1. 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

2. 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

3. Closure Devices 3

4. 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

5. 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

6. 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

7. 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

8. 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

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

10. 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

11. 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.

12. 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

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

14. 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

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

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