Closure Devices



Closure Devices


John F. Angle, Auh Whan Park and Alan H. Matsumoto



Clinical Relevance


Manual compression (MC) after femoral arterial access removal has a high success rate with a relatively short compression time (5-15 minutes). The biggest drawback to MC is that 1 to 6 hours of postprocedure bedrest are required. The ideal duration of bedrest is unknown, but recent literature suggests that ambulation at 4 hours after MC for an 8F sheath and 3 hours after a 5F catheter placement may be safe.1,2 In patients with orthopnea, musculoskeletal disorders, or other conditions that make lying supine difficult or painful, it can be challenging or nearly impossible to manage the puncture site with MC. Anticoagulation and antiplatelet drugs can prolong the time to hemostasis and increase the risk of delayed complications with MC. Hematomas are the most common complication of MC, but most of these are self-limited.3 Other potential complications associated with MC include retroperitoneal hemorrhage, arteriovenous fistula (AVF), pseudoaneurysm, vessel thrombosis, and vasovagal reaction. Roughly 2% of MC leads to a major complication.47 The origins of the current interest in vascular closure devices is unclear but likely was the result of an effort to decrease the need for MC, speed the time to ambulation, and potentially reduce hematoma rates. Since the first edition of this chapter, their use has skyrocketed: in 2007 approximately 30% of the 10 million endovascular procedures performed in the United States employed a closure device.8



Indications


The most common indication for use of a closure device in our practice is a patient’s inability to comply with the bedrest required after MC. Examples include patients with chronic low back pain, severe chronic obstructive pulmonary disease, or nausea and vomiting. Prior to the availability of these closure devices, many of these patients would be denied angiography, require a femoral cutdown, or would be electively intubated for respiratory support or pain control. More clinically important is that these devices allow patients to have a procedure while on anticoagulation (thereby avoiding reversal to remove the femoral introducer) and allow patients to be started on anticoagulation or antiplatelet agents prior to completion of the procedure. This is associated with better outcomes, at least for coronary artery interventions. Closure devices are increasingly being used during aortic endograft or aortic valve prosthesis placement. In this application, very large caliber (up to 24F) puncture sites are preclosed using a suture-based device that allows the large arteriotomy to be drawn closed after the introducer sheath is removed.9,10


MC is difficult beyond a 10F sheath size but is also more challenging with larger (>7F) sheaths. Use of larger sheaths during interventional procedures is now common (e.g., covered stent placements for aneurysms, bare metal aortic stents for occlusive disease, balloon pumps for ventricular assistance, and the introducers required for endovascular treatment of patent ductus arteriosus and other large vessel embolizations). Not all the devices are approved for 8F sheaths, but there are studies demonstrating that some of these devices are reliable for closure of 8F sheaths.10


Closure devices are also an important tool for very large patients, where groin complications with MC or cutdown are more common. Careful procedure planning is important in this setting because many of the devices have a limited working length (skin to artery). Lastly, there are two unusual clinical applications of these devices: (1) to close an inadvertent subclavian artery puncture and (2) to close a needle track, such as after percutaneous biopsy in a coagulopathic patient.


There are other less well-defined reasons for using vascular access closure devices. One is that these devices shorten the time to ambulation and discharge, but the procedure performed may dictate prolonged bedrest or in-hospital observation. Secondly, some proponents of closure devices use them in every case because they appear to reduce bleeding complications, but the risks and costs of these devices must be assessed before widespread application can be recommended. Lastly, their use in patients with irreversible coagulation disorders (e.g., liver failure) remains controversial. Although these devices are highly reliable, even in a coagulopathic patient, there may be no backup plan (MC or cutdown) if the device fails.



Contraindications


In the Equipment section, we will divide our discussion of aids to closure into hemostasis aids (Table e28-1), and invasive devices (Table e28-2). Aside from allergy, there are few contraindications to the noninvasive devices. Several contraindications are shared by the invasive devices: brachial artery closure due to possible nerve injury, a too-small vessel (<5 mm for most of the invasive devices), arteriotomy too large for chosen device, severely diseased vessels, systemic infection or infection in the region of the arteriotomy, an introducer sheath in place for a prolonged time (e.g., second day after a thrombolysis procedure), which may increase risk of infection, puncture into a bypass graft (relative contraindication), scarred groin that makes many of these devices more difficult to advance and deploy, and a known allergy to device components (bovine collagen, etc.). If repeat arterial access in the same groin is anticipated, devices that deposit a collagen plug outside the vessel are relatively contraindicated because of the induration they create over the femoral artery for several weeks (Fig. e28-1). Similarly, suture-based devices may create a fibrous cap that can complicate subsequent femoral cutdown for stent-graft placement.69 The use in antegrade access may also be a relative contraindication, although there are reports using the Perclose device,70 and there is no literature to suggest it imposes additional risks.



TABLE e28-1


Commonly Available Aids to Hemostasis






































































































































Product Name Manufacturer Mechanism Clinical References
Compression Aids
CompressAR Advanced Vascular Dynamics, Portland, Ore. Clamp 11
RadAR Advanced Vascular Dynamics Band for radial artery puncture compression 12
Safeguard Maquet Getinge Group, Wayne, N.J. Pneumatic compression device 13, 14
RadStat Merit Medical, South Jordan, Utah Brace and straps for radial artery compression  
FemoStop HD and FemoStop Plus St. Jude Medical, St. Paul, Minn. Pneumatic compression device 11, 1517
RadiStop Plus St. Jude Medical Pneumatic compression device for radial arteries 18, 19
TR Band Terumo Medical, Somerset, N.J. Pneumatic compression device for radial arteries 12, 19
QuicKlamp TZ Medical, Portland, Ore. Clamp (discs available with and without Neptune hemostasis patch 20
Comfort Band
Neptune Comfort Band
TZ Medical Band around arm for hemostasis in brachial and radial puncture (with or without Neptune patch)  
D-stat Rad-Band Vascular Solutions, Minneapolis, Minn. Band that uses D-stat pad for radial access compression 21
Topical Hemostasis Agents
Chito-seal Abbott Vascular Devices, Redwood City, Calif. Chitosan 2224
Celox Vascular Advanced Vascular Dynamics Chitosan  
HemCon Patch HemCon Medical Technologies, Portland, Ore. Chitosan 25
V+Pad Angiotech Pharmaceuticals, Vancouver, BC d-glucosamine  
Excelarrest XT Hemostasis LLC, St. Paul, Minn. Chitosan  
SyvekExcel
SyvekNT
Marine Polymer Technologies, Danvers, Mass. Cellulosic polymer and poly-n-acetyl glucosamine 22, 26, 27
MPatch Medafor Inc., Minneapolis, Minn. Microporous polysaccharide hemospheres  
SafeSeal Patch Medrad Interventional/Possis, Warrendale, Pa. Microporous polysaccharide particles 28
FemoStop HD Radi Medical Systems, Reading, Mass. Microdispersed calcium salt of oxidized cellulose 29
Clo-sur Plus P.A.D. Scion Cardio-Vascular, Miami, Fla. Chitosan 22, 24, 30, 31
Stasys Patch St. Jude Medical Microporous polysaccharide particles 32
Neptune
Neptune Plus
TZ Medical Calcium alginate fiber pad (plus has added calcium and polymer backing) 33
D-stat Dry Silver Vascular Solutions Lyophilized pad with thrombin, sodium carboxymethylcellulose, and calcium chloride (silver added for antimicrobial effect) 27, 34
D-stat Flowable Vascular Solutions Paste with thrombin, calcium chloride, mannitol, and collagen for topical application with a syringe  


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TABLE e28-2


Vascular Closure Devices


















































































Product Name Manufacturer Mechanism Closure Size* Clinical References
Invasive Devices without Foreign Body Deposition  
Axera Arstasis, Redwood City, Calif. Guides arterial puncture with extended track in arterial wall 6F  
Catalyst II
Catalyst III
Cardiva Medical, Sunnyvale, Calif. Umbrella temporarily inserted in artery to promote hemostasis (Catalyst III has protamine sulfate on the shaft) 6F 35, 36
Invasive Devices with Active Closure of Vessel
Perclose AT ProGlide Abbott Vascular Devices, Abbott Park, Ill. Suture 8F 3744
ProStar XL Abbott Vascular Devices Suture 10F 45, 46
StarClose SE Abbott Vascular Devices Nitinol clip 6F 4751
Mynx Access Closure, Mountain View, Calif. Occlusion balloon in femoral artery with injection of polyethylene glycol polymer at puncture site 7F 5255
EXOSEAL Cordis Corp., Bridgewater, N.J. Polyglycolic acid plug deployed at artery entry site 7F 56
FISH Morris Innovative, Bloomington, Ind. Bioabsorbable patch made from porcine small intestine submucosa deployed against arterial entry site 8F 57
Femoseal Radi Medical Systems, Reading, Mass.     58
Angio-Seal Evolution
Angio-Seal STS Plus
Angio-Seal VIP
St. Jude Medical, St. Paul, Minn. Collagen plug with intravascular lactide and glycolide anchor inside vessel 8F 17, 51, 5966
Duett
Duett Pro
Diagnostic Duett Pro
Vascular Solutions, Minneapolis, Minn. Temporary balloon catheter inflated in femoral artery and procoagulant (thrombin and collagen) injected just outside vessel 9F 60, 61, 67, 68


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*Published results or manufacturer recommendation for maximum access size closure.


Can close much larger arteriotomies by delivering sutures prior to dilatation of track.9




Equipment


There are several classes of devices that can aid femoral artery closure (see Tables e28-1 and e28-2). The most mature class of devices is the group of compression devices that includes bedside C clamps and pneumatic compression straps.1121,71 These do little to minimize groin complications or shorten bedrest time, but they do free up the operator and his/her assistants from compression. The second class is the topical agents; all the products in this class are procoagulants applied to the puncture site at the time of the MC. They are generally very safe, but their utility remains unproven because of the lack of appropriate clinical testing.2234 It makes intuitive sense that these devices are most useful when the puncture is superficial, such as with radial artery punctures or dialysis graft access. The third class is invasive devices, but no foreign body is left behind. This class is represented by just two devices, an umbrella temporarily inserted into the artery and pulled back against the arteriotomy to provide temporary hemostasis, and a device that directs the arterial puncture to aid with hemostasis.35,36 The final class of devices are invasive devices, where the arteriotomy is mechanically or pharmacologically closed. This group includes all the devices that instantly seal the arteriotomy, but they are invasive in that they require the operator to deposit either a procoagulant (e.g., piece of bovine collagen) next to the artery or deliver a suture or clip into the arteriotomy.15,17,3768 Each of these devices requires training and careful technique, introducing risks not usually associated with MC.



Technique




Technical Aspects


First and foremost, exceptional sterile technique must be maintained throughout the procedure. Every patient must have a surgical-type skin preparation. Although controversial and not substantiated by experiment, antibiotic prophylaxis may be beneficial in preventing infection as well.72


All the invasive devices benefit from a predeployment angiogram to confirm that the puncture site is adequate. Most of the devices do not work well in a sidewall puncture, so the operator must review the planning angiogram carefully. It may be beneficial to puncture under ultrasound, although there is no study to confirm this step reduces closure failures.

Dec 23, 2015 | Posted by in INTERVENTIONAL RADIOLOGY | Comments Off on Closure Devices
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