Transfemoral Access Devices & Tips for Closures Devices James P. Zidar, M.D., F.A.C.C., F.S.C.A.I Clinical Professor of Medicine, UNC Health Systems Corporate Chief of Cardiology, Rex Healthcare Raleigh, North Carolina

Disclosures In the past year, I have been on a scientific advisory board, worked as a consultant for, or conducted clinical research for: Abbott Vascular, Medtronic, Cordis, Boston Scientific and CSI All of these companies produce cardiovascular and endovascular products

Closure Devices 3

Compaction & Compressive Sealing Force Angio-Seal™ Evolution™ Compaction & Compressive Sealing Force What is compressive sealing force? Force between the collagen and the anchor after completion of Angio-Seal™ deployment Critical part of achieving hemostasis Consistent Collagen Compaction Forces

Mynx™ Vascular Closure Device Handle and shuttle Sealant freeze dried and integrated into delivery catheter 6 mm semi-compliant balloon Delivered through existing 6-7F sheath Diagnostic and interventional indication Bio-inert, conformable sealant 95% Water and 5% PEG Dissolves within 30 days Balloon for Temporary Hemostasis

Why Big Holes? 26 Fr 23 Fr 18 Fr 14 Fr 12 Fr Introduction of lower profile Endovascular thoracic and abdominal devices have expanded the market Closure devices have facilitated the adoption of transcatheter aortic valves

Perclose Suture-Mediated Closure Improvements in Suture Prostar 9-11F 1994 ProstarXL 8-10F 1996 TechstarXL 6F 1997 Closer 6F 1999 Perclose A-T 6F 2002 ProGlide 6F 2003

Most physicians currently use Abbott’s closure devices for large access closure Suture-based Prostar XL and Perclose ProGlide are used to “pre-close” EVAR access sites1,2 Perclose is the preferred device due to its easy of use1 Pre-close technique: 2 Perclose devices are crossed at 90o and “pre-closed” Each Perclose (5-8Fr) device costs ~$300, which equals to ~$1200/case Prostar XL 10 approved for 8.5 to 10Fr closure; Each costs ~$1000, which equals $2000/ case

Femoral Anatomy Landmarks Anterior superior iliac spine Inguinal skin crease ligament Femoral head Common femoral artery Superficial Profunda X CFA PFA SFA

Our Standard Approach Learn from the CTA Puncture the contralateral femoral artery and perform an arteriogram with Rim or pigtail catheter make a cross with 2 small needles with the maximum pulse vertically and the groin grease horizontally If CKD, advance pigtail to mid femoral head and give 2 cc of contrast If height is perfect, puncture vessel in the center of the circle Place a stand 6Fr sheath over a standard J wire. Some groups use U/S guidance Anterior superior iliac spine Inguinal skin crease ligament Femoral head Common femoral artery Superficial Profunda

Abbott Vascular – Perclose® Device How Does it Work? Locate anterior wall of artery Needles deploy suture on either side of the arteriotomy Deploy 2 ProGlides at 10 and 2 positions and secure with hemostats Exchange for stiff wire with the 1st dilator Perform TAVR or EVAR Tissue is pulled closed with sutures at end of procedure with hand pressure upstream Options with higher risk patient Occlude aorta with a soft Cook Coda balloon in distal aorta Advance a .018” Steelecore wire over a Rim catheter into distal SFA from contralateral groin Pull TAVR sheath back to mid EIA and occlude CIA with an 8 x40mm balloon at low pressure while pulling the TAVR sheath and tightening sutures.

Most physicians use suture based closure systems to “pre-close” the large arteriotomies Step 1: The device is deployed over a wire prior to any interventions1 Step 2: The deployed device is removed leaving the sutures in place around the arteriotomy1 Step 3: Interventional devices are tracked through the vasculature with the sutures in place1 Step 4: Following interventions, the vessel is closed with pre-deployed sutures1 This is an off label use of the suture based devices S

Complications of Pre-close technique Inadequate closure Suture breakage Embolism Infections Device misfire Hematoma

Each Perclose (6Fr) device costs ~$390, which equals to ~$780/case Pre-close technique: 2 ProGlide devices are crossed at 90o and “pre-closed” Each Perclose (6Fr) device costs ~$390, which equals to ~$780/case Prostar XL 10 approved for 8.5 to 10Fr closure; Each costs ~$900 Pre-close technique: 2 Perclose devices are crossed at 90o and “pre-closed” Each Perclose (5-8Fr) device costs ~$300, which equals to ~$1200/case Prostar XL 10 approved for 8.5 to 10Fr closure; Each costs ~$1000, which equals $2000/ case

Vascular Closure Devices Have Patient Limitations Peripheral vascular disease Bifurcation sticks Small femoral vessel Obesity/Low BMI 15

Caveats Initial Access Matters Learning Curve Spend the extra minute to make an adequate tissue track We still do not have the ideal device