- Email: [email protected]
Vascular Closure Devices: A Comparative Overview
Vascular Closure Devices: A Comparative Overview Lye-Quen Hon, MB BCh, MRCP (UK), FRCR,a Arul Ganeshan, BSc, MB BCh, MRCP (UK), FRCR,b Steven Mark Thomas, MB BS, MRCP (UK), FRCR, MSc,c Dinuke Warakaulle, MB BS, MRCP (UK), FRCR,d Jagalpathy Jagdish, MB BS, MRCPCH (UK),a and Raman Uberoi, BSc, MB BChir, MRCP (UK), FRCRb
The use of closure devices is widespread and becoming more common. Radiologists performing arterial access procedures should be aware of when and how to use them, as well as the advantages and disadvantages of various devices, and any complications that may occur. This review intends to provide an overview of these devices, focusing on how they work, their efficacy in achieving hemostasis, any risks associated with their use, and our view as to which should be used for particular indications. There are three main categories of vascular closure devices: collagen based, suture based, and staples and clips. Newer generation devices use the same technique of closure and there are some that utilize newer techniques. Vascular closure devices have been demonstrated to reduce time to hemostasis, facilitate ambulation, and potentially decrease length of stay. The choice of a device would depend on the availability of that particular device, operator preference, anticipation of repeat arterial access, and size of the arteriotomy hole.
As the number of cardiovascular and radiological interventional procedures increase, there is a drive to develop more efficient techniques and user-friendly tools, which address the increasing time constraints and issues of patient satisfaction. One of the issues for From the aRoyal Hallamshire Hospital, Sheffield, United Kingdom; bJohn Radcliffe Hospital, Oxford, United Kingdom; cSheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom; and dStoke Mandeville Hospital, Buckinghamshire, United Kingdom. Reprint requests: Lye-Quen Hon, MB BCh, MRCP (UK), FRCR, C Floor Radiology Department, Royal Hallamshire Hospital, Sheffield S10 2 JF, United Kingdom. E-mail: [email protected]. Curr Probl Diagn Radiol 2009;38:33-43. © 2009 Mosby, Inc. All rights reserved. 0363-0188/2009/$34.00 ⫹ 0 doi:10.1067/j.cpradiol.2008.02.002
Curr Probl Diagn Radiol, January/February 2009
vascular interventional procedures has been the laborintensive and time-consuming process of achieving hemostasis. Traditionally, hemostasis is accomplished by manual compression. Manual compression, introduced in conjunction with the Seldinger technique in the 1950s, is generally safe and has been the standard method to achieve hemostasis for nearly 50 years. This requires 10 to 20 minutes of sustained pressure over the puncture site followed by bed rest for a period of 4 to 6 hours. Prolonged immobilization results in increased patient discomfort and noncompliance of bed rest after manual hemostasis can lead to increased complications. This is now being challenged by the introduction of various aids to achieve hemostasis. This article gives a comparative overview of the methods available as an alternative to manual compression to achieve hemostasis after arterial puncture.
Vascular Closure Devices Adjuncts to manual compression include mechanical clamp devices and hemostatic pads. Mechanical clamp devices apply direct pressure onto the puncture site. The major disadvantages of these pressure devices are the lack of direct supervision over the groin site and the need for careful placement superficially over the arteriotomy hole. Topical hemostatic pads contain procoagulants, which promote clot formation; however, these pads still require a degree of manual compression. There are no randomized controlled trials comparing the efficacy of these pads or mechanical clamps to manual compression. In general, these
33
TABLE 1. Types of vascular closure devices Collagen/thrombin based products Intra/extraluminal Angio-Seal (St. Jude Medical) Extraluminal ● VasoSeal (Datascope) ● On-Site (Datascope) ● Duett Pro (Vascular Solutions) ●
Suture-based products Intraluminal stitches ● Perclose (Abbott Vascular) ● X-Site (Datascope) ● SuperStitch (Sutura Inc.)
are unsatisfactory alternatives to the standard method of manual compression and will not be discussed further. During the last decade, technological advancements have introduced novel ways of closing the arteriotomy holes using a variety of devices specifically designed to achieve closure of the arteriotomy. An ideal vascular closure device (VCD) should provide effective and rapid hemostasis, is simple to use, and produces complication rates that are lower or at least comparable to manual compression. The calculated overall cost effectiveness should also be favorable. In broad terms, these vascular closure devices are divided according to their mechanism of gaining hemostasis. There are three basic types: suture based, collagen based, and staples and clips (Table 1). These can be further subdivided into either extra- or intraluminal devices, depending on the position of the deployed hemostatic closure components.
Collagen-Based Vascular Devices Collagen-based vascular devices are bovine collagenbased products that augment clot formation. The device promotes the process of hemostasis in the two following ways: first, it increases the availability of collagen at the arterial wall defect, promoting platelet adherence, aggregation, and activation; second, the swelling of the collagen mass that occurs after deployment mechanically seals the vessel and tissue tract.1 There are several examples that exist in the market, mainly, Angio-Seal (St. Jude Medical, St. Paul, MN), VasoSeal (Datascope, Montvale, NJ), and Duett (Vascular Solutions, Minneapolis, MN). In general, these are used in patients who are unlikely to require immediate re-access. Once deployed, it may be difficult to re-access close to the site of previous puncture. Repeat puncture within 3 months is generally not recommended, as time is needed for resorption and degradation of the collagen.2 These devices are therefore
34
Staples and clips Extraluminal ● EVS Vascular Closure System (Medtronic) ● StarClose (Abbott Vascular)
Others No intra/extraluminal components ● Boomerang (Cardiva Medical) ● SoundSeal (Therus/ Boston Scientific)
generally only employed in patients in whom re-access should not be required. Table 2 lists a comparison between the different types of collagen-based devices.
Angio-Seal Angio-Seal is an established collagen-based vascular closure device. The tip consists of a rectangular 1 ⫻ 2 ⫻ 10 mm anchor, attached to a bovine sponge collagen plug by an absorbable suture. The anchor remains intraluminal post deployment (Fig 1). This is a popular collagen-based closure device that has also been used in radial and subclavian arterial puncture sites as well as the venous punctures sites.4-6
VasoSeal VasoSeal is a purified collagen-based plug device. There are several versions of VasoSeal including the VasoSeal Elite and ES. Fig 2 demonstrates the deployment of VasoSeal Elite. VasoSeal Elite and ES use a temporary J-shaped locator segment. The main difference from Angio-Seal is that the VasoSeal devices do not possess any intraluminal components. The collagen plug is deposited outside the arterial wall along the puncture tract. The VasoSeal basic design has been used in the working of On-Site (Datascope), another collagen-based product that uses a temporary nitinol mesh disc as a locator (Fig 3). Results observed during the original VasoSeal ES studies have been applied to this device. At this time, there are no formal trials for the device.7
Duett Pro Sealing Device The Duett vascular device uses extraluminal collagen-based vascular closure components. The device consists of a 7-mm balloon mounted on a 3-F catheter (Fig 4). A mixture of thrombin and bovine collagen is injected into the subcutaneous tract. Conversion of fibrinogen into fibrin by the action of thrombin in the presence of collagen results in accelerated coagulation
Curr Probl Diagn Radiol, January/February 2009
Curr Probl Diagn Radiol, January/February 2009
TABLE 2. Collagen-based devices Device Angio-Seal2,3
VasoSeal2,3
Variations/evolvement Angio-Seal STS (selftightening suture) platform Angioseal V-Twist VIP (provides larger coverage with twisting action) VasoSeal VHD (uses needle depth indicator), 11.5 F
VasoSeal Low Profile
Duett Sealing device2,3
Vasoseal ES and Elite (uses J locator) Duett Pro
Diagnostic Duett Pro (contains less procoagulant)
Intra/extraluminal component
Technical success-deployment
Successful hemostasis
Time to hemostasis
6 to 8 F for 6 F device
Intra and extraluminal component present
92 to 98.5%
84 to 98.5%
4.4 min (1.0 to 18)
4 hours (1.4 to 9)
0.8 to 3.6%
8 to 10 F for 8-F device
(Intraluminal platform for anchorage)
4 to 5 F for low profile
Extraluminal only, with temporary intraluminal component (J locator for ES and Elite)
90 to 100%
87 to 100%
7.2 min (4.8 to 13)
6.3 hours (2.3 to 9)
1.2 to 13%
Extraluminal only, with temporary intraluminal balloon
92.6%
93 to 100%
5.9 min (4.0 to 7.5)
3.8 hours (2.3 to 6.4)
2.5 to 3.4%
Sheath size
Time to ambulation
Major complications
One size fitting 5 F-8 F
One size fits 5 to 9 F
35
FIG 1. Deployment of Angio-Seal (images provided courtesy of St. Jude Medical). (A) The Angio-Seal sheath is placed within the vessel via the existing guide wire. It is advanced until blood flows out through the exit hole in the dilator as shown. It is then withdrawn until blood flow ceases and is advanced until the blood flow restarts. (B) Locator and guide wire are removed. The Angio-Seal is inserted fully into the sheath with two arrows on the sheath and device assembly meeting. The anchor will then be released beyond the sheath tip. The barrel of the device is retracted with a double “click,” and the whole assembly is then withdrawn. The anchor will be fixed against the inside of the vessel by gentle traction. A tamper becomes visible on the suture as the sheath is removed. (C) Once fully visible, the tamper is advanced forward to tie a knot over the collagen plug, which becomes compressed against the puncture site. The suture is then cut above the tamper and the tamper is removed. Finally, the suture is cut close to skin. (Color version of figure is available online.)
FIG 3. On-Site device (images provided courtesy of Datascope Corp.). (Color version of figure is available online.)
prospective trial.9 Successful deployment and complication rates were similar. Angio-Seal, however, was found to be slower in achieving hemostasis compared with its counterparts, yet resulted in earlier ambulation (in the diagnostic angio arm) (P ⫽ 0.0001). Another prospective randomized study compared Angio-Seal with VasoSeal in diagnostic and interventional procedures and showed no statistical difference in terms of hemostasis, ambulation, complications, and device failure.10
Suture-Based Vascular Devices
FIG 2. Deployment of VasoSeal Elite (images provided courtesy of Datascope Corp.). (A) The arteriotomy locator is inserted through an introducer into the sheath. With occlusive pressure above the arteriotomy, the sheath is removed, and the locator is retracted until the J-segment is deployed. The entire segment is retracted until resistance is felt. The white tissue dilator is advanced, followed by the blue sheath dilator, until a marker indicates the tip is at the arteriotomy site. (B) Locator and tissue dilator are removed, leaving only the outer sheath. The collagen cartridge is inserted into the sheath and the plunger is advanced initially; then the sheath is retracted to fully deploy the collagen plug. The sheath is removed, and pressure is applied to the skin until hemostasis is achieved. (Color version of figure is available online.)
cascade. Unlike the other collagen-based vascular devices, there is no contraindication to repuncture. The major potential complication of this device is that of accidental injection of the procoagulant mixture into the artery.8 The safety and efficacy of Angio-Seal, VasoSeal ES, and Duett have been compared against each other in a
36
Suture-based vascular devices deploy a pair of needles accurately at the arteriotomy hole to enable a suture to be placed and tied. The knot is usually tied with a knot tier but can also be tied manually. Arterial closure is usually instantaneous, and repuncture can be performed immediately if necessary. Current examples include Perclose (Abbott Vascular, Abbott Labs, IL), X-Site (Datascope), and SuperStitch (Sutura, Fountain Valley, CA). Table 3 represents a brief summary of the suture-based devices.
Perclose Perclose was one of the earliest available suturemediated closure devices with two different versions, depending on the number of deployed sutures. The single suture version can close 6- to 8-F arteriotomies. The bi-suture devices are intended for use for larger arteriotomies (⬎8 F ⫹ punctures), although many people simply place two single suture devices at 90° to each other, using a “preclose” technique, whereby the devices are placed at the outset of the interventional procedure before dilation of the arteriotomy above that recommended for these single suture device. Recent
Curr Probl Diagn Radiol, January/February 2009
changes to this device include the introduction of a pretied knot, to ease the knot tying step, and the usage of monofilament sutures, which has been noted to cause less inflammatory reaction. Fig 5 shows the deployment of Perclose A-T.
X-Site The X-Site (Fig 6) is a relatively recently developed suture-based device. It consists of an over-the-wire device, a suture attached to two needles, and a knot pusher/cutter. Unlike the Perclose, this system has no intraluminal component. Deployment involves sequential throw of the first needle, then a 180° twist, followed by the throw of the second needle. The knot is then tied manually or by using a knot tier. The current commercially available version can only be used to close arteriotomies up to 6 F.
SuperStitch SuperStitch uses nonabsorbable surgical sutures (monofilament polypropylene) to close the arteriotomy hole (Fig 7). It fits a conventional access sheath and is advanced without wire guidance. The design of the tip allows the use in antegrade procedures. Three buttons on the body of the device are depressed in a sequential fashion to deploy the sutures. Fig 8 demonstrates the deployment of SuperStitch. There is a paucity of data comparing the different types of suture-based devices against each other. Most of the trials compare the Perclose with either AngioSeal or VasoSeal. One prospective study compared Angio-Seal with Closer S (earlier version of Perclose)15 and showed no significant difference between major and minor complications but found a shorter learning curve with the use of Angio Seal devices.
Staples and Clips The Angiolink EVS Vascular Closure System (Medtronic) and StarClose (Abbott Vascular) are ex-
FIG 4. Deployment of Duett Pro (images provided courtesy of Vascular Solutions Inc.). (A) The 3-F catheter is advanced through the working sheath. (B) The balloon is inflated with a syringe. (C) The balloon is retracted until it engages the arterial wall at the puncture site. (D) Procoagulant mixture is then delivered through the sheath side arm directly to the puncture site and continued as the sheath is retracted. The entire tissue tract is filled. (E) The balloon is deflated, and the catheter and sheath are removed. The skin is compressed for 2 to 5 minutes. (Color version of figure is available online.)
Curr Probl Diagn Radiol, January/February 2009
37
2.2 to 4.1 hours 9 to 10 min 79 to 92% 92% 6 to 8 F (12 F not yet licensed) SuperStitch14
Intraluminal stitches
92% 6F X-Site12,13
Intraluminal stitches
94%
0.7%
0.5 to 6.1% 4.3 hours (1.8 to 7.1) 13.4 min (6.0 to 20) 85.7 to 99% 89 to 100% Perclose A-T (Auto Tie) Perclose Proglide (monofilament) Prostar XL (currently not marketed in the UK) for larger sheaths, 8 to 10 F Perclose2,3,11
5 to 10 F
Intraluminal stitches. Has temporary footplate to engage the vessel
0.4%
Major complications Time to ambulation Time to hemostasis Successful hemostasis Technical success-deployment Intra/extraluminal component Sheath size Variations/evolvement Device
TABLE 3. Suture-based devices 38
FIG 5. Deployment of Perclose (images provided courtesy of Abbott Vascular). The sheath is removed and exchanged with the Perclose device over a guide wire. When the device is within the vessel to an adequate depth, arterial blood returns from the marker lumen (arrow). Raising the lever deploys the footplate, which is then retracted to the vessel wall. The plunger is depressed, sending two needles from the sheath through the artery wall to the footplate. The needles engage the suture, and the plunger is withdrawn, which draws the suture out through the proximal part of the device. The lever is lowered so the device can be partially withdrawn and the suture/knot combination can be pulled free. The device is removed and the slip part of the knot (green in color) is pulled to advance the knot to the arteriotomy, aided with a knot pusher. The knot is then pulled tight to secure the arteriotomy. (Color version of figure is available online.)
amples of metal-based extraluminal devices that remain in situ post deployment (Table 4). Both of these devices use the surgical concept of “purse-string closure.”
EVS Vascular Closure System and StarClose The EVS Vascular Closure System delivers a titanium staple that is designed so that it should not penetrate all three layers of the vessel, making it extraluminal. Before deployment of the staple, vessel stabilizers pull the arteriotomy hole into a linear configuration (Fig 9). The StarClose device applies a nitinol clip to the arteriotomy hole once position is confirmed (Fig 10). The inert properties of titanium and nitinol induces less biologic response in comparison to collagen based devices. These devices have only been commercially available relatively recently and reports of their use have mainly been in comparison to manual compression.16-19 The results show a significant reduction in time to hemostasis and ambulation (Table 4). A recent study20 demonstrated similar efficacy and safety of StarClose in comparison to AngioSeal and manual compression. However, there were significantly more patients with StarClose who required additional compression post-successful deployment.
Curr Probl Diagn Radiol, January/February 2009
Novel Devices Collagen- and suture-based closure devices have been the mainstay of the approach to arterial closure to date. Some of the newer devices in the market continue to use these basic concepts but clips and staples have also been incorporated into newer techniques to establish vascular hemostasis. Other more recently developed devices have used a nitinol-based mesh disc and ultrasound-based thermal coagulation to achieve vascular closure. The Boomerang Closure Device System (Cardiva Medical) utilizes a 18-G wire with a temporary nitinol braided mesh disc to achieve hemostasis. It creates a site-specific compression between the arteriotomy and tissue tract, resulting in targeted internal compression (Fig 11). The device is then completely removed, leaving nothing intra- or extraluminal. Five to 7 minutes of occlusive finger pressure is applied to close the remaining needle puncture site. It is applicable to 4- to 10-F arteriotomies. Preliminary data quote hemostasis rates to be 99%, with no major complications and an ambulation time of 82 minutes,21 although clearly the need for some manual compression is a relative disadvantage. The SoundSeal hemostasis system uses focused ultrasound for thermal coagulation to seal the access site. The device does not enter the subcutaneous tract and no implantable foreign material is used. It is also said to be independent of the patient’s coagulation status and puncture size. This product is yet to be launched commercially.
Complications Complications related to vascular closure devices are generally similar to those observed with the use of
FIG 6. Deployment of X-Site (images provided courtesy of Datascope Corp.). (A) The device is advanced over a guide wire until the notched part of the device reaches the artery, indicated by back bleeding through the side port of the sheath. (B) The needle pusher is advanced to deploy the first needle. (C) The needle pusher is fully retracted until an audible click is heard, indicating that second needle is in position. The device is rotated 180° and the needle pusher is advanced again to deploy the second needle. (D) X-Site is withdrawn 1 inch above skin level to retrieve needles. Holding both needles in one hand, the index finger of other hand is used to gently tug at the suture loop. (E) The knot is tied manually or by using X-Site knot tier. (Color version of figure is available online.)
Curr Probl Diagn Radiol, January/February 2009
39
FIG 7. SuperStitch Device (images provided courtesy of Sutura Inc.). (A) SuperStitch device. (B) Tip of device. (C) Kwiknot. (Color version of figure is available online.)
FIG 8. Deployment of SuperStitch Device (images provided courtesy of Sutura Inc.). (A) The device is advanced through an existing sheath. The first button is depressed. (B) This opens out the “arms.” (C) The device is retracted against the vessel wall. (D) Button number 2 is depressed, which deploys the needles. (E) Button number 3 closes the “arms.” The needles retract and draw the sutures out of the vessel. (F) The knot can be tied manually or by using the Kwiknot device. The Kwiknot ties and cuts the suture close to the vessel wall. (Color version of figure is available online.)
TABLE 4. Staple and clip devices Device
Sheath size
Angiolink 6 to 8 F EVS16,17 StarClose18,19 6 F
Intra/extraluminal Technical component success-deployment
Time to hemostasis 3.3 to 5.5 min
Time to ambulation 2.4 to 3.4 hours
Major complications
Extraluminal
96.4%
92.1%
Extraluminal
86.8 to 94.1%
98.9 to 100% 1.46 min (⫾4.5) 2.7 hours (⫾1.8) No major complications observed in diagnostics 1.1% observed in interventional procedures
mechanical compression. If a closure device fails to deploy, then an understanding of the specific device should enable successful placement of another device, or at least control to avoid the development of significant complications. It may be necessary for a patient to undergo surgical exploration, often for delayed failure or complication, and it is important for the surgeon to have an understanding of the device used, particularly if there may be intraluminal components of the device.
40
Successful hemostasis
0.4%
In general, there are three main complications which can occur, listed as follows.
Hemorrhage ●
Bleeding or hematoma requiring blood transfusion ● Pseudoaneurysms, the most frequent access-siterelated complication ● Arteriovenous fistulas Curr Probl Diagn Radiol, January/February 2009
FIG 10. Deployment of Starclose (images provided courtesy of Abbott Vascular). (A) The StarClose device is inserted into the sheath. The vessel locator button is depressed. The device slides out until resistance is felt. (B) The advancement of the thumb advancer completes the splitting of the sheath. The device is raised to an angle of slightly less than 90°. (C) The clip is deployed. (D) The device is retracted. (Color version of figure is available online.)
Vascular Occlusion ● ●
Local vascular thrombosis Distal embolic events
Collagen-based closure devices are associated with a 0.2 to 1.6% distal embolization rate, usually of the plug or anchor.2 This is less common with suturebased devices. Distal embolization may result in significant compromise to the distal vessel and may necessitate urgent surgical exploration/thrombectomy.
Infection Infection is more common in devices in which foreign material is left at the access site. Severe peri-arterial infection and endarteritis have been re-
FIG 9. Deployment of Angiolink EVS (images provided courtesy of Medtronic). (A) A guide wire is reinserted through the existing procedure sheath. The sheath is then removed. The introducer is advanced over the guide wire until arterial entry is indicated by back bleeding. (B) The transition sheath is retracted. (C) The dilator is advanced to release the vessel stabilizers. (D) These stabilizers retract to form T-anchors within the artery and change the round arterial puncture site into an elliptical opening. The dilator is then removed. (E) The preloaded staple is advanced into the introducer until it reaches the level of the stabilized anterior vessel wall. This is confirmed by an audible “click.” A squeeze of the trigger deploys the staple and this simultaneously straightens the stabilizers, which are then removed. (Color version of figure is available online.)
Curr Probl Diagn Radiol, January/February 2009
41
as such, are cost-minimization studies and do not take into account the costs incurred when complications occur.2,25 Minor complications such as bleeding and hematoma formation are more common than major complications. This most commonly results in increased in hospital stay associated with blood transfusion and evaluation with ultrasound.26 It is the relatively high cost of minor complications that drives the net cost-saving analysis. The newer generation devices have more or less similar complication rates, if not lower, compared with manual compression. This factor, in addition to early ambulation, makes VCDs a more cost-effective option.26,27
FIG 11. Deployment of Boomerang (images provided courtesy of Cardiva Medical). (A) The wire is inserted through an existing sheath. (B) The tip is deployed and opens into a conformable disc. (C) The sheath is removed; this tamponades the arteriotomy. (D) The device is removed, and light manual compression is applied until hemostasis is achieved. (Color version of figure is available online.)
ported following the use of closure devices.22 It has been suggested that resterilization of the arteriotomy site and irrigation with antibiotics may reduce the risk on infection.2 Subgroup meta-analysis on the safety of these devices reveals an increase in complications rates for hematoma and pseudoaneurysm compared with manual compression.23,24 VCD designs are rapidly evolving and the effectiveness of recently introduced devices are yet to be analyzed comprehensively. Metaanalysis findings continue to be flawed by heterogeneous patient groups and lack the inclusion of physicians’ learning curves, the absence of good quality randomized controlled trials, and the inclusion of early forms of VCDs. An accurate analysis of the complication rates between different closure devices is not yet possible, although it does not seem that there are significant differences between any of these devices.
Costs Early ambulation should allow same day discharge with reduction in physician and nursing time. Inclusion of the cost of physician time in performing the compression reduces the cost difference between the VCD and manual compression significantly. However, the calculations usually assume similar efficacy and,
42
Conclusion Establishing guidelines for the use of vascular closure devices is not straightforward. The decision to use a vascular closure device depends on the risk– benefit ratio, which the operator determines for each procedure. Vascular closure devices have been demonstrated to reduce time to hemostasis, facilitate ambulation, and potentially decrease the length of hospital stay. Data on cost-effectiveness favor the use of closure devices in the day case setting. However, the cost– effectiveness has not been proven for patients who are not candidates for early discharge. The incidences of infections and embolic complications remain a concern. However, emerging newer techniques continue to reduce the risks of devicerelated complications. The choice of a device would depend on the availability of that particular device, operator preference, anticipation of repeat arterial access, and size of the arteriotomy hole. Newer techniques may reduce the risks of complications by eliminating foreign material at the closure site, although whether it will be feasible or desirable to aim for the use of vascular closure devices routinely for all diagnostic and interventional vascular procedures is debatable.
REFERENCES 1. Abbott WM, Austen WG. The effectiveness and mechanism of collagen-induced topical hemostasis. Surgery 1975;78: 723-9. 2. Hoffer EK, Bloch RD. Percutaneous arterial closure devices. JVIR 2003;14:865-86. 3. Katz SG, Abando A. The use of closure devices. Surg Clin North Am 2004;84:1267-80.
Curr Probl Diagn Radiol, January/February 2009
4. Hatfield MK, Zaleski GX, Kozlov D, et al. Angio-seal device used for hemostasis in the descending aorta. AJR 2004;183: 612-4. 5. Blanc R, Mounayer C, Piotin M, et al. Hemostatic closure device after carotid puncture for stent and coil placement in an intracranial aneurysm: technical note. AJNR Am J Neuroradiol 2002;23:978-81. 6. Micha JP, Goldstein BH, Lindsay SF, et al. Subclavian artery puncture repair with Angio-Seal deployment. Gynecol Oncol 2007;104:761-3. 7. On-Site Precision Closure device, instructions for use. 8. Mooney MR, Ellis SG, Gershony G, et al. Immediate sealing of arterial puncture sites after cardiac catheterization and coronary interventions: initial U.S. feasibility trial using the Duett vascular closure device. Catheter Cardiovasc Interv 2000;50:96-102. 9. Michalis LK, Rees MR, Patsouras D, et al. A prospective randomised controlled trial comparing the safety, efficacy of 3 commercially available closure device (Angio-seal, Vasosea and Duett). Cadiovasc Intervent Radiol 2002;25:423-9. 10. Shammas NW, Rajendran VR, Alldredge SG, et al. Randomized comparison of Vasoseal and Angio-Seal closure devices in patients undergoing coronary angiography and angioplasty. Catheter Cardiovasc Interv 2002;55:421-5. 11. Haas PC, Krajcer Z, Diethrich EB. Closure of large percutaneous access sites using the Prostar XL percutaneous vascular surgery device. J Endovasc Surg 1999;6:168-70. 12. Sanborn TA, Ogilby JD, Ritter JM, et al. Reduced vascular complications after percutaneous coronary interventions with a non mechanical suture device: Results from the randomized RACE study. Catheter Cardiovasc Interv 2004;61:327-32. 13. Mehta H, Fleisch M, Chatterjee T, et al. Novel femoral artery puncture closure device in patients undergoing interventional and diagnostic cardiac procedures. Invasive Cardiol 2002;14: 9-12. 14. Eggebrecht H, Naber C, Woertgen U, et al. Percutaneous suture-mediated closure of femoral access sites deployed through procedure sheath: initial clinical experience with a novel vascular closure device. Catheter Cardiovasc Interv 2003;58:313-21. 15. Park Y, Roh HG, Choo SW, et al. Prospective comparison of collagen plug (Angio-Seal) and suture mediated (Closer S) closure devices at femoral access sites. Korean J Radiol 2005;6:248-55.
Curr Probl Diagn Radiol, January/February 2009
16. Caputo RP, Ebner A, Grant W, et al. Percutaneous femoral arteriotomy repair: initial experience with a novel staple closure device. J Invasive Cardiol 2002;14:652-6. 17. Ansel G, Yakubov S, Nielson C, et al. Safety and efficacy of staple mediated femoral arteriotomy closure: Results from a randomised multicentre study. Catheter Cardiovasc Interv 2006;67:545-53. 18. Hermiller J, Simonton C, Hinohara T, et al. Clinical experience with a circumferential clip based vascular closure device in diagnostic catheterisation. J Invasive Cardiol 2005;17:50410. 19. Hermiller J, Simonton C, Hinohara T, et al. The Starclose vascular closure system. Catheter Cardiovasc Interv 2006;68: 677-83. 20. Ratnam LA, Raja J, Munneke GJ, et al. Prospective nonrandomized trial of manual compression and AngioSeal and StarClose. Cardiovasc Intervent Radiol 2007;30:182-8. 21. Doyle BJ, Godfrey MJ, Lennon RJ, et al. Initial experience with Cardiva Boomerang Vascular Closure Device in diagnostic catheterization. Catheter Cardiovasc Interv 2007;16: 203-8. 22. Lasic Z, Nikolsky E, Kesanakurthy S, et al. Vascular closure devices: A review of their use after invasive procedures. Am J Cardiovasc Drugs 2005;5:185-200. 23. Koreny M, Riedmuller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: Systematic review and meta-analysis. JAMA 2004;291:350-7. 24. Nikolsky E, Mehran R, Halkin A, et al. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: A meta-analysis. J Am Coll Cardiol 2004;44:1200-9. 25. Brown DB. Current status of suture mediated closure: What is the cost of comfort? JVIR 2003;14:677-81. 26. Resnic FS, Arora N, Matheny M, et al. A cost-minimization analysis of the angio-seal vascular closure device following percutaneous coronary intervention. Am J Cardiol 2007;99: 766-70. 27. Geyik S, Yavuz K, Akgoz A, et al. The safety and efficacy of the Angio-Seal closure device in diagnostic and interventional neuroangiography setting: a single-center experience with 1,443 closures. Neuroradiology 2007;49:739-46.
43
The use of closure devices is widespread and becoming more common. Radiologists performing arterial access procedures should be aware of when and how to use them, as well as the advantages and disadvantages of various devices, and any complications that may occur. This review intends to provide an overview of these devices, focusing on how they work, their efficacy in achieving hemostasis, any risks associated with their use, and our view as to which should be used for particular indications. There are three main categories of vascular closure devices: collagen based, suture based, and staples and clips. Newer generation devices use the same technique of closure and there are some that utilize newer techniques. Vascular closure devices have been demonstrated to reduce time to hemostasis, facilitate ambulation, and potentially decrease length of stay. The choice of a device would depend on the availability of that particular device, operator preference, anticipation of repeat arterial access, and size of the arteriotomy hole.
As the number of cardiovascular and radiological interventional procedures increase, there is a drive to develop more efficient techniques and user-friendly tools, which address the increasing time constraints and issues of patient satisfaction. One of the issues for From the aRoyal Hallamshire Hospital, Sheffield, United Kingdom; bJohn Radcliffe Hospital, Oxford, United Kingdom; cSheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom; and dStoke Mandeville Hospital, Buckinghamshire, United Kingdom. Reprint requests: Lye-Quen Hon, MB BCh, MRCP (UK), FRCR, C Floor Radiology Department, Royal Hallamshire Hospital, Sheffield S10 2 JF, United Kingdom. E-mail: [email protected]. Curr Probl Diagn Radiol 2009;38:33-43. © 2009 Mosby, Inc. All rights reserved. 0363-0188/2009/$34.00 ⫹ 0 doi:10.1067/j.cpradiol.2008.02.002
Curr Probl Diagn Radiol, January/February 2009
vascular interventional procedures has been the laborintensive and time-consuming process of achieving hemostasis. Traditionally, hemostasis is accomplished by manual compression. Manual compression, introduced in conjunction with the Seldinger technique in the 1950s, is generally safe and has been the standard method to achieve hemostasis for nearly 50 years. This requires 10 to 20 minutes of sustained pressure over the puncture site followed by bed rest for a period of 4 to 6 hours. Prolonged immobilization results in increased patient discomfort and noncompliance of bed rest after manual hemostasis can lead to increased complications. This is now being challenged by the introduction of various aids to achieve hemostasis. This article gives a comparative overview of the methods available as an alternative to manual compression to achieve hemostasis after arterial puncture.
Vascular Closure Devices Adjuncts to manual compression include mechanical clamp devices and hemostatic pads. Mechanical clamp devices apply direct pressure onto the puncture site. The major disadvantages of these pressure devices are the lack of direct supervision over the groin site and the need for careful placement superficially over the arteriotomy hole. Topical hemostatic pads contain procoagulants, which promote clot formation; however, these pads still require a degree of manual compression. There are no randomized controlled trials comparing the efficacy of these pads or mechanical clamps to manual compression. In general, these
33
TABLE 1. Types of vascular closure devices Collagen/thrombin based products Intra/extraluminal Angio-Seal (St. Jude Medical) Extraluminal ● VasoSeal (Datascope) ● On-Site (Datascope) ● Duett Pro (Vascular Solutions) ●
Suture-based products Intraluminal stitches ● Perclose (Abbott Vascular) ● X-Site (Datascope) ● SuperStitch (Sutura Inc.)
are unsatisfactory alternatives to the standard method of manual compression and will not be discussed further. During the last decade, technological advancements have introduced novel ways of closing the arteriotomy holes using a variety of devices specifically designed to achieve closure of the arteriotomy. An ideal vascular closure device (VCD) should provide effective and rapid hemostasis, is simple to use, and produces complication rates that are lower or at least comparable to manual compression. The calculated overall cost effectiveness should also be favorable. In broad terms, these vascular closure devices are divided according to their mechanism of gaining hemostasis. There are three basic types: suture based, collagen based, and staples and clips (Table 1). These can be further subdivided into either extra- or intraluminal devices, depending on the position of the deployed hemostatic closure components.
Collagen-Based Vascular Devices Collagen-based vascular devices are bovine collagenbased products that augment clot formation. The device promotes the process of hemostasis in the two following ways: first, it increases the availability of collagen at the arterial wall defect, promoting platelet adherence, aggregation, and activation; second, the swelling of the collagen mass that occurs after deployment mechanically seals the vessel and tissue tract.1 There are several examples that exist in the market, mainly, Angio-Seal (St. Jude Medical, St. Paul, MN), VasoSeal (Datascope, Montvale, NJ), and Duett (Vascular Solutions, Minneapolis, MN). In general, these are used in patients who are unlikely to require immediate re-access. Once deployed, it may be difficult to re-access close to the site of previous puncture. Repeat puncture within 3 months is generally not recommended, as time is needed for resorption and degradation of the collagen.2 These devices are therefore
34
Staples and clips Extraluminal ● EVS Vascular Closure System (Medtronic) ● StarClose (Abbott Vascular)
Others No intra/extraluminal components ● Boomerang (Cardiva Medical) ● SoundSeal (Therus/ Boston Scientific)
generally only employed in patients in whom re-access should not be required. Table 2 lists a comparison between the different types of collagen-based devices.
Angio-Seal Angio-Seal is an established collagen-based vascular closure device. The tip consists of a rectangular 1 ⫻ 2 ⫻ 10 mm anchor, attached to a bovine sponge collagen plug by an absorbable suture. The anchor remains intraluminal post deployment (Fig 1). This is a popular collagen-based closure device that has also been used in radial and subclavian arterial puncture sites as well as the venous punctures sites.4-6
VasoSeal VasoSeal is a purified collagen-based plug device. There are several versions of VasoSeal including the VasoSeal Elite and ES. Fig 2 demonstrates the deployment of VasoSeal Elite. VasoSeal Elite and ES use a temporary J-shaped locator segment. The main difference from Angio-Seal is that the VasoSeal devices do not possess any intraluminal components. The collagen plug is deposited outside the arterial wall along the puncture tract. The VasoSeal basic design has been used in the working of On-Site (Datascope), another collagen-based product that uses a temporary nitinol mesh disc as a locator (Fig 3). Results observed during the original VasoSeal ES studies have been applied to this device. At this time, there are no formal trials for the device.7
Duett Pro Sealing Device The Duett vascular device uses extraluminal collagen-based vascular closure components. The device consists of a 7-mm balloon mounted on a 3-F catheter (Fig 4). A mixture of thrombin and bovine collagen is injected into the subcutaneous tract. Conversion of fibrinogen into fibrin by the action of thrombin in the presence of collagen results in accelerated coagulation
Curr Probl Diagn Radiol, January/February 2009
Curr Probl Diagn Radiol, January/February 2009
TABLE 2. Collagen-based devices Device Angio-Seal2,3
VasoSeal2,3
Variations/evolvement Angio-Seal STS (selftightening suture) platform Angioseal V-Twist VIP (provides larger coverage with twisting action) VasoSeal VHD (uses needle depth indicator), 11.5 F
VasoSeal Low Profile
Duett Sealing device2,3
Vasoseal ES and Elite (uses J locator) Duett Pro
Diagnostic Duett Pro (contains less procoagulant)
Intra/extraluminal component
Technical success-deployment
Successful hemostasis
Time to hemostasis
6 to 8 F for 6 F device
Intra and extraluminal component present
92 to 98.5%
84 to 98.5%
4.4 min (1.0 to 18)
4 hours (1.4 to 9)
0.8 to 3.6%
8 to 10 F for 8-F device
(Intraluminal platform for anchorage)
4 to 5 F for low profile
Extraluminal only, with temporary intraluminal component (J locator for ES and Elite)
90 to 100%
87 to 100%
7.2 min (4.8 to 13)
6.3 hours (2.3 to 9)
1.2 to 13%
Extraluminal only, with temporary intraluminal balloon
92.6%
93 to 100%
5.9 min (4.0 to 7.5)
3.8 hours (2.3 to 6.4)
2.5 to 3.4%
Sheath size
Time to ambulation
Major complications
One size fitting 5 F-8 F
One size fits 5 to 9 F
35
FIG 1. Deployment of Angio-Seal (images provided courtesy of St. Jude Medical). (A) The Angio-Seal sheath is placed within the vessel via the existing guide wire. It is advanced until blood flows out through the exit hole in the dilator as shown. It is then withdrawn until blood flow ceases and is advanced until the blood flow restarts. (B) Locator and guide wire are removed. The Angio-Seal is inserted fully into the sheath with two arrows on the sheath and device assembly meeting. The anchor will then be released beyond the sheath tip. The barrel of the device is retracted with a double “click,” and the whole assembly is then withdrawn. The anchor will be fixed against the inside of the vessel by gentle traction. A tamper becomes visible on the suture as the sheath is removed. (C) Once fully visible, the tamper is advanced forward to tie a knot over the collagen plug, which becomes compressed against the puncture site. The suture is then cut above the tamper and the tamper is removed. Finally, the suture is cut close to skin. (Color version of figure is available online.)
FIG 3. On-Site device (images provided courtesy of Datascope Corp.). (Color version of figure is available online.)
prospective trial.9 Successful deployment and complication rates were similar. Angio-Seal, however, was found to be slower in achieving hemostasis compared with its counterparts, yet resulted in earlier ambulation (in the diagnostic angio arm) (P ⫽ 0.0001). Another prospective randomized study compared Angio-Seal with VasoSeal in diagnostic and interventional procedures and showed no statistical difference in terms of hemostasis, ambulation, complications, and device failure.10
Suture-Based Vascular Devices
FIG 2. Deployment of VasoSeal Elite (images provided courtesy of Datascope Corp.). (A) The arteriotomy locator is inserted through an introducer into the sheath. With occlusive pressure above the arteriotomy, the sheath is removed, and the locator is retracted until the J-segment is deployed. The entire segment is retracted until resistance is felt. The white tissue dilator is advanced, followed by the blue sheath dilator, until a marker indicates the tip is at the arteriotomy site. (B) Locator and tissue dilator are removed, leaving only the outer sheath. The collagen cartridge is inserted into the sheath and the plunger is advanced initially; then the sheath is retracted to fully deploy the collagen plug. The sheath is removed, and pressure is applied to the skin until hemostasis is achieved. (Color version of figure is available online.)
cascade. Unlike the other collagen-based vascular devices, there is no contraindication to repuncture. The major potential complication of this device is that of accidental injection of the procoagulant mixture into the artery.8 The safety and efficacy of Angio-Seal, VasoSeal ES, and Duett have been compared against each other in a
36
Suture-based vascular devices deploy a pair of needles accurately at the arteriotomy hole to enable a suture to be placed and tied. The knot is usually tied with a knot tier but can also be tied manually. Arterial closure is usually instantaneous, and repuncture can be performed immediately if necessary. Current examples include Perclose (Abbott Vascular, Abbott Labs, IL), X-Site (Datascope), and SuperStitch (Sutura, Fountain Valley, CA). Table 3 represents a brief summary of the suture-based devices.
Perclose Perclose was one of the earliest available suturemediated closure devices with two different versions, depending on the number of deployed sutures. The single suture version can close 6- to 8-F arteriotomies. The bi-suture devices are intended for use for larger arteriotomies (⬎8 F ⫹ punctures), although many people simply place two single suture devices at 90° to each other, using a “preclose” technique, whereby the devices are placed at the outset of the interventional procedure before dilation of the arteriotomy above that recommended for these single suture device. Recent
Curr Probl Diagn Radiol, January/February 2009
changes to this device include the introduction of a pretied knot, to ease the knot tying step, and the usage of monofilament sutures, which has been noted to cause less inflammatory reaction. Fig 5 shows the deployment of Perclose A-T.
X-Site The X-Site (Fig 6) is a relatively recently developed suture-based device. It consists of an over-the-wire device, a suture attached to two needles, and a knot pusher/cutter. Unlike the Perclose, this system has no intraluminal component. Deployment involves sequential throw of the first needle, then a 180° twist, followed by the throw of the second needle. The knot is then tied manually or by using a knot tier. The current commercially available version can only be used to close arteriotomies up to 6 F.
SuperStitch SuperStitch uses nonabsorbable surgical sutures (monofilament polypropylene) to close the arteriotomy hole (Fig 7). It fits a conventional access sheath and is advanced without wire guidance. The design of the tip allows the use in antegrade procedures. Three buttons on the body of the device are depressed in a sequential fashion to deploy the sutures. Fig 8 demonstrates the deployment of SuperStitch. There is a paucity of data comparing the different types of suture-based devices against each other. Most of the trials compare the Perclose with either AngioSeal or VasoSeal. One prospective study compared Angio-Seal with Closer S (earlier version of Perclose)15 and showed no significant difference between major and minor complications but found a shorter learning curve with the use of Angio Seal devices.
Staples and Clips The Angiolink EVS Vascular Closure System (Medtronic) and StarClose (Abbott Vascular) are ex-
FIG 4. Deployment of Duett Pro (images provided courtesy of Vascular Solutions Inc.). (A) The 3-F catheter is advanced through the working sheath. (B) The balloon is inflated with a syringe. (C) The balloon is retracted until it engages the arterial wall at the puncture site. (D) Procoagulant mixture is then delivered through the sheath side arm directly to the puncture site and continued as the sheath is retracted. The entire tissue tract is filled. (E) The balloon is deflated, and the catheter and sheath are removed. The skin is compressed for 2 to 5 minutes. (Color version of figure is available online.)
Curr Probl Diagn Radiol, January/February 2009
37
2.2 to 4.1 hours 9 to 10 min 79 to 92% 92% 6 to 8 F (12 F not yet licensed) SuperStitch14
Intraluminal stitches
92% 6F X-Site12,13
Intraluminal stitches
94%
0.7%
0.5 to 6.1% 4.3 hours (1.8 to 7.1) 13.4 min (6.0 to 20) 85.7 to 99% 89 to 100% Perclose A-T (Auto Tie) Perclose Proglide (monofilament) Prostar XL (currently not marketed in the UK) for larger sheaths, 8 to 10 F Perclose2,3,11
5 to 10 F
Intraluminal stitches. Has temporary footplate to engage the vessel
0.4%
Major complications Time to ambulation Time to hemostasis Successful hemostasis Technical success-deployment Intra/extraluminal component Sheath size Variations/evolvement Device
TABLE 3. Suture-based devices 38
FIG 5. Deployment of Perclose (images provided courtesy of Abbott Vascular). The sheath is removed and exchanged with the Perclose device over a guide wire. When the device is within the vessel to an adequate depth, arterial blood returns from the marker lumen (arrow). Raising the lever deploys the footplate, which is then retracted to the vessel wall. The plunger is depressed, sending two needles from the sheath through the artery wall to the footplate. The needles engage the suture, and the plunger is withdrawn, which draws the suture out through the proximal part of the device. The lever is lowered so the device can be partially withdrawn and the suture/knot combination can be pulled free. The device is removed and the slip part of the knot (green in color) is pulled to advance the knot to the arteriotomy, aided with a knot pusher. The knot is then pulled tight to secure the arteriotomy. (Color version of figure is available online.)
amples of metal-based extraluminal devices that remain in situ post deployment (Table 4). Both of these devices use the surgical concept of “purse-string closure.”
EVS Vascular Closure System and StarClose The EVS Vascular Closure System delivers a titanium staple that is designed so that it should not penetrate all three layers of the vessel, making it extraluminal. Before deployment of the staple, vessel stabilizers pull the arteriotomy hole into a linear configuration (Fig 9). The StarClose device applies a nitinol clip to the arteriotomy hole once position is confirmed (Fig 10). The inert properties of titanium and nitinol induces less biologic response in comparison to collagen based devices. These devices have only been commercially available relatively recently and reports of their use have mainly been in comparison to manual compression.16-19 The results show a significant reduction in time to hemostasis and ambulation (Table 4). A recent study20 demonstrated similar efficacy and safety of StarClose in comparison to AngioSeal and manual compression. However, there were significantly more patients with StarClose who required additional compression post-successful deployment.
Curr Probl Diagn Radiol, January/February 2009
Novel Devices Collagen- and suture-based closure devices have been the mainstay of the approach to arterial closure to date. Some of the newer devices in the market continue to use these basic concepts but clips and staples have also been incorporated into newer techniques to establish vascular hemostasis. Other more recently developed devices have used a nitinol-based mesh disc and ultrasound-based thermal coagulation to achieve vascular closure. The Boomerang Closure Device System (Cardiva Medical) utilizes a 18-G wire with a temporary nitinol braided mesh disc to achieve hemostasis. It creates a site-specific compression between the arteriotomy and tissue tract, resulting in targeted internal compression (Fig 11). The device is then completely removed, leaving nothing intra- or extraluminal. Five to 7 minutes of occlusive finger pressure is applied to close the remaining needle puncture site. It is applicable to 4- to 10-F arteriotomies. Preliminary data quote hemostasis rates to be 99%, with no major complications and an ambulation time of 82 minutes,21 although clearly the need for some manual compression is a relative disadvantage. The SoundSeal hemostasis system uses focused ultrasound for thermal coagulation to seal the access site. The device does not enter the subcutaneous tract and no implantable foreign material is used. It is also said to be independent of the patient’s coagulation status and puncture size. This product is yet to be launched commercially.
Complications Complications related to vascular closure devices are generally similar to those observed with the use of
FIG 6. Deployment of X-Site (images provided courtesy of Datascope Corp.). (A) The device is advanced over a guide wire until the notched part of the device reaches the artery, indicated by back bleeding through the side port of the sheath. (B) The needle pusher is advanced to deploy the first needle. (C) The needle pusher is fully retracted until an audible click is heard, indicating that second needle is in position. The device is rotated 180° and the needle pusher is advanced again to deploy the second needle. (D) X-Site is withdrawn 1 inch above skin level to retrieve needles. Holding both needles in one hand, the index finger of other hand is used to gently tug at the suture loop. (E) The knot is tied manually or by using X-Site knot tier. (Color version of figure is available online.)
Curr Probl Diagn Radiol, January/February 2009
39
FIG 7. SuperStitch Device (images provided courtesy of Sutura Inc.). (A) SuperStitch device. (B) Tip of device. (C) Kwiknot. (Color version of figure is available online.)
FIG 8. Deployment of SuperStitch Device (images provided courtesy of Sutura Inc.). (A) The device is advanced through an existing sheath. The first button is depressed. (B) This opens out the “arms.” (C) The device is retracted against the vessel wall. (D) Button number 2 is depressed, which deploys the needles. (E) Button number 3 closes the “arms.” The needles retract and draw the sutures out of the vessel. (F) The knot can be tied manually or by using the Kwiknot device. The Kwiknot ties and cuts the suture close to the vessel wall. (Color version of figure is available online.)
TABLE 4. Staple and clip devices Device
Sheath size
Angiolink 6 to 8 F EVS16,17 StarClose18,19 6 F
Intra/extraluminal Technical component success-deployment
Time to hemostasis 3.3 to 5.5 min
Time to ambulation 2.4 to 3.4 hours
Major complications
Extraluminal
96.4%
92.1%
Extraluminal
86.8 to 94.1%
98.9 to 100% 1.46 min (⫾4.5) 2.7 hours (⫾1.8) No major complications observed in diagnostics 1.1% observed in interventional procedures
mechanical compression. If a closure device fails to deploy, then an understanding of the specific device should enable successful placement of another device, or at least control to avoid the development of significant complications. It may be necessary for a patient to undergo surgical exploration, often for delayed failure or complication, and it is important for the surgeon to have an understanding of the device used, particularly if there may be intraluminal components of the device.
40
Successful hemostasis
0.4%
In general, there are three main complications which can occur, listed as follows.
Hemorrhage ●
Bleeding or hematoma requiring blood transfusion ● Pseudoaneurysms, the most frequent access-siterelated complication ● Arteriovenous fistulas Curr Probl Diagn Radiol, January/February 2009
FIG 10. Deployment of Starclose (images provided courtesy of Abbott Vascular). (A) The StarClose device is inserted into the sheath. The vessel locator button is depressed. The device slides out until resistance is felt. (B) The advancement of the thumb advancer completes the splitting of the sheath. The device is raised to an angle of slightly less than 90°. (C) The clip is deployed. (D) The device is retracted. (Color version of figure is available online.)
Vascular Occlusion ● ●
Local vascular thrombosis Distal embolic events
Collagen-based closure devices are associated with a 0.2 to 1.6% distal embolization rate, usually of the plug or anchor.2 This is less common with suturebased devices. Distal embolization may result in significant compromise to the distal vessel and may necessitate urgent surgical exploration/thrombectomy.
Infection Infection is more common in devices in which foreign material is left at the access site. Severe peri-arterial infection and endarteritis have been re-
FIG 9. Deployment of Angiolink EVS (images provided courtesy of Medtronic). (A) A guide wire is reinserted through the existing procedure sheath. The sheath is then removed. The introducer is advanced over the guide wire until arterial entry is indicated by back bleeding. (B) The transition sheath is retracted. (C) The dilator is advanced to release the vessel stabilizers. (D) These stabilizers retract to form T-anchors within the artery and change the round arterial puncture site into an elliptical opening. The dilator is then removed. (E) The preloaded staple is advanced into the introducer until it reaches the level of the stabilized anterior vessel wall. This is confirmed by an audible “click.” A squeeze of the trigger deploys the staple and this simultaneously straightens the stabilizers, which are then removed. (Color version of figure is available online.)
Curr Probl Diagn Radiol, January/February 2009
41
as such, are cost-minimization studies and do not take into account the costs incurred when complications occur.2,25 Minor complications such as bleeding and hematoma formation are more common than major complications. This most commonly results in increased in hospital stay associated with blood transfusion and evaluation with ultrasound.26 It is the relatively high cost of minor complications that drives the net cost-saving analysis. The newer generation devices have more or less similar complication rates, if not lower, compared with manual compression. This factor, in addition to early ambulation, makes VCDs a more cost-effective option.26,27
FIG 11. Deployment of Boomerang (images provided courtesy of Cardiva Medical). (A) The wire is inserted through an existing sheath. (B) The tip is deployed and opens into a conformable disc. (C) The sheath is removed; this tamponades the arteriotomy. (D) The device is removed, and light manual compression is applied until hemostasis is achieved. (Color version of figure is available online.)
ported following the use of closure devices.22 It has been suggested that resterilization of the arteriotomy site and irrigation with antibiotics may reduce the risk on infection.2 Subgroup meta-analysis on the safety of these devices reveals an increase in complications rates for hematoma and pseudoaneurysm compared with manual compression.23,24 VCD designs are rapidly evolving and the effectiveness of recently introduced devices are yet to be analyzed comprehensively. Metaanalysis findings continue to be flawed by heterogeneous patient groups and lack the inclusion of physicians’ learning curves, the absence of good quality randomized controlled trials, and the inclusion of early forms of VCDs. An accurate analysis of the complication rates between different closure devices is not yet possible, although it does not seem that there are significant differences between any of these devices.
Costs Early ambulation should allow same day discharge with reduction in physician and nursing time. Inclusion of the cost of physician time in performing the compression reduces the cost difference between the VCD and manual compression significantly. However, the calculations usually assume similar efficacy and,
42
Conclusion Establishing guidelines for the use of vascular closure devices is not straightforward. The decision to use a vascular closure device depends on the risk– benefit ratio, which the operator determines for each procedure. Vascular closure devices have been demonstrated to reduce time to hemostasis, facilitate ambulation, and potentially decrease the length of hospital stay. Data on cost-effectiveness favor the use of closure devices in the day case setting. However, the cost– effectiveness has not been proven for patients who are not candidates for early discharge. The incidences of infections and embolic complications remain a concern. However, emerging newer techniques continue to reduce the risks of devicerelated complications. The choice of a device would depend on the availability of that particular device, operator preference, anticipation of repeat arterial access, and size of the arteriotomy hole. Newer techniques may reduce the risks of complications by eliminating foreign material at the closure site, although whether it will be feasible or desirable to aim for the use of vascular closure devices routinely for all diagnostic and interventional vascular procedures is debatable.
REFERENCES 1. Abbott WM, Austen WG. The effectiveness and mechanism of collagen-induced topical hemostasis. Surgery 1975;78: 723-9. 2. Hoffer EK, Bloch RD. Percutaneous arterial closure devices. JVIR 2003;14:865-86. 3. Katz SG, Abando A. The use of closure devices. Surg Clin North Am 2004;84:1267-80.
Curr Probl Diagn Radiol, January/February 2009
4. Hatfield MK, Zaleski GX, Kozlov D, et al. Angio-seal device used for hemostasis in the descending aorta. AJR 2004;183: 612-4. 5. Blanc R, Mounayer C, Piotin M, et al. Hemostatic closure device after carotid puncture for stent and coil placement in an intracranial aneurysm: technical note. AJNR Am J Neuroradiol 2002;23:978-81. 6. Micha JP, Goldstein BH, Lindsay SF, et al. Subclavian artery puncture repair with Angio-Seal deployment. Gynecol Oncol 2007;104:761-3. 7. On-Site Precision Closure device, instructions for use. 8. Mooney MR, Ellis SG, Gershony G, et al. Immediate sealing of arterial puncture sites after cardiac catheterization and coronary interventions: initial U.S. feasibility trial using the Duett vascular closure device. Catheter Cardiovasc Interv 2000;50:96-102. 9. Michalis LK, Rees MR, Patsouras D, et al. A prospective randomised controlled trial comparing the safety, efficacy of 3 commercially available closure device (Angio-seal, Vasosea and Duett). Cadiovasc Intervent Radiol 2002;25:423-9. 10. Shammas NW, Rajendran VR, Alldredge SG, et al. Randomized comparison of Vasoseal and Angio-Seal closure devices in patients undergoing coronary angiography and angioplasty. Catheter Cardiovasc Interv 2002;55:421-5. 11. Haas PC, Krajcer Z, Diethrich EB. Closure of large percutaneous access sites using the Prostar XL percutaneous vascular surgery device. J Endovasc Surg 1999;6:168-70. 12. Sanborn TA, Ogilby JD, Ritter JM, et al. Reduced vascular complications after percutaneous coronary interventions with a non mechanical suture device: Results from the randomized RACE study. Catheter Cardiovasc Interv 2004;61:327-32. 13. Mehta H, Fleisch M, Chatterjee T, et al. Novel femoral artery puncture closure device in patients undergoing interventional and diagnostic cardiac procedures. Invasive Cardiol 2002;14: 9-12. 14. Eggebrecht H, Naber C, Woertgen U, et al. Percutaneous suture-mediated closure of femoral access sites deployed through procedure sheath: initial clinical experience with a novel vascular closure device. Catheter Cardiovasc Interv 2003;58:313-21. 15. Park Y, Roh HG, Choo SW, et al. Prospective comparison of collagen plug (Angio-Seal) and suture mediated (Closer S) closure devices at femoral access sites. Korean J Radiol 2005;6:248-55.
Curr Probl Diagn Radiol, January/February 2009
16. Caputo RP, Ebner A, Grant W, et al. Percutaneous femoral arteriotomy repair: initial experience with a novel staple closure device. J Invasive Cardiol 2002;14:652-6. 17. Ansel G, Yakubov S, Nielson C, et al. Safety and efficacy of staple mediated femoral arteriotomy closure: Results from a randomised multicentre study. Catheter Cardiovasc Interv 2006;67:545-53. 18. Hermiller J, Simonton C, Hinohara T, et al. Clinical experience with a circumferential clip based vascular closure device in diagnostic catheterisation. J Invasive Cardiol 2005;17:50410. 19. Hermiller J, Simonton C, Hinohara T, et al. The Starclose vascular closure system. Catheter Cardiovasc Interv 2006;68: 677-83. 20. Ratnam LA, Raja J, Munneke GJ, et al. Prospective nonrandomized trial of manual compression and AngioSeal and StarClose. Cardiovasc Intervent Radiol 2007;30:182-8. 21. Doyle BJ, Godfrey MJ, Lennon RJ, et al. Initial experience with Cardiva Boomerang Vascular Closure Device in diagnostic catheterization. Catheter Cardiovasc Interv 2007;16: 203-8. 22. Lasic Z, Nikolsky E, Kesanakurthy S, et al. Vascular closure devices: A review of their use after invasive procedures. Am J Cardiovasc Drugs 2005;5:185-200. 23. Koreny M, Riedmuller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: Systematic review and meta-analysis. JAMA 2004;291:350-7. 24. Nikolsky E, Mehran R, Halkin A, et al. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: A meta-analysis. J Am Coll Cardiol 2004;44:1200-9. 25. Brown DB. Current status of suture mediated closure: What is the cost of comfort? JVIR 2003;14:677-81. 26. Resnic FS, Arora N, Matheny M, et al. A cost-minimization analysis of the angio-seal vascular closure device following percutaneous coronary intervention. Am J Cardiol 2007;99: 766-70. 27. Geyik S, Yavuz K, Akgoz A, et al. The safety and efficacy of the Angio-Seal closure device in diagnostic and interventional neuroangiography setting: a single-center experience with 1,443 closures. Neuroradiology 2007;49:739-46.
43