Iliac Disease Core Curriculum ICVWG 09 1 Iliac

Iliac Disease: Core Curriculum ICVWG 09 -1

Iliac Disease ü Diagnosis Indications Technical Issues Treatment Options - PTA - Surgical Complications Prognosis ICVWG 09 -2

Iliac Disease : Initial Assessment • Physical examination – signs of peripheral ischemia – distal embolization – status of the peripheral pulses. • Rest and exercise ABI ICVWG 09 -3

Iliac Disease: Diagnosis Noninvasive imaging modalities • • Pressure Gradients Duplex ultrasound (DUS) scans Magnetic resonance angiography (MRA) Computed tomography angiography (CTA) ICVWG 09 -4

Pressure Gradients obtained during revascularization of iliac occlusion A. Baseline gradient. B. Gradient after administration of nitroglycerine. C. Postballoon, significant resting gradient remains, evn without provocation. D. Gradient eliminated after stenting, demonstrating superior hemodynamic result. Grossmans “Catheterization” 7 th Ed. pg. 588 -592. ICVWG 09 -5

Iliac Disease: Duplex Ultrasound • DUS has proved to be cost-effective and accurate for the detection of significant vascular stenoses and is therefore often used as the first diagnostic modality. 1, 2 • The poor monophasic duplex waveform at the common femoral artery is in itself an accurate marker of aortoiliac obstructive disease. Other waveforms are nondiagnostic for aortoiliac disease. 3 1. Kohler et al Ann vasc surg 1990 (4) 280 -287 2. Visser et al Radiology 2000 (16) 67 -77 3. Spronk et al J vasc surg 2005; 42(2): 236 -242 ICVWG 09 -6

Triphasic : Three waveform “phases” consisting of a sharp systolic forward up rise and fall, an element of reverse flow during diastole, and an element of forward flow during diastole Sharp Monophasic One waveform “phase” with a sharp systolic rise, the lack of a reverse diastolic element, and a fast diastolic fall, expected in arterial segments proximal to an obstruction Biphasic Two waveform “phases” consisting of a sharp systolic forward up rise and fall and an element of reverse flow during diastole Poor (blunted) monophasic The loss of “sharpness” in systole, the lack of a reverse diastolic element, and a slow diastolic fall expected in arterial segments distal to an obstruction Spronk et al J vasc surg 2005; 42(2): 236 -242 ICVWG 09 -7

Iliac Disease: MR Angiography • Enhanced MR angiography showed significant improvement (P <. 001) compared with unenhanced MR angiography for diagnosis of clinically significant aortoiliac occlusive disease Rapp et al Radiology 2005; 236: 71 -78 ICVWG 09 -8

Iliac Disease: MR Angiography Gadofosveset-enhanced MR angiography Transverse reconstruction of a steady-state gadofosveset dataset showing stenoses (arrows) in both right and left common iliac arteries. Rapp et al Radiology 2005; 236: 71 -78 ICVWG 09 -9

Iliac Disease: Computed Tomography Angiography • CT angiographic examination is less invasive and less expensive than conventional angiography • Improves resolution with decreased contrast load and acquisition time without increasing radiation exposure A 4 -channel MDCT angiogram: Coronal curved planar reformatted images of the abdominal aorta and right iliac artery Rubin et al 2000 Radiology 215: 63 -70 Karcaaltincaba M, Foley D Cardiovasc Interv Rad 2005; 28(2): 169 -172 ICVWG 09 -10

Morphological Stratification of Iliac Lesions • Single stenosis less than 3 cm of the CIA or EIA (unilateral/bilateral) TASC Type A iliac lesions • Single stenosis 3 to 10 cm in length, not extending into the CFA TASC Type B • Total of 2 stenosis less than 5 cm long in the CIA iliac lesions and/or EIA and not extending into the CFA • Unilateral CIA occlusion ACC/AHA Guidelines ICVWG 09 -11

Morphological Stratification of Iliac Lesions • Bilateral 5 to 10 cm long stenosis of the CIA and/or EIA, note extending into the CFA TASC Type C • Unilateral EIA occlusion not extending into the CFA iliac lesions • Unilateral EIA stenosis extending into the CFA • Bilateral CIA occlusion • Diffuse, multiple unilateral stenosis involving the CIA, EIA and CFA (usually more than 10 cm long) TASC Type D • Unilateral occlusion involving both the CIA and EIA iliac lesions • Bilateral EIA occlusions • Diffuse disease involving the aorta and both iliac arteries • Iliac stenosis in a patient with an abdominal aortic anuerysm or other lesion requiring aortic or iliac surgery ACC/AHA Guidelines ICVWG 09 -12

Iliac Disease Diagnosis ü Indications Technical Issues Treatment Options - PTA - Surgical Complications Prognosis ICVWG 09 -13

Indications for Revascularization • Relief of symptomatic lower extremity ischemia, including claudication, rest pain, ulceration or gangrene, or embolization causing blue toe syndrome www. emedicine. com • Restoration y/o preservation of inflow to the lower extremity in the setting of pre-existing or anticipated distal bypass • Procurement of access to more proximal vascular beds for anticipated invasive procedures. Occasionally revascularization is indicated to rescue flow-limiting dissection complicating access for other invasive procedures Grossmans “Catheterization” 7 th Ed. pg. 588 -592. ICVWG 09 -14

Specific Indications for Revascularization Iliac artery revascularization before cardiac surgery • Significant bilateral disease in order to allow the intra-aortic balloon pump insertion Rigateli et al Internat J Cardiovasc Imag 2002; 22: 305 -310 ICVWG 09 -15

Iliac Disease Diagnosis Indications ü Technical Issues Treatment Options - PTA - Surgical Complications Prognosis ICVWG 09 -16

Iliac Disease: Angiography • Diagnostic aortogram: Inflow and outflow of the target lesion • Run-off angiography: Visualization of the lower extremity circulation Transbrachial aortography documents a Trans. Atlantic Inter-Society Consensus class D iliac occlusion with right external iliac occlusion and complete occlusion of the left iliac system in a 46 -year-old man with disabling claudication Leville et al J Vasc Surg 2006; 43(1): 32 -39 ICVWG 09 -17

Iliac Disease: Technical Issues Endovascular Access • • • Ipsilateral femoral artery Contralateral femoral artery Brachial artery: In patients with flush occlusions at the aortic bifurcation Multiple access sites may be required for successful treatment: • • Bilateral femoral Femoral/brachial Endovascular recanalization was performed with a hydrophilic guidewire and catheter, and femoral access was obtained with ultrasound guidance Leville et al J Vasc Surg 2006; 43(1): 32 -39 ICVWG 09 -18

Iliac Disease: Technical Issues Anticoagulation • Aspirin (325 mg) once a day several days prior to the procedure • Heparin (2500 -5000 IU) after access has been obtained and prior to the intervention ICVWG 09 -19

Iliac Disease Diagnosis Indications Technical Issues ü Treatment Options - PTA - Surgical Complications Prognosis ICVWG 09 -20

Iliac Artery Disease: Treatment Percutaneous transluminal angioplasty (PTA) with or without implantation of a stent is still considered as the gold standard in the treatment of a peripheral lesion. ICVWG 09 -21

Interventional Management of Iliac Lesions • Endovascular treatment of iliac stenoses – High technical success rates – Low morbidity • Iliac PTA/stenting – High rates of patency – Improvement in functional outcome for the individual patient Bosch et al Circulation 1999; 99: 3155 -3160 ICVWG 09 -22

Iliac Artery Disease: PTA Iliac Angioplasty: metaanalysis of 2697 procedures before 1990 75% claudicants 2 year primary patency of 81% 5 year primary patency rate 75% Becker, Radiology 1989 Short segment Iliac stenoses: PTA has 5 year 80 -90% patency rate Pentacost Circulation 1994 ICVWG 09 -23

Iliac Artery Disease: Surgical vs PTA Randomized Data VA Randomized Study: • Patients with limited disease suitable for PTA or surgery. • Excluding initial PTA failure rate of 15%, 3 - year patency of 75% was equivalent in both arms Wilson SE, J Vasc Surg 1989 Swedish Study: • Equivalent 1 year results Holm, Eur J Vasc Surgery 1991 ICVWG 09 -24

Iliac Artery Disease: Stent vs PTA Kauffmann 1991: BE stent vs PTA • Randomized trial enrolled 131 patients • 2 year clinical patency: • 89% after stent, • 70% after PTA. Bosch 1997: meta-analysis of studies between 1990 -1997 • Stent placement lowered risk of long term failure by 39% ICVWG 09 -25

Contraindications (Relative) to Iliac Balloon Angioplasty • Occlusion • Long lesions (>5 cm) • Aortoiliac aneurysm • Atheroembolic disease • Extensive bilateral aortoiliac disease ICVWG 09 -26

Iliac Disease: Stent Placement Balloon expandable stent • Greater radial force Useful in extremely calcified stenoses and especially occlusions of the common iliac artery • Allow greater precision for placement Self-expandable stent Used predominantly in : • cross-over techniques and tortuous vessels • occlusions of the external iliac artery Useful in Ostial Lesions ICVWG 09 -27

Iliac Disease: Stent vs Stent JVIR 15: 911; 2004 ICVWG 09 -28

Interventional Management of Iliac Lesions Type A Type C Endovascular treatment of choice Currently, surgery treatment is more often used but insufficient evidence for recommendation Type B Type D Currently, endovascular treatment is Surgical treatment of choice more often used but insufficient evidence for recommendation Dormandy JA et al J Vasc Surg 2000; 31: S 1 -S 296 ICVWG 09 -29

Interventional Management of Iliac Lesions • Complex long-segment and bilateral iliac occlusions can be safely treated via endovascular means with high rates of symptom resolution. • Initial technical success, low morbidity, and mid-term durability are comparable to results with open reconstruction. A liberal posture to open femoral artery reconstruction extends the ability to treat diffuse TASC-C and -D lesions via endovascular means. Leville et al J Vasc Surg 2006; 43(1): 32 -39 ICVWG 09 -30

The Aortoiliac Kissing Stent Technique • Reconstructs the aortic bifurcation by simultaneous deployment of bilateral CIA stents • The kissing stent technique was developed to avoid complications during PTA of the aortic bifurcation, such as dissection, thrombosis, or significant residual stenosis. Primary placement of kissing stents has been shown to be safe and technically practicable, even in aortoiliac segments with complex atherosclerotic disease. 2 1. Greiner et al, Journal of Endovascular Therapy: Vol. 12, No. 6, pp. 696– 703 2. Greiner et al Eur J Vasc Endovasc Surg 2003; 26: 161– 165. ICVWG 09 -31

“Non-crossing” group • The proximal ends of the stents extend into the aorta such that two adjacent stent walls come into apposition for at least one centimeter in the native aorta Not Stable • Stents positioned in this manner reshape the aortic bifurcation more or less anatomically The silhouettes of the right and left stents are marked with black and white lines, respectively. The proximal ends of the bilateral iliac stents extend into the aorta and overlap each other less than half their width ICVWG 09 -32

“Crossing” Group • The distal end of the stents slip over each other into a crossover position Stable • The stents do not really imitate the aortic bifurcation perfectly The silhouettes of the right and left stents are marked with black and white lines, respectively. The proximal ends of the bilateral iliac stents extend into the aorta and overlap each other more than half of their radiologically verified width ICVWG 09 -33

Interventional Management of Iliac Lesions Patient Aftercare • • Remove the vascular sheath when the activated clotting time (ACT) falls to <160 seconds Continue oral aspirin (325 mg/day) indefinitely / Clopidogrel? • Perform ABIs and duplex scanning prior to hospital discharge • Follow-up the patient with non - invasive testing to document continued patency. ICVWG 09 -34

Iliac Disease: surgical Treatment • Aortoiliac bypass • Aortofemoral bypass • PTA Vs surgery – 157 iliac lesions was treated with PTA or bypass surgery – No significant difference between PTA or surgery for death, amputations, or loss patency at 3 years – No significant difference in the hemodynamic (ankle-brachial index) result of a successful procedure between the surgery group and the PTA group Wilson et al J Vasc Surg 1989; 9: 1 -9 ICVWG 09 -35

PTA Vs surgery P=0. 041 82% 73% Bar graph of the 3 -year event -free survival of PTA Vs surgery for iliac lesions Wilson et al J Vasc Surg 1989; 9: 1 -9 ICVWG 09 -36

PTA Vs surgery Ankle- Barchial Index in Randomized Iliac Lesions Baseline Post-treatment 3 year PTA 0. 50 ± 0. 01 0. 78 ± 0. 04 0. 80 ± 0. 07 Surgery 0. 50 ± 0. 02 0. 82 ± 0. 03 0. 78 ± 0. 05 p, ns for all Wilson et al J Vasc Surg 1989; 9: 1 -9 ICVWG 09 -37

Iliac Disease Diagnosis Indications Technical Issues Treatment Options - PTA - Surgical ü Complications Prognosis ICVWG 09 -38

Iliac Disease: Complications Iliac PTA Note – Numbers are percentages Johnston KW Radiology 1993; 186(1): 207 -12 ICVWG 09 -39

Iliac Disease: Complications Intraoperative complications • Dissection • Extravasation • Perforation • Rupture Postoperative complications • At the access site: Pseudoaneurysm, atrioventricular fistula • Distal embolization • Hematoma • Stent thrombosis • Systemic complications (<0. 5%): Contrast or atheroembolic induced renal failure, MI, CVA, death ICVWG 09 -40

Iliac Disease: Perforation ICVWG 09 -41

Iliac Disease Diagnosis Indications Technical Issues Treatment Options - PTA - Surgical Complications ü Prognosis ICVWG 09 -42

Iliac Disease: Predictors of long-term failure • • • Hypertension Hypercholesterolemia Poor tibial runoff Clinical status: Critical limb ischemia Smoking, Diabetes mellitus Female gender Vessel diameter < 8 mm Outflow status Lack of antiplatelet regimen Number of stents Occlusion vs. stenosis Grossmans “Catheterization” 7 th Ed. pg. 588 -592. ICVWG 09 -43

Iliac Disease: Favorable predictors • Short, focal lesion • Large vessel size • Common iliac (as opposed to external iliac) • Single lesion ( as oppsosed to multiple serial lesions) • Male gender • Lesser Rutherford category (Claudication as opposed to critical limb ischemia) • Presence of good runoff Grossmans “Catheterization” 7 th Ed. pg. 588 -592. ICVWG 09 -44

Ideal Iliac PTA Lesions • Stenotic lesion • Non-calcified • Discrete (< 3 cm) • Patent run – off vessels (> 2) • Non- diabetic patients Grossmans “Catheterization” 7 th Ed. pg. 588 -592. ICVWG 09 -45

Iliac Disease: Comparison of 3 year Results Severity/Site/Variable 3 year Success rate Iliac Occlusion 1 site 66 % † > 1 site 17 % † Iliac Stenosis Common iliac 68 % ‡ External iliac Men 57 % † Women 34 % † Both common and external Good runoff 73 % † Poor runoff 30 % † † Cox regression estimate Johnston KW Radiology 1993; 186(1): 207 -12 ‡ Kaplan-Meier ICVWG 09 -46

Patency after iliac PTA by Clinical and Lesion variables 1 year % 3 year % 5 year % ST/CL/GR 81 70 63 ST/LS/GR 65 48 38 OC/CL/PR 61 43 33 OC/LS/PR 56 17 10 CL, claudication; GR, good run-off; LS, limb-threatening ischemia; OC, occlusion; PR, poor run-off; ST, stenosis Johnston et al Semin Vasc Surgery 1989; 3: 117 -22 ICVWG 09 -47

Iliac Artery Revascularization: Stenoses Patients Technique Follow-up Primary Patency Secondary Patency Tegtmeyer 1991 200 PTA 7. 5 yrs 85% 92% Palmaz 1992 486 BE stent 2 yrs 92% Strecker 1993 114 SE stent 3 yrs 95% Henry 1995 184 BE stent 4 yrs 86% Murphy 1995 83 BE stent 2 yrs 87. 5% Martin 1995 140 SE stent 2 yrs 71% 86% Vorwerk 1996 109 SE stent 4 yrs 82% 91% Schurmann 2002 110 SE stent 10 yrs 46% 55% (50%mortality) Gaines 2005 116 BE stent 6 months 82. 7& Leville 2006 89 SE/BE stents 3 yrs 76 90 ICVWG 09 -48

Long-term success Primary and subsequent endovascular procedures for iliac lesions in 151 limbs Kudo et al J Vasc Surg 2005; 42 (3): 466. e 1 -466. e 13 ICVWG 09 -49

Endovascular Treatment of Symptomatic Iliac Occlusions Leville et al J Vasc Surg 2006; 43(1): 32 -39 ICVWG 09 -50

Iliac Disease: Outcomes Kaplan-Meier curve estimates for primary patency, secondary patency, and limb salvage in all patients treated for iliac occlusion over 36 months. Primary patency was 76%, secondary patency was 90%, and limb salvage was 97% at 36 months with an SE less than 10%. Leville et al J Vasc Surg 2006; 43(1): 32 -39 ICVWG 09 -51

Iliac Disease: Primary Patency Kaplan-Meier curve estimates for primary patency in patients treated for iliac occlusion stratified by Trans. Atlantic Inter-Society Consensus (TASC) level over 36 months. No significant difference was found between groups. *SE exceeded 10%. Leville et al J Vasc Surg 2006; 43(1): 32 -39 ICVWG 09 -52

Iliac Disease: Secondary Patency Kaplan-Meier curve estimates for secondary patency in patients treated for iliac occlusion according to Trans. Atlantic Inter-Society Consensus (TASC) stratification. There was no significant difference between groups, and patency was greater than 90% for patients with type B and C iliac occlusions. *SE exceeded 10%. Leville et al J Vasc Surg 2006; 43(1): 32 -39 ICVWG 09 -53

Iliac Artery Revascularization: Occlusions Patients Technique Follow-up Primary Patency Secondary Patency Vorwerk 1995 103 stents 4 yrs 78% 88% Henry 2000 155 stents 8 yrs 73% 86% Scheinert 2001 212 BE/SE/ covered 4 yrs 76% 85% Mouanoutoua 2003 50 stents 2 yrs 93% 86% Balzer 2005 43 Excimer laser BE/SE/ covered 4 yrs 86. 1% 95. 4% ICVWG 09 -54