculum

Superficial Femoral Arterial Disease Prevalence Clinical Presentation Diagnosis Indications Technical Issues Treatment Options - PTA - Surgical Complications Prognosis

Responsible for > 50% of PAD Cases SFA disease: Responsible for > 50% of PAD Cases One of the longest vessels in the body Torsion/compression/flexion/extension by the largest muscle group Two flexion points Few collateral sources Occlusions predominate

Superficial Femoral Arterial Disease Most common in men than women Most common in older patients with concomitant coronary disease Strong relationship between increased tortuosity and disturbed hemodynamic patterns in regions of the SFA Predilection for the region of the adductor canal 1 1. Wood et al J Appl Physiol 2006 (6)

Forces Exerted in SFA Extension / Contraction 1. Torsion 2. Flexion 4. Compression 3.

Superficial Femoral Arterial Disease Isolated SFA disease predicts low amputation risk (0-1%) without surgical revascularization 1 Cumulative smoking history Contralateral superficial femoral artery occlusion Presence of diabetes DISEASE PROGRESSION Other arterial segments involved Increasing risk of critical limb ischemia 1. Hertzer NR Circulation 1991; 83(Suppl.1):I-12 – I-19

Superficial Femoral Arterial Disease Prevalence Clinical presentation Diagnosis Indications Technical Issues Treatment Options - PTA - Surgical Complications Prognosis

Clinical Presentation Claudication Critical limb ischemia (less common) The presence of the Profunda Femoris Artery, the main nutritive artery of the thigh, protects patients with SFA occlusion from critical limb ischemia

Morphological Stratification of Femoropopliteal Lesions TASC Type A Single stenosis less than 3 cm of the superficial femoral artery or popliteal artery TASC Type B Single stenosis 3 to 10 cm in length, not involving the distal popliteal artery Heavily calcified stenoses up to 3 cm in length Multiple lesions, each less than 3 cm (stenoses or occlusions) Single or multiple lesions in the absence of continuous tibial runoff to improve inflow for distal surgical bypass TASC Type C Single stenosis or occlusion longer than 5 cm Multiple stenoses or occlusions, each 3 to 5 cm in length, with or without heavy calcification TASC Type D Complete common femoral artery or superficial femoral artery occlusions or complete popliteal and proximal trifurcation occlusions ACC/AHA Guidelines

Superficial Femoral Arterial Disease Prevalence Diagnosis Indications Technical Issues Treatment Options - PTA - Surgical Complications Prognosis

Superficial Femoral Arterial Disease: Diagnosis Clinical evaluation Stevens et al JAMA 2006;295(5):584

Diagnostic Methods Ankle-and Toes – Brachial Indices, segmental pressure examination Pulse volume recording Continuous wave doppler ultrasound Treadmill exercise testing with and without ABI assessments and 6 minute walk test Duplex ultrasound Computed tomographic angiography Magnetic resonance angiography Contrast angiography Hirsh et al Circulation 2006; 113(11): e463-654 ACC/AHA Guidelines

Diagnostic Methods: Duplex Ultrasound Stenosis in the superficial femoral artery visualized satisfactorily in the color mode Ramaswami et al J Endovasc Surg. 1995; 2(1): 27-35

Diagnostic Methods: MRA Lower extremity MRA showing severe stenoses in left superficial femoral artery and smaller stenoses in right superficial femoral artery. Cochrane J Radiology Rounds MGH 2004;2(11)

Diagnostic Methods: CTA The diagnostic accuracy of CT angiography has been proved superior to that of conventional arteriography in several applications CT angiography is substantially less invasive and less expensive, and it allows three-dimensional visualization from any angle and in any direction, which cannot be achieved with projection techniques such as DSA Coronal multi–detector row CT angiography : Occlusion of the right superficial femoral artery (thick arrow) Catalano et al Radiology 2004;231:555-563

Diagnostic Methods: DSA B Digital subtraction angiography (DSA) shows A the occlusion of the left common iliac artery and external iliac artery, long occlusion of both superficial femoral arteries (SFAs) with no visible stump on the left, and B restoration of both distal SFAs through collaterals (arrows) Yılmaz et al Eur Radiol. 2002;12(4): 911-4

Superficial Femoral Arterial Disease Prevalence Diagnosis Technical Issues Treatment Options - Medical - PTA - Surgical Complications Prognosis

Superficial Femoral Artery Technical Approach Diagnostic Arteriogram: Showing inflow and outflow of the target lesion Run-off angiography to visualize the lower extremity circulation Grossmans “Catheterization” 7th Ed. pg. 254-280

Vascular Access Antegrade common femoral artery puncture : Most common Contralateral retrograde access over the aortic bifurcation Advantages: The ability to image the common femoral and its bifurcation The ability to treat iliac and infrainguinal disease in the same timing Disadvantages: Working from a distance with exchange-length wires and balloons Retrograde popliteal artery access Rare cases where the antegrade or contralateral approach fails to traverse an occluded segment In the event that a subintimal channel has been created Brachial access Provides better radiation protection, since one is working far from the actual target site, but requires the use of lengthy wires and devices

Superficial Femoral Artery Anticoagulation Aspirin (325 mg) once a day several days prior the procedure After access has been obtained and prior to intervention: 2500 – 5000 international units of heparin

Superficial Femoral Arterial Disease Prevalence Diagnosis Technical Issues Treatment Options - Medical - PTA - Surgical Complications Prognosis

Superficial Femoral Arterial Disease: Treatment Patients with Claudication Aggressive risk factor modification Exercise program Patients with Critical Limb Ischemia Revascularization

Superficial Femoral Arterial Disease: Angioplasty PTA is the preferred initial treatment in patients with disabling claudication 1 In patients with critical leg ischemia, PTA is better for the treatment of femoropopliteal stenosis, whereas femoropopliteal occlusion is best managed with bypass grafting 1 Percutaneous transluminal angioplasty (PTA) has been recommended only for short lesions of the superficial femoral artery 2 1. Hunink et al JAMA 1995; 274(2) 165-171 2. Dormandy JA, Rutherford B J Vasc Surgery 2000; 31:S1-S296

Superficial Femoral Arterial Disease: Angioplasty Low procedural morbidity and mortality Reduced costs Shortened hospital stay Preserves collaterals so that even if the angioplasty site occludes, symptoms might not return Patients who are expected to live for less than 1–2 years and have significant comorbidity should probably, when possible, be offered angioplasty first. If the procedure fails, the patient may not be disadvantaged in the short term and can go on to have surgery if regarded as appropriate Adam et al Lancet 2005;366:1925-1934.

Adjunct Therapies Stents Directional atherectomy Rotational atherectomy Laser angioplasty Intra-arterial radiation Cryotherapy

Superficial Femoral Arterial Disease: Stenting Is recommended only as a bailout procedure after technical failure of angioplasty Flow limiting dissections Residual pressure gradient >15mmHg Remaining stenosis >30% An elastic recoil as well as failure to maintain initial patency Heuser R, Biamino G. Peripheral Vasc Stenting.2nd Ed. 91-108

Superficial Femoral Arterial Disease: Balloon Expandable Stents : Not indicated in the femoropopliteal region, with exception of short, very calcified lesions less than 2 cm in length. The Palmaz TM stent High radial force: valuable in highly calcified lesions Precise placement Disadvantage: significant stiffness Strecker TM stents Very flexible: Allows for a contralateral placement using crossover approach Disadvantage: deformability by extrinsic compression, which can lead to restenosis and reocclusion in the femoropopliteal tract Heuser R, Biamino G. Peripheral Vasc Stenting.2nd Ed. 91-108

Superficial Femoral Arterial Disease: Stenting Stents of choice for implantation in the SFA Advantages over balloon expandable stents: Higher flexibility Recoil tendency after external deformation The Wallstent Difficult exact placement: shortening up to one-third Ninitol Stents Implantation more precise foreshortening (Max 5%) Superior accommodation to different artery diameters

Duplex-guided Balloon Angioplasty and Stenting Duplex methodology can be used to map the arterial disease process and to guide wires, sheaths, balloons, and stents for the treatment of superficial femoral Effective in achieving excellent anatomic and hemodynamic improvement regardless of the extent of the stenotic lesion Benefic in patients severely allergic to contrast material or those with renal insufficiency Power Doppler image of severe (81%) superficial femoral artery stenosis. The hemodynamic significance of this lesion was confirmed by a peak systolic velocity of 388 cm/s with marked spectral broadening. Ascher et al J Vasc Surgery 2005; 42(6): 1108-1113

Directional Atherectomy Directional atherectomy of right superficial femoral artery. A. Angiography via antegrade punctureinto right common femoral artery demonstartes high-grade stenosis in proximal SFA, not favorable for balloon angioplasty owing to ostial location/eccentricity. B. An 8Fr directional atherectomy catheter introduced via sheat, which is then pulled back to common femoral artery. C. Angiography following DA demonstrates excellent result Grossmans “Catheterization” 7th Ed. pg. 593-595.

Excimer laser Atherectomy Excimer laser atherectomy of peripheral arteries has been practiced commercially in Europe since 1994 and has been shown to be a useful adjunct for the treatment of long superficial femoral artery (SFA) occlusions Scheinert et al J Endovasc Ther. 2001;8:156–166

Superficial Femoral Arterial Disease: When PTA has been attempted for more diffuse disease and long occlusions, limb salvage rates are considerably lower Laird et al J Endovasc Ther. 2006 Feb;13(1):1-11

A) A rather extreme case of severe ulceration with associated infection on the bottom of the foot prior to intervention. (B) At 6 months after treatment with excimer laser atherectomy , healing is nearly complete Laird et al J Endovasc Ther. 2006 Feb;13(1):1-11

Surgery Bypass surgery with venous grafts Good long-term anatomical patency Clinical durability Bypass surgery vs. angioplasty : Angioplasty also seems to be a much less expensive option than surgery, at least in the short term The rates of amputation – free survival after surgery and balloon angioplasty are similar for the first two years. Adam et al Lancet 2005;366:1925-1934.

Amputation-free survival after bypass surgery and balloon angioplasty Adam et al Lancet 2005;366:1925-1934.

All-cause mortality after bypass surgery and balloon angioplasty Adam et al Lancet 2005;366:1925-1934.

Poor Surgical Candidates Severe distal tibial occlusive disease Inadequate distal targets for revascularization, Absent venous conduit, or Significant medical or cardiac comorbidities rendering them at high risk for complications from surgery. Laird et al J Endovasc Ther. 2006 Feb;13(1):1-11

Superficial Femoral Arterial Disease Prevalence Diagnosis Technical Issues Treatment Options - Medical - PTA - Surgical Complications Prognosis

Complications Acute or subacute thrombosis Restenosis Dissection Distal embolization Perforation Hematoma Stent fractures

Superficial Femoral Arterial Disease Prevalence Diagnosis Technical Issues Treatment Options - Medical - PTA - Surgical Complications Prognosis

Unfavorable Predictors Type of lesion (occlusion) Long or eccentric lesions Diffuse atherosclerosis Limb-threatening ischemia Poor initial post-PTA appearance Diabetes mellitus Congestive heart failure Poor distal outflow

Favorable Predictors Higher preoperative ABI Performance of angioplasty Type of lesion (stenosis)

Percutaneous angioplasty or stenting of the SFA 1986-2004 Primary Patency Rates (%) Months 380 limbs 66% IC The objectives of this study were to examine factors predictive of success or failure after percutaneous angioplasty (PTA) and stenting (S) of the superficial femoral artery (SFA) and to compare the results of PTA/S with a contemporary group of patients treated with femoropopliteal bypass. METHODS: A database of patients undergoing PTA and/or S of the SFA between 1986 and 2004 was maintained. Intention-to-treat analysis was performed. Patients underwent duplex scanning follow-up at 1, 3, and every 6 months after the intervention. Angiograms were reviewed in all cases to assess lesion characteristics and preprocedure and postprocedure runoff. Results were standardized to current TransAtlantic Inter-Society Consensus (TASC) and Society for Vascular Surgery (SVS) criteria. Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Cox proportional hazard analyses were performed to assess factors associated with patient survival and treatment efficacy. RESULTS: Three hundred eighty total limbs underwent PTA/S in 329 patients (67% male, 33% female; average age, 65 years). Mean follow-up was 1.8 years from the date of initial intervention. Indications for intervention were claudication in 66%, rest pain in 16%, and tissue loss in 18%. Runoff at the tibial level was 2.1 +/- 0.8 patent vessels. Mean SVS ischemia grade was 3.1 (range, 1 to 5). TASC lesion grades were A (48%), B (18%), C (22%), and D (12%). Angioplasty alone was used in 63% of cases. Primary treatment failure (inability to cross lesion) was seen in 7% of patients. There was one periprocedural death. Primary patency rates were 86% at 3 months, 80% at 6 months, 75% at 12 months, 66% at 24 months, 60% at 36 months, 58% at 48 months, and 52% at 60 months. Assisted primary patency rates were slightly higher ( P = not significant). By Cox proportional hazards analysis, patency of PTA/S was associated with higher preoperative ankle/brachial index ( P = .016) and the performance of angioplasty only ( P = .011). Failed or occluded PTA/S was associated with TASC C ( P < .0001) and TASC D lesions ( P < .0001). Patient death was associated with the presence of congestive heart failure ( P = .003). Subgroup analysis revealed that primary patency rates are highly dependent on lesion type (A > B > C > D, P < .0001). PTA/S patency for TASC A and B lesions compared favorably to prosthetic and venous femoropopliteal bypass. Surgical bypass was superior to PTA/S for TASC C and D lesions. CONCLUSIONS: PTA and stenting of the SFA can be performed safely with excellent procedural success rates. Improved patency of these interventions was seen with increased ankle/brachial index and the performance of angioplasty only. Worse patency was seen with TASC C and TASC D lesions. Patency rates were strongly dependent on lesion type, and the results of angioplasty and stenting compared favorably with surgical bypass for TASC A and B lesions. Surowiec SM. J Vasc Surg. 2005;41(2):269-78

3-year Primary Patency Rates SFA Patency Rates Meta-analysis 1993-2000 3-year Primary Patency Rates Roehring JVS 2005

Rates of Restenosis on Angiography Angiplasty Stenting P=0.05 P=0.02 Restenosis Rate % 43% (23 of 53) 24% (12 of 51) 50% (18 of 36) 25% (17 of 68) Schillinger et al N Eng J Med 2006;354:1879-1888

Rates of Restenosis on Duplex Ultrasonography Angioplasty Stenting P=0.36 P=0.06 P=0.01 Restenosis Rate % 23% (12 of 53) 14% (7 of 51) 45% (24 of 53) 25% (13 of 51) 63% (33 of 52) 37% (18 of 49) Schillinger et al N Eng J Med 2006;354:1879-1888

Clinical Outcomes Angioplasty Vs Ninitol Stent Group Maximum Walking Distance (m) Schillinger et al N Eng J Med 2006;354:1879-1888

Comparison with Venous and Prosthetic Bypass SFA PTA or Stenting 1986-2004 Comparison with Venous and Prosthetic Bypass TASC LESION TASC LESION Surowiec SM. J Vasc Surg. 2005;41(2):269-78

Stent or PTA of the SFA 1986-2004: Freedom from symptom recurrence TASC lesion Despite loss of patency, patients feel better. Tissue healed, better colaterals, exercise program able to be initiated etc Surowiec SM. J Vasc Surg. 2005;41(2):269-78

Durability of Endovascular Intervention for Iliac and Femoropopliteal Disease Primary Patency at 1, 3, 5, Years TASC Working Group , J Vasc Surg 2000;31:S1-S296

Femoro-popliteal Bypass Graft Occlusion: Dutch BOA Study Multicenter, randomized comparison of coumadin vs. ASA for prevention of graft occlusion 2690 patients with mean follow-up of 21 months: 51% claudicants, 48% with CLI Conduits: 64% venous 36% prosthetic conduits Smeets et al Eur J Vasc Endovasc Surg 2005; 30(6):604-9

Durability of Surgical Bypass: Multicenter Randomized VASCAN Trial Primary patency rates (%) 328 femoropopliteal bypass operations utilizning end-to-end versus end-to-side distal anastomosis Primary patency was 75 vs 74%, 65 vs 66% and 63 vs 55% for ETE vs ETS after 1, 2 and 3 years, respectively, (p = 0.26) Schouten et al Eur J Vasc Endovasc Surg. 2005; 29:457-62

Proximal SFA occlusion

Excimer Laser

After Stenting