11/20/2014. Disclosures. Kissing Balloons and Stents. Treatment of Aortoiliac Occlusive Disease. Data on Patency of Kissing Stents.

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1 RESULTS FROM A MULTI-CENTER, RETROSPECTIVE REVIEW OF THE AFX ENDOGRAFT FOR USE IN AORTOILIAC OCCLUSIVE DISEASE Disclosures Cook Endologix Medtronic Thomas Maldonado, MD Associate Professor Department of Vascular Surgery New York University Langone Medical Center Presentation Title Goes Here 2 Treatment of Aortoiliac Occlusive Disease Aortobifemoral bypass Operative mortality 1 4% -Higher for elderly and comorbidities 10-year patency 75 95% - Lower for younger and female patients, and those with critical limb ischemia Kissing Balloons and Stents Distal aortic and proximal iliac lesions difficult to treat endovascularly Kissing balloons described in Kissing stents described in ,3 Limitations: - Limited data on performance in CLI - Decreased patency in more complex lesions, particularly involving significant portions of the infrarenal aorta DeVries SO et al. JVS 1997 Hertzer NR et al. JVS Tegtmeyer CJ. Radiology Kuffer G. Cardiovasc Intervent Radiol Palmaz JC. J Vasc Intervent Radiol 1991 Kissing Stents Patency affected by - Radial mismatch associated with failure 1 - Crossing stent configuration associated with patency loss 2 Raises the bifurcation Data on Patency of Kissing Stents Study 3 year 4 year 5 year Haulon %, 98% Sharafuddin %, 94% Abello %, 82% Above studies have significant variability of TASC classification and Rutherford category Primary assisted patency 65% at 2 years in more advanced TASC lesions 4 Covered stents appear to have better patency than bare metal stents in TASC C and D lesions 5 This effect may also apply to kissing stents 6 1. Sharafuddin MJ et al. Ann Vasc Surg Yilmaz S et al. J Endovasc Ther Haulon S et al. J Endovasc Ther Sharafuddin MJ et al. Ann Vasc Surg Abello N et al. Ann Vasc Surg Greiner A et al. Eur J Vasc Endovasc Surg Mwipatayi BP, COBEST Co-investigators. JVS Sabri SS et al. J Vasc Interv Radiol

2 CERAB Technique 3 Covered Stents to Reduce Radial Mismatch Requires large, covered stents to cover distal aorta -- not available in U.S. Endologix AFX Stent Graft Unibody design for AAA repair (EVAR) Sits on the aortic bifurcation Sizes from 22mm to 28mm with various iliac sizes and lengths Low 17F profile (percutaneous) Percutaneous approval Role in Aortoiliac Occlusive Disease? AFX : Advantages for AIOD Preserves aortic bifurcation Avoid the possibility of missing CIA lesion No limb competition in a narrow distal aorta Fabric allows for significant oversizing without wrinkle / in-folding Does not preclude future aortic interventions (TEVAR etc) Covered stent - protective in cases of potential rupture (heavily calcified lesions) Why AFX? Pro s and Con s (compared with BE or SE stents) PROS Avoid the possibility of missing CIA lesion as with CIA stents (kissing technique) No limb competition in a narrow distal aorta No gate cannulation in narrow distal aorta Low profile, at least on one side Has percutaneous approval Recreates/preserves aortic bifurcation (no competing kissing stents) Useful in recannalization Does not preclude future aortic interventions (TEVAR etc) Just one piece Low morbidity and mortality Presentation Title Goes Here 9 Why AFX? Pro s and Con s Multicenter Retrospective Review: AFX for AIOD CONS Larger profile sheath Poor radial force Adjunct stenting is required Procedure is time consuming for occlusive disease Requires higher level of endovascular skill Procedure Code not available (yet) Risk of thromboembolism (?) 80 patients (9 centers) IRB approved retrospective review Aorto-Iliac Occlusive disease (non-aneurysmal) Demographics Procedural detail Technical Success Clinical Success (Rutherford classification, ABI s) Follow-up: Mean 350d ± 274 2

3 Multicenter Retrospective Review 9 Centers, 80 patients Patient Demographics and Baseline Characteristics Characteristic Result Age (years) 68 ±10 Rijnstate Hospital Michel Reijnen, MD Aurora Healthcare Mark Mewissen, MD Wheaton Franciscan Thomas Shimshak, MD Louis Kostopoulos, MD UC Denver Omid Jazaeri, MD Mercy Hospital St. Louis Vito Mantese, MD San Antonio Military Hospital Zak Arthurs, MD New York University Thomas Maldonado, MD University of Louisville Amit Dwivedi, MD UT Memphis Ed Garrett, MD Anton Perera, MD George Hipp, MD Male Gender (n) 64% II 19% ASA Class III 61% IV Concomitant AAA 3.5cm 1.7% Ambulatory 91% Ambulatory Status Amb w/ assistance 6% Wheelchair 3% Baseline Risk Factors / Medical History Patient Clinical Presentation 8 Smoking Hypercholesterolemia Hypertension 9 89% 85% % N=53 Coronary Artery Disease Carotid Disease PCI 41% 32% 51% % 5 PAD Endovascular COPD CABG CVI CEA/CAS CHF Major Amputation AAA Repair 6% 3% 3% 16% 1 4% N=3 9% N=7 13% N=10 8% N= Rutherford Classification 1% N=1 TASC Classifications A n=1 (1%) Candidates for Open Surgery B n=10 (13%) B1 B3 B2 B4 B1 n=9 B2 n=1 33% Unfit for open repair C n=3 (4%) C1 C2 C3 C1 n=2 C3 n=1 67% Candidate for open repair D n=61 (83%) D1 D2 D3 D4 D5 D6 D1 n=17 D2 n=40 D3 n=1 D4 n=2 D6 n=1 3

4 10mm Oversizing in 12mm tube 25mm AFX 21 TASC D Lesions Courtesy of Zachary Arthurs, MD 4

5 TASC D Lesions Courtesy of Zachary Arthurs, MD Courtesy of Zachary Arthurs, MD Procedural Characteristics Procedural Complications 1 5% Procedure Time (min) 19% < 90 90, < , < 210 > % General Anesthesia 98.7% Technical success 96% Non-percutaneous access 63% Mean Blood Loss 195cc Median hospital stay 3 days 5% Fluoroscopy Time (min) 27% < 10 10, < 20 20, < 30 > 30 N=70 % Groin Infection 6 9% Respiratory Failure 4 6% Groin Hematoma 3 4% Rupture 2 3% Dissection 3 4% Thromboembolic Event 2 3% Iliac Injury 2 3% Femoral Thrombosis 1 1% Stroke 1 1% 30 Day Mortality : 0 Improvement in Rutherford Classification Improvement in ABI % Over 8 improvement between 3 to 5 45% 24% 42% 13% 1 1% 3% 9% 7% Follow-up = Change from baseline to last available visit 1 5% Follow-up = Change from baseline to last available visit 5

6 Adjunctive Procedures: 43 patients (53.7%) Adjunctive Procedures: 43 patients (54%) Aortic Stent 9 (11%) Palmaz Right Iliac Stent 32 (42%) 27 uncovered, 7 covered Left Iliac Stent 33 (41%) 23 uncovered, 10 covered As extension 19 2 unplanned As relining 19 All planned Surgical Procedures 19 (23%) 18 planned CFA Endarterectomy 16 Bypass 3 Type Number of Patients (n=80) Planned vs Unplanned Total patients 43 (54%) Endovascular Procedures 41 (51%) 16 planned Aortic Stent 10 (12%) Palmaz (unplanned) Iliac Stent 39 (48%) Right 35 Left 33 As extension 19 As relining 18 Surgical Procedures 26 (32%) 23 planned CFA Endarterectomy planned Right 19 Left 21 Bypass 3 3 planned 32 Secondary Interventions: 5 patients (6%) : angioplasty/stenting Freedom from Secondary Interventions Intervention Site Total (n patients) 1 Month 6 Months 1 Year Total patients 5 Aorta 0 Common Iliac Artery Left 3 3 Common Iliac Artery Right 1 1 External Iliac Artery Left External Iliac Artery Right Common Femoral Artery Left 1 1 Common Femoral Artery Right Year 33 Graft Patency Patency 30d 6 mo 1 yr 2 yr Primary 98.1% (n=51/52) 98.1% Assisted (n=51/52) 93.1% (n=27/29) 10 (n=29/29) 94% (n=31) 96.7% (n=29/30) 10 (n=16) 10 (n=16) Limitations of the Technique Larger profile sheath 4cm main body Potential for coverage of collaterals Requires higher level of endovascular skill Cost? (depends on procedure being compared) 6

7 Conclusions: AFX for treatment of AIOD High technical success, even in TASC C and D Low 30-day mortality and low procedural complication rate Primary patency throughout follow-up Freedom from Secondary interventions: 92% Procedure can be safely combined with adjunctive lower extremity interventions (usually planned) Concept of AFX Stent Graft for AIOD: Coverage of Lesions Involving the Aorta 27% 17% Presentation Title Goes Here 39 S. Six et al, JEVT 2013; 20: