Perspectives on Vascular Closure Device and the Latest Evidence

<strong>Perspectives</strong> on Vascular Closure Device 

and the Latest Evidence 

S. Chiu Wong MD 

Director, Cardiac Catheterization Laboratories 

New York Presbyterian Hosp.- Cornell Campus 

Professor of Medicine 

Weill Medical College of Cornell University 

CIT 2008 

March 19 th – 23 rd , Beijing China

ECLIPSE Trial 

Presenter Disclosure 

• S. Chiu Wong MD 

Consultant: Cordis JNJ, Medtronics, Abott Vascular 

Member, Advisory Board: Cordis JNJ, Medtronics, 

Abott Vascular 

Clinical Trial Grants: Boston Scientific, Cordis JNJ, 

Medtronics, Abott Vascular


Summary 

• Historical Perspective: Background & Rationale 

• Current Perspective: Current Devices & Evidence 

• Future Perspective: Selective New Devices 

• Conclusions: Role of Vascular Closure Devices







“Catheter Replacement of the Needle in Percutaneous Arteriography; a new Technique” 

2008 marks the 55 TH anniversary of Seldinger’s seminal 

work on percutaneous approach in catheterization 

a) The artery punctured. 

The needle pushed 

upwards. b) The leader 

inserted. c) The needle 

withdrawn and the artery 

compressed. d) The 

catheter threaded onto the 

leader. e) The catheter 

inserted into the artery. f) 

the leader withdrawn 

Seldinger SI Acta Radiol 1953; 39: 368–76.

<strong>Perspectives</strong> on Vascular Closure Devices 

Impact of Access Site Complications: Patient’s Perspective 

No matter how Good a job you did 

for the coronaries, 

this is a Bad procedure! 

No matter what kind of a job you 

did for the patient’s coronaries, 

this is a Good procedure!


Access Site Complications Associated w/ Invasive Procedures 

Vascular complication rates ranged from 0.5% 1,3 to as high as 27% 2 (diagnostic 

& interventional) were reported following invasive coronary procedures. 

• Hematoma 

• AV fistula 

• Pseudoaneurysm 

• Infection 

• Retroperitoneal Bleed 

• Dissection & Thrombosis 

• Nerve Damage 

• Late Perivascular Scarring 

• MI, Death secondary to bleeding & infection 

1 Hoffer and Bloch. JVIR 2003;14: 865-885, 2 Kussmaul et al, JACC 1995;7: 1685-92, 

3 Dauerman HL et al JACC 2007;50:1617-26


An Ugly Groin Can have More Implications than Just Pt Dissatisfaction! 

You could have spent a few hours to open a CTO perfectly, 

if this happened at the procedure, this is Bad for the patient 

both in the short and long run!


Attributable Cost of Vascular Complications 

In a cost-minimization study comparing routine AngioSeal versus 

mechanical compression involving 3,943 PCI pts from 1/02 to 12/04 at 

the Brigham & Women’s Hospital… 

Complications 

Attributable Cost 

Hematoma $1339 

Arterio-venous fistula $1415 

Access Site Infection $5127 

Bleeding $5440 

Acute limb ischemia $5534 

Pseudoaneurysm $6357 

Retroperitoneal hemorrhage $6698 

Resnic F et al; Am J Cardiol 2007;99:766-770


Independent Predictors of 1-Year Mortality Post PCI 

Using the combined database on 5,384 patients from 4 randomized placebocontrolled 

trials (ISAR-REACT, -SWEET, -SMART-2, and –REACT-2 )….. 

Hazard Ratio (95% 

Variable 

p Value 

Confidence Interval) 

Bleeding within 30 days 2.96 (1.96–4.48)


Other Access-Site Related limitations in Invasive Procedures 

• Discomfort Associated with Sheath Removal 

• Inability to Tolerate Prolonged Supine Position in 

Selected Patients due to a Variety of Co-morbid 

Conditions Including: 

Genital Urinary Problems (e.g. BPH) 

Spinal Stenosis 

Congestion Heart Failure 

Severe COPD 

Severe Valvular Disease 

Patients with Various Mental Disable Conditions


Rationale for Development of Access Site Closure Devices 

• Minimize Patient Discomfort Associated with 

Sheath Removal 

• Reduce the Need for Long Recumbent 

Position Following procedure 

• Decrease the Time to Ambulation 

• Increase Cath Lab Throughput 

• Shorten Time to Potential Hospital Discharge







Percutaneous Coronary/Peripheral Procedure Landscape 

• 9.577 MM Worldwide procedures 

(interventions and diagnostic procedures for 

both coronary and peripheral) 

• 5.681 MM US procedures (interventions and 

diagnostic procedures for both coronary and 

peripheral) 

• Global VCD Penetration Rate: 38% 

• US VCD Penetration Rate: 55% 

Projected for 2008 based on Millennium Research Group 2007 report


Current Closure Devices 

• Passive External Compression: 

Mechanical: C-Clamp, FemoStop 

Patch Mediated Manual: Syvek, Chito-Seal, HemCon 

• Passive Temporary Indwelling: 

Pro-coagulant Along Tissue Track: Boomerang 

• Active Device Mediated: 

Suture Based: Perclose 

Collagen Based: Angio-Seal, VasoSeal 

Synthetic Biosealant Based: Mynx 

Gel/foam Based: Duett, QuickSeal 

Staple Based: StarClose, Angiolink


US VCD Market by Device Q307 

Source: Millennium Research Group


Penetration of Vascular Closure Market 

• Although most of the currently 

available access site closures devices 

have reduced time to ambulation and 

hemostasis with similar complication 

rates compared to manual 

compression, the adoption rate is 

relatively low due to limitations 

associated with these devices


Collagen Based Homeostasis Devices: Meta-analysis 

Medline search from 1990 on (to ?97), a total of 6007 pts received 

Vasoseal or AngioSeal for access site Closure in controlled studies.. 

Minor** 


Major* 


VasoSeal 

VasoSeal 

Control 

Angio-Seal 

Angio-Seal 

Control 

7.6% 5.7% 6.7% 11.7%* 

3.8% 1.7%* 1.8% 1.4% 

* Difference is significant 

*Major : thrombosis or loss of distal pulses, larger 

pseudoaneurysm or AV fistula, and bleeding with need for 

transfusion or surgery. 

**Minor: bleed not require transfusion or surgery and small 

pseudoaneurysm treated medically Silber S. AHJ 1998 Jan;135:152-6.


Cleveland Clinic: Perclose Versus Angio-Seal 

Manual 

(N=2099) 

Angio-Seal 

(N=411) 

Perclose 

(N=408) 

P value 

Hematoma ≥5cm(%) 1.4 1.5 1.0 0.8 

AV Fistula(%) 0.7 0 0.2 0.13 

Pseudoaneurysm(%) 0.9 0.5 0.7 0.29 

Retroperitoneal Bl (%) 0.1 1.0 0.8 0.01 

Transfusion (%) 0.8 1.2 1.7 0.16 

Vascular Occlusion (%) 0.3 0.2 0 0.49 

Infection (%) 0 0 0.5 0.02 

Vascular Surgery (%) 0.4 0.2 1.0 0.25 

All Complications (%) 3.1 2.9 3.2 0.96 

Cura et al, AJC 2000;86:780-782


Vascular complications* by access site hemostasis strategy 

From 1/98 to 12/99, 3027 pts underwent PCI at Brigham Hosp. & 

eligible for VCD placement, 49.1% received VCD at the discretion of 

the operator [89.8% AngioSeal, 7.3% Vasoseal, 3% Prostar]. 

Vascular Complications 

*Vascular complications included need for surgical repair, transfusion, 

development of arteriovenous fistula, pseudoaneurysm, or large hematoma 

Resnic FS et al AJC 2001;88:493-6


Meta-analysis: VCDs Vs. MC Post Percutaneous Procedures 

By systemically searching the 

Medline, EMBASE, PASCAL, 

BIOSIS, CINHAL and 

Cochrane databases sites, they 

identified 30 randomized 

clinical trials (1993-2002) 

comparing VCDs and manual 

compression in up to 4,000 pts. 

While TTH and hospital stay 

were shorter in the VCD pts, 

there was no difference in AV 

Fistula, pseudoaneurysm, 

hematoma, and bleeding 

between the 2 cohorts in the 

overall study populations,….. 

Koreny M et al JAMA2004;291:350-7


Meta-analysis: VCDs Vs. MC Post Percutaneous Procedures 

When they repeated the analysis only in 

trials with explicit intention to treat 

analysis, the RR of hematoma was 

higher in the VCD group (1.89;95% 

CI=1.13-3.15) in 4 trials involving 404 

pts in VCD and 259 pts in MC group. 

The RR of developing pseudoaneurysm 

was also higher in the VCD group (5.40, 

95% CI=1.21-24.5). The authors 

concluded that “there is only marginal 

evidence that VCD are effective and 

there is reason for concern that these 

devices MAY increase the risk of 

hematoma and pseudoaneurysm.” 

Koreny M et al JAMA2004;291:350-7


Vascular Access-related Complications in Pts With any VCD Vs. MC 

A database search 

(Cochrane, Medline, 

CINAHL, EMBASE) 

from 1991 to 2003 

identified 30 

randomized, case 

controlled or registry 

studies for analysis 

involving 37,066 pts. 

No difference in access 

site complications was 

noted between VCD 

and MC pts overall. 

Diamonds = all studies; squares = randomized studies 

Nikolsky E et al JACC 2004;44:1200-9


Meta-analysis: Vascular Complications Post Angio-Seal vs. MC 

While no difference in 

access site complications 

was noted between 

Angio-Seal and MC 

following diagnostic 

procedures, there was a 

trend toward less vascular 

complications following 

PCIs in pts who received 

Angio-Seal 

*Fixed effects model; †random effects model. Nikolsky E et al JACC 2004;44:1200-9


Vascular access complications in pts with VasoSeal Vs. MC 

The authors concluded 

that in the setting of 

diagnostic angiogram, the 

risk of access site 

complication was similar 

with VCD vs. MC. In the 

setting of PCI, the rate of 

complications appeared to 

be higher with VasoSeal 

but not AngioSeal or 

Perclose. 

*Fixed effects model. 

Nikolsky E et al JACC 2004;44:1200-9


Vascular Complications Post Diagnostic and PCI Procedures 

Using propensity score analysis to compare risk of vascular complications post VCD vs. MC in 

21,841 pts post Dx (N=13,124) or PCI (N=8,717) procedures at Wake Forest Univ. Med. 

Ctr… 

In this large singlecenter 

large observation 

study, the risk adjusted 

occurrence of vascular 

complications following 

VCD use for femoral 

artery access 

management is NOT 

increased by VCD use. 

Thus, “benefits of VCD 

are NOT offset by 

reduced safety in pts 

undergoing Dx and PCI 

procedures.” 

Applegate RJ et al 2006;67:556-62


Incidence of Complications Post Invasive Procedures 

More Recently, in a retrospective propensity score analysis on 12,937 consecutive Pts treated at 

BWH between 2002-2005, vascular complications occurred in 0.7% diag. and 2.7% PCI pts 

Complication 

Diagnostic cases (n = 6024) PCI cases (n = 6913) 

MC 

(n = 1990) 

VCD 

(n = 4034) 

P 

value 

MC 

(n = 951) 

VCD 

(n = 5962) 

Groin bleeding 0.3% (6) 0.1% (4) .07 1.0% (9) 0.5% (31) .1 

P 

value 

Hematoma 0.4% (8) 0.2% (7) .09 2.5% (24) 1.1% (66)

Study 


Large Controlled/ Meta-analysis Studies: VCDs Vs MC 

Study 

Type 

N 

Device 

Comparison 

End Point 

Outcomes 

Cura et al Registry 2918 VCD vs. mc Vas. Complication AngioSeal 2.9% 

Perclose 3.2% 

MC 3.1% P=NS 

Dangas et al Registry 5039 VCD vs. MC Surgicl Repair VCD 2.5% 

MC1.5% P=0.03 

Resnic et al Rigietry 3027 VCD vs. MC Vas. Complication MC5.5% 

Vcd3.0% P=0.002 

Dangas et al 

Tavris et al 

Exaire e tal 

Koreny et al 

Viatkus 

Nikolsky et al 

Pooled 

Rand.Trial 

ACC- 

NCDR 

Target s 

Stbstudy 

Metaanalysi 

Metaanalysis 

Metaanalysis 

Applegagte et al Registry 4699 AngioSeal vs 

MC 

2095 VCD vs. mc Device Complic. VCD8.5% 

MC5.9% P=0.02 

166,680 VCD vx. MC Vasc. Complic. 1.05to 1.48% VCD 

1.7% for MC P







Investigational Vascular Closure Technology 

Name 

Intraluminal/ 

Extraluminal 

Mechanism 

Permanent 

Foreign Body 

Arstasis Intraluminal Tunnel in media No. Tunnel seals itself 

after sheath removal 

EpiClose 

Plus 

Extraluminal 

Local “energy” with 

balloon indeflation 

No. Nothing left behind 

Vasorum Intraluminal Anchor & plug Yes Permanent 

(316LSS) 

ExoSeal Extraluminal Sealing No. PEG Hydrolysed 

in 3 mths


Eclipse ® Closure Device 

• The ExoSeal ® device 

(Cordis, Miami FL) is a novel 

3rd generation 6 Fr. extravascular 

closure device with a 

painless deployment mechanism 

that delivers a poly-glycolic acid 

(PGA) “felt-like” plug atop the 

femoral artery anchored by the 

neuro-vascular bundle sheath.


ExoSeal ® : Degradation of PGA 

• The PGA plug 

undergoes 

hydrolysis in the 

body and is 

degraded into CO 2 

and H 2 O via the 

Kreb Cycle over a 

3-month period


ECLIPSE Trial Design 

• U.S. multicenter study comparing 

ExoSeal ® and manual compression 

with 2:1 randomization was performed 

to assess the safety and efficacy of 

ExoSeal ® in patients undergoing 6Fr. 

diagnostic and interventional 

coronary/peripheral procedures







Lessons Learned From Literature 

• Compared with manual compression, all 

closure devices demonstrated a marked 

reduction in time to homeostasis and 

ambulation with overall similar rate of 

complications 

• However, not all devices have the same 

safety and efficacy profile. 

• The technique and ease of deployment is as 

unique as the construct for each device


The Role of VCDs in Access Site Management 

• Selective use of VCDs and manual compression will 

both have their own important roles in the access site 

management in the cath Lab. 

• Improvements in the currently available and more 

novel access site closure systems that further secure 

and simplify the deployment process are ongoing. 

• Randomized clinical trials and post market registries 

are clearly needed to further assess what roles closure 

devices (old or new) should play in the management 

of femoral access site following percutaneous 

invasive procedures

Perspectives on Vascular Closure Device and the Latest Evidence

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