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Journal of the American College of Cardiology Vol. 50, No. 17, 2007© 2007 by the American College of Cardiology Foundation ISSN 0735-1097/07/$32.00P

STATE-OF-THE-ART PAPER

Vascular Closure DevicesThe Second Decade

Harold L. Dauerman, MD, FACC,* Robert J. Applegate, MD, FACC,† David J. Cohen, MD, MSC‡

Burlington, Vermont; Winston-Salem, North Carolina; and Kansas City, Missouri

Vascular closure devices (VCDs) introduce a novel means for improving patient comfort and accelerating ambu-lation after invasive cardiovascular procedures performed via femoral arterial access. Vascular closure deviceshave provided simple, rapid, and reliable hemostasis in a variety of clinical settings. Despite more than a decadeof development, however, VCD utilization has neither been routine in the U.S. nor around the world. Their limitedadoption reflects concerns of higher costs for cardiac procedures and a lack of data confirming a significant re-duction in vascular complications compared with manual compression. Recent data, however, suggest that VCDare improving, complication rates associated with their use may be decreasing, and their utilization may im-prove the process of care after femoral artery access. Challenges in the second decade of VCD experience willinclude performing definitive randomized trials, evaluating outcomes in higher-risk patients, and developingmore ideal closure devices. (J Am Coll Cardiol 2007;50:1617–26) © 2007 by the American College ofCardiology Foundation

ublished by Elsevier Inc. doi:10.1016/j.jacc.2007.07.028

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ascular closure devices (VCDs) were first developed in theid-1990s, largely propelled by concerns of high rates of

ccess site bleeding associated with percutaneous coronaryntervention (PCI) procedures. Despite the goals of improv-ng patient outcomes, patient comfort, and catheterizationaboratory efficiency (1,2), VCD adoption has not paralleledhe rapid pace of other interventional cardiology technolo-ies (e.g., drug-eluting stents) (3). In an American Collegef Cardiology-National Cardiovascular Data RegistryACC-NCDR) analysis of 166,680 diagnostic catheteriza-ion or PCI procedures performed in 2001, only one-thirdf patients received a VCD (4). Despite the considerablenowledge that has been gained in the past 10 yearsegarding the strengths, weaknesses, and potential applica-ions of VCD, concerns about costs of VCD use and lack ofuperiority over manual compression have dampened enthu-iasm for their routine use. While VCD use is not routine,he volume of VCD utilization in 2006 suggests that thisechnology is an important part of invasive cardiovascular

rom the *Division of Cardiology, University of Vermont College of Medicine,urlington, Vermont; †Division of Cardiology, Wake Forest University Medicalenter, Winston-Salem, North Carolina; and the ‡Saint Luke’s Mid-America Heart

nstitute, Kansas City, Missouri. Dr. Dauerman has significant disclosures of researchupport and/or consulted on behalf of Boston Scientific, The Medicines Company,bbott Vascular, and St. Jude. Dr. Cohen has received grant support from Cordis,oston Scientific, The Medicines Company, Eli Lilly, and Bristol-Myers Squibb/anofi. Dr. Applegate has significant research grants from Cordis Corporation andascular Solutions as well as consulting for both Abbott Vascular and St. Judeedical. In addition, Drs. Dauerman and Applegate receive fellowship support from

oston Scientific.

iManuscript received May 3, 2007; revised manuscript received July 5, 2007,

ccepted July 15, 2007.

rocedures in many institutions: over 2 million VCD wereold in 2006 (1.6 million in the U.S. and 0.5 million inurope) with a market growth of 11% in the U.S. and 8%

n Europe (5). In this review, we will examine the evidencease concerning VCD use and comment on the challengesacing more widespread adoption of VCD use in the nextecade.

CDs: The First Decade

brief history. Vascular closure devices are in their secondecade of development for diagnostic and interventionalardiovascular procedures. The technologies approved from995 to 1998 focused on active closure methods includinguture alone (2), extravascular collagen alone (6), anduture-collagen combinations (1) (Fig. 1). Since their intro-uction, the original devices (Perclose, Abbott Vascular,edwood City, California; Angio-Seal, St. Jude Medical,t. Paul, Minnesota) have undergone multiple iterationshile maintaining their core concept (7). Recently, a con-

eptually different type of active-closure VCD involvingurgical staple/clip technology has also become availableStarClose, Abbott Vascular, Redwood City, California;VS-Angiolink, Medtronic Co., Minneapolis, Minnesota)

8–10) (Fig. 2, Table 1). “Passive closure” technologies haveeen developed in parallel with the active closure devices.assive closure approaches have focused on enhanced man-al compression utilizing external patches with prothrom-otic coatings (Syvek Patch, Marine Polymer Technologies,anvers, Massachusetts) (11,12), wire-stimulated track

hrombosis (Boomerang Wire, Cardiva Medical, Mounta-
nview, California) (13), or assisted compression with me-

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1618 Dauerman et al. JACC Vol. 50, No. 17, 2007VCD Utilization and Outcomes October 23, 2007:1617–26

chanical clamps; the passive clo-sure devices do not affordimmediate (�5 min) hemostasis(14,15) (Fig. 2). This review willfocus on the immediate, activehemostasis closure devices giventheir greater utilization over thepast decade.

The adoption of VCD has occurred because of a clearechnological feat: VCD reliably shortens the time toemostasis (elapsed time between sheath removal and firstbserved hemostasis) compared with manual compressionnd thus allows earlier patient ambulation (1,8,10,16,17)Table 2). Alternative strategies for achieving early ambu-ation are the use of smaller sheaths for diagnostic catheter-zation as well as the use of the radial artery approach. Thedvantage of femoral vascular closure is that it can beerformed immediately at the end of the procedure regard-

ess of anticoagulation status; procedural success is expectedn �95% of patients, and time to hemostasis is generally lesshan 5 min with Angio-Seal, Perclose, and staple/clip-ediated VCD (1,2,10,18). This compares favorably with

emostasis times of 15 to 30 min with standard 6-F manualompression. In addition, sheath removal via manual com-ression generally requires the operator to wait for thectivated clotting time to reach a level of �180 s (19), whileCD allows immediate removal of the femoral sheath

egardless of anticoagulation status. While length of stay forCI patients will not necessarily be reduced by earlymbulation (unless same-day PCI is adopted), it can beeduced for diagnostic patients (2,16,20). And, for manyatients, VCD can allow improved patient satisfaction andomfort related to the avoidance of prolonged sheathnsertion and manual compression (19). Given this techno-ogical feat, it may be somewhat surprising that VCD have

Figure 1 The First Decade of Vascular Closure Devices

The first decade of vascular closure devices according to their year of Food andDrug Administration approval. During this transition from bare-metal to drug-eluting stent eras, other factors may have influenced vascular complicationrates (i.e., percutaneous coronary intervention pharmacology). GP �

glycoprotein.

Abbreviationsand Acronyms

PCI � percutaneouscoronary intervention

VCD � vascular closuredevice

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ot become the standard of care for invasive cardiac proce-ures (21).

ssues Challenging VCD Adoption:omplications and Cost

hat is the current rate of vascular complications associatedith VCD? Vascular closure device pivotal studies haveenerally included 250 to 600 randomized patients. Givenheir limited sample sizes, such studies can reliably identifyhose complications that occur in 3% to 5% of the highlyelected subjects enrolled in the trials (1,2,8,10,22). Vascularlosure device trials have not been expanded to higher-riskatient cohorts; thus, there is a lengthy list of precautionsnd warnings on the instructions for use for each deviceTable 1). For example, in the randomized trial leading toood and Drug Administration (FDA) approval of thetarClose nitinol clip system for diagnostic cardiac cathe-erization, the list of angiographic and clinical exclusionsncluded obesity, small femoral artery diameters, bleedingiatheses, femoral arterial disease, and nonfemoral sheathnsertion (20).

There are concerns that the VCD may cause increasedates of rare complications, primarily based upon anecdotalase reports. Infections, femoral artery compromise, arterialaceration, uncontrolled bleeding, pseudoaneurysm, atrio-entricular fistula, as well as device embolism and limbschemia have all been reported after VCD utilization4,23). These reports span all VCD types including Perclose24,25), Angio-Seal (26), and StarClose (27). One studyuggests that the severity of individual complications may beorse after VCD use compared with manual compression

or PCI patients as VCDs are deployed at the point of

Figure 2 Overview of Vascular Closure Device Types

Vascular closure methods are: 1) passive and delayed—manual compressionwith assistance (Femostop) or enhancement (patches); and 2) active andimmediate—collagen-based with or without anchor and suture, suture-based,and staple/clip-mediated.

aximal anticoagulation while manual compression is de-

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1619JACC Vol. 50, No. 17, 2007 Dauerman et al.October 23, 2007:1617–26 VCD Utilization and Outcomes

ayed (27). Thus, the severity of bleeding complicationswhen they occur) would be expected to be greater withCD than manual compression.Reports of adverse events after VCD use prompted the

DA to initiate the largest study of 166,680 patients via theCC-NDR database “to assess the relative risk of compli-

ations after the use of the 2 main types of hemostasisevice” (4). However, concerns that VCD outcomes areorse in comparison with manual compression are not

upported by review of published meta-analyses, multicenteregistries, and longitudinal registries (Table 3). These stud-es evaluated a larger number of patients than were studiedn the pivotal trials, but are limited by variable study endoints. Some studies use a composite end point (4,7,17,22,

ndications, Contraindications,nd Cautions for 3 VCDs

Table 1 Indications, Contraindications,and Cautions for 3 VCDs

Angio-Seal* Perclose† StarClose†

Closure indication

Diagnostic cath � � �

PCI � � �

5-F sheath NM � �

6-F sheath � � �

7-F sheath � � No

8-F sheath � � No

Ipsilateral access �90 days 1 cm higher No restriction‡ Not indicated

MRI safe NM NM �

Contraindication None None None

Warnings: “Do not use if . . .”

SFA or Profunda insertion � � �

Bifurcation insertion � � �

Above inguinal ligament � � �

Posterior wall puncture NM � �

Multiple punctures NM � �

Precautions: “Safety andeffectiveness of the VCDhas not beenestablished if . . .”

Patient on warfarin � NM NM

Inflammatory disease � � �

Morbid obesity NM � �

Thrombolysis � NM NM

Access via vascular graft � � �

Significant PVD � � �

Uncontrolled HTN � NM �

Bleeding diathesis � � �

Ipsilateral venous sheath NM � �

Femoral artery calcium NM � �

Small femoral artery size � � �

Iliofemoral stenosis �50% NM � �

Use of GP IIb/IIIa inhibitor NM � NM

Instructions for Use Angio-Seal VIP; St. Jude Medical February 2006 (www.sjm.com); †Instruc-ions for Use Perclose A*T (August 2006) and StarClose (February 2007). Abbott Vascularwww.abbottvascular.com/ifu); ‡no restriction is only for reaccess after prior arteriotomy repairedith Perclose.cath � catheterization; GP � glycoprotein; HTN � hypertension; MRI � magnetic resonance

maging; NM � not mentioned in instruction for use as indication, warning, or caution; PCI �

ercutaneous coronary intervention; PVD � peripheral vascular disease; SFA � superficial femoralrtery; VCD � vascular closure device; � � explicitly mentioned in instruction for use as indication,arning, or caution.

8–34), some studies use a single end point, (16,35,36), and a

ome studies define “vascular complications” differently37). Nevertheless, there are several conclusions that may berawn from these larger studies of vascular complications:

Among patients undergoing diagnostic cardiac catheter-ization, there is a 0.5% to 1.7% rate of vascular compli-cations (4,7,16,31,34,38); this risk is not consistentlyincreased or decreased by VCD usage across all studies;the largest study, from the ACC-NCDR, suggested a signif-icant decrease in complications with VCD usage comparedwith manual compression (4); it is possible this reductionin complications is directly related to the VCD oralternatively reflects a reluctance by the operator to use aVCD in patients who are already having a complicationat the completion of the diagnostic procedure or incircumstances where both VCD use and manual com-pression have been associated with increased complica-tions (e.g., high or low femoral insertion sites).Among patients undergoing PCI, there is a 0.8% to 5.5%rate of heterogeneously defined vascular complications;with the exception of Vasoseal, there are no data toclearly suggest an increased risk of vascular complicationswith VCD use (4,29,33); some studies suggest thatVCDs decrease complications compared with manualcompression (17,33,34,36), some studies suggest poten-tially increased risk with VCD (22,28,30), and somesuggest complication rates are similar (7,29,31,35); theACC-NCDR study suggests a nonsignificant reductionin complications with VCD as compared with manualcompression for patients undergoing PCI (4).

iven the equipoise with respect to vascular complicationsuggested by overview of these many VCD studies, it is noturprising that manual compression has remained the mostommon method for achieving hemostasis after invasiveardiac procedures both in the U.S. and worldwide (4,8)Fig. 2). An example of this practice pattern can be seen inhe TARGET (Comparison of 2 Platelet Glycoprotein IIb/IIa Inhibitors, Tirofiban and Abciximab, for the Prevention ofschemic Events With Percutaneous Coronary Revasculariza-ion) trial comparing abciximab to tirofiban. Of 4,809 patientsndergoing PCI, 4,736 had femoral access. Use of VCD waseft to the discretion of investigators—only 20% (n � 985)ere treated with a VCD (35). While the interventional

ardiology community has been noted for its aggressive adop-ion of new technologies beyond FDA labeling and random-zed clinical trial conclusions (3), VCD utilization demon-trates the critical perspective that hospitals and interventionalardiologists do bring to adoption of new technology.

actors Affecting Vascular Complication Rates:atient Selection, Newer Anticoagulation, andntiplatelet Strategies and Device Improvements

ccurate estimation of the relative benefits of VCD versusanual compression should also reflect what appears to be
change in the incidence of vascular complications in the
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urrent era. In studies from the 1990s, vascular and bleedingomplications after PCI were frequently in the 3% to 6%ange (17,28,30,39,40). Recently, rates of major vascularomplications after PCI are estimated at closer to 2%4,40,41) (Fig. 3). This observation is supported by datarom the PCI Registry of the Northern New Englandardiovascular Study Group. Using a standard definition ofajor vascular complications (arterial injury and/or arterial-

Efficacy of VCDs for Reducing Time to Hemosta

Table 2 Efficacy of VCDs for Reducing Time

CLIP Study Diagnostic Arm—ITTStarC(n �

Procedure success (%) 100 (13

Mean time to hemostasis (min) 1.5 (�

Mean time to ambulation (min) 162 (�

Major complications (% patient-based) 0 (0/

Minor complications (% patient-based) 2.2 (3/

Mean time to dischargeability (h) 3.5 (�

CLIP Study Interventional Arm—ITTStarC(n �

Procedure success (%) 98

Mean time to hemostasis (min) 8.0 (�

Mean time to ambulation (min) 411 (�

Major complications (% patient-based) 1.1 (2/

Minor complications (% patient-based) 4.3 (8/

ITT � intention to treat; VCD � vascular closure device.

elected Studies of VCDs as Compared With Manual Compression

Table 3 Selected Studies of VCDs as Compared With Manual C

Study Study Type n Device Compa

Cura et al. (28) Registry 2,918 VCD vs. MC

Dangas et al. (30) Registry 5,093 VCD vs. MC

Resnic et al. (17) Registry 3,027 VCD vs. MC

Dangas et al. (22)† Pooled randomized trials 2,095 VCD vs. MC

Tavris et al. (4)† ACC-NCDR 166,680 VCD vs. MC

Exaire et al. (35) TARGET trial substudy 4,736 VCD vs. MC

Koreny et al. (16)† Meta-analysis 4,000 VCD vs. MC

Vaitkus et al. (33)† Meta-analysis 5,045 VCD vs. MC

Nikolsky et al. (29) Meta-analysis 37,066 VCD vs. MC

Applegate et al. (7) Registry 4,699 Angio-Seal vs.

Arora et al. (34)† Registry 12,937 VCD vs. MC

Vascular complication may be defined differently for each study; †data include both diagnostic and inteACC-NCDR � American College of Cardiology-National Cardiovascular Data Registry; MC � manual com

njury-related bleeding), there has been a 42% relativeecrease in complications from 2002 to 2006 (p � 0.001)D.J. Malenka and W.D. Piper, personal communication,anuary 2007) (40). Changes in the characteristics of pa-ients undergoing PCI do not appear to account for thiseduction in complications, since the major known riskactors for vascular complications have remained constanturing this period—advanced age (39,40), vascular disease

LIP Randomized Trial

emostasis: CLIP Randomized Trial

Standard Compression(n � 72) p Value

) 100 (72/72) NA

15.5 (� 11.4) �0.001

269.3 (� 134.8) �0.001

0 (0/72) —

1.4% (1/72) 1.000

5.2 (� 2.1) �0.001

Standard Compression(n � 91) p Value

98.7 NA

29.1 (� 35.3) �0.001

) 466 (� 257.2) �0.137

1.1 (1/91) 1.000

9.9 (9/91) 0.107

atients Undergoing PCI

ression for Patients Undergoing PCI

End Point Outcomes

Vascular complication* Angio-Seal 2.9%Perclose 3.2%MC 3.1%p � NS

Surgical repair VCD 2.5%MC 1.5%p � 0.03

Vascular complication MC 5.5%VCD 3.0%p � 0.002

Device complications VCD 8.5%MC 5.9%p � 0.02

Vascular complication 1.05% to 1.48% VCD1.70% for MCp � 0.001

Transfusions VCD 1.0%MC 0.8%p � NS

Hematoma RR 1.14 for VCD (0.86–1.51)

Vascular complication RR 0.89 for VCD (0.86–0.91)Increased risk for Vasoseal

Vascular complication p � 0.06 for Angio-Seal benefit compared with MCIncreased risk for Vasoseal

Vascular complication Angio-Seal 1.5%MC 1.7%p � NS

Vascular complication 42% to 58% reduction in vascular complicationswith VCD vs. MC

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4,7,40), female gender (4,40), emergent procedures (4,40),nd low body surface area (7,40). The reasons for the decreasen vascular complications possibly reflects the influence ofeveral factors: better patient selection for VCD, improvedemoral access techniques, changing PCI pharmacology, im-roved VCD, and improved operator experience with VCDse (32).atient selection. Routine femoral angiography at the endf the catheterization procedure is a significant advance42–44). Such angiography allows identification of theajor risk factor for retroperitoneal hemorrhage-sheath

nsertion above the inferior epigastric artery (44–46). Inddition, femoral angiography identifies the estimated 13%f patients with nonfemoral artery sheath insertion forhich VCD utilization is of unclear efficacy (Fig. 4) (20,43).

Figure 3 The Declining Rate of Vascular Complications

Over the past 5 years, major vascular complications have decreased amongpatients undergoing percutaneous coronary intervention (PCI) in the NorthernNew England Cardiovascular Disease Study Group. *Arterial injury and/or arte-rial injury-related bleeding (n � 36,631 patients undergoing PCI).

Figure 4 High-Risk Femoral Anatomy

Nonideal femoral anatomy includes patients with femoral arterial disease and shethe common femoral artery. Utilization of vascular closure devices in these situatio

dentification of significant femoral arterial disease mayllow selective use of manual compression in situationshere implantation of an intravascular device may be

ssociated with an increased risk of complications (Table 1)7,47). Furthermore, femoral angiography may be especiallymportant in the setting of multiple procedures at the sameemoral access site; there is limited data regarding the safetyf repeat access, and further study regarding the patholog-cal and potential anatomical effects of repeat access withifferent devices is warranted (48–50).ewer anticoagulation and antiplatelet strategies. Lower

oses of unfractionated heparin have almost certainly con-ributed to the reduction in vascular complications (51).ivalirudin also reduces the risk of bleeding complicationsfter PCI compared with heparin � glycoprotein IIb/IIIanhibitors (41). Thus, changes in PCI-related pharmacologyould be expected to decrease bleeding and vascular com-lication rates up to 40%. Whether or not PCI pharmaco-

ogic changes may have preferentially benefited VCD oranual compression requires further clarification via pro-

pective trials or subgroup analysis of recent trials (52).evice improvements. The first VCD (Vasoseal) was a

ollagen device and the only VCD significantly associatedith increased risk of vascular complications compared withanual compression in 2 meta-analyses (29,33). The dom-

nant types of VCD in current practice are the suture-ediated device (Perclose), the collagen-anchor-suture-ediated device (Angio-Seal), and clip-mediated VCD

StarClose). The learning curve for each device may beteep, and thus complication rates may have been higher inhe mid-to-late 1990s related to slow improvement inperator proficiency (29,30,32). In addition, each of theseevices has undergone modification and simplification overime. For example, 1 longitudinal registry observed that these of the third generation of Angio-Seal VCD was

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ssociated with a 37% lower risk of vascular complicationsompared with the first Angio-Seal VCD (7).ost concerns. One important consideration in determin-

ng the optimal role of VCDs is their cost. Although mostCDs currently cost on the order of $150 to $200, given the

arge volume of both diagnostic angiograms and PCIrocedures at many U.S. hospitals (5), even such a modestncremental cost has the potential to substantially impactatheterization laboratory and hospital budgets. Whetherheir utilization is cost effective depends on a variety ofactors including the frequency of vascular complications,he impact of VCD use on the complication rate, and theotential for VCD to substantially alter post-procedureanagement patterns.To date, several studies have examined the cost-

ffectiveness of vascular closure devices. The first suchnalysis was performed by Bos et al. (53). They used aecision analytic model to examine the potential cost-ffectiveness of a collagen plug versus manual compressionor achieving hemostasis at arterial puncture sites. Althoughhey concluded (based on fairly limited evidence at the time)hat a collagen plug (either Vasoseal or Angio-Seal) couldeduce complications by �50%, they estimated that use of aCD would increase post-procedure costs by �$135/patientith an overall cost-effectiveness ratio of $9,000 per vascular

omplication avoided. They concluded that this representedrelatively inefficient use of medical resources comparedith other treatments. Whether this analysis is applicable tocontemporary U.S. catheterization laboratory population

s debatable, however. In particular, it is unclear whether theascular complication rates in their study (which wereerived from a very small number of early studies) areomparable to those observed in current practice.

More recently, Resnic et al. (54) used a decision analyticpproach to evaluate the potential cost savings associatedith routine use of a collagen-suture plug (Angio-Seal)

ompared with manual compression. Data on specific com-lication rates for the 2 strategies were derived from poolednalysis of published randomized clinical trials while costsssociated with various complications were derived from aatched case-control study conducted at a single U.S.

cademic medical center. They concluded that comparedith manual compression (using the Femostop device, Radiedical, Uppsala, Sweden), routine use of the Angio-Seal

educed both complications and cost. Most of the costavings they projected were driven by reductions in vascularomplications such as rebleeding, which they estimated to haven attributable cost of �$5,000 per event. It is important toote that the conclusions of this study were somewhat sensitiveo the cost of the compression strategy. In particular, VCD useas no longer cost saving if the manual compression

trategy cost �$66/patient (as might be anticipated withanual compression alone). Thus, it is unclear whether

heir conclusions can be generalized to all U.S. hospitals.oreover, these findings probably do not apply to patients

ndergoing diagnostic catheterization alone where the ex- p

ected risk of vascular complications is substantially lowerhan with PCI (4).

The strongest economic argument in favor of VCDs maye their potential to convert an inpatient PCI procedurento an outpatient procedure (55,56). This possibility wasxplored in a small randomized clinical trial by Rickli et al.57). They randomized 191 patients undergoing electiveCI at a single Swiss hospital to either a routine manualompression strategy or use of a suture-based closure devicePerclose). Patients assigned to manual compression under-ent sheath removal 4 h after PCI and were kept at bed restvernight. In contrast, patients assigned to suture-mediatedlosure underwent immediate sheath removal and werembulated after 4 h of bed rest. Although there were noignificant differences between the 2 strategies in terms ofajor or minor vascular complications, use of suture-ediated closure was associated with a 12-h reduction in

he post-PCI bed rest requirement (6.8 vs. 18.4 h) withssociated benefits in terms of groin pain, back pain, andrinary problems. Their cost minimization analysis sug-ested that despite the cost of the closure device (225€), thisas more than offset by reductions in hospital length of stay

nd physician time) with net savings of �70€/patient.lthough similar savings might be achievable in a U.S.

etting as well, given the current U.S. reimbursement systemwhich may reimburse substantially more for an inpatientCI procedure than a similar procedure performed on anutpatient basis), many hospitals may actually lose substan-ial revenue by adopting such a strategy.

What can we conclude from the available studies? Firstnd foremost, there is no single answer to the questionhether VCDs are cost effective. The answer depends on a

arge number of factors, most of which are particular to theocal healthcare environment. For example, if a hospitaloutinely utilizes adjuncts to manual compression (such ashe Femostop device or additional staff), it appears that byeducing vascular complications a VCD device might beost neutral or cost saving for the vast majority of patients.owever, if the relevant comparator is true manual com-

ression without additional staff, the cost offset is probablyot sufficient to fully offset device costs at the present time.n this case, a more restrictive patient selection might beustified by which VCD use was reserved for those patientst greatest risk for bleeding (38,40) or for patients where arolonged period of bed rest would lead to unacceptableiscomfort or risk of complications. Finally, the majorconomic value of VCDs appears to be their potential toonvert PCI from an inpatient to an outpatient procedure,t least for select individuals judged to be at low risk fororonary ischemic complications (55). Whether this strategyecomes accepted and viable within the U.S. health careystem will depend more on changes to the reimbursementystem and the associated financial incentives than on the
otential cost-effectiveness of the overall strategy, however.

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CDs: The Next 10 Years

efinitive clinical trials. To date, there have been noarge-scale randomized clinical trials comparing outcomesith VCD use with those with manual compression. Norave there been large-scale trials pitting devices head-to-ead to determine the possible superiority of 1 device overnother. There are several factors that account for theseeficiencies in our current evidence base. First, from thetandpoint of revenue, the VCD market represents a rela-ively small component of the total interventional cardiologyarket (5). As such, the incentive for device companies to

ponsor expensive large-scale clinical trials is reduced. Sec-nd, sheaths are pulled only after the effects of anticoagu-ants have worn off for manual compression but are removedmmediately after PCI when a VCD is used. Thus, anylinical trial comparing manual compression to VCD wouldepresent a comparison of 2 alternative closure strategies asell as a direct comparison of closure efficacy. Additionally,

here have been no consistent standards for defining vascularomplications, particularly hematoma formation (37). Moreecently, a consistent definition has been adopted as part ofhe FDA approval process and that definition would need toe the basis of any future randomized trials (10). These priorimitations have led to the circumstances of a less-than-ptimal evidence base to guide VCD use. If the results of aarge randomized clinical trial establishing vascular out-omes with VCD compared with manual compressionndicated that rates of vascular complications were lowerith VCD, however, such a study would provide a strong

mpetus for VCD use in routine clinical practice.hallenges for expanded VCD utilization. Vascular clo-

ure devices decrease the time to ambulation, the time toischarge, and decrease complications for patients undergo-

ng diagnostic angiographic procedures (4): How can similarenefits be shown for a broader group of patients? Two

Figure 5 Intravascular Versus Extravascular Closure Devices

New staple- and clip-mediated (StarClose or Angiolink) vascular closure devices ha(Perclose). This may be especially significant in situations where minor femoral artarterial disease).

roups believed to be at high risk for VCD use have beenoutinely excluded from the pivotal studies leading to VCDpproval: patients undergoing PCI for acute myocardialnfarction (58) and patients who have documented femoralrterial disease or other peripheral vascular disease8,20,40,47). Prior studies of PCI patients with clinicallymportant peripheral vascular disease have suggested annhanced relative risk of vascular complications of 40% to9% with absolute rates of complications from 2.6% to 8.9%7,40,59–62) (Fig. 4). There are only limited data regardingse of VCDs in patients with vascular disease involving theemoral artery (59,60). Whether use of an extravascularCD could result in an overall reduction in PCI-related

ascular complications for high-risk populations such ashose with femoral arterial disease is an intriguing concepthat requires further study (49,60,62,63) (Fig. 5).

We believe that several studies should be performedefore expanding VCD use for both diagnostic and PCIatients. Several of these potential studies are enumerated inhe following text:

A randomized trial of VCD versus manual compressionamong patients at high risk of vascular complications; ifmajor vascular complication rates with manual compres-sion were expected in �5% of an enriched controlpopulation (i.e., those with femoral disease [62] and/orPCI for acute myocardial infarction [58,64]), a devicethat incurred a �2% rate of major vascular complicationcould be studied and shown to be superior to manualcompression (p � 0.05) in a 1,000-patient randomizedtrial.Surveillance registries to identify high-risk patient sub-sets and low-frequency adverse events; utilization ofpost-marketing surveillance registries of �10,000 pa-tients may be advantageous given the relatively low rateof current vascular complications; this concept is directly

otential advantage of being “extravascular” with no anchor (Angio-Seal) or sutureen compromise would be clinically consequential (i.e., mild-moderate femoral

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analogous to the challenges with analyzing other low-frequency events in high-frequency procedures (i.e.,drug-eluting stent thrombosis) (65); one advantage ofVCD studies is that major vascular complications occurearly and thus the design of these studies (as opposed todrug-eluting stent thrombosis) might require only 30-day patient follow-up; utilizing data from only 2001, theACC-NCDR provided the largest registry data so far onVCD (4); expanding this study to the period 2003 to2006 could provide even more convincing data on VCDimpact on complications for diagnostic and PCI patientsespecially among subgroups for which there are currentcautions (Table 1).Studies to enhance detection of complication risk; use ofa surrogate marker for clinically important vascularcomplications could provide a marker for device andmanual compression complications (15); for example, asmaller randomized trial might utilize routine 30-dayfemoral arterial duplex ultrasound (15,66) to determinewhether issues of nonclinical vascular compromise war-rant caution with staple, collagen, suture, or manualclosure methods.

t is clear from the first decade of experience with VCD usehat outcomes in an individual patient reflect characteristicsf the patient, the operator, and the device. While aonsiderable number of studies have identified “high”-riskatient characteristics (40,44), there are fewer studies thatave evaluated the role of the operator in contributing toascular complications. One criticism of the trials used tobtain FDA approval for a VCD is that the results reflectnitial operator experience with the device, and in someases the initial experience with closure devices in general32). Thus, the rates of device failure and device-associatedascular complications in early studies may represent out-omes from the steep portion of the “learning curve” ofCD experience. Studies have documented a “learning

urve” phenomenon associated with VCD use (26,62).mportantly, in the study by Warren et al. (26), there was a3-fold increase in device failure for the first 50 patients

reated with Angio-Seal compared with subsequent deploy-ents (14% early learning curve failure rate vs. 3.5% later

xperience of nondeployments, p � 0.009) (26). In thetudy by Balzer et al. (62), the learning curve for technicaluccess with suture-based closure was even steeper andonger (�350 patients).

While not definitive, these data strongly suggest thatperator and programmatic expertise occurs only afterubstantial VCD experience has accrued. If VCD utilizations to achieve its maximum potential to improve clinicalutcomes, it will thus be imperative to provide the educa-ional and practice opportunities to achieve a high level ofxpertise. This education must address more than a partic-lar VCD device: excellent access technique as a part of auccessful VCD procedure cannot be overemphasized. It is
ifficult to determine what percentage of VCD failures are p
result of suboptimal access technique, but expanding these of VCDs will most likely occur in the setting ofnhanced access skills.oward a more ideal VCD. Although the Angio-Seal anderclose devices, the 2 VCDs with the longest period ofommercial availability, have both undergone significantvolution and improvement (7), closure failures with theseevices still occur. Moreover, the newest commerciallyvailable closure device, StarClose, has not eliminated thisroblem. In the CLIP (CLosure In Percutaneous Proce-ures) study, there was an 11% failure rate in the PCI armf the study (10). Closure failure may occur for a number ofeasons independent of the VCD used. Clinical and treat-ent factors, such as use of glycoprotein IIb/IIIa inhibitors

nd advanced age (40), will likely always challenge arterialccess management. Procedural factors such as multiplettempts to gain access, back wall sticks, and access sitesutside of the common femoral artery likely contribute tolosure failure (10). The challenge for successful VCD usen these situations is substantial.

The patient factors influencing closure success notwith-tanding, the “ideal” closure device remains to be developed.

hat would this device look like? 1) A single device capablef providing successful closure for all patient and access sitenatomical variations; 2) an atraumatic device without aoreign body or vascular alteration of the femoral artery; and) a simple-to-use device with �95% procedural success andow cost. Access site closure with heat, delivered via ultra-ound guidance, may be the closest approximation to thedeal VCD to date—an active closure with no potentialompromise of the femoral artery (67). Unfortunately, theherus device (Therus Corporation, Seattle, Washington)as had limitations that have delayed its introduction intolinical practice. Further innovation will be required tochieve the “ideal VCD” in the next decade.

onclusions

ver the past decade, our information base has improved; soave the devices, pharmacology, and techniques associatedith VCD. Based upon these more recent data, should allatients get a VCD? No—those with severe femoral arterialisease and sheath insertion above the inferior epigastricrtery may have a higher risk with VCD than manualompression (45). Should most patients undergoing femoralrterial access get a VCD? For diagnostic cases, the answeray be “yes” based upon both decreased complication rates

nd improved time to ambulation (1,4,8,16,54). As outlinedn the preceding text, however, there are numerous sub-roups of diagnostic patients for whom insufficient data arevailable to make a clear recommendation. For PCI pa-ients, contemporary data support a neutral effect on com-lications in the setting of ongoing concerns regardingevice costs. The ability to convert an inpatient PCI
rocedure to an outpatient procedure (without adversely

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mpacting hospital reimbursement) by use of a VCD wouldargely overcome these financial concerns.

The second decade of VCD launches with a history thats characterized by cautious adoption of this particularechnology and frightening case reports of adverse experi-nces (4,32). Fortunately, the studies of the past 5 yearseem to suggest that selected VCD technology not onlymproves time to hemostasis, but also reduces complicationst least in patients undergoing diagnostic cardiac catheter-zation (4,33,54). Expanded use of VCD technology seemsikely over the next decade as cost-effectiveness is demon-trated with respect to reduction in complications; the driveror this expanded use will be definitive trials in enrichedopulations, adoption of same-day PCI, mega-registriesith information on high-risk subgroups, and improving

echnology/pharmacology/closure technique.

eprint requests and correspondence: Dr. Harold L. Dauerman,niversity of Vermont College of Medicine, Fletcher Allen Healthare, 111 Colchester Avenue, McClure 1 Cardiology, Burlington,ermont 05401. E-mail: [email protected].

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