1. Vascular Closure Techniques
Femoral Approach
Clifford J Kavinsky, MD, PHD
Professor of Medicine and pediatrics
Associate Director, Center for Congenital and Structural Heart Disease
Rush University Medical Center
Number of coronary interventions per annum in excess of 500,000 and >1,000,000 worldwide
Major complications related to site of peripheral access including hematoma, bleeding, arteriovenous fistula, pseudo aneurysm occur with rates of 1.5%-9% % of these patients require surgical repair.
According to recent data from the ACC National cardiovascular data registry fewer then 2% of cases performed from the radial access site.

2. How to Improve Safety Take time to do puncture right
Use fluoroscopy and/or ultrasound
Angiogram every femoral puncture
Diagnostic catheterization associated with 3.4% rate of serious vascular complications.

3. Local Complications of FA Access: 2-10%
Hematoma (1-12%)
Pseudoaneurysm (1-6%)
AV fistula (<1%)
Vessel laceration (<1%)
Free bleeding
Intimal dissection
Ante- or retro-grade
Acute vessel closure (<1%)
Thrombosis (small artery lumen)
Retroperitoneal hemorrhage ( %)
Thickening of the perivascular tissues
Neural damage
Infection
Venous thrombosis
Pericatheter clot
Montreal Heart CCI 3/ %/4% (7,953/3,868)
The local complications of femoral artery access have remained relatively high. The availability of vascular closure devices have not had any significant affect on these numbers. There are multiple reasons for continuing vascular access morbidity that will be discussed in detail in the following slides.
Complications persist despite availability of vascular sealing devices.

4. Why Complications of Manual Closure Persist
Puncture technique
Sheath management
Adjunctive drug therapy
Sicker population
Age, gender, comorbidity
Coexistent vascular disease
Inherent limitations of technique
Adjunctive drug therapy also accounts for some elements of closure complications.

5. How to Decrease Risk of Complications
Puncture over the lower half of the femoral head above the bifurcation of the CFA and below the lowest excursion of the Inferior epigastric artery, and above the inguinal ligament.
With puncture above the inguinal ligament, the external iliac artery moves away from the skin and the track passes through layers of muscle and fascia en route to the artery. Passage of a VCD may be impeded by the fascia and muscle.
Courtesy of Zoltan Turi

6. Femoral Head and the CFA Bifurcation
55.5%
22%
17%
4.0%
1.5%
Above center of head
At center of head
Below center of head
At inferior border
Below inferior border
n=200 V IV
III II I
In our 200 patients, the femoral bifurcation occurred below the femoral head in only some 55% of patients. Puncture at the level of the upper-inner quadrant of the femoral head on the other hand would avoid the bifurcation in all except 1.5% of the population.
Number
of patients
I: 111
II: 44
III: 34
IV: 8
V: 3

7. Consequences of Low Arterial Puncture
“Low” puncture into the SFA and PF:
Pseudoaneurysm 2° inability to compress
AV fistula
Thrombosis - embolism
Occlusion with large sheaths
Primarily due to
Low stick
Inadequate compression time
Aggressive anticoagulation
The consequences of low puncture, as seen above, include pseudoaneurysm, in particular because the bifurcation vessels do not course over bone, and therefore manual compression tends to be less effective.

8. High Puncture
“High” puncture of the femoral artery: Increases risk of retroperitoneal bleeding
High puncture is most commonly associated with retroperitoneal bleeding. Unlike low puncture, external soft tissue compression does not occur, and there is a predisposition to uncontrolled blood loss, particularly in the setting of full anticoagulation.

9. Predictors of Complications
Age (>70)
Female sex
Diabetes
Body Surface Area (<1.6 m2
Sheath size
Renal failure or Cr > 2mg/dL
Emergent Procedure
Periprocedural use of Glycoprotein
IIb/IIIa inhibitors
Comorbidities
Multilesion and more complex lesion interventions
Use of intra-aoortic balloon pump
A list of factors that appear to be associated with increased complication rates is listed here. Glyocoprotein IIb/IIIa inhibitors have not consistently been shown to increase bleeding, although this may reflect the associated decrease in heparin dose when these drugs is used. A red star is placed next to several variables that can only be addressed if a femoral angiogram is performed during the catheterization.
Piper WD et al 2003, Am Heart J 145:1022

10. The Promise of Vascular closure Devices
Patient comfort and convenience
Decreased Time to hemostasis
Early ambulation
Shorter hospital stay
First used in the united states in First approved was VasoSeal device. Second was the Prostar XL device (Abbott Vascular). Since that time numerous devices have been introduced and the VCD market has experienced substantial growth.
Decreased overall procedure-related
hospital costs
Decreased complication rates

11. Closure Device Market $1 billion $900 $800 $700 $600 $500 $400 $300
Most of the VCD use lies with adult interventional the overwhelming majority of devices being used in the setting of coronary diagnostic and interventional procedures. However, as we move further in the area of percutaneous interventions with the use of larger vascular access sheaths, pediatric cardiologists have shown interest in this technology.
Estimated 825 millinon in 2010
Estimated to be 1 billion dollar market in 2012
Despite this only 38% of the 9.6 million catheterization procedures done globally utilize VCDs
$300
$200
$100 $0 00 01 02 03 04 05 06 10 13
Medtech Insight.

12. VCDs-The Promise Meta-analysis of 30 randomized trials Efficacy
Shorter time to hemostasis- mean difference 17 min
Decreased duration of bedrest- mean difference 10.8 hours
Decreased hospital length of stay- mean difference 0.6 days
Koreny, Riedmuller and Nikfardjam et al., JAMA. 2008;291:

13. VCDs-The Promise Decreased Vascular Complication rate Pseudo aneurysm
Arteriovenous fistula
Retroperitoneal hematoma/hemorrhage
Femoral artery dissection
Bleeding
Femoral artery thrombosis
Many feel that the complications relate to VCDs can in some cases be additive to that of manual compression particularly as it relates to RPH

14. Complications Specific to VCDs
Device-related:
Embolization
Infection
Vessel obstruction
Direct mechanical
Injection into vessel
Bleeding
Mechanical secondary to device
Secondary to early sheath pull
A fair assessment of the complication rates associated with VCD’s has been challenging. A number of complications are seen with manual compression of course, but some of the complications above are arguably additive.
Nevertheless, it is clear that some complications are additive to manual compression.

15. Sterile Technique
Groin infections after vascular closure devices are particularly severe. This groin infection is an example; these are far worse than any groin infection I have seen after manual compression. Meticulous attention to sterile technique is advisable – we reprep the area, place fresh towels and reglove, and have a low threshold for giving antibiotics or avoiding closure device use in immune compromised patients.
Courtesy Dr. John Eidt, UAMS.

16. VCDS-Reduced Complications
Lack of large randomized trials compared VCDs to std. manual hemostasis
Multiple different devices
Lack of homogeneous endpoints
Small sample size
Operator experience
Level of anti-coagulation and adjunctive pharmacotherapy
Selection bias

17. Complication Rate Nikolsky et. al. JACC 2004;44:1200 Dx studies
Heterogeneity test
P-value
0.1
0.2
0.5
1.0
2.0
5.0
10.0
OR (95% CI)
1.44 [0.43, 4.82]†
0.66 [0.18/, 2.38]*
0.0003
0.16
Dx studies
1.11 [0.94, 1.33]*
1.35 [0.87, 2.11]*
0.22
0.15
PCI studies
1.83[1.15,2.90]†
1.15 [0.67, 1.98]*
0.001
0.43
Both Dx+PCI studies
In an attempt to salvage some utility from the existing series, two large meta-analyses were published in 2004, one by Koreny and colleagues and the other by Nikolsky et al. The results were similar: some subgroup advantage in favor of manual compression, although the results generally straddle the null hypothesis. The solid squares above refer to the randomized studies in the literature. The studies being analyzed are in general of poor quality.
1.34 [1.01, 1.79]†
1.30 [0.90,1.87]*
<0.0001
0.19
All studies
Favors Closure Device
Favors Manual Compression
Nikolsky et. al. JACC 2004;44:1200

18. Propensity Score Analysis
Graph of propensity score adjusted odds ratio of the incidence of any vascular complication for all VCDs compared to the incidence of vascular complications after manual compression
Single center non-randomized retrospective study of 21,841 patients from (angioseal, perclose and vasoseal)
Appelgate et.al.,CCI 2006, 67:556

19. Compilation of Meta- and Propensity Analyses
Meta analyses by Koreny et al, Nikolsky et al and propensity analyses by Appelgate et al and Resnic et al comparing VCDs and Manual compression. The meta-analyses suffered from weak underlying studies. The propensity analyses may not fully compensate for variables that may have influenced patient selection for VCDs. In general, the data suggest parity or superiority with VCDs, with the exception of the Koreny et al study which had a strong trend in favor of manual compression. Only Resnic shows a statistically significance in favor of VCDs.
Turi,Z., Endovascular Today 2008,7:28

20. Vascular Closure Devices
Active Closure
mechanically secures arteriotomy effects
closure either through approximation of
margins or mechanical fixation of a “plug”
Passive Closure
devices which assist with compression (clamps),
assist or enhance coagulation, and sealants

21. Current FDA-Approved VCDs
Caputo RP, 2012 Card Int Today 6:70

22. Anchored Plugs Active Approximation Angio-Seal (St.Jude Medical)
Angio-Seal combines both active and passive properties. Anchored plugs leave a resorbable anchor inside the arterythat is tethered by a polymer filament to an extravascular collagan plug applied directly over the arteriotomy.Resorb in days.Have 50% of the VCD market. They combine the potential benefits (and also potential downsides) of a collagen plug in the tissue track with the predictability of successful closure that an anchored closure provides. The anchor itself is also a potential liability, particularly in patients with peripheral vascular disease. Angio-Seal, shown above, is currently the most commonly used closure device, in part because of a short learning curve, and relatively high efficacy.
Handicapped by two properties. 1) the anchor placed inside the vessel produces a transiently visible filling defect in the arterial lumen and is occasionally obstructive. 2) it leaves a mass of collagen inside the tissue tract and a suture that extends from the arteriotomy to near the skin surface providing a potential nidus for infection.
re-puncture should be done with caution during the first three months.
Collagen Thrombosing agent
Advantages- High success rate, short learning curve, short deployment time
Disadvantages-vascular occlusion, potential infection

23. Perclose (Abbott Vascular)
Suture-Mediated active approximation
Suture mediated closure has approximately 20%of the Market share. Delivers 2 needles through the anterior wall opf the artery. Needles are deployed through a intra-arterial footplate, engaging a non-biodegradeable polypropylene suture that is then pulled back through the arterial wall.
Suitable for closure using 5-8 French access.
Prostar XL uses four needles and two sutures and is approved for use in 8.5 F to 10 French arteriotomies.
Has a longer learning curve and has a definite skill set to using it successfully

24. Preclosure Balloon Aortic Valvuloplasty-12F PVAD 15 – 18 F
Percutaneous Valve
Technology F
Endovascular Aneurysm Repair 12 – 24 F
Has become an important tool for vascular access management in some of the procedures using large sheath such as TAVR, BAV, endovascular stent placement. In these settings one to two devices are deployed after vascular access is obtained using a standard size introducer sheath. The needles are deployed and the sutures harvested and set to the side for the duration of the procedure. At the end the knots are secured and hemostasis is obtained.

25. Preclosure Success Rates
N = 279 20 56 30 45 67 25 36
Patients n = 258
Success = 93.8%
Lee WA et al: J Vasc Surg 2007

26. StarClose SE (Abbott Vascular)
Active Approximation
Deployed through procedure sheath. Effects active closure through deployment of a disc-shaped nitinol clip that actively approximates the edges of the arteriotomy.
Permanent implant
19.4% market share

27. Passive Approximation
Vascular Sealants
MynxGrip
ExoSeal (Cordis)
Mynx (AccessClosure)- uses a biopolymer (polyethylene glycol) deployed while a small balloon tamponades the puncture site while the sealing agent is deployed. The sealant rapidly expands in the tissue tract and attracts blood which the coagulates. Dissolves in 30 days.
Exoseal (cordis) –also uses a sealant (polyglycolic acid). Delivers through existing sheath. Just completed testing in pivotal trial. Eclipse trial looked at 400 patients 50% Dx and 50%Int. success rate of 89%
Unknown whether they are superior to collagen matrix
AccessClosure

28. No footprint devices Passive approximation
Catalyst II (Cardiva Medical)
Cardiva Medical (Mountain View California) Unique device in the world of VCDs-relies on a nitinol disc inside the artery along with a spring mechanism to maintain traction at the arteriotmy site inside the vessel until hemostasis occurs. The shaft of the device is coated with two proprietary agents which promote coagulation and thrombosis.
Advantages-No foreign body
No thrombosing or sealing agents

29. Closure Begins with Access
Axera Device( Arstasis )
Femoral Introducer Sheath and Hemostasis
A new class of devices has entered the VCD world. Best described as “closure begins with access” or CBA. Not to be confused with suture-mediated preclosure which has been around for over 10 years and has had considerable success. Now two true CBA devices have appeared on the scene.
FISH (femoral Introducer sheath and hemostasis, Morris innovative research) uses small intestinal submucosa wrapped around the introducer sheath which is deployed as the sheath is removed. The device is FDA approved.
Arstasis device (Modesitt) . Device creates a dissection plane in the femoral artery at the time of access to create a self-sealing mechanism as the sheath is withdrawn. No foreign body left behind
Morris Innovative, Inc.

30. Topical Hemostatic Patches
Passive Approximation
NON-INVASIVE
patch assisted hemostasis. Whole variety on the market. Patches coated with clot promoting substance i.e. murine Chitin (murine biopolymer, Chito-Seal),poly-D-glucosamine, poly-N-acetyl glucosamine(Clo-Sur PAD), Thrombin and carboxy-methyl-cellulose (D-stat),Calcium alginates (Neptune), woven poly-N-acetylglucomaine isolated from murine algae (Syvek),
Advantages-non-invasive, no foreign body, no risk of infection or vascular damage.
Disadvantages- no carefully controlled trials. High failure rate in heavily anti-coagulated patients.
Chito-Seal, Clo-Sur P.A.D., D-Stat, Neptune, Stasys, Syvek

31. Which Device to Use? Patient and Vessel specific
Heavily anti-coagulated- invasive active approximation
Diseased vessel- passive approximation
Residual oozing- thrombosing sealing agent or topical
hemostatic patch
Operator experience/competence

32. The Importance of Operator Experience10 8 6 % 4 2
Failure rate with a suture-mediated closure device. An additional major problem in these studies is the role of the physician and institutional learning curve. The data above show a failure rate of 9% with one device in the first 50 cases declining to approximately 3% after 930 cases; with an inflection point in the 350 to 450 patient range. Some studies compare experiences with as few as 6 devices against several hundred with another device. The fact that the learning curve is this extensive is of course in itself an important drawback of some of the closure devices. 25 75
150
250
350
450
550
650
750
850
930
Patients
Balzer et al. CCI 2001; 53: 174

33. Learning Curve With Angio-Seal
3.5 %
14 %
Retrospective study of frequency and groin complications when Angio-Seal used in 252 patients by a single operator. 66% interventional case, 34% Diagnostic.
First 50 patients-14% failure, subsequent 202 patients-3.5% non-deployment.
Warren, Warren and Miller, CCI 1999, 48:162

34. Moral of the Learning Curve
Learn one or two devices and learn them extremely well
Consider an additional device for special circumstances
Remember that manual compression is always an option

35. Figure-of-8 for Venous Access Closure

36. AHA Recommendations
Use of VCDs is reasonable after invasive cardiovascular procedures
performed via the femoral artery to achieve faster hemostasis, shorter
duration of bedrest, and possibly improved patient comfort
VCDs should not be used routinely for the specific purpose of reducing
vascular complications in patients undergoing invasive cardiovascular
procedures via the femoral artery approach
Patel et al 2010 Circ 122:1882

37. Thank you