Vascular Closure Devices: Technical Tips, Complications, and Management

Vascular Closure Devices: Technical Tips, Complications, and Management Venkatesh P. Krishnasamy, MD,*,† Michael J. Hagar, MD,‡ Daniel J. Scher, MD, MS,‡ Mamadou L. Sanogo, MD,‡ Gaby E. Gabriel, MD,* and Shawn N. Sarin, MD, MBA*,†,‡,§ Vascular closure devices (VCDs) are used to obtain hemostasis at the vascular access site while limiting the need for manual compression. They have gained significant popularity since their introduction in the mid-1990s. In the past 20 years, there has been a multitude of different devices introduced with various mechanisms of action. Manual compression remains the gold standard but can be very time consuming and painful for the patient. VCDs are advantageous in that they can reduce time to hemostasis and patient recovery and improve patient comfort. However, a large number of catheterbased procedures are performed without these closure devices owing to lack of operator familiarity, risk of complications, and cost. Most VCDs are approved for arteriotomies between 5 and 8 F, with 1 device approved for up to 21 F. Major complications include infection and limb ischemia. This article provides an update on currently approved VCDs, a brief overview of the literature, and our institutional experience with these devices. Tech Vasc Interventional Rad 18:100-112 Published by Elsevier Inc. KEYWORDS vascular closure device, hemostasis, manual compression, vascular access

Introduction to Vascular Closure Devices Sven Ivar Seldinger introduced the peripheral arterial access technique in 1959.1 With the subsequent introduction of arterial access sheaths in 1980s, repeated and larger vascular access with minimal trauma became a possibility.2 Since then, the growth in the spectrum and volume of endovascular therapy has been dramatic. This is in the part owing to the growing need for percutaneous procedures required to address health issues associated with the aging population of the United States. The United States Census Bureau estimates a 50% increase in the population older than 80 years in 2030 (compared with 2000), with more than 90 million Americans being older than 65 years.3 *Section of Vascular and Interventional Radiology, George Washington University Hospital, Washington, DC. †Section of Vascular and Interventional Radiology, National Institutes of Health, Bethesda, MD. ‡Department of Diagnostic Radiology, George Washington University Hospital, Washington, DC. §Division of Vascular Surgery, George Washington University Hospital, Washington, DC. Address reprint requests to Venkatesh Krishnasamy, MD, 10 Center Dr. MSC1182/1C370, Bethesda, MD 20892. E-mail: venkatesh. [email protected]

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1089-2516/15/$ - see front matter Published by Elsevier Inc. http://dx.doi.org/10.1053/j.tvir.2015.04.008

In the early years of vascular procedures, clinicians commonly used manual compression (MC) to achieve hemostasis after removal of a femoral sheath. Although MC remains the Food and Drug Administration (FDA) standard of care for hemostasis, it entails some drawbacks. Patient discomfort, significant postprocedure observation, and bed rest are required to assure adequate hemostasis. Additionally, the physical strain of providing manual pressure should not be discounted.4,5 In the 1990s, various vascular closure devices (VCDs) were introduced as alternative or additional methods of managing postprocedural access sites.6 In 1995, the VasoSeal device (St. Jude Medical, St. Paul, MN) was the first FDA-approved VCD for diagnostic and interventional procedures; it is not commercially available at the time of this publication. Angio-Seal (St. Jude Medical, St. Paul, MN) received FDA approval in 1996. Because of its easy deployment and simple design, Angio-Seal accounts for more than half of the VCD market in the USA. The Prostar XL device (Abbott Vascular, Abbott Park, IL) received FDA approval soon after in 1997. In 2002, Perclose A-T, also from Abbott Vascular, was introduced simplifying the process with a pretied knot.2,7,8 Several additional VCDs have been developed over the past 20 years. There has been a substantial growth in the global VCD market, which is estimated to have grown from $400 million (USD) in 2005 to nearly a $1 billion in 2013.2,9

Vascular closure devices

Available VCDs The ideal VCD is safe and simple to use. Deployment should be reliable and consistent without a significant number of complications when compared with MC regardless of arteriotomy size, anticoagulation status, and patient risk factors.8 Additionally, there should not be a significant inflammatory reaction in the surrounding tissue, so a repeat puncture may be readily performed.3 Finally, they must be cost effective. Although no device currently satisfies all these criteria, VCDs, in general, have introduced a means of achieving hemostasis, improving patient comfort, and accelerating ambulation after interventional procedures.8 VCDs fall into 3 main categories. The active approximators are those that will physically close the arteriotomy site with sutures or nitinol clips. The passive approximators deploy a plug or gel at the site without active closure of the arteriotomy site. Within the category of the passive approximators are the compression assisted devices, which achieve hemostasis without implanting a retained suture, clip, or plug. The last category is the external hemostatic devices, which either provide mechanical pressure at the arteriotomy site or promote coagulation by concentrating clotting factors via patches or pads. These devices are advantageous in that they can be used in conjunction with other VCDs.9

Active Approximators The Perclose A-T (Abbott Vascular, Abbott Park, IL) device is one of the original suture-based devices. It deploys a braided polyester suture with a preformed knot. The Perclose Proglide deploys a similar preformed knot using a single monofilament polypropylene suture. The change in suture enabled increased tensile strength, easier knot delivery, and less inflammatory response.7 The Perclose Proglide, as per its manufacturer’s instructions for use (IFU), can be used to close arteriotomies between 8.5 and 21 F. Larger access site closures require the use of the “preclose” technique. The Proglide is placed over the indwelling guidewire after removal of the working sheath. The marker lumen will demonstrate a flashback of arterial blood once the device is intravascular and placed at an adequate depth. The lever is then raised (steps of the procedure are numbered on the device), deploying the footplate, which is then retracted to the vessel wall causing the blood marking to slow. The plunger is depressed, deploying 2 needles through the artery wall engaging the sutures and footplate. The plunger is withdrawn and the lever lowered, which draws the sutures out allowing them to be “harvested” as the device is partially withdrawn. One suture limb known as the “rail” is solid blue whereas the other suture limb has a white tip and is only pulled when the knot is to be “locked” as mentioned later. Care must be taken while using hemostats to grab the sutures as the compression can damage and break the sutures. If hemostats must be used, place them on the suture tails.

101 Another important note is that when the plunger is withdrawn, only the anterior needle will have an attached suture. If this is not present, the suture was not captured and the device should be removed and discarded. A new device or other type of closure device can then be used. The device can then be fully withdrawn, and the slip or rail limb is pulled driving the knot tight to the arteriotomy site with the aid of the knot pusher. Finally, the knot is locked by pulling on the white-tipped limb.7 An added safeguard with this device is the ability to readvance the guidewire before removal of the device. If hemostasis is not achieved, a second Proglide or different device can be placed. For arteriotomies greater than 8 F, the “preclose” technique is employed just after the initial vessel access. For this technique, 2 devices are required. The first device is deployed and rotated slightly clockwise to 301 and second device is deployed and rotated slightly counterclockwise to 301.10 Neither device is tied before insertion of the working sheath.2 This technique has been used to close arteriotomy sizes up to 26 F.7 To increase the safety profile of the “preclose” technique, the authors recommend that ultrasound be used to gain initial arterial access to ensure single-wall puncture over a minimally diseased and compressible location. To ensure the Proglide knots reach the vessel surface, liberal blunt dissection is essential through the skin incision. During the procedure, and before closure, it is essential to keep the sutures organized and free of any debris that can accumulate on them. Poor dissection and debris accumulation on the sutures can prevent the knot from being pushed down to the actual arterial wall. Patient selection is key, as we have seen “preclose” failures with access vessels that have calcified plaque or are less than 6 mm in diameter, or both. The 10-F ProStar XL (Abbott Vascular, Abbott Park, IL) is indicated for 8.5- to 10-F closure using two 3-0 braided polyester nonabsorbable sutures,9 although closure up to 24-F arteriotomy sites have been described.2 After removing the indwelling working sheath, the device is placed over guidewire. Predilation of the subcutaneous tissues is recommended. Once the device hub has reached the level of the skin, the interlocks are depressed between the thumb and forefinger allowing the hub to rotate and further dissect the subcutaneous tract to the anterior vessel wall. Continuous blood return from the marker lumen is necessary before needle deployment. The handle is rotated counterclockwise and retracted deploying 4 nitinol needles from inside the vessel out through the rotating barrel. Moreover, 2 green and 2 white suture ends attached to the needles create a diagonal pattern at the arteriotomy site.10 If the needles do not easily deploy or not all the needles deploy, they can be backed down allowing the device to be removed and replaced. The needles are removed from the hub with hemostats and then cut from the sutures. The sutures are used to manually tie sliding knots, which are delivered to the arteriotomy sites after the device is removed similar to the Proglide device. Additionally, the

102 guidewire can be replaced as a safeguard analogous to the Proglide device. A single Prostar device can also be used to “preclose” the arteriotomy site as well for sheath sizes larger than 10 F. The Prostar has CE mark approval for closure up to 24 F in Europe. Some advantages of these devices include arteriotomy reapproximation, option for immediate reaccess, and lack of any intraluminal or extraluminal implant material. The Proglide and Prostar XL devices have earned approximately 20%-40% share of the VCD market.2,7 The Percutaneous Endovascular Aneurysm Repair (PEVAR) trial demonstrated shorter time of procedure and time to hemostasis as well as trends toward improved blood loss and decreased groin pain using both devices compared with femoral cut down during endovascular aortic aneurysm repair.11 However, a separate study demonstrated that a ratio of sheath size to common femoral artery (CFA) diameter greater than 0.75 predicted failure of closure in percutaneous endovascular aortic aneurysm repair cases using the Prostar XL device and suggested a primary open approach in this setting.12 The StarClose SE (Abbott Vascular, Abbott Park, IL) is a clip-based device which is approved for access sites of 5-6 F but has been used for up to 8-F arteriotomies.4 It delivers a 4-mm nitinol clip in the shape of a disc extravascularly to the arteriotomy.8 As with the previously mentioned closure devices, blunt dissection of the subcutaneous tissue to allow better apposition of the closure device to the arteriotomy site is recommended. The device is inserted through an Abbott proprietary sheath that comes with the device. Intravascular flexible locator wings are deployed, which are withdrawn until resistance is felt identifying the anterior vessel wall and appropriate deployment location for the clip. Performing the steps of deployment will split the sheath. To deploy the clip, the device is raised to a 601-751 angle, pushed down slightly to feel the pulsation of the artery, and deployment button pressed. This grabs the adventitia pulling the access site edges together.8 The locator wings simultaneously collapse. The safety release will collapse the locator wings manually in the event of unsuccessful deployment to allow removal of the device. Depressing the medial and lateral access ports will release the internal locking mechanism to also allow easier removal of the device. Steep punctures can cause the device to get stuck in the patient’s tissues.7 This device allows for immediate mechanical closure and does not incite an inflammatory response.8,9 A possible drawback of this device is that it requires a sheath exchange.2 The Starclose has been shown to be magnetic resonance imaging compatible immediately following implantation, but artifact may limit magnetic resonance evaluation of the local vasculature.9

Passive Approximators Angio-Seal (St. Jude Medical, St. Paul, MN) is the most frequently used VCD; it uses an intravascular resorbable

V.P. Krishnasamy et al polymer anchor and an extravascular collagen plug to sandwich the arteriotomy site. The platform consists of a rectangular co-polymer footplate of 1  2  10 mm attached to an 18-mg bovine collagen plug by an absorbable traction suture. After removal of the indwelling sheath and over the existing guidewire, the device sheath is advanced until there is backflow of blood from the vessel locator aperture signifying that the tip is intravascular. It is important to not advance the sheath tip more than 2 cm into the vessel as this may result in premature anchor engagement of the arterial wall proximal to the arteriotomy site and limit the ability to achieve hemostasis. After the dilator is removed, the actual device is inserted and intravascular anchor deployed. The device hub is separated visualizing the colored indicator signifying correct anchor position at the tip of the sheath. If this does not occur, the device hub must be pushed back together and then separated again to attempt to position the anchor correctly. The entire device is retracted to seat the anchor against the anterior wall and expose the extravascular plug. Constant tension is important in preventing the plug from being pushed intravascularly. The tamper is used to push the plug onto the arteriotomy site exposing the black marker. An important note is that the black marker is usually only partially exposed in routine use. It may, however, not be exposed or fully exposed per IFU. The suture must also be cut below the skin to help prevent infection.7 The components are degrade by hydrolysis and are absorbed by 90 days. Repeat access within 90 days has been thought to raise the risk of distal embolization of the intravascular component.2 The device can be used in arteriotomies of 5-8 F and allows for discharge and ambulation after 60 minutes.9 Sarin et al13 demonstrated efficacy of the 8-F device up to 12-F access. The device is available in 6- and 8-F sizes. Multiple studies have demonstrated a closure success rate of greater than 95%.2 The next-generation Angio-Seal Evolution has an automated collagen compaction design in which all components will still be reabsorbed by 90 days.9 The Vascade Vascular Closure System (Cardiva Medical, Sunnyvale, CA) is another collagen-based closure system. It is used for arteriotomy sites of 5-7 F. There are 2 different devices that are available—a 5 F and a 6/7 F. Like the Angio-Seal, it leaves no permanent components behind as the extravascular collagen plug is completely resorbable. The device can be used with the existing indwelling sheath up to 12 cm in length. An intravascular collapsible 6.5mm nitinol disc allows for temporary tamponade at the arteriotomy site during deployment of the patch. Once introduced into the sheath, the black actuator is retracted and locked exposing the green segment on the device signifying deployment of the intravascular disc. The sheath is removed and the device is retracted to seat the disc against the arteriotomy and achieve hemostasis. An important note is that if any of the distal white portion of the device is visible, the tissue tract is less than 2.5 cm and may not be long enough for the collagen plug, increasing the risk for infection. The clip is applied at the skin to maintain tension and hemostasis at the

Vascular closure devices arteriotomy. The collagen plug is unlocked, deployed, and allowed to swell for up to 30 seconds per IFU. Finally, the disc is collapsed and device removed with subsequent short duration of MC. The patch is made of type 1 bovine collagen. It achieves hemostasis using a dual mechanism of action. First, it provides tamponade because of rapid expansion of the collagen in fluid. Additionally, it accelerates coagulation by leveraging natural thrombogenic properties of collagen to enhance coagulation. In the RESPECT IDE trial for premarket approval, this device showed low complication rates, improved over MC.9 The Mynx Grip (Cardinal Health, Dublin, OH) delivers a polyethylene glycol (PEG) sealant over the arteriotomy site. The device has a tip that will soften with body temperature and pH level and grips the artery with an intra-arterial balloon.2 The device is inserted through the existing sheath with subsequent balloon inflation. Inflation can be performed with 50% contrast per IFU to better visualize the arteriotomy fluoroscopically as the device is retraced. The sheath stopcock can be opened as well to identify achievement of hemostasis at the arteriotomy site with retraction ensuring appropriate location. In the final stages of deployment, an advancer tube is used to push the plug onto the arteriotomy for 30 seconds with continued tension on the entire device. After laying the device down for 90 seconds, the balloon is deflated and device removed. Short duration manual pressure is performed. The PEG can rapidly expand to 300%-400% of its size with absorption of fluid and blood allowing a mechanical seal and initiating clot formation. Without an intra-arterial anchor, immediate repeat access and distal embolization are less of a concern. This device is also approved for closure of femoral veins. It is indicated for arteriotomy sites of 5-7 F and is available in 5- and 6/7-F sizes. The PEG plug degrades within 30 days, quicker than collagen and also with less inflammation. The Mynx Ace is a nextgeneration device, which uses the Grip technology in conjunction with a newer and simplified deployment system. It does require a sheath exchange and still requires a short duration of manual pressure after implantation.8,9 The ExoSeal (Cordis Corporation, Bridgewater, NJ) is very similar to the Mynx device in that it deploys an absorbable sealant made of polyglycolic acid over the arteriotomy site through the existing procedural sheath.2 It is used for arteriotomy sites of 5-7 F and has an indication for use with glycoprotein IIb/IIIa inhibitors per IFU. A unique visual indicator system as opposed to tactile feedback is used for deployment. The appropriatesized device must be chosen based on the indwelling access sheath. After inserting the device to the marker band, the sheath is retracted allowing the bleed-back port to be exposed intravascular and pulsatile blood flow from the bleed-back indicator. The sheath snaps into the device exposing the intravascular nitinol indicator wire. The entire device is retracted until 2 visual indications are observed, decrease in pulsatile flow and indicator window turning all black. The plug is deployed with the push of a button, and manual pressure of short duration is applied.

103 The indicator window provides real-time feedback. If it is black and red, tension on the device must be slightly released to ensure optimal positioning at the arteriotomy. Conversely, if the indicator window is black and white, the device needs to be retracted further. The “lockout” feature is also activated when the window is black and white limiting risk of intravascular deployment of the plug. The plug itself creates mechanical hemostasis and does not activate the coagulation cascade.8 It is fully resorbed within 60-90 days.9 It is important to note that this device should not be used in vessels less than 5 mm in diameter and cannot be used with sheaths longer than 12 cm.2 The 2 Femoral Introducer Sheath and Hemostasis devices (Morris Innovative, Bloomington, IN) are used for arteriotomy sites of 5-8 F. The CombiClose device comes in 4 sizes, 5-8 F, and can be used as a vascular sheath before closure. The ControlClose device comes in 2 sizes, 6 and 7 F, but can still be used to close up to 8-F access sites. This device uses an extracellular matrix closure patch created from a ribbon of porcine small intestinal submucosa (SIS) that promotes remodeling of the arterial wall and minimizes scar tissue. This is deployed intraluminally and retracted into the arteriotomy forming a plug in the artery wall.2,9,14 The CombiClose is advanced until the SIS cuff is at the arteriotomy signified by bleed back. The release wire is removed and the sheath is advanced causing the release suture to curl and the SIS ribbon to be delivered intravascular. The suture tab is then retracted to compress the SIS ribbon in the artery wall. At the completion of the procedure, the sheath, catheter, and wire are sequentially removed while simultaneously retracting the suture tab and holding manual pressure. Finally, the suture is cut below the skin level, and a short duration of manual pressure is applied. The ControlClose device is different in that the whole sheath is retracted after advancement instead of just the suture tab to allow compression of the SIS ribbon in the artery wall. The suture tab is then retracted, the suture cut after wire removal, and manual pressure applied. An important point is the blood flow does not always completely stop early in the sequence of these steps. The plug gets absorbed in 30 days. Per IFU, the device has an intravascular sleeve and extravascular positioning cuff after deployment; thus, repeat access in 30 days is recommended either at the contralateral groin or 2 cm away from the previous access in the ipsilateral groin. The plug is pliable allowing for closure in small and diseased vessels as well as with bifurcation or low-access points. Of note, it allows for delayed sheath removal after transport of patient and discontinuation of anticoagulants. At this time, the Femoral Introducer Sheath and Hemostasis device is only approved for diagnostic procedures.2,14 The Axera 2 Access Device (Arstasis, Inc, Redwood City, CA) is a passive approximator that does not use a clip, suture, or plug. It is used for arteriotomy sites of 5-7 F. The Axera device creates a more shallow and longer access tract, which hastens hemostasis postprocedurally by creating increased tissue overlap.9 The provided 0.035-in

104 Latchwire is initially inserted intra-arterially in standard fashion. The proximal tip of this wire is then attached to the distal tip of the device with subsequent advancement of the device tip intravascular as a unit. Once blood return is seen, the heel is deployed, the device is retracted to identify the anterior vessel wall, and plunger depressed creating the second more shallow arteriotomy. Blood return will again be seen from the marker port. A 0.018in wire is introduced through the marker port, the plunger retracted, and the device removed leaving the second wire in place. The working sheath is subsequently inserted using the provided Dilator Adapter that allows transition of the 0.035-in lumen of a standard sheath up to 23-cm long to the 0.018-in indwelling wire. Alternatively, the device can be ordered with a proprietary sheath obviating the need for the Adapter. The angle of access becomes approximately 51-151, which allows for the vessel to tamponade itself in theory given the radial force of the blood flow. MC for a short time is still necessary.3,9 This device does not implant any foreign material, which is advantageous with potential need for repeat access.5 The Cardiva Catalyst II or III (Cardiva Medical, Sunnyvale, CA) is another passive approximator that can be used in access sites of 5-7 F with sheaths up to 25 cm in length. Of note, this is the newer generation of the Boomerang device. The intravascular 6.5-mm nitinol disc is attached to an 18-gauge wire, which is held in place at the skin surface with a tension clip.4,9 In the Catalyst II, coagulation is promoted by the coating of kaolin, a type of clay, and chitosan, a polysaccharide which helps reduce bleeding and acts as an antibacterial. After completion of the procedure, the Catalyst II wire is placed through the existing sheath. The Catalyst nitinol disc is deployed within the lumen of the artery by pulling the black actuator and locking it in place exposing the green marker (approximately 7 mm in length) on the wire. The introducer sheath is then removed over the wire, and gentle tension is applied to conform the disc to the contours of the vessel, tamponading the arteriotomy intravascularly. The Catalyst clip is applied externally to maintain tension and hemostasis at the access site. The Catalyst disc is then collapsed (when 1 mm of the green mark is visible), and the device is removed from the artery after a predetermined time. The Catalyst III is intended for patients receiving heparin as it has a protamine sulfate coating neutralizing the effect of heparin. It is deployed in similar fashion to the Catalyst II. Advantages include the lack of biological material or permanent implants. A disadvantage of these devices is that they must stay in place for 15 minutes following a diagnostic procedure and 2 hours following an interventional procedure.2 Afterward, MC of approximately 5 minutes must be applied until hemostasis is achieved.4

External Hemostatic Devices This category includes patches and pads, which promote coagulation by concentrating clotting factors, and devices that manually exert pressure on the arteriotomy site at the

V.P. Krishnasamy et al skin level.9 These devices do not leave implants behind. If these devices are used by themselves, additional MC is required.8 Alternatively, they may be used to supplement another VCD. There are multiple examples of external hemostatic devices. The Syvek Patch (Marine Polymer Technologies, Danvers, MA) is made of poly-N-acetyl glucosamine and is placed over the arteriotomy site with MC.8 The D-Stat Dry pad (Vascular Solutions, Minneapolis, MN) is made up of thrombin, sodium carboxymethycellulose, and calcium chloride and is applied in similar fashion to the Syvek Patch.8 The FemoStop (St. Jude Medical, St. Paul, MN) is made of an arch with a sterile pneumatic pressure dome, an integrated pump with manometer, and a belt. The dome is placed over the puncture site, and the belt is placed around the patient. The pressure of the dome is controlled by the pump, whereas the arch and belt provide counter pressure. The dome is inflated to 70 mm Hg during sheath removal, suprasystolic for approximately 2 minutes, mean arterial pressure for approximately 15 minutes (allowing pedal pulses to be palpable), and then deflated over the next 1-2 hours before removal.4 The ClampEase mechanical compression device (ClampEase, Milwaukie, OR) is a MC device that consists of a 3-knob clamp with ball-head pin to fit ball attachment pressure discs. The device adjusts easily to apply pressure at the arteriotomy site. The sterile pressure disc is aligned over the puncture site, and the height is adjusted while the sheath is pulled. Given the increasing usage of transradial access, devices such as the TR Band (Terumo Interventional Systems, Somerset, NJ) have seen increasing usage. It has even been used to obtain pedal access hemostasis. It is a transparent device, which increases visual control. A unique characteristic is its dual compression balloons, which allow compression of radial artery without compromising the local nerves. Its air-injection port allows manual pressure adjustment. One unique use of this device has come to light with homolateral ulnar artery compression. It has been used as a nonpharmacologic method for the treatment of acute radial artery occlusion.15

Operators’ Experience Our experience, as any institution, is biased by the use of certain devices. We routinely use the Proglide, Starclose, Angio-Seal, and Mynx devices. We also always use ultrasound guidance for all access sites arterial and venous, radial to pedal. Regarding femoral access, this allows us to identify a soft, relatively less diseased anterior wall access site above the bifurcation to allow more confident and successful VCD use at the completion of the procedure. This also allows us to find an optimal access site adjacent to a site of recent previous closure device placement. Ultrasound guidance, we feel, allows us to forego femoral arteriography to evaluate the access site in most routine cases where a sheath of 5-6 F is used. Regarding alternative arterial access sites and venous access sites, our experience with closure devices is limited as our methodology for

Vascular closure devices hemostasis is primarily MC. The one exception is usage of the TR Band for radial artery hemostasis. The Proglide is frequently our VCD of choice to close larger access. For up to 7-F access, we generally use a single device placed at the completion of the procedure. For up to 12-F access, we will use 1 device with a “preclose” technique. For 12-F and above, we will “preclose” with the double Proglide technique. We often use this device for young and thin patients as we feel that plug implantation can result in inflammation and a palpable lump at the dermatotomy site. We often use this device in patients with need of repeat access, soon to be restarted on anticoagulation, and postthrombolysis infusion. We have occasionally used this device for common femoral and popliteal vein closure in limited fashion and only in patients that are fully anticoagulated. We have had no complications with venous use; however, we only advocate its use in rare circumstances where manual pressure would be detrimental or ineffective. With arterial placement, we aggressively dissect the connective tissue between the dermatotomy and the arteriotomy. Our failures with the device predominantly relate to attempted use with calcified and smaller vessels less than 6 mm in diameter. We always tighten the knot with the guidewire in place allowing us to use alternative means of closure if we do not achieve hemostasis. Additionally, when the plunger is retracted and no suture is connected to the anterior needle signifying device failure, the guidewire allows use of another Proglide or different device. Care must be taken with tortuous iliac vessels as advancement of the device may be difficult. The presence of an ipsilateral iliac occasion or stent may also be a relative contraindication. The Starclose device is also commonly used in our institution for young and thin patients. With the lack of inflammation subsequent to placement, this device is also optimal for patients in need of repeated arterial access over time. Like the Proglide, fastidious dissection is necessary to ensure successful placement. We do not use this device in diseased vessels as placement failure occurs more often in our experience. Finally, regarding this device, it is not uncommon to have pulsatile blood flow upon placement of the clip and removal of the device. As the nitinol clip warms and expands, the arteriotomy closes and hemostasis is achieved. Angio-Seal is our most commonly used device. With disease-free access sites, we will use the 8-F device in up to 12-F access sites as has been described.13 This is our device of choice for after thrombolysis and soon to be anticoagulated patients given the sandwich effect of the arteriotomy. We have used this device in proximal superficial femoral artery (SFA) (retrograde and antegrade) as well as distal external iliac artery access sites, both with success. Although there is deemed to be a higher risk of closure device failure with groin scarring from any reason,6 we prefer to use the Angio-Seal in these cases. We analogize these situations to dialysis access where the perivascular scarring limits the risk of dissection of blood products through the subcutaneous

105 tissue. We have had good success using this device in these clinical situations. As with the Proglide and Starclose devices, we feel manual dissection to the arteriotomy site is very important to allow the collagen plug to seat against the anterior vessel outer wall. Our delayed failures tend to predominate with improper tissue dissection. Unsurprisingly, our acute failures with this device generally occur in calcified and stenotic vessels. The footplate can catch more proximally in the vessel in this situation and not seat against the anterior vessel inner wall. This does not create hemostasis at the arteriotomy site and even worse allows the collagen plug to be pushed intravascular causing eventual vessel occlusion. Thus, we often avoid use of this device with severely diseased access vessels. Another important note is that deployment of this device near an indwelling stent can have the same result as deployment in a diseased vessel with the footplate being caught on a stent strut allowing the plug to be pushed intravascular. Thus, we also avoid using the Angio-Seal adjacent to stents. Mynx Grip is occasionally used in our practice. Our primary uses of this device are with low-access sites and in diseased vessels. If there is concern about the access vessel, we will inflate the intravascular balloon with contrast and use fluoroscopy to better identify when the balloon is at the arteriotomy site. We often also use a buddy wire technique. Through the access sheath alongside the device, we will place a 0.035-in floppy guidewire, usually the J-wire from the sheath kit. As the inflated balloon is retracted, if hemostasis is achieved, we will remove the wire. If the balloon bursts and the device pulls out of the vessel, as can happen if diseased, access is still maintained to place another closure device if needed. In patients with severe peripheral arterial disease (PAD) at the access site, we often hold manual pressure as opposed to risking complication with a closure device as has been suggested.16 Although PAD has been linked to complication after both MC and VCD use, Kara et al. demonstrated no difference with VCD use in patients with and without PAD. It should be noted that the authors did not evaluate for disease at the access site.17 Thus, these data do not alter our use of MC for hemostasis in these situations. Access through previously inserted stents is unfortunate but occasionally required. For hemostasis, we generally prefer manual pressure though occasionally use the Mynx and rarely the Angio-Seal VCD. We feel VCDs within stents may frequently lead to vessel occlusion. We are extremely proactive in preventing VCD infections. Although preoperative antibiotics have been recommended for diabetic patients and access in prosthetic grafts, we have a low threshold to administer antibiotics for infection prevention. This is especially the case if access was maintained overnight before closure. We also practice strict sterile technique. Before device placement, we reprepare and redrape the groin with sterile towels. We will also routinely change our sterile gloves. We have had success in preventing infection with these methods. If an infection is diagnosed, aggressive treatment is recommended.8,18

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Figure 1 (A) A 67-year-old paraplegic man with bilateral lower extremity critical limb ischemia with tissue loss. On right lower extremity angiography and intervention from left common femoral artery access, collagen-based VCD was used. On 1-month follow-up, the patient presented with worsening tissue loss of the left lower extremity. Image from right common femoral artery access in the RAO position demonstrates total occlusion of the left external iliac, thick arrow, and common femoral artery secondary to the closure device. Superficial femoral artery origin, thin arrow, demonstrates reconstitution of flow. (B) After recanalization of the total occlusion, bare metal self-expanding stent placement in the external iliac artery, and angioplasty of the common femoral artery, completion arteriography demonstrated brisk antegrade flow. There is a residual non–flow-limiting dissection flap of the common femoral artery, arrow. On follow-up, the common femoral artery was widely patent, and the patient demonstrated ulcer healing. RAO, right anterior oblique.

Regarding limb ischemia, we are very diligent in monitoring preoperative and postoperative distal pulses. We have a resultantly low threshold to obtain noninvasive imaging to identify limb ischemia from vessel stenosis or occlusion. If this occurs, endovascular and surgical treatment options are available (Figs. 1-5). With collagen-based devices, our preference is rotational atherectomy and balloon angioplasty. Femoral cut down with repair is also acceptable. With suture-based devices, femoral cut down is preferred by some given the possibility of breaking the sutures and opening the arteriotomy. Our experience has demonstrated that prolonged angioplasty at the site is safe and efficacious. As a bailout, self-expanding covered stent placement can be performed though generally in nonoperative patients. We have not experienced VCD component embolization. However, given our experience with chasing

atheromatous embolization, our preference would be the use of a suction catheter or device as has been described.19 Our catheter of choice is usually a 6-F guide catheter. Other available proprietary aspiration catheters may also work, such as the Pronto Extraction Catheter (Vascular Solution, Minneapolis, MN). Another device for this use is the Indigo System (Penumbra, Alameda, CA). This mechanical thrombectomy catheter is analogous to the company’s ischemia stroke device and connects to an external vacuum pump for added aspiration power.

Discussion The main benefits of VCDs are that they reduce discomfort, promote earlier ambulation and discharge, and reduce time to hemostasis.2,3,8,20 In a recent study,

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107 should be noted that some series have demonstrated high technical success with antegrade access, and we routinely use it in antegrade CFA and SFA access.22,23 Stenosed access, as described previously, can lead to higher complication rates. Stented vessel or prosthetic graft VCD use has not been well evaluated.6

Choosing a Device

Figure 2 (A) A 72-year-old woman following collagen-based VCD placement in the right common femoral artery 1 week prior, presented with rest pain. Of note, distal pulses were present postoperatively. Computed tomography scan demonstrates lack of opacification of the right common femoral artery, white arrow. (B) Open femoral exposure demonstrates the plug in intravascular location, arrow, of the collagen-based VCD used. (C) Image of the plug after removal.

immediate mobilization following diagnostic coronary angiogram or intervention with femoral access using the Angio-Seal device demonstrated no increased bleeding risk when compared with standard care.21 Accepted major complication rates are 3% for VCD use as well as with MC. Recommended deployment and hemostasis success rates are 90%.8 Calcified, antegrade, and scarred access can lead to higher failure rates.6 It

A recent prospective trial compared intravascular and extravascular VCDs (neither suture based) with each other and MC. Time to hemostasis was shorter and device failure was lower for the intravascular VCDs whereas VCDs as a whole demonstrated noninferior complication rates and much improved time to hemostasis.24 Another study compared ExoSeal with Angio-Seal and Proglide and found a statistically significant increase in complication rate in the ExoSeal group.25 Angio-Seal has been shown to have shorter time to hemostasis and ambulation as well as less device failure compared with Proglide.26 Nevertheless, few studies have compared VCDs; there is insufficient evidence with respect to efficacy and complications.8 Therefore, the decision to choose a particular device depends on a number of factors, including availability, operator familiarity/preference, and size of the arteriotomy.7 No one single device is ideally suited for all patients, and all closure devices are associated with a definite learning curve.3 Preprocedural planning is paramount if there is the potential for hemodynamic instability or when rapid arteriotomy closure is desired. In this setting, the ideal device is quick and easy to apply. Most devices are easy to use requiring 5-8 steps for successful deployment. For the MynxGrip, Angio-Seal, and Perclose ProGlide devices, 1012 steps are required. The Prostar XL device requires more than 30 steps.2 In general, collagen-based devices are thought to be easier to deploy.7 If there is a potential need for repeat access, the ideal VCD should cause no significant periarterial inflammatory changes that would prevent repeat arterial access. There should also be minimal risk of dislodgement of the hemostatic plug.8 Therefore, in this setting, suture-based closure devices are preferred as the closure is secure almost immediately and there is no collagen plug or intravascular anchor to consider.7 In 1 study, ultrasound follow-up of closure devices at 6 months demonstrated no perivascular soft tissue change with Perclose or Starclose. Conversely, 3 of 4 Angio-Seals and 3 of 3 ExoSeals showed only partial absorption of hemostatic material, with one Angio-Seal demonstrating perivascular soft tissue changes.27 However, repeat access within 90 days after Angio-Seal usage has shown a lack of major complications.4

Complications and Minimizing Their Risk Despite recent trends toward safety, the use of VCDs has remained controversial with several earlier studies demonstrating higher complication rates when compared with MC.4 Risk of access site complications were demonstrated

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Figure 3 (A). A 68-year-old man with loss of left pedal pulses after suture-based VCD placement in the left common femoral artery with subsequent occlusion, arrow. (B). Given that the patient was not a operative candidate, a selfexpanding covered stent was placed in the left common femoral artery with return of brisk antegrade flow. (Color version of figure is available online.)

to be higher with the VasoSeal device,8,28 which is no longer commercially available. However, more recent studies have shown a decrease or no difference in complications with VCDs suggesting improved safety.5,11,24,29 In a large

meta-analysis, significantly lower bleeding and vascular complication rates were seen with Angio-Seal, Perclose, StarClose, Boomerang Closure Wire, and hemostasis patches than with MC controls.5

Figure 4 (A) A 56-year-old female with loss of right pedal pulses after placement of a collagen-based VCD in the right common femoral artery. Flow-liming stenosis, arrow, is seen. (B) After cutting balloon angioplasty, there is brisk antegrade flow. A residual non–flow-limiting dissection flap, arrow, was still present, but on follow-up, the common femoral artery remained widely patent. (Color version of figure is available online.)

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Figure 5 (A) A 54-year-old woman with loss of right pedal pulses after collagen-based VCD placement in the right common femoral artery, arrow. (B) After rotational atherectomy, debris is identified within the distal embolic protection device, arrow. (C) After subsequent angioplasty, completion arteriogram demonstrates minimal residual stenosis, arrow, with brisk antegrade flow. On follow-up, the common femoral artery was widely patent. (Color version of figure is available online.)

Some complications remain more common with VCDs than with MC, including limb ischemia, groin infections, and complications requiring surgical repair.4 In a review of more than 6500 cases involving the use of the Angio-Seal device, 6 cases of limb-threatening ischemia were reported in which 5 of 6 were obstructive in origin owing to traumatic dissection or occlusion of the artery mainly caused by malpositioning of the device.30 There are also reports of embolization of device components such as with the Angio-Seal device which was successfully retrieved endovascularly.31 Although infections associated with VCD placement are rare, morbidity is high and aggressive medical and surgical interventions are required.18 Complications from VCDs that require surgical repair also tend to be more complex such as the need for an interposition graft.29,30,32 However, the risk of severe complications is low and decreases with operator experience.2,11 When considering the use of a VCD, clinicians must be aware of the many predictors of vascular complications reported in the literature. Some commonly reported risk factors for vascular complications include the following: age 470 years, female sex, body surface area less than 1.6 m2, 8-F access or greater, and previous access at the same site. Duration, complexity, and emergent procedures are also associated with poor outcomes. There is also increased risk with use of IIb/IIIa inhibitors, thrombolytics, low-molecular-weight or unfractionated heparin, and use of an intra-aortic balloon pump during the procedure. Finally, there is increased risk of vascular

complications in patients with renal failure, peripheral vascular disease, hypertension, and congestive heart failure.5,8,33,34 Additionally, VCD IFUs carry numerous cautions including use outside of the CFA, femoral artery size less than 4 mm, obesity, and inflammatory disease. However, many of the published studies exclude these highrisk patients limiting knowledge of VCD safety and efficacy in these patient populations. VCDs may actually be beneficial in patients with risk factors for bleeding.3,4,7,35,36 Additionally, they may be safer in obese patients.16 There are steps that can be taken to reduce the risk of complications, specifically infection and limb ischemia. Preoperative antibiotics can be considered in diabetic patients and patients with prosthetic grafts. There are no data to support routine primary or secondary antibiotic prophylaxis.18 Using sterile technique and repreparing the arteriotomy site before closure may also have a protective effect.8 Important points include the fact that hematoma development can be a nidus for infection, and median time to clinical presentation is 8 days.18 Risk for limb ischemia can be lowered if access is gained under ultrasound guidance ensuring optimal entry into the vessel lumen.37,38 Additionally, ultrasound-guided VCD deployment may decrease complications.39 A limited femoral angiogram is helpful to assess vessel size as well as to confirm proper access site location above the femoral bifurcation and below the takeoff of the inferior epigastric artery.8 Additionally, ultrasound and fluoroscopic imaging allows evaluation of the access site for disease and calcification.

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110 VCDs should be avoided here as use and device failure are both associated with vascular complication. Additionally, Angio-Seal, Perclose, and Starclose have all been shown to decrease ankle-brachial systolic pressure index slightly subsequent to use.4 MC may be safer in such situations.16

Off-Label Usage The off-label use of VCDs has been widely reported in the literature. The Angio-Seal device has been successfully used in many off-label locations, including in suboptimally “high” arteriotomies above the takeoff of the inferior epigastric artery and “low” arteriotomies at the bifurcation of the SFA or profunda femoral artery, as well as in the SFA or profunda femoral artery themselves.40 There are also multiple studies that report the successful use of the Angio-Seal device beyond the CFA, including access site closure following transbrachial interventions,41,42 management of inadvertent subclavian artery cannulation,43 and percutaneous closure of a perforated right ventricle.44 Successful endovascular management of an inadvertent subclavian artery cannulation during central line placement in an unstable patient with sepsis, multiorgan failure, and severe coagulopathy using an Angio-Seal device has been reported.43 Off-label application of the Angio-Seal device for percutaneous closure of a perforated right ventricle in a high-risk patient with carcinoma and cardiac tamponade who suffered a right ventricle perforation following pericardiocentesis has been described.44 Off-label successful use of many other VCDs has also been reported in the literature, including the ExoSeal, StarClose, Mynx Grip, and Boomerang VCDs. In a small case series, 8 patients underwent 13 extrafemoral procedures in which ExoSeal device was used for attempted closure, including a venous femoropopliteal bypass and arteriotomies in the brachial artery, femoropopliteal segment, and in the proximal SFA. In only one of the brachial puncture cases, safe plug deployment was not feasible because there was no consensus between the 2 visual indicators.45 In a cadaveric study designed to explore the endoscopic management of arterial injury at the skull base, arteriotomies that were created at the cavernous portion of the internal carotid artery were successfully closed with the Angio-Seal, StarClose, and Mynx Grip VCDs.46 StarClose and Boomerang devices have been successfully used to close brachial artery access sites.47,48

Cost-Effectiveness VCD effectiveness over MC with respect to cost is often attributed to decreased physician time and hospital stay. Reduction of minor complications allowing cost savings on treatment has also been implicated. However, cost of managing VCD complications is not always evaluated.7,8 Despite decreasing complication rates by up to 50%, the modest cost of the VCD itself diminishes any potential

savings with the incremental cost of averting 1 complication exceeding $9000 in 1 analysis.49 Others have suggested that implementing the use of VCDs in a more selective patient population, such as those at risk for bleeding or a prolonged period of bed rest that would lead to unacceptable discomfort or risk of complications, might justify their cost and use.33 A more recent study concluded that the use of VCDs was associated with a reduction in the rate of vascular complications and the postintervention length of hospital stay and proved to be cost saving across all vascular risk profiles. Importantly, this study incorporated cost analysis of complications after VCD placement.50

Conclusion VCDs have contributed to the advancement of endovascular procedures and revolutionized the management of postprocedural hemostasis through various mechanisms. Despite this, VCDs are only used in an estimated 30%50% of catheter-based procedures performed worldwide to obtain hemostasis. This may in part be owing to the complexity of the devices, operator unfamiliarity and learning curve, cost, uncertain efficacy, and more severe complications.2,7 These variables may, however, relate to operator technical skill and experience with these devices.4 Clinicians must have a broad understanding of the indications, potential complications, and troubleshooting of the available VCDs to make an informed decision on which device is appropriate to use based on the clinical situation.6,29 However, given the increasing push for outpatient procedures and shift toward percutaneous large-bore access instead of surgical cut down for larger devices, the VCD market will only continue to grow. In the future, more randomized studies comparing the latest generation of closure devices with each other is needed as current evidence in this area is lacking.8 Additionally needed is further evaluation of VCDs in higher risk patients and procedures, as published studies generally do not include these patients.7 We feel the routine use of VCDs has improved patient care in our practice. In our opinion, it is essential for an operator to be well versed with the selection and use of VCDs. For example, the adoption of the “preclose” technique (with the concurrent progressive miniaturization of endoprostheses) has dramatically changed the way we approach endovascular aneurysm repair. With continued industry interest in this space, it is likely these devices will only continue to improve and become even more valuable.28

References 1. Ivar Seldinger S: Catheter replacement of the needle in percutaneous arteriography: A new technique. Acta Radiol 49:47-52, 2008. http://dx.doi.org/10.1080/02841850802133386 2. Caputo RP: Currently approved vascular closure devices. Card Interv Today:70-76, 2012

Vascular closure devices 3. Bechara CF, Annambhotla S, Lin PH: Access site management with vascular closure devices for percutaneous transarterial procedures. J Vasc Surg 52:1682-1696, 2010. http://dx.doi.org/10.1016/j.jvs. 2010.04.079 4. Schwartz BG, Burstein S, Economides C, et al: Review of vascular closure devices. J Invasive Cardiol 22:599-607, 2010 5. Tavris DR, Wang Y, Jacobs S, et al: Bleeding and vascular complications at the femoral access site following percutaneous coronary intervention (PCI): An evaluation of hemostasis strategies. J Invasive Cardiol 24:328-334, 2012 6. Barbetta I, van den Berg J: Access and hemostasis: femoral and popliteal approaches and closure devices—Why, what, when, and how? Semin Interv Radiol 31:353-360, 2014. http://dx.doi.org/10. 1055/s-0034-1393972 7. Hon LQ, Ganeshan A, Thomas SM, et al: An overview of vascular closure devices: What every radiologist should know. Eur J Radiol 73:181-190, 2010. http://dx.doi.org/10.1016/j.ejrad.2008.09.023 8. Sheth RA, Walker TG, Saad WE, et al: Quality improvement guidelines for vascular access and closure device use. J Vasc Interv Radiol 25:73-84, 2014. http://dx.doi.org/10.1016/j.jvir.2013.08.011 9. Ward TJ, Weintraub JL: Vascular closure device update. Endovasc Today:54-60, 2015 10. Krajcer Z: The preclose technique for AAA repair. Endovasc Today:46-54, 2011 11. Nelson PR, Kracjer Z, Kansal N, et al: A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg 59:1181-1193, 2014. http://dx.doi.org/10.1016/j. jvs.2013.10.101 12. Rijkee M, Statius van Eps R, Wever J, et al: Predictors of failure of closure in percutaneous EVAR using the Prostar XL percutaneous vascular surgery device. Eur J Vasc Endovasc Surg 49:45-49, 2015. http://dx.doi.org/10.1016/j.ejvs.2014.12.005 13. Sarin SN, Shah RK, Chun A, et al: Use of the 8-F Angio-Seal vascular closure device in large-caliber arteriotomies. J Endovasc Ther 19:497-500, 2012 14. Buyer’s guide—closure devices. Endovascular Today, 2015. http:// evtoday.com/buyers-guide/2015/chart.asp?id=closure_devices. 15. Bernat I, Bertrand OF, Rokyta R, et al: Efficacy and safety of transient ulnar artery compression to recanalize acute radial artery occlusion after transradial catheterization. Am J Cardiol 107:1698-1701, 2011. http://dx.doi.org/10.1016/j.amjcard.2011.01.056 16. Biancari F, D’Andrea V, Marco CD, et al: Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J 159:518-531, 2010. http://dx. doi.org/10.1016/j.ahj.2009.12.027 17. Kara K, Kahlert P, Mahabadi AA, et al: Comparison of collagen-based vascular closure devices in patients with vs. without severe peripheral artery disease. J Endovasc Ther 21:79-84, 2014 18. Sohail MR, Khan AH, Holmes DR Jr, et al: Infectious complications of percutaneous vascular closure devices. Mayo Clin Proc 80: 1011-1015, 2005 19. Rao S, Kaul P, Stouffer GA: Successful aspiration of mynx vascular closure device sealant that embolized to the popliteal artery. J Invasive Cardiol 25:E172-E174, 2013 20. Haas PC, Krajcer Z, Diethrich Edward B: Closure of large percutaneous access sites using the Prostar XL percutaneous vascular surgery device. J Endovasc Surg 168-170, 1999 21. Larsen EN, Hansen CB, Thayssen P, et al: Immediate mobilization after coronary angiography or percutaneous coronary intervention following hemostasis with the AngioSeal vascular closure device (the MOBS study). Eur J Cardiovasc Nurs 13:466-472, 2014. http://dx.doi. org/10.1177/1474515113516702 22. Boschewitz JM, Pieper CC, Andersson M, et al: Efficacy and time-tohemostasis of antegrade femoral access closure using the exoseal vascular closure device: A retrospective single-center study. Eur J Vasc Endovasc Surg 48:585-591, 2014. http://dx.doi.org/10.1016/ j.ejvs.2014.08.006 23. Gutzeit A, van Schie B, Schoch E, et al: Feasibility and safety of vascular closure devices in an antegrade approach to either the

111

24.

25.

26.

27.

28.

29.

30.

31.

32.

33.

34.

35.

36.

37.

38.

39.

40.

41.

common femoral artery or the superficial femoral artery. Cardiovasc Intervent Radiol 35:1036-1040, 2012. http://dx.doi.org/10.1007/s0 0270-012-0454-5 Schulz-Schüpke S, Helde S, Gewalt S, et al: Comparison of vascular closure devices vs manual compression after femoral artery puncture: The ISAR-CLOSURE randomized clinical trial. J Am Med Assoc 312:1981, 2014. http://dx.doi.org/10.1001/jama.2014.15305 Kara K, Mahabadi A, Rothe H, et al: Safety and effectiveness of a novel vascular closure device: A prospective study of the ExoSeal compared to the Angio-Seal and ProGlide. J Endovasc Ther 21: 822-828, 2014 Martin JL, Pratsos A, Magargee E, et al: Randomized trial comparing compression perclose Proglide and Angio-Seal VIP for arterial closure following percutaneous coronary intervention: The CAP trial. Catheter Cardiovasc Interv 71:1-5, 2008 Choo HJ, Jeong HW, Park JY, et al: Ultrasonographic features of vascular closure devices: Initial and 6-month follow-up results. Ultrasonography 33:283-290, 2014. http://dx.doi.org/10.14366/ usg.14023 Nikolsky E, Mehran R, Halkin A, et al: Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures. J Am Coll Cardiol 44: 1200-1209, 2004. http://dx.doi.org/10.1016/j.jacc.2004.06.048 Georg Y, Thaveau F, Lejay A, et al: Arterial thrombosis after using Angio-Seal. Ann Vasc Surg 25:1078-1093, 2011. http://dx.doi.org/ 10.1016/j.avsg.2010.11.021 Wille J, Albert Vos J, Overtoom TT, et al: Acute leg ischemia: The dark side of a percutaneous femoral artery closure device. Ann Vasc Surg 20:278-281, 2006 Rafeh NA, Saiful FB, Khoueiry G, et al: Successful endovascular extraction of newer generation Angio-Seal collagen plug and anchor after acute embolization. Vascular 22:214-217, 2014. http://dx.doi. org/10.1177/1708538113481028 Bangalore S, Arora N, Resnic FS: Vascular closure device failure: Frequency and implications: A propensity-matched analysis. Circ Cardiovasc Interv 2:549-556, 2009. http://dx.doi.org/10.1161/CIR CINTERVENTIONS.109.877407 Dauerman HL, Applegate RJ, Cohen DJ: Vascular closure devices. J Am Coll Cardiol 50:1617-1626, 2007. http://dx.doi.org/10.1016/j. jacc.2007.07.028 Chevalier B, Lancelin B, Koning R, et al: Effect of a closure device on complication rates in high-local-risk patients: Results of a randomized multicenter trial. Catheter Cardiovasc Interv 58:285-291, 2003. http://dx.doi.org/10.1002/ccd.10431 Marso SP, Amin AP, House JA, et al: Association Between Use of Bleeding Avoidance Strategies and Risk of Periprocedural Bleeding Among Patients Undergoing Percutaneous Coronary Intervention. J Am Med Assoc 303:2156-2164, 2012 Applegate RJ, Grabarczyk MA, Little WC, et al: Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor inhibitors during percutaneous revascularization. J Am Coll Cardiol 40:78-83, 2002 Kolluri R, Fowler B, Nandish S: Vascular access complications: Diagnosis and management. Curr Treat Options Cardiovasc Med 15:173-187, 2013. http://dx.doi.org/10.1007/s11936-0130227-8 Seto AH, Abu-Fadel MS, Sparling J, et al: Real-time ultrasound guidance facilitates femoral arterial access and reduces vascular complications—FAUST (femoral arterial access with ultrasound trial). JACC Cardiovasc Interv 3:751-758, 2010 Lucatelli P, Cannavale A, Cirelli C, et al: Use of ultrasound in the insertion of a vascular closure device: A comparative retrospective study with the standard blind technique. Radiol Med (Torino) 120:283-288, 2015. http://dx.doi.org/10.1007/s11547-014-0439-3 Bose R, Schussler JM: Use of Angio-Seal closure device when the arteriotomy is above or below the common femoral artery. Clin Cardiol 34:700-702, 2011. http://dx.doi.org/10.1002/clc.20961 Lupattelli T, Clerissi J, Clerici G, et al: The efficacy and safety of closure of brachial access using the AngioSeal closure device: Experience with 161 interventions in diabetic patients with critical

V.P. Krishnasamy et al

112

42.

43.

44.

45.

46.

limb ischemia. J Vasc Surg 47:782-788, 2008. http://dx.doi.org/ 10.1016/j.jvs.2007.11.050 Bilecen D, Bongartz G, Ostheim-Dzerowycz W: Off-label use of AngioSealTM vascular closure device for brachial artery puncture closure— deployment modification and initial results after transbrachial PTA. Eur J Vasc Endovasc Surg 31:431-433, 2006. http://dx.doi.org/10.1016/j. ejvs.2005.05.030 Cohen JE, Moshe Gomori J, Anner H, et al: Inadvertent subclavian artery cannulation treated by percutaneous closure. J Clin Neurosci 21:1973-1975, 2014. http://dx.doi.org/10.1016/j.jocn.2014.04.009 Petrov I, Dimitrov C: Closing of a right ventricle perforation with a vascular closure device. Catheter Cardiovasc Interv. http://dx.doi. org/10.1002/ccd.21997 Pieper CC, Wilhelm KE, Schild HH, et al: Feasibility of vascular access closure in arteries other than the common femoral artery using the exoseal vascular closure device. Cardiovasc Intervent Radiol 37:1352-1357, 2014. http://dx.doi.org/10.1007/s00270-0140853-x Van Rompaey J, Bowers G, Radhakrishnan J, et al: Endoscopic repair of an injured internal carotid artery utilizing femoral endovascular

47.

48.

49.

50.

closure devices: Carotid repair with endovascular devices. Laryngoscope 124:1318-1324, 2014. http://dx.doi.org/10.1002/lary.24403 Cirillo P, Petrillo G, D’Ascoli GL, et al: Successful use of the Cardiva BoomerangTM vascular closure device to close a brachial artery puncture site after emergency PTCA. Heart Vessels 25:565-568, 2010. http://dx.doi.org/10.1007/s00380-010-0003-6 Mirza AKH, Steerman SN, Ahanchi SS, et al: Analysis of vascular closure devices after transbrachial artery access. Vasc Endovascular Surg 48:466-469, 2014. http://dx.doi.org/10.1177/15385744 14551576 Bos JJ, Hunink MGM, Mali WPTM: Use of a collagen hemostatic closure device to achieve hemostasis after arterial puncture: A costeffectiveness analysis. J Vasc Interv Radiol 7:479–486,1996. Kerré S, Kustermans L, Vandendriessche T, et al: Cost-effectiveness of contemporary vascular closure devices for the prevention of vascular complications after percutaneous coronary interventions in an all-comers PCI population. EuroIntervention 10:191-197, 2014. http://dx.doi.org/10.4244/EIJV10I2A32