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Starclose
Features
The StarClose is a vessel closure device designed to close arterial punctures after endo-vascular procedures.
Design/construction
The device applies a nitinol clip to the adventitial surface of the vessel. The clip is preloaded into the single-use delivery system. This is introduced via a dedicated sheath. The device is licensed for use with 5 & 6fr sheath arteriotomies, although it has successfully been used in 8fr sheath arteriotomies.
In Use
The dedicated 6fr sheath is inserted over a 0.035 guidewire. The wire is then removed. The device locks into the sheath (at this point it is no longer possible to reintroduce a guidewire). A nitinol footplate is deployed intraluminally and withdrawn to locate the intimal wall of the vessel at the puncture site. The sheath is then split as the clip introducer is slid down through the tissue tract onto the adventitial surface of the artery. Finally the clip is applied with the push of a button.
The device can be used for both antegrade and retrograde arterial punctures. The majority of use has been in the CFA, but various other arteries (SFA, brachial artery, common carotid artery) have been closed successfully. The most important requirement is a intraluminal diameter of at least 5mm to allow the footplate to be withdrawn. Care must be taken if angioplasty or stenting has taken place near the puncture site. Various techniques with fluoroscopy or ultrasound can be used to ensure the footplate does not disturb these sites. Immediate repuncture is possible. Hypertension and anticoagulants/clotting disorders do not seem to reduce its efficacy.
Results so far
As a unit we have success rates of >96% for antegrade CFA punctures and >97% for retrograde CFA punctures (over 400 uses). Failure of the device does not preclude use of manual compression. Apparent initial failure with heavy bleeding can normally be stopped by 30 seconds of massage over the clip to help the teeth engage. It would appear that the nitinol clip sometimes needs a little time and help to fully engage. Problems can occur with scarred groins, obese patients (due to a tortuous tissue track) and heavily calcified vessels - I would recommend using ultrasound for the initial puncture to avoid the worst areas of plaque, followed by gentle blunt dissection of the tissue track with arterial forceps before clip deployment.
Comparison with?
The two main alternatives are the AngioSeal and the PerClose. The angioseal leaves an intra-vascular component which can occaionally cause complications. The PerClose is more difficult to use and is not designed for antegrade femoral punctures. The suture can become infected.
Conclusion
The StarClose is at least as effective as any other closure device, and in our hands more so. It is extremely simple to use. Care is needed with obese patients, scarred groins and very calcified vessels.
Dr Rob Williams
Consultant Interventional Radiologist
For images and full review, please visit radRounds Partner Site: WhichInterventionalDevice
http://www.whichradiologydevice.com/product-categories/vascular/clo...
The StarClose is a vessel closure device designed to close arterial punctures after endo-vascular procedures.
Design/construction
The device applies a nitinol clip to the adventitial surface of the vessel. The clip is preloaded into the single-use delivery system. This is introduced via a dedicated sheath. The device is licensed for use with 5 & 6fr sheath arteriotomies, although it has successfully been used in 8fr sheath arteriotomies.
In Use
The dedicated 6fr sheath is inserted over a 0.035 guidewire. The wire is then removed. The device locks into the sheath (at this point it is no longer possible to reintroduce a guidewire). A nitinol footplate is deployed intraluminally and withdrawn to locate the intimal wall of the vessel at the puncture site. The sheath is then split as the clip introducer is slid down through the tissue tract onto the adventitial surface of the artery. Finally the clip is applied with the push of a button.
The device can be used for both antegrade and retrograde arterial punctures. The majority of use has been in the CFA, but various other arteries (SFA, brachial artery, common carotid artery) have been closed successfully. The most important requirement is a intraluminal diameter of at least 5mm to allow the footplate to be withdrawn. Care must be taken if angioplasty or stenting has taken place near the puncture site. Various techniques with fluoroscopy or ultrasound can be used to ensure the footplate does not disturb these sites. Immediate repuncture is possible. Hypertension and anticoagulants/clotting disorders do not seem to reduce its efficacy.
Results so far
As a unit we have success rates of >96% for antegrade CFA punctures and >97% for retrograde CFA punctures (over 400 uses). Failure of the device does not preclude use of manual compression. Apparent initial failure with heavy bleeding can normally be stopped by 30 seconds of massage over the clip to help the teeth engage. It would appear that the nitinol clip sometimes needs a little time and help to fully engage. Problems can occur with scarred groins, obese patients (due to a tortuous tissue track) and heavily calcified vessels - I would recommend using ultrasound for the initial puncture to avoid the worst areas of plaque, followed by gentle blunt dissection of the tissue track with arterial forceps before clip deployment.
Comparison with?
The two main alternatives are the AngioSeal and the PerClose. The angioseal leaves an intra-vascular component which can occaionally cause complications. The PerClose is more difficult to use and is not designed for antegrade femoral punctures. The suture can become infected.
Conclusion
The StarClose is at least as effective as any other closure device, and in our hands more so. It is extremely simple to use. Care is needed with obese patients, scarred groins and very calcified vessels.
Dr Rob Williams
Consultant Interventional Radiologist
For images and full review, please visit radRounds Partner Site: WhichInterventionalDevice
http://www.whichradiologydevice.com/product-categories/vascular/clo...
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