Secondary Intervention in Unfavorable AAA Neck Anatomy Congress Symposium 2007 John T. Collins, MD Borgess Medical Center Kalamazoo, MI

Powerlink ® System:  Unibody-Bifurcated Design  Long Main Body  Low-Porosity Proprietary ePTFE Formulation  Cobalt Chromium Alloy Stent  Single-wire Main Body Construction  Fully Supported

Minimally Invasive Access  21 Fr Delivery System - Ipsilateral No introducer sheath used No introducer sheath used No upsizing of arteriotomy required No upsizing of arteriotomy required  9 Fr Percutaneous Sheath - Contralateral

Powerlink ® U.S. Pivotal Trial  192 patients enrolled between July 2000 and March 2003  Eligibility Criteria Proximal Infrarenal Neck: Proximal Infrarenal Neck: >15mm length >15mm length <60° angle<60° angle 26mm maximum diameter, 18mm minimum diameter26mm maximum diameter, 18mm minimum diameter AAA >4.0 cm diameter or rapidly growing AAA AAA >4.0 cm diameter or rapidly growing AAA Iliac diameter >7mm on at least one side (for access) Iliac diameter >7mm on at least one side (for access) Dispensable inferior mesenteric artery Dispensable inferior mesenteric artery Preservation of at least one hypogastric artery Preservation of at least one hypogastric artery Iliac seal zone of >15mm length ( 15mm length (<18mm diameter) Aortic bifurcation diameter >18mm Aortic bifurcation diameter >18mm >18 years old >18 years old Not pregnant Not pregnant Candidate for open AAA repair Candidate for open AAA repair Serum creatinine <1.7mg/dlL Serum creatinine <1.7mg/dlL Willingness to comply with follow-up schedule Willingness to comply with follow-up schedule No bleeding disorders No bleeding disorders Life expectancy >2 years Life expectancy >2 years No connective tissue disorders No connective tissue disorders

Summary of Significant Early Clinical Findings PowerlinkControlP-value  Age <  Successful Deployment 188/192 – 97.9% N/A N/AN/A  Patients with at least 1 Major † AE (0-30days) 13/ % 14/ % 14/ %<  All Death < 30 days 2*/ % 4/ % 4/ % <  Anesthesia Time (min) <  Procedure Time (min) <  Blood Loss (l) <  Days in ICU <  Days to Discharge < † Defined as death, MI, stroke, AAA rupture, conversion, secondary procedure, coronary intervention, renal failure, or respiratory failure * Not device related Carpenter JP, et al. Midterm results of the multicenter trial of the Powerlink bifurcated system for endovascular aortic aneurysm repair. J Vasc Surg 2004;40:

Secondary Procedures (through 60 months*) 34 procedures in 26 patients Endoleak –23 (Cuffs, embolization, balloon dilatation) Endoleak –23 (Cuffs, embolization, balloon dilatation) Type I Endoleak – 5Type I Endoleak – 5 Type II Endoleak –18Type II Endoleak –18 Graft Limb Occlusion – 7 Graft Limb Occlusion – 7 Embolectomy,Stent, PTA, or Lytic TherapyEmbolectomy,Stent, PTA, or Lytic Therapy Native Artery Procedures – 3 Native Artery Procedures – 3 Migration - 1 Migration - 1 * As of Dec. 2006

Sac Diameter Over Time † † As of Dec * 192 patients enrolled, 3 patients’ CT’s lost before submission to core lab Diameter (mm) Pre-op (N=189) * 12 mo (N=147) 24 mo (N=142) 36 mo (N=130) 48 mo (N=114) 60 mo (N=54) Mean(SD) 50.40(6.98)45.77(7.94)43.13(9.01)41.49(9.35)40.70(9.78)38.16(8.71) Minimum Maximum

Sac Volume Over Time † † As of Dec 2006 * 192 patients enrolled, 3 patients’ CT’s lost before submission to core lab ** Some CT scans are not evaluable for some parameters most often due to poor image quality, no contrast, CT’s taken at greater than 3mm slices, etc. Volume (cc) Pre-op(N=187)* 12 mo (N=144) 24 mo (N=139) 36 mo (N=129) 48 mo (N=114) 60 mo (N=54) Mean(SD) 135.4(39.4)124.6(40.3)119.1(38.4)115.3(37.2)113.6(37.9)110.6(37.2) Minimum Maximum Unevaluable **

 Large diameter (>28mm)  Short landing zone (<15mm)  Extreme Angulation  Accessory renal arteries  Reverse tapered neck Challenging Infrarenal Aortic Neck Anatomy

Objective  Evaluate the incidence of Type I endoleaks and device migration in patients with reverse tapered neck anatomy  Determine effect on seal zone  Incidence of secondary interventions in patients with this neck geometry

Reverse Tapered Neck Definition Neck Dilation of  2mm within the first 20mm below the most caudal renal artery

Reverse Tapered Neck

Sub-group Analysis  N = 50 test patients (Total group = 192) had reverse tapered neck anatomy  Neck anatomy Mean Proximal Diameter Mean Proximal Diameter mm ( )20.94 mm ( ) Mean Distal Diameter Mean Distal Diameter mm (21.5 – 28.6)24.38 mm (21.5 – 28.6)

Implant Procedure  All procedures technically successful  24 patients (24/50 = 48%) received proximal extensions during procedure  Diameter of stent grafts 25 or 28mm 25 or 28mm  6 patients also received stents during implant procedure  No endoleaks noted at end of procedure

Follow-up of Sub-Group  Mean follow-up: 40.2 months Range: 1 mo – 64 mo Range: 1 mo – 64 mo  No AAA-related deaths  No secondary procedures for proximal Type I endoleak  Graft migration: 1 (12.5mm); no clinical sequelae

Courtesy of Rodney White, MD

Differences in CT Assessment Graft attached to endoskeleton proximal and distal end Graft “balloons” off stent cage May allow graft to provide longer seal zone in unfavorable proximal neck geometry

Reverse Tapered Neck

Summary of Late Clinical Findings  97.9 % Freedom from AAA-Related 5 years with the Powerlink System  No aneurysm ruptures  Only 1 late conversion 1 yr.)  No ePTFE graft material 5 years  No cobalt chromium stent graft failure or 5 years

Conclusions  Simple implantation technique  Minimally invasive access  No proximal Type I endoleak in this group of patients with reverse taper neck anatomy through 5 year follow-up  Sac regression and improving morphology